louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05113732: Association of Cognition With Functional Mobility in People With Alzheimer's Disease
Official title: Association of Cognition With Functional Mobility in People With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Dementia
Alzheimer's Disease
Dementia, Alzheimer Type
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Alzheimer's disease

Brief summary: This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease.

Detailed description: Our hypothesis is that the decrease in cognitive function in individuals with Alzheimer's disease is associated with the level of functional mobility. Sociodemographic information of participants will be recorded. Cognition will assessed with Montreal Cognitive Assessment (MoCA), global score and MoCA's visuospatial executive functions, naming, attention, language, abstract thinking, delayed recall, orientation sub-scores will recorded. Functional mobility will assessed Timed Up and Go Test and 5 Times Sit\&Stand Test.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Alzheimer's disease according to the National Institute of --Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
* Over 65 years old,
* Cases who could understand the instructions given in Turkish were included in the study,
* Having ambulation skill independently or with walking aid.

Exclusion Criteria:

* Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
* Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
* Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
* Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.

Primary outcomes:
measure: Montreal Cognitive Assesment (MoCA)
timeFrame: Baseline
measure: Timed Up and Go Test
timeFrame: Baseline
measure: 5 Time Sit to Stand Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
Clinical trial NCT06551532: "Ecological Program Changes Pelvic Kinematics in Soccer Players: Pilot Study on Hamstring Injury Implications"
Official title: An In-season Ecological Program Performed by Soccer Players Changes Pelvic Kinematics During Static, Linear Sprinting and Sport-specific Tasks: a Pilot Study on the Implication for Hamstring Injuries.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Pelvic Tilt
Sprint Kinematics
Keywords: Hamstring strain
Muscle Injury
Pelvic Tilt
Sprint Kinematics
Sprint Mechanics
Lead sponsor: RX2 Sports and Health
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either an intervention group receiving the multicomponent intervention or a control group with no intervention, with both groups being monitored concurrently throughout the 6-week period.
Primary purpose: PREVENTION

Brief summary: The present pilot study aimed to investigate whether a 6-week multicomponent intervention, comprising a structural lumbopelvic and sprint technique program, could reduce anterior pelvic tilt in soccer players who regularly participated in soccer practice.

Detailed description: This pilot study aimed to evaluate the impact of a 6-week multicomponent intervention combining lumbopelvic control exercises and running technique training on pelvis structure and lower limb kinematics in semi-professional soccer players. Seventeen players were randomly assigned to a control group (CG) or an intervention group (IG). Data on static anterior pelvic tilt (APT) and three-dimensional kinematics during high-speed running (HSR) and high-speed soccer running (HSSR) were collected before (PRE) and after (POST) the intervention period.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for both groups were: (a) being between 18 and 40 years old, and (b) being available for their teams

Exclusion Criteria:

* Exclusion criteria for both groups included (a) not having suffered any musculoskeletal injuries in the previous 3 months and (b) not being involved in any additional strength program outside of their regular team training.

Primary outcomes:
measure: Anterior Pelvic Tilt (APT) Reduction.
timeFrame: Baseline (PRE) and immediately after 6 weeks of intervention (POST).
Secondary outcomes:
measure: biomechanical variables during high-speed running (HSR) and high-speed soccer running (HSSR) tasks
timeFrame: Baseline (PRE) and immediately after 6 weeks of intervention (POST).
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: RX2 Sports and Health
Study officials:
References:
Clinical trial NCT04094532: Transversus Thoracic Muscle Plane Block for Open Heart Surgery
Official title: Ultrasound Guided Transversus Thoracic Muscle Plane Block for Open Heart Surgery: Randomized Controlled Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Pain, Chest
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 48
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: Poststernotomy pain is a complication of cardiac surgery. Poorly controlled pain is associated with myocardial ischemia, cardiac arrhythmias, hypercoagulability, pulmonary complications, and increased rates of delirium and wound infection.

The transverse thoracic muscle plane (TTMP) block is a novel plane block that provide pain for sternotomy. The aim of this study was to evaluate the analgesic effect of ultrasound guided TTMP block in patients undergoing open heart surgery.


Eligibility criteria: Inclusion Criteria:

American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart Surgery

Exclusion Criteria:

chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: first 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postextubation 0-24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
References:
citation: Murata H, Hida K, Hara T. Transverse Thoracic Muscle Plane Block: Tricks and Tips to Accomplish the Block. Reg Anesth Pain Med. 2016 May-Jun;41(3):411-2. doi: 10.1097/AAP.0000000000000374. No abstract available.
Clinical trial NCT04900532: Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients
Official title: Effects of Supplementation With Tocotrienol on Inflammation, Oxidative Stress and Microbiota of Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Hemodialysis
Microbiota
Oxidative Stress
Inflammation
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2021-05-25
Enrollment: 61
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: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to evaluate the supplementation with tocotrienol, a vitamin E compound on inflammation, oxidative stress, and microbiota on Chronic Kidney Disease patients.

Detailed description: In Chronic Kidney Disease (CKD), inflammation and oxidative stress are common statuses, which are aggravated by renal replacement therapy such as hemodialysis. Currently, intestinal microbiota imbalance has been associated with both inflammation and oxidative stress. In this regard, strategies in the management of this framework are necessary. It has been observed that vitamin E plays an important role in the modulation of transcription factors involved in inflammation such as NF-kB and Nrf2, acting on cell membrane protection and tissue recovery. Its benefits have been proven both in renal and intestinal health, however, studies analyzing the vitamin E supplementation in the modulation of intestinal microbiota with consequent effect on CKD and its reflexes are scarce. Thus, the current randomized, double-blind, placebo-controlled study will evaluate the effects of vitamin E supplementation on the modulation of the expression of nuclear cytokine (NF-kB e Nrf2), activators and inhibitors, as well as, on inflammation and oxidative stress and on the modulation of the intestinal microbiota in patients CKD.

Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease
* Aged from 18 to 60 years
* Must be able to swallow capsules

Exclusion Criteria:

* Pregnant patients
* Smokers
* Using antibiotics in the last 3 months
* Using antioxidant supplements in the last 3 months
* Usual intake Autoimmune
* Hemodialysis started less than 6 months for hemodialysis patients

Primary outcomes:
measure: Change in antioxidants and anti-inflammatory biomarkers
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in inflammatory biomarkers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
Study officials:
References:
Clinical trial NCT02000232: Impact of Unapproved Drug Initiative on Colchicine Use
Official title: Impact of Unapproved Drug Initiative on Colchicine Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gout
Keywords: gout
colchicine
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults diagnosed with gout. Patient's from Stanford hospital and clinics and VA Palo Alto Heath care system are eligible

Brief summary: Measure if FDA regulation of Colchicne in 2009 has resulted in safer use in clinical settings.

Our study will assess the impact of this Initiative on colchicine use and will provide data that supports its continuation and expansion.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of gout
* Current use of colchicine/colcrys to treat gout
* Ablility to provide Informed consent

Exclusion Criteria:

-Inability to provide Informed consent

Primary outcomes:
measure: Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice.
timeFrame: This is an oberservational study and patients will be followed for upto 2 years from enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
Study officials:
References:
Clinical trial NCT01845532: Analgesic Effect of Trigger Point Injection and EMLA for Shoulder Pain in Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myoma of Uterus
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparoscopic operative procedures have revolutionized gynecological surgery. These have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs. However, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge. Trigger point injection removes the pain developing point and block the pain signal. EMLA cream shows analgesic effect when being spread on the skin. An literature showed that patch of local anesthetics showed the effect of trigger point inject. The purpose of this study is to investigate the alleviation of shoulder pain, headache, abdominal pain, and back pain after trigger point injection or EMLA cream applying on shoulder in patients undergoing total laparoscopic hysterectomy.


Eligibility criteria: Inclusion Criteria:

* ASA class I or II
* age 20\~70
* patients undergoing total laparoscopic hysterectomy

Exclusion Criteria:

* history of shoulder surgery
* coagulopathy
* infection or trauma of shoulder
* general inflammation
* allergy to local anesthetics

Primary outcomes:
measure: postoperative shoulder pain
timeFrame: 3 hr after end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT05705232: Inflammatory Marker in Ibd and Peripheral Arthritis
Official title: Correlation Between Disease Activity of Inflammatory Bowel Disease, Inflammatory Markers and Peripheral Arthritis .
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IBD-Inflammatory Bowel Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient With inclusion criteria attending Internal Medicine Department clinics ,Assiut University Hospital

Brief summary: The Objective Of This Study Is To Estimate The Correlation Between Disease Activity In IBD, Inflammatory Markers And Peripheral Arthritis After Exclusion Of Other Causes Arthritis

Detailed description: Inflammatory Bowel Diseases (IBD) Are Chronic Relapsing Inflammatory Disorder Of The Gastrointestinal Tract (GIT) , Which Represented Mainly By Ulcerative Colitis (UC) And Crohn's Disease .

IBD Is To Be Considered Systemic Disease Since They Are Often Associated With Extra intestinal Manifestation, Especially During Activity, Which Reflect A Pathogenic Mechanism As Arthritis ,Erythema Nodosum ,Pyoderma Gangrenosum , Apthous Ulceration ,Iritis And Uveitis.

Peripheral Arthritis (Pa) Is Observed Rather Than Frequently, The Arthritis Involves Predominantly The Joint Of The Lower Limb ,And In Most Cases It Accompanies The Activity Of The Intestinal Disease Pauciarticular, Asymmetric, Migratory And Non Deforming.

Predicting Relapse By Measuring Non Invasive Biomarkers Could Allow Early Treatment Adaptation .Several Studies Have Shown A Correlation Between Intestinal Inflammation And Serum C-Reactive Protein Or Fecal Calprotectin Levels .

Eligibility criteria: Inclusion Criteria:

* 1-Pt Above 18 Yrs. 2- IBD Pt. Confirmed By Colonoscopy 3- IBD Patient with Arthritis During Activity

Exclusion Criteria:

* 1-Age Below 18 Yrs. Old 2-Arthritis Of Other Causes Than IBD PT

Primary outcomes:
measure: Correlation between IBD Patients Presented With Peripheral Arthritis and degree of Disease activity
timeFrame: 1/2/2023to 1/12/2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Eman Mohamed
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mostafa Mansor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Nabila Fayek
role: STUDY_CHAIR
References:
citation: Palm O, Moum B, Jahnsen J, Gran JT. The prevalence and incidence of peripheral arthritis in patients with inflammatory bowel disease, a prospective population-based study (the IBSEN study). Rheumatology (Oxford). 2001 Nov;40(11):1256-61. doi: 10.1093/rheumatology/40.11.1256.
Clinical trial NCT02060032: 1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
Official title: COMPARATIVE EVALUATION OF CLINICAL EFFICACY OF SUBGINGIVALLY DELIVERED 1.2% ATORVASTATIN AND 1.2% SIMVASTATIN IN TREATMENT OF CHRONIC PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis, Local drug delivery,
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 96
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Statins are the recently evolved agents that aid in periodontal regeneration and ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2% SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic periodontitis.

Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic defect depth reduction was evaluated using computer-aided software at baseline, 6 months and 9 months.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe CP subjects with PD ≥ 5 mm or clinical attachment level (CAL) ≥ 4 mm and vertical bone loss ≥3 mm on intraoral periapical radiographs and no history of antibiotic or periodontal therapy in the preceding 6 months

Exclusion Criteria:

* Individuals with systemic diseases known to alter the course of periodontal disease and treatment outcome, known or suspected allergy to the SMV/ATV/statin group, those on systemic SMV/ATV/statin therapy, individuals with aggressive periodontitis, use of tobacco in any form, alcoholics, individuals with diabetes, immunocompromised individuals, and pregnant or lactating females

Primary outcomes:
measure: Change in Radiographic intra-bony defect depth.
timeFrame: 9 months from baseline
Secondary outcomes:
measure: Change in Probing depth.
timeFrame: 9 months from baseline
measure: Change in Relative attachment level
timeFrame: 9 months from baseline
measure: Change in mSBI (gingival index)
timeFrame: 9 months from baseline
measure: Change in plaque index
timeFrame: 9 months from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Avani R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00128232: Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
Official title: Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
untreated
newly diagnosed
octreotide LAR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or previously untreated acromegalic patients
* Lack of suppression of growth hormone (GH) nadir to \<1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test \[OGTT\])
* Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

Exclusion Criteria:

* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
* No evidence of pituitary adenoma on magnetic resonance imaging (MRI)
* Symptomatic cholelithiasis

Primary outcomes:
measure: Mean GH and IGF-I at baseline, week 12, 24 and 48
Secondary outcomes:
measure: Tumor volume at baseline, week 24 and 48
measure: Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
measure: Safety and tolerability at any time on treatment
Other outcomes:
Locations:
Study officials:
affiliation: Universität Duisburg-Essen
name: Stephan Petersenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398332: Evaluation of the GORE® C3 Delivery System Module
Official title: Global Registry for Endovascular Aortic Treatment (GREAT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 399
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo endovascular treatment for aortic pathologies with the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

Brief summary: This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

Detailed description: This is a retrospective and prospective observational cohort Registry designed to obtain data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System. Patient and device performance outcomes will be collected during treatment and throughout all post-treatment visits, including follow-up extending up to 10 years.

Eligibility criteria: Inclusion Criteria:

1. Minimum age required by local regulations (as applicable)
2. Indication for aortic endovascular stent graft repair as determined by the treating physician (refer to current Instructions for Use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System)

Primary outcomes:
measure: Evaluate procedural outcomes for the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System when used in accordance with the standard medical practice at each participating hospital.
timeFrame: Up to 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Nurnberg
country: Germany
facility: Klinikum Nürnberg-Süd
Study officials:
affiliation: Klinikum Nürnberg-Süd
name: Eric Verhoeven, MD
role: PRINCIPAL_INVESTIGATOR
References: