louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06679192: Thickness-Varied Soft Surface on Shoe-Insoles Based on In-Shoe Pressure Measurement
Official title: Comparing a Thickness-Varied Soft Surface of Custom Made Shoe Insoles Based on Plantar Pressure Analysis in Shoes, to Insoles With Even Thickness Surfaces: A Cross Sectional Study Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: plantar pressure
shoe insert
ulcer prevention
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: three-intervention cross over study.
Primary purpose: PREVENTION

Brief summary: The goal of this cross-sectional study is to evaluate a new shoe insole manufacturing method with the goal of further preventing foot ulceration for people with diabetes. This is achieved by decreasing pressure under risk areas of the foot, often on the insole; the interface between the shoe and the foot. The main question it aims to answer is:

Does a thickness-varied surface based on plantar pressure measurement decrease pressure at high risk areas compared to even thickness surfaces.

Researchers will compare three different pairs of insoles for each participant.

Participants will partake in two sessions. The first one being a pre-measurement and foot status for manufacturing the insoles. During the second session, three pairs of insoles will in a random order be tested for each participant. The pressure measurement of the insoles will be made using F-Scan(TM), while participants walk.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age at the date of signing consent.
* Diabetes mellitus 1 or 2
* Diabetic foot risk group 2: Signs of distal neuropathy and/or peripheral circulatory disorder.
* Able to walk 10 meters without walking aids
* Able to speak and understand Swedish

Exclusion Criteria:

* Diabetic foot risk group 3: Distal neuropathy or peripheral circulatory disorder and foot ulcers, or amputation, foot deformity of clinical importance or skin pathology.
* Diabetic foot risk group 4: Occuring foot ulcer, severe osteoarthropathy or chronic foot pain.

Primary outcomes:
measure: Plantar pressure
timeFrame: Pre-measurement used for insole design at first meeting. Intervention-measurement for all patients and interventions at second meeting, approximately 3-4 weeks after pre-measurement.
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: TeamOlmed Hagaplan
Study officials:
affiliation: Vastra Gotaland Region
name: Roy Tranberg, PhD, Docent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05094492: Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride
Official title: Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries; Initial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.

Detailed description: This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).

Eligibility criteria: Inclusion Criteria:

* Active carious white spot lesions.
* Patient compliance.
* Controlled oral hygiene condition.

Exclusion Criteria:

* Participant in another trial.
* Non carious lesions.
* Systemic diseases or concomitant medication affecting salivary flow.
* Cavitation of carious lesions.
* Parafunctional habits.
* Pregnancy.

Primary outcomes:
measure: Remineralization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: El Manial
Study officials:
affiliation: Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
name: Omar O Shaalan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02216292: Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants
Official title: Impact of Preterm Single Donor Milk on Enteral Feeding in Very Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature, Diseases
Keywords: preterm single donor milk
human milk
very lo birth weight infants
enteral feedings
NEC
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inborn very low birth weight infants with a birthweight \<1500g and a gestational age \<32 weeks

Brief summary: Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available. Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical University Vienna was to start with formula feedings within the first 6 hours of life of a premature infant and switch over to breastmilk as soon it was available. In June 2012 the investigators changed this feeding regimen and started to use single donor milk of mothers of preterm infants for the first hours and days of the preterm infants life. In a prospective observational study the investigators evaluated the impact of single donor milk from preterm infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data will be compared with a historical control group starting with preterm formula as source of enteral nutrition. The investigators hypothesize that starting enteral nutrition with single donor milk of mothers from preterm infants with shorten time to full enteral feedings.


Eligibility criteria: Inclusion Criteria:

* very low birth weight infants with a birthweight \<1500g
* Gestational Age \<32 weeks
* Informed consent

Exclusion Criteria:

* major congenital malformations
* systemic metabolic diseases
* short bowl syndrome
* gastrointestinal abnormalities
* when preterm infant was transferred or discharged

Primary outcomes:
measure: Time to full enteral feeding
timeFrame: birth up to 40 weeks of gestation
Secondary outcomes:
measure: necrotizing enterocolitis
timeFrame: birth to 40 weeks of gestation
measure: Gastric residuals
timeFrame: birth to 7th day of life
measure: Frequency of stool
timeFrame: birth until 14th day of life
measure: culture positive sepsis
timeFrame: birth to 40th week of gestation
Other outcomes:
measure: body weight
timeFrame: birth to 40th week of gestation
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Pediatrics
name: Nadja Haiden, Prof.MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02391792: Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance
Official title: Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Sepsis and Septic Shock
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group patient: patients with septic shock group control: patients without septic shock

Brief summary: Microparticules (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with merging role in pathophysiology of immune and cardiovascular diseases. MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. This a prospective observational study of circulating MPs and blood coagulation in septic shock patients admitted in medical intensive care units (ICUs) of four tertiary hospitals at baseline (D1, D2, D3, D4, D7).


Eligibility criteria: Inclusion Criteria:

* Septic shock (patients)
* Without septic shock (control)
* Informed consent

Exclusion Criteria:

* Class IV heart failure
* Child-plugh grade C cirrhosis
* Cancer under active treatment
* BMI\>35kg/m2
* Moribund patient
* DNR decision

Primary outcomes:
measure: Change from baseline in number and type of circulating microparticles at 7 days
timeFrame: Baseline and 7 days
measure: Change from baseline in blood coagulation markers at 7 days
timeFrame: Baseline and 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
state: Alsace
Study officials:
References:
citation: Helms J, Severac F, Merdji H, Clere-Jehl R, Francois B, Mercier E, Quenot JP, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Performances of disseminated intravascular coagulation scoring systems in septic shock patients. Ann Intensive Care. 2020 Jul 10;10(1):92. doi: 10.1186/s13613-020-00704-5.
Clinical trial NCT04131192: Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
Official title: A Phase Ib, Multi-center, Open-label Study of Z650 and Gemcitabine in Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-18
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.

Detailed description: This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.This phase IB trial is Multi-center and open。

Eligibility criteria: Inclusion Criteria:

18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.

Exclusion Criteria:

adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction \< 50%

Primary outcomes:
measure: Rate of dose limiting toxicities of each subject
timeFrame: 21 days
Secondary outcomes:
measure: Adverse events related to pulse dose Z650 and gemcitabine
timeFrame: up to 4 weeks after last dose
measure: Overall response rate (ORR)
timeFrame: up to approximately 24 months
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 24 months
measure: Duration of Response (DOR)
timeFrame: up to approximately 24 months
measure: Progression-free Survival (PFS)
timeFrame: up to approximately 24 months
measure: Overall Survival (OS)
timeFrame: up to approximately 24 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: China/jiangsu
city: Jinan
country: China
facility: shandong Cancer Hospital
state: China/shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: shu zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: lianke liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926692: Investigations Regarding B-cell Subsets in Humans
Official title: Investigations Regarding B-cell Subsets in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: B-cells
CD5+
B1 Cells
Healthy Controls
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Control Population

Brief summary: The aim of this research is to define the human equivalent of mouse B1 cells.

Detailed description: The specific aim of this research project is to define the human equivalent of mouse B1 cells. This will be done by evaluating IgM secretion, surface markers, functional characteristics, V gene usage, N-region addition, and phosphorylation status of intracellular proteins, gene expression, sequencing of immunoglobulin genes, determination of antigenic specificity, replication history, and response to different stimuli.

The goal of this project is to begin to the translation of decades of basic science research and research in the mouse model into the human system. It is believed that properly defining this B cell subset in humans will lead to better therapeutics, prognostics and prevention for a number of disease including infections, autoimmune disease, and cancer.

Eligibility criteria: Inclusion Criteria:

* Subject is considered by the physician to be a healthy adult.

Exclusion Criteria:

* Subject is under the age of 18
* Subject has an infection or is currently ill

Primary outcomes:
measure: Presence of B-1 cells in humans
timeFrame: determined over the years study in effect
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Daniel Griffin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844792: Study of Antioxidants on Prostate Tumors in Men Undergoing Radical Prostatectomy for Prostate Cancer
Official title: A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer of the Prostate
Prostate Cancer
Prostatic Neoplasms
Keywords: Male Urogenital Diseases
Antioxidants
Vitamin E
Vitamin D
Lycopene
Selenium
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium and lycopene) can change (reduce) prostate tumor size and alter certain markers that can affect tumor growth and prostate cancer aggressiveness.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a Gleason score \> or = to 7 adenocarcinoma of the prostate
* At least 30% of one core involved
* Radical prostatectomy planned
* Willingness to discontinue use of supplements at least 4 weeks prior to study intervention (for subjects using vitamin E, selenium or lycopene at time of consent)
* ability and willingness to consume study intervention for 6 - 8 weeks prior to radical prostatectomy.

Exclusion Criteria:

* Previous treatment for prostate cancer
* Current use of finasteride or dutasteride

Primary outcomes:
measure: To determine the impact of combination Vitamin E, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage.
timeFrame: Blood samples will be collected prior to intervention and 8 weeks later , prior to surgery. Prostate tissue will be harvested at time of surgery, after the prostate has been removed.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Neil Fleshner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00892892: Sympathetic Nerve Activity in Renal Failure
Official title: Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Hypertension
Keywords: sympatholytic treatment
sympathetic nerve activity
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 0
Sex: ALL
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: The primary purpose is to assess the role of sympathetic activation for the development and progression of chronic renal failure. Using microneurography sympathetic activity will be registered in various stages of kidney affection or failure and hypertension.

A sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect sympathetic activation and on the progression of kidney disease.

The effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be examined.


Eligibility criteria: Inclusion Criteria:

* chronic renal failure stages I-IV

Exclusion Criteria:

* pregnancy and lactation
* severe heart failure or ischemic heart disease
* patients with NYHA III-IV

Primary outcomes:
measure: sympathetic activation for the development and progression of chronic renal failure
timeFrame: 3 months
Secondary outcomes:
measure: effects of a sympatholytic agent on cardiovascular reactivity to various stressors
timeFrame: 3 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg, CRC, med. Clinic 4
state: Bavaria
Study officials:
affiliation: University of Erlangen-Nurnberg
name: Roland E Schmieder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03923192: Evaluation of Reliability of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions.
Official title: Evaluation of Validity of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions: Diagnostic Accuracy Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: screening of the Patients who join the Conservative Dentistry Department clinic will be done until the target population is achieved. The Patients' teeth will be subjected to visual examination and diagnosis using dental charts. once the patient is eligible to be included in this study, they will be contacted by the research investigator who will explain the study and identify the patient interests .If the patient show interest ,further clarification and discussing wil be held .
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the Clinical performance of the near-infrared imaging system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in detection of approximal carious lesions.


Eligibility criteria: Inclusion Criteria:

* Patients aged from 18 to 40 years.
* No gender restriction.
* Patients should have an acceptable oral hygiene level.
* Patients must have at least one posterior proximal caries

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease.
* Heavy bruxism or a traumatic occlusion.
* Acute or chronic dental infection.
* Pregnant or breastfeeding women.
* Patients with posterior restorations on molars or premolars

Primary outcomes:
measure: dental caries
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The British University in Egypt
state: Other
Study officials:
References:
Clinical trial NCT00318292: Preemptive Local Anesthesia in Vaginal Surgery
Official title: Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: preemptive analgesia
paracervical block
vaginal hysterectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.


Eligibility criteria: Inclusion Criteria:

* Women undergoing vaginal hysterectomy with McCall's culdoplasty

Primary outcomes:
measure: Visual Analogue Scale (VAS) Pain Score
timeFrame: 30 minutes post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Jaime B. Long, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.