louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05960487: Effect of Cervical Multifidus Muscle Area on Interlaminar Epidural Steroid Injection Outcomes
Official title: Can Multifidus Muscle Area Affect Cervical Interlaminar Epidural Steroid Injection Outcomes?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Radiculopathy
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have cervical disc herniation at the C5-C6 level and have radicular pain complaints for at least 3 months will be included in the study. Cervical interlaminar epidural steroid injection was applied to the patients and their follow-ups at the 3rd week and 3rd month should have been recorded completely.

Brief summary: Cervical radiculopathy is one of the most important causes of chronic neck pain. Cervical epidural steroid injections including interlaminar approach are frequently used for treatment option in patients that more conservative modalities are ineffective.

Paraspinal muscles have an important role in supporting neck movements and providing stability of the cervical spine. The multifidus muscle, located in the deepest part of the neck extensor muscle group, has become the muscle that is frequently emphasized in spinal pain in recent years. In the literature, it has been shown that the multifidus muscle on the affected side is atrophied in patients with cervical radiculopathy.

Although many factors are known to be effective on the outcomes of cervical interlaminar epidural injection, there are limited data on the effect of the multifidus muscle area. In this retrospective study, it was planned to investigate the effect of the multifidus muscle area on the results of cervical interlaminar epidural steroid injection.


Eligibility criteria: Inclusion Criteria:

* Patients with unilateral radicular pain due to cervical disc herniation for at least 3 months
* Patients with disc herniation level C5-C6
* Patients who are unresponsive to other conservative treatments and who have undergone cervical interlaminar epidural steroid injection

Exclusion Criteria:

* Patients with incomplete medical records (absence of MR imaging, incomplete data of 3rd week and 3rd month follow-up periods after cervical interlaminar epidural steroid injection)

Primary outcomes:
measure: Cervical multifidus muscle area
timeFrame: Through study completion, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University
name: Gunay Yolcu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Osman Hakan Gunduz, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT00916487: Efficacy of Fructose Metabolizing Enzymatic Product in Fructose Malabsorption
Official title: Efficacy of Fructose Metabolizing Enzymatic Product Fructosin(R) in Patients With Fructose Malabsorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fructose Malabsorption
Lead sponsor: Sciotec Diagnostic Technologies GmbH
Sponsor class: INDUSTRY
Collaborators: name: Austrian Research Promotion Agency
First posted: 2009-06-09
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the enzymatic product Frucosin(R) is able to degrade fructose in vivo in the small intestine of patients with known fructose malabsorption by measuring hydrogen in the expiratory air.

Detailed description: Fructose malabsorption is a digestive disorder in which the uptake of fructose in the small intestine is deficient. This leads to an increase of the concentration of fructose in the large intestine after the intake of fructose-rich meals. The exzess fructose is then degraded by intestinal microbes into CO2, CH4, H2 and short chain fatty acids causing symptoms like bloating, diarrhea, flatulence or stomach pain.

The clinical diagnosis requires a hydrogen breath test after challenge with fructose. After an oral challenge with fructose the emerging hydrogen is measured in the expiratory air. A fructose malabsorption is diagnosed if the hydrogen in the expiratory air reaches 20ppm or more.

In the course of this study the participants will take 2 hydrogen breath tests. Before each of these tests the participants will take either the active treatment (Fructosin(R)) or a placebo. The active treatment should reduce the exhaled hydrogen indicating a reduced concentration of fructose in the large intestine after fructose metabolization by the verum.

Eligibility criteria: Inclusion Criteria:

* diagnosed fructose malabsorption

Exclusion Criteria:

* Gravidity
* diabetes mellitus
* recent gastrointestinal surgery
* recent endoscopy
* recent antibiotics therapy

Primary outcomes:
measure: area under the curve (AUC) of the exhaled breath hydrogen in ppm*min
timeFrame: 4 hours
Secondary outcomes:
measure: Symptoms during and after the hydrogen breath test (abdominal pain, flatulence, nausea and diarrhea/constipation)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Peter Komericki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sciotec Diagnostic Technologies GmbH
name: Christian Pongracz, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04761887: Cool Pre-operative TAP Blocks
Official title: Pilot Study on the Thermal Effects of Local Anesthetics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Anesthetics, Local
Keywords: ropivacaine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study of approximately 20 pre-operative patients scheduled for a transversus abdominis plane (TAP) block as pain management for a previously scheduled surgery. Subjects will be randomly assigned to receive either cooled ropivacaine (4°C) during a TAP block or room temperature (between 20-25°C) ropivacaine during the block. The effects of a TAP block generally diminish within 24 hours. We believe that cooling ropivacaine before administration may slightly prolong the analgesic effects of the block and delay time before additional analgesic is requested, resulting in less opioid use following surgery.

Detailed description: After consenting, subjects will be randomized to receive either cooled ropivacaine, administered at approximately 4°C) or room temperature ropivacaine, administered at approximately 20-25°C), during an ultrasound-guided TAP block. Time to anesthesia, or loss of sensation, will be recorded for each subject by a single evaluator, employing the pinch technique and thermosensory perception, using a glove, filled with a slurry of ice water placed on both anesthetized and non-anesthetized areas, for approximately 5 seconds. Time to anesthesia will be recorded when there is a definitive difference on a categorical scale (painful/not painful or cold/not cold) as measured by the subject, between the anesthetized and non-anesthetized areas. Safety outcomes and opioid morphine equivalency will be recorded for all subjects, for approximately 48 hours following surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients, aged =18 years of age.
2. Patients, scheduled for surgery, with an order for a TAP block.

Exclusion Criteria:

1. Patients with a history of opioid use disorder.
2. Patients, which are scheduled as the first case of the day.
3. Patients with any history of paralysis/palsy.
4. Patients with a history of sensitivity to local anesthetics, including ropivacaine.
5. Patients, whose blocks are scheduled to be administered by a PGY-1 or PGY-2 resident.

Primary outcomes:
measure: Time to block of pain and thermosensory perception
timeFrame: 35 minutes
Secondary outcomes:
measure: Morphine equivalency units of adjunct pain medications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Daniel Wambold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04750187: Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain
Official title: Effects of Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Patients With Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. A total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic non-specific low back pain

Exclusion Criteria:

* Congenital diseases
* Rheumatic or neuro-muscular diseases
* Respiratory conditions
* Surgery
* Pregnancy

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: Change from baseline inspiratory muscle strength at 8 weeks
Secondary outcomes:
measure: Diaphragm muscle thickness
timeFrame: Change from baseline diaphragm muscle thickness at 8 weeks
measure: Pressure pain threshold
timeFrame: Change from baseline pressure pain threshold at 8 weeks
measure: Disability
timeFrame: Change from baseline disability at 8 weeks
Other outcomes:
Locations:
city: Pozuelo De Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
References:
citation: Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28.
Clinical trial NCT05865587: THE EXPERIENCES OF PROFESSIONALS WITH REFUGEE PATIENTS
Official title: A QUALITATIVE RESEARCH ON THE EXPERIENCES OF PEDIATRIC EMERGENCY SERVICE PROFESSIONALS WITH REFUGEE PATIENTS
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Emergencies
Health Personnel Attitude
Child Development
Qualitative
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The total number of healthcare professionals working in the pediatric emergency unit is 17 \[8 doctors, 9 nurses\]. Health professionals who worked in the pediatric emergency department for at least 1 year were included. Two health professionals were working for less than one year and three of them were on leave. The study was completed with a total of 12 health professionals, 8 females and 4 males. Although there is no rule specified for sample size in literature for qualitative studies, situations such as the data repeating and not obtaining additional data are important indicators for terminating the application (Yıldırım \& Şimşek, 2011b). Data saturation was reached when health professionals began to use similar or same expressions and it was achieved with 12 health professionals \[4 doctors, 8 nurses\].

Brief summary: This study was conducted to examine the experiences and feelings of health professionals while providing care to refugee children and families in pediatric emergency service.


Eligibility criteria: Inclusion Criteria:

* Health professionals who worked in the pediatric emergency department for at least 1 year were included.

Exclusion Criteria:

-

Primary outcomes:
measure: This qualitative research data were collected by semi-structured interview form
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
state: Eyalet/Yerleşke
Study officials:
affiliation: Yozgat Bozok University
name: Selda Yüzer Alsaç, DR
role: STUDY_DIRECTOR
References:
Clinical trial NCT05337787: Flipped Classroom Approach on Nursing Students' Blood Pressure
Official title: Effects of the Flipped Learning Model on Blood Pressure Knowledge and Self-directed Learning Skills of First-Year Nursing Students: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Student
Blood Pressure
Education
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Effects of the Flipped Learning Model on Blood Pressure Knowledge and Self-directed Learning Skills of First-Year Nursing Students: A Randomized Controlled Study

Detailed description: This study is to determine the effect of flipped learning model on blood pressure knowledge level and self-directed learning skills of first-year nursing students.

This study was a pre-post test open-label randomized controlled trial. Settings and Participants: This research was conducted with 94 first-year students (experimental group = 48, control group = 46) studying at a university in Turkey, Faculty of Health Sciences, Department of Nursing. The students were divided into experimental and control groups using a simple randomization method. The study data were collected using the Descriptive Characteristics Form, the Blood Pressure Knowledge Test, and the Self-Managed Learning Skills Scale. The students in the experimental group were trained using the flipped learning model. The students in the control group were trained using only a traditional education method.

Eligibility criteria: Inclusion Criteria:

* The first to enroll in the Fundamentals of Nursing course,
* Volunteer to participate in the research
* had continuous Internet Access

Exclusion Criteria:

* Having graduated from Health Vocational High School or having studied a health-related department,
* Have taken fundamentals of nursing course before

Primary outcomes:
measure: Blood Pressure Information Test
timeFrame: 15 minute
measure: Self-Managed Learning Skills Scale
timeFrame: 15 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University
Study officials:
References:
citation: Khodaei S, Hasanvand S, Gholami M, Mokhayeri Y, Amini M. The effect of the online flipped classroom on self-directed learning readiness and metacognitive awareness in nursing students during the COVID-19 pandemic. BMC Nurs. 2022 Jan 19;21(1):22. doi: 10.1186/s12912-022-00804-6.
citation: Hu R, Gao H, Ye Y, Ni Z, Jiang N, Jiang X. Effectiveness of flipped classrooms in Chinese baccalaureate nursing education: A meta-analysis of randomized controlled trials. Int J Nurs Stud. 2018 Mar;79:94-103. doi: 10.1016/j.ijnurstu.2017.11.012. Epub 2017 Nov 29.
Clinical trial NCT02914587: Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
Official title: Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: Restoration Robotics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 32
Sex: MALE
Minimum age (years): 29
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate and compare the safety and effectiveness of the ARTAS™ System to manual hair follicle implantation method following a nine month period of post-procedure evaluation.

Detailed description: This comparative study is a multi-center, prospective, blinded, randomized controlled clinical study where subjects act as their own control.

The purpose of this study is to demonstrate that the ARTAS System is safe and effective for implanting follicular hair units.

Patients will be followed for a nine months period of time.

Eligibility criteria: Inclusion Criteria:

* Subject is male with clinical diagnosis of androgenetic alopecia with Norwood-Hamilton grade of IV-VI;
* Subject is 29 to 70 years old;
* Subject has black or brown hair color;
* Subject has straight hair;
* Subject agrees to cut hair short (about 1-1.4 mm) on the scalp in the designated study areas for harvesting and implantation;
* Subject agrees to have 6 dot tattoos placed on scalp;
* Subject is able to understand and provide written consent; and
* Subject consents to post-operative follow-up per protocol.

Exclusion Criteria:

* Subject has prior history of scalp reduction surgery(s);
* Subject has prior history of hair restoration procedure(s) using the strip excision technique;
* Subject has bleeding diathesis;
* Subject has active use of anti-coagulation medication;
* Subject has used finasteride in the previous 6 months, or plans to use finasteride during the study;
* Subject has used minoxidil in the previous 2 weeks, or plans to use minoxidil during the study; or
* Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study.

Primary outcomes:
measure: Hair Survival rate 9-months post procedure
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Berman Skin Institute
state: California
Study officials:
References:
Clinical trial NCT03807687: Registry of Pancreatic Disease
Official title: Registry of Subjects Affected by Pancreatic Disease and Evaluated at the Pancreas Institute of Verona
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Diseases
Pancreatic Neoplasms
Pancreatitis
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient affected by pancreatic disease admitted to General and Pancreatic Surgery Department of Verona University Hospital from 01/01/1990 to 12/01/2046

Brief summary: This clinical data registry records information about the health status and healthcare performances received by participants affected by every type of pancreatic disease or disorder. All data (demographic, clinical, biochemical, radiological, pharmacological, genetic...) and audio and/or video recording from operative room are collected in order to be used for prospective or retrospective studies.


Eligibility criteria: Inclusion Criteria:

* any type of pancreatic disease: inflammatory and neoplastic (including solid and cystic lesions)

Exclusion Criteria:

* physically or mentally inability to provide consent

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Postoperative morbidity
timeFrame: 90 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
affiliation: AOUI Verona
name: Claudio Bassi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03266887: Vitamin D Levels and Survival in Cancer Patients
Official title: Association of Pre-diagnostic Vitamin D Levels and Survival in Older Individuals With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Lead sponsor: Icelandic Heart Association
Sponsor class: OTHER
Collaborators: name: University of Iceland
First posted: 2017-08-30
Enrollment: 5764
Sex: ALL
Minimum age (years): 66
Maximum age (years): 98
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In 1967, all 30,795 men and women living in the capital area of Iceland and born between 1907 and 1935 were invited by the Icelandic Heart Association to join a prospective cohort study. Approximately 19,000 attended the clinic at least once and became participants of the Reykjavik Study. Subsequently, in 2002, a random sample of the cohort comprising 5,764 men and women who were still alive in Iceland and aged 66 to 96 years entered the Ages Gene/Environment Susceptibility (AGES) - Reykjavik Study (20). Serum 25(OH)D was measured in 5,519 of all 5,764 (96%) participants at study entry in year 2002 through 2006.

Brief summary: Using the population-based data sources in Iceland and the well-characterized AGES-Reykjavik cohort, our overarching aims are on exploring whether pre-diagnostic serum levels of 25-hydroxyvitamin D (25(OH)D) among older individuals living in Iceland were associated with survival after cancer diagnosis. We also wanted to assess the risk of being diagnosed with cancer in association with 25(OH)D levels. In this population living just south of the arctic circle, vitamin D levels largely depend on dietary- and supplemental sources.


Eligibility criteria: Inclusion Criteria:

To be part of the AGES-Reykjavik Study, initiated between 2002 and 2006.

Exclusion Criteria:

Diagnosed with cancer at study entry

Primary outcomes:
measure: Overall mortality among cancer patients
timeFrame: Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
Secondary outcomes:
measure: Cancer-specific mortality among cancer patients
timeFrame: Patients were followed from date of diagnosis since 2002 until death or censored at end of the follow-up (December 31, 2014)
Other outcomes:
measure: Pre-diagnostic 25(OH)D levels and cancer risk
timeFrame: Participants without cancer were followed from the study entry since 2002 until cancer diagnosis, death or end of the observation period whichever occurred first (December 31, 2014)
Locations:
Study officials:
References: