louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00700648: An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised Subjects
Official title: A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study in Hospitalized Subjects Using Intravenous NovoRapid® (Insulin Aspart)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 3024
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized subjects requiring intravenous insulin therapy

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate the side effects profile and benefits of using intravenous insulin aspart infusion in hospitalised subjects under normal clinical practice conditions in India.


Eligibility criteria: Inclusion Criteria:

* Any hospitalized subject with hyperglycaemia requiring intravenous insulin therapy is eligible for the study based on the discretion of the physician.

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude;
* Subjects with a hypersensitivity to NovoRapid or to any of the excipients.
* Subjects with conditions considered as contraindications.

Primary outcomes:
measure: Incidence of AEs (adverse event)
timeFrame: After 6 months
measure: Incidence of SAEs (serious adverse event)
timeFrame: After 6 months
Secondary outcomes:
measure: Other safety & efficacy measures
timeFrame: After 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Intravenous insulin aspart in a hospital setting: results from an observational study examining patient outcomes and physician preferences; Udwadia F, Bhattacharyya A, Seshiah V et al.; Diabetes Manage. (2012) 2(2), 103-110
Clinical trial NCT03515148: Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance
Official title: Effectiveness of Eccentric Exercise With a Vibration Program Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance in Patients With Chronic Mid Portion Achilles Tendinopathy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Diastasis Recti
Keywords: Achilles Tendinopathy
Rectus Abominis
Vibration
Cryotherapy
Eccentric Exercise
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 61
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: The purpose of this study is to determinate de efectiveness of eccentric exercise combined with vibration or cryotherapy in achilles tendinopathy and its effects on the anterior rectus abdominis muscle.

The investigators hypothesis is the combined eccentric exercise with vibration get better results than cryotherapy with eccentric exercise in rectus abdominis muscle parameters.


Eligibility criteria: Inclusion Criteria:

* Sports people
* Positive initial ultrasound diagnosis
* Presence of degenerative changes at achilles mid portion
* Chronic Achilles tendon pain, (3/10 VAS)
* Pain when walking or running of Achilles tendon, (3/10 VAS)
* Pain in load in plantar flexion of Achilles tendon, 3/10 VAS)
* Pain in palpation of Achilles, (3/10 VAS)
* Morning Stiffness

Exclusion Criteria:

* Receive physical, orthotic or physiotherapeutic treatment
* Asociated low back pain, ankle/knee/hip injury that may affect the study
* Previous injury or surgery of Achilles tendon.
* Pathologies that may limit the joint of ankle
* Pregnancy
* Obesity
* Patients with diabetes and/or other endocrine or metabolic pathologies or neurologic pathologies
* Patients diagnosed with cardiovascular disease
* Subjets diagnosed with familiar hypercholesterolemia and/or presence of xanthomas or with hyperuricemia
* Patients who have received renal transplantation
* Subjects who have suffered retinal detachment
* Subjects who have received oral contraceptives, statins, corticoids or hormone replacement therapy in the last six months
* Subjects who have received treatment wiht fluoroquinolones in the last two years
* Subjects who have received treatment with AINE's in the last four weeks

Primary outcomes:
measure: Inter-recti distance
timeFrame: 3 months
measure: Rectus abdominis thickness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea
Study officials:
affiliation: Pejamalla@gmail.com
name: Pedro J Martin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00535548: Hematopoietic Stem Cell Therapy in Chronic Wounds Using a Pressure Sore Model
Official title: Effect of Hematopoietic Stem Cells in Chronic Wounds Using a Pressure Sore Model: A Pilot Study on Feasibility, Safety and Potential Effects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Wounds
Pressure Sores
Hematopoietic Stem Cells
Wound Healing
Keywords: Chronic wounds
Pressure sores
Hematopoietic stem cells
Wound healing
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2007-09-26
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: BASIC_SCIENCE

Brief summary: Aim of the study:

Evaluation of feasibility, safety and potential effects of stem cells on chronic wounds using a pressure sore model.

Clinical relevance:

* Accelerated healing of uncomplicated wounds
* Enhanced healing of complicated (chronic, non-healing) wounds

Study design:

* Prospective controlled phase I/II study
* Cohort of 5 patients in pilot study, then reevaluation

Patients:

- Para- and tetraplegic patients with sacral pressure sores grade III-IVA according to the classification of Daniel and Seiler

Methods:

1. First surgical intervention:

* Radical debridement of pressure sore
* Bone marrow harvest from the iliac crest
* Isolation of hematopoietic stem cells, aiming to gain \> 1 mio. CD 34+ cells per patient under GMP conditions

  3. Stem cell therapy (after 2 days)
* Injection of stem cells in suspension (50'000 CD 34+ cells in 100 microliter saline per cm2 of wound surface) on one half of the total wound surface and cell-free saline on the other half as a control

  4. Second surgical intervention (after 3-4 weeks):
* Complete excision of the wound
* Closure of the defect by fasciocutaneous flap

  5. Evaluation of wound healing:
* Clinical
* 3D laser imaging
* Histology
* Growth factor assay


Eligibility criteria: Inclusion Criteria:

* Para- or tetraplegic
* Sacral pressure sores
* Grade III-IV according to classification of Daniel and Seiler

Exclusion Criteria:

* Diabetes mellitus
* Peripheral vascular disease
* Coronary artery disease
* Smoking
* Steroids and other immunosuppressive drugs
* Systemic autoimmune or rheumatoid diseases
* HIV
* Hepatitis B/C

Primary outcomes:
measure: feasibility, safety, efficacy
timeFrame: 1 yr
Secondary outcomes:
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Center
Study officials:
affiliation: University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland
name: Oliver Scheufler, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Wettstein R, Savic M, Pierer G, Scheufler O, Haug M, Halter J, Gratwohl A, Baumberger M, Schaefer DJ, Kalbermatten DF. Progenitor cell therapy for sacral pressure sore: a pilot study with a novel human chronic wound model. Stem Cell Res Ther. 2014 Jan 29;5(1):18. doi: 10.1186/scrt407.
Clinical trial NCT04174248: Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life
Official title: The Evaluation of Intelligence Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life for Newly Diagnosed Non-metastatic Breast Cancer Women: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Quality of Life
Keywords: breast cancer
m-Health application
self-management
life of quality
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 112
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to investigate the quality of life (QoL) for women with breast cancer in Taiwan after using the BCSMS App.

Detailed description: After receiving their first diagnosis of breast cancer, women with stage 0 to III were randomized into intervention and control groups. Intervention group subjects used BCSMS App and the control group subjects received usual care. Two questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR 23 were distributed to subjects in both arms at baseline and at 1.5 and 3 months. All evaluations were anonymous.

Eligibility criteria: Inclusion Criteria:

* first diagnosis of breast cancer with stage 0 to III in past year.
* aged 20 to 65 years
* had an Android/iOS smartphone;
* able to read and write in Chinese;
* willing to participate in the study and provide informed consent.

Exclusion Criteria:

* not matched to inclusion criteria
* mental illness
* serious illness and life-threatening

Primary outcomes:
measure: Baseline EORTC QLQ-C30
timeFrame: Baseline
measure: Change of EORTC QLQ-C30 at 1.5 month
timeFrame: 1.5 month
measure: Change of EORTC QLQ-C30 at 3 month
timeFrame: the 3rd month
Secondary outcomes:
measure: Baseline EORTC QLQ-BR23
timeFrame: Baseline
measure: Change of EORTC QLQ-BR23 at 1.5 month
timeFrame: 1.5 month
measure: Change of EORTC QLQ-BR23 at 3 month
timeFrame: the 3rd month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
affiliation: National Yang Ming Chiao Tung University
name: ICing Hou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hou IC, Lin HY, Shen SH, Chang KJ, Tai HC, Tsai AJ, Dykes PC. Quality of Life of Women After a First Diagnosis of Breast Cancer Using a Self-Management Support mHealth App in Taiwan: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 4;8(3):e17084. doi: 10.2196/17084.
Clinical trial NCT01264848: Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Official title: Endovascular Correction of Chronic Cerebrospinal Venous Insufficiency (CCSVI) and Evaluation of Influence of These Treatments on the Symptoms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
venous insufficiency
Lead sponsor: Euromedic Specialist Clinics, Poland
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients.

Detailed description: The aim of this study is to assess the efficacy of endovascular treatment (balloon angioplasty and/or stenting) for the improvement of clinical symptoms in multiple sclerosis patients measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance

Eligibility criteria: Inclusion Criteria:

* patients with clinically defined multiple sclerosis

Exclusion Criteria:

* contraindication for endovascular procedure performed in local anesthesia

Primary outcomes:
measure: Change in clinical symptoms of multiple sclerosis measured by Extended Disability Severity Score (EDSS), Multiple Sclerosis Impact Scale-29 (MSIS-29), Fatigue Severity Scale (FSS) and heat intolerance
timeFrame: 6 months after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Euromedic Specialist Clinics
Study officials:
affiliation: Euromedic Specialist Clinics , Katowice , Poland
name: Marian Simka
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162448: A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Official title: Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Patients With Implanted Dual-Chamber Pacemakers or Defibrillators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Diseases
Keywords: Patients requiring dual-chamber pacemakers or defibrillators
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators


Eligibility criteria: Inclusion Criteria:

* Patients with dual-chamber pacemakers or defibrillators

Exclusion Criteria:

* Recent acute ischemic events
* Recent atrial or ventricular arrhythmias
* Uncompensated heart failure
* Amiodarone use within last year
* Women of childbearing potential
* QTc \<430 msec males
* QTc \<450 msec females

Primary outcomes:
measure: Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period)
Secondary outcomes:
measure: Effect of BMS-394136 on atrial vs ventricular refractoriness
measure: Effect of BMS-394136 on the QTc interval
measure: Assess the safety and tolerability of a single dose of BMS-394136
measure: Explore the relationship between plasma concentration of BMS-394136 and refractoriness
Other outcomes:
Locations:
city: Salisbury
country: United States
facility: Local Institution
state: Maryland
city: Ann Arbor
country: United States
facility: Local Institution
state: Michigan
city: Columbus
country: United States
facility: Local Institution
state: Ohio
Study officials:
References:
Clinical trial NCT04716348: Muscle Energy Technique on Forward Head Posture and Cervical Mobility in Visually Impaired Children
Official title: Efficacy of Muscle Energy Technique on Forward Head Posture and Cervical Mobility in Visually Impaired Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children With Visual Disabilities
Lead sponsor: Egyptian Chinese University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forward head posture is one of the most common postural deviation seen among visually impaired children and, it is characterized by hyperextension of upper cervical and flexion of lower cervical spine. These changes lead to muscle imbalance and resulting in weakness of the deep cervical flexors, shortening of the opposing cervical extensors and reduction in cervical range of motion. Muscle energy technique is a manual therapy technique using in the treatment of shortened muscles, muscle weakness, restricted joints range of motion. so this study aimed to investigate the efficacy of muscle energy technique on forward head posture and cervical mobility in visually impaired children.

Detailed description: subjects will be allocated according to the inclusion and exclusion criteria from different schools for visually impaired children. They will be divided randomly into study group and control group. Study group will be participated in suboccipital muscle energy technique. Control group will be participated in sham technique. The duration of treatment for both groups will be 3 times/week for 6 weeks. Autodesk AutoCAD software will be used to analyze the measured angles and CROM will be used to assess cervical mobility

Eligibility criteria: Inclusion Criteria:

* Visual acuity will be 6/24, 6/36 and 6/60 after correction.
* Wearing glasses more than one year.
* Craniovertebral angle \< 50°.
* Functional hearing.

Exclusion Criteria:

* Injury of cervical region (e.g: atlantoaxial instability).
* Cervical spine deformities or/disorders.
* History of previous cervical spine surgery.
* Rheumatic and congenital heart disease.
* Regular participation in any sport activities.
* Intellectual or/mental disabilities

Primary outcomes:
measure: change in craniovertebral angle
timeFrame: baseline pre intervention and immediately after the intervention
measure: change of cervical range of motion
timeFrame: baseline pre intervention and immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Noha Elserty
Study officials:
affiliation: Lecturer of physical therapy- Egyptian Chinese University
name: Noha S Elserty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00137748: Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients
Official title: Does Replacement With CMVIG in Hypogammaglobulinemic Patients Decrease the Rate of Opportunistic Infections and Chronic Rejection?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypogammaglobulinemia
Keywords: Lung transplantation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2005-08-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Detailed description: This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Eligibility criteria: Inclusion Criteria:

* Lung transplant
* Hypogammaglobulinemia

Primary outcomes:
measure: CMV infection
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jeff T Chapman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02436148: Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire
Official title: Reliability and Validity of the Finnish Version of the Prothesis Evaluation Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation Stump
Keywords: PEQ validation study, Finland
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with major lower extremity amputation who has been prothetized.

Brief summary: The present study assesses the reliability and validity of the Finnish version of Prothesis Evaluation Questionnaire. Major lower extremity amputees who use prosthesis are requited for the present study from the Helsinki and Uusimaa Hospital District and the Central Finland Health Care District.

Detailed description: \> 100 lower extremity prosthetic users with major lower extremity amputation are recruited for the present study. The aim is to assess the reliability and validity of the Finnish version of the Prothesis Evaluation Questionnaire (PEQ). The participants fill in a pre information form, the PEQ, the 15D health-related quality of life questionnaire, Houghton prothesis questionnaire, Locomotor Capabilities Index - 5, Prothesis Evaluation Questionnaire Mobility Section - 5. The psychometric abilities of the PEQ instrument are analyzed.

Eligibility criteria: Inclusion Criteria:

* Major lower extremity amputation Prothetization

Exclusion Criteria:

* Other amputation besides major lower extremity
* No prothesis in use

Primary outcomes:
measure: Assessing the reliability and validity of the PEQ questionnaire
timeFrame: 1-10 years
Secondary outcomes:
measure: Prothesis Evaluation Questionnaire
timeFrame: 1-10 years
measure: Houghton prothesis user score
timeFrame: 1-10 years
measure: Locomotor Capabilities Index - 5
timeFrame: 1-10 years
measure: Prothesis Evaluation Questionnaire Mobility Section - 5
timeFrame: 1-10 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Erkki J Tukiainen, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04024748: Verification of Imaging System PCD-1000A
Official title: Verification of Imaging System PCD-1000A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Patients
Lead sponsor: Canon Medical Systems, USA
Sponsor class: INDUSTRY
First posted: 2019-07-18
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Cancer Patients, 40 years or older, scheduled for a standard-of-care PET/CT scan.

Brief summary: Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain.

* Define and confirm all supported clinical protocols
* Evaluate performance

Detailed description: The study aim is system verification and associated software. Clinical data and clinical feedback will be used for verification.

Eligibility criteria: Inclusion Criteria:

* Patients already scheduled for an FDG test at SDMI
* 40 years and older
* Capable of providing their informed consent

Exclusion Criteria:

* Patients not scheduled for an FDG test at SDMI
* 39 years or younger
* Adult female patients that are and/or could become pregnant
* Not capable of providing their informed consent

Primary outcomes:
measure: Confirm that PCD-1000A PET/CT System is Effective for Its Intended Use
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Steinberg Diagnostic Medical Imaging Centers
state: Nevada
Study officials:
References: