louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02966990: Biomechanical Analysis of the Effects of Upper Limb Orthosis During the Execution of a Functional Task
Official title: Biomechanical Analysis of the Effects of Upper Limb Orthosis During the Execution of a Functional Task
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthotic Devices
Electromyography
Biomechanical Phenomena
Hand
Upper Extremity Dysfunction
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The orthotics are auxiliary therapeutic resources indicated for the relief of pain, improves functional standard or correction of deformities. There is a lack of studies that analyze the biomechanical changes promoted by the Orthotics in functional pattern of the upper limb. The objective of this proposal is to analyse biomechanical changes in the functional upper limb pattern with the use of orthoses for patients with dysfunctions arising from musculoskeletal system trauma or burns, aiming to contribute with scientific evidence to clinical practice. The project will analyze the changes in the pattern of the upper limb functional through the use of dynamic and static Orthotics by means of kinematic and electromyographic analysis while conducting a functional task. These comparisons will be carried out with and without the use of functional Orthotics, and the controls are the patients themselves. Methods: 25 patients will be included over 18 years with malfunctions resulting from orthopaedic trauma and Burns of the upper limb with indication and Orthotics for improving functional pattern. For characterization of the sample will be performed: esthesiometric , hand and the (Disabilities of the Arm, Shoulder and Hand) DASH Questionnaire. Biomechanical assessment will be used for the analysis and electromyographic kinematics. For statistical analysis will be applied the method of analysis of variance (ANOVA) for repeated measures, and when necessary, the post hoc Bonferroni test. Will be adopted as significance level p ≤ 0.05.


Eligibility criteria: Inclusion Criteria:

* patients who are using hand orthosis for functional purposes

Exclusion Criteria:

* neurological problems; cognitive deficits

Primary outcomes:
measure: Electromyographic assessment
timeFrame: one day
measure: Kinematic analysis
timeFrame: one day
Secondary outcomes:
measure: Functional assessment
timeFrame: one day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04801290: TIPS in Patients With Decompensated Liver Cirrhosis
Official title: Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Decompensated Liver Cirrhosis
Keywords: Portal hypertension
TIPS
Refractory ascites
Variceal bleeding
Liver cirrhosis
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with decompensated liver cirrhosis and an indication for TIPS placement at Hannover Medical School.

Brief summary: This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School. By collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize TIPS therapy (e.g. specify selection criteria).


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* Indication for TIPS insertion
* Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School
* Informed consent

Exclusion Criteria:

* Pregnancy or Lactation
* Age \<18 years
* Lack of Informed consent
* Symptomatic anemia with Hb \<7g/dl

Primary outcomes:
measure: Mortality
timeFrame: 1 year
measure: Occurrence of (Minimal) Hepatic Encephalopathy
timeFrame: 1 year
measure: Change in Nutritional Status
timeFrame: 1 year
measure: Change in Quality of Life
timeFrame: 1 year
Secondary outcomes:
measure: Change in inflammatory markers (e.g. cytokine)
timeFrame: 12 months
measure: Change in different metabolites using mass spectroscopy (metabolomics measurements)
timeFrame: 12 months
measure: Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs)
timeFrame: 12 months
measure: Analysis of stool samples
timeFrame: 12 months
measure: Measurement of portal hypertension
timeFrame: 6 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School
name: Benjamin Maasoumy, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01399190: An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer
Official title: An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-21
Enrollment: 68
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: Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine and oxaliplatin.

Brief summary: This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Treatment in accordance with current Summary of Product Characteristics and local guidelines

Exclusion Criteria:

* Contraindications according to current Summary of Product Characteristics and local guidelines

Primary outcomes:
measure: Progression-free Survival
timeFrame: From randomization to progression or death during the study (up to approximately 30 months)
Secondary outcomes:
measure: Response Rate (Tumor Assessments According to RECIST)
timeFrame: Up to approximately 30 months
measure: Percentage of Participants With Adverse Events
timeFrame: Up to approximately 30 months
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Poprad
country: Slovakia
city: Presov
country: Slovakia
city: Ruzomberok
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01033890: Local Anesthesia With Sedation for Cochlear Implant Surgery
Official title: Local Anesthesia With Sedation for Cochlear Implant Surgery: 3 Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implant Surgery
Keywords: local anesthesia
cochlear implant
sedation
3 patients submitted to cochlear implant surgery with local anesthesia with sedation
Lead sponsor: Instituto Paranaense de Otorrinolaringologia
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 3
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: 3 adult patients with total deafness

Brief summary: ABSTRACT

Objectives: The aim of this article is to illustrate the possibility of performing a cochlear implant with local anesthesia and sedation, the anesthesic technique and the advantages of that in comparison to a general anesthesia.

Materials and method: The investigators describe two successful surgeries done with local anesthesia, including the neural telemetry and the conditions the patient presented after the surgery, with a very good recovery and no complications during and after the procedure.

Key words: local anesthesia, cochlear implant


Eligibility criteria: Inclusion Criteria:

* adult patients with total deafness

Exclusion Criteria:

* children under 18 years old

Primary outcomes:
measure: Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Instituto Paranaense de Otorrinolaringologia
state: PR
Study officials:
affiliation: Instituto Paranaense de Otorrinolaringologia
name: Rogerio Hamerschmidt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03286790: Incidence of pNeumonia and Related ConseqUences in Nursing Home Residents
Official title: Incidence of pNeumonia and Related ConseqUences in Nursing Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: elderly
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 800
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living in the participating EHPAD for more than 30 days since the baseline study visit

Brief summary: In the present proposal, we hypothesize that specifically targeting pneumonia events with preventive interventions in the French EHPAD (Etablissements d'Hébergement pour Personnes Agées Dépendantes) setting (thus, improving the health status and quality of life of patients) may simultaneously produce relevant reductions in the healthcare costs. In fact, although the number of pneumonia cases may be numerically limited, the consequences of each event are potentially catastrophic for both the patient and the healthcare system. Unfortunately, to date, information about the incidence and economical effects of pneumonia in the older population living in the French EHPAD are extremely scare. To adequately evaluate whether there is room to implement preventive interventions aimed at reducing the onset of pneumonia in a cost-effective fashion on a large scale, preliminary data from this specific population are needed. This first step is crucial towards the appropriate design and conduction of possible future large-scale intervention trials in the EHPAD setting.


Eligibility criteria: Inclusion Criteria:

* Groups Iso-Resources (GIR) ranging between 5 (included) and 2 (included)
* Ability and willingness to participate to the study and to provide informed consent
* Agreement with the patient's physician about the enrolment to the study

Exclusion Criteria:

* Refusal of the EHPAD to participate
* Patients with severe disability (GIR 1)
* Patients with no evidence of functional impairment (GIR 6)
* Patients living in the participating EHPAD for less than 30 days since the baseline study visit

Primary outcomes:
measure: Incidence of pneumonia
timeFrame: months 12
measure: healthcare costs
timeFrame: months 12
Secondary outcomes:
measure: Mortality risk
timeFrame: Months 12
measure: Physical Function
timeFrame: Months 12
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Mateo Cesari, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00807690: Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo
Official title: Treatment of Vitiligo With Narrowband UVB (TL01) Combined With Tacrolimus (0.1%) Versus Placebo Ointment, a Randomized Right/Left Double Blind Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitiligo
Keywords: vitiligo
tacrolimus ointment 0.1%
narrowband UVB (TL01)
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2008-12-12
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: BACKGROUND Vitiligo is a common, often distressing condition. Many of the patients do not achieve sufficient effect from what is regarded as the treatment of choice at present, narrow band(NB)UVB(Tl01). There are reports on some patients partly successfully treated with Tacrolimus ointment.

AIM OF THE STUDY We want to study whether Tacrolimus ointment may give an additive effect on symmetric vitiligo in combination with NB-UVB.

METHODS This is a double blind left/right comparative study with 6 months treatment time. Patients are treated with whole body NB-UVB x 2 or x 3 weekly, in addition to Tacrolimus ointment versus placebo every night on affected half body sites. To measure effects we use photodocumentation in addition to morphometric registration of symmetric target lesions every 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients aged at least 18 years with a stable, symmetric vitiligo

Exclusion Criteria:

* Patients with segmental vitiligo, aged \< 18 years, known hypersensitivity to Tacrolimus, pregnant or breastfeeding women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rikshospitalet HF, Dept. of Dermatology
name: Eli Johanne Nordal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02428790: Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury
Official title: Gastrointestinal Transit Time in Patients With Severe Acquired Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Constipation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Hammel Neurocenter
First posted: 2015-04-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Hammel Neurocenter and University Clinic, during rehabilitation after aquired brain injury

Brief summary: Empirically patients with acquired brain injury (ABI) are often constipated. This is a major clinical issue. Nevertheless, this has only been sparsely studied.

The investigators will measure gastrointestinal transit time (GITT) in 30 patients with ABI, and compare this to healthy controls. Secondly heart rate variability (HRV) is measured in these patients, and associations between HRV and GITT are investigated.


Eligibility criteria: Inclusion Criteria:

* ABI:
* Moderate to severe traumatic brain injury (TBI) (Glasgow Coma Scale (GCS) score 3-12 at admission)
* or Stroke
* or Anoxic brain injury
* Ability to swallow the capsules used to assess GITT
* Ability to give meaningful informed consent to participate in the study

Exclusion Criteria:

* Major abdominal disorders
* Severe acute comorbidity
* Known cancer
* Pregnancy
* Known autonomic neuropathy
* Other known neurological disorder

Primary outcomes:
measure: Gastrointestinal transit time (GITT) [in days]
timeFrame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.
Secondary outcomes:
measure: Association between heart rate variability (HRV) and GITT
timeFrame: During rehabilitation, when the patient meet the inclusion criteria. This is expected to be between 2 weeks and 4 months after the primary injury.
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Henning Andersen, Professor, Dr. med. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947790: Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease
Official title: Pioglitazone Regress Left Ventricular Mass in Type 2 Diabetes With Ischeamia Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: LVM
Type 2 Diabetic Patients With IHD
Endothelial Function
Keywords: Type 2 diabetes
left ventricular mass
pioglitazone
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to ischeamia heart disease (IHD). Most of the attention in treating IHD in type 2 diabetes is understandably directed toward treating coronary artery conditions. However there are other treatable culprits in these patients.

Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with IHD, even in the absence of hypertension. It is a strong predictor of cardiovascular events and all-cause mortality. In one study, the presence of LVH was a stronger predictor of mortality than either multivessel coronary disease or impaired left ventricular function. Regression of LVH has been associated with an improved prognosis, independent of change in blood pressure (BP). Therefore, cardiovascular events and mortality in type 2 diabetes with IHD might will be reduced if we can find novel therapies to regress LVH.

Pioglitazone can improve atherosclerosis. Therefore, we hypothesied that pioglitazone can regress the left ventricular mass (LVM) in type 2 diabetes with IHD.Therefore, in this study, we will treat patients with pioglitazone, and we will also metformin as control.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* aged 40～75 years old
* with IHD

Exclusion Criteria:

* heart failure
* renal failure
* hypertension (\>130/80 mmHg)
* hemoglobin A1c 9%

Primary outcomes:
measure: The changes of LVM
timeFrame: The LVM will be measured at baseline, 6 momth and 9 month
Secondary outcomes:
measure: The changes of endothelial function
timeFrame: The endothelial function will be measured at baseline, 6 month and 9 month
Other outcomes:
Locations:
city: Wuhan City
country: China
state: Hubei
city: Wuhan
country: China
facility: Xiang Guangda
state: Hubei
Study officials:
References:
Clinical trial NCT03944590: Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures
Official title: Radiological and Clinical Outcome After Screw Osteosynthesis of Radial Head Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Head Fractures
Keywords: screw osteosynthesis
rupture of the interosseous membrane
collateral ligaments
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing screw osteosynthesis of radial head fractures at Universitätsspital Basel between June 2010 until June 2016

Brief summary: This cohort study investigates radiological and clinical outcome after screw osteosynthesis of radial head fractures with associated injuries (such as rupture of the interosseous membrane and collateral ligaments). Interpretation of radiographs 3 and 9 months post- surgery and patient surveys will be analyzed.


Eligibility criteria: Inclusion Criteria:

* screw osteosynthesis of radial head fractures

Exclusion Criteria:

* unable to give consent
* dementia

Primary outcomes:
measure: Change in status of bone healing assessed by radiographs
timeFrame: 3 months and 9 months post surgery
Secondary outcomes:
measure: elbow status assessed by Mayo Elbow Score (MEPS)
timeFrame: single time point, assessment 2 to 7 years after surgery
measure: Patient reported outcome of elbow surgery assessed by Oxford Elbow Score (OES)
timeFrame: single time point, assessment 2 to 7 years after surgery
measure: Patient reported outcome assessed by Quick Dash
timeFrame: single time point, assessment 2 to 7 years after surgery
measure: Assessment on employment
timeFrame: single time point, assessment 2 to 7 years after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Daniel Rikli, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03987490: Usability of HPV Vaccine Reminders
Official title: A Feasibility Trial of Parent-targeted Strategies to Increase HPV Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus (HPV)
Keywords: vaccine
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This study will assess the usefulness of parent-targeted strategies in improving care seeking among parents of 11-12 year old adolescents. Specifically, the study team will focus on reminders (postcard or text message) and motivational interviewing to improve adolescent vaccination.

Detailed description: Despite the impressive cancer preventing potential of human papillomavirus (HPV) vaccines, HPV vaccine coverage rates in the United States remain substantially lower than other vaccines and Healthy People 2020 targets. HPV vaccine initiation can be improved through targeted reminders that motivate parents. Our long-term goal is to maximize HPV vaccination rates among girls and boys within the United States using efficient and sustainable strategies. The objective of this protocol is to evaluate the usefulness of a tiered strategy of a parent-targeted strategies in improving care seeking and receptiveness to vaccine recommendations. Strategies include HPV vaccine reminders via postcard or text message and phone-based Motivational Interview sessions. The central hypothesis is addressing key health beliefs (e.g., perceived benefits and barriers) will increase parental acceptance and, thus, HPV vaccine initiation.

Eligibility criteria: Inclusion Criteria:

* Parents of 11-12 year olds who attend the Schiebler CMS clinic at University of Florida in the previous year

Exclusion Criteria:

* Unable to meet inclusion criteria

Primary outcomes:
measure: Percentage of Patients with deliverable text messages
timeFrame: up to 2 weeks
measure: Percentage of phone calls where interviewer is adherent to MI
timeFrame: During phone interview
Secondary outcomes:
measure: Percentage of adolescent who get one dose of the HPV vaccine
timeFrame: Six months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Pediatrics - Gerold L. Schiebler CMS Center
state: Florida
Study officials:
affiliation: University of Florida
name: Stephanie Staras
role: PRINCIPAL_INVESTIGATOR
References: