cyrilzakka/clinical-trials huggingface dataset:
Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina


Eligibility Criteria:
Inclusion Criteria

1. Age \>18 years.
2. Stable or unstable coronary artery disease.
3. Native coronary artery lesion in vessel with diameter \<2.75 mm.
4. Clinical indication to percutaneous coronary intervention (PCI).

Exclusion criteria

1. Enrolment in another study with any investigational drug or device.
2. Acute or recent (≤48 hours) myocardial infarction.
3. Creatinine clearance \<50 ml/min.
4. Left ventricle ejection fraction \<30%.
5. Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.
6. Heavily calcified and severely tortuous lesions.
Endoscopic Ultrasound Radiofrequency Ablation, Database Repository

The purpose of having this database is to collect data related to endoscopic ultrasound RFA procedures performed by Indiana University EUS physicians for the treatment of tumors or adenopathy. This database is a repository database only, all information will be obtained in the electronic medical record. No additional clinical procedures will be performed outside current standard of care for endoscopic ultrasound. The patient will have already signed an informed consent for the endoscopic ultrasound. Subjects will be entered into the database for up to 10 years after the most recent procedure.

Radiofrequency ablation (RFA) is a well-established therapeutic option for ablation of dysplastic and neoplastic tissue by the use of local thermal coagulative necrosis. Options for administration include percutaneous or a surgical approach. Percutaneous RFA is effective and safe, but it is unfeasible in cases of lesions with interposition of organs and/or vessels. For lesions such as the pancreas, surgery-assisted RFA has been described but requires general anesthesia and is associated with a substantial risk of thermal injuries to major vessels or adjacent structures.

EUS-guided RFA is a minimally invasive approach that offers high-quality real-time imaging guidance during selective ablation of benign (1-5) or malignant (6-7) pancreatic lesions. Treatment in small case series has shown to produce local necrosis with minimal adverse events. Other sites treated include the liver and metastatic adenopathy.

This database will collect data related to endoscopic ultrasound RFA procedures performed by Indiana University EUS physicians for the treatment of tumors or adenopathy. No additional clinical procedures will be performed outside current standard of care for endoscopic ultrasound. The patient's information collected will be pre-procedure identification of the adenopathy, labs, the endoscopic ultrasound(s) and post procedure follow up and care related to the adenopathy.

Patients will be contacted by phone at post-procedure 1 \& 2 weeks and asked to report symptoms related to the procedure.

Eligibility Criteria:
Inclusion Criteria:

Subjects 14 years of age and older Referral for the treatment of a benign or malignant tumor or adenopathy

Exclusion Criteria:

* Subjects less than 14 years of age Unable to comprehend the study consent due to language or disability
Stress Urinary Incontinence in Women With Multiple Sclerosis

Objective: To report the prevalence and risk factors of stress urinary incontinence (SUI) and the prevalence of intrinsic sphincter deficiency in women with multiple sclerosis (MS). Methods: A retrospective study was conducted among Female patients with MS, followed for lower urinary tract symptoms (LUTS) during a 15-year period. Demographic data, MS history, expanded disability status scale (EDSS) score at the urodynamic visit, obstetrical past, birth weight, LUTS, and urodynamic findings were collected. SUI was defined as incontinence during cough, or any effort. A maximum urethral closure pressure less than 30 cm H2O defined intrinsic sphincter deficiency. Results: In total 363 women with a mean age of 46.7±10.8 years and a mean disease duration of 12.9±8.7 years were included. The incidence of relapsing remitting MS, a secondary progressive form, and a primary progressive form was 60.6%, 32.8%, and 6.6%, respectively. The prevalence of SUI was 31.4%. The prevalence of intrinsic sphincter deficiency was 1.4% and 0.8% of these patients had a SUI (P=0.300). In a multivariate analysis, women with a SUI had significantly higher birth weight (P=0.030), a pelvic organ prolapse (P=0.021), urgent urinary incontinence (P=0.006), a lower EDSS score (P=0.019), and a weaker containing effort (P\<0.001). Conclusions: The prevalence of SUI in women with MS was 31.4%. This symptom could affect the quality of life of women with MS.


Eligibility Criteria:
Inclusion Criteria:

* Women aged \>18 years
* Multiple sclerosis
* Urodynamic test for lower urinary tract symptoms
* Followed in Saint Philibert Hospital between December 1999 to June 2014

Exclusion Criteria:

* Non confirmation of diagnosis of Multiple sclerosis
Quality of Care in French HIV Infected Patients

The objective of the Dataids cohort is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking care in 15 HIV centers in France in order :

1. to provide and develop a surveillance system to describe clinical practice and temporal changes in the clinical course of HIV and HIV-related co-infections and co-morbidities in France.
2. to assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities

The specific objectives are as follows

* To continue surveillance of HIV infection in France to describe temporal changes
* To evaluate the efficacy of ART and factors associated with ART efficacy
* To monitor the uptake and outcome of HCV therapy

The Dataids cohort is a prospective observational cohort of 30,000+ patients followed in 15+ HIV centers scattered throughout France. The Dataids cohort is an ongoing collaboration and patients have been enrolled into the study since 2010; the data are collected from the clinics as part of routine care. Included patients should be patients who had a scheduled visit in the outpatient clinic regardless of CD4 cell count, HIV viral load or ART status. For all HIV patients enrolled and under follow up, demographic data, immunological and virological data, serological evidence for infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis, laboratory, therapeutic and clinical data are collected annually.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patients regardless of CD4 cell count and antiretroviral therapy status

Exclusion Criteria:

* Patients under 18 years of age
* Patients without written informed consent
Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia

Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR.


Eligibility Criteria:
Inclusion Criteria:

Have a medical record in the Endocrinology service at the Hospital Juarez de Mexico

* Patients with type 2 diabetes mellitus
* Age between 40 and 60 years
* Present Insomnia based on the criteria of The Diagnostic and Diagnostic Manual Statistics of Mental Disorders (DSM-V) which defines insomnia such as predominant dissatisfaction with the quantity or quality of sleep, associated with one (or more) of the following symptoms: a) Difficulty starting the dream,or b) Difficulty maintaining sleep, characterized by awakenings frequent and c) Waking up early in the morning with inability to return to sleep; with clinically significant distress or social impairment, work, educational, academic, behavioral or other important areas of operation, at least three nights a week, for a minimum of three months even with favorable sleeping conditions.
* Sign an informed consent letter and agree to participate in the study.
* Accept taking a blood sample pre and post intervention
* HbA1c level above 6.1% (120 mg/dL;7 mmol/L) or BMI less than 34.9 units

Exclusion Criteria:

* Do not agree to sign the informed consent
* Have a previous psychiatric diagnosis
* Have neurological disorders
* Be diagnosed with type 1 diabetes mellitus or BMI greater than 35 units
* Missing more than 20% of the sessions (2 sessions)
Use of an Ocular Telemetry Sensor in Tafluprost Treated Patients

This clinical trial is designed to investigate the performance of SENSIMED Triggerfish® during 24-hour continuous IOP fluctuation monitoring, defined as the number of valid recording intervals over the 24-hour period.

The investigation will recruit male and female patients older than 18 years and diagnosed with glaucoma and treated with tafluprost in both eyes. 20 subjects will be enrolled in the study. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and one 24-hour IOP fluctuation monitoring session during a 36-hour hospitalisation, are planned for each patient.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years.
* Untreated IOP of ≥22 mmHg in both eyes.
* Documented, typical glaucomatous visual field (VF) loss (nasal step, or arcuate, paracentral or Seidel's scotoma) determined by automated static threshold perimetry (Octopus 100), and glaucomatous optic nerve head cupping (neural rim notching or saucerization) in both eyes.
* Patients under tafluprost treatment since at least 4 weeks in both eyes.
* Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion Criteria:

* Patients not able to understand the nature of the research
* Patients under tutorship
* Corneal abnormalities in both eyes
* Subjects with contraindications for wearing contact lenses
* History of ocular surgery within the last 3 months
* Known hypersensitivity to tafluprost or to any of its excipients
* Full-frame metal glasses during monitoring with SENSIMED Triggerfish®
* Pregnancy and lactation
* Simultaneous participation in other clinical research
* Patients with evidence of ocular infection or inflammation
A Pilot Clinical Trial Study to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator

To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.


Eligibility Criteria:
Inclusion criteria

1. Patients aged 19 to 80 years old
2. Those who are confirmed to have lesions in only one cerebral hemisphere or one brainstem on brain computed tomography (CT) or brain magnetic resonance imaging (MRI)
3. Patients with subacute stroke between 2 weeks and less than 3 months after onset
4. Motor function evaluation The total score is 0 to 56 points based on the FMA of the upper extremity on the affected side \[1\], and patients show impairment in upper extremity motor function.
5. After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions.

Exclusion Criteria:

1. Cases accompanied by existing serious neurogenic diseases such as history of underlying stroke, brain tumor, hypoxic brain injury, epilepsy, or organic brain disease
2. Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc., that are receiving continuous drug treatment before the stroke.
3. Those with unstable conditions in the cardiovascular, digestive, respiratory, and endocrine systems, or with severe internal diseases such as signs of systemic infection, with unstable vital signs, or with poor overall health with a life expectancy of less than 1 year.
4. Those with impaired cognitive ability (MMSE less than 10 points)
5. If there are difficulties in conducting research
6. If you have difficulty communicating
7. Other patients who are deemed difficult to participate in this study by the principal investigator.
8. Patients who are participating in other therapeutic clinical studies or who have participated in other therapeutic clinical studies within the past 30 days (observational studies are not relevant)
9. Exclusion criteria for repetitive transcranial magnetic stimulation
10. Patients with medical devices implanted in the body (e.g. pacemaker)
11. When a metal object is inserted into the skull
12. If there is a wound on the skin at the attachment site
13. History of epilepsy
14. If you have cervical pain or musculoskeletal disease
15. Pregnant and lactating women
Investigating and Characterizing the Immune Response to Prostate Cancer

This study is a clinical study to investigate and characterize the immune response profile to four different prostate cancer treatments (total cryotherapy, focal cryotherapy, Cyberknife SBRT, and radical prostatectomy) in patients with localized prostate cancer.

The immune system plays an important role in cancer, and there is evidence that different types of cancer treatment can elicit different responses from the body's immune system. This study is designed to look at immune markers in the blood and urine of patients undergoing four different types of prostate cancer treatment and compare the differences.

Patients who have elected Total Cryotherapy (freezing of the entire prostate), focal cryotherapy (freezing only the side of the prostate affected by cancer), Cyberknife stereotactic body radiation therapy (SBRT) and Radical Prostatectomy (removal of the entire prostate) for the treatment of their prostate cancer will be eligible to participate in this study. The study is expected to enroll 40 patients, 10 patients per treatment group. The study includes a screening visit during which the subject will provide informed consent, and provide a blood sample and a urine sample. At 2-3 weeks following their scheduled treatment, they will again provide another blood and urine sample. At their regularly scheduled follow up at 3 months, they will again provide another blood and urine sample. These samples are collected for research purposes only, and the costs will be covered by the study grant account, without any additional cost to the patient.

The investigators have determined that this study presents no more than minimal risk to patients due to the minimal risks involved with a blood draw and urine specimen collection.

Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to freely sign informed consent to enroll in the study.
* Histologically proven Prostate Carcinoma.
* Undergoing total cryotherapy, focal cryotherapy, Cyberknife SBRT or radical prostatectomy for prostate cancer treatment.

Exclusion Criteria:

* Has previously had a radical prostatectomy for prostate cancer.
* Has previously received cryotherapy for prostate cancer.
* Previous treatment with chemotherapy within the past 6 months.
* Previous treatment with radiation within the past 18 months.
* Has evidence of metastatic disease.
* Has a current or history within the past 6 months of alcohol and/or substance abuse which would impair participation in the study.
* Has a major medical disorder (i.e. uncontrolled diabetes, significant hepatic, renal or hematological disorders, recent stroke or myocardial infarction), in the opinion of the urologist, is an illness or complication which is not consistent with the protocol requirements.
* Is not willing to undergo the necessary follow-up for the trial period.
* Has known immunologic disease, human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
Effects of Supervision During a Community-based Exercise Intervention (Urban Training) in Patients With COPD

This project plans on a community-based exercise intervention (Urban Training) combined with therapeutic education program, by using public spaces and urban walkable trails, adapted to each patient needs and capabilities in patients with chronic obstructive pulmonary disease (COPD). The main objective of the present study is to evaluate the effects comparing different levels of supervision (face-to-face vs telematic) in the short-, medium- and long-term with respect to: (primary outcome): exercise capacity, and (secondary outcomes): physical activity, quality of life, mental health and COPD exacerbations.

It is a single-blind randomized clinical trial study. Each participant will be randomly assigned to one of the following groups: (1) Urban training Intervention + therapeutic education program with face-to-face supervision, (2) Urban training Intervention + therapeutic education program with telematic supervision

Each exercise training program will be applied once per day, 3 sessions per week during 12 weeks.

The group with Urban training Intervention with face-to-face supervision will be supervised by a physiotherapist once a week. The group with Urban training Intervention with telematic supervision will be supervised by a phone call once a week. To record compliance, participants from all groups were asked to complete a diary at the end of every training session.

The therapeutic education program will consisted of 1 session/week during 4 weeks.

Participants received baseline assessments at the beginning of the intervention, post-intervention assessments at the end of the 13th week, 6 months of follow-up and 12 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* COPD diagnosed by pulmonary function tests during clinical stability, with a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ≤ 0.70
* Clinical stability, defined as at least 6 weeks without COPD exacerbation

Exclusion Criteria:

* Neuromuscular or neurological disorders and/or psychiatric or cognitive conditions that hindered they ability to cooperate
* Comorbidity that could interfere with study intervention (e.g., severe orthopaedic problems)
* Previous inclusion in a rehabilitation programme (previous 6 months)
Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele

Evaluate the effect of recent ejaculation on scrotal duplex parameters in infertile males with varicocele

Varicocele is abnormal dilatation of the pampiniform plexus veins draining the testicles.

It manifests as an abnormal retrograde flow in the internal spermatic venous system or dilation of venous branches in the external cremasteric system .

It affects approximately 15% in the general population, 35 - 40% in men with primary infertility and approximately 80% of men with secondary infertility. It could often concomitantly occur with infertility or chronic scrotal pain causing impaired spermatogenesis and is the most common correctable cause of male infertility. it may affects spermatogenesis via different mechanisms such as increased testicular heat, hormonal disorders and reflux of toxic metabolites.

Scrotal colour Doppler ultrasonography (USG) is a widely used method for evaluation of varicocele patients . It can be used along with physical examination in these patients through evaluation of vein reflux and diameter; in cases where palpation may be problematic. Furthermore, the degree of reflux and vein diameter can be used during the decision-making stage while treating varicocele .

Ejaculation is the process by which sperms move from epididymis via vas deferens to urethra and finally expelled out through the urethral meatus by the contraction of smooth muscles. A normal antegrade ejaculation consists of emission, expulsion (ejection), and orgasm .

In the evaluation of infertile patients, semen analysis is required for evaluation of number, motility and morphology of spermatozoa with scrotal colour Doppler USG. Ejaculation for the purpose of sperm analysis is known to significantly increase testicular blood supply .

Eligibility Criteria:
Inclusion Criteria:

1. Infertile male patients.
2. patients with scrotal varicocele.
3. male patients aging over 18 years old.

Exclusion Criteria:

1. Pyospermia.
2. Epididymitis.
3. Orchitis.
4. Anejaculation.
5. Recurrent varicocele.
6. Patients who previously underwent scrotal or inguinal surgery.
Low Back Motor Control in Rhythmic Gymnasts During Hip Extension

CONTEXT: Low back pain (LBP) is a common complaint in gymnasts. A deficit in the control of lumbopelvic movement has been related to low back pain. OBJECTIVE: This study aims to examine the effectiveness of an education session about low back motor control during hip extension in the lumbopelvic sagittal movement control of elite gymnasts.

DESIGN: single-group, pretest-posttest clinical trial. PARTICIPANTS: 70 Elite Rhythmic Gymnasts INTERVENTION: One standardized theoretical practical session of 15 Min that includes anatomical issues and one practical exercise in quadruped position for controlling the movement of lumbar spine during hip extension and flexion.


Eligibility Criteria:
Inclusion Criteria:

* pre-established level of practice: minimum 13 hours
* taking part in the Italian federal championship
* sign an informed consent form

Exclusion Criteria:

* not fulfill Inclusion Criteria
* had surgery in the low back pain or the hip joint
Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma

"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.

Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.

One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
* ECOG performance status of \<=2
* Measurable disease according to modified RECIST
* Life expectancy of greater than 12 weeks
* LDH \<= 2.0 x ULN
* Clinical lab values within protocol parameters.
* At least 18 years old and able and willing to provide informed consent to participate

Exclusion Criteria:

* Previous cytotoxic chemotherapy treatment for melanoma
* Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
* Presence of brain metastases
* Presence or history (\<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
* Female subjects who are pregnant or nursing