louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03038841: Mobile Health Technology for Palliative Care Patients
Official title: Mobile Health Technologies for Palliative Care Patients at the Interface of In-patient to Out-patient Care: A Feasibility Study Aiming to Early Predict Deterioration of Patient's Health Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Cancer
Mobile Health
Chronic Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: Swiss Academy of Medical Sciences (SAMS)
First posted: 2017-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at one of the wards of the Clinic of Radiation-Oncology University Hospital Zurich, including a ward of specialized Palliative Care

Brief summary: To test the potential and acceptance of wireless activity tracking in palliative care patients leaving hospital care. Explorative study, collaboration project of the Clinic of Radiation-Oncology, University Hospital Zurich and the Wearable Computing Laboratory, Swiss Federal Institut of Technology. Patients receive a tracking bracelet and a smart phone in order to gather objective physical activity parameters as step count, sleep duration, heart rate, social activity patterns (e.g. making calls) as well as subjective ratings of pain and distress. Quality of life (QoL) will be captured by paper questionnaire. Correlations between patients' physical activity patterns and the pain and distress level assessed from electronic scales as well as QoL-questionnaire will be performed. Acceptance will be evaluated by quantitative questionnaires and interviews. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on fostering early interventions for symptom relief and support of QoL.


Eligibility criteria: Inclusion Criteria:

* established diagnosis of metastatic cancer or other severe illness with limited life-expectancy (physicians guess \<12 months, \> 8 weeks)
* Karnofsky Index ≥50%
* ECOG≤ 2
* aged \> 18 years
* passed a short handling test with devices (tracking bracelet, smart phone)

Exclusion Criteria:

* relevant cognitive impairment
* insufficient knowledge of German language.

Primary outcomes:
measure: Feasibility (time of complete data transfer in weeks)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Clinic of Radiation-Oncology University Hospital Zurich
state: Zurich
Study officials:
affiliation: Clinic of Radiation-Oncology USZ
name: Matthias Guckenberger, Prof
role: STUDY_CHAIR
affiliation: ETH Zürich
name: Gerhard Tröster, Prof
role: STUDY_CHAIR
affiliation: Clinic of Radiation-Oncology USZ
name: Gudrun Theile, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03553641: The Effect of Central Sensitization on Assessment Capacity of Patients
Official title: The Effect of Dental Hyperalgesia and Mechanical Allodynia on Assessment Capacity of Patients in a Local Turkish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Irreversible Pulpitis
Acute Apical Periodontitis of Pulpal Origin
Keywords: capacity
clinical ethics
autonomy
competence
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non

Brief summary: the aim of this study is to evaluate the effect of dental hyperalgesia and mechanical allodynia on the assessment capacity of individuals in a local Turkish population. The hypothesis of this study is that excessive amounts of pain and a major functional shift in the somatosensory system due to central sensitization might cause unwitting intent.

Detailed description: It included patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent. Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study. A total of 30 patients were included in the study. A data sheet including patients' demographic data, diagnostic data, and data of explicit declaration of intent was completed. All pain scores were recorded according to the Visual Analog Scale (VAS). After the demographic data, diagnostic data. Patients were explicitly informed that the answers they were going to provide to the questions related to their explicit declaration of intent would not affect their diagnosis or the treatment they would undergo.

Eligibility criteria: Inclusion Criteria:

* patients between the ages of 18 and 70 who had a symptomatic tooth in need of non-surgical root canal treatment. All enrolled subjects volunteered and signed a written informed consent

Exclusion Criteria:

* Patients diagnosed with systemic diseases and those who had used an analgesic within 12 hours prior to the appointment were excluded from the study.

Primary outcomes:
measure: pain explicit declaration of intent
timeFrame: 30 minutes
Secondary outcomes:
measure: aesthetics
timeFrame: 30 minutes
measure: previous RCT
timeFrame: 30 minutes
measure: excessive pain
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medipol University
Study officials:
affiliation: Istanbul Medipol University Faculty of Dentistry
name: Tan F EYUBOGLU, PROF
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Medipol University Faculty of Law
name: Fulya I GONENC, PROF
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woolf CJ, Salter MW. Neuronal plasticity: increasing the gain in pain. Science. 2000 Jun 9;288(5472):1765-9. doi: 10.1126/science.288.5472.1765.
Clinical trial NCT02241941: Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
Official title: Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Burn Injury
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.


Eligibility criteria: Inclusion Criteria:

* Male or female of 18 years or older
* Second and/or third degree thermal injury
* Total body surface area burned ≥ 15%
* Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich
* Probability of ICU stay of \>14 days
* Written informed consent by the patient or in patients unable to be informed or to sign according to section 4.4 of the study protocol

Exclusion Criteria:

* Evidence of renal failure (Creatinine clearance \<30ml/min) or continuous renal replacement therapy such as continuous hemofiltration
* History of muscle disease or skeletal muscle disorder
* Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN)
* History of hypersensitivity to the drug
* Pregnancy
* Severe coagulation disorder

Primary outcomes:
measure: Pharmacokinetic parameters of daptomycin
timeFrame: up to 30 days
Secondary outcomes:
measure: Correlation of daptomycin plasma concentrations with tissue concentration
timeFrame: up to 30 days
measure: degree of variability of daptomycin pk parameters in dependency of body surface area burned
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Division of Infectious Diseases and Hospital Epidemiology, Universitit Hospital Zurich
name: Rainer Weber, MD Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01889641: IL-26 and Systemic Lupus Erythematosus
Official title: Intérêt de l'IL-26 Comme Nouveau Marqueur Biologique du Lupus érythémateux systémique
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diagnosis of Lupus According to ACR criteriaAgreement for the Blood Sampling
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient and healthy volunteers

Brief summary: Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. Concordant with preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could be a marker of the disease activity and then a potential therapeutic target. In the present study, serum IL 26 level in lupus patients and control will be measured.


Eligibility criteria: Inclusion Criteria:

* diagnostic of Lupus according to ACR criteria ( four criteria are necessary)
* age \> 18 years old

Exclusion Criteria:

* treatment by cyclophosphamide, rituximab, belimumab in the year before inclusion study

Primary outcomes:
measure: Assess serum IL-26 as a biological marker of SLE compared with sera from control subjects
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
state: Bas Rhin
Study officials:
References:
Clinical trial NCT00171041: A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
Official title: A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: PEDIATRIC HYPERTENSION
PEDIATRIC
VALSARTAN
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 265
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.


Eligibility criteria: Inclusion Criteria:

* CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =\>95th PERCENTILE FOR AGE/GENDER/HEIGHT
* CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED

Exclusion Criteria:

* BLOOD PESSURE IS =\>5% HIGHER THAN 99th PERCENTILE FOR AGE
* SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS

Other protocol-defined inclusion/exclusion criteria will also apply.

Primary outcomes:
measure: Change from baseline in sitting systolic blood pressure after 2 weeks
Secondary outcomes:
measure: Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks
measure: Change from baseline systolic blood pressure after 4 weeks
measure: Change from baseline diastolic blood pressure after 2 weeks
measure: Change in diastolic blood pressure after 2 weeks to 4 weeks
measure: Change from baseline diastolic blood pressure after 4 weeks
Other outcomes:
Locations:
city: E.Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Wells T, Blumer J, Meyers KE, Neto JP, Meneses R, Litwin M, Vande Walle J, Solar-Yohay S, Shi V, Han G; Valsartan Pediatric Hypertension Study Group. Effectiveness and safety of valsartan in children aged 6 to 16 years with hypertension. J Clin Hypertens (Greenwich). 2011 May;13(5):357-65. doi: 10.1111/j.1751-7176.2011.00432.x. Epub 2011 Mar 18.
Clinical trial NCT04126941: Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism
Official title: Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypoparathyroidism
Keywords: Hypoparathyroidism
Teriparatide
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 9
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypoPTH (Hypoparathyroidism) treated with teriparatide

Brief summary: Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy.

The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.


Eligibility criteria: Inclusion Criteria:

* Patients with hypoparathyroidism
* Patients treated with teriparatide
* Patients followed in the reference center for calcium and phosphate metabolism diseases of Lyon.
* For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their non-opposition

Exclusion Criteria:

* No social security support

Primary outcomes:
measure: Serum calcium concentration
timeFrame: 3 months after treatment initiation
Secondary outcomes:
measure: Serum calcium concentration
timeFrame: 1 month after treatment initiation
measure: Serum calcium concentration
timeFrame: 6 months after treatment initiation
measure: Serum calcium concentration
timeFrame: 12 months after treatment initiation
measure: Serum calcium concentration
timeFrame: 3 years after treatment initiation
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT04155541: Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)
Official title: Special Investigation for Vizimpro Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EGFR Mutation-positive Inoperable or Reccrent NSCLC
Keywords: VIZIMPRO
EGFR mutation-positive inoperable or recurrent NSCLC
non-small cell lung cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patient who meet the inclusion criteria and who were registered to this study within 84 days including the start date of treatment with this product will be subjects for this study.

Brief summary: Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice


Eligibility criteria: Inclusion Criteria:

* patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate)

Exclusion Criteria:

* Exclusion criteria is not provided in this study

Primary outcomes:
measure: The number and proportion of patients with ILD (interstitial lung disease)
timeFrame: 52 weeks form the start date
Secondary outcomes:
measure: Response rate
timeFrame: 52 weeks from the start date
measure: The number and population of patients with adverse reactions
timeFrame: 52 weeks from the start date
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Japan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02881541: Study of the Benefit of a Nurse (IDE) Pre and Post-operative Framework in Proctology Outpatient Surgery
Official title: Study of the Benefit of a Nurse (IDE) Pre and Post-operative Framework in Proctology Outpatient Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Proctology
Surgery
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 0
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: Evaluate the complement of patient care course in the development of proctology outpatient surgery (CAP) by providing:

* An additional preoperative nurse consultation day hospital
* And a phone call from a nurse at D + 1 of the operation

This corresponds to a reinforced support.

Detailed description: Main objective of the study: help improve the care of patients in CAP including during their exit after surgery. To evaluate the quality of patient care related to this enhanced system is a lever of development assistance outpatient surgical activity.

Secondary Objectives: To evaluate the impact of this new organization

* Satisfaction of patients and caregivers
* The effectiveness of the management of patients' pain

Study period: 3 months extendable a month, no start date announced

Workforce to include 100 patients at 3 months (10 per week), 50 in the "enhanced support" group and 50 in the group "usual care"

Expected results:

The main objective evaluation criteria: Evaluation support the success rate.

Evaluation performed 45 days after the patient's surgery.

Secondary objectives: patient satisfaction (telephone questionnaire to 45 days of operation), caregivers, pain assessment (painkillers booklet completed by the patient during his first consultation), consultation or rehospitalization for emergency patients and finally degree trust the doctor vis-à-vis this new support.

Eligibility criteria: Inclusion Criteria:

* Patient man or woman major
* Patient primary surgery and requiring care in CAP
* Patient affiliated to a social security scheme or of such a scheme

Exclusion Criteria:

* Bedridden patient and / or not communicating
* Patient opposing his participation in the study after information
* Patient has already undergone anal surgery

Primary outcomes:
measure: Assessment of the success rate of the treatment using intern questionary score
timeFrame: Day 45 after surgery
Secondary outcomes:
measure: Assessment of patient satisfaction by intern phone questionary Score
timeFrame: Day 45 after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Tasseau P Angélique, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498641: Anisometropia Amblyopia Improved by Perceptual Learning and Patching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anisometropic Amblypia
Keywords: perceptual learning
occlusion therapy
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2007-07-10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of perceptual learning with patching on improving visual acuity and contrast sensitivity in payient with anisometropic amblyopia.

Detailed description: Patients with anisometropic amblyopia were randomized to patching or perceptual learning group. Corrected amblyopic logMAR visual acuity and contrast sensitivity function were measured at four-weekly intervals until visual acuity stabilized or amblyopia resolved. Improvement in visual acuity, contrast sensitivity, and the resolution of amblyopia were compared between groups.

Eligibility criteria: Inclusion Criteria:

* Anisometropia without strabismus
* An interocular acuity difference of at least 0.2 logMAR in children (3-7 years of age) or in older children and adult patients without a history of patching or atropine penalization
* All patients wore their spectacle at least one year

Exclusion Criteria:

* A history of prior spectacle correction
* A history of patching or optical penalization
* The existence of an ocular disease that could contribute to decreased visual acuity
* Learning difficulties
* The presence of strabismus

Primary outcomes:
measure: Corrected amblyopic logMAR visual acuity and contrast sensitivity function
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tri-Service General Hospital
name: Po Chen, MD
role: STUDY_DIRECTOR
References: