louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02615522: Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration
Official title: Prospektive, Klinische Verlaufsuntersuchung (Post Market Follow-Up) Der primären Knieendoprothese BPK-S Integration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis, Knee
Joint Instability
Keywords: primary TKR
Lead sponsor: Peter Brehm GmbH
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary total knee endoprosthesis with BPK-S Integration of age 18 and older

Brief summary: Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.

200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.


Eligibility criteria: Inclusion Criteria:

* Congenital or acquired knee joint defects/deformation or
* Defects or malfunction of the knee joint or
* Arthrosis (degenerative, rheumatic) or
* Post-traumatic arthritis or
* Symptomatic knee instability or
* Reconstruction of flexibility or
* Patients with metal hypersensitivity (ceramic tibia/femur)

Exclusion Criteria:

* Illnesses which can be treated without using a knee joint implant.
* Acute or chronic infections near the implantation
* Systemic diseases and metabolic disorders
* Serious osteoporosis
* Serious damage to the bone structures that impedes stable implantation of the implant components
* Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc.
* Bone tumors in the area of the implant anchoring
* Obesity or overweight of the patient
* Overload of the knee implant to be expected
* Abuse of medication, drug abuse, alcoholism or mental disease
* Lack of patient cooperation
* Sensitivity to foreign matter in the implant materials
* Patients under the age of 18
* Patients participating in another trial

Primary outcomes:
measure: Time until revision
timeFrame: 10 years
Secondary outcomes:
measure: Improvement of clinical situation based on Knee Society Score
timeFrame: 3 and 12 months, 2, 5, 10 years
measure: Documentation of incidents
timeFrame: Up to 10 Years
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Landesklinikum Amstetten
state: Niederoesterreich
Study officials:
References:
Clinical trial NCT06849622: Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease
Official title: Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Celiac Disease in Children
Diabetes Mellitus, Type I
Screening
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.


Eligibility criteria: Inclusion Criteria:

* Patients aged 2-13 years
* Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls)
* Obtained informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Comparability between spot and serum tests of the following parameters tissue transglutaminase Immunoglobuline A (tTg IgA) test, reference values <16 Units/ml
timeFrame: Baseline
Secondary outcomes:
measure: Comparability between spot and serum tests of the following parameters: anti-insulin antibodies (IAA) test, reference values <10 Units/ml
timeFrame: Baseline
measure: Comparability between spot and serum tests of the following parameters: protein tyrosine phosphatase antibodies (IA2) test, reference values <7.5 Units/ml
timeFrame: Baseline
measure: Comparability between spot and serum tests of the following parameter glutamic acid decarboxylase antibodies (GAD-65) test, reference values <5.5Units/ml
timeFrame: Baseline
measure: Comparability between spot and serum tests of the following parameter zinc transporter 8 (ZnT8) test, reference values <15Units/ml
timeFrame: Baseline
measure: Antibody titers (Units/ml) for coeliac disease autoantibodies and type 1 diabetes
timeFrame: Baseline
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
Study officials:
References:
Clinical trial NCT02460822: Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
Official title: Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: McKesson Foundation
First posted: 2015-06-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research project addresses critical gaps in cancer symptom management through the creation of a mobile chemotherapy symptom management application. This application will assess for the presence and severity of common chemotherapy side-effects and provide personally tailored symptom-related video and narratives to enhance self-management of cancer and treatment-related symptoms. This study will examine patient acceptance and use of this mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive Cancer Center.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with colon or rectal cancer
* Expected to live at least 6 months
* Initiating chemotherapy for the first time in their treatment history
* Physically and mentally able to participate
* Able to read English
* Willing and able to sign informed consent

Exclusion Criteria:

* A treatment plan that does not include cytotoxic chemotherapy for colon or rectal cancer
* A medical history that includes cancer with the exception of in situ cancers of the cervix and basal cell cancers of the skin
* A current diagnosis that includes multiple cancers (this does not exclude metastatic disease)
* Received prior cytotoxic chemotherapy for any reason
* A diagnosed psychiatric disorder

Primary outcomes:
measure: Patient Retention and Engagement With the MyChemoCare Application
timeFrame: 8 weeks post-enrollment
measure: Patient Satisfaction and Usability of the MyChemoCare Application
timeFrame: 8 weeks post enrollment
Secondary outcomes:
measure: Physician Use of the Study Feedback Mechanism
timeFrame: 8 weeks post-enrollment
measure: Increased Mastery of Cancer and Chemotherapy Symptoms
timeFrame: 8 weeks post enrollment
measure: Symptom Burden Reduction
timeFrame: 8 weeks post enrollment
measure: Improved Quality of Life
timeFrame: Baseline and 8 weeks post enrollment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Larry C An, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06333522: Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty
Official title: Losartan Use to Mitigate Arthrofibrosis Following Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Arthrofibrosis of Knee
Keywords: Total Knee Arthroplasty (TKA)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 effect of Losartan, an Angiotensin II Receptor Blocker (ARB), on the formation development of arthrofibrosis in patients who have had a primary total knee arthroplasty. This study aims to assess the post-operative range of motion and the incidence of MUA within three months following the index arthroplasty in the treatment arm (losartan) and the control arm.


Eligibility criteria: Inclusion Criteria:

1. Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
2. Patients ≥18 years of age
3. Patients have been medically cleared and scheduled for surgery
4. Patients' primary care physician has verified that the patient can safely take the described dose of Losartan for the duration of the study period.

Exclusion Criteria:

1. Patients already taking Losartan will not be included in the prospective study
2. Patients already taking an ARB (angiotensin receptor blockers) or other ACE (Angiotensin-converting-enzyme) inhibitor
3. Low blood pressure
4. Currently taking hypertensive medication
5. Revision surgery
6. Surgery for fracture, infection, or malignancy
7. Patients with a diagnosis of post-traumatic arthritis
8. Bilateral, simultaneous surgery

Primary outcomes:
measure: Change in range of motion
timeFrame: Baseline, Day 90
measure: Rate of manipulation under anesthesia (MUA) after elective total knee arthroplasty
timeFrame: Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Rozell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00574522: Energy Specific Far Infrared Radiation Treatment for AIDS
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for HIV/AIDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
AIDS
Radiation
Far infrared
Treatment
Acquired Immunodeficiency Syndrome
Complimentary therapies
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators are proposing that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of killer cells to fight and destroy the human immunodeficiency virus.

Detailed description: Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (AIDS or Aids) is a collection of symptoms and infections resulting from the specific damage to the immune system caused by the human immunodeficiency virus (HIV) in humans. The late stage of the condition leaves individuals prone to opportunistic infections and tumors. Although treatments for AIDS and HIV exist to slow the virus' progression, there is no known cure.

The investigators are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of CD4+ T cells and other killer cells to fight and destroy the human immunodeficiency virus.

The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 20μm wavelength) on HIV/AIDS.

Eligibility criteria: Inclusion Criteria:

* 1 Year and above

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 15μm wavelength) on HIV/AIDS.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01029522: Dyslipidemia in Cardiovascular Disease
Official title: A Multi-center, Randomized, Double-blinded Equivalence Clinical Trial to Evaluate Efficacy and Safety of LipiLou 20 mg Versus Lipitor 20 mg in Hypercholesterolemic Patients With Higher Risk Cardiovascular Disease in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemia
Keywords: Dyslipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-12-10
Enrollment: 244
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.


Eligibility criteria: Inclusion Criteria:

1. Dyslipidemic patients with high-risk cardiovascular disease meeting more than 1 requirement below (LDL-C ≥ 100mg/dL) 1) Coronary artery disease

   * diagnosed with atheroma in Coronary CT or Angiography, or SPECT positive or Treadmill test positive 2) Diabetes Mellitus 3) intervened with stent in coronary artery disease more than 1 year before 4) diagnosed with atheroma in carotid artery 5) Peripheral artery disease
2. Aged 20\~85 years
3. Volunteers consented with participating clinical trial and submitted consent paper

Exclusion Criteria:

1. Experimental examination at screening 1) Active liver disease or more than 2 x ULN of AST/ALT 2) Creatine Kinase \> 2 x ULN 3) Creatinine \> 2.5mg/dL 4) Triglycerides \> 500mg/dL
2. intervened with stent in coronary artery disease less than 1 year before
3. Hyper-sensitive or resistant to other HMG-CoA reductase inhibitors, or experienced serious adverse events
4. Patients taking dyslipidemic treatments within 4 weeks (HMG-CoA reductase inhibitors, fibrates, nicotinic acids or bile acid resins, etc.)
5. As uncontrolled DM patients, HbA1c≥11% or fasting plasma glucose ≥200mg/dL
6. DBP \> 100mmHg, SBP \> 160mmHg
7. Diagnosed with myopathy
8. Appear to be a risk of myopathy below

   * renal impairment or prior renal dysfunction
   * hypothyroidism
   * genetic defects or family history of myopathy
   * experienced prior muscle toxicity with taking statins or fibrates
   * prior liver disease or higher intakes of alcohol
   * aged over 70, and a risk of myopathy
9. Women pregnant or breast-feeding
10. Women capable of pregnancy without using contraceptives
11. contra-indicated medically or mentally, or forbidden legally
12. Enrolled to other clinical trial within 4 weeks
13. Impossible to participate clinical trial according to investigator's decision

Primary outcomes:
measure: LDL-C
timeFrame: after taken medicine for 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: yongon-dong, jong-ro gu, Seoul National University Hospital, South of Korea
name: KIM hyo soo, ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02056522: Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
Official title: Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Lesions
Keywords: Melanoma
Skin Cancer
Lead sponsor: Orlucent, Inc
Sponsor class: INDUSTRY
First posted: 2014-02-06
Enrollment: 357
Sex: ALL
Minimum age (years): 21
Maximum age (years): 97
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.

Brief summary: The use of MDS to access the presence of melanoma in the skin.

Detailed description: A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Eligibility criteria: Inclusion Criteria:

* Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
* The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
* Male and female ≥ 21 years old.
* Subject is capable of giving written informed consent.
* Primary excision.

Exclusion Criteria:

* The lesion is less than 1 cm from the eyes.
* The lesion is on the palms of hands or soles of the feet.
* Mucosal lesion.
* Pregnant females.
* Low study procedure compliance.
* Patients who are mentally or physically unable to comply with all aspects of the study.
* Undergoing chemotherapy.
* Minor or legally incompetent and not able to sign the consent form.
* Patient previously tested by MDS and was diagnosed with melanoma during the study.

Primary outcomes:
measure: To validate the performance of MDS
timeFrame: 28 days
Secondary outcomes:
measure: To calculate and specify the PPV and NPV of the MDS for melanoma detection when used as an adjacent tool to visual skin examination.
timeFrame: 28 days
Other outcomes:
measure: To further establish the safety of the MDS.
timeFrame: 28 days
Locations:
city: Kiryat Bialik
country: Israel
facility: Clalit Health Services
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Head of Plastic Surgery
name: Shokrey Kassis, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02160522: Endotracheal Tube (ETT) Cuff Pressure Study in the Emergency Department (ED)
Official title: Endotracheal Tube Cuff Pressure in the Pediatric Emergency Department: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Tube Cuff Pressure Pediatric Emergency
Keywords: Intubation
cuff
cuffed
endotracheal
tube
pressure
pediatric
child
children
emergency
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are intubated with a cuffed endotracheal tube in the emergency department of Nationwide Children's Hospital.

Brief summary: Our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.

Detailed description: Although manometers are available for the purpose of measuring ETT intra-cuff pressures, they are not currently in use at our institution's Emergency Department. This prospective cohort study will endeavor to determine the incidence of unacceptably high ETT cuff pressures in the ED, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ED.

Eligibility criteria: Inclusion Criteria:

* cuffed ETT in place on arrival in the ED
* cuffed ETT placed while in the ED

Exclusion Criteria:

* ETT cuff electively left deflated by practitioner
* Uncuffed ETT used

Primary outcomes:
measure: Cuff pressure
timeFrame: One time in the ED prior to discharge to the ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Edward Ferenczy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04776122: Usability of a Breathing-CBT Platform (CBT = Cognitive Behavioural Therapy)
Official title: Breathing and CBT Platform Usability Take-home Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing, Mouth
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will examine the usability of a breathing platform in the home environment. It will be a randomized, open-label crossover study of 10 participants who will complete the CBT and breathing components in their home, prior to sleeping. Usability will be measured by scores assigned by participants. Qualitative feedback and compliance information will also be collected.


Eligibility criteria: Inclusion Criteria:

* Participants are willing to give written, informed consent
* Participants are healthy adults
* Participants are able to comprehend and speak English
* Participants are at least 18 years of age

Exclusion Criteria:

* Participants who are/may be pregnant or lactating
* Participant that have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
* Participants who are unsuitable for the inclusion at the discretion of the investigator

Primary outcomes:
measure: Ease of use
timeFrame: 8 days
Secondary outcomes:
measure: Compliance
timeFrame: 8 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed Ltd
Study officials:
affiliation: ResMed
name: Jeff Armitstead
role: PRINCIPAL_INVESTIGATOR
References: