cyrilzakka/clinical-trials huggingface dataset:
Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED

A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

At Screening

* Males 18-64 years of age
* Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator's usual clinical practice
* Surgery scheduled within about 1 month of screening (Visit 1)
* Expressed an interest in resuming sexual activity as soon as possible after prostatectomy
* Heterosexual relationship
* No pre-operative erectile dysfunction:
* International Index of Erectile Function (IIEF) Erectile Function Domain Score score EF domain =26 at screening without any therapy/devices for improvement of erections
* No perforation of the prostate capsule by tumor

At Randomization:

Before being randomized subjects must still be meeting all Screening Inclusion Criteria, as well as the following criteria:

* bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report
* BNSRRP occurred within approximately 1 month post screening (Visit 1)
* No perforation of the prostate capsule by tumor:

No positive tumor margins confirmed after surgery: =T2 stage on pathology report from the surgery

Exclusion Criteria:

* Subjects who are taking nitrates or nitric oxide donors
* Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin
* Known hypersensitivity to Vardenafil
* Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
* History of retinitis pigmentosa
* Unstable angina pectoris
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Severe chronic or acute liver disease
* Symptomatic postural hypotension in the past 6 months
* NYHA Class III or IV heart failure
* Life expectancy \<3 years
* Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h)
* Anti-androgens use
* Residual prostate cancer, or requirement for radiotherapy or ADT after surgery
P200TxE Diseased Eye Image Collection

The primary objective is to collect images on the P200TxE device in diseased eyes.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 22 years of age or older who have full legal capacity to subject on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site;
3. Subjects who agree to participate;
4. Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve.

For glaucoma subjects:

a. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable images.
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin

The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 and \< 65 years
* Good general condition (according to history and clinical examination)
* Written informed consent
* No pregnancy
* No breast feeding
* Efficacious contraception (e.g. oral, double-barrier) during the study and 4 weeks after termination of the study
* No participation in other clinical trials 4 weeks before, during participation, and 4 weeks after participation in this study
* Planned travel period between 6 and 28 days
* Planned travel to South- and Southeast Asia
* Planned time to arrival in South- or Southeast Asia ≤ 24 hours

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Age \< 18 and ≥ 65 years
* No written informed consent
* Chronic gastrointestinal disease and/ or immune insufficiency
* Low general condition (according to history and clinical examination)
* Regular medication with gastrointestinal side-effects and/or immunosuppressive medication
* Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study
* No efficacious contraception
* Planned travel period \< 6 and \> 28 days
* Planned travel outside South- and Southeast Asia
* Vaccination against cholera using DUKORAL within 12 months prior to inclusion
* Planned time to arrival in South- or Southeast Asia \> 24 hours
* Known hypersensitivity against rifaximin or rifamycin-derivatives in general
* Known lactose intolerance
Korean Post-marketing Surveillance for Xeljanz

The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.


Eligibility Criteria:
Inclusion Criteria:

To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)

Exclusion Criteria:

1. Patients with a history of hypersensitivity to any ingredients of the product.
2. Patients with serious infection (eg, sepsis) or active infection including localized infection.
3. Patients with active tuberculosis.
4. Patients with severe hepatic function disorder.
5. Patients with an absolute neutrophil count (ANC) \<500 cells/mm3.
6. Patients with a lymphocyte count \<500 cells/mm3.
7. Patients with a hemoglobin concentration \<8 g/dL.
8. Pregnant or possibly pregnant women.
9. Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

According to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) \<500 cells/mm3 Patients with a hemoglobin level \<8 g/dL
Bioavailability of Potassium From Potatoes and Potassium Gluconate

This study is designed to compare the effect of sources of potassium on uptake and the effect of potassium on blood pressure.

The study will compare uptake of potassium from three different doses and sources; supplements (720, 1440 and 2160 mg) potatoes (720, 1440 and 2160 mg) or French fries (2160 mg).

During 9 phases, participants will consume a controlled diet with the supplements, potato or french fries (every other week for 5 days). On the 4th day, blood and urine samples will be taken to monitor potassium uptake and excretion. Measures of blood pressure will be analyzed at defined time points throughout the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Able to adhere to the visit schedule, protocol requirements and available to complete the study
* Normotensive men and women
* Aged 20-60 years
* BMI of 15-35

Exclusion Criteria:

* Medication to treat hypertension or hypotension
* Medication known to affect electrolyte metabolism or contain high levels of potassium or sodium
* smoke cigarettes or use illegal drugs
* Hypertension or hypotension
* Diseases known to affect potassium metabolism
* Pregnant
* Allergic to nuts
Effect of Language and Confusion on Pain During Peripheral Intravenous Catheterization (KTHYPE)

The purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).

Clinicians used to warn patients of pain or discomfort before potentially painful procedures like peripherical intravenous catheterization (PIVC). However, suggestions for negative perceptual experiences causes more pain and anxiety. During This does not improve at all the real-life experience of the act. On the contrary, the use of gentler words improves pain perception and subjective patient experience. Furthermore, hypnosis has been demonstrated as efficient and the pain perception seems to be modulate by hypnotic suggestions.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years
* peripheral intravenous catheterization of 20 G on the dorsal face of the hand before a planned surgery
* written and informed patient consent

Non inclusion Criteria:

* patient unable to communicate in french
* difficult vein access characteristics
* premedication
* pregnant, breast-feeding woman
* patient subject of legal protection

Exclusion criteria :

* failed of the first attempt of peripheral intravenous catheterization
Phielix et al.: Hepatic Fat Content and Adipokines

Thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. Here the investigators examined whether pioglitazone (PIO) improves insulin sensitivity independently of glycemic control and whether adipokines or non-esterfied fatty acids (NEFA) serve as mediators.


Eligibility Criteria:
Inclusion Criteria:

* well controlled patients with type 2 diabetes (Hb1Ac \< 8%)
* no insulin therapy
* no co-morbidities
* stable medication use for the last 6 months
* stable body weight the last 6 months
* no diet in the last 6 months

Exclusion Criteria:

* Hb1Ac \> 8%
* insulin therapy
* diabetes-related co-morbidities, like cardiovascular disease, neuropathology
* unstable medication use
* unstable body weight in the last 6 months (\> 5 kg)
* following a diet in the last 6 months
Selegiline in Treatment of Cocaine Dependence - 2

The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine dependence.


Eligibility Criteria:
Please contact site for information.
Understanding of Genetic Risk Information for Type 2 Diabetes

This research study is being conducted to learn about how health and genetic literacy (i.e., how well a person understands health and genetic information) affects a person's ability to understand genetic risk information for Type 2 diabetes and whether that person chooses to change their lifestyle and health behaviors to reduce their risk. The investigators also want to learn if the manner in which the genetic risk information is communicated affects the level of understanding and potential behavior changes. Participants will be tested for genetic risk of developing Type 2 diabetes and will received results either via a web-based computer program, or in-person from a genetic counselor.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 or older
* Speak fluent English
* Have an email address and access to the internet
* Not diagnosed with type 2 diabetes

Exclusion Criteria:

-
PeriOperative ISchemic Evaluation-3 Trial

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

The POISE-3 study is a 10,000 patient, multicentre, international, non-inferiority randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy. The primary objective of the study is to determine; if TXA is superior to placebo for the occurrence of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic event; and to determine the impact of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of vascular death and major vascular events in patients who are followed for 30 days after noncardiac surgery.

Eligibility Criteria:
Inclusion criteria:

1. Undergoing noncardiac surgery;
2. ≥ 45 years of age;
3. Expected to require at least an overnight hospital admission after surgery;
4. Provide written informed consent to participate in the POISE-3 Trial, AND
5. Fulfill ≥1 of the following 6 criteria (A-F):

A. NT-proBNP ≥200 ng/L B. History of coronary artery disease C. History of peripheral arterial disease D. History of stroke E. Undergoing major vascular surgery; OR F. Any 3 of 9 risk criteria i. Undergoing major surgery; ii. History of congestive heart failure; iii. History of a transient ischemic attack; iv. Diabetes and currently taking an oral hypoglycemic agent or insulin; v. Age \>70 years; vi. History of hypertension; vii. Serum creatinine \> 175 µmol/L (\> 2.0 mg/dl); viii. History of smoking within 2 years of surgery; ix. Undergoing emergent/urgent surgery.

Exclusion criteria:

1. Patients undergoing cardiac surgery
2. Patients undergoing cranial neurosurgery
3. Planned use of systemic TXA during surgery
4. Low-risk surgical procedure (based on individual physician's judgment)
5. Hypersensitivity or known allergy to TXA
6. Creatinine clearance \<30 mL/min (Cockcroft-Gault equation) or on chronic dialysis
7. History of seizure disorder
8. Patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (\<3 month)
9. Patients with fibrinolytic conditions following consumption coagulopathy
10. Patients with subarachnoid hemorrhage within the past 30 days
11. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
12. Previously enrolled in POISE-3 Trial
Stress-induced Scratching in Healthy and AD

The purpose of this study is to examine scratching behavior and identify brain areas responsible for stress-induced spontaneous scratching in patients with atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects and AD patients between 18 and 59 years of age.
2. Healthy subjects: In general, good health without history of neurological and psychiatric diseases.
3. AD patients: An average itch rating of 3 out of 10 or greater in the past two weeks using a Numerical Rating Scale (NRS).
4. All patients will be required to cease use of oral antihistamines from the night before each study visit until the end of the experiment. The purpose is to avoid that participants fall asleep during MRI measurement due to side effect oral antihistamine (i.e., sedation).
5. Women of child bearing potential will be administered a pregnancy test to verify that they are not pregnant.
6. MRI Compatibility, criteria include having no major contraindication for MRI (pacemaker, vascular stents, metallic ear tubes, and absence of metal implants or braces) as assessed by MRI technologist using site approved screening form.
7. Participants have to be able to speak and read English fluently.
8. Participants must have signed a written informed consent before being enrolled in the study

Exclusion Criteria:

1. Individuals under 18 or over 59 years of age.
2. Inability to complete the required measures.
3. Suffering from any disease state or physical condition, which would increase their health risk by study participation.
4. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
5. Recent initiation (within last 3 months) of centrally acting agents such as antidepressants, neuroleptics or neuropathic medications.
6. Patients who use centrally acting agents only when they need. The purpose is to avoid a risk of acute effect of these agents on brain activity and perceived stress due to the stress task.
7. Current treatment with opioid analgesics.
8. Uncontrolled thyroid disease.
9. Use of illicit drugs or history of opiate addiction.
10. Diagnosis of a major psychiatric disorder such as schizophrenia, major depression or bipolar disorder that is active right now.
11. Any known diseases or disorders that may affect conducting the experiments (e.g., intracranial pathology, claustrophobia, severe respiratory or cardiovascular problems, active fibromyalgia) or diseases that have potential risks of infections (e.g., HIV, Hepatitis C, etc).
12. Inability to speak and read English.
13. Being pregnant.
14. Incarcerated.
Effect of Proprioceptive Exercises on Pain and Function in Non-specific Chronic Neck Pain

This study was conducted to see the effect of proprioceptive exercises on pain and function in Non-specific chronic neck pain.

Twenty participants with chronic Non-specific neck pain were enrolled in this study. During the final week of treatment, 14 patients were assessed at the end of the sixth treatment week. Participants were randomized into two groups treatment group and control group. Both groups were treated with conventional treatment which were strengthening exercises. Treatment group was also treated by proprioception exercises. For measurement of pain and disability NPRS and NDI scales were used. Exercise regime distributed in six weeks period one session per week exercise, 10-12 repetitions with 1-minute rest interval, lasted 45 minutes in both groups. pre-treatment and post-treatment measurements were taken.


Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific neck pain\>3 months
* Postural neck pain

Exclusion Criteria:

* Vascular neoplasia
* Fibromyalgia
* Rheumatoid arthritis
* Radiculopathy
* Neuropathy
* Tumor
* Cervical fractures
* Vestibular problems
* Congenital disorder of cervical spine
Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO

Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with glioma


Eligibility Criteria:
Inclusion Criteria:

* Indication for glioma surgery
* Karnofsky \> 70

Exclusion Criteria:

-
Arterial Pulse Waveform Contour Analysis for Intraoperative Goal Directed Therapy in Major Spine Surgery

This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with a shorter hospital stay after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for major spine surgery at LLUMC University Hospital will be eligible for participation in this study

Exclusion Criteria:

* age under 18yr,
* coagulopathy, significant renal or hepatic dysfunction (creatinine or liver enzymes \> 50% above normal values),
* congestive heart failure,
* cardiac arrhythmias producing irregular rhythms, and patient refusal.
The Effects of a Results Management System on Physician Awareness of Post-Discharge Test Results

This project aims to define the problem of results that return after patient discharge and to study the implementation of an Electronic Medical Record (EMR)-based system for tracking these results.

The transfer of care at hospital discharge is complex and requires the transmission of large amounts of data between inpatient physicians (hospitalists) and outpatient physicians (PCPs), including information about pending tests. Frequently, laboratory and radiology tests are not finalized until after a patient is discharged, and when the responsibility for these pending results is not clearly defined, they can be missed. Our project aims to define the problem of these post-discharge results and to study the implementation of an EMR-based system (Hospitalist Results Manager, HRM) for tracking these results on the hospitalist services at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH). The project consists of two phases: a cross-sectional study before intervention to define the epidemiology of post-discharge results, and a randomized trial of HRM to determine its effect on physician awareness of these results.

Eligibility Criteria:
Inclusion Criteria:

* Admitted under enrolled study Attendings at the two study locations
* Patient had test result finalized after discharge and prior to subsequent admission

Exclusion Criteria:

* Test result noted in discharge summary
* Test result not clinically actionable
Does a Home-based Exercise Programme Affect Physical Capacity and Quality of Life in Patients With Pulmonary Embolism?

In a randomised design the study aims to investigate whether an intervention of 8 weeks home-based exercise in addition to usual care can positively influence the physical capacity, quality of life, sick leave and use of psychoactive drugs in patients medically treated for pulmonary embolism.

Background: The existing knowledge regarding pulmonary embolism is primarily focused on the diagnostic methods and medical treatment of the condition, and furthermore on the short term prognosis in terms of mortality and complications. Very few studies investigate how every day life is affected in patients struck by a pulmonary embolism, although many patients display worries and concerns about their physical, emotional and social well-being after discharge. For the time being, no rehabilitation options are available for these patients in Denmark.

Methods and materials: 140 patients medically treated for pulmonary embolism will be recruited from 6 different hospitals. After inclusion the patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, receiving an 8-week home-based exercise programme in addition to usual care. At the time of inclusion, after 2 months and after 6 months, the patients' physical capacity is measured using the Incremental Shuttle Walk test.

Furthermore the patients' complete a questionnaire on quality of life (EQ-5D and Pulmonary Embolism Quality of Life Questionnaire), self-reported sick leave and use of psychoactive drugs. All follow-up measurements and visits take place at the hospital from which the patient was discharged.

Expected outcome and perspective: The investigators expect that the home-based exercise programme will improve the overall treatment outcome for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation for this group of patients, and may thereby form the basis of future recommendations in this field.

Eligibility Criteria:
Inclusion Criteria:

* Objectively verified acute pulmonary embolism
* Treatment with anticoagulant drugs
* 18-70 years of age
* Competency in the Danish language

Exclusion Criteria:

* Pulmonary embolism as a secondary finding in relation to scan performed due to another disease.
* Severe co-morbidity (malignant, inflammatory or psychiatric)
* Unable to perform the Incremental Shuttle Walk test for other reasons (e.g. amputation or intermittent claudication).
Left Ventricular Free-wall Ruptrue After Acute Myocardial Infarction (LVFR-AMI)

The Left Ventricular Free-wall Ruptrue (LVFR) is a serious complication caused high mortality.

The actual mortality of LVFR is close to 100%. Despite the mortality rate for LVFR has been decreasing with the development of reperfusion therapy, the serious complication remains a difficult challenge. The coronary anatomy distribution associated with LVFR has an interesting phenomenon. From the perspective of different coronary distribution, we can better known the risk factors related to LVFR.

Eligibility Criteria:
Inclusion Criteria:

* Patients be admitted for acute myocardial infarction (STEMI or NSTEMI)

Exclusion Criteria:

* Non-cardiovascular comorbidity for AMI