louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01134471: Improvement of Hemostasis Techniques After Median Sternotomy
Official title: Improvement of Hemostasis Techniques After Median Sternotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sternal Dehiscence
Sternal Infection
Sternal Pain
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Ceremed, Inc.
First posted: 2010-06-02
Enrollment: 75
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 2 different hemostatic agents (Bonewax and Ostene)to a control group with regards to bleeding, bone healing, pain and infection in a patient group all undergoing median sternotomy.


Eligibility criteria: Inclusion Criteria:

* men undergoing elective cardiac surgery at the Cardiac surgery department of Aarhus University Hospital, Skejby
* no clopidogrel-treatment
* no osteoporoses
* less than 2 co-morbidities in the form of obesity (BMI\>30), COPD, chronic steroid use, renal failure, immunosuppression and diabetes

Exclusion Criteria:

* profuse sternal bleeding
* serious complications to the surgery fx cerebral infarction
* re-operation due to bleeding

Primary outcomes:
measure: Bone healing in sternum
timeFrame: 6 months after surgery
measure: Questionnaire regarding physical and emotional well being
timeFrame: 6 months after surgery
measure: Pain-score (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Blood product consumption
timeFrame: 6 months
measure: Mediastinitis
timeFrame: 6 months
measure: superficial infection
timeFrame: 6 months
measure: Bleeding through the chest tube
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby, Dept. of Cardiothoracic surgery
Study officials:
affiliation: Dept. of Cardiothoracic surgery, Aarhus University Hospital, Skejby
name: Rikke Vestergaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02021071: Virtual Path Planning for Image-guided Needle Interventions
Official title: Evaluation of Adding Virtual Path Planning to the Philips FD20 XperGuide to Reduce Radiation Dose During Image-guided Needle Interventional Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Bone Diseases
Muscular Diseases
Spinal Diseases
Vascular Diseases
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 24
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 of all ages. Patient weight is limited to the specification of the patient table.

Brief summary: Philips Healthcare has added a virtual path planner to the current commercially available XperGuide software platform and that has the potential to significantly reduce dose during image-guided needle interventions.

Detailed description: The investigational device is used for image guidance by virtually planned path and X-ray data.

Eligibility criteria: Inclusion Criteria:

* Patients at any age who are referred for a clinically indicated XperGuide interventional procedure.
* The informed consent has been signed by the participant, parent or legal guardian as appropriate.

Exclusion Criteria:

-Pregnant patients.

Primary outcomes:
measure: System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness
timeFrame: Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest
Secondary outcomes:
measure: Fluoroscopy Time
timeFrame: Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: John Racadio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06002971: CONNEQT Pulse Validation Study
Official title: Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Pre-Eclampsia
Gestational Hypertension
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
Collaborators: name: AtCor Medical, Inc.
First posted: 2023-08-21
Enrollment: 45
Sex: FEMALE
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: Pregnant patients 18 years or older and beyond the first trimester, as defined as 12 completed weeks of gestation.

Brief summary: The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.

Detailed description: Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.

Eligibility criteria: All Groups:

1. Able to provide informed consent
2. Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
3. 18 years of age, or older

Normotensive:

1. Systolic blood pressure \<140 mmHg (18,66 kPa) and diastolic blood pressure \<90 mmHg (12 kPa)

Hypertensive:

1. Without proteinuria \>300 mg in 24 h; and
2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)

Pre-Eclampsia:

1. With proteinuria \>300 mg in 24 h; and
2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)

Primary outcomes:
measure: Comparison of reference auscultatory blood pressure readings to CONNEQT Pulse blood pressure readings.
timeFrame: Up to 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel East
state: Ohio
Study officials:
References:
Clinical trial NCT06429371: Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain
Official title: Biopsychosocial Contributors to Irritability in Individuals With Shoulder Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Pain
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2024-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with shoulder pain

Brief summary: Irritability was defined by Geoffrey Maitland as the vigor of activity to provoke symptoms, the severity of symptoms, and time for symptoms to subside. Irritability is deeply embedded in the physical therapy clinical decision-making process. However, the mechanisms contributing to irritability are unknown. Therefore, the purpose of this study is to characterize pain sensitivity and pain-related psychological factors by irritability level in individuals with shoulder pain.


Eligibility criteria: Inclusion Criteria:

* shoulder pain symptom intensity rated as 3/10 or higher in the past 24 hours
* attending physical therapy for shoulder pain

Exclusion Criteria:

* non-English speaking
* systemic medical conditions that affect sensation, such as uncontrolled diabetes
* history of shoulder surgery or fracture within the past 6 months
* history of a chronic pain condition, such as fibromyalgia
* blood clotting disorder, such as hemophilia
* contraindication to the application of ice (blood pressure \> 140/90 mmHg, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory compromise)
* currently pregnant

Primary outcomes:
measure: Heat pain Threshold
timeFrame: Day 1
measure: Cold Pain Threshold
timeFrame: Day 1
measure: Pressure Pain Threshold
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Abigail Anderson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04999371: Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption
Official title: Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption: Study Protocol for a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The existing alcohol intervention studies are mainly conducted in developed countries, few studies have focused on alcohol consumption among ethnic minority migrant people in developing countries. To address this gap, the investigators aim to evaluate the effects of a brief intervention combined with a small financial incentive on alcohol consumption and health outcomes among the migrated population in Liangshan Prefecture. This study was conducted in Liangshan Prefecture for two reasons: first, Liangshan is a region located in the southwestern of Sichuan province and is populated by Yi minority, and the average income in Liangshan is just about two-thirds of the national average income. Second, a study found that the drinking rate of the Yi minority (47.9%) is higher than that of other regions in China.

The aim of this paper is to provide an overview of alcohol consumption among the ethnic populations in China and to test the feasibility and efficacy of small financial incentives with brief advice intervention targeting the reduction of harmful drinking behaviors among poor people.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Age\<18 and Age\>65
* Scores of AUDIT\<8
* Do not speak mandarin
* Less than three-months residence at Xichang
* Income not calculated by hour wage or piece-rate wage
* Those who have previous abstinence experience, epilepsy, liver disease, and is using sedative drugs

Primary outcomes:
measure: Self-reported drinking quantity
timeFrame: 3 months
measure: Self-reported binge drinking frequency
timeFrame: 3 months
measure: Self-reported drinking frequency.
timeFrame: 3 months
measure: Self-reported drinking intensity.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University China Center for Health Economic Research
state: Beijing
Study officials:
References:
citation: Li S, Wu Z, Liu S, Sun Y, Liu GG. Effect of a brief intervention with small financial incentives on alcohol consumption in China: study protocol for a randomised controlled trial. BMJ Open. 2022 May 18;12(5):e056550. doi: 10.1136/bmjopen-2021-056550.
Clinical trial NCT05956171: The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
Official title: The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frozen Shoulder
Shoulder Capsulitis
Shoulder Pain
Keywords: hydrodilatation
hydrodistension
ultrasound
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are:

* Is hydrodilatation better than intraarticular corticosteroid injection?
* Is there any prognostic factors that will help clinicians guide their decision making when choosing between these two treatments?

Participans will receive an injection(cortcosteroid and local anesthetics alone or with hydrodilatation-corticosteroid and local anesthetics plus sterile saline solution) and then they will follow a rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Patients who fulfill the diagnostic criteria for frozen shoulder
* Agree to participate in the study
* Having the opportunity to follow up for at least 3 months

Exclusion Criteria:

* Refusing to participate in the study
* History of shoulder injection in the last 3 months
* Having diabetes mellitus
* Presence of comorbidities that contraindicate injection therapy, such as bleeding diathesis
* Known history of allergy or anaphylaxis to drugs used in treatment

Primary outcomes:
measure: Change from baseline pain score on Visual Analog Scale(VAS)
timeFrame: Baseline, 1 week, 1 month, 3 months
measure: Change in Shoulder Pain and Disability Index(SPADI) scores
timeFrame: Baseline, 1 month, 3 months
Secondary outcomes:
measure: Change in Range of Movement(ROM)
timeFrame: Baseline, 1 week, 1 month, 3 months
measure: Ultrasound Parameters
timeFrame: Baseline, 1 month, 3 months
measure: Proprioception(Active position sense- joint position error)
timeFrame: Baseline, 3 months
measure: Shoulder Strength
timeFrame: Baseline, 3 months
measure: Changes in Depression Score
timeFrame: Baseline, 1 months, 3 months
measure: Changes in Life Quality Score
timeFrame: Baseline, 1 month, 3 months
measure: Treatment Satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03678571: Oocyte Vitrification Aided With Latrunculin A
Official title: Latrunculin A for Oocyte Vitrification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
First posted: 2018-09-19
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Using cytoskeleton Stabilizer the Latrunculin A would improve the outcome of oocyte vitrification


Eligibility criteria: Inclusion Criteria:

* indication for oocyte cryopreservation

Exclusion Criteria:

-

Primary outcomes:
measure: survival after thawing
timeFrame: 6 days after thawing
Secondary outcomes:
measure: fertilization rate
timeFrame: 6 days of culture
measure: Rates of blastocyst formation and quality
timeFrame: 6 days of culture
measure: embryo utilization rate
timeFrame: 6 days of culture
measure: clinical pregnancy rate
timeFrame: three months
measure: ongoing pregnancy rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
Study officials:
References:
Clinical trial NCT03873571: Adherence of Iron Succinylate Therapy in Pregnancy
Official title: An Observational Study to Examine the Iron Treatment in Pregnant Women With Anaemia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnancy Related
Pregnancy Anemia
Iron Deficiency Anemia
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with anaemia treated with iron succinylate

Brief summary: According to the World Health Organization (WHO), anemia is the most common disease, affecting \>1.5 billion people worldwide. Furthermore, iron deficiency anemia (IDA) accounts for 50% of cases of anemia. IDA is common during pregnancy and the postpartum period, and can lead to serious maternal and fetal complications. Measurement of serum ferritin has the highest sensitivity and specificity for diagnosis of IDA unless there is a concurrent inflammatory condition. The lower threshold value for hemoglobin (Hb) in pregnant women is \<11 g/dL during the 1st and 3rd trimesters, and \<10.5 g/dL during the 2nd trimester. In postpartum period a Hb concentration \<10 g/dL indicates clinically significant anemia. Oral iron therapy is given as the first-line treatment for IDA.

Detailed description: Measurement of serum ferritin has the highest sensitivity and specificity for diagnosis of IDA unless there is a concurrent inflammatory condition. The lower threshold value for hemoglobin (Hb) in pregnant women is \<11 g/dL during the 1st and 3rd trimesters, and \<10.5 g/dL during the 2nd trimester. In postpartum period a Hb concentration \<10 g/dL indicates clinically significant anemia.

Oral iron therapy is given as the first-line treatment for IDA. There are several direct and indirect methods to assess adherence to medications, each method has advantages and limits. Many studies have shown that pill counting is more accurate than self-reported adherence.We will investigate the adherence to iron supplementation in pregnant women by using a self-reported adherence questionnaire named SMAQ (Simplified Medication Adherence Questionnaire)

Simplified Medication Adherence Questionnaire (SMAQ) Knobel H; Juega J; Carmona A; Kindelan JM; Ruiz I; Gonzalez J; Collazos J; Casado JL; Alonso J; Ocampo A SMAQ is used to assess non-adherent patients. The six-item SMAQ has been developed to assess adherence in HIV-infected patients, and may be applied in most clinical settings.

Eligibility criteria: Inclusion Criteria:

* Pregnancy
* Anaemia
* Iron treatment before 3 months of pregnancy
* Informed Consent
* Compliant with study procedures

Exclusion Criteria:

* Iron treatment after 3 months of pregnancy

Primary outcomes:
measure: Medication Adherence
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Iaso Hospital
Study officials:
References:
Clinical trial NCT02699671: IRIS-BVS AMI Registry
Official title: Evaluation of Effectiveness and Safety of Bioresorbable Vascular Scaffold in Acute Myocardial Infarction; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Artery Disease
Keywords: Bioresorbable Vascular Scaffold
Routine Clinical Practice
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Artery Disease
drug eluting stent
acute myocardial infarction
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-03-04
Enrollment: 69
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute myocardial infarction patients with Bioresorbable Vascular Scaffold

Brief summary: The purpose of this study is to evaluate the relative effectiveness and safety of Bioresorbable Vascular Scaffold in acute myocardial infarction compared to other (drug eluting stents) DES.


Eligibility criteria: Inclusion Criteria:

* Age 19 and more
* Acute myocardial infarction
* Intervention with Bioresorbable Vascular Scaffold
* Agreed with written informed consent form

Exclusion Criteria:

* Bypass graft surgery (CABG) recommended
* Lesion with previous bypass graft surgery (CABG)
* Severe calcification and/or severe tortuosity
* Contraindication to antiplatelet agent or Inability to take dual antiplatelet therapy within 1 year
* Life expectancy of 1year and under
* Subjects scheduled to receive cardiac surgery or serious non-cardiac surgery
* Cardiac shock

Primary outcomes:
measure: Composite event
timeFrame: 1year
Secondary outcomes:
measure: All death
timeFrame: 5years
measure: Cardiac death
timeFrame: 5years
measure: Myocardial infarction
timeFrame: 5years
measure: Composite event of death or myocardial infarction
timeFrame: 5years
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5years
measure: Target Vessel revascularization
timeFrame: 5years
measure: Target Lesion revascularization
timeFrame: 5years
measure: Stent thrombosis
timeFrame: 5years
measure: Stroke
timeFrame: 5years
measure: Procedural success
timeFrame: 3days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01889771: A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
Official title: A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 1495
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 study is to understand whether distribution of two different supplies of nicotine patches through a telephone quitline has an effect on quit rates. The two different supplies are four vs. eight (in two separate four-week mailings) weeks of nicotine patches. The hypothesis is that eight weeks will be slightly more efficacious but four weeks will be more cost-effective.


Eligibility criteria: Inclusion Criteria:

* All callers to the Colorado QuitLine who report currently smoking 16-20 cigarettes
* who enroll in QuitLine services
* who do not require physician approval to obtain nicotine replacement therapy
* who are willing to receive the nicotine patch

Exclusion Criteria:

* Contraindications to receiving the nicotine patch through the QuitLine without physician approval include: history of hearth disease (heart attack, chest pain, or coronary artery disease), high blood pressure, pregnancy, skin conditions such as difficult to manage psoriasis or eczema, or history of a local reaction to the nicotine patch
* those who do not complete the call in English

Primary outcomes:
measure: 7-day smoking abstinence
timeFrame: 7 days
measure: 6-month smoking abstinence
timeFrame: 6 months
measure: cost-effectiveness
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Emily K Burns
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burns EK, Hood NE, Goforth E, Levinson AH. Randomised trial of two nicotine patch protocols distributed through a state quitline. Tob Control. 2016 Mar;25(2):218-23. doi: 10.1136/tobaccocontrol-2014-051843. Epub 2014 Nov 21.