louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01828996: Shocking Therapy for Chronic Pelvic Pain Syndrome
Official title: Shocking Therapy for Pelvic Pain: Evaluation of Shock Wave Therapy to Treat Chronic Pelvic Pain in Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Chronic pelvic pain syndrome
Chronic prostatitis
Shock wave therapy
Prostate
Pelvic floor
Pain
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic prostatitis/chronic pelvic pain syndrome is an extremely common urologic diagnosis and accounts for approximately 2 million outpatient visits to urology practices in the United States alone. Up to 6% of men in Canada recently experienced at least moderate to severe prostatitis-like symptoms with two thirds having symptoms lasting more than one year. There are a myriad of therapies for prostatitis, some of which work on some of the men but none works for all the men. Recently, a number of centres have been using low energy shock waves applied on the skin to target the prostate and the muscles around the prostate. The initial reports showed a significant reduction in the pain experienced by the men with prostatitis. However, this potentially highly promising therapy has not been widely used at least in part due to a lack of properly designed studies to validate this therapy. The investigators plan a randomized control trial using shock wave therapy on men with prostatitis. The goal is to provide some solid evidence that either shock waves are or are not of clinical benefit.

The investigators hypothesize men with chronic prostatitis/ chronic pelvic pain syndrome will have a reduction in pain and improved voiding and sexual function following low power transdermal shock wave therapy to the prostate and surrounding pelvic muscles.


Eligibility criteria: Inclusion Criteria:

* Exhibit symptoms of pain typical for prostatitis/CPPS
* Have had the symptoms for at least 3 months
* Have no evidence of infection in the urine or expressed prostatic secretions (the seminal plasma may be substituted if expressed prostatic secretions are not available).
* Have failed at least one therapy for CPPS

Exclusion Criteria:

* Suspected or confirmed to have prostate cancer
* Have a coagulation disorders
* Use anticoagulants
* Have thrombosis
* Have used cortisone therapy up to 6 weeks before first treatment
* Are actively trying to conceive

Primary outcomes:
measure: Changes in pain
timeFrame: 32 weeks after entering into trial
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Keith Jarvi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01141296: Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
Official title: Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Primary Biliary Cirrhosis
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2010-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 21 and ≤ 75 years old
2. Established diagnosis of PBC and positive AMA
3. Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
4. Incomplete response to UDCA defined as serum ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA
5. Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period
6. Signed informed consent after careful review of information and study details

Exclusion Criteria:

1. Hypersensitivity to fenofibrate
2. Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
3. Prisoners and institutionalized subjects, pregnant or nursing women
4. Anticipated need for liver transplantation within one year (estimated 1-year survival \<80% as predicted by the Mayo risk score).
5. Recipients of liver transplantation
6. Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
7. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
8. Acute or chronic renal failure, defined as GFR \< 60 ml/min
9. Known history of cholecystitis with intact gallbladder
10. History of, or known high risk for, venous thromboembolism
11. Current use of warfarin or statins

Primary outcomes:
measure: Serum alkaline phosphatase level
timeFrame: one year
Secondary outcomes:
measure: Symptoms - quality of life
timeFrame: one year
measure: symptoms - pruritus
timeFrame: one year
measure: symptom -fatigue
timeFrame: one year
measure: interleukin 1
timeFrame: one year
measure: interleukin 6
timeFrame: one year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: University of Miami
name: Cynthia Levy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01085396: Use of Fiber-optic Probe for Non-invasive Diagnosis of Melanoma and Assessment of Impact of Ultraviolet (UV) Exposure on Skin
Official title: Optical Spectroscopy for Non-invasive Diagnosis of Melanoma and Assessment of Impact of UV Exposure on Skin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Keywords: Fiber Optic
Melanoma
UV Exposure
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. normal volunteers
2. patients without personal and family history of melanoma
3. patients with personal or family history of melanoma who are followed in the UPCI Melanoma Program with either atypical nevi or without atypical nevi.

Brief summary: This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique used routinely as a non-invasive device during subjects' skin examination to aid dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of the skin. Alternatively, this technique would, in the future, also be used to screen patients at risk for melanoma.


Eligibility criteria: Inclusion Criteria:

* Male and female above 18 years of age;
* Subjects who are planned to undergo skin examinations with and without atypical nevi, with and without personal or family history of melanoma and potentially with pigmented lesions to be removed for medical care or cosmetic purposes.

Exclusion Criteria:

* Individuals whose pathology cannot be obtained or retrieved.
* Inability to provide informed consent.

Primary outcomes:
measure: Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia
timeFrame: 3 years
Secondary outcomes:
measure: To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi;
timeFrame: 3 years
measure: To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure
timeFrame: 3 years
measure: To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions
timeFrame: 3 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Dept. of Dermatology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPCI - Hillman Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Place - Dermatology Unit
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yang Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03520296: Descriptive Study on the Evaluation of Well-being in Relation to Diet and Nutrition and Comparison Between Three Care Units in the Dijon University Hospital Centre
Official title: Descriptive Study on the Evaluation of Well-being in Relation to Diet and Nutrition and Comparison Between Three Care Units in the Dijon University Hospital Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalization in Cardiology, Orthopaedic Surgery or Endocrinology Departments
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients hospitalized in cardiology, orthopaedic surgery or endocrinology departments

Brief summary: The aim of this study is to qualify patient well-being in relation to diet. The notion of dietary well-being is believed to be subjective and we wish to base it on tangible parameters (presentation of meals, variety of menus, social interaction, environment, convenience, pleasure...) in order to establish a score of dietary well-being that we will then correlate to the patient's nutritional status. This tool can then be used more widely as an assessment tool within health institutions.


Eligibility criteria: Inclusion Criteria:

* person who has given oral consent
* adult
* persons admitted to cardiology, orthopaedic surgery and endocrinology units
* absence of cognitive problems
* oral food intake

Exclusion Criteria:

* no affiliation to a national health insurance scheme
* current pregnancy
* blended diet

Primary outcomes:
measure: Questionnaire evaluating well-being in relation to diet and nutrition
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT03921216: Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.
Official title: Cholesterol Metabolism in Plasma and Interstitial Fluid Among Subjects Undergoing Hemodialysis.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Diabetes Mellitus, Type 2
Diabetic Nephropathies
Chronic Kidney Diseases
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.

Brief summary: Because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of developing cardiovascular disease in patients with chronic diseases. The investigators hypothesize that the apoB-containing particles in T2D patients are more susceptible to be retained or consumed in the intercellular compartment, which in turn could be one explanation for the elevated risk of atherosclerosis. The investigators hypothesise that with the progression of chronic kidney disease this process is further increased. Patients undergoing dialysis are known to have a very high risk of cardiovascular disease. The investigators now want to study the cholesterol metabolism in interstitial fluid in subjects undergoing hemodialysis because of diabetic nephropathy and in subjects undergoing hemodialysis because of chronic kidney disease of other causes.


Eligibility criteria: Inclusion Criteria:

Diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis.

Exclusion Criteria:

* Active infection that increases the risk of secondary infection in the skin where the vesicles containing interstitial fluid have been emptied of interstitial fluid with a fine needle and the bladder roof is intact.
* Treatment with Warfarin due to increased risk of Calciphylaxis (calcific uremic arteriolopathy, CUA)

Primary outcomes:
measure: Interstitial fluid-to-serum ratio for LDL cholesterol
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dialysis Unit, M87-89, Karolinska University Hospital, Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Mats Rudling
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03596216: Neuromodulation in Professional Dancers
Official title: One-Shot Percutaneous Electrical Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Performance Flexor Hallucis Longus Muscle in Professional Dancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Sports Physical Therapy
Sport Performance
Dance
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tendinopathy of the flexor hallucis longus (FHL), colloquially referred to as "dancer's tendinitis," is a common condition in dancers and attributed to high demand on this muscle in positions of extreme ankle plantarflexion and metatarsophalangeal (MTP) flexion and extension. Tradicional conservative treatment includes rest from pain-inducing activities including pointe work and jumping, physical therapy a focusing on movilization of the joints of the first ray and subtalar joint, and antiinflamatory medications. Unfortunately, dancer frecuently do not follow recommendations to rest due to the competitive nature of the field. Those who do not respond to conservative treatment undergo more serious interventions including steroid injections or surgery, each with additional risks and recovery time. To develop experimental protocols aimed at prevention and nonsurgical interventions are needed. Therefore, the aim of this study was To investigate the effects of one shot of low-frequency percutaneous electrical nerve stimulation (PENS) vs. one shot of transcutaneous electrical nerve stimulation (TENS) in performance of the Flexor Hallucis Longus muscle in young dancers.


Eligibility criteria: Inclusion Criteria:

* Female dancers
* Training at least twenty-five hours per week
* Pointe training at least five hours per week.

Exclusion Criteria:

* They had sustained an injury to their stance limb in the past year preventing dancing for at least 1 day
* Personal Psychological Apprehension Scale (PPAS) score \>37.5
* Commonly accepted contraindications to invasive phsyiotherapist technique
* Any contraindications to needling per se.
* Commonly accepted contraindications to electrotherapy
* Epilepsy.

Primary outcomes:
measure: Change in balance
timeFrame: 1 day
measure: Change in muscular endurence,
timeFrame: 1 day
measure: Change in range of motion of first MTF joint
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Blanca de La Cruz Torres
Study officials:
affiliation: University of Seville
name: Blanca De la Cruz Torres, Dr
role: STUDY_CHAIR
References:
citation: de-la-Cruz-Torres B, Barrera-Garcia-Martin I, Romero-Morales C. Comparative Effects of One-Shot Electrical Stimulation on Performance of the Flexor Hallucis Longus Muscle in Professional Dancers: Percutaneous Versus Transcutaneous? Neuromodulation. 2020 Aug;23(6):865-870. doi: 10.1111/ner.13040. Epub 2019 Aug 25.
Clinical trial NCT04207216: Use of Alternative Therapy in Psoriasis Vulgaris Patients
Official title: Use of Alternative Therapy in Psoriasis Vulgaris Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 1618
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: psoriasis vulgaris patients

Brief summary: Psoriasis Vulgaris is a chronic, recurrent, inflammatory and hyperproliferative skin disease. Joint involvement is common along with skin involvement. However, metabolic diseases, such as cardiovascular diseases can be accompanied by many systemic diseases, chronic and repetitive due to the quality of life and psychological status of patients can affect. Today, although the treatment is repetitive, chronic and requires follow-up due to the disease patients can turn to alternative and complementary medicine techniques. In recent years, studies on alternative medicine and complementary therapies have been noted in the medical literature. These studies also include Case Reports related to psoriasis vulgaris. However, in our country, there is no study that tells us whether patients with psoriasis vulgaris apply these treatments or not and what the practitioners think about the success of the treatment. The aim of the study will be to clarify issues such as whether patients with Psoriasis Vulgaris apply alternative medicine and complementary therapies for their disease.


Eligibility criteria: Inclusion Criteria:

* psoriasis vulgaris patients

Exclusion Criteria:

* the patients that don't want to answer the questions

Primary outcomes:
measure: Alternative medicine and complementary therapies that psoriasis vulgaris patients apply without informing the doctor, how they learn these techniques, what make them use these techniques for their illness
timeFrame: July 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Melek Aslan Kayıran
Study officials:
References:
Clinical trial NCT04143516: Tissue Analysis After Tumor Ablation for Liver Metastases Leading to Immediate Retreatment
Official title: Clinical Trial Optimizing Tumor Ablation for Liver Metastases: Rapid Tissue Analysis Allowing for Immediate Retreatment; Metabolic Imaging Biomarker Validation; and Predictive Genetic Signatures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Liver Metastases
Keywords: Optimizing Tumor Ablation
Rapid Tissue Analysis
Metabolic Imaging Biomarker Validation
Predictive Genetic Signatures
19-332
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single institution prospective study.
Primary purpose: DIAGNOSTIC

Brief summary: This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of liver metastases from various primary tumors
* Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)
* Lesions of ≤3 cm in maximum diameter
* At least one FDG-avid lesion to be treated\*\*\*
* INR \< 1.5\*
* Platelet count ≥ 50,000

Exclusion Criteria:

* Age \< 18
* Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection
* INR \> 1.5 that cannot be corrected with fresh frozen plasma \*\*
* Platelet count of \<50,000 that cannot be corrected with transfusion
* More than 3 tumors in the liver
* More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)
* Presence of any peritoneal Carcinomatosis

  * For patients on Coumadin, general clinical guidelines for IR ablation will be followed.

    * For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed

Primary outcomes:
measure: Tumor response
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Constantinos Sofocleous, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: