louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02862639: Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
Official title: Efficacy of Viscosupplementation Associated With Intra-articular Corticosteroid Injection Versus Intra-articular Injection of Corticosteroids Alone in Osteoarthritis of Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Osteoarthritis
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 43
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 current management of osteoarthritis is based on non-pharmacological and pharmacological means which include intra-articular injections.

The recommendations on the management of hip osteoarthritis stipulate that intra-articular injections of corticosteroid may be considered in patients with an exacerbation not responding to oral treatments. Several recent studies show the effectiveness of intra-articular corticosteroids compared with anesthetics. The intra-articular injection of viscosupplementation alone has never been validated in this indication since controlled studies did not show efficacy over placebo. At present, viscosupplementation is considered an anti-osteoarthritic symptomatic slow-acting and its interest is not yet established in hip osteoarthritis.

Detailed description: Show the superiority of intra-articular injection of viscosupplementation in combination with corticosteroid compared to intra-articular injection of corticosteroid alone in the treatment of hip osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* patients with hip osteoarthrosis (stage II et III according Kellgren et Lawrence)
* walking alone patients
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* Patients with hip osteoarthrosis (stage I et IV according Kellgren et Lawrence)
* patients with rapidly destructive hip osteoarthritis
* patients with inflammatory rheumatism
* patients with microcrystalline arthritis
* patients with hip osteonecrosis
* patients who received corticosteroids during the previous three months
* patients who received a intra articular injection of viscosupplementation during the previous six months
* patient with haemostatic disorder
* patient with consumption of painkillers tier 3

Primary outcomes:
measure: improving pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT03407339: Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg Municipality
Official title: Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Health
Quality of Life
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 258
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background:

Nationally and internationally, more people over the age of 65 and especially an increase of people over the age of 80 enter nursing homes with natural dentition and complex prostheses and bridges than previous generations. Furthermore, there is an increased incidence of dental diseases in the elderly. This is leading to increased and different oral care needs. There is a large discrepancy between the elderly who need help with oral hygiene and the elderly who actually receive help. In order to improve the oral hygiene competencies of healthcare professionals at nursing homes, it is necessary to increase their education and improve organizational strategies.

Hypothesis:

The Intervention Shared Oral Care improves the elderlys bleeding and plaque index after 6 months.

Study type:

An intervention study.

A cluster randomization of 14 nursing homes in Aalborg municipality is carried out.

Outcome Measures:

Change in mucosal-plaque score (MPS) index

Change in Oral Related Quality of life

Outcome Measure Time Frame:

Change in mucosal-plaque score index measured at 0, 3 and 6 months.

Change in Oral Related Quality of life measured at 0 and 6 months.


Eligibility criteria: Inclusion Criteria:

* Elderly living in nursing homes in Aalborg Municipality Having one or more natural dentition

Exclusion Criteria:

* no natural dentition

Primary outcomes:
measure: Change from baseline at 3 and 6 months in MPS index
timeFrame: baseline, 3 and 6 months
measure: Change from baseline at 6 months in modified Oral Health Impact Profile (OHIP14)
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Karin Aagaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789139: Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
Official title: Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Post Marketing study, Interventional, Prospective, non randomised

Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).


Eligibility criteria: Inclusion Criteria:

* AF thermoablation indication
* Informed Consent signed,
* Age between 18 \& 75

Exclusion Criteria:

* Participation to other clinical trial
* Non compliant patient
* Pregnant women
* Left Atrial thrombus
* Endocarditis, infection

Primary outcomes:
measure: Clinical exam and ECG record
timeFrame: one month, 3 months, 6 months , 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Saint Joseph Hospital
Study officials:
affiliation: Unity Health Toronto
name: ANGE FERRACCI, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: ANDRE PISAPIA, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00254839: Association Between Dental Implants Properties and Malodor Production
Official title: Bacterial Accumulation and Malodor Production in Various Types of Dental Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Halitosis
Keywords: Oral malodor
Dental implants
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: Malodor production is bacterial in origin. The bacterial activity of anaerobic bacteria results in the breakdown of proteins and the production of foul smelling compounds. The aim of the study is to test the hypothesis that bacterial growth on dental implants contributes to malodor production and to see whether this contribution is associated with various properties of the dental implant such as: maker, type, depth ext.


Eligibility criteria: Inclusion Criteria:Dental patients that need dental implants -

Exclusion Criteria:smokers

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadasssah Medical Organization
Study officials:
affiliation: Hadassah - Hebrew University School of Dental medicine
name: Nir Sterer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05860439: Lower Limb Sclerotherapy of Reticular Veins and Telangiectasias
Official title: Long-term Follow-up of Sclerotherapy of Reticular Veins and Telangiectasias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Telangiectasis
Keywords: Sclerotherapy
Veins
Telangiectasias
Hyperpigmentation
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2023-05-16
Enrollment: 191
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 90 years, with lower limb telangiectasias or reticular veins treated in previous studies with polidocanol plus hypertonic glucose or hypertonic glucose.

Brief summary: A long-term follow-up cohort study of patients that were assigned in two previous studies to compare the clinical results of sclerotherapy of telangiectasias and reticular veins of lower limbs using 0.2% polidocanol diluted in 70% hypertonic glucose (PDHG) vs 75% hypertonic glucose (HG) alone.

All women, previously treated as aforementioned, were invited to be reevaluated regarding late maintenance and pigmentation over two years of follow-up.

No new treatments were applied to the cohort.


Eligibility criteria: Inclusion Criteria:

* All patients that concluded the participation of 60 days in both primary studies were invited to reevaluate the actual status of treatment (maintenance of treated vessels) and late complications (pigmentation and matting).

Exclusion Criteria:

* Patients who did not agree to be reassessed;
* Patients who were not found after all available forms of contact had been tried;
* Patients who went through any kind of intervention on the area of interest in lower limbs between the end of the intervention and the reevaluation for long-term follow-up.

Primary outcomes:
measure: Length of Telangiectasias in Centimeters
timeFrame: 730 days
Secondary outcomes:
measure: Length of Hyperchromia in Centimeters
timeFrame: 730 days
measure: Length of Matting in Centimeters
timeFrame: 730 days
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Sao Paulo State University Botucatu Campus
state: SP
Study officials:
References:
Clinical trial NCT05972486: A Study of MUSE Device for Midlife Women
Official title: MUSE Device to Improve Sleep Quality in Midlife Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Insomnia
Sleep Disturbance
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 31
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is feasible for midlife women to wear a brain activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and sleep disruption


Eligibility criteria: Inclusion Criteria:

* Women in the menopause transition or in menopause, based on clinical assessment
* PSQI score \> 5, with overall sleep quality rating of "fairly bad" or "very bad".
* Motivation VAS score equal to or greater than 5 with overall motivation rating of on a scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated.
* Access to an iPad, iPhone, or android device.
* Have ability to provide informed consent.

Exclusion Criteria:

* Suspected or confirmed obstructive sleep apnea.
* Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA categories for hot flash severity are classified as mild (sensation of heat without sweating), moderate (sensation of heat with sweating, able to continue activity), or severe (sensation of heat with sweating cause cessation of activity).
* Use of hormone therapy or hypnotic agents.
* Use of supplements known to affect sleep.
* A known, active, untreated clinically significant psychiatric condition.
* Use of an investigational drug within 30 days of study enrollment or presence of a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
* Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.

Primary outcomes:
measure: Change in quality of sleep
timeFrame: Baseline, 3 months, 6 months
measure: Change in sleep impact
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in perceived stress levels
timeFrame: Baseline, 3 months, 6 months
measure: Change in perceived anxiety
timeFrame: Baseline, 3 months, 6 months
measure: Change in sexual function
timeFrame: Baseline, 3 months, 6 months
measure: Change in sexual distress
timeFrame: Baseline, 3 months, 6 months
measure: Change in quality of life
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amber Klindworth, PA-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01193439: Safety of Thoracoscopy in Patients With High Risk
Official title: Safety of Thoracoscopy in Patients With High Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Diseases
Keywords: thoracoscopy
pleural diseases
complications
safety
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 355
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require thoracoscpic investigation

Brief summary: Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The indication of thoracoscopy in patients with pleural effusion has been optimized. In some studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate of complications. However the investigators do not know its safety on high risk patients. Because many patients having suspected malignancy have bed conditions due to other health problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the investigators aimed to test the safety of medical thoracoscopy in the patients with high risk for complications.


Eligibility criteria: Inclusion Criteria:

* Patients with exudative pleural effusion

Exclusion Criteria:

* Patients without pleural effusion

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: ESOGU
Study officials:
affiliation: Head of Department, Professor of pulmonary medicine
name: Muzaffer Metintas, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez-Panadero F. Medical thoracoscopy. Respiration. 2008;76(4):363-72. doi: 10.1159/000158545. Epub 2008 Nov 12.
Clinical trial NCT02394639: EEG@HOME (Phase 4 of the Project)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Pilipili NV
name: Imec
First posted: 2015-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU.

Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype.

There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists will also be collected.


Eligibility criteria: Inclusion Criteria:

* Epilepsy with on EEG prominent IEDs

Exclusion Criteria:

* /

Primary outcomes:
measure: EEG signal quality (visual and clinical) (scale)
timeFrame: 5 hours
measure: EEG signal quality (technical) (signal to noise ratio)
timeFrame: 5 hours
measure: User experience (questionnaire)
timeFrame: 5 hours
Secondary outcomes:
measure: EEG-technologist experience (questionnaire)
timeFrame: 5 hours
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent
city: Leuven
country: Belgium
facility: University Hospital, Leuven
Study officials:
References:
Clinical trial NCT00401739: Safety, Tolerability and Pharmacokinetics of CSL360 in the Treatment of Acute Myeloid Leukemia
Official title: Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia (AML)
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute myeloid leukemia
* Recent bone marrow biopsy
* Prior treatment or medically unfit for standard therapy

Exclusion Criteria:

* Peripheral blood blast count \> 30 x 109/L, or rapidly progressive AML
* Previous solid organ transplant
* Active GvHD or immunosuppression
* Concurrent treatment with other anti-cancer therapy
* Active infections

Primary outcomes:
measure: Adverse events, pharmacokinetics
timeFrame: September 2009
Secondary outcomes:
measure: Maximum tolerated dose
timeFrame: September 2009
measure: Partial, complete and overall response
timeFrame: September 2009
measure: Biological activity
timeFrame: September 2009
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Institute of Medical & Veterinary Science
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Institute
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Andrew Roberts, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00928239: Laparoscopic Sacropexy: Comparison of Mesh Attachment
Official title: Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Vault Prolapse
Keywords: vaginal vault prolapse
laparoscopic sacropexy
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.

Detailed description: Laparoscopic sacropexy has become a well established treatment option for vaginal vault prolapse with excellent outcome and low rates of recurrence. Compared to the similar vaginal sacropexy procedure a significant rate of postoperative constipation is reported. As the surgical technique is very similar for both procedures it could be possible that the exposure of the lower vaginal wall and placement and of the dorsal mesh and closer proximity to the colon in laparoscopic sacropexy might cause this. In this randomized controlled clinical trial we compare two different attachment sites for the dorsal mesh during laparoscopic sacropexy. One group is randomized for attachment in the middle of the dorsal wall of the vaginal stump and for the other group preparation and attachment for the dorsal mesh is performed deeper in the lower pelvis for an attachment at the distal part of the dorsal vaginal wall.

Peri-operative data, intra- and postoperative complications and results of short-term (constipation) and long-term( recurrences rate) outcome are recorded.

Eligibility criteria: Inclusion Criteria:

* vaginal vault prolapse
* recurrence of vaginal vault prolapse
* signed consent

Exclusion Criteria:

* rectocele
* BMI\>40

Primary outcomes:
measure: Rate of Postoperative Constipation
timeFrame: 6 to 8 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Aargau
Study officials:
affiliation: Kantonsspital Aarau, Department of Gynecology and Obstetrics
name: Dimitri Sarlos, MD
role: STUDY_CHAIR
References: