louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00724399: Preventive Health Practices in Women
Official title: Preventive Health Practices in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 1418
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective survey study on women who attend screening mammography and routine/annual gynecology visits to assess baseline knowledge regarding CVD.

Brief summary: The purpose of this study is to evaluate women's level of knowledge and health practices regarding cardiovascular health and identify barriers to appropriate health practice.

Detailed description: Increasingly, gender differences in manifestation of cardiovascular disease (CVD) and myocardial infarction (MI) are being reported. Gender specific presentations of MI in particular have contributed to underdiagnosis of cardiac events in women. Furthermore, previous studies from the 2002 Behavioral Risk Factors Screening Surveillance demonstrated decreased compliance with standard cardiovascular health practices in women compared to men. We seek to validate these findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.

Eligibility criteria: Inclusion Criteria:

* Women attending screening mammography and gynecology visit.

Exclusion Criteria:

* Patient refusal to participate (assessed by non-submission of the completed survey).

Primary outcomes:
measure: To validate findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.
timeFrame: To be determined later
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ruth Carlos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01019499: The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
Official title: The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Platelet Function
Inflammation
Keywords: human
intervention
blood pressure
cardiovascular risk factors
polyphenols
bioavailability
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Agrifood Research Finland
name: The Finnish Funding Agency for Technology and Innovation (TEKES)
name: Academy of Finland
name: University of Oslo
First posted: 2009-11-25
Enrollment: 37
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).

Detailed description: The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with no washout period between periods. The participants are blinded to treatments. The subjects are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks. After that they are crossed over to the other diet for another 8 weeks. The main visits to the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/ cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk; these visits are for compliance checks, meeting the study nurse and receiving the study products. The subjects are asked to maintain their normal dietary and lifestyle habits, as well as to keep alcohol intake and physical activity constant during the study.

Eligibility criteria: Inclusion Criteria:

* mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg)

Exclusion Criteria:

* smoking
* regular use of medications (except hormone replacement therapy) or dietary supplements
* intestinal disorders
* obesity (BMI\> 35 kg/m2)
* vegetarianism
* pregnancy

Primary outcomes:
measure: Blood pressure
timeFrame: 0, 8 and 16 weeks
Secondary outcomes:
measure: PFA-100 measurement
timeFrame: 0, 8 and 16 weeks
measure: biomarkers of cardiovascular disease risk
timeFrame: 0, 8 and 16 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Institute for Health and Welfare
city: Turku
country: Finland
facility: National Institute for Health and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Antti Jula, DR.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02661399: Peripheral Blood Biomarkers Associated With CIPN
Official title: Investigation of Peripheral Blood Biomarkers Associated With CIPN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Neuropathy, Secondary to Drugs or Chemicals
Keywords: CIPN
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have diagnoses which might be treated with CIPN causing therapy, and/or who have CIPN symptoms without potential confounding neuropathies (antecedent diabetic or anatomical peripheral neuropathies).

Brief summary: The investigators are doing a research study that will teach us about the tingly pain that people develop when they get chemotherapy.

Detailed description: The investigators are asking for a blood sample, information about patients symptoms during chemotherapy, and past medical history from people who have taken or will take certain types of chemotherapy. The investigators hope to examine blood for proteins that could help us learn which patients get neurological symptoms while getting chemotherapy. The investigators' main research goal is to improve the treatment of patients getting chemotherapy to help their quality of life and/or help to increase the chance of their cancer being cured.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a tumor for which Platinums, Vinca Alkaloids, Bortezomib or Taxanes are indicated
* No prior history of diabetic, anatomical or regional neuropathies (except pre-existing CIPN)
* Age ≥ 18 years
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.

Exclusion Criteria:

* Inability to give consent
* Inability to tolerate venipuncture for any reason
* Age \< 18 years
* Any known medical, surgical or psychiatric condition that may interfere with the conduct of the study or be detrimental to the donor in the opinion of the PI or caring physician
* Consent Refusal by patient

Primary outcomes:
measure: Collection of blood samples, medical history, CIPN symptomology (via questionnaire) and clinical laboratory data for a correlative evaluation of potential CIPN related molecular and cellular variance (biomarkers).
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Jack Lionberger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02058199: Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery
Official title: A Pharmacodynamic Study of Rivaroxaban in Subjects Who Have Undergone Roux-en-Y Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Gastric Bypass Status
Keywords: gastric bypass
rivaroxaban
pharmacodynamics
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this medication, but this has not been previously studied.

The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers who are in one of four groups

1. Non obese people who have not had a gastric bypass.
2. Obese people who have not had a gastric bypass
3. People who have had a gastric bypass
4. People who are planning to undergo gastric bypass surgery in the near future who are willing to be studied before and after the bypass.

The study will involve taking a single low dose of rivaroxaban and multiple blood samples will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban will be compared between the different groups.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers in one of four groups

  1. Normal weight and not having prior gastric bypass surgery,
  2. Obese and not having prior gastric bypass surgery,
  3. Subjects with prior roux en Y gastric bypass surgery,
  4. Obese and planning to undergo roux en Y gastric bypass

Exclusion Criteria:

* Active renal or liver disease,
* bleeding diathesis,
* concurrent treatment with anticoagulants or aspirin,
* indication for aspirin or anticoagulant treatment,
* gastrointestinal bleeding,
* uncontrolled hypertension,
* active malignancy,
* anemia,
* thrombocytopenia,
* pregnant,
* allergy to rivaroxaban,
* coagulopathy or any other medical condition that would increase risk to the subject

Primary outcomes:
measure: median inhibition of factor xa inhibition
timeFrame: 24 hours
Secondary outcomes:
measure: median prolongation of prothrombin time
timeFrame: 24 hours
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Thomas E Coyle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01708499: Feasibility Study: Evaluation of the Ulthera® System for Treatment of Abdominal Tissue
Official title: Feasibility Study: Evaluation of the Ulthera® System for Efficacious and Safe Treatment of Laxity/Crepiness and Texture of Abdominal Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Skin Crepiness
Keywords: Ulthera® System
Ultherapy™ Treatment
Ulthera, Inc.
Ultrasound treatment for skin tightening
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-17
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Enrolled subjects will receive one UltherapyTM treatment on the abdomen. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

Detailed description: This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System for improving laxity/crepiness and texture of abdominal tissue. Changes from baseline in the laxity, crepiness and texture of abdominal skin will be assessed at each study follow-up visit. Global Aesthetic Improvement Scale scores, assessments of dermal thickness, and patient satisfaction questionnaires will also be obtained.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged 25 to 60 years.
* Subject in good health.
* Skin laxity in the abdomen
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the abdomen.
* Excessive skin laxity on the abdomen.
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Inability to understand the protocol or to give informed consent.
* BMI equal to and greater than 30.

Primary outcomes:
measure: Improvement laxity/crepiness and texture of abdominal tissue
timeFrame: 90 days post-treatment
Secondary outcomes:
measure: Overall aesthetic improvement
timeFrame: 180 days post-treatment
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Sasaki Advanced Aesthetic Medical Center
state: California
Study officials:
name: Gordon Sasaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06567106: Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
Official title: Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Function
Keywords: Ultrasound
Heart
Cardiac function
Lead sponsor: ShanghaiTech University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant is randomly assigned to receive either ultrasound intervention at varying intensities or sham control.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the influence of ultrasound on cardiac functrion.

The main question it aims to answer is:

How will ultrasound affect the cardiac function?

Researchers will： Apply ultrasound to the body and observe cardiac functions.

Participants will:

Receive ultrasound application and physiological signal monitoring.

Detailed description: All procedures conducted in this trial comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures were approved by the Research Ethics Committee of ShanghaiTech University (Q2024-004).

The primary outcome is heart rhythm. It will be measured by electrocardiogram. The secondary primary outcome is the incidence of treatment-related adverse events. It will be measured by electrocardiogram and observation.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals without significant diseases or chronic conditions.
* Aged between 18 and 65 years.
* Voluntary participation with signed informed consent.
* No history of cardiovascular disease.

Exclusion Criteria:

* Individuals with heart disease or other conditions that may affect cardiac function measurement.
* Individuals with implanted electronic devices such as pacemakers or defibrillators.
* Those on medications that significantly alter heart rate, such as beta-blockers, unless under stable control for a specific period.
* Individuals at risk of severe complications.

Primary outcomes:
measure: Heart rhythm.
timeFrame: Throughout the intervention, an average of 1 hour.
measure: Incidence of treatment-related adverse events.
timeFrame: Baseline, during the intervention (an average of 1 hour) and immediately after the intervention (same day, approximately 1 hour after baseline).
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Bingbing Cheng
Study officials:
References:
Clinical trial NCT02896699: Advanced HIV Prevention (PrEP Chicago)
Official title: Advanced HIV Prevention (PrEP Chicago)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Pre-exposure prophylaxis (PrEP)
diffusion of innovation
men who have sex with men
LGBT
African American
Black
HIV
network analysis
network intervention
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 424
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study will evaluate the feasibility of a network intervention to train individuals to disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in their social networks.

Detailed description: The specific aims of this study are:

1. To recruit 450 participants in Chicago, Illinois, and to train them as peer change agents (randomized to cross-over groups) to disseminate PrEP information and motivate PrEP interest and knowledge of PrEP in their local networks.
2. To evaluate feasibility of the program over 2 years of participant follow-up through: 1) peer change agent exit survey; 2) peer change agent booster sessions; 3) peer change agent communication with University of Chicago PrEP program social media; 4) referrals into the project and; 5) calls into the PrEP warmline.

Eligibility criteria: Inclusion Criteria:

* Lives on the South Side of Chicago, Illinois
* Born male
* Has had sex with men in the previous year
* Is an active Facebook user
* Does not have plans to leave Chicago

Exclusion Criteria:

-

Primary outcomes:
measure: Network member call into the PrEPline
timeFrame: 2 years
Secondary outcomes:
measure: PrEP Attitudes questionnaire
timeFrame: 2 years
measure: Peer change agent boosters sessions completed
timeFrame: 2 years
measure: Number of Facebook posts with respect to PrEP and sexual health
timeFrame: 2 years
measure: Number of referrals enrolled into the study
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References:
citation: Young LE, Schumm P, Alon L, Bouris A, Ferreira M, Hill B, Khanna AS, Valente TW, Schneider JA. PrEP Chicago: A randomized controlled peer change agent intervention to promote the adoption of pre-exposure prophylaxis for HIV prevention among young Black men who have sex with men. Clin Trials. 2018 Feb;15(1):44-52. doi: 10.1177/1740774517730012. Epub 2017 Sep 1.
Clinical trial NCT06758999: Validity and Reliability of the Turkish Form of the OPTIMAL
Official title: Validity and Reliability of the Turkish Form of the Outpatient Physical Therapy Improvement in Movement Assessment Log
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outpatient Treatment
Keywords: reliability
validity
outpatient physical therapy
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients to be included in the study will be those who are receiving outpatient treatment at the Kırşehir Ahi Evran University Physical Therapy and Rehabilitation Center and who meet the inclusion criteria.

Brief summary: The primary aim of the study was to determine the reliability and validity of the Turkish version of the questionnaire named "The Outpatient Physical Therapy Improvement in Movement Assessment Log". The secondary aim of the study was to measure the physical activity and mobility of outpatients receiving physical therapy.


Eligibility criteria: Inclusion Criteria:

1. Being 18 years of age or older
2. Receiving outpatient physical therapy
3. Volunteering to participate in the study
4. Knowing how to read and write

Exclusion Criteria:

1. Having a cognitive problem that prevents you from completing the survey independently.

Primary outcomes:
measure: The Outpatient Physical Therapy Improvement in Movement Assessment Log
timeFrame: 20 weeks
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kirsehir Ahi Evran University
state: Merkez
Study officials:
References:
Clinical trial NCT03780699: Hysteroscopic Evaluation of Cesarean Scar Defect
Official title: Hysteroscopic Evaluation of Cesarean Scar Defect Features & Its Correlation With Women Complaints
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Scar Defect
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be carried on 200 patients with cesarean scar defect recruited from Early Cancer Detection Unit.

Brief summary: The aim of this study is to identify hysteroscopic findings of cesarean scar defect in women underwent at least one prior cesarean section and its relation to any of the different un explained gynecological presentations.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 35 years.
2. Had at least one prior cesarean section

Exclusion Criteria:

1. History of uterine surgery that could change the cavity anatomy.
2. Uterine Abnormalities as submucous fibroid, endometrial or endocervical Polyps.
3. Recent intra-uterine contraceptive device (IUCD) in place.
4. Known history of endometriosis

Primary outcomes:
measure: cesarean section scar defect shapes
timeFrame: at least six months after CS
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams university maternity hospital
state: Abbassya
Study officials:
References: