louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01217710: Promoting Physical Activity in Chronic Obstructive Pulmonary Disease (COPD) Through New Technology and Health Coaching
Official title: Next Generation Technology for Chronic Care Self Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Physical Activity
Keywords: Chronic Obstructive Pulmonary Disease
Physical Activity
Self Management
Exercise
Technology
Motivational Interviewing
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-10-08
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this project is to validate the proposed smartphone-based activity monitor and to test its use for Motivational Interviewing based counseling for physical activity in Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Men and women age 40 years and older
* Current or former smoker of at least 10 pack-years
* Diagnosis of GOLD stage II to IV COPD as documented by pulmonary function testing (FEV1 (Forced expiratory volume in 1 second) \<80 percent predicted, FEV1/FVC(Forced vital capacity)\<0.71)
* Able to walk independently or with a walking aid (e.g. wheeled walker, cane, standard walker)

Exclusion Criteria:

* Unable to walk without assistance of another person
* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Primary outcomes:
measure: Validity of activity monitor/smartphone to accurately measure and record physical activity of COPD patients
timeFrame: 3 months
Secondary outcomes:
measure: Determine the feasibility of using the smartphone/activity monitoring technology for motivational interviewing based counseling .
timeFrame: 3 months
measure: Determine the effectiveness of smartphone/activity monitor plus the motivational interviewing based coaching to increase physical activity, improve quality of life or palliate symptoms .
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo, M.D., MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03175510: Reliabılıty,Validity Of The Turkish Version Of The Back Pain Function Scale
Official title: Reliabılıty,Validity Of The Turkish Version Of The Back Pain Function Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: validity, reliability, low back pain
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic back pain between the ages of 18-65

Brief summary: This study, we performed the Turkish version validity and reliability of the Back Pain Function Scale.

Detailed description: Low back pain is defined as the pain that can occur in the region between the lower border of the scapula and the hip, sometimes spreading to the lower extremities, which causes activity limitation and is one of the most common health problems in the society. Appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. The purpose of our study is to determine the Turkish version, validity and reliability of Back Pain Function Scale. 180 patients with chronic low back pain were included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results were evaluated using the Intraclass Correlation Coefficient method. Intraclass Correlation Coefficient results vary between 0.857 and 0.951, and the total Intraclass Correlation Coefficient value is found to be 0.961. These results indicate that the test-retest responses have a high degree of correlation. For internal consistency analysis, the Cronbach Alpha score was fou nd to be 0.910, indicating that the survey has high internal consistency. The total score obtained from the Back Pain Function Scale was assessed using the Pearson correlation analysis with the total scores obtained from the Roland Morris Disability Scale , Oswestry Disability Scale. Pearson's correlation coefficient was -0.840 with Oswestry Disability Scale of Back Pain Function Scale, Pearson's correlation coefficient was -0.803 with Roland Morris Disability Scale. The results show that the Back Pain Function Scale correlates perfectly with the Oswestry Disability Scale and the Roland Morris Disability Scale. In conclusion, Turkish version of Bac Pain Function Scale is valid and reliable.

Eligibility criteria: Inclusion Criteria:

Having a low back pain Literate

Exclusion Criteria:

pregnant canser trauma

Primary outcomes:
measure: Roland Morris disability questionnaire
timeFrame: 10 minute
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 10 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: gazi üniversity
name: seyit citaker
role: STUDY_CHAIR
References:
Clinical trial NCT06560710: Clinical Characteristics and Surgical Outcomes of Full-thickness Macular Hole Without Focal Vitreomacular Traction.
Official title: Clinical Characteristics and Surgical Outcomes of Full-thickness Macular Hole Without Focal Vitreomacular Traction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Holes
Keywords: macular hole
epiretinal prolidferation
vitrectomy
Lead sponsor: St. Marianna University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Toyama
name: Takaoka city Hospital
First posted: 2024-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese

Brief summary: This multicenter, retrospective, observational comparative study. We occasionally encounter FTMHs in which PVD has not been achieved and VMT is absent. These FTMHs cannot be defined by stage in the Gass1) or IVTS3) classification. It is not known whether traction is involved in the development of these atypical macular holes, but they are often classified as Gass stage 2 or 3 according to the size of the hole.

The aim of this study was to investigate the clinical features and surgical outcomes of FTMHs without focal VMT and to discuss possible underlying mechanisms.

Detailed description: The clinical characteristics and surgical outcomes the patients diagnosed with FTMH without focal VMT in the macula (classified as VMT-) are presented, in addition to a comparative analysis of the patients presenting with classic stage 2 FTMH with focal VMT (classified as VMT+) according to international classification criteria.

Eligibility criteria: Inclusion Criteria:

- macular hole without posterior vitreous detachment at the fovea

Exclusion Criteria:

* macular hole with posterior vitreous detachment at the fovea
* Stage1.3.4 macular hole
* Macular hole-associated retinal detachment
* Macular hole with subretinal hemorrhage
* Traumatic MH

Primary outcomes:
measure: postoperative visual acuity
timeFrame: 1month, 3, 6 and 12 months
Secondary outcomes:
measure: postoperative status of outer retinal layer in OCT B-scan images
timeFrame: 1month, 3, 6 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Akita University
name: Jiro Kogo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05806710: Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
Official title: Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Keywords: dysphagia
diet
elderly subjects
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the MoDiet study is to evaluate the usefulness of the GourMed© prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

Detailed description: The objective of the MoDiet study is to evaluate the usefulness of the GourMed© (MedicAir Food srl, Milano, Italy) prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

Eligibility criteria: Inclusion Criteria:

* age 65 years and over
* Gugging Swallowing Screen ranging 10-20;

Exclusion Criteria:

* known or suspected intolerance to any ingredient
* taking other prepackaged products for dysphagia
* creatinine ≥1,5 mg/dl

Primary outcomes:
measure: safety of GourMed© meal
timeFrame: during each GourMed© meal (up to day 7)
Secondary outcomes:
measure: evaluate the amount of GourMet© meal consumed
timeFrame: after each GourMed© meal (up to day 7)
Other outcomes:
Locations:
city: Casatenovo
country: Italy
facility: IRCCS INRCA Hospital
state: Lecco
city: Merate
country: Italy
facility: Ospedale Mandic
state: Lecco
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
References:
Clinical trial NCT06309810: Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia
Official title: Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spasticity/Paresis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity.

The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year.


Eligibility criteria: Inclusion Criteria:

* Malignant spasticity measured with the Modified Ashworth Scale (MAS≥3) or highly impairing spasticity and hypertonia (Numeric Rating Scale \>8 scored by patient or care-giver)
* Age ≥ 18 years old
* Availability of a diagnostic MR scan of the spine segment of interest and electromyography of inferior limbs within 3 months prior to study entry
* Previous ineffective conventional treatment for spasticity or absence of others therapeutic strategies (i.e. negative baclofen pump test, comorbidity limiting the pump implant as spondylodiscitis or severe obesity)
* Plegic patients or minimally conscious state patient
* Signed informed consent (in case of minimally conscious state patients, consent form will be signed by her / his legal representative)

Exclusion Criteria:

* Age \< 18 years old
* Previous radiation in the same anatomical site

Primary outcomes:
measure: MAS
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Acute and late toxicity (CTCAE)
timeFrame: 90 days from the RT treatment
measure: Quality of life (SF-12)
timeFrame: 1 year after treatment
measure: Quality of nursing (VAS)
timeFrame: 1 year after treatment
measure: Radiological characteristics and treatment-related changes of the spinal roots
timeFrame: 6 months after SRS
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria di Negrar
state: Verona
Study officials:
References:
Clinical trial NCT05540210: Analytical Validation of the abioSCOPE Device With the in Vitro Device (IVD) CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood
Official title: Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Stone Protein
Device
Keywords: Pancreatic Stone Protein
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Abionic society has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. The PSP is a host protein biomarker produced by the pancreas in response to a sepsis-related organ dysfunction and has shown a great potential in the early identification of septic patients This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 50 microliters of K2/K3-EDTA venous anticoagulated whole blood. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809).

The main goal of this study is to evaluate the analytical performances components of this product in a point-of-care environment, in particular the sample type comparability between arterial and venous whole blood.


Eligibility criteria: Inclusion Criteria:

1. Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;
2. Male or female, 18 years of age or older;
3. Patient admitted to hospital
4. Need for venous and arterial blood samples as part of standard of care
5. Covered by a social security scheme.

Exclusion Criteria:

1. Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
2. Subject under juridical protection.

Primary outcomes:
measure: PSP measurement
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
References:
Clinical trial NCT03380910: An Interprofessional Intervention to Reduce Smoking Rates
Official title: An Interprofessional Intervention With Behavioral Health and Pharmacy Trainees to Reduce Smoking Rates at a Free Health Clinic in Richmond
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of an experimental process to aid Spanish-speaking patients in quitting smoking with the help of pharmacists and behavioral health psychologist trainees and clinicians.


Eligibility criteria: Inclusion Criteria:

* Spanish-speaking
* Uninsured
* Current cigarette smoker

Exclusion Criteria:

* Pregnant or breastfeeding
* Heart attack or stroke in the last 3 months

Primary outcomes:
measure: Change in smoking abstinence
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Readiness to Quit Smoking
timeFrame: Baseline to 6 months
measure: Change in Nicotine Dependence
timeFrame: Baseline to 6 months
measure: Change in Number of Cigarettes Smoked
timeFrame: Baseline to 6 months
measure: Change Carbon Monoxide Levels
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Henrico
country: United States
facility: CrossOver Healthcare Ministry
state: Virginia
Study officials:
References:
Clinical trial NCT00852410: The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery
Official title: The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Sinusitis
Keywords: Endoscopic sinus surgery
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Obtaining adequate hemostasis is crucial during endoscopic sinus surgery. Submucosal injection of local anaesthetic containing adrenaline has frequently been used to improve surgical milieu. However, injection of adrenaline has potential side effects including tachycardia, hypertension as well as inducing arrhythmia. The aim of this randomized clinical trial is to assess the hemodynamic and hemostatic effects of two different concentrations of adrenaline in local anaesthetic used during endoscopic sinus surgery.


Eligibility criteria: Inclusion Criteria:

* recurrent acute sinusitis, chronic sinusitis, or nasal polyposis

Exclusion Criteria:

* bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications

Primary outcomes:
measure: Reduction of Intraoperative bleeding
timeFrame: during surgery
Secondary outcomes:
measure: hemodynamic fluctuation
timeFrame: during surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Ali Moshaver, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1005-9. doi: 10.1001/archoto.2009.144.
Clinical trial NCT01980810: First Line Chemotherapy for Advanced Cancer
Official title: Pase 2 Study of Albumin-bounded Paclitaxel Plus S-1 as First-line Chemotherapy for Locally Advanced or Metastatic Gastric or Gastro-esophageal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2013-11-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether albumine-bounded paclitaxel plus S-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

Detailed description: This phase II study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with S-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.Primary endpoint was overall response rate.

Eligibility criteria: Inclusion Criteria:

* Inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction
* Adult patients \>=18 years of age
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
* At least have one measurable disease(according to RECIST)
* Adequate bone marrow,renal and liver function

Exclusion Criteria:

* Previous chemotherapy for advanced/metastatic disease
* Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome

Primary outcomes:
measure: response rate
timeFrame: 12 weeks
Secondary outcomes:
measure: progression free survival
timeFrame: 1 year
measure: overall survival
timeFrame: 1 year
measure: number of adverse event
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Medical Oncology,Cancer Hostpital and Institute,CAMS
Study officials:
affiliation: Department of medical oncology,Cancer hospital and institute,CAMS
name: Lin Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: