louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05091047: Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
Official title: A Pilot Evaluation of the Effect of the Erchonia® EVRL OTC™ for the Relief of Diabetic Peripheral Neuropathy Foot Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy
Lead sponsor: Erchonia Corporation
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 9
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 study is to see if applying red and violet low-level laser light can help to reduce foot pain associated with diabetic peripheral neuropathy,

Detailed description: The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy, when used at home by non-medical professionals.

Eligibility criteria: Inclusion Criteria:

* Previously diagnosed with diabetes-induced Peripheral Neuropathy by a qualified health Physician.
* Over the age of 18 years of age
* Able to read and write English.
* Constant feet pain on-going over at least the past 3 months.
* Subject is willing and able to refrain from consuming any OTC and/or prescription medications including muscle relaxants and/or herbal supplements and/or recreational and medical drugs including cannabis intended for the relief of pain and/or inflammation throughout the course of study participation, except for the study-specific pain relief medication of OTC Tylenol.
* Subject is willing and able to refrain from engaging in any non-study procedure therapies for the management of foot pain throughout the course of study participation, including conventional therapies such as physical therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as chiropractic care and acupuncture.
* Self-reported foot pain on the Numerical Rating Scale (NRS) is 50 or greater

Exclusion Criteria:

* Pregnant or think you might be pregnant.
* Open wounds (sores, cuts, ulcers, etc) around the feet
* Cancerous growths around the feet

Primary outcomes:
measure: Change in Pain Numerical Rating Scale (NRS)
timeFrame: Baseline and 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: United States
facility: Erchonia
state: Florida
Study officials:
References:
Clinical trial NCT00524147: Drainage of Tuberculous Pleural Effusions
Official title: Drainage of Tuberculous Pleural Effusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculous Pleurisy
Keywords: loculated pleural effusion
pigtail drainage
pleural effusion
pleural thickening
tuberculosis
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tuberculous (TB) pleurisy can cause clinical symptoms and pleural fibrosis with resultant residual pleural thickening (RPT). Therapeutic thoracentesis or initial complete drainage in addition to anti-TB drugs have been tried to rapidly relieve dyspnea caused by effusion and to decrease the occurrence of RPT. However, contradictory results are reported without clear reasons. The researchers' hypothesis is that, in addition to anti-TB medications, early effective evacuation of inflammatory exudates with or without fibrinolytic agents may hasten resolution of pleural effusion, reduce the occurrence of RPT and finally improve long-term functional outcome in patients with TB pleurisy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of tuberculous pleurisy

Exclusion Criteria:

* History of invasive procedures directed into the pleural cavity
* Recent severe trauma, hemorrhage, or stroke; bleeding disorder or anticoagulant therapy
* Use of streptokinase in the previous 2 years
* Lack of clinical symptoms caused by effusions

Primary outcomes:
measure: Chest radiography, daily monitoring of the volume of fluid drained, the time needed for resolution of fever and dyspnea, and total amounts of fluid drained, and the length of chest drainage and hospitalization
timeFrame: baseline, daily after treatment within admission
Secondary outcomes:
measure: Chest radiography and pulmonary function testing with spirometry
timeFrame: At discharge and at 2, 4, 6, and 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Department of Internal Medicine, Taipei Medical University Hospital
name: Chi-Li Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung CL, Chen CH, Yeh CY, Sheu JR, Chang SC. Early effective drainage in the treatment of loculated tuberculous pleurisy. Eur Respir J. 2008 Jun;31(6):1261-7. doi: 10.1183/09031936.00122207. Epub 2008 Jan 23.
Clinical trial NCT05997147: A Preoperative Model to Predict the Lymphovascular Invasion in Pancreatic Ductal Adenocarcinoma
Official title: Development and Validation of a Preoperative Model to Predict the Lymphovascular Invasion of Pancreatic Ductal Adenocarcinoma: a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Predictive Cancer Model
Pancreas Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 1009
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were pathologically diagnosed as PDAC and received curative surgery.

Brief summary: Importance: Lymphovascular invasion (LVI) is a poor prognosis pathologic feature in pancreatic ductal adenocarcinoma (PDAC) patients. Neoadjuvant therapy may bring survival benefits to these patients.

Objective: To construct a preoperative model which could predict LVI in PDAC patients and further validate it in other cohorts.

Design, Setting, and Participants: Patients from 3 three tertiary hospitals were included in this study. Univariate and multivariate Logistic regression analyses were conducted to define independent prediction factors of LVI. A nomogram was constructed based on the result of multivariate analysis.The predictive value of the model was assessed using receiver operating characteristic (ROC) curves and the maximum Youden index of the ROC curve was defined as the cut-off point. The calibration plot was utilized to assess the concordance of the model. The decision curve analyses (DCA) were applied to estimate the clinical benefit of using this model to predict LVI.


Eligibility criteria: Inclusion Criteria:

* Patients who were pathologically diagnosed as PDAC and received curative surgery.

Exclusion Criteria:

* Patients with distant metastasis; Patients who received neoadjuvant therapy; Patients with a survival time of less than 1 month.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 10 years
Secondary outcomes:
measure: Overall survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Jihui Hao, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01428947: Does Coronary Angiography Cause Cognitive Dysfunction?
Official title: Study of Cognitive Function Before and After Coronary Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Heart Valve Diseases
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective coronary angiography at one center

Brief summary: The purpose of the study is to study if coronary angiography cause cognitive dysfunction.

Detailed description: We have previously shown, using transcranial doppler, that coronary angiography cause cerebral microembolism. Cerebral microemboli were more common using the radial than femoral approach. Previously, cerebral microembolism has been associated with new cerebral lesions on MRI. The clinical significance of these new lesions is not determined. The primary aim of this pilot study is to see if coronary angiography cause cognitive dysfunction determined by the MoCA-test. A secondary aim is to relate cognitive dysfunction to cerebral microembolism measured by transcranial doppler. A third aim is to study potential differences between the femoral and radial approaches.

Eligibility criteria: Inclusion Criteria:

* Elective coronary angiography irrespective of cause

Exclusion Criteria:

* Previous CABG, language problems, not willing to participate

Primary outcomes:
measure: Change in cognitive dysfunction from baseline to two days after coronary angiography
timeFrame: Baseline and two days
Secondary outcomes:
measure: Number of patients with cerebral microemboli
timeFrame: Baseline
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Cardiology Clinic, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Per - Tornvall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jurga J, Nyman J, Tornvall P, Mannila MN, Svenarud P, van der Linden J, Sarkar N. Cerebral microembolism during coronary angiography: a randomized comparison between femoral and radial arterial access. Stroke. 2011 May;42(5):1475-7. doi: 10.1161/STROKEAHA.110.608638. Epub 2011 Mar 10.
Clinical trial NCT01703247: Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation
Official title: Ganglionated Plexi Ablation vs Linear Ablation in Patients Undergoing Pulmonary Vein Isolation for Persistent/Longstanding Persistent Atrial Fibrillation: A Randomized Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent Atrial Fibrillation
Keywords: Arrhythmias
Ablation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2012-10-10
Enrollment: 264
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 investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF. Results were assessed after follow-up of at least 3 years with the use of an implanted monitoring device (IMD).


Eligibility criteria: Inclusion Criteria:

* Persistent and longstanding persistent AF

Exclusion Criteria:

* congestive heart failure
* LV ejection fraction \< 35%
* left atrial diameter \> 60 mm

Primary outcomes:
measure: freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00324077: Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
Official title: A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Myeloid Leukemia, Chronic, Chronic-Phase
Keywords: Chronic phase chronic myelogenous leukemia (CML)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-05-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.


Eligibility criteria: Inclusion Criteria:

* males and females, 18 or older
* chronic phase Ph+ or BCR-ABL positive CML
* current complete hematologic response to imatinib
* lack of major molecular response
* on imatinib for at least one year
* on the same imatinib dose for at least 6 months
* adequate hepatic and renal function

Exclusion Criteria:

* History of accelerated or blast phase CML
* Serious uncontrolled medical disorder or active infection
* Significant cardiovascular disease or bleeding disorder
* Concurrent use of medications at risk of causing Torsades de Pointe

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.
Secondary outcomes:
measure: assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
measure: identify dose limiting toxicities
measure: characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
measure: measure major molecular response rate
measure: measure the major cytogenetic response rate
measure: characterize mutations in the BCR-ABL gene
measure: evaluate progressive free survival and overall survival
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: New York
country: United States
facility: Local Institution
state: New York
Study officials:
References:
Clinical trial NCT04978077: Networks of Bacterium-Metabolite Interactions in the Small Intestine
Official title: Networks of Bacterium-Metabolite Interactions in the Small Intestine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diet, Healthy
Microbial Colonization
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Probands with an Ileo- or Colostomy are assigned to consume a test meal which is either high in fat or high in carbohydrates. After the test meal samples from the stoma, urine, blood and skin are retrieved. These will be subjected to large scale analyses of microbiota and metabolite content. To get a better comparability test subjects will consume a standardized liquid diet three days before the study day.

Detailed description: Between both study days a two week wash out phase will be done. During the study day sampling will be done at set time points until 8 hours after the consumption of the test meal.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* General good health
* Ileostomy or colostomy

Exclusion Criteria:

* Hematologic disorders with contraindication of blood draw
* Participation in other clinical trial interfering with study protocol

Primary outcomes:
measure: Identification of stimulating and inhibiting metabolite and bacteria interactions
timeFrame: 8 hours
measure: Reproduction of metabolite-bacteria interactions in vitro culture
timeFrame: 2 weeks
Secondary outcomes:
measure: Analysis of bacteria species composition
timeFrame: 8 hours
measure: Cultivation of bacterial strains in various conditions including ileal fluids
timeFrame: 2 weeks
measure: Metabolite composition in intestinal fluids
timeFrame: 8 hours
measure: Metabolite composition in blood
timeFrame: 8 hours
measure: Metabolite composition in urine
timeFrame: 8 hours
measure: Metabolite composition in intestinal fluids, blood and urine
timeFrame: 8 hours
measure: Analyze eucaryotic and viral microbiome composition
timeFrame: 8 hours
measure: Analysis of microbiota metabolic potential
timeFrame: 8 hours
measure: Analysis of microbiota metabolic activity
timeFrame: 8 hours
measure: Analysis of microbiota biomass
timeFrame: 8 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: University Clinic for Visceral Surgery and Medicine
name: Benjamin Misselwitz, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02614677: To Advance the New Disability Evaluation System in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Dysfunction
Keywords: Disability Evaluation System
SF-12
ICF model
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with disabilities want to issue a disability identification

Brief summary: Before 2007, the disability evaluation was based on the medical model in Taiwan. According to the People with Disabilities Rights Protection Act announced on 11 July 2007, the assessment of a person's eligibility for disability benefits has to be determined as suffering one of eight malfunction categories based on the International Classification of Functioning, Disability, and Health (ICF) framework. People with disabilities want to issue a disability identification and other welfare \& services need processes of evaluation \& assessment based on the ICF framework for the evaluation report and result of living need by the committee composed of professionals from medicine, social work, special education and employment counseling and evaluation.

In this year, investigators planed the project with the Taiwan Society of ICF to develop the evaluation form. The experts from various disciplines of the ICF Office convened internal integration meetings to reach a consensus for developed the ICF evaluation form, add the code of pain and sleep and the items from Short-Form 12 for quality of life to the questionnaire. The results were used to analysis other relevant factors affecting the disability evaluation. And then add the core set from World Health Organization to both physical and mental disorders linked coding group, compared the new disability evaluation system and evaluate the living need of people with disability to provide suggestion for core set.


Eligibility criteria: Inclusion Criteria:

* comply with a standard of the disability evaluation

Exclusion Criteria:

* no

Primary outcomes:
measure: Assessment of Quality of life by disability evaluate system
timeFrame: One day when patients came first
measure: Pain intensity on the Numerical Rating Scale
timeFrame: One day when patients came first
Secondary outcomes:
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: Changhua Christian Hospital
state: Changhua
Study officials:
References:
Clinical trial NCT01863277: Safety Study of Melatonin in Stroke Patients
Official title: A Double Blind, Placebo Controlled Study to Evaluate the Efficacy of Melatonin in Acute Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-05-27
Enrollment: 140
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: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of Melatonin (in a dosage of 14mg daily) for a better clinical outcome in the period three days post stroke.

Detailed description: Stroke is the third most common cause of stroke. The cascade of event is separated into hyperacute,,acute,sub-acute and chronic. In the acute, sub acute state there are mechanisms of inflammation apoptotic death and effect of free radicals. Melatonin was proved to effect these mechanisms and to have a favourable effect in different diseases. The aim of the study is to prove That the use of Melatonin in a higher dosage may have a anti-destructive effect in stoke.

Eligibility criteria: Inclusion Criteria:

* within 72hours of ischemic stroke
* age 18-80
* both gender
* ability to sign consent form

Exclusion Criteria:

* intra-cerebral bleeding
* tumour of brain
* multiple sclerosis
* s/p craniotomy
* known allergy to melatonin

Primary outcomes:
measure: Improvement of at least one point on the MRS score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: E. Wolfson Medical Center
Study officials:
References:
Clinical trial NCT04237077: Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home
Official title: Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects Aged 75 Years or More Living at Home
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 165
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Since the last few decades, developed societies have been evolving towards a global aging of their populations. This evolution has been accompanied by the problematic of the dependence of aging populations. Dependence is today a challenge posed to social, healthcare or medico-social organizations.

Many studies have shown the positive effect of changes in health (physical activity, nutrition, socialization) on functional abilities of aged subjects. Intervention at subject's home is an easy and inexpensive way to delay the onset of dependence in the elderly population. Health coaching is defined as "a regular series of phone calls between the patient and the health care professional to support and encourage the patient and promote healthy behaviors such as treatment control, healthy eating and physical activity ".

Detailed description: The aim of the study will be evaluate impact of a telephone coaching program on evolution of autonomy in subjects aged 75 years or more living at home

Eligibility criteria: Inclusion Criteria:

* subjects aged 75 years or more
* subjects living at home
* subjects able to use phone
* subjects agree to participate to the study

Exclusion Criteria:

* subjects do not speak French

Primary outcomes:
measure: Autonomy evolution
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References: