louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03592719: Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)
Official title: Motivational Interviewing to Increase PrEP Uptake (MI-PrEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Factor
Keywords: HIV Prevention
PrEP
Black
African American
Women
Motivational Interviewing
At risk for HIV
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
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 test a counseling program for Black women at high risk for HIV


Eligibility criteria: Inclusion Criteria:

* HIV-negative
* Identify as Black and/or African American
* Age 18 or older
* Cis-gender Female
* English speaking
* Is capable of completing and fully understanding the informed consent process and the study procedures and
* Meets the Center for Disease Control's indications for PrEP use (17): (a) any sex with opposite sex partners in the past 6 months and (b) not in a monogamous partnership with a recently tested HIV-negative partner or (c) any injection of drugs not prescribed by a clinician in the past 6 months AND (d) at least one of the following: (i) infrequently uses condoms in sex with one/more partners of unknown HIV status (ii) in a sexual relationship with an HIV-positive partner or (iii) any sharing of injection/drug preparation equipment in past 6 months.

Exclusion Criteria:

* Not capable of completing/fully understanding the consent process and the study procedures.

Primary outcomes:
measure: Change in Motivation for PrEP
timeFrame: Baseline, Up to 6 weeks
measure: Change in PrEP uptake
timeFrame: Baseline, Up to 6 weeks
Secondary outcomes:
measure: Change in Knowledge of PrEP
timeFrame: Baseline, Up to 6 weeks
measure: Change in Barriers for PrEP
timeFrame: Baseline, Up to 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sannisha K Dale, PhD, EdM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03347019: Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery
Official title: Accelerated Rehabilitation After Arthroscopic Bankart Repair Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bankart Lesion
Keywords: bankart repair
accelerated rehabilitation
shoulder
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to prospectively evaluate the efficacy of an accelerated rehabilitation regime for patients undergoing early arthroscopic stabilization for first-time anterior dislocation in terms of clinical outcome, return to play data and recurrence rates.

Detailed description: Traditional rehabilitation regimes post arthroscopic stabilization commonly stipulate a period of immobilization of between 2 weeks and 6 weeks.This is apparently embedded in practice and is reportedly based on tissue healing times. However early mobilisation would allow good clinical results in terms of clinical outcome, return to play data and recurrence rates.

Eligibility criteria: Inclusion Criteria:

* Patient were included based on their history of a clear mechanism of injury resulting in traumatic anterior dislocation, with clear evidence of labral injury confirmed on magnetic resonance imaging.

Exclusion Criteria:

* patients with inflammatory, autoimmune, endocrine or kidney diseases
* Recurrence
* Bony Bankart Lesion

Primary outcomes:
measure: 3 Dimensional Kinematic Analysis
timeFrame: at sixth months after surgery
Secondary outcomes:
measure: Pain Assessment
timeFrame: at sixth months after surgery
measure: First Functional Assessment
timeFrame: at sixth months after surgery
measure: Second Functional Assessment
timeFrame: at sixth months after surgery
measure: Third Functional Assessment
timeFrame: at sixth months after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01256619: Evaluation of an Oral Contraceptive Containing 30 mg Ethinyloestradiol and 150 mg Desogestrel on Women's Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Women With PMS
Keywords: Marvelon
PMS
serum Lipids
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The desogestrel (150 mg) in combination with ethinyl estradiol (EE, 30 mg) is known as Marvelon in European countries. Previous studies revealed that the Marvelon is good and safe for women. As a study from Thailand showed that the Marvelon to be effective and acceptable in Thai women. Moreover compared to Caucasian women, the incidences of irregular bleeding and side effects were apparently lower in these Asian women . Although Marvelon was used in many countries but it's efficacy didn't reported among Iranian women.


Eligibility criteria: Inclusion Criteria:

being on married, being within 18-40 years old, having normal Body mass index (ranged from 20 to 27 kg/m2), don't use any OCP during 3 months ago, having a normal menstruation cycle for the last three cycles, having at least one of following mental and behavioural symptoms ( Fatigue, mood changes, lack of energy, irritability, aggression, depression, decreased concentration, decreased social relationships, having a greed and increased appetite to eating food), having at least one of following physical symptoms (Breast sensitivity, swelling and flatulence) and women tend to use OCP for six consecutive months.

Exclusion Criteria:

pregnancy, having Anorexia or Bulimia, doing breastfeeding, smoke cigarette, Taking sleeping pills more than 3 days per month, Injection estrogen, progesterone or androgen during the past 3 months, Contraindications for OCP (including: thrombophlebitis - Severe liver disease - cerebrovascular accident and heart disease - unexplained uterine bleeding - lupus - breast cancer - migraines - sickle cell anemia - Epilepsy - gallbladder disease - kidney problems - varicocele and family history thrombosis).

Primary outcomes:
measure: serum Lipids
timeFrame: baseline-1 month & 2month & 3month &6month after intervention
Secondary outcomes:
measure: PMS
timeFrame: baseline-1 month & 2month & 3month &6month after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences-BASIR center
Study officials:
References:
Clinical trial NCT04752319: BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment After a Long-term Use (Pilot).
Official title: BreEStim for Post-Stroke Motor Recovery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Motor Recovery
Keywords: Finger flexor spasticity
Motor Recovery
BreEStim
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment after a long-term use.


Eligibility criteria: Inclusion criteria:

* has post stroke ≥ 6 months , medically stable;
* Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
* MAS score ≥ 1, i.e., detectable finger flexor hypertonia;

Exclusion criteria include:

* Patients with visual deficit/neglect; hearing or cognitive impairment;
* Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);
* Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
* Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \< 2 years;
* Patients with a pacemaker;
* Women who are pregnant.

Primary outcomes:
measure: Change in finger flexor spasticity measured by Modified Ashworth Scale (MAS)
timeFrame: Baseline, after 10 intervention sessions, about 3 weeks
Secondary outcomes:
measure: Change in finger extensors and hand function measured by Fugl Myer Assessment (FMA) Scale
timeFrame: Baseline, after 10 intervention sessions, about 3 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Sheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01844219: Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach
Official title: Accuracy of Pre-existing Risk Scoring Models for Predicting Acute Kidney Injury in Patients Who Underwent Aortic Surgery Using a Gray Zone Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Surgery
Postoperative Acute Kidney Injury
Keywords: aortic surgery
acute kidney injury
gray zone approach
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 375
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.

Brief summary: Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models using a gray zone approach in patients who underwent aortic surgery in our institution.

Detailed description: Acute kidney injury after cardiac surgery has been reported to increase morbidity and mortality. Several risk scoring models for prediction of aortic kidney injury after cardiac surgery have been developed. However, predictive accuracy of these models is stil unclear. The aim of this study is to evaluate the accuracy of four pre-existing prediction models (AKICS, Wijeysundera, Mehta, and Thakar model)using a gray zone approach in patients who underwent aortic surgery in our institution. Based on receiver operating characteristic (ROC) curve analysis, we will construct a gray zone using the cut-off values with a sensitivity of \< 90%, and a specificity of \< 90% (diagnostic tolerance of 10%).

Eligibility criteria: Inclusion Criteria:

* Those who underwent elective or emergency aortic surgery in Samsung Medical Center during between 2004 and 2010.

Exclusion Criteria:

* missing laboratory data
* preoperative hemodialysis
* death during or within 48 hours after surgery

Primary outcomes:
measure: presence of acute kidney injury
timeFrame: within 48 hour after aortic surgery
Secondary outcomes:
measure: Gray zone range of each risk scoring model
timeFrame: within 48 hours
measure: Number of patients in the gray zone
timeFrame: within 48 hours after aortic surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University, School of Medicine
Study officials:
References:
Clinical trial NCT01644019: Prehospital Telemedical Support in Acute Stroke
Official title: Prehospital Telemedical Support in Acute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke
Keywords: stroke
teleconsultation
telemedicine
emergency medical service
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the quality of prehospital emergency care in acute stroke, when paramedics are supported telemedically by an EMS physician.

Detailed description: Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of suspected acute stroke (including intracranial hemorrhage), the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures (taken with a smartphone), 12-lead-ECGs and video streaming from the inside of the ambulance can also be carried out, if indicated. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, neurological diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

Eligibility criteria: Inclusion Criteria:

* suspected acute stroke
* verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency

Exclusion Criteria:

* no suspected stroke
* patient refuses consent

Primary outcomes:
measure: Quality of prehospital care
timeFrame: average 1 hour
Secondary outcomes:
measure: Clinical time intervals
timeFrame: 12 hours
measure: Diagnostic quality
timeFrame: up to 28 days
measure: Information transfer
timeFrame: 2 hours
measure: choice of appropriate hospital
timeFrame: average 1 hour
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
Study officials:
affiliation: University Hospital Aachen, Germany, Department of Anesthesiology
name: Rolf Rossaint, Prof. Dr.
role: STUDY_CHAIR
affiliation: University Hospital Aachen, Germany, Emergency Department
name: Jörg C Brokmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03200119: MyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management
Official title: A Study of the Management of the Patient's Disease Based on the Life Log Data of Patients With Lifestyle-related Diseases Through a Wearable Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback from clinicians


Eligibility criteria: Inclusion Criteria:

* Study participants must agree to support by him/herself at enroll time
* Patients without severe cardiopulmonary disease, cancer, or other acute diseases
* Patients must be over BMI \> 23 kg/m2

Exclusion Criteria:

* Patient who did not agree with this study
* Patients with severe cardiopulmonary disease, cancer, or other acute diseases
* Patients who were pregnant

Primary outcomes:
measure: Body weight change
timeFrame: baseline and after 4weeks of lifestyle intervention
Secondary outcomes:
measure: Blood test result change
timeFrame: baseline and after 4weeks of lifestyle intervention
measure: Mobile-app usage change
timeFrame: baseline and after 4weeks of lifestyle intervention
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Se young Jung, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryu B, Kim N, Heo E, Yoo S, Lee K, Hwang H, Kim JW, Kim Y, Lee J, Jung SY. Impact of an Electronic Health Record-Integrated Personal Health Record on Patient Participation in Health Care: Development and Randomized Controlled Trial of MyHealthKeeper. J Med Internet Res. 2017 Dec 7;19(12):e401. doi: 10.2196/jmir.8867.
Clinical trial NCT00094419: Complementary and Alternative Medicine Use in Low-Income African American and Caucasian Adults With Asthma
Official title: The Role of Complementary and Alternative Medicine (CAM), Folk Care and Faith-Based Approaches in the Home Management of Persistent Asthma in Low-Income African American and Caucasian Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to identify the types of and frequency of use of complementary and alternative medicine (CAM) strategies among low-income Caucasian and African American adults with persistent asthma. The overall goal is to collect data that will increase understanding of health beliefs and behaviors in people with low-income backgrounds so that studies can be created that may help modify and improve patients' symptoms of asthma.

Detailed description: The rates of asthma-related deaths and disease are disproportionately high among African Americans compared to Caucasians. Surveys indicate that middle- and upper-income Caucasians use more CAM than African Americans, but the therapies utilized are different. This study will determine how well people with persistent asthma adhere to their treatment and whether the type and frequency of use of CAM affects treatment adherence.

Participants will begin this study by taking part in an interview about adherence to their current inhaled corticosteroids (ICS) regimen and their personal CAM use. After completing the interview, participant adherence to their ICS regimen will be monitored for 6 weeks. Depending on the type of ICS participants are taking, monitoring will be conducted either by participant self-reporting or electronic monitors that record the time and date of medication inhalation. Participant adherence will also be assessed at study completion.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed asthma with episodes that last for long periods of time
* Medicaid recipients
* Self-identify as African American or Caucasian
* Daily use of inhaled corticosteroids
* Able to speak English
* Have mental capacity to understand and participate in the study

Exclusion Criteria:

* Prisoners
* History of smoking at least ten packs of cigarettes per year
* Currently smoke more than one and a half packs of cigarettes per week

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Campus
state: Maryland
city: Philadelphia
country: United States
facility: Presbyterian Medical Center at the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Medical Institute
name: Maureen George, PhD RN AE-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01672619: Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results
Official title: Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children With Craniosynostoses
Keywords: craniosynostoses
Osteogenesis Distraction
craniotomy
Lead sponsor: Nucleo de Plastica Avancada
Sponsor class: NETWORK
First posted: 2012-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with craniosynostoses

Brief summary: Being the craniostenoses sutural basically a disease, the fact that the brain being trapped in an enclosure that does not have complacency required to accompany their growth constitutes the challenge of treatment, which aims to restore the complacency of the suture and correct the stenotic compensatory cranial deformity.

This paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided by the use of springs distracting.

Detailed description: As demonstrated by some authors, the curved shape of the helix fits perfectly the remodeling of a curved surface as well as the skullcap. If you do not receive fixation, however, trace the helicoid of the bone osteotomy can turn on a spring that can expand or contract depending on the direction of the force that is received. This form of osteotomy was therefore chosen by the authors to induce bone compliance areas of secondary defect that should expand or compress indirectly during the process of dynamic remodeling of primary defect with springs.

Eligibility criteria: Inclusion Criteria:

* age between 6 months to 13 years

Exclusion Criteria:

* absence of clinical conditions for the surgical treatment

Primary outcomes:
measure: Nautilus: dynamic craniotomy; new surgical technique and preliminary results
timeFrame: Up to 3 years
measure: cranial remodeling
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Beneficencia Portuguesa de São Paulo
state: SP
Study officials:
References:
citation: Lauritzen CGK, Davis C, Ivarsson A, Sanger C, Hewitt TD. The evolving role of springs in craniofacial surgery: the first 100 clinical cases. Plast Reconstr Surg. 2008 Feb;121(2):545-554. doi: 10.1097/01.prs.0000297638.76602.de.