louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05595902: Normative Value for Navicular Drop Test in Older Adults
Official title: Determination of Normative Values of Navicular Height and Navicular Drop Amount in Geriatric Individuals and Investigation of the Effect of Age, Gender and Body Mass Index on Normative Values
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 445
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy older adults

Brief summary: The aim of this study is to determine the normative values of navicular height and navicular drop in individuals over 65 years of age. The secondary aim is to investigate the effects of age, gender, and body mass index on these normative values.


Eligibility criteria: Inclusion Criteria:

* Being 65 years or older
* Having a body mass index between 18.5 and 29.0 kg/m2

Exclusion Criteria:

* Having chronic diseases that affect the foot structure and connective tissue (such as diabetes mellitus, rheumatoid arthritis, gout, etc.).
* Have had foot or ankle surgery in the last 6 months
* Having orthopedic or neurological deformities (related to stroke, Parkinson's, multiple sclerosis, spinal cord injury, etc.) that will affect the foot structure and mobility.
* Dependence on standing and ambulation (except independence gained through the use of assistive devices)

Primary outcomes:
measure: Navicular Drop Test
timeFrame: 10 minutes
Secondary outcomes:
measure: Age
timeFrame: 1 minute
measure: Gender
timeFrame: 1 minute
measure: Body-Mass index
timeFrame: 3 minutes
measure: Foot Posture Index
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00572884: Metabolism of the Insecticide Permethrin
Official title: CCRC:Identification and Development of Biological Markers of Human Exposure to the Insecticide Permethrin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Metabolism
Keywords: permethrin
pyrethroid
pharmacokinetics
metabolism
accelerator mass spectrometry
human exposure
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2007-12-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Military personnel are exposed to the insecticide permethrin when using the DOD Insect Repellent System. A urinary metabolite of permethrin that is in high abundance and is relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a biomarker can prevent over-exposure. The objectives are to identify the most abundant human urinary metabolite following dermal exposure; to utilize this information to develop rapid laboratory-based and field portable methods to monitor the degree of an individual's exposure to permethrin.

Detailed description: Permethrin is applied to the forearm of the subject and remains for 8 hours. The exposed area is then washed with soap and water several times. 24 hour urine samples are collected at daily intervals for 192 hours. Blood and saliva samples are taken at pre-dose, 1, 3, 6, 9 12, 24, 48, 72, 96, 120, 144, 168 and 192 hours. Subjects must return to the clinic daily to drop off urine collections and have blood and saliva samples taken.

Eligibility criteria: Inclusion Criteria:

* self-report healthy adult men and premenopausal women

Exclusion Criteria:

* unusual alcohol, drug, cigarette use for last 3 years
* unusual exercise program for last 3 years
* under the care of a physician for a disease
* participated in any radioactive drug study
* pregnant
* lactating
* people who rely more on their arm due to illness or injury
* people with neurological or musculoskeletal diseases
* use of permethrin in the last 6 months
* people who apply pesticides as their primary occupation

Primary outcomes:
measure: Concentration of individual metabolites in urine
timeFrame: 192 hours
Secondary outcomes:
measure: total carbon-14 in serum
timeFrame: 192 hours
measure: Total carbon-14 in saliva
timeFrame: 192 hours
measure: Total carbon-14 in urine samples
timeFrame: 192 hours
Other outcomes:
Locations:
city: Mather
country: United States
facility: CTSC Research Center
state: California
Study officials:
affiliation: University of California, Davis
name: Bruce D Hammock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03843684: Effects of 3D-printed on Lower Extremity Biomechanics in Individuals With Knee Osteoarthritis
Official title: Effects of 3D-printed Insoles on Lower Extremity Biomechanics and Knee Joint Loading During Walking and Stair Climbing in Individuals With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medial Knee Osteoarthritis
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2019-02-18
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purposes of this study are: (1) to determine the kinematics, kinetics, and muscle co-activation ratio of level walking and stair negotiation under three different conditions (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges), (2) to build a detailed patient-specific knee model via MR images and musculoskeletal model, then, evaluate the compressive forces acting on the medial aspect of the knee during level walking and stair negotiation.

Detailed description: This study is a cross-sectional study with patients serving as their own control. The investigators will recruit 20 patients with knee osteoarthritis. Using motion capture system, force plates, wireless EMG to capture the motion data of patients during walking and stair negotiation in each condition.

Eligibility criteria: Inclusion Criteria:

* Medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
* Aged from 50 to 70 years

Exclusion Criteria:

* Neuromuscular illness (e.g., Parkinson disease, Neuropathy)
* Predominant lateral or patella-femoral OA
* Previous of planned hip or knee replacement
* Hip or ankle arthritis
* Rheumatoid arthritis
* Unable to walk without a cane or walker
* Unable to walk up and down the stairs

Primary outcomes:
measure: Knee adduction moment during level walking and stair negotiation
timeFrame: 10 minutes
measure: Medial knee joint contact force during level walking and stair negotiation
timeFrame: 10 minutes
measure: Muscle co-activation ratio during level walking and stair negotiation
timeFrame: 10 minutes
Secondary outcomes:
measure: Knee flexion moment during level walking and stair negotiation
timeFrame: 10 minutes
measure: Path of center of pressure during level walking and stair negotiation
timeFrame: 10 minutes
measure: Lower limbs joint angles during level walking and stair negotiation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: Li-Wei Chou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04890184: Grape Juice and Dermatitis in Breast Cancer
Official title: The Effect of Grape Juice Consumption on Radiotherapy-induced Dermatitis in Breast Cancer - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effect of grape juice on acute radiation dermatitis in breast cancer (BC) patients undergoing radiotherapy (RT). 50 eligible BC patients will randomly assign to consume 100 gr of grape juice per day during and 1 week after RT or with no intervention (control group). The radiation dermatitis will be assessed weekly according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/EORTC) scales.

Detailed description: Dietary intake of patients will be examined by expert dietitians at baseline and end of RT using the average of three-day 24-hour recalls. Weight (kg), body fat percentage, skeletal muscle percentage and visceral fat level will be measured using the OMRON Body Composition Monitor and Scale.

Eligibility criteria: Inclusion Criteria:

* women with Brest Cancer undergoing adjutant Radiation therapy

Exclusion Criteria:

* previous history of RT, MRM,
* concomitant presence of two or more malignant tumors
* metastasis to other areas
* allergy or intolerance to tahini
* skin diseases and wounds
* severe liver and renal disease
* autoimmune diseases
* pregnant and lactating women
* those who treated with hypo fraction RT

Primary outcomes:
measure: severity of dermatitis
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05121584: Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth
Official title: Evaluation of Two Different Types of Zirconia Crowns Used in Carious Primary Anterior Teeth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Keywords: Zirconia crowns in pediatric dentistry
Dental caries
Aesthetic primary teeth restoration
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of two different types of zirconia crowns ( Kinder Krown , Nusmile crown) used in carious primary anterior teeth

Detailed description: Assess the clinical and radiographic evaluation of Kinder Krowns and Nusmile crowns in restoring carious primary canines And compare between the two crowns used

Eligibility criteria: Inclusion Criteria:

* Children age ranging from 7 to 10 years
* Deep carious primary upper canines
* The tooth need pulpal treatment
* The tooth need a crown restoration
* The tooth not submerged
* The tooth is not mobile

Exclusion Criteria:

* Children with bruxism or deep bite
* Children with especial need
* Presence of pathological root resorption in preoperative x-ray
* Presence of tooth wear (abrasion/attrition) on the opposing teeth

Primary outcomes:
measure: Crown retention
timeFrame: 12 months
measure: Opposing tooth wear
timeFrame: 12 months
measure: Gingival health
timeFrame: 12 months
measure: Immediate color match
timeFrame: 12 months
measure: Gingival index (Loe and Silness)
timeFrame: 12 months
measure: Crown margins
timeFrame: 12 months
measure: Child/parent satisfaction
timeFrame: 12 months
measure: Pathological external/internal root resorption
timeFrame: 12 months
measure: Periapical radiolucency
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: Tanta University
name: Fatma Abdelmonem Elhendawy, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Fatma Ahmed Elshehaby, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Fatma Korany Ismail, Ass.Professor
role: STUDY_DIRECTOR
affiliation: Tanta University
name: arig samir abdelmonem, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01961102: OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
Official title: Pilot-study of OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Atypical Hyperplasia
Keywords: postmenopausal bleeding
postmenopausal hyperplasia
endometrial cancer
atypical hyperplasia
curettage
intraoperative rapid section
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women

Brief summary: It is to be achieved that in postmenopausal women through the combination of Hysteroscopy and intraoperative rapid section a positive predictive value (PPV) regarding the objective illness like endometrial cancer or adenomatous hyperplasia of 100% so as a negative predictive value (NPV) of 99%.

Detailed description: If a patient fulfills the inclusion criteria, the surgeon decides intraoperatively due to the aspect in the hysteroscopy if it is a clearly benign result or if it looks suspicious or malign.

In case of a hysteroscopical benign result the patient will be informed about the result after the operation.

In case of a hysteroscopal suspicious or malignant aspect, the curettement will be sent for a rapid section. If the hysteroscopic result confirms the hysteroscopic suspicion the patient will be informed after the operation and the further treatment can be planned right away.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal status (more than 1 year of last menopausal bleeding)
* Postmenopausal vaginal bleeding
* Asymptomatic postmenopausal endometrial hyperplasia
* Understanding of the german language
* Signature and consent of the patient

Exclusion Criteria:

* Not able to understand and participate in the study
* Premenopausal status
* no informed consent

Primary outcomes:
measure: A negative predictive value of 99 %
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department of Gynaecology, Barmherzige Schwestern
Study officials:
References:
citation: Hefler-Frischmuth K, Hirtl-Goergl E, Unterrichter V, Lafleur J, Brunnmayr-Petkin G, Moinfar F, Hefler L. One-stop clinical assessment of risk for endometrial hyperplasia (OSCAR-Endo): a fast-track protocol for evaluating endometrial pathologies. Arch Gynecol Obstet. 2017 Apr;295(4):959-964. doi: 10.1007/s00404-017-4326-8. Epub 2017 Mar 6.
Clinical trial NCT03924102: Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study
Official title: Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acute Decompensated Heart Failure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this sub-study is to use positron emission tomography and computed tomography imaging (PET/CT) with an investigational drug called \[11C\] acetate to see if inflammation in patients with acute decompensated heart failure (ADHF) can cause changes in blood flow and oxygen use in the heart. This study may help physicians better understand how to treat patients diagnosed with ADHF in the future.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Enrollment in the UAB CMC-ADHF study under the separate UAB approved research protocol (IRB-300000114, PI Rajapreyar)
* Negative urine or serum β-hCG test within 48 hours of \[11C\] acetate administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Inability to lie still for the imaging study
* Weight exceeding the weight limit of the PET imaging table (500 pounds).

Primary outcomes:
measure: Inflammation in patients with acute decompensated heart failure (ADHF) will be measured with rest-stress [11C] acetate PET/CT to see if the inflammation can cause changes in the blood flow and oxygen use in the heart.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
Study officials:
References:
Clinical trial NCT05820802: High Dimensional Analysis of Immune Cells in Pediatric Patients
Official title: High Dimensional Analysis of Immune Cells Using scRNA-seq in Pediatric Patients With Allergic Reactions to Neuromuscular Blockers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug Allergy
Neuromuscular Blockade
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 294
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients between the ages of 2 and 18 undergoing general anesthesia using the rocuronium.

Brief summary: The purpose of this study is to characterize immune cells using single-cell transcriptomic analysis in pediatric patients aged 2 to 18 years undergoing general anesthesia who are expected to receive Rocuronium, a non-depolarizing neuromuscular blocking agent, in the event of an allergic reaction.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients between the ages of 2 and 18 undergoing general anesthesia and surgery using the neuromuscular blocker, rocuronium.

Exclusion Criteria:

* Patients who have received immunomodulators, immunosuppressants, etc.
* Patients with autoimmune diseases (rheumatoid arthritis, lupus, Behcet's disease, etc.)
* Patients who regularly take, or have taken within 4 weeks, medications that may affect the immune system (oral steroids, anti-inflammatories, etc.)
* Other cases where the Principal Investigator determines that it is difficult to conduct the study.

Primary outcomes:
measure: Transcriptomic profile analysis of the T lymphocytes by RNA sequencing
timeFrame: until end of surgery (usually up to 12 hours from the first dose of rocuronium)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02885402: Functional Exploration of Cartilage in Patients With Osteoarthritis of the Knee Through MRI Sodium ( 23Na )
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an infection or an inflammatory process that affects millions of people. The first symptoms usually appear from 40-50 years and at this point, conventional radiological tests provide diagnostic elements relatively late, poorly correlated with pain relief and providing no functional information. In this context, there is a real need for imaging techniques for early detection of osteoarthritic changes in a still reversible stage for faster support and MRI appears to be the tool of choice.

Conventional proton MRI sequences already allow improved detection possibilities compared to conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to recent technological advances, exploration MRI other nuclei such as sodium is now possible. Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and ultimately a gradation osteoarthritic reached.

This project's main objective is to quantify the biochemical changes (sodium content) occurring at different stages of osteoarthritis defined by clinical algofunctional scores (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).


Eligibility criteria: Inclusion Criteria:

* Patient with osteoarthritis

Exclusion Criteria:

* patient with contraindication for MRI

Primary outcomes:
measure: Percentage of sodium released in osteoarthritis patient vs healthy volunteers
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Jean-Pierre MATTEI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique Hopitaux De Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
Clinical trial NCT00168402: A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhidrosis
Keywords: Axillary Hyperhidrosis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a three-year study in subjects with axillary hyperhidrosis involving injection of Botulinum Toxin Type A into the axilla to reduce sweating.


Eligibility criteria: Inclusion Criteria:

* Marked axillary hyperhidrosis

Exclusion Criteria:

* Previous use of botulinum toxin for hyperhidrosis

Primary outcomes:
measure: Subject's assessment of the severity of hyperhidrosis
Secondary outcomes:
measure: Measurement of axillary sweat production
Other outcomes:
Locations:
Study officials:
References: