louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05561062: Atorvastatin in Patients With Ulcerative Colitis
Official title: Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 50
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: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Both male and female will be included
* Negative pregnancy test and effective contraception

Exclusion Criteria:

* Breastfeeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies

Primary outcomes:
measure: Improvement in health related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: changes in the level of inflammatory biomarkers
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
References:
Clinical trial NCT06818162: MULTICENTER ULNAR NERVE ULTRASONOGRAPHIC and NEUROPHYSIOLOGICAL STUDY: NORMATIVE DATA COLLECTION
Official title: MULTICENTER ULNAR NERVE ULTRASONOGRAPHIC and NEUROPHYSIOLOGICAL STUDY: NORMATIVE DATA COLLECTION
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Collecting Normative Data of Ulnar Nerve CSA
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indication to perform an EMG/ENG for upper limb which fulfill inclusion/exclusion criteria

Brief summary: The study population will include a total of 500 subjects, selected from outpatients accessing the Neurophysiology Service for a neurophysiological study of the upper limbs. Only those whose neurophysiological examination results negative for Peripheral Nervous System pathology (i.e., negative electroneurography and electromyography according to AANEM guidelines) will be recruited. The subjects will be enrolled in 22 centers distributed throughout Italy, with our center planning to recruit 50 subjects.

The diagnostic procedures include electroneurography and electromyography, which are standard clinical practice. Ultrasound (ultrasonographic study) is not an experimental technique but is considered an additional procedure specifically included in the study protocol.

The primary objective of the study is to establish normative values for the CSA of the ulnar nerve and assess the reliability of the measurement through inter-operator comparison (between a physician and a neurophysiology technician). Therefore, during an evaluation lasting approximately 30-60 minutes, the enrolled subjects will undergo an electroneurographic/electromyographic and ultrasound study of the ulnar nerve. The latter will be performed by two independent operators (a physician and a neurophysiology technician).


Eligibility criteria: Inclusion Criteria:

* Over 18 years old EMG/ENG completely negative for pathologies of the peripheral nervous system (ENG and EMG negative according to the regulatory data of each single Center) Signature of the informed consent

Exclusion Criteria:

* Diabetes, Hepatitis, Renal Failure History of NPL or previous CT Previous pathologies of the peripheral nervous system Previous trauma to the limb in question Positive familiarity for neuromuscular disorders

Primary outcomes:
measure: CSA Normative value
timeFrame: single evaluation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02119962: A Working Memory Training in Burnout Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burnout
Keywords: burnout
working memory
working memory training
cognitive behavioral therapy
executive control
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: HSK
First posted: 2014-04-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Burnout patients show deficient working memory functioning. Several studies showed a training can increase working memory capacity. In the current study we explored whether training working memory can reduce burnout and burnout related symptoms and increase working memory capacity.


Eligibility criteria: Inclusion Criteria:

* undifferentiated somatoform disorder with a work related cause

Exclusion Criteria:

* age which exceeded the range of 18 to 67 years
* a severe major depressive episode
* substance dependence or abuse

Primary outcomes:
measure: Change in Utrechtse Burnout Scale (UBOS) score on pre and post training and two months after training
timeFrame: Baseline, post (4 weeks after baseline), after last session of cognitive behavioral therapy and follow-up (2 months after post-test)
Secondary outcomes:
measure: Change in Cognitive Failure Questionnaire (CFQ) score on pre and post training and two months after training
timeFrame: Baseline, post (4 weeks after baseline), after last session of cognitive behavioral therapy and follow-up (2 months after post-test)
Other outcomes:
measure: Change in Symptom Checklist-90-Revised (SCL-90) score on pre and post training and two months after training
timeFrame: Baseline, post (4 weeks after baseline), after last session of cognitive behavioral therapy and follow-up (2 months after post-test)
measure: Change in Digit Span score on pre and post training and two months after training
timeFrame: Baseline, post (4 weeks after baseline), after last session of cognitive behavioral therapy and follow-up (2 months after post-test)
measure: Change in Reading Span partial-credit unit score on pre and post training and two months after training
timeFrame: Baseline, post (4 weeks after baseline), after last session of cognitive behavioral therapy and follow-up (2 months after post-test)
Locations:
city: Arnhem
country: Netherlands
facility: HSK
state: Gelderland
Study officials:
References:
Clinical trial NCT06763562: Food Orders on Blood Glucose and Fuel Use At Rest
Official title: The Impact of Different Food Orders on Blood Glucose and Fuel Use At Rest
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glucose Metabolism Disorders
Hunger
Fat Burn
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Consuming a carbohydrate-rich food as the final food in a meal, as compared to the first food in a meal, has been shown to reduce blood glucose levels after eating in both diabetes patients and in healthy controls. However, gaps remain in the literature in this area of research, and currently little is known about how substrate (fuel) use is impacted by altering food order. In addition, most studies to date have used a mix of meat and plant foods, while little research has focused exclusively on vegetarian foods. This randomized experiment will examine how altering the order of foods eaten in a vegetarian meal impacts blood glucose and fuel utilization at rest.


Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* Free from any allergy or condition that precluding consumption of edamame, butter, and rice
* Not currently pregnant
* Free of any medical conditions requiring the use of insulin
* Have no history of bariatric surgery
* Have no implanted electrical devices such as a pacemaker

Exclusion Criteria:

* Younger than 18 and older than 70 years old
* Having an allergy or condition that precludes consumption of edamame, butter, and rice
* Currently pregnant
* Any medical conditions requiring the use of insulin
* A history of bariatric surgery
* Having an implanted electrical device such as a pacemaker

Primary outcomes:
measure: Respiratory exchange ratio
timeFrame: 90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
Secondary outcomes:
measure: Fat use
timeFrame: 90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
measure: Carbohydrate use
timeFrame: 90 minutes (baseline/premeal and at 30, 60, and 90 minutes postmeal)
measure: Blood glucose
timeFrame: 90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)
measure: Hunger-satiety perceptions
timeFrame: 90 minutes (baseline/premeal and 30, 60, and 90 minutes postmeal)
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Old Dominion University Human Performance Laboratory
state: Virginia
Study officials:
References:
Clinical trial NCT05975762: Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital
Official title: Outcome of Surgical Fixation of Multiple Fractured Ribs at Sohag University Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Fractures of Ribs
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ribs are rigid and flexible structures that make up the chest skeleton and are a set of twelve paired bones. After Blunt trauma rib fractures incidence is about 30 to 40% \[1\].

Due to trauma, (4th -9th) ribs are often affected and the fracture point of the ribs is often on the midaxillary line. In ( 1st\&2nd) ribs fractures subclavian vessels and brachial plexus damage may occur. In fractures in the lower ribs (8th-12th ribs), intra-abdominal organs injury such as liver, spleen and kidney should be investigated. 11-12. ribs fractures are rare because the ribs are more flexible (floating).

Pain is the most important symptom indicating rib fracture, and it usually increases with coughing, breathing, and movement. Broken rib ends can be felt with palpation with sever tenderness at the site of fracture. Pneumothorax and/or hemothorax may develop as a result of the sharp end of the broken rib causing lung parenchymal damage\[2\].


Eligibility criteria: Inclusion Criteria:

* multiple fractured ribs pre ventilation

Exclusion Criteria:

-

Primary outcomes:
measure: mechanical ventilation
timeFrame: 1 year
measure: thoracic pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Marasco SF, Martin K, Niggemeyer L, Summerhayes R, Fitzgerald M, Bailey M. Impact of rib fixation on quality of life after major trauma with multiple rib fractures. Injury. 2019 Jan;50(1):119-124. doi: 10.1016/j.injury.2018.11.005. Epub 2018 Nov 3.
citation: Schuurmans J, Goslings JC, Schepers T. Operative management versus non-operative management of rib fractures in flail chest injuries: a systematic review. Eur J Trauma Emerg Surg. 2017 Apr;43(2):163-168. doi: 10.1007/s00068-016-0721-2. Epub 2016 Aug 29.
citation: Beks RB, Peek J, de Jong MB, Wessem KJP, Oner CF, Hietbrink F, Leenen LPH, Groenwold RHH, Houwert RM. Fixation of flail chest or multiple rib fractures: current evidence and how to proceed. A systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):631-644. doi: 10.1007/s00068-018-1020-x. Epub 2018 Oct 1.
Clinical trial NCT01523262: Preventing Myocardial Ischemia by Preconditioning in Elective Operation for Abdominal Aortic Aneurysm
Official title: The Effect of Preconditioning to Prevent Perioperative Myocardial Ischemia in Elective Operation of Abdominal Aortic Aneurysm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Aortic Aneurysm
Keywords: preconditioning
aortic aneurysm
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary To investigate whether peripheral predonditioning induced by brief, intermittent constriction of blood supply to an arm can reduce the incidence of perioperative myocardial ischemia in patients operated electively for infrarenal aortic aneurysm.

Secondary To investigate the impact of peripheral preconditioning on perioperative inflammatory response.

To investigate whether peripheral preconditoning can protect against perioperative myocardial infarction and reduced cardiac pump function.


Eligibility criteria: Inclusion Criteria:

* All patients older than 18 years, hospitalized for elective surgery of abdominal aortic aneurysm

Exclusion Criteria:

* Lack of informed consent.
* Hemiparetic patient.
* Pregnancy or nursing patient.

Primary outcomes:
measure: measurements of CKMB and Troponin T
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
state: Aarhus N
city: Aalborg
country: Denmark
facility: Aalborg Hospital
Study officials:
References:
Clinical trial NCT05496062: Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
Official title: Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Positive Airway Pressure Therapy
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 91
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery.

The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

Detailed description: This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. A target recruitment goal of 45, current PAP therapy users per mask type (e.g. Nasal and Nasal Pillows) will be recruited to participate in this investigation to achieve a total sample of 90. The investigation will involve participation in a two week in home trial of the F\&P Toffee Nasal or Toffee Nasal Pillows mask.

The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

Eligibility criteria: Inclusion Criteria:

1. Persons who are ≥ 22 years of age
2. Persons who weigh ≥ 66 lbs (30 kgs)
3. Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
4. Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
5. Persons who are currently using either a nasal, sub-nasal or nasal pillows mask
6. Persons who have an IPAP pressure of \< 20 cmH2O
7. Persons who currently use a PAP therapy device with data recording capabilities
8. Persons who are fluent in spoken and written English
9. Persons who possess the capacity to provide informed consent

Exclusion Criteria:

1. Persons who are intolerant to PAP therapy
2. Persons who are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
3. Persons using full face masks
4. Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
5. Persons who are pregnant or think they may be pregnant
6. Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2

Primary outcomes:
measure: Therapeutic Efficacy
timeFrame: After two weeks of use
Secondary outcomes:
measure: Comfort
timeFrame: After two weeks of use
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Site Partners, LLC - DBA CSP Miami
state: Florida
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
References:
Clinical trial NCT05545462: Comparison Of Doxycycline And Common Salt For Treatment Of Umbilical Granuloma: A Randomised Control Trial
Official title: Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Granuloma
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 196
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: it is the study for the disease called umbilical granuloma to look for the better treatment option which can be performed by healthcare physicians and local nurses and even parents

Detailed description: umbilical granuloma is a condition for which multiple treatments are available those including interventional and non interventional, most of the treatments are performed by the health care physician like application of silver nitrate cryotherapy, electrocautery, double ligation.

the main goal of this study is to prefer those method or drugs which could be safely used by the nurses the health care personal and even by parents at home with fewer side effects

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

  1. Neonates and infants (age\<1yr)
  2. Both genders
  3. Confirmed by ultrasonography and sinography (if applicable)

Exclusion Criteria:

* 1. If any treatment is already given 2. Patient lost in follow up 3. Refusal

Primary outcomes:
measure: Comparison Of Doxycycline And Common Salt (TableCooking) For Treatment Of Umbilical Granuloma In Children: A Randomised Control Trial
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan institute of medical Sciences/ Shaheed Zulfiqar Ali Bhutto Medical University
Study officials:
References:
Clinical trial NCT02379962: Public Perception and Attitude of Chinese Towards Biomedical Research and Biobanking in China
Official title: Public Perception and Attitude of Chinese Towards Biomedical Research and Biobank in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Public Knowledge and Attitude Towards Biospecimen-based Research and Their Willingness to Participate in Biobanking
Keywords: biobanking
research participation
China
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 478
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese people

Brief summary: The purpose of this study is to collect date related to public knowledge and attitude towards biospecimen-based research and their willingness to participate in biobanking in China.


Eligibility criteria: Inclusion Criteria:

* individuals aged 18 years and above
* could understand the content of the questionnaire and express themselves
* voluntary to participate in this survey

Exclusion Criteria:

* history of mental illness or the deaf
* not able to express their views and opinions clearly

Primary outcomes:
measure: measure public knowledge of biobanking and biospecimen-based research with self-complied questionnaire
timeFrame: 4 months
measure: measure public attitude towards biobanking and biospecimen-based research with self-complied questionnaire
timeFrame: 4 months
measure: measure public willingness to participate in biobank with self-complied questionnaire
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: XinHua Hospital Afficilated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT06308562: Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease
Official title: A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking.


Eligibility criteria: Inclusion Criteria:

* \>18 years
* Male and female
* Transtibial amputation expected.
* Peripheral arterial disease and Transcutaneous partial pressure of oxygen (TCP02, if performed)
* Ability of subject to give appropriate consent or have an appropriate representative available to do so.

Exclusion Criteria:

* Known allergies to any of the components of the compression.
* Terminal illness or current cancer therapy with chemotherapy
* Inability to undergo ongoing care in Rochester.
* Lack of cognitive ability to follow instructions or monitor residual limb.
* Vulnerable study population
* Pregnancy

Primary outcomes:
measure: Surgical site infection
timeFrame: 8 weeks post-operatively
measure: Wound dehiscence
timeFrame: 8 weeks post-operatively
measure: Days on negative pressure wound therapy
timeFrame: 8 weeks post-operatively
measure: Pain control
timeFrame: 8 weeks post-operatively
measure: Time to prosthetic fitting
timeFrame: 8 weeks post-operatively
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 8 weeks post-operatively
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Melin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: