louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00515840: GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study
Official title: GPIAG and Leicester Asthma and Dysfunctional Breathing (GLAD) Study: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Respiratory
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2007-08-14
Enrollment: 182
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breathing retraining supervised by a physiotherapist will result in improvements in the quality of life and asthma control of patients treated for asthma in the community with symptoms suggestive of dysfunctional breathing.

To investigate the effects of breathing retraining on clinical and physiological parameters of asthma control, to identify the characteristics of patients who benefit, to perform a health economic evaluation.

Detailed description: Objectives:

* To assess the effect of breathing retraining on asthma-related health status, asthma control and objective indices of asthma severity (bronchial hyper-reactivity (BHR), sputum eosinophilia and nitric oxide production) in patients with symptomatic asthma.
* To compare the relationship between symptoms of dysfunctional breathing (Nijmegen Questionnaire screening score), changes in asthma-related health status and other parameters resulting from breathing retraining
* To explore the relationship between dysfunctional breathing, baseline asthma symptoms, treatment and asthma-related quality of life.
* To estimate the cost effectiveness of the breathing retraining intervention

Eligibility criteria: Inclusion Criteria:

* Asthma diagnosis in medical records
* Age 17-70 yrs.
* One or more prescription for asthma medication in previous 12 months
* Impaired asthma related quality of life (AQLQ score \<5.5)

Exclusion Criteria:

* COPD
* Unstable or under-treated asthma at enrollment.

Primary outcomes:
measure: Change in AQLQ scores between intervention and control groups in subjects with positive NQ screening scores 1 month post intervention Change in AQLQ scores between intervention groups of subjects with positive and negative NQ screening scores
timeFrame: Dec 2006
Secondary outcomes:
measure: Changes in bronchial hyperresponsiveness(PC 20), sputum eosinophil counts and exhaled NO between intervention and control groups in subjects with positive and negative NQ screening scores Change in ACQ Score between the intervention and the control gr
timeFrame: Dec 2007
Other outcomes:
Locations:
Study officials:
affiliation: University of Aberdeen
name: Mike Thomas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00359840: A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Official title: A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Keywords: darbepoetin alfa
anemia
cancer patients
chemotherapy
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-08-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the clinical effective dose of KRN321 administered with once triweekly schedule.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed as solid tumor or malignant lymphoma
* patients receiving cyclic chemotherapy
* written informed consent
* hemoglobin concentration below 11 d/dL at enrollment
* life expectancy of more than 4 months

Exclusion Criteria:

* hemolysis, gastrointestinal bleeding, postoperative bleeding
* iron deficiency
* megaloblastic anemia
* received \> 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
* any primary hematological disorder that could cause anemia
* prior treatment with KRN321
* received erythropoetin therapy within 8 weeks before treatment

Primary outcomes:
measure: To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
Secondary outcomes:
measure: To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
measure: To compare the proportion of subjects who receive red blood cell transfusions
measure: To compare the effectiveness of KRN321 based on quality of life scores
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Tokai region
city: Ehime
country: Japan
facility: Shikoku region
city: Fukuoka, Kumamoto
country: Japan
facility: Kyusyu region
city: Hokkaido
country: Japan
facility: Hokkaido region
city: Kyoto, Osaka, Nara
country: Japan
facility: Kinki region
city: Miyagi
country: Japan
facility: Tohoku region
city: Niigata, Ishikawa
country: Japan
facility: Hokuriku region
city: Tochigi, Saitama, Tokyo, Kanagawa
country: Japan
facility: Kanto region
Study officials:
affiliation: National Cancer Center Hospital East
name: Nagahiro Saijo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00396240: ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
Official title: ORBITAL: Open-Label Primary Care Study: Rosuvastatin Based Compliance Initiatives Linked To Achievement Of LDL Goals
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Primary Hypercholesterolaemia
Keywords: rosuvastatin
hypercholesterolaemia
cholesterol
LDL-C
triglyceride
plasma lipids
compliance
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 1294
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: 24 week open label study to compare the treatment either with rosuvastatin or rosuvastatin plus initiatives to improve compliance. If the subject does not reach the EAS LDL-C treatment goal at week 12, rosuvastatin will be titrated from 10mg to 20mg.


Eligibility criteria: Inclusion Criteria:

* Primary hypercholesterolaemia:
* Statin naïve subjects (LDL-C level \> 3.5 mmol/L) or subjects on an ineffective "start dose" of a lipid-lowering therapy (LDL-C level \> 3.1 mmol/L).
* CV risk \> 20%,
* history of CHD or other established atherosclerotic disease

Exclusion Criteria:

* History of severe adverse events with another HMG-CoA reductase inhibitor
* Secondary hypercholesterolaemia;
* Unstable cardiovascular disease;
* Uncontrolled diabetes, active liver disease;
* Severe hepatic or renal impairment;
* Treatment with cyclosporin.

Primary outcomes:
measure: Comparison of the rosuvastatin therapy (10mg daily, titrated to 20mg at 12 weeks if necessary), alone or in combination with enhanced compliance initiatives, at 6 months, in bringing subjects with prim. hypercholesterolaemia to the EAS LDL-C target goals
Secondary outcomes:
measure: To investigate the effect of rosuvastatin, both with and without compliance initiatives on number and percentage of subjects within the EAS or local LDL-C and TC target goals after 12 week therapy,
measure: Safety of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Madeleine Billeter, MD
role: STUDY_DIRECTOR
affiliation: Cantonal Hospital of St. Gallen
name: W. Riesen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUV (Centre Hospitalier Universitaire Vaudois) Lausanne
name: R. Darioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04210440: The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression
Official title: Core Decompression With Bone Chips Allograft Adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS): Results in Avascular Necrosis of Femoral Head (AVN) After 2 Years Minimum Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Necrosis
Hip Injuries
Keywords: hip avascular necrosis
hip conservative surgery
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN) treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and concentrated autologous mesenchymal stromal cells (MSCs).

Detailed description: We report 52 cases of avascular necrosis of the hip (AVN), operated by decompression of the necrotic area with bone chips allograft, adjuvanted by concentrated autologous mesenchymal stromal cells (MSCs) and fibrin platelet rich-plasma (PRP).

The patients were followed-up at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year. Each time a clinical evaluation by Harris Hip Score (HHS) was carried out by the same orthopedic surgeon. Radiological controls (pelvis and hip affected) were performed at 6 weeks, 3 months, 6 months, 12 months, 24 months and then every year.

The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR), while the secondary outcomes were the assessment of any change in clinical performance as measured by Harris Hip Score

Eligibility criteria: Inclusion Criteria:

- hip avascular necrosis

Exclusion Criteria:

* protrusio acetabuli
* concentric femoral head migration;
* presence of extensive surgery of the reference joint (osteotomies around the hip, open or arthroscopic osteochondroplasty for femoral-acetabular impingement)
* presence of excessive deformity (acetabular or femoral head dysplasia; collapse deformity and deformed femoral head sequelae of Perthes);
* concomitant rheumatic diseases;
* bone tumors

Primary outcomes:
measure: Avoiding arthroplasty
timeFrame: 24 months after surgery
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 6 weeks after surgery
measure: Harris Hip Score
timeFrame: 3 months after surgery
measure: Harris Hip Score
timeFrame: 6 months after surgery
measure: Harris Hip Score
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzli
Study officials:
References:
Clinical trial NCT05288140: Efficacy of the Use of Diaries in Intensive Care Units
Official title: Efficacy of the Use of Diaries in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diary (Blank Journal)
Intensive Care Unit
Patient
Family
PICS
Stress
Anxiety
Depression
Quality of Life
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A control group and an experimental group
Primary purpose: PREVENTION

Brief summary: Randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an ICU in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after ICU discharge.

Detailed description: Randomized, parallel, open, non-blinded, multicenter clinical trial, with an experimental group (diary) and a control group (usual practice), to compare the effect produced on quality of life by post-traumatic stress and anxiety/depression of patients and relatives, whether or not they have access to a diary during the stay in the unit. Three validated scales will be used at three different times. 120 cases per group, carrying out a preliminary pilot test. Data analysis according to IBM SPSS v.24 to describe and compare both groups.

Eligibility criteria: Inclusion Criteria:

* admitted intensive care unit
* sedated and mechanically ventilated for 24hours
* signed consent
* not language barrier
* willingness to attend follow-up visits

Exclusion Criteria:

* verbal manifestation of psychiatric, mental or cognitive antecedents
* who do not coluntarily agree to participate

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: SF-36 Health Survey
timeFrame: 2 months
measure: SF-36 Health Survey
timeFrame: 6 months
measure: SF-36 Health Survey
timeFrame: 12 months
measure: Revised Impact of Event Scales (IES-R)
timeFrame: 2 months
measure: Revised Impact of Event Scales (IES-R)
timeFrame: 6 months
measure: Revised Impact of Event Scales (IES-R)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universidad de Barcelona
Study officials:
References:
Clinical trial NCT00280540: Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension
Official title: A 6-week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
High blood pressure
Blood pressure control
Blood pressure reduction
Valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-23
Enrollment: 648
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).


Eligibility criteria: Inclusion Criteria:

* Male or female age 18 or older
* Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and \<110 mm Hg)

Exclusion Criteria:

* Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
* History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
* History of myocardial infarction, stroke \[e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)\], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline systolic blood pressure after 4 weeks
measure: Change from baseline systolic blood pressure after 2 and 6 weeks
Secondary outcomes:
measure: Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period
measure: Blood pressure less than 140/90 mmHg after 6 weeks
measure: Change from baseline diastolic blood pressure after 6 weeks
measure: Change from baseline in blood and urine markers after 6 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Zappe DH, Palmer BF, Calhoun DA, Purkayastha D, Samuel R, Jamerson KA. Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension. J Hum Hypertens. 2010 Jul;24(7):483-91. doi: 10.1038/jhh.2009.90. Epub 2009 Dec 10.
Clinical trial NCT03910140: TILA-TACE in Treatment of Hepatocellular Carcinoma
Official title: A Prospective Non-controlled Single-arm Study of TILA-TACE in Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumor Response Rate
Overall Survival
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To validate the tumor response rate: in the previous study, the investigators showed that TILA-TACE achieved 100% tumor response rate. However, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; To validate the overall survival: in the previous study, the investigators showed that TILA-TACE significantly prolonged the overall survival of the patients with large and massive tumor. Again, the sample size was small, the investigators need to validate the data using a large sample size.


Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma is confirmed by tissue pathology or in accordance with clinical diagnosis standard;
* ECOG score 0-1;
* HCC BCLC grading 0, A, B, C;
* Child-Pugh score prior to therapy A and B;
* As judged by investigators, the patient can comply with the study protocol;
* Patient voluntarily participates in this study, understands the process of the study, and is willing to sign the written consent form.

Exclusion Criteria:

* HCC BCLC grading D;
* Child-Pugh score prior to therapy C.

Primary outcomes:
measure: The response to treatment
timeFrame: 1 month after therapy
Secondary outcomes:
measure: Lifetime (months)
timeFrame: 6 months once after therapy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT01902940: Natural History in CCFDN and IBM Syndromes
Official title: Retrospective Cohort Study Assessing the Natural Course in Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and Sporadic and Hereditary Inclusion Body Myopathies (IBM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inclusion Body Myositis, Sporadic
Inclusion Body Myopathy, Autosomal-recessive
Inclusion Body Myopathy, Autosomal-dominant
Congenital Cataracts, Facial Dysmorphism, And Neuropathy
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 350
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 CCFDN and IBM

Brief summary: So far, only limited data is available regarding the natural course in Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body myopathies (IBM). Several criteria and outcome measures have led to contradicting results. The investigators want to retrospectively assess the natural course of the disease in CCFDN and IBM patients according to the data recorded during clinical routine visits.

Detailed description: We wanted to assess the natural course in Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body myopathies (IBM) over 10 years to gain new insights in both conditions.

Eligibility criteria: Inclusion Criteria:

* Clinical and/or genetic diagnosis of Congenital Cataract Facial Dysmorphism Neuropathy Syndrome (CCFDN) and sporadic and hereditary inclusion body myopathies (IBM)

Exclusion Criteria:

* Additional neuromuscular diseases

Primary outcomes:
measure: Manual Muscle Strength assessed by Medical Research Council (MRC)
timeFrame: 6-months intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Friedrich-Baur-Institut, Ludwig-Maximilians-University of Munich
state: Bavaria
Study officials:
affiliation: Friedrich-Baur-Institute, Dept. of Neurology
name: Maggie C Walter, MD, MA
role: STUDY_CHAIR
References:
Clinical trial NCT06437340: Life Satisfaction of Fathers of Children With Cerebral Palsy
Official title: Determinants of Life Satisfaction Levels of Fathers of Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Father-Child Relations
Life Satisfaction
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 122
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with a diagnosis of cerebral palsy were examined by a physiatrist. Children diagnosed with cerebral palsy and their fathers who met the inclusion criteria and agreed to participate in the study were included.

Brief summary: The purpose of this study is to examine the determinants of life satisfaction among fathers of children diagnosed with Cerebral Palsy.


Eligibility criteria: Inclusion Criteria:

* to be literate and to have no communication problems
* to be the father of a child with Cerebral Palsiy (CP) and no other medical diagnosis (aged between 1-18 years)
* to have a child with CP who regularly receives physiotherapy and rehabilitation
* to live in the same house with his wife and child/children
* to be willing to participate in the study

Exclusion Criteria:

* to care for individuals in need of care (such as disabled, elderly, chronically ill) additionally to the child with CP
* to have a chronic disorder (such as neurological, rheumatologic, psychiatric disorder) that would affect life satisfaction.

Primary outcomes:
measure: Sociodemographic Data
timeFrame: 20week
measure: Satisfaction with Life
timeFrame: 20week
measure: Gross Motor Function
timeFrame: 20week
Secondary outcomes:
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Atahan TURHAN
state: Merkez
Study officials:
References: