louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00013273: Physical Conditioning in Management of Chronic Venous Insufficiency
Official title: Physical Conditioning in Management of Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Insufficiency
Keywords: Venous insufficiency, plethysmography, hypertension
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). The study will also investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group.

Detailed description: The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). A secondary purpose is to investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group. All subjects will undergo a complete hemodynamic and psychiatric assessment. Key measures will be repeated twice to quantify trend and stability of the baseline measures. Skin biopsies will be obtained in selected patients who demonstrate a response to the physical therapy to evaluate the ultrastructural response therapy. Physical therapy will be conducted 1-3 times per week. Participants will be visited at home and a program will be tailored for each individual to maximize compliance. Validated, standardized questionnaires (FIM, SF-36, OARS, CHART) and functional ratings will be employed at commencement,3,6 and 12 months. Evaluations of hydrodynamics, muscle strength, and ankle motion will be conducted monthly during active physical therapy. Participants in active therapy will be offered to wait listed control group after 6 months.

Eligibility criteria: Patients with severe form of chronic venous insufficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: East Orange
country: United States
facility: VAMC, East Orange, NJ
state: New Jersey
Study officials:
affiliation: Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph.D. Assistant Director
affiliation: Program Analysis and Review Section (PARS), Rehabilitation Research and Development Service
name: Wijegupta Ellepola, Program Analyst
References:
Clinical trial NCT01812473: Plasma Protein Binding Characteristics of Voriconazole
Official title: Impact of Hypoalbuminemia on Voriconazole Pharmacokinetics in Critically Ill Adult Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus of the Study:Protein Binding Characteristics of Voriconazole.
Keywords: protein binding
voriconazole
pediatrics
hematology
intensive care
albumin
alpha-1-acid-glycoprotein
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care unit

Brief summary: The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.


Eligibility criteria: Inclusion Criteria:

* treated with voriconazole

Exclusion Criteria:

* None

Primary outcomes:
measure: Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.
timeFrame: At steady state plasma concentration of voriconazole (after day 4 of therapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Kim Vanstraelen, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304173: Retrospective Chart Review of Valstar
Official title: A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma in Situ of Bladder
Keywords: BCG
refractory
NMIBC
CIS
non-muscle invasive
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-02-25
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been treated with valrubicin in a clinical practice setting.

Brief summary: This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.

Detailed description: Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG. Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. The recommended course of therapy is 6 doses of 800 mg each administered intravesically once a week. While the benefit risk profile of valrubicin has been established in several clinical trials, current data on effectiveness and tolerability when used in clinical practice are lacking. This protocol outlines a retrospective study to evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the treatment of NMIBC in a clinical practice setting.

Eligibility criteria: Inclusion Criteria:

* age 18 years old or greater
* diagnosis of CIS (physician defined in the medical record)
* treated with at least one IVe dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment
* willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A 46.117

Exclusion Criteria:

* route of administration of valrubicin other than intravesical

Primary outcomes:
measure: Event-free survival
timeFrame: 12 months
Secondary outcomes:
measure: Worsening-free Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael Cookson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06280573: COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)
Official title: COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.

Researchers will compare the effect to control groups of MS patients without intervention.


Eligibility criteria: Inclusion Criteria:

* RRMS diagnosed according to the official 2020 McDonald's criteria,
* age 18-55 years,
* MS duration up to 10 years,
* EDSS 1.0-5.5,
* willingness to participate

Exclusion Criteria:

* relapse or corticosteroid treatment within 3 months prior to study enrollment
* severe/unstable comorbidity

Primary outcomes:
measure: concentration of pro-inflammatory cytokines
timeFrame: 12 weeks
measure: concentration of markers of oxidative stress
timeFrame: 12 weeks
measure: concentration of NfL
timeFrame: 12 weeks
measure: concentration of GFAP
timeFrame: 12 weeks
measure: concentration of ecDNA
timeFrame: 12 weeks
Secondary outcomes:
measure: Expanded Disability Status Scale
timeFrame: 12 weeks
measure: Timed 25-Foot Walk
timeFrame: 12 weeks
measure: Nine-Hole Peg Test
timeFrame: 12 weeks
measure: Symbol Digit Modalities Test
timeFrame: 12 weeks
measure: Fatigue Scale for Motor and Cognitive Functions
timeFrame: 12 weeks
measure: General Anxiety Disorder-7
timeFrame: 12 weeks
measure: Patient Health Questionnaire-9
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Derer's University Hospital
Study officials:
References:
Clinical trial NCT02719431: Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study specific evaluation is performed.
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m², inclusive.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.
* Subject has abnormal prolongation of skin bleeding time at Screening.

Primary outcomes:
measure: International normalized ratio (INR)
timeFrame: 22 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT05550831: Radiofrequency Before to Surgical Removal of a Recalcitrant Morton´s Neuroma
Official title: Radiofrequency Before to Surgical Removal of a Recalcitrant Morton´s Neuroma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morton Neuroma
Radriofrequency
Keywords: Foot
Morton Neuroma
Radiofrequency
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Performing a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact.

* Step 1: Visualize the needle on the long axis of the probe.
* Step 2: Neurostimulate
* Step 3: Deposit of 1-2cc of anesthetic and wait about 2 minutes.
* Step 4: we apply the continuous radiofrequency at that point and once done we change the position of the needle to more dorsal planes anatomically and we made 2 more applications (in this case we will no longer have neurostimulation because the patient will be anesthetized).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to perform a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 18 and 70 years
* Patient with neuroma of morton of more than 1 year of evolution
* Patient treated by conservative treatments, stencils, various infiltrations, stretching and with symptomatology that limits his daily activities.
* Healthy patients without previous systemic pathologies (diabetes, coagulation or immunological disorders), ASA I or II that require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study.
* freely accept and sign the informed consent for participation in the study.

Exclusion Criteria:

* Allergy to local anesthesia.

Primary outcomes:
measure: Nerve Damage
timeFrame: 1 week
measure: Quality of Life, FFI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Plasencia
country: Spain
facility: Alfonso Martínez Nova
state: Cáceres
Study officials:
References:
Clinical trial NCT04899531: PANGeA - Physical Activity and Nutrition for Quality Ageing
Official title: Longitudinal PANGeA Mass Measurement - Physical Activity and Nutrition for Quality Ageing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging
Sarcopenia
Cognitive Decline
Keywords: elderly
longitudinal
physical activity
cognition
dietary habits
Lead sponsor: Science and Research Centre Koper
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 950
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All males and females who participated in PANGeA mass measurements in 2013 will bi considered in the study.

Brief summary: General objectives of the project

Defining healthy ageing factors; Setting up content-related bases of the international excellence centre (SLO-ITA) in the field of health of elderly citizens; Raising awareness on the significance of healthy ageing, social inclusion and mobility of less privileged populations (the elderly); Reducing the costs of health care; Connecting the existing health care, social and private entities and improving their mutual coordination.

Detailed description: Physical activity, dietary habits, social and private entities strongly affect the quality of health and quality of life of the elderly. The main object of this study will be to evaluate physical and cognitive performance in combination with physical activity and dietary habits of the elderly. The investigators are interested in longitudinal monitoring of the elderly that participated in measurements in 2013 and measurements after a decade. The results of this study will give important epidemiological information about physical and cognitive status, health status in combination with physical activity which occurs in a longer period of time.

Eligibility criteria: Inclusion Criteria:

* singed written consent
* age above 60
* healthy

Exclusion Criteria:

* severe musculoskeletal injuries
* inability to follow instructions when performing the test

Primary outcomes:
measure: Grip strength
timeFrame: change in grip strength between two observational time points (pre-post 8-10years)
Secondary outcomes:
measure: Gait speed
timeFrame: change in gait speed between two observational time points (pre-post 8-10years)
Other outcomes:
Locations:
city: Koper
country: Slovenia
facility: Science and research centre Koper
Study officials:
affiliation: Science and Research Centre Koper
name: Rado Pišot, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03654131: Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver
Official title: Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver - a Randomized Phase II Trail
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Colorectal Carcinoma
Liver Metastases
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 100
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: This study is a randomized phase II trial between microwave ablation (MWA) and stereotactic body radiotherapy (SBRT) - two standard treatment modalities for colorectal patients with metastatic disease in the liver. Primary endpoint is freedom form local lesion progression.

Detailed description: Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.

Eligibility criteria: Inclusion Criteria:

1. Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of

   1. non-resectability
   2. small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
   3. previous extensive liver surgery
   4. comorbidity
2. The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
3. Tumor sizes ≤4.0 cm
4. Age \> 18 years
5. Signed informed consent

Exclusion Criteria:

1. Previous radiotherapy to the liver
2. Liver volume \< 700 ml
3. Another active cancer disease within the past 36 months
4. Not able to understand written or oral protocol information

Primary outcomes:
measure: Freedom from local lesion progression (analyzed on patient-level)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: Freedom from local lesion progression (analyzed on lesion-level)
timeFrame: 3 years
measure: ≥ grade 3 toxicity potentially associated with the treatment
timeFrame: 3 years
measure: Toxicity profile as descriptive statistics
timeFrame: 3 years
measure: Quality of life as descriptive statistics: EORTC QLQ-C30
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Righospitalet
Study officials:
References:
Clinical trial NCT04106531: Validation of a Quality of Life Metric "Prolac-10"
Official title: Validation of a Novel Patient-Reported Quality of Life Metric "Prolac-10" for Patients Undergoing Medical Therapy for Prolactinoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prolactinoma
Prolactin-Producing Pituitary Tumor
Pituitary Tumor
Prolactinoma Macroadenoma
Prolactinoma Microadenoma
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be 18 years or older, diagnosed with a prolactinoma via appropriate laboratory testing and imaging, and will be naive to medical treatment for prolactinoma.

Brief summary: This is a short-term validation study of a quality of life metric "Prolac-10" for patients diagnosed with a prolactinoma, undergoing new medical therapy.

Detailed description: This is a single-site validation study of a novel quality of life study for patients undergoing medical therapy for prolactinoma. Patients will be consented before starting their medical regimen and complete the "Prolac-10" questionnaire for baseline and will continued to be followed for 13-weeks into their medical care. The primary goal of this study is to validate the novel quality of life questionnaire in terms of sensitivity, repeatability, and consistency. Secondarily, we aim to validate the test-retest characteristics to further validate sensitivity, repeatability, and consistency.

The Prolac-10 metric is Copyright © 2019. The Ohio State University. Modification/derivative rights reserved, all other rights available.

Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging.
* 18 years of age or older
* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent

Exclusion Criteria:

* Patient is a prisoner
* Patient is not English speaking
* Patient has been previously treated for prolactinoma
* Patient is pregnant at time of diagnosis and treatment

Primary outcomes:
measure: Validate the "Prolac-10" quality of life metric
timeFrame: 13-weeks post medical therapy start date
Secondary outcomes:
measure: Validate the test-retest characteristics of the Prolac-10
timeFrame: 13-weeks post medical therapy start date
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Douglas Hardesty, MD
role: PRINCIPAL_INVESTIGATOR
References: