louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03242967: Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
Official title: Phase 3, Randomized, Open Label, Active Controlled Study Evaluating the Efficacy and Safety of Three Times Per Week (TIW) Oral Dosing of Vadadustat for the Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (TRILO2GY)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Anemia
Dialysis-Dependent Chronic Kidney Disease
Keywords: Anemia
hemoglobin
darbepoetin alfa
TIW
hypoxia-inducible factor prolyl-hydroxylase inhibitor
HIF-PHI
AKB-6548
vadadustat
renal
hypoxia-inducible factor
HIF
dialysis-dependent chronic kidney disease
CKD
DD-CKD
kidney
erythropoiesis stimulating agent
ESA
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 0
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: This is a Phase 3 Study to Evaluate Three Times Per Week (TIW) Oral Dosing of Vadadustat for Anemia in Subjects with Dialysis-Dependent Chronic Kidney Disease (DD-CKD)


Eligibility criteria: Inclusion Criteria:

* Male and female subjects ≥18 years of age
* Receiving chronic maintenance in-center hemodialysis (3 times per week) for end-stage kidney disease
* Currently maintained on ESA therapy
* Mean screening Hb between 8.0 and 11.0 g/dL (inclusive)

Exclusion Criteria:

* Anemia due to a cause other than CKD or presence of active bleeding or recent blood loss
* Sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
* Red blood cell transfusion within 4 weeks prior to or during screening
* Anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Primary outcomes:
measure: Mean change in Hb between baseline and the primary evaluation period
timeFrame: Baseline visit, Week 36
Secondary outcomes:
measure: Mean change in Hb between baseline and the secondary evaluation period
timeFrame: Baseline visit, Week 52
measure: Proportion of subjects with mean Hb within the target range during the primary evaluation period
timeFrame: Baseline visit, Week 36
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Research Site
state: California
Study officials:
affiliation: Sponsor GmbH
name: Akebia Therapeutics
role: STUDY_DIRECTOR
References:
Clinical trial NCT01451567: The Effect of a Structured Personalised Ergonomic Intervention for Hospital Nurses With Musculoskeletal Complains
Official title: Study That Examined the Effect of a Structured Personalised Ergonomic Intervention Program for Hospital Nurses With Musculoskeletal Complains.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Nurses, Workload, Musculoskeletal System, Intervention
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
name: Meir Medical Center
First posted: 2011-10-13
Enrollment: 31
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of a structured personalised ergonomic intervention program for hospital nurses with musculoskeletal complains.

Detailed description: In a randomised controlled trial 31 nurses with musculoskeletal complains were observed at work, and an intervention program was completed in 14 nurses with the other 17 acting as controls. The intervention included four meetings during three months. Outcome measures were collected before the intervention and post-tests were gathered three months after the determination of the program.

Eligibility criteria: Inclusion Criteria:

* A minimum of half-time work for at least one year
* musculoskeletal pain complaints
* agreement to participate in the interventional study.

Exclusion Criteria:

* Male nurses
* nurses with previously defined job restrictions and
* pregnancy

Primary outcomes:
measure: Level of stress and control at work, measured by Karasek's questionnaire and Reba
timeFrame: 6 monthes
Secondary outcomes:
measure: The prevalence and the level of pain measured by Nordic Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Netta Abraham Bar-Niv, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00848367: Binge Eating Disorder Treatment Study
Official title: Optimizing Outcomes for Binge Eating, Depression and Weight Loss for Obese Women With Binge Eating Disorder by Matching to Group Psychological Treatments Based on Level of Attachment Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating Disorder
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2009-02-20
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the proposed study is to determine whether the effectiveness of a group therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by optimally matching women with BED who have high attachment anxiety to Group Psychodynamic Interpersonal Psychotherapy (GPIP). This study represents the next phase in a program of research stemming from a previously conducted randomized controlled trial (RCT).


Eligibility criteria: Inclusion Criteria:

•Overweight Women 18 years of age or older who binge eat at least twice per week for the past month.

Exclusion Criteria:

* unable speak English
* history of an eating disorder other than Binge Eating Disorder
* concurrent Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of bipolar disorder, psychosis, drug or alcohol problem
* pregnant or planning on becoming pregnant within the next year
* are currently or plan to become enrolled in a weight loss program within the next year

Primary outcomes:
measure: Frequency of Binge Eating in the Past 28 Days
timeFrame: Pre and Post treatment, 6 months and 1 year
Secondary outcomes:
measure: Depression Symptoms
timeFrame: Pre and Post treatment, 6 months and 1 year
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Regional Centre for the Treatment of Eating Disorders
state: Ontario
Study officials:
affiliation: University of Ottawa, Ottawa Hospital-General Campus
name: Giorgio Tasca, Ph.D.C.Psych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tasca GA, Ritchie K, Demidenko N, Balfour L, Krysanski V, Weekes K, Barber A, Keating L, Bissada H. Matching women with binge eating disorder to group treatment based on attachment anxiety: outcomes and moderating effects. Psychother Res. 2013;23(3):301-14. doi: 10.1080/10503307.2012.717309. Epub 2012 Aug 24.
Clinical trial NCT04552067: Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients
Official title: Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Keywords: enoxaparin
Lovenox
ani-Xa
acute coronary syndrome
Enoxa
Lead sponsor: University of Monastir
Sponsor class: OTHER
Collaborators: name: University Hospital Fattouma Bourguiba
First posted: 2020-09-17
Enrollment: 172
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: Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended.

Demonstrate that Enoxa® is comparable to that of Lovenox® in the anti-Xa activity action.

Detailed description: Single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-Xa activity between H0 and H4.the study was done on two groups ; ENOXA® group : In this case the patient is given an injection of enoxaparin ( ENOXA® ; UNIMED Laboratories) intravenously. Curative dose (100 IU/10 kg).

Control group ( LOVENOX ® ):

In this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .

Eligibility criteria: Inclusion Criteria:

* Age over 18 year old
* With an acute coronary syndrome confirmed

Exclusion Criteria:

* Age less than 18 years
* Persistent ST segment elevation
* Contre indication of enoxaparin and heparin in general.
* Patient participating in another study,
* Pregnant or nursing women
* patients taking an anticoagulant in the last three months,
* Patients with coagulopathy

Primary outcomes:
measure: anti Xa activity (UI/ml)
timeFrame: 4 hours
Secondary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency Department of University Hospital of Monastir
Study officials:
affiliation: University hospital of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02625467: Treatment of Keratoconus With PALK Versus PK
Official title: Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Keratoconus
Keywords: Keratoconus
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of keratoconus grades III or IV in the Amsler Krumeich classification.
* Need of surgical procedure
* No endothelial scar
* Best corrected visual acuity \<20/40
* Contact lens intolerance
* Imagenological map pachymetric acquisition over 90% at 9 mm corneal diameter

Exclusion Criteria:

* Contraindication for any of the techniques evaluated.
* Requiring additional surgical procedures.
* Diagnostic of other ectasia that were not primary keratoconus.

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: Corneal measurements: pachymetry
timeFrame: 6 months
measure: Corneal aberrometry: Coma, spherical aberration and trefoil
timeFrame: 6 months
measure: Corneal measurements: anterior and posterior elevation
timeFrame: 6 months
measure: Corneal measurements: keratometries.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Oftalmologia Conde de Valenciana
name: Enrique Graue Hernandez, MD, MsC
role: STUDY_DIRECTOR
References:
Clinical trial NCT04141267: Inhaled Sedation Using the Anesthetic-conserving Device ( ANACONDA) in Prehospital Emergency Medecine.
Official title: Feasibility of Isoflurane Sedation Using an Anesthetic-conserving Device in Prehospital Emergency Medicine: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Intubation
Deep Sedation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who were sedated by isoflurane with Anesthetic-conserving device in pre-hospital by the emergency teams of SAMU 29

Brief summary: Achieving the optimal sedation level for patient management is not always possible using our standard intravenous medications in Pre-hospital Emergency medicine. Inhaled sedation is possible with the Anesthetic-conserving device with a standard respirator.

The pharmacodynamics and pharmacokinetics of halogenated agents allow deep sedation quickly after absorption.

The feasibility of inhaled sedation has never been studied in hospital.

Detailed description: Retrospecive clinical monocentric study with sedated ventilated patients with isoflurane with the AnaConda® system out of hospital.

Eligibility criteria: Inclusion Criteria:

* Patient sedated by isoflurane with Anesthetic-conserving device in pre-hospital
* Major patient
* not opposed to participating

Exclusion Criteria:

* Adults Under legal protection
* patient refusal to participate in study

Primary outcomes:
measure: depth of sedation
timeFrame: up to 1 day
Secondary outcomes:
measure: hemodynamic tolerance of patients during isoflurane sedation
timeFrame: up to 1 day
measure: hemodynamic tolerance of patients during isoflurane sedation
timeFrame: up to 1day
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT00001667: Genotype/Phenotype Correlation of Movement Disorders and Other Neurological Diseases
Official title: Genotype/Phenotype Correlation of Movement Disorders and Other Neurological Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders
Myoclonus
Nervous System Diseases
Tic Disorders
Tremor
Keywords: Family Studies
Genetic
Myoclonus
Tics
Tremor
Movement Disorders
Neurological Disease
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this protocol is to identify families with inherited neurologic conditions, especially movement disorders, to evaluate affected and unaffected individuals clinically, and to obtain blood samples for genetic analysis.

Detailed description: The purpose of this protocol is to identify families with inherited neurologic conditions, especially movement disorders, to evaluate affected and unaffected individuals clinically, and to obtain blood samples for genetic analysis.

Eligibility criteria: Neurologic disease or movement disorders affecting 2 or more family members.

No conditions in which phlebotomy is contra-indicated.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Higgins JJ, Nee LE, Vasconcelos O, Ide SE, Lavedan C, Goldfarb LG, Polymeropoulos MH. Mutations in American families with spinocerebellar ataxia (SCA) type 3: SCA3 is allelic to Machado-Joseph disease. Neurology. 1996 Jan;46(1):208-13. doi: 10.1212/wnl.46.1.208.
citation: Silveira I, Lopes-Cendes I, Kish S, Maciel P, Gaspar C, Coutinho P, Botez MI, Teive H, Arruda W, Steiner CE, Pinto-Junior W, Maciel JA, Jerin S, Sack G, Andermann E, Sudarsky L, Rosenberg R, MacLeod P, Chitayat D, Babul R, Sequeiros J, Rouleau GA. Frequency of spinocerebellar ataxia type 1, dentatorubropallidoluysian atrophy, and Machado-Joseph disease mutations in a large group of spinocerebellar ataxia patients. Neurology. 1996 Jan;46(1):214-8. doi: 10.1212/wnl.46.1.214.
citation: Ichinose H, Ohye T, Matsuda Y, Hori T, Blau N, Burlina A, Rouse B, Matalon R, Fujita K, Nagatsu T. Characterization of mouse and human GTP cyclohydrolase I genes. Mutations in patients with GTP cyclohydrolase I deficiency. J Biol Chem. 1995 Apr 28;270(17):10062-71. doi: 10.1074/jbc.270.17.10062.
Clinical trial NCT03418467: Risk Factors in Tachycardiomyopathy
Official title: Evaluation of Risk Factors for Therapeutic Outcome in Patients with Tachycardiomyopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Atrial Flutter
Ventricular Premature Complexes
Keywords: Tachycardiomyopathy
atrial fibrillation
EMID (enrichment of mitochondria at the intercalated discs)
Biopsy
empathy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at the University Hospital Tübingen with decreased left ventricular ejection fraction.

Brief summary: Decision between rate control and rhythm control can be a challenge in clinical practice. While there is some guiding evidence, we still lack a comprehensive insight into different subgroups of patients that will benefit from a rhythm control treatment.

EMPATHY is a prospective clinical study in patients presenting with heart failure and a tachyarrhythmic rhythm disturbance. Biomarkers, routinely obtained results from clinical examinations, and results from endomyocardial biopsies shall be evaluated to identify patients which have better outcome from a rhythm control strategy by ablation therapy or, if contraindicated by pharmacological rhythm control.

This study is designed to identifying risk factors and subgroups profiting from rhythm restoration and therefore improve current therapeutic approaches and the rate of recurrence-free survival.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed left ventricular ejection fraction ≤ 50%
* endomyocardial biopsy available
* tachycardic rhythm disturbance with a rhythm control strategy planned for tachycardic atrial fibrillation or flutter (≥100/min) or more than 10000 ventricular premature beats in 24 hours

Exclusion Criteria:

* age \<18 years
* patient unable or unwilling to give informed consent
* coronary artery stenosis \>50%
* relevant valvular disease
* simultaneous contraindications against amiodarone treatment and pulmonary vein isolation/ablation therapy
* present or suspected alcohol/drug dependency will result in exclusion from the study

Primary outcomes:
measure: histological characteristics
timeFrame: 3 months
Secondary outcomes:
measure: recurrence of rhythm disturbance
timeFrame: 3 months
measure: rehospitalization
timeFrame: 3 months
measure: all-cause mortality
timeFrame: 3 months
measure: NYHA class (New York Heart Association)
timeFrame: 3 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Medizinische Klinik III (Kardiologie)
Study officials:
References:
Clinical trial NCT02487667: Therapeutic Exercise Training in the Elderly
Official title: Effects of a Therapeutic Exercise Program by a Feedback a Motor Control System in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Insufficiency
Aging
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In adulthood, limited mobility and pain are very common and often the first clear sign of functional decline. The loss of independent mobility is related to higher rates of functional disability and mortality; however, it is also susceptible to interventions through exercises. With aging, changes in peripheral and central nervous system also occur, which lead to degradation of the sensory receptors as well as a loss of muscle mass and coordination. However, both, structural and functional dysfunctions of the nervous system, can be mitigated by increasing physical activity.

The aim of this study is therefore, to study the effects on pain and functional capacity of a therapeutic exercise training program in an adult people sample. The therapeutic exercise machines proposed in this trial have not been previously analyzed and provide insight into this field due to their design. The design of this new machines allows the adaptation to each concrete clinical situation by the adjustment of different parameters such as feedback, range of movement, time of repetition, intensity, speed and rhythm, which facilitate motor control training.


Eligibility criteria: Inclusion Criteria:

* Ability to complete self-reported questionnaires
* Autonomous ambulation that allows the realization of functional test
* Accept and consent to voluntarily participate in the study
* Preclinical mobility restriction and/or pain in absence of important pathologies.

Exclusion Criteria:

* Present contraindications for physical exercise
* Receiving physiotherapy treatment during the time of the trial.
* Modification of physical habits
* Change the pattern or usual pharmacotherapy

Primary outcomes:
measure: Change from baseline in pain intensity
timeFrame: 8 weeks
measure: Change from baseline in range of movement
timeFrame: 8 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 8 weeks
measure: Functional capacity
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Alazne Ruiz de Escudero Zapico
Study officials:
affiliation: Unidad de Investigacion en Fisioterapia. Universida de Zaragoza
name: Alazne Ruiz de Escudero Zapico
role: PRINCIPAL_INVESTIGATOR
References: