louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02165163: Virtual Reality-Based Exercise in Cancer Patients
Official title: Virtual Reality-Based Exercise in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distorted; Balance
Motor Deficit
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in cancer patients.

The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in cancer patients compared to a control group receiving usual care only.


Eligibility criteria: Inclusion Criteria:

* ability to ambulate without assistance
* willingness to provide informed consent
* cancer
* neuropathy related to chemotherapy

Exclusion Criteria:

* severe neurologic, cardiovascular, metabolic, or psychiatric disorders
* severe visual impairment
* cognitive impairment

Primary outcomes:
measure: Postural Balance
timeFrame: after 4 weeks
Secondary outcomes:
measure: Gait performance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, College of Medicine, University of Arizona
name: Bijan Najafi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080963: Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections
Official title: Prospective Randomised Study of Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections After Median Sternotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Infection
Keywords: Prophylaxis
Antibiotic
Sternotomy
Heart-Lung Machine
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2010-03-05
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 show that the incidence of sternal wound infections at day 30 after cardiac surgery is 50% lower with the additional use of Daptomycin on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone.


Eligibility criteria: Inclusion Criteria:

* age between 18-80
* written informed consent (IC)

Exclusion Criteria:

* pregnant and lactating women
* patients operated for a transplantation
* patients with a increased myopathy risk
* patients with a creatinine clearance \< 30ml/min; patients on hemodialysis
* patients after a previous sternotomy
* treatment with any antibiotics 14 days prior study start
* treatment with Daptomycin or Cefuroxime within 3 month prior study start

Primary outcomes:
measure: Incidence of sternal wound infection is at least 50% lower if Daptomycin is used on top of a standard antibiotic prophylaxis as compared to the standard antibiotic prophylaxis alone
timeFrame: day 30
Secondary outcomes:
measure: Incidence of sternal wound infections at day 30 after cardiac surgery
timeFrame: day 30
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery
Study officials:
affiliation: Hannover Medical School
name: Martin Strueber, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644263: Turkish Validity and Reliability of The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
Official title: Turkish Validity and Reliability of The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disorders
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-test: 10 patients temporomandibular disorders evaluated. Inclusion and exlusion criteria listed above.

Validation and reliability: 111 patients with temporomandibular disorders evaluated.Inclusion and exlusion criteria listed above.

Brief summary: Objective: The aim of this study is to evaluate the validity and reliability of the Turkish version of the 'The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)' questionnaire used to assess kinesiophobia in temporomandibular joint disorders.

Method: The "Tampa Kinesiophobia Scale in Temporomandibular Disorders" (TSK-TMD), which consists of 12 item, was adapted to Turkish with the translation and back-translation method. 111 patients (75 females, 36 males) who had been diagnosed with temporomandibular joint for at least 6 months and diagnosed as Temporomandibular Joint Disorder were participated to fill out the questionnaire. In the present study, participants were assessed with the Temporomandibular joint disorders evaluation form, Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS). The internal consistency and test-retest reliability with a 3-5 days time were used to evaluate the reliability of the TSK-TMD. The reliability of the corelatıon was checked with PCS. Construct validity was assessed based on conﬁrmatory factor analysis (CFA).

Detailed description: We used Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS) questionnaires in our study.

Eligibility criteria: Inclusion Criteria::

* volunteer participation in the study, between 18 and 65 years old,
* having symptoms for at least 6 months,
* being literate, and having communication to understand and answer questions.

Exclusion Criteria:

* toothache
* Cognitive impairment affecting their ability to understand and complete the study questionnaire

Primary outcomes:
measure: The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
timeFrame: The measurement is one-time and take 20 minutes. It take an average of 6 month after the data of all participants are collected.
measure: Pain Catastrophizing Scala
timeFrame: The measurement is one-time and take 15 minutes. It take an average of 6 month after the data of all participants are collected.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04013763: Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
Official title: Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wheat Allergy
Children
Keywords: wheat allergy
skin sensitization
specific IgE
wheat containing skin care
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2019-07-10
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Wheat allergy is increasing in Thailand. Some studies show that cutaneous exposure of allergen may cause allergy and there are many wheat containing skin care products that are over-the-counter. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to wheat and omega-5 gliadin in wheat allergy patients after stop using wheat containing skin care products.

Detailed description: All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by medical history, medical examination included skin status (suspected atopic dermatitis or not). Blood sample was taken for baseline determination of immunoglobulin E antibodies to wheat and to omega-5 gliadin. Transepidermal water loss was examined in case with atopic dermatitis. The primary outcome was the specific immunoglobulin E antibodies to wheat and omega-5 gliadin in case that stop using wheat containing skin care product and case that continue using products.

Eligibility criteria: Inclusion Criteria:

* children age 1 to 18 years
* History of IgE-mediated wheat allergy

Exclusion Criteria:

* Parents refused to sign the consent
* severe atopic dermatitis
* on oral immunothery
* severe IgE mediated reaction after using wheat containing skin care product

Primary outcomes:
measure: Specific IgE to wheat and omega-5 gliadin level
timeFrame: 1 year
Secondary outcomes:
measure: level of transepidermal water loss
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok noi
country: Thailand
facility: Siriraj hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Punchama Pacharn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakamura M, Yagami A, Hara K, Sano A, Kobayashi T, Aihara M, Hide M, Chinuki Y, Morita E, Teshima R, Matsunaga K. A new reliable method for detecting specific IgE antibodies in the patients with immediate type wheat allergy due to hydrolyzed wheat protein: correlation of its titer and clinical severity. Allergol Int. 2014 Jun;63(2):243-9. doi: 10.2332/allergolint.13-OA-0618. Epub 2014 Apr 25.
Clinical trial NCT03131063: Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation (PHARMECMO)
Official title: A Pilot Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation
Sepsis
Intensive Care Unit
Antibiotics
Keywords: Extracorporeal Membrane Oxygenation
Sepsis
Antibiotics
Pharmacokinetic
Intensive Care Unit
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were selected from patients hospitalized in cardiac surgical intensive care units with clinico-biological elements in favor of sepsis and for whom antibiotic therapy was instituted. An ECMO treatment before study enrollement was required.

Brief summary: The PHARMECMO study is a pilot, prospective, pharmacokinetic study, conducted in a cardiac surgery intensive care unit of 18 beds. Optimization of antibiotic therapy for extracorporeal membrane oxygenation (ECMO) patients remains a pharmacological challenge. Clinical studies suggest that individualized dosing strategies and therapeutic drug monitoring could facilitate the achievement of adequate antibiotic concentration. The objective of this pilot study was to observe the pharmacokinetic characteristics of commonly used antibiotics in intensive care for patients treated with extracorporeal membrane oxygenation.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Extra corporeal membrane oxygenation treatment
* Parenteral antibiotherapy for known or suspected sepsis
* Informed consent

Exclusion Criteria:

* Refusal of participation
* Pregnancy
* Burned patient
* Steady state conditions not reached
* Non-intravenous administration of antibiotherapy

Primary outcomes:
measure: Minimum Antibiotics plasma concentration (Cmin) (C min)
timeFrame: Up to 24 hours
measure: Medium Antibiotics plasma concentration (CT 50)
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Universitaire La Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris, Faculté de médecine, Université Pierre et Marie Curie, Paris, INSERM U1166-ICAN, France
name: Amour Julien, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00616863: Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Oxcarbazapine 600 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Seizures
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of a potential generic 600 mg oxcarbazepine tablet formulation with Novartis Pharmaceutical's 600 mg oxcarbazepine tablet, Trileptal, folloiwng a single 600 mg dose administered with food.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or advers response to oxcarbazepine or any other comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, two period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: MDS Pharma Services
state: Quebec
Study officials:
affiliation: MDS Pharma Services
name: Gaetano Morrelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295163: Stellate Ganglion Block for Hot Flushes in Men Treated With ADT
Official title: Short-term Efficacy of Stellate Ganglion Block in Men to Reduce Hot Flushes Related to Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Stellate ganglion block
hot flushes
androgen deprivation therapy
prostate cancer
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 0
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: Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.

Objective of this study:

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

Detailed description: Androgen deprivation therapy (ADT) is widely used as standard therapy in the treatment of locally advanced and metastatic prostate cancer. Hot flushes and night sweats are one of the main side-effects of ADT. There are no successful and well-tolerable treatment options available. A possible treatment for hot flushes is stellate-ganglion block (SGB), used as a means of interrupting parts of the sympathetic nervous system involved in temperature regulation.

Objective of this study

Eligibility criteria: Inclusion Criteria:

* Male
* Age: \>18 years
* Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
* Treatment with ADT because of prostate cancer
* Absence of any other cause of flushing

Exclusion Criteria:

* Use of medication that affects flushing: oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteinizing hormone-releasing hormone receptor antagonist
* Still receiving chemotherapy of radiotherapy
* Psychiatric disease
* Any unstable concurrent disease
* Allergic reactions against bupivacaine or contrast media.

Primary outcomes:
measure: Hot flush score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
Study officials:
affiliation: Rijnstate Hospital
name: jw. kallewaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02980263: Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
Official title: Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Kawasaki Disease
Keywords: Kawasaki disease
Coronary artery aneurysm
mucocutaneous lymph node syndrome
lymph node syndrome
canakinumab
intravenous immunoglobulin naïve (IVIG-naïve)
intravenous immunoglobulin refractory (IVIG-refractory)
pediatric
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 28
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.


Eligibility criteria: Key Inclusion Criteria:

-Active Kawasaki disease defined as:

* fever ≥38.5°C for ≥5 days
* four out of five of the following criteria: (i) conjunctival injection, (ii) oral mucous membrane changes, (e.g., injected pharynx, or strawberry tongue), (iii) erythema of hands or feet, (iv) polymorphous rash, (v) cervical lymphadenopathy

Key Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

* Previous Kawasaki Disease diagnosis, refractory and/or incomplete Kawasaki disease (for IVIG-naïve patients, Cohort 1)
* Patients who had fever for longer than a week (for Intravenous Immunoglobulin-naïve patients, Cohort 1), or longer than 14 days (for Intravenous Immunoglobulin-refractory patients, Cohort 2)
* History of hypersensitivity to any of the study drugs or to drugs or similar chemical classes or excipients (e.g. citric acid and anhydrous sodium chloride disodium edetate dehydrate polysorbate 80; sodium hydroxide; water for injections)

Other protocol-defined inclusion/exclusion may apply.

Primary outcomes:
measure: resolution of fever
timeFrame: Day 3/4
Secondary outcomes:
measure: proportion of patients with C-reactive Protein reduction
timeFrame: 12 weeks
measure: proportion of patients developing coronary artery aneurysms
timeFrame: 12 weeks
measure: time to resolution of fever
timeFrame: 12 weeks
measure: proportion of patients with remittent fever
timeFrame: 12 weeks
measure: size of coronary artery aneurysm
timeFrame: 24 weeks
measure: Coronary artery aneurysm evolution over time
timeFrame: 12 weeks
measure: proportion of patients with coronary artery aneurysm
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02648763: Staging Procedures to Diagnose Malignant Pleural Mesothelioma
Official title: Staging Procedures to Diagnose Malignant Pleural Mesothelioma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mesothelioma
Solitary Fibrous Tumor of the Pleura
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving treatment at the Mayo Clinic Rochester that are scheduled to undergo staging procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy, endobronchial ultrasound and laparoscopy) as part of their standard of care.

Brief summary: The purpose of this study is to evaluate the accuracy of participants imaging versus staging procedures. The investigators will consent subjects that are scheduled to undergo staging procedures to diagnose malignant pleural mesothelioma (including pleuroscopy, bronchoscopy, endobronchial ultrasound and laparoscopy) as part of their standard of care.


Eligibility criteria: Inclusion Criteria:

* Subject provides informed consent
* Subject is \>18 years of age
* Subject is deemed competent for making medical decisions
* Subject is scheduled to undergo a staging pleuroscopy
* Subject is a surgical candidate
* A negative pregnancy test is required in women of child-bearing potential, as standard of care.

Exclusion Criteria:

* Subject is \<18 years old.

Primary outcomes:
measure: Accuracy of surgical staging versus imaging procedures based on surgical findings.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dennis Wigle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636363: Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Solutions
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution


Eligibility criteria: Inclusion Criteria:

* subject is a habitual wearer of a silicone hydrogel or group IV contact lens
* VA correctable to 0.3 LogMar or better (driving vision)
* Clear central cornea
* Subject uses a lens care system on a regular basis

Exclusion Criteria:

* Systemic disease affecting ocular health
* Using systemic or topical medications
* wear monovision, multifocal or toric contact lenses
* Any grade 2 or greater slit lamp findings

Primary outcomes:
measure: Slit-lamp Findings > Grade 2
timeFrame: Over 4 visits for 3 month period
measure: Subjective Responses to Comfort Related Symptoms/Complaints
timeFrame: Over 4 visits for the 3 month period
measure: Contact Lens Deposits
timeFrame: At each visit for 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: LeRoy
country: United States
facility: Place Eye Care
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Mohinder Merchea, OD, PhD
role: STUDY_DIRECTOR
References: