louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07016529: Diagnostic Study for Differentiating Functional From Organic Diseases in Patients With Lower GIT Symptoms
Official title: Diagnostic Utility of Myeloperoxidase for Differentiating Irritable Bowel Syndrome From Inflammatory Bowel Disease in Patients With Lower GIT Symptoms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Irritable Bowel Syndrome (IBS)
Inflammatory Bowel Disease (IBD)
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with lower GIT symptoms seeking medical advice at Department of Internal Medicine, Gastroenterology Outpatient Clinic, Sohag University Hospital

Brief summary: The study is intended to find a new trusted, cost-effective biomarker for differentiating irritable bowel syndrome from inflammatory bowel disease to decrease the use of unnecessary invasive methods in patients with irritable bowel syndrome

Detailed description: Myeloperoxidase is a lysosomal protein that is released from granules of neutrophil granulocytes during inflammation. the study design relies on the fact that there is no mucosal inflammation in case of functional gastrointestinal tract (GIT) disorders like irritable bowel syndrome (IBS), but organic gastrointestinal conditions like inflammatory bowel diseases (IBD) has mucosal inflammation and neutrophil influx into the mucosa.

the study is designed to assess myeloperoxidase levels in both conditions and assessing its reliability in differentiation between them.

Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years) presenting with chronic lower gastrointestinal symptoms, such as diarrhea, abdominal pain, or altered bowel habits, for a duration exceeding 6 weeks.
* Patients with no prior diagnosis of IBD or IBS.
* Patients willing to provide informed consent and comply with study requirements.
* Those without recent use of immunosuppressants or anti-inflammatory medications that could affect biomarker levels

Exclusion Criteria:

* Patients with a confirmed diagnosis of IBD and currently on treatment.
* Those with acute gastroenteritis, infectious colitis, or positive stool cultures for pathogens.
* Patients diagnosed with colorectal cancer, celiac disease, or other known organic GI disorders.
* Recent antibiotic, NSAID, or corticosteroid use within the past 4 weeks.
* Pregnant or lactating women.

Primary outcomes:
measure: efficacy of myeloperoxidase for differentiating irritable bowel syndrome from inflammatory bowel disease.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04748029: Evaluation of the Prognostic Role of the Systemic Immune Inflammation Index in Postmenopausal Osteoporosis
Official title: Evaluation of the Prognostic Role of the Systemic Immune Inflammation Index in Postmenopausal Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Osteoporotic Fractures
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In the study, the data of 139 patients who were evaluated in our clinic between January 2017 and January 2020 with a pre-diagnosis or diagnosis of postmenopausal osteoporosis were retrospectively reviewed.

Brief summary: This study is a retrospective case-control study. In the study, the data of 304 patients who were evaluated in our clinic between January 2017 and January 2020 with a pre-diagnosis or diagnosis of postmenopausal osteoporosis were retrospectively reviewed. Lumbar 1-4 and femoral neck bone mineral densitometry values T scores, ages, sedimentation, C-reactive protein, neutrophil, leukocyte and platelet levels, and mean platelet volume values of the patients were recorded. The neutrophil-lymphocyte ratio was calculated by dividing the neutrophil count by the lymphocyte count, and the platelet-lymphocyte ratio was calculated by dividing the platelet count by the lymphocyte count. The systemic immune inflammation index (SII) was calculated using the formula, SII = platelet count x neutrophil count / lymphocyte count. The aim of this study is to evaluate the prognostic value of the systemic immune inflammation index in postmenopausal osteoporosis and to examine the SII, N / L, PLT / L, MPV, sedimentation (ESR), C reactive protein (CRP), femur and lumbar BMD values and their relationships with each other.


Eligibility criteria: Inclusion Criteria:

* Having applied to our clinic with the diagnosis or pre-diagnosis of postmenopausal osteoporosis or osteoporosis with pathological fractures

Exclusion Criteria:

* Having a diagnosis of osteoporosis due to conditions other than postmenopausal osteoporosis
* Those with acute or chronic infection, malignancy and systemic diseases that may change the hematological inflammation parameters to be checked
* Persons who are missing one or more of the parameters planned to be considered among the obtained data

Primary outcomes:
measure: Systemic immune inflammation index (SII)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
state: Çankaya
Study officials:
References:
Clinical trial NCT00454129: ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis
Official title: ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiography
Keywords: Feasibilty of cholangiography via double-balloon enteroscopy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-03-30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed anatomy commonly not possible. The aim of the study is to test the feasibility to perform direct cholangiography in these patients via double-balloon enteroscopy and to compare it to MR cholangiography.


Eligibility criteria: Inclusion Criteria:

* Biliodigestive anastomosis; and
* Suspicion of biliary disorder

Exclusion Criteria:

* Exclusion criteria of double-balloon enteroscopy and MR-cholangiography

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Medical University of Heidelberg, Department of Gastroenterology
Study officials:
affiliation: Medical University of Heidelberg
name: Jens Encke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02214329: Sensor-based Balance Training in Diabetes: A Virtual Reality Paradigm
Official title: Game-Based Virtual Reality Approach for Improving Balance, Reducing Falls, and Preventing Complications In Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: Postural Balance
Gait
Fall risk
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Qatar National Research Foundation, Qatar
First posted: 2014-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients, thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy of a virtual reality game based exercise training for improving postural body sway and gait in diabetes patients with peripheral neuropathy. The exercise training has been specifically designed for DPN patients with lost lower extremity joint perception and uses state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time joint feedback through an interactive interface on a LCD monitor. The investigators hypothesize that tailored exercise with real-time visual joint feedback during exercise will reduce improve balance and gait.

Detailed description: The game includes a series of ankle reaching tasks and crossing of virtual obstacles on the monitor screen; these exercises are aimed to improve weight shifting capabilities and medial-lateral movement of body.

Eligibility criteria: Inclusion Criteria:

* Diabetic peripheral neuropathy
* Age \> 50 (Men or Women)
* Able to walk 60 feet

Exclusion Criteria:

* Major lower extremity amputation
* Cognitive deficits (MMSE 24 or below)
* Severely impaired vision

Primary outcomes:
measure: Postural Balance
timeFrame: 6 weeks
measure: Gait
timeFrame: 6 weeks
Secondary outcomes:
measure: Physical Activity
timeFrame: 6 weeks
measure: Functional Performance
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University Medical Center
state: Arizona
Study officials:
References:
Clinical trial NCT05599529: A Retrospective Cohort Study of Differential Attainment, COVID-19 and Chaos
Official title: A Retrospective Cohort Study of Differential Attainment, COVID-19 and Chaos: Taking the Difference Out of a Terrible Trinity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
COVID-19
Keywords: Core Surgical Training
Differential Attainment
COVID-19
Lead sponsor: Health Education and Improvement Wales
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 303
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Core Surgical Trainees in HEIW 2014-2022

Brief summary: A retrospective cohort study of Differential Attainment, COVID and Chaos: taking the difference out of a terrible trinity

Detailed description: Background: This study aimed to evaluate Core Surgical Training (CST) Differential Attainment (DA) related to COVID-19 and gender in three ethnic cohorts: White UK (WUKG), Black \& Minority Ethnic UK (BMEUKG), and International Medical Graduates (IMG). The hypothesis was that COVID-19 adversely influenced CST outcome.

Methods: Anonymised 234 CST and 37 IST records (152 WUKG, 81 BMEUKG, 38 IMG) in a UK Statutory Education Body (SEB) were examined. Primary effect measures were: Annual Review of Competency Progression Outcome (ARCPO), MRCS pass, and National Training Number (NTN) appointment.

Eligibility criteria: Inclusion Criteria:

* CST

Exclusion Criteria:

* Not completed training

Primary outcomes:
measure: Successful outcome in Membership of the Royal College of Surgeons examination
timeFrame: 2014-2022
measure: Succesful Annual Review of Competence Progression Outcome
timeFrame: 2014-2022
measure: National Training Number Appointment
timeFrame: 2014-2022
Secondary outcomes:
measure: Operative Logbook Volume
timeFrame: 2014-2022
measure: Attrition rate
timeFrame: 2014-2022
Other outcomes:
Locations:
city: Nantgarw
country: United Kingdom
facility: HEIW School of Surgery
state: Caerdydd
Study officials:
affiliation: HEIW
name: Osian James
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06445829: Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty
Official title: Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: intraarticular injection
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. However, the safety accumulation dose for simultaneous bilateral knee injection is still an issue. Recently, adding magnesium sulfate to intraarticular cocktail injection in unilateral total knee arthroplasty has been proved effective for prolong pain control. We tempt to conduct a double blinded study to evaluate that whether adding magnesium sulfate intraarticular cocktail injection to one of the knees in simultaneous bilateral total knee arthroplasty patient could effectively decrease pain score with less analgesia dose or not.


Eligibility criteria: Inclusion Criteria:

* bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty

Exclusion Criteria:

* hypersensitivity to magnesium sulfate
* hypermagnesemia
* severe cardiac, hepatic or renal compromised

Primary outcomes:
measure: VAS score
timeFrame: day 0, day 1, day 2, day 3, day 7
measure: muscle power
timeFrame: day 0, day 1, day 2, day 3
measure: Straight leg raised test
timeFrame: day 0, day 1, day 2, day 3
measure: active range of motion
timeFrame: day 0, day 1, day 2, day 3
Secondary outcomes:
measure: Magnesium level in blood
timeFrame: day 0, day 1
measure: Calcium level in blood
timeFrame: day 0, day 1
Other outcomes:
Locations:
Study officials:
References:
citation: Zhao C, Wang L, Chen L, Wang Q, Kang P. Effects of magnesium sulfate on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial. J Orthop Surg Res. 2023 Apr 14;18(1):301. doi: 10.1186/s13018-023-03790-w.
citation: Wang Q, Zhao C, Hu J, Ma T, Yang J, Kang P. Efficacy of a Modified Cocktail for Periarticular Local Infiltration Analgesia in Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2023 Mar 1;105(5):354-362. doi: 10.2106/JBJS.22.00614. Epub 2023 Mar 1.
Clinical trial NCT02122029: Lifestyle vs.Surgery for Morbid Obesity Treatment
Official title: A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Morbid Obesity
Keywords: Lifestyle intervention
Bariatric surgery
Weight management
Physical activity
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: The University of Texas Medical Branch, Galveston
First posted: 2014-04-24
Enrollment: 29
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.

Detailed description: Behavioral/lifestyle interventions produce acceptable success in treating moderately obese subjects. However, their effectiveness on weight loss and maintenance in morbidly obese subjects remains elusive.

Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty. Subjects in the lifestyle group attended 30 behavioral modification sessions over three years, whereas the surgery group received the standard of care nutrition. Body weight, resting metabolic rate, physical activity, body composition measurements and dietary intake data were assessed at standard time points during the first 3 years post-intervention. Follow-up data on body weight and physical activity were also collected 9 years later.

Eligibility criteria: Inclusion Criteria:

* female sex
* Age ≥ 18 years
* BMI ≥ 40 kg/m2
* Absence of mental illness as determined by evaluation by an experienced psychiatrist
* Additional inclusion criteria for vertical banded gastroplasty were history of multiple, non-successful, previous attempts for weight loss

Primary outcomes:
measure: The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
timeFrame: 9 years
Secondary outcomes:
measure: Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.
timeFrame: 9 years
measure: Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.
timeFrame: 3 years
measure: Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.
timeFrame: 3 years
measure: Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.
timeFrame: 3 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Harokopio University
Study officials:
affiliation: Department of Internal Medicine, Surgery, and Nutrition and Metabolism, University of Texas Medical Branch at Galveston, Texas, USA
name: Labros S Sidossis, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01305629: Intervention Targeting Substance Using Older Adults With HIV
Official title: Intervention Targeting Substance Using Older Adults With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Medication Adherence
Substance Dependence
Keywords: HIV
Medication Adherence
Substance Use
Older adults
Treatment
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: Fordham University
First posted: 2011-03-01
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study uses a randomized controlled experimental design to evaluate the efficacy of a brief intervention using spiritual self schema (3S+) counseling to simultaneously target HIV health outcomes, and substance use among alcohol and/or drug dependent HIV positive older adults (age 50+), relative to an attention control condition. Participants will be randomly assigned to receive either: (1) 12 sessions of 3S+ counseling, adapted for the present study to target both non-injection drug use, drinking, and HIV health; or (2) 12 sessions of education about HIV health and the associated with alcohol and drug use that will serve as an attention-control.


Eligibility criteria: Inclusion Criteria:

* HIV+ (provide HIV medication bottle with name on it)
* Age 50 or older (provide picture ID with DOB at baseline)
* Report current alcohol/drug dependence (AUDIT score of 8 or DAST-10 score of 4 on screener; C-DIS at baseline)
* On a prescribed HAART medication regimen and reports sub-optimal adherence (self-report missed at least 3 days in last 30 at 1 pill/day that is 90%)
* Communicate with staff and complete a survey in English or Spanish (English only for the pilot)

Exclusion Criteria:

* Current intravenous drug use (self-report at screener and baseline)
* Currently in a methadone drug treatment program (screener self-report)
* Unstable, serious psychiatric symptoms (SCID-Psych at baseline)
* Currently suicidal/homicidal (SCID-Psych at baseline)
* Gross cognitive impairment (Mini-Mental at baseline)
* Current enrollment in alcohol/drug treatment or HIV study (screener self-report)

Primary outcomes:
measure: Adherence to HIV medication
timeFrame: every four months over the course of a year
measure: Substance use
timeFrame: every four months over the course of a year
Secondary outcomes:
measure: Mental Health/Quality of Life
timeFrame: every four months over the course of a year
measure: Sexual Risk
timeFrame: every four months over the course of a year
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
state: New York
Study officials:
affiliation: Hunter College, CUNY
name: Jeffrey T. Parsons, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05489029: Peculiarities of Pain in Patients With Gunshot Wounds Depending on the Localization of the Wound at the Stages of Treatment
Official title: Peculiarities of Pain in Patients With Gunshot Wounds Depending on the Localization of the Wound at the Stages of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: pain
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 1555
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients were injured during hostilities

Brief summary: Chronic pain, in turn, is associated with a whole cohort of mutually aggravating factors - this can lead to the development of extremely serious long-term consequences. The features of pain in this category of patients have not been sufficiently studied. Taking into account continuity and consistency, clear and high-quality pain treatment is necessary at all stages of treatment.

Detailed description: The peculiarities of pain in patients with gunshot wounds, depending on the localization of the wound at the stages of treatment, need to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics.

Eligibility criteria: Inclusion Criteria:

* the presence of gunshot wounds

Exclusion Criteria:

* no gunshot wounds

Primary outcomes:
measure: visual analog scale
timeFrame: 12 months
measure: pain diagnostic questionnaire
timeFrame: 12 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Chaban Quality of Life Scale
timeFrame: 12 months
measure: Mississippi PTSD scale (military version)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets National Medical University, Ministry of Health of Ukraine
Study officials:
References: