louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01432795: Practicability of Gliding Aids for Medical Compression Stockings
Official title: Gliding Aids for Medical Compression Stockings - Practicability in Elderly Patients With Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Venous Insufficiency
Post-thrombotic Syndrome
Keywords: chronic venous insufficiency
post-thrombotic syndrome
medical compression therapy
compression stocking
gliding aid
stocking butler
adherence to treatment
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: JH Rahn Foundation, Zurich
First posted: 2011-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. Non-adherence to the prescribed compression treatment concerns approximately 40% of patients. Elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. Gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings.

The present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. The study is conducted with forty consenting subjects with advanced chronic venous insufficiency.

Detailed description: Subjects: 40 consenting patients \>65y old, with CEAP C4-6 chronic venous insufficiency

Stockings:

One class 3 (36 - 46 mmHg interface pressure) with closed tip One class 3 with open tip Two superimposed class 1 (18 - 21 mmHg)

Gliding aids and stocking "butlers" Three types of gliding aids for closed tip stockings Three types of gliding aids for open tip stockings Two types of stocking "butlers", one optional with mounted handles

Eligibility criteria: Inclusion Criteria:

\> 65 years old Chronic venous insufficiency CEAP C4-6

Exclusion Criteria:

Dementia Blindness Paraplegia

Primary outcomes:
measure: Number of successfully dressed medical stockings per subject
timeFrame: Per subject: 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
Secondary outcomes:
measure: Patient satisfaction by gliding aid or stocking butler (score)
timeFrame: Per subject 120 minutes (one "run"); to complete the whole study (40 subjects): 14 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital of Zurich, Switzerland
Study officials:
affiliation: Department of Dermatology, University Hospital of Zurich, Switzerland
name: Jürg Hafner, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sippel K, Seifert B, Hafner J. Donning devices (foot slips and frames) enable elderly people with severe chronic venous insufficiency to put on compression stockings. Eur J Vasc Endovasc Surg. 2015 Feb;49(2):221-9. doi: 10.1016/j.ejvs.2014.11.005. Epub 2015 Jan 8.
Clinical trial NCT07000695: Managed Access Programs for TQJ230, Pelacarsen
Official title: Managed Access Programs for TQJ230, Pelacarsen
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Atherosclerotic Cardiovascular Disease, ASCVD
Keywords: MAP
Manage Access Program
TQJ230
Pelacarsen
Atherosclerotic Cardiovascular Disease
ASCVD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-06-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this registration is to list Managed Access Programs (MAPs) related to TQJ230, pelacarsen

Detailed description: CTQJ230A12013M - Available - Managed Access Program (MAP) Cohort Treatment Plan (CTQJ230A12013M) to provide access to pelacarsen (TQJ230) for (Atherosclerotic Cardiovascular Disease, ASCVD)

Eligibility criteria: Inclusion Criteria:

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005495: Primary Prevention of CHD Risk Factors Occurring in US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Heart Disease Risk Reduction
Coronary Disease
Hypertension
Hypercholesterolemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate the effectiveness of primary prevention of coronary heart disease risk factors by examining data from the National Health Examination Survey (NHES) and the National Health and Nutrition Examination Surveys (NHANES) to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts.

Detailed description: BACKGROUND:

The coronary heart disease risk factor profile of Americans has been improving, with decreasing blood pressure and cholesterol levels. However, it is not apparent whether this improvement is due to primary prevention of risk factors through lifestyle choices or to secondary prevention (management) of established risk factors. Since secondary prevention only targets people with high blood pressure or cholesterol levels, the effect should be demonstrated by temporal declines in the upper percentiles (75th, 90th) of the blood pressure and cholesterol distributions. Primary prevention should shift the entire risk factor distribution, including the percentiles in the middle (50th) and lower (10th, 25th) portions of the distribution. Thus, the effectiveness of primary prevention programs can be evaluated by examining temporal changes in the middle and lower percentiles, and the effectiveness of secondary prevention can be evaluated by examining temporal changes in the higher percentiles.

DESIGN NARRATIVE:

Data from the National Health Examination Survey and the National Health and Nutrition Examination Surveys were examined to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts. The results of these analyses provided information that may help guide further research and application of population prevention strategies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University
name: David Goff, Jr.
References:
citation: Goff DC Jr, Labarthe DR, Howard G, Russell GB. Primary prevention of high blood cholesterol concentrations in the United States. Arch Intern Med. 2002 Apr 22;162(8):913-9. doi: 10.1001/archinte.162.8.913.
citation: Goff DC, Howard G, Russell GB, Labarthe DR. Birth cohort evidence of population influences on blood pressure in the United States, 1887-1994. Ann Epidemiol. 2001 May;11(4):271-9. doi: 10.1016/s1047-2797(00)00224-6.
Clinical trial NCT06507995: The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection
Official title: The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Postoperative Pain
Chest Pain
Back Pain
Keywords: Chronic thoracic pain
chest wall pain
thoracic interlaminar epidural injections
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain.

Materials and Methods One hundred patients were randomly divided into two groups, each consisting of 50 patients. Group I received only a local anesthetic, while Group II received a combination of local anesthetic and steroids. The random assignment to either Group I or Group II was determined using a simple computer-generated sequence.

Outcomes were evaluated using the Numeric Rating Scale (NRS) and the revised Oswestry Disability Index (rODI). Patients who showed significant improvement for more than four weeks after the first two procedures were deemed successful. Those who did not were classified as failed participants. Significant improvement was defined as a reduction of more than 50% in both NRS and rODI scores, with assessments conducted at baseline and at 3, 6, and 12 months post-treatment.

The center where the study was conducted: Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Division of Algology, Ankara, Turkey


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* \> 6 months pain duration
* Failed conservative management (including medication, physical therapy, and exercise programs)
* Facet joint pain ruled out (confirmed through diagnostic blocks)

Exclusion Criteria:

* \< 18 years old
* Having a psychological illness
* Allergies to local anesthetics or steroids
* Thoracic facet joint pain
* Significant disc herniation
* Infection ( which were ruled out by pre-procedure blood tests and C-reactive protein levels)

Primary outcomes:
measure: The effect of thoracic epidural injection on upper back pain
timeFrame: 1 year
measure: The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
timeFrame: 1 year
Secondary outcomes:
measure: The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
timeFrame: 1 year
measure: The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
timeFrame: 1 year
measure: The effect of thoracic epidural steroid and local anesthetic injection on upper back pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
References:
Clinical trial NCT03034395: Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
Official title: Pilot Study of 1cm Versus 2cm Margins for the Surgical Treatment of cT2N0M0 Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Melanoma
Keywords: Melanoma
cT2N0M0
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 15
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 is a randomized non-blinded pilot study for patients with melanoma staging cT2N0M0 who are candidates for surgical resection. The primary objective is to determine the feasibility of randomizing participants with cT2N0M0 malignant melanoma to surgical treatment with 1cm versus 2cm margins. Study will try to determine overall survival for cT2N0M0 malignant melanoma after surgical treatment with 1cm versus 2cm margins.

Detailed description: After randomization, participants will undergo surgery with wide local excision with either 1cm or 2cm margins. The margin will be based upon the previous biopsy site or area of pigmentation. The skin and subcutaneous tissue (down to fascia) will be resected. Closure considerations may require removal of additional tissue for non-oncologic purposes. As per standard of care, sentinel lymph node biopsy will be performed using a dual tracer technique (technetium radiolabeled sulfur colloid and isosulfan blue) with or without lymphoscintigraphy.

Eligibility criteria: Inclusion Criteria:

* Biopsy proven T2 malignant melanoma.
* Eastern Cooperative Oncology Group (ECOG) score of 0-2.

Exclusion Criteria:

* Visible additional disease that suggests a greater than T2 malignant melanoma
* Unable to tolerate general anesthesia
* Evidence of distant metastatic disease
* Melanoma located on face or digits

Primary outcomes:
measure: Number of participants who agree to blinded randomization to a surgical margin trial for the treatment of early stage melanoma.
timeFrame: 2 years
Secondary outcomes:
measure: Recurrence (disease free survival)
timeFrame: Every 4 months post-surgery for 2 years and then every 4-6 months for an additional 3 years
measure: Quality of life following surgery
timeFrame: One month post-surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Joshua Mammen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00310895: Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
Official title: A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor Malignancies
Keywords: Refractory
Relapsed
Lead sponsor: Geron Corporation
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.

Detailed description: GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Male or female
* Measurable or evaluable solid tumor malignancy
* Relapsed, refractory, locally advanced, or metastatic disease
* Disease refractory to or not amenable to standard therapy
* Karnofsky performance status 70-100%
* Life expectancy 3 months or greater

Exclusion Criteria:

* Pregnant or lactating women
* Primary central nervous system(CNS) malignancy or active CNS metastases
* Hematologic malignancy
* Chemotherapy within 4 weeks prior to study
* Mitomycin C, nitrosoureas within 6 weeks prior to study
* High dose chemotherapy with stem cell support within 6 months prior to study
* Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study
* Systemic hormonal therapy within 4 weeks prior to study
* Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
* Radiotherapy within 4 weeks prior to study
* Significant cardiovascular disease
* Serious/active infection
* Major surgical procedures within 2 weeks

Primary outcomes:
measure: Safety, DLT, and MTD
timeFrame: Measured during the first cycle of treatment
Secondary outcomes:
measure: PK profile and disease response
timeFrame: Within the first 2 cycles of treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Detroit
country: United States
facility: Wayne State University, Karmanos Cancer Center
state: Michigan
Study officials:
References:
Clinical trial NCT01410695: Masitinib in Refractory Active Rheumatoid Arthritis
Official title: A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid Arthritis
RA
masitinib
DMARD
methotrexate
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 324
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: The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.


Eligibility criteria: Inclusion Criteria:

1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months
2. Patient with ACR functional class I-III
3. Patient who have active RA
4. Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs
5. Patient with a disease onset at \> 16 years of age

Exclusion Criteria:

1. Patient for whom the use of methotrexate is contraindicated as per its SPC
2. Patient with documented fibromyalgia
3. Patient with lactose intolerance
4. Patient presenting with cardiac disorders

Primary outcomes:
measure: ACR50
timeFrame: week 24
Secondary outcomes:
measure: ACR
timeFrame: week 12
Other outcomes:
Locations:
city: Hostivice
country: Czechia
facility: ARTMEDI UPD s.r.o
Study officials:
affiliation: Centre Hospitalier Lyon Sud, Pierre-Bénite, France
name: Jacques Tebib, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142595: Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP
Official title: Comparison of the Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing Transurethral Prostatic Resection(TURP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Quality of Patients Undergoing TURP
Keywords: dexmedetomidine
midazolam
sleep quality
delirium
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 111
Sex: MALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.

Detailed description: The investigators designed a study to determine whether dexmedetomidine versus midazolam combined with spinal anesthesia would provide same postoperative sleep quality in patients undergoing transurethral prostatic resection.The bispectral index score (BIS) was monitored during the operation and the first postoperative night

Eligibility criteria: Inclusion Criteria:

* Participants were deemed eligible if they were candidates for spinal anesthesia undergoing TURP

Exclusion Criteria:

* The exclusion criteria were body mass index exceeding 30 kg/m2, preoperative Pittsburgh Sleep Quality Index global scores higher than 6, anesthesia time longer than 3 hours, allergy to drugs used in the study and treatment with sedatives and analgesics during the postoperative BIS-Vista monitoring period.

Primary outcomes:
measure: The Change of postoperative sleep quality
timeFrame: preoperation, first postoperative night
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Department of Anesthesiology the first hospital of CMU
name: Hong Ma, M.D.,PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01341795: Genetic Variation in the Transporters and Hypoglycemic Agents
Official title: Effect of Genetic Variation in the Transporters on Glycemic Response and Pharmacokinetics of Sitagliptin and Metformin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: Newly diagnosed type 2 diabetes patients
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2011-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly Diagnosed Type 2 Diabetes Patients

Brief summary: Type 2 diabetes have become a major global health problem. Currently, metformin is used as first-line therapy in combination with lifestyle changes, and sitagliptin can be added to metformin in case of insufficient glycemic control by metformin alone, and fixed-dose combination of sitagliptin and metformin is available.

In clinical practice, inter-individual variations in response to sitagliptin and metformin treatment are commonly found, which may reflect inter-patient differences in disposition of these medications.

Sitagliptin and metformin are known as substrates of some transporters (P-gp, OAT3, OCT1 and OCT2) and some functional variations of these transporters were reported. This study is designed to clarify the effect of these transporter variants on response to sitagliptin and metformin in type 2 DM patients.


Eligibility criteria: Inclusion Criteria:

* Newly Diagnosed Type 2 Diabetes Patients
* 20-80 years old
* Taking sitagliptin and metformin for more than 3 months

Exclusion Criteria:

* Taking other oral hypoglycemic agents
* Taking medications can induce or inhibit transporters

Primary outcomes:
measure: differences of sitagliptin and metformin trough concentration according to genetic variations of transporters
timeFrame: After 3 months of sitagliptin and metformin treatment
Secondary outcomes:
measure: differences of HbA1c change according to genetic variations of transporters
timeFrame: Baseline and after 3 months of sitagliptin and metformin treatment
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeonggi
Study officials:
affiliation: Ajou University School of Medicine
name: Doo-Yeoun Cho, MD
role: PRINCIPAL_INVESTIGATOR
References: