louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03804346: Infantile - Postoperative Residual Curarization - Study
Official title: Observational Study to Detect Postoperative Residual Curarization in Infantile Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Residual Curarization
Neuromuscular Blockade
Neuromuscular Monitoring
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children/youths between 1 Month to 18 years who are undergoing general anaesthesia with muscle relaxation due to surgical or diagnostical procedures.

Brief summary: The primary object of this study is, to investigate the current procedure of neuromuscular monitoring at a tertiary academic university medical center.

Detailed description: Residual neuromuscular block is known to be a significant but frequently overlooked complication after the use of neuromuscular blocking agents. Aim of this prospective, observational study is to detect the incidence and severity of residual paralysis at a tertiary academic german university medical center.

Methods:

All infantile patients recieving neuromuscular blocking agents are included over a 12 week observational period. At the end of the operation procedure, directly prior to tracheal extubation a train-of-four ratio was assessed quantitatively by an independet observer using the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the operating theatre, during the way to the postoperative care unit (PACU) and during the stay in the PACU:

* incidence of residual paralysis
* incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway obstruction,

Eligibility criteria: Inclusion Criteria:

* General aneasthesia with muscle relaxation
* Children between 1 Month to 18 Years
* Endotracheal Intubation due to surgical or diagnostical procedures

Exclusion Criteria:

* older than 18 years
* local aneasthesia
* regional aneasthesia
* larynx mask
* patient comes from ICU
* children who are not planned to be extubated

Primary outcomes:
measure: Residual paralysis
timeFrame: Directly prior to extubation
Secondary outcomes:
measure: Airway obstruction
timeFrame: 1, 10, 30, 60 minutes after extubation
measure: Oxygen desaturation
timeFrame: 1, 10, 30, 60 minutes after extubation
measure: Bronchospasm, laryngospasm
timeFrame: 1, 10, 30, 60 minutes after extubation
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
state: Bavaria
Study officials:
affiliation: University medical center Regensburg, Department of anaesthesiology
name: Christoph Unterbuchner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01511146: Intrahepatic Chemotherapy to Patients With Non-resectable Liver Metastases From Solid Tumor
Official title: Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Metastasis
Keywords: oxaliplatin
mitomycin
gemcitabine
intrahepatic
liver metastasis
response in liver metastasis
downsized to operation
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 100
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 purpose of this study is to see if treatment with intrahepatic chemotherapy is a good options in patients with liver metastases. If the patients have colorectal cancer and never had got chemotherapy the investigators will use oxaliplatin together with capecitabine. If the patient is K-RAS wild type the investigators will add cetuximab. In patients who had received oxaliplatin or in patients with other cancers the investigators will use mitomycin and gemcitabine together with capecitabine.

Detailed description: Two regiment are used: N.B. The two regiments will be reported separately

1. Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be offered patients with solid tumors where all standard treatments have been used. The patients are not allowed to have extrahepatic disease. The purpose of the treatment are to prolonged life.
2. FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only for patients with colorectal cancer where cure is possible but resection straight ahead is not possible. The patients are allowed to have their colorectal cancer in situ for operation latter on. If the patients are KRAS Wild-type, cetuximab are added.

Eligibility criteria: Inclusion Criteria:

* liver metastasis
* solid tumor

Exclusion Criteria:

* poor performance

Primary outcomes:
measure: tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival, adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Unaffliated
name: Finn O Larsen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02952846: Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment
Official title: Tapering of Analgosedation and Occurrence of Withdrawal Syndrome in Paediatric Intensive Care Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Withdrawal Symptoms
Critical Care
Child
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a prospective interventional study with three main aims:

1. Describe the frequency and severity of withdrawal syndrome in a population of paediatric intensive care patients.
2. Test whether implementation of an algorithm for tapering of analgosedation changes the frequency and severity of withdrawal symptoms in the same population.
3. Investigate how the health care providers experience having to adhere to such an algorithm.

Detailed description: Patients \< 18 years of age treated in an intensive care unit for 5 days or more with infusion of opioids and/or benzodiazepines, are eligible for inclusion. Patients are included at the time tapering of these drugs is initiated. Part one of the study is observational. Drugs administered, complications, Comfort score and WAT-1 (Withdrawal Assessment Tool-1) score is recorded. Before part two of the study, an algorithm for tapering of analgosedation is implemented, and the data set is obtained as in part one.

For part three of the study, focus group interviews will be used.

Eligibility criteria: Inclusion Criteria:

* \< 18 years
* treated in PICU
* Infusion of opioids and/or benzodiazepins for 5 days or more.

Exclusion Criteria:

* Neuromuscular disease
* Cognitive/neurological disturbance caused by a disease
* Multiple disabilities

Primary outcomes:
measure: Change in mean peak WAT-1 score
timeFrame: Through study completion, up to 21 days
Secondary outcomes:
measure: Time used tapering analgosedation
timeFrame: Through study completion, up to 21 days
measure: Ventilator days
timeFrame: Through study completion, up to 21 days
measure: ICU days
timeFrame: Through study completion, up to 21 days
measure: Drug doses used
timeFrame: Through study completion, up to 21 days
measure: Adverse events
timeFrame: Through study completion, up to 21 days
measure: Comfort score
timeFrame: Through study completion, up to 21 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Gunnar bentsen, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04099446: A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
Official title: A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer Including Melanoma and Non-Melanoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Skin Cancer
Melanoma (Skin)
Squamous Cell Carcinoma
Basal Cell Carcinoma
Microbiome
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults 18 and older with a diagnosis of skin cancer

Brief summary: This study seeks to correlate microbial sequencing data from a punch biopsy in patients with skin cancer both melanoma and non-melanoma.

Detailed description: The human Skin microbiome is a complex, interconnected web of microbes, living in a symbiotic relationship with their host. There are greater than ten times more bacteria on our bodies than there are human cells, all in a delicate and ever-changing balance to maintain a healthy skin microbiome. When this balance is disrupted, a condition known as dysbiosis, disease can occur. There is still a debate over whether dysbiosis is a cause of disease or a symptom of it. Naturally, since the microbiome has such a profound impact on human health, we want to study and learn as much about the microbiome as possible. By correlating this data with medical records for the patient's skin cancer, connections may begin to be drawn between organisms present in the microbiome of the skin microbiome, and skin cancer. Much like fingerprints, no microbiome is identical therefore the only chance we have at understanding disease is by looking at the skin microbiome and comparing the microorganisms on a patient with skin cancer biopsy and non-skin cancer biopsy.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* 18 years of age or older
* Diagnosis of skin cancer, both melanoma and non-melanoma
* Able/willing to have a skin punch biopsy in a non-cancerous location

Exclusion Criteria:

* Unable/unwilling to sign informed consent
* Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study.

Primary outcomes:
measure: Correlation of Skin Microbiome to Cancer via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
measure: Validation of sequencing methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068846: BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
Official title: BK Virus in Salivary Gland Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Salivary Gland Disease
Benign Lymphoepithelial Lesion
Keywords: HIV
Salivary Gland Disease
Benign Lymphoepithelial Lesion
BK Polyomavirus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2014-02-21
Enrollment: 17
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 analyze BK viral infection in salivary gland diseases; specifically, to determine a definitive relationship between BK Virus and HIV associated salivary gland disease (HIVSGD). Participants are adults HIV+SGD+ who will be randomized 1:1 to receive BK Virus antiviral (ciprofloxacin) or placebo for 28 days. Salivary function/protein secretion will be correlated with BK polyomavirus titers. It is expected that patients with HIV+SGD+ will have elevated oral BK polyomavirus viral loads and will benefit from Ciprofloxacin.

Detailed description: The study duration is 12 weeks with a baseline visit, a visit at 4 weeks and a visit at 12 weeks. At baseline participants are randomized to Ciprofloxacin or placebo and take the drug or placebo for 28 days. At subsequent visits BK polyomavirus presence and salivary gland function will be assessed.

Eligibility criteria: Inclusion Criteria:

* HIV positive with Salivary Gland Disease
* Ability to read and understand English

Exclusion Criteria:

* Allergy to the family of fluoroquinolones (including ciprofloxacin)
* Currently taking tizanidine
* Concurrently taking antiacids containing magnesium hydroxide or aluminum hydroxide
* Current use of Theophylline
* Previous tendon disorder such as Rheumatoid arthritis
* History of seizures
* Current use of phenytoin
* Current use of glyburide
* Current use of methotrexate
* Severe renal impairment (known creatinine clearance \< 30 or on dialysis)

Primary outcomes:
measure: BK Viral Status in Saliva at Week 4
timeFrame: Week 4
measure: BK Viral Status in Saliva at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Unstimulated Salivary Flow Rate at Week 4
timeFrame: Week 4
measure: Unstimulated Salivary Flow Rate at Week 12
timeFrame: Week 12
measure: Number of Participants Reporting Dry Mouth "Yes/No" at Week 4
timeFrame: Week 4
measure: Number of Participants Reporting Dry Mouth "Yes/No" at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina School of Dentistry
state: North Carolina
Study officials:
affiliation: The University of North Carolina School of Dentistry
name: Jennifer Webster-Cyriaque, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03462446: Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events
Official title: Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
VKA
Stroke
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2018-03-12
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.

Brief summary: The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Diagnosis of non-valvular AF (ICD code 427.31)
* Pharmacological treatment with VKAs or rivaroxaban following diagnosis

Exclusion Criteria:

-

Primary outcomes:
measure: Time in therapeutic range (TTR) values in the last 6 months
timeFrame: 6 months
measure: Presence of stroke
timeFrame: 12 months
measure: Active substance received
timeFrame: 12 months
Secondary outcomes:
measure: Date of stroke
timeFrame: 12 months
measure: Type of stroke
timeFrame: 12 months
measure: Duration of treatment (in days)
timeFrame: 12 months
measure: Dose of the prescribed treatment
timeFrame: 12 months
measure: Frequency of the prescribed treatment (in hours)
timeFrame: 12 months
Other outcomes:
measure: Date of AF diagnosis
timeFrame: 12 months
measure: Comorbidities
timeFrame: 12 months
Locations:
city: Granada
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03476746: Dermatopharmacokinetic Trial of LEO 90100 Foam
Official title: Dermatopharmacokinetic Trial of LEO 90100 Foam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2018-03-26
Enrollment: 58
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A single application of LEO 90100 foam and Dovobet® ointment will be applied to multiple test sites on the innerside of both arms of trial subjects. The trial consists of 2 parts. The first part, (pilot part) will evaluate the pharmacokinetic profile of LEO 90100 foam and Dovobet® ointment by measuring the amount of each of the active ingredients in the stratum corneum and determine conditions for the second part of the trial. The second part (pivotal part) will compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 90100 foam and Dovobet® ointment. The sample size and the number of application sites in the pivotal part will be determined based on the results of the pilot part.
Primary purpose: OTHER

Brief summary: This is a phase 1, single centre trial in Japanese healthy male subjects comparing the amount of active ingredients of LEO 90100 foam and Dovobet® ointment in the stratum corneum.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male subjects, aged 20 to 40 years inclusive

Exclusion Criteria:

* Body Mass Index outside the range 18-25 kg/m²
* Use of any medication (systemic or topical) within 2 weeks of Day 1.

Primary outcomes:
measure: The amount of each of the 2 active ingredients, calcipotriol and betamethasone dipropionate, in the stratum corneum obtained by means of tape stripping after application of LEO 90100 foam and Dovobet® ointment.
timeFrame: 2, 4, 6, 8, 12 and 24 hr after drug application.
Secondary outcomes:
measure: Safety data - number of adverse events
timeFrame: up to 15 Days after drug application
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Investigational site
Study officials:
affiliation: LEO Pharma
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00420446: The Effect of Daily Intakes of Dairy Products on Blood Pressure in Human Beings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2007-01-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the project is to elucidate the effect on blood pressure by daily intake of dairy products. Previous studies have demonstrated a beneficial effect on blood pressure.

In total 90 subjects will be enrolled. For eight weeks, the participants will ingest one of two different dairy produces. Before, during and after the study period, the blood pressure is measured.


Eligibility criteria: Inclusion Criteria:

* Borderline hypertension

Exclusion Criteria:

* CVD, Diabetes, any kind of antihypertensive therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of clinical physiology, Glostrup Hospital
Study officials:
affiliation: Department of Clinical Physiology, Glostrup Hospital, DK-2600 Glostrup, Denmark
name: Lars T Jensen, M.D., Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine M, Glostrup Hospital, DK-2600 Glostrup, Denmark
name: Hans Ibsen, M.D., D.M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05262946: Sensorimotor Training for Adults With Diabetic Peripheral Neuropathy
Official title: Somatosensory Restoration and Postural Control Improvement in People With Diabetic Peripheral Neuropathy Applying Sensorimotor Training: a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Somatosensory Disorders
Sensorimotor Gait Disorder
Keywords: gait
diabetes
sensorimotor training
peripheral neuropathy
somatosensory system
postural control
quality of life
fear of falling
Feldenkrais method
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms and single blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Adults with diabetic peripheral neuropathy tend to fall more frequently than healthy population as a consequence of multiple sensorimotor and cognitive damages. In this protocol study, a randomized controlled trial is proposed using a sensorimotor intervention based on Feldenkrais method to improve somatosensory aspects and, therefore, postural control of participants.

Detailed description: Among all the systems suffering damage due to hyperglucemia toxicity in diabetes, somatosensory system, composed by proprioception and skin sensory receptors has a key role since it is in charge of the faster body reaction when a postural control response is needed. Despite of it, few studies have focused on this issue. This randomized controlled trial proposed a safe and easy training adapted to adults and old people with diabetic peripheral neuropathy. Pressure, touch, proprioception and graphesthesia sensibility were measured, as well as functionality in daily basis, quality of life and fear of falling.

Eligibility criteria: Inclusion Criteria: having peripheral neuropathy and history of falls or risk factors for it. Current ulcer -

Exclusion Criteria: amputation and cognitive or mental issues

-

Primary outcomes:
measure: Cumulative Somatosensory Impairment Index
timeFrame: 2 years
Secondary outcomes:
measure: Up and Go test
timeFrame: 2 years
measure: Four Square Step test
timeFrame: 2 years
measure: Tinetti- Performance-Oriented Mobility Assessment (POMA-T)
timeFrame: 2 years
measure: Falls Efficacy Scale
timeFrame: 2 years
measure: SF-36 Health Survey questionnaire , 1.4 version.
timeFrame: 2 years
measure: Validated Spanish version of Short-Form Late-Life Function and Disability Instrument
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSIDAD COMPLUTENSE MADRID
name: MARIA TERESA ANGULO CARRERA, DR
role: STUDY_DIRECTOR
affiliation: HOSPITAL UNIVERSITARIO DE LA PAZ
name: NOEMI GONZALEZ PEREZ DE VILLAR, DR
role: STUDY_DIRECTOR
References: