louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03369119: Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children
Official title: Phase 4 Study of Oral Montelukast Hospitalized Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Asthma
Acute Wheezy Bronchitis
Keywords: Acute asthma
Montelukast
Hospitalized children
Preschool children
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.However, there is very little information as to their role in acute asthma exacerbations.

The purpose of this study is to determine if adding oral montelukast to the maximal standard treatment in children hospitalized for acute asthma has any additive benefit.

Detailed description: Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor antagonist with a rapid onset of action.

Objective: To evaluate the effect of the addition of a single dose of oral montelukast to standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel group trial. Setting: Pediatric service of Education and training Hospital Patients: Children with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical asthma score was recorded before administering study medication and thereafter, 4 hourly until discharge. Main outcome measure: The primary outcome was discharge rates.

Eligibility criteria: Inclusion Criteria:

* Medical history of at least 4 wheezing attacks
* Children with the ages of 6-60 months
* Children whose parents accept to give written informed consent

Exclusion Criteria:

* Chronic diseases (e.g. malnutrition, anatomic malformation of the respiratory tract, chronic lung or heart disease, gastroesophageal reflux disease and cystic fibrosis)
* Children with a history of chronic drug use (e.g. antiepileptics and immune suppressives)

Primary outcomes:
measure: Length of hospital stay
timeFrame: within the 5 days from hospitalization
Secondary outcomes:
measure: Difference in clinical asthma score
timeFrame: Within 72 hours from hospitalization
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Kecioren Education and Training Hospital
state: Keçiören
Study officials:
affiliation: Pediatric Allergy Specialist
name: Cem H. Razi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01419119: Vitamin Deficiency in Immigrants, a Treatment Study
Official title: A Study, Four Parallel Arms, Included Two Arms Open Randomisation to Different Doses of Vitamin D, for Assessment of Efficacy of Treatment With Vitamin D at Vitamin D Deficiency, Vitamin D Insufficiency and Suboptimal Levels of Vitamin D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: vitamin D insufficiency
Cholecalciferol
D3
Parathyroid Hormone
25-hydroxyvitamin D3
RDA, recommended daily intake (nutrition policy)
Vitamin D
Hypovitaminosis-D
Pharmacologic treatment
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 160
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of different doses of vitamin D in persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.

Detailed description: The participants in the study have taken part in a previous screening study. They are now asked to participate in this treatment study. At a screening visit blood samples for vitamin D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun, clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the treatment dose.

Eligibility criteria: Inclusion Criteria:

* Serum- vitamin D below 75 nmol/L
* Men and female
* 25-65 years of age
* Born in Middle East or Africa, living in Umeå district

Exclusion Criteria:

* Hypersensitive to Cholecalciferol, cocos oil, palm kernel or rubber
* Serum D3 equal to or above75 nmol/L
* Hypercalcemia
* Renal insufficiency
* History of Kidney Calculi
* Nephrocalcinosis
* History of sarcoidosis and other Granulomatous Diseases
* Known malignancy
* Ongoing treatment with phenytoin, barbiturates, rifampicin, isoniazid
* Ongoing treatment with cardiac glycosides
* Ongoing treatment with thiazides
* Ongoing treatment with Etalpha, Rocaltrol, ergocalciferol, Dygratal
* Ongoing treatment with drugs involving fat absorption; Orlistat Colestyramin
* Oral treatment with glucocorticoids
* Ongoing treatment with Aluminum Compounds drugs
* Ongoing treatment with Omega -3, vitamin D and/or calcium
* Immobilisation
* Other medial reason not to participate according to the investigator
* Pregnancy (women with S-D3 below 25 nmol/)
* Breastfeeding

Primary outcomes:
measure: Serum-vitamin D
timeFrame: Baseline
measure: Level of Vitamin D at End of the Treatment Period of 12 Weeks
timeFrame: End of treatment period 12 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Ålidhems hälsocentral, Umeå
Study officials:
affiliation: Dept of Epidemiology and Global Health, Umeå University
name: Margareta Norberg, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01868919: Triple P to Improve Behaviour in Children
Official title: Implementation Research of a Parenting Intervention to Improve Behaviour in Children in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Child Behaviour
Mental Health Wellness 1
Family Research
Keywords: "Pilot Projects"[Mesh]
"Parenting"[Mesh]
"Child Behaviour"[Mesh]
"Mental Health"[Mesh]
"Family Practice"[Mesh]
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Joint research (quantitative and qualitative methodology) with quasi-experimental design, before-after without control group to evaluate the pilot implementation of Positive Parenting Program (Triple P) in the context of primary health care in Chile. The hypothesis is that the program is feasible and acceptable to the Chilean population.

Detailed description: General Purpose:

● Evaluate the pilot implementation of the Triple P program in the context of primary health care in Chile.

Specific Objectives:

1. To assess the fidelity of implementation of the Triple P program
2. Analyze the perception of participants, providers and organization on determinants of program implementation.
3. Identify barriers and facilitators to plan future implementation of Triple P program in contexts similar to those in the study.
4. To estimate the magnitude of change in children's behavior, emotional difficulties and rearing practices of caregivers before and after participation.

Eligibility criteria: Inclusion Criteria:

* Parents or caregivers of children from 2 to 10 years old attending primary care clinic
* Parents or caregivers must be worried about child behaviour or their parenting skills and be willing to get professional help

Exclusion Criteria:

* Children: Pervasive Developmental Disorder, severe intellectual disability or severe psychopathology
* Caregivers: illiteracy, decompensated severe psychopathology or current psychotherapy

Primary outcomes:
measure: Assess implementability of the program in primary care in terms of feasibility, acceptability and level of participation
timeFrame: After one year of implementation
Secondary outcomes:
measure: Percentage of change in intensity of behaviour in children
timeFrame: After one year of implementation
measure: Fidelity of program implementation
timeFrame: After one year of implementation
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Católica de Chile
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Gladys Moreno, Dra.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071819: Clinical Markers of Panic and Generalized Anxiety Disorder
Official title: Generalized Anxiety Disorder and Panic Disorder: Differences in Clinical Manifestation and Prognosis, a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Generalized Anxiety Disorder
Panic Disorder
Duration of Untreated Illness
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2023-10-10
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients suffering from PD or GAD identified from medical records in the pre-pandemic period (2016-2019).

Brief summary: The goal of this observational study is to compare socio-demographic and clinical features in patients affected by Generalized Anxiety Disorder (GAD) and by Panic Disorder (PD). The main questions it aims to answer are:

* which socio-demographic/clinical markers are associated to GAD or PD diagnosis?
* which factors are associated with a longer duration of untreated illness (DUI) in GAD and in PD? Participants will signed a written informed consent and socio-demographic/clinical variables will be retrospectively collected. Researchers will compare GAD and PD groups in terms of socio-demographic and clinical features, including DUI, to better characterize the two disorders and to investigate factors associated to a longer DUI.


Eligibility criteria: Inclusion Criteria:

* age 18-65 years;
* ability and willing to give informed consent;
* fluency in Italian language;
* diagnosis of GAD or PD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, 5th edition.

Exclusion Criteria:

* intellectual disability;
* lack of clinical and socio-demographic information;
* patients treated for less than three months in the outpatient clinics for the impossibility of a comprehensive collection of clinical variables.

Primary outcomes:
measure: Quantitative socio-demographic / clinical variables
timeFrame: Three months
measure: Sex
timeFrame: Three months
measure: Occupation
timeFrame: Three months
measure: Pre-/post-onset Comorbidity
timeFrame: Three months
measure: Substance misuse
timeFrame: Three months
measure: Treatment
timeFrame: Three months
measure: Dichotomous socio-demographic / clinical variables
timeFrame: Three months
Secondary outcomes:
measure: Duration of untreated illness (DUI) in months = time between the onset of PD and the first appropriate pharmacological treatment.
timeFrame: Three months
Other outcomes:
Locations:
city: Monza
country: Italy
facility: University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori
state: MB
Study officials:
affiliation: University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori
name: Alice Caldiroli, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02828319: Clinical Study of Z-213 in Subjects With Iron-deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To confirm the safety and efficacy of Z-213 until 12 weeks after start of Z-213 administration in patients with iron deficiency Anemia


Eligibility criteria: Inclusion Criteria:

* Patients with iron deficiency anemia

Exclusion Criteria:

* Patients with anemia caused by conditions other than iron deficiency
* Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase
* Patients with liver, kidney or circulatory system disease
* Patients with a history or present illness that is a malignant tumor or autoimmune disease
* Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
* Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Primary outcomes:
measure: Number of participants with Adverse Drug Reactions
timeFrame: 12 weeks
measure: Number of participants with Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Maximum change in Hb value
timeFrame: 12 weeks
measure: Change in Hb value
timeFrame: 12 weeks
measure: Proportion of responders
timeFrame: 12 weeks
measure: Proportion of subjects with normalization in Hb value
timeFrame: 12 weeks
measure: Proportion of cumulative dosage
timeFrame: 12 weeks
measure: Number of doses to total dose achieved
timeFrame: 12 weeks
measure: Time to total dose achieved
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT06893419: Geriatric Telemanagement of HEALTH Conditions in Nursing Home Residents Recently Discharged From the Hospital- GET HEALTH-I
Official title: Definition and Testing of a New Model of Clinical Governance Based on the Integration of Tools Such as Health Technology Assessment, Clinical Practice Guidelines, Clinical Pathways, and Healthcare Performance Measurement for Planning, Implementation and Management of Healthcare Interventions in Different Settings - INTEGRATE-HEALTH-GOV - Geriatric Telemanagement of HEALTH Conditions in Nursing Home Residents Recently Discharged From the Hospital GET HEALTH-I
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older Hospitalized Patients
Keywords: older patients
comprehensive geriatric assessment
nursing home
health technology assessment
telemanagement
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2025-03-25
Enrollment: 102
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Get-HEALTH-I Study is a prospective interventional study to evaluate the impact of a geriatric telemanagement program on cost-effectiveness and clinical outcomes in nursing home residents post-hospital discharge.

Detailed description: The primary objective of the study is to develop a geriatric co-management governance model using telemedicine for elderly patients with multimorbidity discharged from the hospital to nursing homes.The model will integrate geriatric specialists with nursing home staff and general practitioners. This model will be implemented in selected nursing homes in the Marche Region (Italy).

A secondary objective of the study is to measure the performance of the model in terms of effectiveness and cost-effectiveness. In particular, an evaluation will be conducted on the effects of implementing the geriatric telemanagement governance model on the risk of hospitalization, geriatric syndromes (falls, delirium, pressure ulcers), number of medications, and inappropriate prescriptions. Adherence to the intervention by GPs and nursing home staff, satisfaction and perception of utility, costs, healthcare resource utilization, and cost-effectiveness will be evaluated."

Eligibility criteria: Inclusion Criteria:

* Nursing home residents discharged from the hospital within one week of admission to the nursing home

Exclusion Criteria:

* Residents admitted for a short-term stay

Primary outcomes:
measure: reduction in hospitalization rate
timeFrame: After 6 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Antonio Cherubini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04396119: Developing Lung Cancer Screening in Hodgkin Lymphoma Survivors: a Qualitative Study
Official title: Developing Lung Cancer Screening in Hodgkin Lymphoma Survivors: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Lymphoma
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have previously been treated for Hodgkin lymphoma without evidence of relapse for at least 5 years

Brief summary: To explore the topic of lung cancer screening following treatment for Hodgkin lymphoma from the perspective of survivors

Detailed description: Explore survivors' attitudes towards lung cancer and lung cancer screening Explore survivors' understanding of cancer screening as a concept and the benefits of screening and early detection Explore survivors' level of awareness of and attitudes towards their lung cancer risk Explore survivors' views on the barriers and motivating factors that would impact their decision to attend a lung cancer screening test

Eligibility criteria: Inclusion Criteria:

* Details held in the ADAPT database at The Christie NHS Foundation trust
* Responded to most recent ADAPT study questionnaire (April - August 2019)
* Aged 18-80
* Previously treated for Hodgkin lymphoma without evidence of relapse for at least 5 years
* Able to provide informed consent
* Treated with radiotherapy (with lung tissue in the radiotherapy field) and/or alkylating agent containing chemotherapy.

Exclusion Criteria:

* Previous or current diagnosis of lung cancer
* Stated within 2019 health questionnaire that they did not wish to be contacted
* Have participated in lung cancer screening through the Manchester Lung Health Checks

Primary outcomes:
measure: Explore survivors' attitudes towards lung cancer and lung cancer screening
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02086019: Revascularisation or Medical Therapy in Elderly Patients With Acute Anginal Syndromes
Official title: A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: Revascularisation, octogenarian,acute coronary syndromes
Lead sponsor: Brighton and Sussex University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Medtronic Vascular
First posted: 2014-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For octogenarian patients with NSTEMI (non-ST segment elevation myocardial infarction) an invasive-guided strategy will prove superior to a conservative strategy with respect to a combined endpoint of all cause mortality and non-fatal myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* AGE\>80 Non-STEMI - characteristic chest pain accompanied by
* Typical ischaemic ECG changes
* A troponin rise

Suitable for conservative or invasive strategy

Exclusion Criteria:

* Lack of suitability for whatever clinical reason to be randomised eg dementia, co-morbidity
* Acute STEMI
* Cardiogenic shock
* Platelet count =50 x 109/mm3
* Patient life expectancy \< 1 year
* Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
* Recent major GI haemorrhage (within 3 months)
* Any previous cerebral bleeding episode
* Participation in another investigational drug or device study
* Patient unable to give consent
* Clinical decision precluding the use of stents

Primary outcomes:
measure: Death
timeFrame: 1 year
measure: non-fatal myocardial infarction
timeFrame: 1 year
Secondary outcomes:
measure: Unplanned revascularisation
timeFrame: 1 years
measure: Permanent Stroke
timeFrame: 1 year
measure: Major bleeding
timeFrame: 1 year
measure: Deterioration of renal function during hospital admission
timeFrame: During index admission
measure: Angina symptoms (3 months; 1yr)
timeFrame: 3 months and 1 year
measure: Stent thrombosis
timeFrame: 1 year
measure: All cause mortality
timeFrame: 2,3 and 4 year
measure: Hospital readmission for ACS/STEMI
timeFrame: At 3, 6 and 12 months and at 2,3 and 4 years
measure: In-hospital major complications
timeFrame: At 3, 6 and 12 months and at 2,3 and 4
Other outcomes:
Locations:
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
Study officials:
References:
Clinical trial NCT02079519: A Study of Avastin (Bevacizumab) in Patients With Multiple Myeloma
Official title: Bevacizumab as Treatment for Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluated the efficacy and safety of Avastin (bevacizumab, 5 mg/kg intravenously every 2 weeks) in patients with multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 19-75 years of age
* Multiple myeloma.
* Progressive disease after at least 2 lines of prior therapy.

Exclusion Criteria:

* Non-secretory myeloma.
* History of malignancy, other than squamous cell cancer, basal cell cancer, or cancer in situ of the cervix within the last 5 years.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start.
* Clinically significant cardiac disease.

Primary outcomes:
measure: Percentage of Participants With a Complete Response or a Partial Response
timeFrame: Baseline to the end of the study (up to 1 year)
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 1 year)
measure: Overall Survival
timeFrame: Baseline to the end of the study (up to 1 year)
Other outcomes:
Locations:
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: