louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04471259: Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity
Official title: Functional Follow-up After Endoscopic Calcaneoplasty for Haglund's Deformity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haglund's Deformity
Keywords: Haglund's Deformity
Biodex System
Isokinetic muscle testing
Endoscopy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 42 cases of 37 patients diagnosed with Haglund disease treated by the author from 2012 to 2018 treated with endoscopic surgery (5 of whom were patients with left and right feet, 33 men, 4 women, average age 32.3 (range:15 to 62, SD=13.6) years, 2 of whom are professional athletes.

Brief summary: Isokinetic muscle strength test implemented by the Biodex system is a method used for evaluating muscle function that has been applied clinically in the field of sports and rehabilitation medicine. However, information on its application on Haglund's deformity remain insufficient. Therefore, the present study is designed to examine the effectiveness of the muscle strength test using the Biodex system in evaluating the recovery of athletic capacity in patients with Haglund's deformity following endoscopic surgery.

Detailed description: Patients. A retrospective (medical records), level 3 evidence study was designed to evaluate the outcomes of patients who underwent endoscopic surgery for Haglund's deformity. The present study was approved by the Peking University Third Hospital's ethics committee. Written informed consent was obtained from all patients, parents or guardians of the patients prior to the present study. The rights of the patients were protected.

Diagnosis. Patients were designed to be diagnosed based on subjective complaints, combined with clinical and radiological examinations. Radiological measurements for this disease include the Fowler-Phillip angle, calcaneal pith angle, parallel pitch lines, Chauveaux-Liet angle and the X/Y ratio.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent endoscopic surgery for Haglund's deformity

Exclusion Criteria:

* None

Primary outcomes:
measure: Biodex results on both sides before surgery
timeFrame: pre-surgery
measure: Biodex results on both sides at 3 months
timeFrame: 3 months after surgery
measure: Biodex results on both sides at 6 months
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02181959: Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers
Official title: Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy man or woman, between 20 to 70 years
* Fit to work
* Volunteers have given informed consent and signed the consent form

Exclusion Criteria:

* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc)
* Treatment with other drugs that might interfere with the evaluation of the safety of the test drug
* Known hypersensitivity to any ingredients of the study drug
* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
* Drug and alcohol abuse
* Participation in another trial
* Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 60 days
measure: Assessment of overall tolerability rate on a 4-point scale
timeFrame: Day 30 and 60
Secondary outcomes:
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: Day 0, 30 and 60
measure: Number of patients with abnormal findings in physical examination
timeFrame: Day 0, 30 and 60
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04982159: Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis
Official title: Correlation Between Minimum Inhibitory Concentration and Clinical Outcome of Invasive Fusariosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fusariosis
Keywords: invasive fusariosis
minimum inhibitory concentration
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital patients diagnosed with invasive fusariosis.

Brief summary: Multi-centered, international, observational and retrospective study to analyze the correlation between MIC and clinical outcome in patients with invasive fusariosis.


Eligibility criteria: Inclusion Criteria:

* Invasive fusariosis diagnostic
* Proof of anti-fungic susceptibility according to EUCAST or CLSI, for the medicine used in the treatment of invasive fusariosis.
* Available data about anti-fungic medicines used: name of medicine, start and end date of treatment.
* Available information about clinical outcome of illness after 30 days, 6 weeks and 90 days (dead or alive).
* Only cases of invasive fusariosis proven or possible will be included.

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical Evolution
timeFrame: 6 weeks after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
References:
Clinical trial NCT03562559: Skin to Adductor Canal Distance in Various Positions
Official title: The Impact of Leg Movement on the Skin to Adductor Canal Distance: a Potential Cause for Catheter Displacement?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthritis
Keywords: Total Knee Arthroplasty
Adductor Canal Block
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are recruiting patients undergoing total knee replacement. Per hospital protocol, patients will receive a spinal anesthetic and adductor canal block as part of their anesthetic regimen. After surgery, previously consented patients will have their skin to adductor canal distance measured by ultrasound in 5 different positions.

Brief summary: To control pain after total knee replacement surgery a catheter (tubing) is sometimes inserted into an anatomic space containing nerves that provide sensation to parts of the knee. This space is called the adductor canal.

The catheters often stop working before we remove them for unclear reasons. The investigators think this is because the catheters become dislodged from where it was meant to be. This could be due to repeated movements of the catheter tip brought on by patients contracting their leg muscles when they ambulate or perform physio.

The investigators want to confirm this by measuring the distance from a fixed spot on the patient's thigh to the adductor canal using an ultrasound machine. The leg will be measured in various positions to simulate muscle movements. A significant change in the distance could possibly contribute to catheter dislodgement and result in catheter failure.


Eligibility criteria: Inclusion Criteria:

* Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
* Patients must be undergoing a primary total knee arthroplasty with neuraxial anaesthesia

Exclusion Criteria:

* Patients with an allergy to ultrasound transducer gel or measuring tape

Primary outcomes:
measure: Skin to Adductor Canal Distance Disparity
timeFrame: Measurements will be made on the day of surgery, no other assessment or follow up needed
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jason Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tholin M, Wilson J, Lee S, Tang R, Sawka A, Vaghadia H. Impact of leg movement on skin-adductor canal distance: a potential cause for catheter tip displacement? Can J Anaesth. 2020 Aug;67(8):936-941. doi: 10.1007/s12630-020-01693-6. Epub 2020 May 8.
Clinical trial NCT01934959: A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Official title: A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Probiotics
Hirschsprung's Disease Associated Enterocolitis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Anhui Provincial Hospital
First posted: 2013-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).


Eligibility criteria: Inclusion Criteria:

The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry.

Exclusion Criteria:

* Age\> 13 years old
* Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive.
* Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children.
* Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities.
* Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora.
* Drug allergies, or allergic diseases..
* Poor compliance with oral probiotics treatment.

Primary outcomes:
measure: Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wang X, Li Z, Xu Z, Wang Z, Feng J. Probiotics prevent Hirschsprung's disease-associated enterocolitis: a prospective multicenter randomized controlled trial. Int J Colorectal Dis. 2015 Jan;30(1):105-10. doi: 10.1007/s00384-014-2054-0. Epub 2014 Nov 5.
Clinical trial NCT02214459: Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot
Official title: Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: mHealth
Hypertension
Mobile
smartphone
diet
lifestyle
bluetooth
physical acitvity
behavior change
motivational interviewing
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk interventions. The DASH program of diet and exercise based lifestyle change is the most well-established, evidence-based behavioral intervention to control HTN. Its recommendations are central to HTN control national guidelines and consumer health products aimed at behavioral management of HTN. However, translating these recommendations into population-wide, inexpensive, sustainable programs have to date proven largely unrealized. The objective of the proposed study is to determine the efficacy of a HTN intervention behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about the DASH diet, physical activity and HTN related behaviors from health coaches trained in evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity and 2) a web-based coaching portal through which health coaches view and respond to patients' behavioral data and assist them in setting goals for changing behaviors consistent with their HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine improvement from baseline to 3-month follow-up in physiological (blood pressure, weight); behavioral (diet \& physical activity); and psychological (e.g., quality of life) measures over a 3-month intervention. Completing this research will result in preliminary feasibility and efficacy data for a larger randomized efficacy trial.


Eligibility criteria: Inclusion Criteria:

* hypertension
* prehypertension
* smartphone
* english speaking

Exclusion Criteria:

* on more than 1 medicine for hypertension
* live outside Boston metro area

Primary outcomes:
measure: Blood pressure reduction
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT00150059: Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis, eczema, mild to moderate, children, IGA
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-08
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients \> 3 months of age with mild to moderate atopic dermatitis)

This study is not enrolling patients in the United States.


Eligibility criteria: The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.

Primary outcomes:
measure: Investigator Global Assessment (IGA) score for the whole body and for the face only.
measure: Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation.
measure: Safety assessed by adverse events.
Secondary outcomes:
Other outcomes:
Locations:
city: Investigative Site
country: Philippines
facility: This study is not being conducted in the United States
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Healthcare Philippines
role: STUDY_CHAIR
References:
Clinical trial NCT01793259: Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
Official title: An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age between 18 and 75 years
* Rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria 1987 or ACR/European Liga Against Rheumatology (EULAR)2010
* Disease activity score (DAS) 28 \> 2.6

Main Exclusion Criteria:

* Prior or other current subcutaneous treatment with self-injection
* Prior or concomitant treatment with biologics
* Contraindications to MTX treatment
* History or diagnosis of a dermatological disease at the injection site
* Women with child-bearing potential who do not use a highly effective method of contraception or men who have a partner with child-bearing potential and do not use a contraception during the study and at least 6 months thereafter.

Primary outcomes:
measure: number of patients preferring the MTX pre-filled pen to the pre-filled syringe
timeFrame: after 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Clinic
Study officials:
affiliation: Kerckoff clinic, Bad Nauheim, Germany
name: Ulf Müller-Ladner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demary W, Schwenke H, Rockwitz K, Kastner P, Liebhaber A, Schoo U, Hubner G, Pichlmeier U, Guimbal-Schmolck C, Muller-Ladner U. Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience. Patient Prefer Adherence. 2014 Aug 6;8:1061-71. doi: 10.2147/PPA.S64111. eCollection 2014.
Clinical trial NCT03722459: Novel MRI Sequence- MR Fingerprinting
Official title: Novel MRI Sequence- MR Fingerprinting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Magnetic Resonance Imaging (MRI) has become one of most important medical imaging tools over the past 30 years because it is non-invasive, requires no ionizing radiation, and provides exquisite images of soft tissues and anatomic structures with many tissue/disease specific contrasts. While MRI has served the community well for many years, it is increasingly clear that it also has significant limitations.

One of the principle limitations is the lack of quantitative information for tissue/structure characterization. The current paradigm of MRI is to use a set of scanner settings to generate an image "weighted" by a specific MR contrast mechanism (physical parameter), where it is hoped that variations in the parameter will be accentuated. However, without quantitative knowledge of the parameters, the final image contrast may depend on many factors, which complicates image interpretation and diagnostic performance. Quantitative measurement can provide a great deal of information about tissue properties and pathological conditions, since these parameters ultimately determine the contrast that is observed in conventional images.

Detailed description: The purpose of this study is to evaluate novel quantitative MRI techniques in clinical studies to determine whether they can provide better, faster and more useful information for clinical diagnosis. In this study, the investigators propose to apply MR Fingerprinting and evaluate its performance for different diseases. These include, but are not limited to, diseases in the liver, kidney, cardiac, pancreas etc. The investigators hypothesize that the quantitative MR Fingerprinting imaging technique will lead to improved tissue characterization and diagnosis.

Eligibility criteria: Inclusion Criteria:

* The study will include English-speaking patients that are already scheduled to undergo a clinical MRI for diagnostic purposes.

Exclusion Criteria:

* Pregnant women will be excluded.
* Women will be excluded from the healthy volunteers, due to a lack of funding for pregnancy testing. Funding for this will be considered for the future.

Primary outcomes:
measure: Percent of Patients With Visible Region of Interest (Imaging Visibility)
timeFrame: Immediately following MRI completion, within approximately 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: William Hyslop, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: