louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00925626: Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial
Official title: Sub-Vastus Versus Mid-Vastus Arthrotomy for Total Knee Arthroplasty: a Randomized Clinical Trial With One Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricompartmental Gonarthrosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, single-blind trial in which one group of patients will be operated with a "Mid-Vastus approach" of the knee joint and the other group will undergo knee surgery with a "Sub-Vastus approach".


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with osteoarthrosis of the knee
* patients must be in good general health condition

Exclusion Criteria:

* patients with morbid obesity (BMI \>45)
* patients with history of knee surgery, infection or inflammatory disease of the knee joint or large cartilage lesion

Primary outcomes:
measure: VAS, KOOS and HSS scales
timeFrame: at day 1, day 2, day 3, day 4 and day 5 post-operatively
measure: Rehabilitation time; time needed for 90° flexion of the knee joint
timeFrame: post-operatively
Secondary outcomes:
measure: VAS, HSS, KOOS questionnaires
timeFrame: at 6 weeks, 3 months and 12 months after surgery.
measure: Amount and type of analgesic drugs used.
timeFrame: pre-operatively and post-operatively
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Peter Verdonk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03844126: Transition of Diabetes Care From Pediatric to Adult Healthcare Providers.
Official title: Adolescents With Type 1 Diabetes Who Attend Pre-transition Classes, Are Better Prepared to Transition Their Care From Pediatric to Adult Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transition
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A dedicated pre-transition class, as proposed in this study, could help facilitate a smooth transition between pediatric and adult diabetes care. The innovation in this study is that these classes are an opportunity for the patients and their families to meet with the Adult Diabetes Team consisting of a diabetologist, RD and CDE, prior to the transition of care. Having met them would then increase the likelihood of compliance with the Adult clinic visits.


Eligibility criteria: Inclusion Criteria:

Adolescents with Type 1 Diabetes

Exclusion Criteria:

Not wanting to participate in the classes

Primary outcomes:
measure: Transition preparedness
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: PSHMC
name: Kanthi Bangalore Krishna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03541226: Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome (CIS)
Official title: Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinically Isolated Syndrome
Multiple Sclerosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with clinically isolated syndrome (CIS)

Brief summary: The purpose of this study is to develop tools to detect, measure, monitor and predict axonal damage in the course of CIS and during Multiple sclerosis (MS), in order to be able to consider as early as possible an adaptation of the background treatment in patients with MS. patients with radiological criteria of poor long-term clinical course.


Eligibility criteria: Inclusion Criteria:

* Any patient who has had a CIS of less than 4 months (+/- 15 days), with at least 1 inflammatory lesion on his initial brain MRI or with normal brain MRI associated with the presence of oligoclonal bands in the CSF,

Exclusion Criteria:

* Atypical CIS for a first relapse of multiple sclerosis (extensive myelitis, bilateral retrobulbar optic neuritis immediately)
* CIS dating more than 4 months (+/- 15 days)
* Corticotherapy in the last 4 weeks

Primary outcomes:
measure: severity of the disease defined by Expanded Disability Status Scale (EDSS) ≥ 2.0
timeFrame: At 5 years
Secondary outcomes:
measure: Occurrence of a second push
timeFrame: At 5 years
measure: Occurrence of progression of the EDSS (Expanded Disability Status Scale) score
timeFrame: At 5 years
measure: Occurrence of a handicap objectified by the Multiple Sclerosis Functional Composite(MSFC)
timeFrame: At 5 years
measure: variation of parameters measuring axonal pain / degeneration in MRI
timeFrame: At 5 years
measure: variation of parameters measuring axonal pain / degeneration in OCT
timeFrame: At 5 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Olivier Outteryck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04777526: Effectiveness of Proprioceptive Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis
Official title: Clinical Effects of a Proprioceptive Thumb Exercise for Individuals With Carpometacarpal Joint Osteoarthritis: A Prospective Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Keywords: Thumb pain
Thumb proprioception
Thumb Osteoarthritis
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To establish the effectiveness of a proprioceptive training program as a complementary therapy for a traditional protocol in position control, pain intensity, upper limb function and occupation performance for patients with thumb CMC joint OA.

Methods: Standard conservative thumb CMC joint OA treatments were received for both the control (n=26) and experimental groups (n=26) for a period of 12 weeks. The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions). The severity of pain with activity was measured according to the visual analog scale (VAS). QuickDASH questionnaire was used to measure upper extremity function. Patient's occupational performance was measured with the Canadian Occupational Performance Measure (COPM) and proprioception was assessed using Joint position sense (JPS) testing.


Eligibility criteria: Inclusion Criteria:

Patients were included if they satisfied the following inclusion criteria; over 18 years of age with a diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage (14), a minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the therapy initial evaluation,and the ability to read and understand the patient information sheets and exercises.

Exclusion Criteria:

Patients were excluded from participation if they had a neurological disorder affecting the upper limb, had received specific treatment for hand or thumb pain in the same limb in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb, had fractures or a significant hand injury or previous surgery to the wrist or hand, or had hand or finger tenosynovitis and/or Dupuytren disease. We also excluded patients with cognitive impairments who were not able to understand the informed consent and/or exercise program.

Primary outcomes:
measure: Joint position Sense (JPS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: baseline- 3- 12 weeks
measure: Canadian Occupational Performance Measure
timeFrame: baseline- 3- 12 weeks
measure: Quick-dash
timeFrame: baseline- 3- 12 weeks
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Raquel Cantero-Téllez
Study officials:
References:
Clinical trial NCT00409526: Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.
Official title: Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Keywords: Iloprost
PPHN
Newborn
Pulmonary Hypertension
Term
Persistent Pulmonary Hypertension of the Newborn
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2006-12-11
Enrollment: 1
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Inhaled Iloprost will be administered to near term infants with Persistent Pulmonary Hypertension of the Newborn in two different doses in order to test safety and efficacy in reducing pulmonary artery pressure.

Detailed description: Infants eligible for the study will be divided into two arms according to oxygenation index: Infants in arm A (OI \<20) will receive nebulized Iloprost in a lower dose (50 ng/kg/min) for one hour, and a higher dose (100 ng/kg/min) for another hour. Infants in arm B (OI\>20) will receive NO, and in addition will receive nebulized Iloprost in a lower dose for one hour and a higher dose for another hour.

Eligibility criteria: Inclusion Criteria:

* Near-term infants (\>34 gestational age) with evidence of persistent pulmonary hypertension and severe hypoxia(PaO2\<100 mmHg with mechanical ventilation with FiO2=100%).

Exclusion Criteria:

* Major congenital malformation
* Congenital diaphragmatic hernia
* Structural cardiac anomalies
* Hydrops fetalis
* Pulmonary hemorrhage
* Severe perinatal depression
* Patients on high frequency oscillation ventilator

Primary outcomes:
measure: Oxygenation index and PaO2 after treatment with inhaled Iloprost.
timeFrame: three hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Comer Children's Hospital, The University of Chicago Hospitals
state: Illinois
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: University of Chicago
name: Michael D Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297426: Leptin Signaling in Lean and Obese Humans
Official title: Leptin Signaling in Humans
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-02-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic or nondiabetic lean and obese subjects

Brief summary: Obesity does not respond to high circulating levels of the hormone leptin. This study is aiming at finding out why this happens and open new avenues for treatment of obesity.

Detailed description: Ex vivo and in vitro identification and study of leptin signaling pathways in commercially available cell lines serum/ plasma samples and discarded tissues from humans.

Eligibility criteria: Inclusion Criteria:

* men and women
* ages 18 to 65
* BMI ranges between 20 and 45 kg/m2

Exclusion Criteria:

* subjects requiring special diets
* history of illness other than obesity of diabetes
* taking medications known to influence glucose metabolism
* subjects with history of anaphylactic reaction or hypersensitivity to e. coli derived proteins or anesthetic agents
* women who are breastfeeding, pregnant or wanting to become pregnant
* subjects with bleeding dyscrasia or poor wound healing

Primary outcomes:
measure: Westerns / activation of signaling pathways (uo to two hours after treatment)
timeFrame: 04/01/2016
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Christos Mantzoros, MD DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02038426: Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not
Official title: Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Entheses
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose:

* Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
* Comparison of the ultrasound semiology of enthesitis in the 3 populations
* Comparison of the MASEI scores in the 3 populations


Eligibility criteria: Inclusion Criteria:

* - Axial spondyloarthritis according to the ASAS classification criteria
* 18-45 years old
* Athletes are defined by sport activities greater than or equal to 6 hours per week
* Non athletes are defined by sport activities lesser than or equal to 1 hour per week

Exclusion Criteria:

* - History of heel or ankle surgery
* Recent corticosteroid infiltration of the heel or the ankle

Primary outcomes:
measure: enthesitis detection
timeFrame: 12 months
Secondary outcomes:
measure: MASEI scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References:
Clinical trial NCT06035926: Survey of Symptoms After a COVID Vaccination in Employees
Official title: Survey of Symptoms After a COVID Vaccination in Employees: a Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptoms Recoding SARS-CoV-2 After Vaccination
Keywords: SARS-CoV-2
Symptoms
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 1093
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employees of the University Clinic Graz who get a booster vaccination.

Brief summary: Background:

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) has had us firmly in its grip for more than two years. In January 2021, the quality and risk management unit of the LKH (Landeskrankenhaus) -Univ. Klinikum Graz commissioned to carry out vaccinations for employees and subsequently for high-risk patients.

In the vaccination line, which was open for 85 days in 2021/22, the vaccines from Astra Zeneca, Biontech-Pfizer and Moderna were vaccinated. There were hardly any complications. The primary immunization, booster vaccination and booster vaccination were carried out.

Despite the small number of incidents in the sense of an immediate reaction, there were numerous sick leave.

Methods:

For this reason, in the course of the booster vaccination, starting from October 2021 to January 2022, every vaccinated person was asked to fill out a questionnaire. Participation was voluntary and was supported by the works councils of the Medical University and the LKH-University clinic Graz approved. The survey served to retrospectively record how many employees developed symptoms in response to the respective vaccination.

With this approach it will be possible to subject the responses to an in-depth statistical analysis in order to obtain a data-based contribution to the side effects of vaccines categorized with different vaccination schemes.


Eligibility criteria: Inclusion Criteria:

* Employees with appropriate indication (\>4 months after the second vaccination) according to the recommendations of the national vaccination committee.
* Signed vaccination information sheet.

Exclusion Criteria:

* no booster vaccination.

Primary outcomes:
measure: Occurrence of symptoms after the respective vaccination
timeFrame: 10 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References:
Clinical trial NCT02739126: Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe.
Official title: Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound Guided Biopsy When Using a Thick (1.7mm) With an Aspiration Needle Biopsy Vs. a Thin USS Probe (1.4mm), in Peripheral Lung Lesions.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Parenchymal Lesions
Keywords: Diagnosis
Lead sponsor: Middlemore Hospital, New Zealand
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous origin is of utmost importance. Due to it's markedly favourable safety profile, a bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success rate), is sub-optimal.

There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be advanced more peripherally to obtain a biopsy.

Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield.

In this study, investigators compare these two types of probes in the ability to diagnose a PPL.

The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too small to accommodate an aspiration needle)


Eligibility criteria: Inclusion Criteria:

* Patient referred for R-EBUS as per routine management.
* Patient judged to be medically stable to give consent for this study.

Exclusion Criteria:-Unsuitable for flexible bronchoscopy and biopsy

* INR\>1.5
* Platelets\<150.
* Hb\> 80g/l
* Liver function tests (AST/ALT) \<2 times upper limit of normal
* Neutrophil count \>1.0
* EGFR \>30ml/kg/min
* On anticoagulation, that cannot be withheld for the procedure, due to medical reasons (e.g. On-clopidogrel with recent drug-eluting stent placement.)

Primary outcomes:
measure: Comparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath.
timeFrame: 18 months
Secondary outcomes:
measure: Suitability of the biopsy samples from each arm to perform EGFR mutation testing.
timeFrame: 18 months
measure: Compare the procedure related bleeding and pneumothorax rates between the two arms.
timeFrame: 18 months
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Middlemore Hospital, Counties Manakau District Health Board
Study officials:
References:
Clinical trial NCT00668226: Dermacyd Delicata Pocket BR - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Delicata Pocket BR.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Delicata Pocket BR.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation;
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Brazil
name: Jaderson Lima
role: STUDY_DIRECTOR
References: