louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05106920: Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous
Official title: How we Apply Ultrasound-guided Neuromodulation in Lower Back Pain Sufferers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 40
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: In the daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation.

In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of the study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Forty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz) during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250 microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Lower Back Pain
* Having no other therapy

Exclusion Criteria:

* Other pathology (discal hernia, injured limbs, neurological pathology)
* Belenophobia

Primary outcomes:
measure: Level of pain
timeFrame: From baseline measurement up to 1 week
measure: Owestry questionnaire
timeFrame: From baseline measurement up to 1 week
measure: Range of motion
timeFrame: From baseline measurement up to 1 week
measure: Y Balance Test
timeFrame: From baseline measurement up to 1 week
measure: Strength
timeFrame: From baseline measurement up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
References:
Clinical trial NCT02973620: Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure
Official title: Expanded Access Protocol; Intermediate Size Protocol: Levosimendan Compassionate Use in Pediatric Patients With Advanced Decompensated Heart Failure Who Are Refractory to Standard Therapy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Heart Decompensation
Lead sponsor: Tenax Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-25
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT

Brief summary: Open label study of levosimendan; planned comparison for effectiveness and safety to historic matched case controls from participating sites.


Eligibility criteria: General Eligibility

All patients must meet at least one of the following definitions of failed standard therapy of decompensated heart failure:

Definition for failure of standard therapy:

1. Decompensated heart failure refractory to standard therapy (Milrinone of ≥0.5mcg/kg/min for \>48 hours with EF \<35%) including any of the following:

   * (SaO2 - SmVO2) \> 30 % or lactate \>3 AND/OR
   * Need for second inotropic agent AND/OR
   * Need for positive pressure ventilation AND
   * Patient not qualifying for long term ventricular assist device support or transplant at the time of assessment.
2. Cardiogenic shock with acute decompensated heart failure (requiring positive pressure ventilation and addition of inotropic support with or without use of Milrinone with EF \<35%) refractory to therapy for more than 48h including any or all of the following:

   * (SaO2 - SmVO2) \> 30 % or lactate \>3
   * Patient not qualifying for long term ventricular assist device support or transplant at the time of assessment.
   * Potential need for short-term mechanical circulatory support.
3. Failure to wean off ECMO support with use of standard inotropic / vasoconstrictor support.

Inclusion Criteria:

1. Male or female, ≤18 years of age with acute or acute on chronic decompensated heart failure.
2. Male or female, ≤18 years of age on ECMO support and unable to wean from ECMO support.
3. Informed Consent signed by the subject's parents or their legally acceptable representatives indicating that they understand the purpose of and procedures required for expanded access and are willing to participate in the study.
4. Patients meeting one of the following definitions of failed standard therapy of decompensated heart failure

Exclusion Criteria:

1. Patients \< 36 weeks gestational age
2. Patients weighing \< 2 kg
3. Obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade
4. Estimated glomerular filtration rate (eGRF) \< 30 mL/min/1.73m2.
5. Known allergic reaction or sensitivity to levosimendan or excipients.
6. A history of Torsades de Pointes, uncorrectable hypo- or hyperkalemia, uncorrectable hypo- or hypercalcemia
7. Pregnant, suspected to be pregnant, or breast-feeding.
8. Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06265974: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio
Official title: ECHOQUALITY: Evaluation of Image Quality in Obstetrical Ultrasonography: Comparison Between Subjective Assessment and Contrast-to-noise Ratio
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Obstetrics
Keywords: Quality
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women having undergone an ultrasound between 18 weeks and 18 weeks + 6 days at the Multidisciplinary Prenatal Diagnostic Center of Poitiers University Hospital

Brief summary: The goal of this observational study is to determine whether the subjective assessment of the quality of obstetrical ultrasonography pictures can be similar to that of an objective tool.

The main question it aims to answer is:

Is the subjective assessment of the quality of obstetrical ultrasonography pictures by a young practitioner and an experienced one can be similar to that of an objective tool, such as the contrast-to-noise ratio (CNR)? The contrast-to-noise ratio is commonly used in radiology to evaluate image quality by assessing the ability to distinguish differences between two elements.

The investigators selected a retrospective cohort of 198 patients, including three pictures per fetus screened between 18 and 18 weeks and 6 days. For each picture, the investigators assessed the quality of two different elements and the entire image, and then calculated the CNR using software. The investigators will compare the three assessment between them


Eligibility criteria: Inclusion Criteria:

* Patient who underwent ultrasound between 18 weeks and 18 weeks + 6 days for prenatal diagnosis
* Ultrasound performed by the same practitioner
* Ultrasound performed on the same ultrasound machine "Voluson E10", with the "RM6C" probe

Exclusion Criteria:

* Patient's refusal
* Use of another ultrasound device other than the "Voluson E10", and/or an ultrasound probe other than the "RM6C"
* Intrauterine fetal deaths

Primary outcomes:
measure: The comparability between a subjective and objective assessment of the contrast to noise ratio of an obstetric ultrasound image
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital La MILETRIE
Study officials:
References:
Clinical trial NCT06464874: Endoscopic Therapy for Laterally Spreading Tumors (LSTs)
Official title: Hybrid Versus Conventional Endoscopic Submucosal Dissection for Laterally Spreading Tumors (LSTs): A Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Compare the Efficacy and Safety of Hybrid ESD and ESD in the Treatment of Colorectal LST
Keywords: Colorectal adenoma；Laterally spreading tumors, Endoscopic submucosal dissection, Hybrid endoscopic submucosal dissection
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 890
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involved a multicenter retrospective analysis of 890 consecutive patients with a colorectal LST \> 10 millimeters who underwent endoscopic treatment at 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) between May 2020 and April 2023.

Brief summary: This study will retrospectively include LST patients who were admitted to 6 medical centers (The Second Affiliated Hospital, College of Medicine, Zhejiang University; The Affiliated Jinhua Hospital, Zhejiang University School of Medicine; First Affiliated Hospital of Huzhou University; The Second Hospital of Jiaxing; Jinhua People's Hospital; Lanxi People's Hospital) from 2020.05.01 to 2023.04.30 with the purpose of comparing the efficacy and safety of hybrid ESD and ESD in the treatment of colorectal LST. The complete resection rate, operation time, operation cost, intraoperative and postoperative complications of hybrid ESD and ESD LST will be compared. To provide strong evidence for the selection of endoscopic treatment strategies for LST.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* LST lesion diameter \>1cm;
* Medical record data integrity

Exclusion Criteria:

* Pedicle lesions;
* Resection of residual lesions after endoscopic treatment;
* Advanced endoscopic imaging showed submucosal infiltrating lesions.
* The lesions are in patients with inflammatory bowel disease;
* Familial polyposis;
* Electrolyte abnormalities;
* Coagulation dysfunction;
* Pregnant or lactating patients;
* Taking nonsteroidal anti-inflammatory drugs or anticoagulants;
* A history of alcoholism;
* Severe organ failure;
* Medical records are incomplete

Primary outcomes:
measure: complete resection rate
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References:
Clinical trial NCT06559774: The Hastiin Bidziil (Strong Man) Intervention
Official title: The Hastiin Bidziil (Strong Man) Intervention: A Study to Measure the Effectiveness of a Secondary Prevention Program Aimed at Reducing Substance Use Among Native Men Ages 18-26
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Keywords: Young Men
Common Elements Treatment Approach (CETA)
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18-26.


Eligibility criteria: Inclusion Criteria:

* Self-identify as American Indian
* Self-identify as a man
* Age 18-26 years at time of enrollment
* Screen positive for at least moderate risk on any substance, except for tobacco use only
* Reside within \~60 miles of a study community (Fort Defiance, AZ; Chinle, AZ)

Exclusion Criteria:

* Any condition that would affect successful participation (e.g., planned move)
* Profound disability that limits the ability to participate in assessments or interventions
* Participated in the preliminary phase of this study to adapt CETA for this project

Primary outcomes:
measure: Number of days of substance sse as assessed by Time Line Follow-back
timeFrame: 6-months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chinle
country: United States
facility: Navajo Nation Center for Indigenous Health - Chinle
state: Arizona
city: Fort Defiance
country: United States
facility: Navajo Nation Center for Indigenous Health - Fort Defiance
state: Arizona
Study officials:
affiliation: Johns Hopkins University
name: Jennifer Richards, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jerreed D Ivanich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00115674: To Examine Smoking Behavior of Prisoners - 1
Official title: Smoking Research With Incarcerated Females
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Behavior
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Cancer Institute (NCI)
First posted: 2005-06-24
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult women incarcerated in a state prison in Virginia are eligible to participate.

Brief summary: The purpose of this study is to understand the smoking behavior of female incarcerated smokers and to determine how smokers differ from non-smokers on measures of substance abuse, personality, criminal history, and mental illness


Eligibility criteria: Inclusion Criteria:

* all smokers, non-smokers, and ex-smokers

Exclusion Criteria:

* inability to understand English and inability to be able to provide informed consent due to mental impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Karen Cropsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cropsey KL, Kristeller JL. Motivational factors related to quitting smoking among prisoners during a smoking ban. Addict Behav. 2003 Aug;28(6):1081-93. doi: 10.1016/s0306-4603(02)00230-7.
citation: Cropsey K, Eldridge GD, Ladner T. Smoking among female prisoners: an ignored public health epidemic. Addict Behav. 2004 Feb;29(2):425-31. doi: 10.1016/j.addbeh.2003.08.014.
citation: Haller DL, Miles DR, Cropsey KL. Smoking stage of change is associated with retention in a smoke-free residential drug treatment program for women. Addict Behav. 2004 Aug;29(6):1265-70. doi: 10.1016/j.addbeh.2004.03.029.
citation: Cropsey KL, Kristeller JL. The effects of a prison smoking ban on smoking behavior and withdrawal symptoms. Addict Behav. 2005 Mar;30(3):589-94. doi: 10.1016/j.addbeh.2004.07.003.
Clinical trial NCT06502574: Self-Care Management in Older Adults
Official title: Strengthening Participation in Social Life Through Rational Drug Use and Disease Self-Care Management inOlder Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Disease Self Management
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Health Institutes of Turkey
First posted: 2024-07-16
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with achronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate thecompliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The researchwas planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronicdiseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will bedeveloped for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention.


Eligibility criteria: Inclusion Criteria:

* Being in the 60-79 age group,
* Having a chronic disease that requires constant monitoring and treatment
* Using at least one medication for your disease regularly
* Having smart phone usage skills

Exclusion Criteria:

* Having vision and hearing problems
* Being 80 or older
* Having a neuro-psychiatric disease

Primary outcomes:
measure: Participation in social life (Social Inclusion Scale)
timeFrame: Baseline
measure: Participation in social life (Social Inclusion Scale)
timeFrame: within first week]
measure: Participation in social life (Social Inclusion Scale)
timeFrame: twelfth week]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06493474: Peer Assisted Breastfeeding Education Program
Official title: Effect of Peer Assisted Breastfeeding Education Program (PABEP) on Breastfeeding Self-Efficacy and Breastfeeding Levels: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Feeding
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Burdur Mehmet Akif Ersoy University
First posted: 2024-07-10
Enrollment: 170
Sex: FEMALE
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was aimed to evaluate the effect of the Peer Supported Breastfeeding Education Program given during the antenatal period on the breastfeeding knowledge and attitude levels, breastfeeding self-efficacy and breastfeeding levels of postpartum women. For this purpose, the hypotheses created in our study are as follows.

1. H1: Breastfeeding knowledge and attitudes of mothers in the PABEP group are significantly higher than those in the control group.
2. H1: Breastfeeding proficiency levels of mothers in the PABEP group are significantly higher than those in the control group.
3. H1: Breastfeeding success of mothers in the PABEP group is significantly higher than the control group, according to the breastfeeding evaluation results.


Eligibility criteria: Inclusion Criteria:

* being in the antenatal period
* having their first pregnancy
* not having received breastfeeding counseling before.

Exclusion Criteria:

* mothers with previous birth history
* previously educated women

Primary outcomes:
measure: Breastfeeding Self-Efficacy
timeFrame: Research data will be collected during training before birth and at 1 and 4 weeks after birth.
Secondary outcomes:
measure: breastfeeding success
timeFrame: Research data will be collected during training before birth and at 1 and 4 weeks after birth.
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Halil HI Taşdemir, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02415374: Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
Official title: Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Metabolism
Avenanthramides
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the "concentration-time profile".


Eligibility criteria: Inclusion Criteria:

* Male and female non-obese subjects (18kg/M2\<BMI\<28kg/M2)
* Age 20-45 years)
* Sign an informed consent form approved by UMN-IRB
* Willing to avoid oat consumption and rigorous physical activity the day prior to and through test, and consume a low-flavonoid diet for 1 week prior to the study

Exclusion Criteria:

* Presence of GI conditions that interfere with absorption;
* Clinically significant endocrine, cardiovascular, pulmonary, renal, hepatic, pancreatic, biliary or neurologic disorders;
* Major trauma or surgery within 3 months of visit;
* Cancer in the prior 2 years;
* Allergic to oat products;
* Women who are pregnant or lactating;
* Smoking;
* Drinking alcohol \>5 drinks/week;
* Using nutraceuticals;
* Blood pressure medication;
* NSAID (\>800 mg ibuprofen/week);
* Vitamin supplementation;
* Anticoagulants or hypoglycemic drugs;
* Oat products consumption the day before the test;
* Rigorous physical activity the day before the test;
* Consumption of a high-flavonoid diet in the week prior to the test.

Primary outcomes:
measure: iAUC for each AVA
timeFrame: 0-10 hours
measure: Cmax for each AVA
timeFrame: 0-10 hours
measure: Tmax for each AVA
timeFrame: 0-10 hours
measure: T1/2 for each AVA
timeFrame: 0-10 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School of Kinesiology (Cooke Hall), 1906 University Ave. SE, Minneapolis, MN 55455
name: Li Li Ji, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang T, Shao J, Gao Y, Chen C, Yao D, Chu YF, Johnson J, Kang C, Yeo D, Ji LL. Absorption and Elimination of Oat Avenanthramides in Humans after Acute Consumption of Oat Cookies. Oxid Med Cell Longev. 2017;2017:2056705. doi: 10.1155/2017/2056705. Epub 2017 Dec 21.