louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00549614: Effect of 4 Weeks Treatment With Acipimox in Patients With Chronic Heart Failure
Official title: Effect of 4 Weeks Treatment With Acipimox on Left Ventricular Function, Work Capacity, Insulin Sensitivity and Substrate Metabolism in Patients With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-10-26
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate whether metabolic modulation improves left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure


Eligibility criteria: Inclusion Criteria:

* EF\<40 %
* IHD
* NYHA-class II-III.

Exclusion Criteria:

* pregnancy
* severe renal failure
* new brady- or tachyArrhythmia
* Severe stenotic valvular disease
* myocardial infarction within last 6 weeks
* insulin treated diabetes mellitus
* peptic ulcer
* pregnancy or lactating women
* allergy towards tested medicine

Primary outcomes:
measure: left ventricular ejection Fraction
timeFrame: 4 weeks
measure: exercise capacity
timeFrame: 4 weeks
measure: muscular metabolism
timeFrame: 4 weeks
Secondary outcomes:
measure: regional left ventricular function
timeFrame: 4 weeks
measure: insulin resistance
timeFrame: 4 weeks
measure: full body metabolism
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiology, Aarhus Universityhospital, Skejby
Study officials:
affiliation: B-research, Aarhus Universityhospital, skejby
name: Mads Halbirk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01785914: Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital.
Official title: Retrospective Evaluation of the Clinical Results Obtained in Patients With Acute Lymphoblastic Leukemia Treated at the San Giovanni Battista Hospital.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disease: Acute Lymphoblastic Leukemia
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute lymphoblastic leukemia patients

Brief summary: This study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. This collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "GIMEMA" or "BFM" or "NILG" approved by the Ethics Committee of Hospital. The purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.


Eligibility criteria: Patients with newly diagnosed of acute lymphoblastic leukemia enrolled from 1999 to 2011 at the Division of Hematology, Molinette University Hospital and candidates for therapeutic approach with curative intent.

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Event-free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Città della Salute e della Scienza di Torino
Study officials:
affiliation: Divisione di Ematologia-Città della Salute e della Scienza di Torino
name: Benedetto Bruno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02185014: Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
Official title: A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 252
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in participants with Crohn's disease.


Eligibility criteria: Inclusion Criteria:

- Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the Week 12 ileocolonoscopy.

Exclusion Criteria:

* If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or malignancy.
* Subject is not in compliance with prior and concomitant medication requirements throughout M14-115 (NCT02185014).
* Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated per M14-115 (NCT02185014) procedures.

Primary outcomes:
measure: Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0
timeFrame: Week 40
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00846014: Asthma Exacerbation and Helium-3 MRI
Official title: Asthma Exacerbation and Helium-3 MRI
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Asthma Exacerbation
Keywords: asthma
exacerbation
Helium
MRI
Lung imaging
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this research is to use Helium-3 MRI to see the changes in airflow of the lungs at different times of an attack. These three stages are immediately after the attack, 1 month later and 4-6 months later.

Detailed description: Asthma is a pulmonary disorder that affects millions of people each year. The exact method of exacerbation is still under some discussion. Currently there is no cure for the disorder but treatment is of a wide variety.

This study is meant to image the asthmatic lung at various time points post exacerbation. Since pulmonary imaging is currently limited to radiation techniques, this method will allow exacerbated images without the unnecessary exposure to radiation.

Eligibility criteria: Inclusion Criteria

* At least 18 years old
* Able to speak and read English
* Acute asthma exacerbation, defined as requirement for hospitalization or emergent outpatient visit, and treatment with high dose corticosteroids ( 40mg prednisone or equivalent)
* FEV1 \< 80% predicted on the day of MRI
* Attending physician agrees that patient is safe to participate on the day of the MRI scan

Exclusion Criteria

* Evidence of pneumonia, based on chest radiograph obtained within 24 hours of enrollment (if performed)
* Documented fever or requirement for antibiotics
* Unable to hold breath for 10 seconds
* Active smoker or history of at least 10 pack years cigarette smoking
* Chest radiograph with active pulmonary disease, except for changes expected with asthma (hyperinflation, subsegmental atelectasis)
* Admission to ICU
* For inpatients: contraindication to leaving hospital room for MRI as determined by Attending physician and RN on day of MRI
* Any other concurrent active pulmonary disease or other unstable or active medical condition (including suspected active coronary ischemia, acute bleeding), as determined by Attending physician
* Pregnancy as self reported
* Need for cardiac monitoring
* Need supplemental oxygen at an amount of 4L/min or a facemask

Primary outcomes:
measure: Image and quantify variation in asthmatic lungs at 0, 6 months, and 12 months
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMASS Medical School Advanced MRI Center
state: Massachusetts
Study officials:
affiliation: UMASS Medical School
name: Mitchell S Albert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01133314: Artemether-Lumefantrine Effectiveness in Guinea-Bissau 2
Official title: The Routine Use of Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Bissau - 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 600
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.

Brief summary: The routine treatment of children with antimalarials will be monitored. Children with a positive malaria film and/or a positive rapid diagnostic test (RDT) will have a capillary blood sample taken to verify the diagnosis and to monitor the pattern of resistance.

Detailed description: Children from Bissau seeking medical advice and who are recommended treatment for malaria in accordance with the current routines will be included as follows:

All children getting the clinical diagnosis of malaria will be registered and basic information collected.

All children with a positive malaria film and/or a positive RDT will be asked for a capillary blood sample (app. 50 - 100 microliters on a filterpaper). Using PCR the parasitological diagnosis will be verified and if parasites are identified the resistance patterns will be examined. Both the capillary blood samples and the RDTs (if taken by the health staff) will be used in order to examine whether the RDTs can be used for routine monitoring of resistance in an area.

The study does not interfere in the routine treatment of the health staff. None of the children will be followed.

Eligibility criteria: Inclusion Criteria:

* Children seeking a health centre and by the health staff given the diagnosis: malaria and/or being treated with an antimalarial.

Exclusion Criteria:

* Children where the parents do not accept to participate in the study.

Primary outcomes:
measure: Percentage of children treated for malaria with a parasitological confirmed malaria.
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of the parasites with mutations coding for resistance to antimalarials.
timeFrame: 2 years
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
state: Bissau Codex
Study officials:
affiliation: Bandim Health Project
name: Poul-Erik Kofoed, MD, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04497714: Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study
Official title: Identifying Ultrasonic Diagnostic Characteristics of Cervical Lymphadenopathy: A Retrospective, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymph Node Disease
Ultrasound Therapy; Complications
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with one of these four diseases

Brief summary: The observed indexes of the four cervical lymph node diseases were identified by informatics methods, and the differences in the diagnosis of the four diseases were evaluated, so as to improve the clinical diagnosis rate and provide a research basis for the ultrasonic evaluation of the surgical indications of cervical lymph node diseases in the future.


Eligibility criteria: Inclusion Criteria:

* Patients with one of these four diseases

Exclusion Criteria:

* 1. Patients with severe heart and brain diseases and poor coagulation function. 2. Undiagnosed patients are not included in the statistical analysis. 3. Image distortion of CEUS acquisition cannot be analyzed.

Primary outcomes:
measure: Cervical lymph nodes tuberculosis
timeFrame: through study completion, an average of 1 year
measure: Cervical lymphoma
timeFrame: through study completion, an average of 1 year
measure: Cervical lymph node metastasis
timeFrame: through study completion, an average of 1 year
measure: Cervical Reactive hyperplasia
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01831414: Effect of Immersion Level on Respiratory Function of Spinal Cord Injury Patients During Balneotherapy
Official title: Etude Pilote évaluant l'Effet du Niveau d'Immersion Sur la Fonction Respiratoire Des Patients tétraplégiques bénéficiant de balnéothérapie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Lung function
Water immersion
Balneotherapy
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Fondation Garches
First posted: 2013-04-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless environment and which is often used in patients with spinal cord injury. In normal subjects, water immersion generates a reduction in lung volumes. The effects of water immersion on the respiratory function of spinal cord injury patient (who are liable to present a respiratory failure secondary to paralysis) are not well known. They could be deleterious (by majoring respiratory failure)or beneficial (by mimicking the effect of a corset and improving respiratory function). Therefore, we are planning to study the effect of different water immersion levels on the respiratory function of spinal cord injury patients.


Eligibility criteria: Inclusion Criteria:

* Adult Patient
* complete tetraplegia from spinal cord injury
* initial spinal cord injury at leat 3 months before study

Exclusion Criteria:

* contra indication to a balneotherapy session (bed-sore, skin infection or irritation, urinary or fecal incontinency, tracheostomy, ongoing infection)
* unstable respiratory state (patient free of respiratory infection or encumbrance)
* refusal to participate to the protocol
* pregnancy

Primary outcomes:
measure: Lung volumes
timeFrame: 1 hour
Secondary outcomes:
measure: Respiratory comfort
timeFrame: 1 hour
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
affiliation: HOPITAL RAYMOND POINCARE
name: HELENE PRIGENT, MDPHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03430414: Analysis of Biopsies With Antibody Mediated Rejection According to the Therapy Response
Official title: Transcriptome Analysis of Stored Biopsy Samples in Clinically Precisely Phenotyped Therapy-responders Versus Non-responders Diagnosed With Antibody Mediated Rejection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibody-mediated Rejection
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ABMR cases in patients who received a kidney transplant between 01.01.2008 - 31.12.2016 will be pre-screened. As an approximate number of 90 kidney transplantations are performed per year at the University Hospital of Zürich, a total of approximately 810 patients will be available for analysis. Yet, according to the inclusion/exclusion criteria we estimate roughly 50 patients to be finally recruited for analysis. Since we estimate a consent rate of about 50%, we will roughly contact 100 patients. A subset of 25 responders and 25 non-responders according to the clinical course will be identified for further analysis

Brief summary: In adult kidney transplant recipients a therapy-responder and non-responder phenotype by antibody mediated rejection will be precisely defined according to clinical and histological characteristics such as creatinine, proteinuria and Banff-classification. Twenty-five patients will be selected each in the therapy-responder and non-responder group. Their stored Formalin Fixed Paraffin Embedded (FFPE) biopsies will be (re)-classified according to the most recent Banff classification. Using Nanostring Technology the gene transcription of therapy-responders versus non-responders will be analyzed and compared to serological and clinical parameters.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant patients at the University Hospital of Zurich between 01.01.2008 - 31.12.2016 with histologically suspected or confirmed ABMR
* Written consent for further use of data for research purposes

Exclusion Criteria:

* Age at transplantation \< 18 years
* Combined organ transplantation (incl. Kidney-Pancreas, Kidney-Liver, Kidney-Heart)
* Incomplete laboratory and/or clinical data
* Recurrence of the initial disease
* Insufficient Biopsy Material for NanoString Analysis
* Documented refusal of further data analysis for research purpose

Primary outcomes:
measure: Transcriptome
timeFrame: 02.15.2018-03.01.2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sazpinar O, Gaspert A, Sidler D, Rechsteiner M, Mueller TF. Histologic and Molecular Patterns in Responders and Non-responders With Chronic-Active Antibody-Mediated Rejection in Kidney Transplants. Front Med (Lausanne). 2022 Apr 29;9:820085. doi: 10.3389/fmed.2022.820085. eCollection 2022.
Clinical trial NCT05896995: Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to MS
Official title: Investigation of the Efficiency of Different Exercise Approaches in Individuals Providing Primary Care to Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: back pain
multiple sclerosis
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multiple Sclerosis is known as an inflammatory central nervous system disease characterized by demyelination and axonal damage.

Detailed description: Individuals with MS cannot perform self-care in many areas due to the problems they encounter during their daily life activities, and they need an individual who will take care of them and a lifelong care.

Eligibility criteria: Inclusion Criteria

* Chronic low back pain he is 18-60 years old
* No verbal communication barrier
* Complaining of pain for more than three months
* Volunteering of participants Exclusion Criteria
* Absence of cognitive impairment (delirium, dementia, amnesia)
* Exercise contraindications (uncontrolled medical conditions)
* Caring for individuals with an unclear diagnosis of MS
* Disagreeing with the measurements to be made or providing incomplete answers
* Previous spinal surgery
* Spinal and joint disorders other than lumbar disc herniation

Primary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 6 weeks
measure: Beck Depression Scale
timeFrame: 6 weeks
measure: Bakas Caregiver Impact Scale.
timeFrame: 6 weeks
measure: Disability status assessment.
timeFrame: 6 weeks
measure: Multiple Sclerosis Quality of Life-54 (MSQOL-54)
timeFrame: 6 weeks
measure: Algometer
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
Study officials:
References:
Clinical trial NCT01765595: Clinical and Economic Impact of an Electronic Medical Record Interfaced Decision Support System for Minimizing Severe Drug-Drug Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthcare
Keywords: health care expenditure
drug drug interactions
electronic decision support systems
Potential reduction
Lead sponsor: Leumit Health Services
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 715
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Leumit Health Services, an health maintenance organization operating in Israel, will incorporate a web-based, decision support system for handling drug-drug interactions and drug information, termed DDI+. the investigators hypothesize that implementing such a system will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).


Eligibility criteria: Inclusion Criteria:

* Number of chronic concomitant drugs ≥5

Exclusion Criteria:

* Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C.

Primary outcomes:
measure: Hospital Admissions
timeFrame: up to 12 months post initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Leumit Health Services
Study officials:
affiliation: Tel Aviv University
name: Abraham Weizman, MD
role: PRINCIPAL_INVESTIGATOR
References: