louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00286884: Heart Rate Variability in White Coat Hypertension and Essential Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
White Coat Hypertension
Healthy
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-02-06
Enrollment: 65
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The aim of the study is to investigate heart rate variability in patients with white coat hypertension and patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* age 30-70 years
* office BP \>150/95 mmHg and 24-h ambulatory BP =/\>135/85 mmHg
* office BP \>150/95 mmHg and 24-h ambulatory BP \<135/85 mmHg
* office BP \<150/95 mmHg and 24-h ambulatory BP \<135/85 mmHg

Exclusion Criteria:

* Clinical signs of disease of the heart, lungs, liver, kidneys, brain or endocrine organs
* neoplastic disease
* daily use of medicine
* alcohol abuse
* abnormal laboratory screening including blood-hemoglobin, blood-white cell count, plasma-creatinine, plasma-alanine-amino-transaminases, plasma-albumin, plasma-sodium, plasma-potassium, urinary glucose, urinary albumin; electrocardiogram
* pregnancy
* unwillingness to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
Study officials:
affiliation: Regional Hospital Holstebro
name: Line B Madsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Hospital Holstebro
name: Erling B Pedersen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04062084: Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
Official title: Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subluxation of Lens
Surgical Instruments，Cataract
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of lens subluxation.
* Patients need to undergo lens subluxation surgery

Exclusion Criteria:

* Active intraocular inflammation
* The intraocular pressure (IOP) was higher than 25 mmHg
* The endothelial cell count (ECC) was less than 1,200 cells/mm2
* Combined with other eye diseases
* Combined with other serious systemic diseases

Primary outcomes:
measure: Surgical success rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Successful implantation rate of intraocular lens
timeFrame: through study completion, an average of 1 year
measure: Visual function
timeFrame: 1day postoperation，1 week，1 month， 3month postoperation
measure: intraocular pressure
timeFrame: 1 day, 1 week, 1 month, and 3 month postoperation
measure: endothelial cell count
timeFrame: 1 week, 1 month, and 3 month postoperation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05605184: Anonymous Survey of Breast Cancer Patients Concerning Their Use of Medical Apps
Official title: Eine Anonyme Umfrage Bei Brustkrebspatient*innen Zum Thema Nutzerverhalten Von Gesundheits-Apps
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Health Care Survey
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 200
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: Breast cancer patients at TUM Department of Gynecology and Obstetrics

Brief summary: Breast cancer patients complete questionnaires concerning their use of medical apps.

Detailed description: Breast cancer patients of the department of gynecology at Technical University of Munich and Berlin Charité complete quesionnaires during routine appointments. Intention of the survey is to evaluate the importance of medical apps and the special needs of breast cancer patients. Moreover approaches to improve health care of breast cancer patients are expected to be developed.

Eligibility criteria: Inclusion Criteria:

* breast cancer patients
* patients who are legally competent and able to understand and follow instructions of the study staff

Exclusion Criteria:

* none

Primary outcomes:
measure: The attitudes of breast cancer patients regarding the use of medical apps: a survey-based study
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Frauenklinik, Technische Universität München
Study officials:
affiliation: Technical University of Munich
name: Heike Jansen, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01264484: ADVANTAGE® Prosthetic Heart Valve Long-term Follow-up Trial
Official title: ADVANTAGE Prosthetic Heart Valve Long Term Follow Up
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Valve Stenosis
Keywords: Advantage
Non-interventional
Post market release study
Germany
Treated with Advantage prosthetic heart valve
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population for this study includes all patients who were already enrolled in the ADVANTAGE Prosthetic Heart Valve Study in two German Centers and are still available for follow-up

Brief summary: The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve.

Detailed description: The objective of this study is to assess long term safety and durability of the Advantage prosthetic heart valve in patients who were already implanted with this device.

Eligibility criteria: Inclusion Criteria:

* Participated in the ADVANTAGE Prosthetic Heart Valve Study in Herz- und Diabeteszentrum (Bad Oeynhausen) or Deutsches Herzzentrum (Munich)
* Signed and dated patient data release form
* Available for follow-up

Exclusion Criteria:

* High probability of non-adherence to physician's follow-up requirements

Primary outcomes:
measure: Long-term safety and durability of the valve
timeFrame: 5 year follw-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabetescentrum Bad Oeynhausen
city: Munchen
country: Germany
facility: Deutsches Herzzentrum Munchen
Study officials:
affiliation: Deutsches Herzzentrum München
name: Rudiger Lange, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herzzentrum Nordrhein-Westfalen, Bad Oeynhausen
name: Jan Gummert, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00310284: A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
Official title: Computerized Self-Help Treatment for Primary Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Sleep
Lead sponsor: PICS, Inc.
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.

Detailed description: Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life. Most people with chronic primary insomnia go untreated, because of a desire to avoid medication or lack of access to quality non-drug treatments. Therefore, an affordable, easy to use, and effective computer to help assess and treat insomnia symptoms could bring treatment to this population.

Comparison: We are comparing a new handheld computer that uses cognitive-behavioral treatment principles to a popular self-help manual for the treatment of primary insomnia symptoms.

Eligibility criteria: Inclusion Criteria:

* sleep less than 6.5 hours per night
* at least 30 minutes of sleep onset latency or wakefulness after sleep onset
* symptoms present for at least 6 months
* must have insomnia symptoms at least 3 days per week

Exclusion Criteria:

* Body Mass Index greater than 32
* Presence of anxiety disorder
* Secondary forms of insomnia
* Presence of a substance use disorder
* Concurrent treatment for another mental disorder
* History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy

Primary outcomes:
measure: Changes in sleep parameters via polysomnography
measure: Changes in sleep parameters via self-reported sleep diary
measure: Changes in symptom severity as measured by Insomnia Severity Index
measure: Changes in symptom severity as measured by Pittsburgh Sleep Quality Index
measure: Changes in symptom severity as measured by the Multi-dimensional Fatigue Inventory
Secondary outcomes:
measure: Changes in depression symptoms as measured by Beck Depression Inventory II
measure: Changes in quality of life as measured by a qualitative instrument
measure: Usability of the device as measured by a qualitative questionnaire
Other outcomes:
Locations:
city: Reston
country: United States
facility: PICS, Inc.
state: Virginia
Study officials:
affiliation: PICS, Inc.
name: Bradford W Applegate, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04809584: 18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer
Official title: 18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Prostate Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-03-22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

Detailed description: This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.

Eligibility criteria: Inclusion Criteria:

1. Patient is older than 18-year-old
2. Biopsy proven prostate adenocarcinoma
3. Planned prostatectomy with lymph node dissection
4. Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
5. Able to provide written consent
6. Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent)

Exclusion Criteria:

1. Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu)
2. Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery
3. Metallic implants (contraindicated for MRI)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Universiy
name: Andrei H Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06600984: WBV on Fascicle Lenght and Knee Joint Angle in CP
Official title: Efficacy of Whole Body Vibration on Fascicle Length and Joint Angle in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral palsy
Fascicle length
Hemiplegia
Range of motion
Whole body vibration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effects of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy

Detailed description: to study the effect of WBV on fascicle length, knee joint angle and function in children with spastic hemiplegic cerebral palsy

Eligibility criteria: Inclusion Criteria:

* Ages varied from four to six years of both sex
* hemiplegic CP children, were suffering from knee joint flexion deformity due to hamstring muscles tightness
* Level I and II motor function, according to the Growth Motor Function Classification System (GMFC) expanded and revised
* Degree of spasticity ranged from 1 to 2 according to modified Ashworth scale
* All children received neuro-developmental techniques

Exclusion Criteria:

* Other causes of knee flexion deformities
* Previous history of orthopedic surgery in knee joint
* Visual or auditory problems
* Seizures
* Sensory or perceptual deficits
* Any acute illness at the time of collection of data.

Primary outcomes:
measure: Knee range of motion
timeFrame: 12 weeks
measure: Fascicle length of hamstring muscle
timeFrame: 12 weeks
measure: gross motor function
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: mostafa ALI
state: Married
Study officials:
References:
Clinical trial NCT03326284: Optimal Protein Dose Per Meal During Weight Loss in Perspective to Maintaining Muscle Mass
Official title: Optimizing Per Meal Protein Intake During Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Metabolism
Keywords: Hypocaloric diet
Dietary protein
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Arla Foods
name: Innovation foundation
name: Mejeribrugets ForskningsFond
First posted: 2017-10-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: : Forty women (\~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses.
Primary purpose: PREVENTION

Brief summary: The primary aim of the trial is to determine the optimal dose of protein per meal in relation to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss during weight loss. In addition, we aim to determine whether the response to protein intake is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.

Detailed description: Aim of this project is to determine the optimal protein dose (high quality milk protein) per meal in relation to enhancing muscle protein synthesis and thereby counteract muscle loss during weight loss.

The hypothesis is that the optimum dose of protein for women on a hypocaloric diet will be greater than when women eat an energy sufficient diet, and also higher than the optimal dose previously determined in weight stable men.

Methods: Forty women (\~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses. The muscle protein response to the different doses of protein will be determined by the muscle protein fractional synthetic rates using tracer kinetics.

Eligibility criteria: Inclusion Criteria:

* healthy
* Postmenopausal women

Exclusion Criteria:

* Smoking
* Metabolic and/or chronic diseases

Primary outcomes:
measure: Fractional synthetic rate
timeFrame: 3 hours after ingestion of protein
Secondary outcomes:
measure: Muscle signalling
timeFrame: 3 hours after ingestion of protein.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
References:
Clinical trial NCT00167284: Patient Provider Partnership: Improving Diabetes Care in the Community
Official title: Patient Provider Partnership: Improving Diabetes Care in the Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: chronic care model, diabetes, community, diabetes education
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: UPMC Office of Community Initiatives
First posted: 2005-09-14
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: With the advent of managed care, increasing responsibility for the care of patients with diabetes is being placed on primary care physicians. Evidence exists that physicians are not meeting established practice guidelines, and outcomes in patients with diabetes are less than optimal. It is thus the objective of this study to institute a community-based diabetes education intervention for both physicians and patients to enhance adherence to guidelines and improve patient outcomes.

We will conduct a chart review (submitted under a separate IRB: #000733) in primary care practices to determine health status and guideline adherence. Following the chart review, physician practices will be assigned to one of three groups: physician + patient education, physician education alone, and usual care. Following the intervention, a repeat chart review will be conducted. Pre and posttest comparisons will be conducted to examine changes primarily in glycemic control, quality of life, patient knowledge, and physician adherence to practice guidelines. Secondarily, we will examine changes in therapeutic intervention, body mass index, and barriers to diabetes care. We will also examine individual barriers to diabetes care and their influence on outcomes in this population. The last phase of the study will encompass a second follow-up visit in which we will examine behavioral factors related to clinical change and sustainability of the intervention.


Eligibility criteria: Inclusion Criteria:

* over age 18, diagnosed diabetes, physician is participating in study

Exclusion Criteria:

* pregnancy, imprisonment

Primary outcomes:
measure: A1c
measure: Blood Pressure
measure: Lipids
Secondary outcomes:
measure: Quality of Well Being
measure: Empowerment
measure: Physician attitudes
measure: Patient and physician barriers to diabetes care
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Janice C Zgibor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05909579: Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis
Official title: Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Endometriosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with endometriosis. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to endometriosis for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.


Eligibility criteria: Inclusion Criteria:

* 18 years or older, fluent in English, and have a formal diagnosis of endometriosis for at least 3 months.

Exclusion Criteria:

* Younger than 18 years of age, nonfluency in English, self-identified diagnosis, endometriosis duration of less than 3 months.

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: At the end of the 3 month program
measure: Pain intensity
timeFrame: 3 months after the end of the program
Secondary outcomes:
measure: Pain catastrophizing
timeFrame: Baseline
measure: Pain catastrophizing
timeFrame: At the end of the 3 month program
measure: Pain catastrophizing
timeFrame: 3 months after the end of the program
Other outcomes:
measure: Sexual distress
timeFrame: Baseline
measure: Sexual distress
timeFrame: At the end of the 3 month program
measure: Sexual distress
timeFrame: 3 months after the end of the program
measure: Pain self-efficacy
timeFrame: Baseline
measure: Pain self-efficacy
timeFrame: At the end of the 3 month program
measure: Pain self-efficacy
timeFrame: 3 months after the end of the program
Locations:
city: Kingston
country: Canada
facility: Sexual Health Research Laboratory, Department of Psychology, Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Caroline Pukall, PhD
role: PRINCIPAL_INVESTIGATOR
References: