louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00582673: Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa
Official title: A Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Parkinson's, L-dopa, dyskinesia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-28
Enrollment: 31
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's Disease
* Patients with L-dopa induced dyskinesia for at least 3 months
* Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion Criteria:

* History of severe allergy to food or drugs
* Very low or high body weight.
* Prior surgery for Parkinson's Disease
* Smokers

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa
timeFrame: throughout the study
Secondary outcomes:
measure: Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa
timeFrame: throughout the study
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Novartis Investigator Site
city: Kassel
country: Germany
facility: Novartis Investigator Site
city: Leun
country: Germany
facility: Novartis Investigator Site
city: Marburg
country: Germany
facility: Novartis Investigator Site
city: Tuebingen
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berg D, Godau J, Trenkwalder C, Eggert K, Csoti I, Storch A, Huber H, Morelli-Canelo M, Stamelou M, Ries V, Wolz M, Schneider C, Di Paolo T, Gasparini F, Hariry S, Vandemeulebroecke M, Abi-Saab W, Cooke K, Johns D, Gomez-Mancilla B. AFQ056 treatment of levodopa-induced dyskinesias: results of 2 randomized controlled trials. Mov Disord. 2011 Jun;26(7):1243-50. doi: 10.1002/mds.23616. Epub 2011 Apr 11.
Clinical trial NCT02714673: Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement
Official title: Management of Patients on Long Term Anticoagulation Therapy Undergoing a Primary Total Hip of Knee Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Lead sponsor: Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on long term effective anticoagulation (ADELC) or not undergoing a primary hip or knee replacement

Brief summary: It is a multicenter, prospective, observational study of standard care. This study analyses the care of patients on long term effective anticoagulation therapy (ADELC) during a primary hip or knee arthroplasty.

The objectives of the study are to:

1. Identify clinical practices set up for patient care
2. Assess the type and the frequency of perioperative complications
3. Look for factors, related to patients or treatments, associated with the occurrence of these complications.

The main objective is to estimate the risks, adjusted and not, of postoperative complications associated to a long term anticoagulation by comparing patients under anticoagulation to a control group of patients having the same interventions but who are not under anticoagulation.


Eligibility criteria: Inclusion Criteria:

* Adult ≥ 18 years
* Programmed for primary hip or knee arthroplasty.
* Effective dose of anticoagulant drugs intake for more than 1 month with the intention to resume it after the intervention for ADELC cohort; no effective dose of anticoagulant drugs intake for the control cohort.

Exclusion Criteria:

* Patient non opposition

Primary outcomes:
measure: a composite criteria including the occurrence of one or more bleeding complications, major thrombotic events, or reoperation for any reason
timeFrame: up to 3 months
Secondary outcomes:
measure: The length of hospital stay
timeFrame: until end of study, an expected 12 months
measure: The proportion of patients who are transfused during the hospitalization
timeFrame: up to day 15
measure: The occurrence of a complication of grade 2 or more from Dindo and Clavien classification .
timeFrame: within 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
state: IDF
Study officials:
References:
Clinical trial NCT06508073: Neural Therapy in Notalgia Paresthetica
Official title: Neural Therapy in Notalgia Paresthetica
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Notalgia Paresthetica
Keywords: back pain
intralesional injection
neuralgia
pruritus
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30-60 years old patients with Notalgia Paresthetica

Brief summary: Patients diagnosed with Notalgia paresthetica and who received neural therapy within the last year were retrospectively screened. In the evaluations before treatment and at the 3rd month after treatment; Numerical rating scale for pain, PainDETECT questionnaire for neuropathic pain, SF-12 for quality of life and 5-D itch scale for itch level were used.


Eligibility criteria: Inclusion Criteria:

* the presence of a hyperpigmented skin lesion consistent with NP
* minimum 6 months for duration of disease
* 30-60 aged
* application of neural therapy in a manner appropriate to the diagnosis

Exclusion Criteria:

* history of previous surgery or injection in the thoracic region
* presence of another treatment in the same period
* presence of any cardiac or pulmonary disease, malignancy, or advanced psychiatric disease

Primary outcomes:
measure: Numeric Rating Scale for Pain
timeFrame: 12 weeks after treatment
measure: PainDETECT Questionnaire for assessing Neuropathic pain
timeFrame: 12 weeks after treatment
measure: Short Form-12 for Quality of life
timeFrame: 12 weeks after treatment
measure: 5-D Itch Scale
timeFrame: 12 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
References:
Clinical trial NCT05674773: Treatment Outcomes of Advanced Neoplasia in IBD
Official title: Endoscopic and Surgical Treatment Outcomes of Colitis-associated Advanced Neoplasia: a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
name: Jeroen Bosch Ziekenhuis
name: University Medical Center Groningen
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Amsterdam UMC, location VUmc
name: Erasmus Medical Center
First posted: 2023-01-06
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IBD patients with advanced neoplasia

Brief summary: In this study, we aimed to (1) compare cumulative incidences of synchronous and metachronous colorectal neoplasia as well as mortality following AN in CD and UC patients who underwent proctocolectomy, (sub)total colectomy, partial colectomy or endoscopic resection, and (2) to determine factors associated with AN treatment choice.

Detailed description: In this retrospective multicenter cohort study, using PALGA (the Dutch nationwide pathology databank), partial colectomy yielded a similar metachronous neoplasia risk compared to (sub)total colectomy after treatment of advanced neoplasia in inflammatory bowel disease. High metachronous neoplasia rates after endoscopic resection underline the importance of strict subsequent endoscopic surveillance.

Eligibility criteria: Inclusion Criteria:

* IBD (ulcerative colitis (UC), CD or IBD-unclassified (IBD-U))
* Histological diagnosis of colorectal AN
* Available treatment data

Exclusion Criteria:

* Familial CRC syndrome
* AN prior to IBD diagnosis

Primary outcomes:
measure: Synchronous
timeFrame: up to 6 months
measure: Metachronous (advanced) neoplasia
timeFrame: up to 30 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: up to 30 years
measure: Associations with treatment choice
timeFrame: up to 30 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboudumc and University of Alberta
name: Frank Hoentjen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05557773: The Effects of Core Stabilization Exercises on Balance, Proprioception, and Knee Muscle Strength in Children with Adolescent Idiopathic Scoliosis
Official title: The Effects of Core Stabilization Exercises on Balance, Proprioception, and Knee Muscle Strength in Children with Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: adolescent idiopathic scoliosis
core stabilization exercises
balance
proprioception
knee muscle strength
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. The gold standard criterion is that the Cobb angle, which determines the lateral deviation of the spine in the frontal plane, is greater than 10°.

Postural control and balance occur as a result of the integration of many sensory information. It is thought that postural control and balance in Adolescent Idiopathic Scoliosis (AIS) patients are adversely affected by biomechanical changes in sensory input, central integration, weight transfer mechanism and the structure of the medulla spinalis. In addition to these, vestibular disorders and proprioceptive losses may have an effect on balance.

Decline in balance reduces the quality of life of individuals with AIS. In addition, exercise has an important place in the treatment of individuals with AIS. In order to get more efficiency from the exercises, it is necessary to improve the balance.

The aim of this study is to evaluate the changes in balance, proprioception, and knee muscle strength of patients, to determine the place of balance exercises in the treatment of individuals with AIS, and to investigate the effect of core stabilization exercises on balance and proprioception in patients with AIS.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with AIS between the ages of 10-18
* Cobb angle is between 10-40 degrees
* The child's and family's consent to participate in the study
* The child does not receive any other treatment that will affect his scoliosis

Exclusion Criteria:

* Surgical operation in the last 3 months
* Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
* Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
* Exercising 3 or more days a week.

Primary outcomes:
measure: Balance
timeFrame: 8 week
measure: Proprioception
timeFrame: 8 week
measure: Muscle Strength of Knee Flexion / Extension
timeFrame: 8 week
Secondary outcomes:
measure: Balance
timeFrame: 8 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Fatih
Study officials:
References:
Clinical trial NCT00002173: An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.
Official title: An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS Vaccines
CD4 Lymphocyte Count
Salk HIV Immunogen
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To provide an alternative therapy to HIV-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* CD4 counts \>= 550 cells/ml.

NOTE:

* If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days for Study 806 or wait 6 months before entering the expanded access program.
* Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies.
* Patient must not meet inclusion criteria for other Remune trials.
* Patient must have laboratory tests within specified limits.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Clinically significant cardiac, hepatic, renal or gastrointestinal dysfunction.
* Current participation in a Remune study.

Concurrent Medication:

Excluded:

* Use of any immune-modulating drugs.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition.
* Current participation in a Remune study.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

* Previous participation in a Remune study.

Excluded within 30 days of study entry:

* Use of any immune-modulating drugs.
* Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Immune Response Corp
state: California
Study officials:
References:
Clinical trial NCT04418973: Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
Official title: Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject, by a Threshold Inspiratory Load and During a Maximal Breath Holding.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: Volatolom
Volatile organic compounds (VOCs)
dyspnea
electronic nose
mass spectrometry
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The dyspnea is a common symptom in patients with many respiratory diseases particularly chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in the deconditioned healthy subjects.

Called volatolom corresponds to the set of volatile organic compounds (VOCs) contained in exhaled air.

The analysis of volatolom can be done either by the methods based on mass spectrometry which allows the identification of each VOC in the exhaled air or by the use of electronic noses which are more simple to use, less specific and produce a quantitive signal change based on pattern recognition algorithms providing a global profile of the VOC without identifying them.

The aim of the study is to determine whether the analysis of VOCs in exhaled air would identify biomarkers related to the intensity and type of experimental dyspnea.


Eligibility criteria: Inclusion Criteria:

* healthy subject
* no dyspnea
* non smoking or daily smoking more than 5 years packs
* perfect knowing of the French language
* the consent form signed
* affiliated to a health insurance plan

Exclusion Criteria:

* chronic disease
* history of asthma or Chronic obstructive pulmonary disease (COPD)
* personal or family atopy
* cannabis use
* electronic cigarette
* medication except contraception
* pregnant woman
* without liberty or guardianship

Primary outcomes:
measure: Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.
timeFrame: at the only one study visit: around 2 hours
Secondary outcomes:
measure: Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea.
timeFrame: at the only one study visit: around 2 hours
measure: Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles.
timeFrame: at the only one study visit: around 2 hours
measure: Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles.
timeFrame: at the only one study visit: around 2 hours
measure: Comparison of VOC profiles in exhaled air according to smoking status.
timeFrame: at the only one study visit: around 2 hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Foch hospital
Study officials:
affiliation: Hopital Foch
name: Philippe Devillier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01428531: Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
Official title: Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ataxia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-09-05
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese patients with acute pulmonary thromboembolism or acute deep venous thrombosis

Brief summary: The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).

("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)


Eligibility criteria: Inclusion Criteria:

* Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
* Fondaparinux injection must be prescribed for the first time

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Number of patients with adverse drug reaction
timeFrame: 3 months
measure: Number of patients with any serious adverse event
timeFrame: 3 months
measure: Number of patients with any hemorrhagic adverse event
timeFrame: 3 months
measure: Presence or absence of reoccurrence of VTE
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01684631: Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement
Official title: Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Hip
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2012-09-13
Enrollment: 107
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: Patients susceptible to receive a PINNACLE® ULTAMET™ implant

Brief summary: The objective is to evaluate the implant survival rate for patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease and true femoral cervical fracture.


Eligibility criteria: Inclusion Criteria:

* Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice

Exclusion Criteria:

* Patient refusal to participate to the data collection
* Pregnant woman
* Patients age is less than 18 years old
* The planned intervention is a revision of a previous intervention on the studied hip joint
* Previous metal implant, except for pure titanium or titanium alloys
* Exposure to cobalt and chromium that could influence serum metal ions levels
* Planned bilateral intervention
* Patient residing outside France
* Patient not implanted with a Pinnacle(R) ULTAMET(TM)

Primary outcomes:
measure: Implant Survival Rate
timeFrame: up to 5 years
Secondary outcomes:
measure: Harris Hip Score
timeFrame: pre-operative, 1, 2, 3, 5 years
Other outcomes:
measure: Cobalt and Chromium serum concentration
timeFrame: 3 to 6 Months, 1, 2, 3, 5 years
measure: Adverse Event Frequency
timeFrame: Per-operative, 3 to 6 Months, 1, 2, 3, 5 years
Locations:
city: Aix-les-Bains
country: France
facility: Clinique Herbert
city: Ales
country: France
facility: Clinique Bonnefon
city: Niort
country: France
facility: Centre Hospitalier Georges Renon
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Royan
country: France
facility: Clinique Pasteur
city: Saint Etienne
country: France
facility: Clinique Mutualiste Saint Etienne
Study officials:
affiliation: Clinique Saint Hilaire Rouen, France 76000
name: Jean-Marie Toupin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.