louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05001100: A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018)
Official title: A Rehabilitation With Virtual Reality in Patients After Hip Arthroplasty Surgery (VRRS2018)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Disease
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized
Primary purpose: TREATMENT

Brief summary: .Assessing efficacy of rehabilitation with virtual reality exercises compared to traditional rehabilitation in the patient's operated hip arthroplasty

Detailed description: Randomized controlled clinical study: Comparison of clinical efficacy between rehabilitation with virtual reality (VRRS) and traditional physiotherapy in post-surgical rehabilitation treatment in hospital. Motor clinical evaluations will be carried out in both groups.

Vrrs Arm: 32 subjects will undergo a virtual motor-reality training during the post-surgical rehabilitation period.

Physiotherapist's arm: 32 subjects with demographic characteristics similar to the subjects of the Vrrs arm will undergo the habitual rehabilitative physiotherapy.

According to normal clinical practice, both groups perform a co-intervention in addition to the assigned group; Manual therapy with exercises and functional activity (walk and stairs).

Eligibility criteria: Inclusion Criteria:

- hip arthroplasty

Exclusion Criteria:

* patient with resence of neurological and psychiatric disorders
* minor patient

Primary outcomes:
measure: disability measurement
timeFrame: on the 21st day
Secondary outcomes:
measure: pain measurement
timeFrame: on the 10st day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Irccs Istituto Ortopedico Galeazzi
Study officials:
affiliation: istituto galeazzi
name: cristina beretta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01021800: Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Tubular Adenocarcinoma
Keywords: Pancreatic tubular adenocarcinoma adjuvant setting
Lead sponsor: Blood Transfusion Centre of Slovenia
Sponsor class: OTHER_GOV
First posted: 2009-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. When included, patients are pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear cells are given.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status 0-2 at the time of inclusion
* Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment

Exclusion Criteria:

* Pregnancy
* Less than 3 mths expected survival
* Serious comorbidity
* Age above 70 yrs

Primary outcomes:
measure: PROGRESSION FREE SURVIVAL
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana, Department for Gastroenterolgy
Study officials:
References:
Clinical trial NCT03412500: Vancomycin Dosage Adjustment for MRSA Infections
Official title: A Comparative Efficacy Study of Vancomycin Dosage Adjustment by Equation-based Method and Vancomycin Trough Concentration Method for Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Methicillin-Resistant Staphylococcus Aureus
Keywords: Methicillin-Resistant Staphylococcus aureus
Vancomycin
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods

Detailed description: An open-label randomized controlled trial to compare two vancomycin dosage adjustment methods; a vancomycin trough concentration method and a equation-based method.

Eligibility criteria: Inclusion Criteria:

1. Thai hospitalized patients, age\>18 years
2. Require vancomycin therapy ≥ 3 days
3. Documented MRSA infection including pneumonia, bacteremia, intra-abdominal infection or skin and soft tissue infection
4. Have been checked for serum creatinine within 48 hours and serum albumin within 7 days prior to enrollment
5. Received an appropriate loading dose of vancomycin
6. Have been treated with an appropriate maintenance dose of vancomycin
7. Willing to sign an informed consent

Exclusion Criteria:

1. CrCl\< 10 ml/min or receiving renal replacement therapy
2. Pregnancy or lactation
3. Actual BW\> 90 kg
4. Serum albumin \<2 g/dl
5. Having an active cancer or receiving chemotherapy
6. Hx of vancomycin allergy

Primary outcomes:
measure: Clinical response
timeFrame: End of therapy (an average of 2 weeks)
Secondary outcomes:
measure: Renal adverse event
timeFrame: Day 5 after vancomycin therapy
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: pinyo rattanaumpawan, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745900: Evaluation and Comparison of Noninvasive Blood Glucose Concentrations
Official title: An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insulin Dependent Diabetes
Non Insulin Dependent Diabetes
Gestational Diabetes
Keywords: Diabetes
Gestational Diabetes
Female
Lead sponsor: VeraLight, Inc.
Sponsor class: INDUSTRY
Collaborators: name: InLight Solutions
First posted: 2012-12-10
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females 18-50 years of age selected from the community 30% with no history of Diabetes 70% with diagnosis of Type I, Type II or Gestational Diabetes

Brief summary: Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.

Detailed description: The objectives of this study are

* collect subject data on a near-infrared spectroscopy-based glucose meter
* evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
* collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.

Eligibility criteria: Inclusion Criteria:

* Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
* Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.

Exclusion Criteria:

* Severe heart disease as evidenced by peripheral edema (self reported)
* Currently taking Lasix (self reported)
* Liver disease as evidenced by jaundice (self reported)
* Receiving dialysis or having known renal compromise (self reported)
* Skin damage at optical sampling site
* Scars, tattoos, rashes or other disruption/discoloration on the right index finger
* Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported)
* Current chemotherapy, or chemotherapy within the past 12 months (self reported)

Primary outcomes:
measure: Continuing validation of near infrared spectroscopy-based glucose meter algorithm
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Accelovance Inc.
state: California
Study officials:
affiliation: Accelovance
name: Amber Brassfield, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01833000: NIRS and Doppler to Predict NEC in Risk Neonates
Official title: Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotizing Enterolitis
Keywords: rectal bleeding
necrotizing enterolitis
splanchnic oxygenation
mesenteric doppler
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 69
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).


Eligibility criteria: Inclusion Criteria:

* less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension
* signed authorization by the parents (consent form)

Exclusion Criteria:

* - cutaneous lesions in the regions of monitoring
* emergency for NEC

Primary outcomes:
measure: Cerebro-splanchnic oxygenation ratio
timeFrame: up to 48h
Secondary outcomes:
measure: Mesenteric Doppler flow
timeFrame: up to 48h
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Gilles Cambonie, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06067100: U-LABA/ICS Effects on Exercise Performance, Indacaterol
Official title: Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Indacaterol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Performance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist indacaterol + mometasonefuroate


Eligibility criteria: Inclusion Criteria:

* Age 18-39
* Physically active \> 5 h weekly
* Maximal oxygen consumption classified as high or very high

Exclusion Criteria:

* Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
* ECG abnormality
* ACQ score \> 1.5
* Severe bronchial hyperreactivity as determined by mannitol test
* FEV1/FVC ratio \< 0.7 determined with spirometry
* Chronic illness determined to be a potential risk for participant during study
* In chronic treatment with medication that may interfere with study results
* Pregnancy
* Smoker
* Blood donation during the past 3 months

Primary outcomes:
measure: Power output during sprint testing
timeFrame: Through study completion, an average of 3 weeks
Secondary outcomes:
measure: Power output during time trial
timeFrame: Through study completion, an average of 3 weeks
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Through study completion, an average of 3 weeks
measure: Quadriceps strength
timeFrame: Through study completion, an average of 3 weeks
measure: Respiratory muscle function
timeFrame: Through study completion, an average of 3 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
affiliation: University of Copenhagen
name: Morten Hostrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00705900: LCD Solution Versus Calcipotriol Cream in the Treatment of Moderate Plaque Psoriasis
Official title: A Randomized, Single-Blind, Active Control, 18-Week Study to Evaluate the Safety and Efficacy of A New Twice-Daily, Topically Applied LCD Solution vs. Calcipotriol Cream for the Treatment of Adult Subjects With Moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Plaque Psoriasis
Keywords: psoriasis
Lead sponsor: NeoStrata Company, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 60
Sex: ALL
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 compare the safety and effectiveness of a new topical LCD solution and a commercially available calcipotriol (Vitamin D) cream in reducing the symptoms of plaque psoriasis and improving the quality of life in adults.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* able and willing to provide written informed consent
* diagnosed with chronic plaque psoriasis
* 3% to 15% body surface area involved
* in good general health

Exclusion Criteria:

* other current treatments for psoriasis
* renal or liver dysfunction
* pregnant or nursing

Primary outcomes:
measure: Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Changes in PLASI, PEASI, Physician Global Assessment (PGA), Pruritus, and Dermatology Life Quality Index (DLQI) Scores between treatment arms
timeFrame: Week 12 and Week 18
Other outcomes:
Locations:
city: Boston
country: United States
facility: Mass General Hospital: Clinical Unit for Research Trials in Skin
state: Massachusetts
Study officials:
affiliation: Massachusettes General Hospital / Brigham Women's Hospital
name: Alexandra B Kimball, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alora-Palli MB, Brouda I, Green B, Kimball AB. A cost-effectiveness comparison of liquor carbonis distillate solution and calcipotriol cream in the treatment of moderate chronic plaque psoriasis. Arch Dermatol. 2010 Aug;146(8):919-22. doi: 10.1001/archdermatol.2010.167. No abstract available.
citation: Alora-Palli MB, Perkins AC, Van Cott A, Kimball AB. Efficacy and tolerability of a cosmetically acceptable coal tar solution in the treatment of moderate plaque psoriasis: a controlled comparison with calcipotriene (calcipotriol) cream. Am J Clin Dermatol. 2010;11(4):275-83. doi: 10.2165/11530380-000000000-00000.
Clinical trial NCT01870700: Lactobacillus Reuteri in Adult With Functional Chronic Constipation
Official title: The Effect of Lactobacillus Reuteri Supplementation to Adult With Functional Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Constipation
Lead sponsor: Catholic University, Italy
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.

Detailed description: Patients affected by functional constipation according to Rome III criteria. The increase of Bowel Movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.

Eligibility criteria: Inclusion Criteria:

* functional constipation rome III

Exclusion Criteria:

* hypothyroidism or other metabolic or renal abnormalities, or
* antibiotic's treatment,
* probiotic or prebiotic supplementation in the last month

Primary outcomes:
measure: The increase of BMs/week frequency
timeFrame: January to June 2012 (up to 6 months)
Secondary outcomes:
measure: the improvement of stool consistency
timeFrame: january to june 2012 (up to 6 months)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University Sacred Heart
state: Italy/rome
Study officials:
affiliation: catholic university
name: veronica ojetti
role: STUDY_CHAIR
References:
citation: Coccorullo P, Strisciuglio C, Martinelli M, Miele E, Greco L, Staiano A. Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. J Pediatr. 2010 Oct;157(4):598-602. doi: 10.1016/j.jpeds.2010.04.066. Epub 2010 Jun 12.
citation: Ojetti V, Ianiro G, Tortora A, D'Angelo G, Di Rienzo TA, Bibbo S, Migneco A, Gasbarrini A. The effect of Lactobacillus reuteri supplementation in adults with chronic functional constipation: a randomized, double-blind, placebo-controlled trial. J Gastrointestin Liver Dis. 2014 Dec;23(4):387-91. doi: 10.15403/jgld.2014.1121.234.elr.
Clinical trial NCT01506700: Real Time Optical Coherence Tomography (OCT) of Human Tissue
Official title: Real Time Optical Coherence Tomography (OCT) of Human Tissue
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Diagnostic Photonics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Illinois at Chicago
First posted: 2012-01-10
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with breast cancer

Brief summary: This is a single-arm, prospective, study of an optical imaging device on approximately twenty (20) subjects undergoing lumpectomies at one study site. In vivo and ex vivo imaging will be performed on study subjects with results being compared to final pathology.

Detailed description: This study is a single-center, prospective, two-part open label study of an optical imaging device on approximately twenty (20) subjects at one (1) study site. Patients scheduled to undergo a lumpectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the in vivo and ex vivo breast tissue samples using the study device during their lumpectomy.

All specimens will be marked with India ink and undergo standard post-operative histology, and digital histology images corresponding to the inked locations will be obtained. The images and the matched digitized post-operative histology images will then be randomized and read by a blinded, independent pathologist. Sensitivity and specificity will be calculated.

Eligibility criteria: Inclusion Criteria:

1. Women 18 years of age or older
2. Signed ICF
3. Women who have been histologically diagnosed with invasive ductal carcinoma or invasive lobular carcinoma of the breast prior to surgery
4. Planning breast preservation
5. Patients undergoing lumpectomy (partial mastectomy) procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Primary outcomes:
measure: The sensitivity and specificity of Optical Coherence Tomography to identify whether or not tumor can be identified ex vivo on breast cancer specimens as compared to post-surgical histology conclusions.
timeFrame: One week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
Study officials:
affiliation: University of Illinois and Diagnostic Photonics, Inc.
name: Stephen A Boppart, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06433700: Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients
Official title: Risk of Revision and Other Complications Following Knee Arthroplasty in Patients Previously Exposed to Bariatric Surgeries: A Nationwide, Register-based Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthritis Knee
Bariatric Surgery Candidate
Prosthesis Failure
Prosthesis Survival
Prosthesis-Related Infections
Keywords: arthroplasty
revision
bariatric
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 90000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will include patients with primary/idiopathic or secondary (due to meniscus or cruciate ligament lesion) osteoarthritis (OA) who received primary KA in the period from 2011 and 2 years earlier to data-extraction date. Patients will be identified from the DKR. Patients are followed for 2 years, until first revision, death or migration, whichever comes first.

Brief summary: Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients.

The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA.


Eligibility criteria: Inclusion Criteria:

* Primary knee arthroplasty due to osteoarthritis

Exclusion Criteria:

* Primary knee arthroplasty due to traumatic osteoarthritis.

Primary outcomes:
measure: Hazard rate of Revision due to any cause
timeFrame: within 90 days and within 2 years
measure: Hazard rate of Revision due to infection
timeFrame: within 90 days and within 2 years
Secondary outcomes:
measure: Hazard rate of Knee related antibiotic use within 30- and 90-days following KA
timeFrame: within 30- and 90-days following KA
measure: Hazard rate of Antibiotic use due to other causes
timeFrame: within 30- and 90-days following KA
measure: Mortality
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Orthopaedic department, Bispebjerg Hospital
Study officials:
affiliation: Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
name: Søren Overgaard, MD,DMSc,Prof
role: STUDY_DIRECTOR
References: