cyrilzakka/clinical-trials huggingface dataset:
The Use of Bioelectrical Stimulation in the Treatment of Post-prostatectomy Erectile Dysfunction

Erectile dysfunction (ED) affects up to 20% of men and is a growing problem with advancing age. There are many causes that contribute to ED, including the concomitant use of prescription drugs for health problems, including hypertension, or diseases such as diabetes. causes an up-regulation or increased local tissue expression of these proteins. This study follows the demonstration of the effectiveness of using BES in the treatment of ED. The aim of this study will be to examine the potentially additive effect of adding a third arm to the previous protocol to include the addition of 4 new target proteins to VEGF, including endothelial nitric oxide (eNOS), stromal-derived factor 1 (SDF-1), insulin-like growth factor (IGF) and follistatin.

For this randomized clinical trial, 10 patients from a private Urology clinic will be selected. Each patient will serve as their own two-month documentation control using the validated IIEF-5 and EHS questionnaires. The intervention period will last 8 weeks. And 6 months of follow-up after the end of treatment to see how long the benefit lasts without continued treatment. The assessment will be carried out before the intervention period (pre-intervention) and after the intervention period (post-intervention and follow-up) for all participants. All patients who, after medical consultation, are diagnosed with erectile dysfunction and who meet the inclusion criteria will be included in the study.

Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument will be completed by a blind researcher and the technique will be applied by a physiotherapist trained in the area.

Erectile dysfunction (ED) was defined as the inability to achieve and/or maintain sufficient penile erection for satisfactory sexual performance 11 for at least 6 months, accompanied by an IIEF5 questionnaire score of less than 22 points.

The patients were in the supine position, in a lithotomy position. They will undergo trichotomy at the site of placement of the self-adhesive surface electrodes. Each patient will have their own pair of electrodes that will be used until the end of therapy, and they will be discarded after the end of the sessions. The intervention will consist of the application of low intensity transcutaneous penile electrical stimulation for 45 minutes using frequency.

Eligibility Criteria:
Inclusion Criteria:

Male patient, aged 40 to 75 years, with a stable marital relationship (6 months) Diagnosis of post-prostatectomy erectile dysfunction (IIEF5 score less than 22)

Exclusion Criteria:

Neurogenic ED (spinal injury, Parkinson, MS) Hypogonadism (total testosterone \< 300 ng/dl) Decompensated diabetes mellitus (Fasting Glucose\>200 and/or Glycated Hemoglobin\>8%) Decompensated systemic arterial hypertension (SBP \> 160 and/or DBP \>100 Morbid obesity Use of vacuum device smokers Diagnosis of coronary artery disease and/or cerebrovascular disease Impossibility of understanding the objectives, study technique and informed consent cognitive deficit
Observational National Vaccine Study

To assess the long-term safety of TURKOVAC in individuals who have not previously received the COVID-19 vaccine or who have received their primary vaccination with inactivated or mRNA vaccine, or who have received their primary vaccination with similarly inactivated or mRNA vaccine and who subsequently received the first dose or second dose of booster vaccine, who meet the inclusion/exclusion criteria of the study.

The primary objective of the study was to evaluate the long-term safety of TURKOVAC in individuals who had never received a COVID-19 vaccine before, or who received their primary vaccination with inactivated or mRNA vaccine, or who received their primary vaccination with similarly inactivated or mRNA vaccine, and who subsequently received a first dose or second dose of booster vaccine, in individuals who met the inclusion/exclusion criteria of the study. The secondary objective of the study was to evaluate the immunogenicity of TURKOVAC in individuals who meet the inclusion/exclusion criteria of the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who meet all of the following criteria will be included in the study:

  1. Individuals aged 18 and over,
  2. Individuals who have never had a COVID-19 vaccine before OR who have received COVID-19 mRNA or inactivated vaccines in the primary vaccination and have selected TURKOVAC as the booster dose (3rd dose and 4th dose),
  3. Individuals who have not had COVID-19 during the last trimester,
  4. Only for subjects who will receive 4th dose of vaccine: Those who have received the third dose of TURKOVAC vaccine and those who have spent at least 90 days since the third dose,
  5. Individuals who agree to provide blood samples and verifiable identification information (in accordance with local regulations), who may be contacted by the investigator during the study and who may come into contact with the investigator,
  6. Individuals who will be able to voluntarily understand and sign informed consent,
  7. Individuals who accept phone calls to be made to them for the purpose of collecting safety-related data.

Exclusion Criteria:

* Subjects who meet one of the following criteria will be excluded from the study.

  1. For subjects who will receive primary vaccination: Individuals who have received any vaccine and/or flu vaccine within 14 days prior to the COVID-19 vaccine.
  2. Individuals who have chosen a vaccine other than TURKOVAC as a booster dose.
Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which are also related to severity of the clinical syndrome of PVD. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to assess the effect of testosterone treatment on PVD arterial stiffness and intima-media thickness in men with type 2 diabetes and hypogonadism,


Eligibility Criteria:
Inclusion Criteria:

* Male patients greater than 18 years of age
* Type 2 Diabetes Mellitus
* Serum testosterone less than 11 nmol/L on two consecutive samples taken on different days
* Peripheral vascular disease as defined by ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene
* Agreement to maintain antihypertensive and anti-lipid treatments at prior doses during 3 months of study
* Ability to give written informed consent after verbal and written explanation in the English Language
* Ability to comply with all study requirements

Exclusion Criteria:

* Current or previous breast cancer
* Current or previous prostate cancer
* Raised prostate specific antigen or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion
* Severe symptoms of benign prostatic hypertrophy ('prostatism')
* Treatment with testosterone in the 3 months prior to the trial
* Investigational drug treatment in the 3 months prior to the trial
Phase II Study of Neoadjuvant Chemotherapy With Doxorubicin Followed by Docetaxel-Cisplatin in Locally Advanced Breast Cancer

Phase II study of neoadjuvant chemotherapy with Doxorubicin followed by Docetaxel-Cisplatin in locally advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced breast cancer

Exclusion Criteria:

* Patients with metastatic breast cancer
Effect of Nasal Continuous Positive Airway Pressure (CPAP) on Oral Feeding in Human Neonates

Current knowledge suggests that, to be successful, oral feeding in preterm babies should be initiated as soon as possible, often at an age where immature respiration still requires ventilatory support in the form of continuous positive airway pressure (CPAP). While some neonatologist teams claim great success with initiation of oral feeding in immature babies with CPAP, others strictly wait for CPAP to be no longer necessary before any attempt at oral feeding. Such controversy is fuelled by ignorance of the effects of CPAP on nutritive sucking and swallowing, including their coordination with breathing, and the fear to induce deleterious problems such as pulmonary aspiration of milk and/or respiratory failure. Ensuing delay in becoming proficient with oral feeding unduly prolongs hospital stays of preterm babies.

The aim of this study is to evaluate the effects of nasal CPAP on oral feeding in human neonates. More specifically, CPAP effects on nutritive sucking and swallowing, including on breathing-swallowing coordination, will be carefully assessed. The investigators hypothesize that nasal CPAP will lead to no or minimal alterations of breathing-nutritive swallowing coordination and will not induce deleterious cardiorespiratory events.

Accordingly, each neonate will be evaluated during 2 bottle feedings spaced of 24 h, one with nasal CPAP 5 cm H2O and the other without any CPAP. Sucking and swallowing activity, respiration, heart rate and oxygenation will be continuously recorded before, during and after bottle-feeding.

By filling a gap in knowledge, results from the study will hopefully help neonatologists afraid of doing more harm than good when initiating bottle-feeding in preterm babies under CPAP to join the many teams for whom it is no more a problem.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24 weeks or more
* Hospitalized in the neonatology unit or the maternity unit of CHUS Fleurimont
* Feeds by complete oral feeding since 24 hours or more

Exclusion Criteria:

* Upper airways anomaly
* Brain injury : periventricular leukomalacia or intracranial hemorrhage \> grade III (Papile classification)
* Neuromuscular disease
* Life-threatening congenital disease
* Any symptomatic intercurrent acute disease (ex.: infection)
Demonstrate the Superiority of the Immune Response of Adjuvanted Influenza Vaccine Induced in an Adult Population

The study is designed to demonstrate a meaningful difference in immunogenicity between the candidate adjuvanted vaccine compared to the licensed Fluarix vaccine in subjects aged 50 years and above.

A control group in younger adults aged 18 to 40 years was included.

This is a study to demonstrate the superiority of the immune response of adjuvanted influenza vaccine induced in an adult population.

Eligibility Criteria:
Inclusion Criteria:

* The subjects must be healthy adults 18-40 years or \>/= 50 years.

Exclusion Criteria:

* Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, or a licensed vaccine within 2 (inactivated) to 4 (live) weeks before vaccination, if women are pregnant or lactating, or if subjects have acute clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination.
Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy

This study will assess the safety and efficacy of Neotrofin in treating the peripheral neuropathy that results from chemotherapy for cancer.


Eligibility Criteria:
* Patient must have diagnosis of cancer and be receiving or have received chemotherapy that has resulted in sensory or motor neuropathy.
* Sensory or motor neuropathy must be \>/= grade 2 per Common Toxicity Criteria at baseline.
* In patients diagnosed with multiple myeloma, grade 1 sensory or motor neuropathy is acceptable.
* Patient must have normal hematological cell counts.
* Patient must have a life expectancy of \>/= 3 months.
GT101 Injection in the Treatment of Metastatic/Recurrent Advanced Solid Tumors

This study is a single center, single arm phase I clinical trial. This study proposes to enroll 20 subjects, with a trial protocol including chemotherapy pretreatment, reinfusion of autologous tumor infiltrating lymphocyte injection, and interleukin-2 injection.


Eligibility Criteria:
Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass Volume ≥1cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

* 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
* 2.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
* 3. Patients who have refractory or intractable epilepsy, active gastrointestinal bleeding or IL-2 contraindications;
* 4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 5.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
Fluid Collections Management in Severe Acute Pancreatitis

Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
* CT density \< 30Hu
* Within 7 days from the onset of the disease
* Available approach for percutaneous penetrate

Exclusion Criteria:

* Pregnant pancreatitis
* Receiving surgery or aspiration before;need of early surgery
* Infected fluid collection
Sustainable Office Intervention, Impact of a Sustainable Lifestyle on Diet, Physical Activity and Carbon Footprint

The main goal of the study, Sustainable Office Intervention (SOFIA), is to promote and ease the adoption of a sustainable lifestyle within an office environment, with the dual goals of enhancing public health and mitigating the adverse effects of climate change. Specifically, the study aims to assess the effectiveness of promoting sustainable lifestyle choices in the office workplace compared to promoting a conventional healthy lifestyle in regards to diet and physical activity.

The participants will be recruited at companies in the Swedish office sector, and after recruitment and baseline assessment, the participants will be randomly assigned to one of two groups Healthy Lifestyle (HL) or Sustainable Lifestyle (SL).

All participants will complete web-based questionnaires including background information about weight, height, diet, physical activity, smoking, education and other relevant background variables at the beginning of the study as well as at the end of the study. Participants will attend separate group-based workshops 6 times during the 8-week intervention period held by trained personnel. During these workshops, participants will be guided by education, food provision, and assistance to identify facilitators and barriers to a healthy or sustainable lifestyle. In addition, adherence to a healthy or sustainable lifestyle will be reinforced using a behavioral support package provided through a digital platform during the intervention period.

We will compare baseline, midpoint, and final (i.e. week 0, 4 and 8) nutrient intake, CO2e, and the dietary sustainability score for the two diets with an ANOVA model. We assume a dropout rate of 10-15% after baseline assessment (based on our previous pilot study from the fall of 2017) Climate Friendly and Ecological Food on Microbiota (CLEAR). Therefore, we will recruit 47 people to each group to have at least 40 at the end of the study. With 40 participants in each group, this analysis has \>90% power to detect a 50% reduction in CO2e for the intervention group. To gain further insight into the development of intake of nutrients, CO2e, and the dietary sustainability score during the follow-up, we will use linear mixed models, with individual-specific baseline trajectories. Moreover, we will perform substitution analyses, i.e. scenarios where a number of meals high in CO2e are substituted for meals low in CO2e. Statistical analyses will be done in R-statistics.

Eligibility Criteria:
Inclusion Criteria:

- Preform office work ≤20 hours/week

Exclusion Criteria:

* Allergies excluding large food groups
* Visual or speech disability
* Not owning a smartphone.
Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA in respiratory muscle unloading in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject has given written informed consent.
* Male or female, aged 18 - 80 years (extremes included).

Exclusion Criteria:

* Pregnant or breast-feeding female. A pregnancy test will be performed in all female volunteers less than 60 yrs of age.
* Known intolerance or allergy against local anesthetic drugs such as procain, lidoocaine, xylocain.
* Any contraindication to the insertion of a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture, bleeding disorder with evidence of active bleeding.
* Presence or suspicion of diaphragm injury.
* Prior medical history that might contribute to a disturbance of the neural system, including, but not limited to: diabetes, prior critical illness, carcinoma, uremia, vitamin B12 deficiency, chronic liver disease, alcohol abuse, malabsorption (sprue), HIV, Lyme disease, Lymphoma, multiple myeloma, hypothyroidism, systemic vasculitis, abnormalities on physical examination of peripheral nervous system (pallesthesia, impaired muscle strength according to the MRC Scale for Muscle Examination in 12 Muscle groups).
Modeling of the Hemoglobin Drop in the Uncomplicated Postoperative Course

transfusion-related decisions in the perioperative setting are often complex due to acute variations in the hemoglobin levels, which typically experience a progressive decrease within days. This process, commonly referred to as "hemoglobin drop" or "hemoglobin drift", has been observed to be highly variable among patients and reliant on several variables, such as the volemic status, fluid balance and blood loss. Although it has been investigated and some predictors have been identified, postoperative hemoglobin drop remains unpredictable and is not fully clarified. In consequence, hemoglobin levels' variations are frequently misunderstood, hindering the decision to transfuse.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients electively scheduled for laparoscopic urologic and gynecologic surgery.

Exclusion Criteria:

* Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
* Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
* Transfusion of red blood cells (RBCs) or use of blood recovery systems during the perioperative period.
* Significant postoperative bleeding (\> 50 ml in surgical drains, gross hematuria, or any other type of significant blood loss).
* Postoperative hemodynamic instability (defined as requirement of vasoactive drugs).
* Other major postoperative complications during the observable period.
A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis

Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary Progressive SPMS.

The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study: 18 Years to 70 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers: No Criteria
* Subject is between 18 and 70 years of age, inclusive.
* Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
* Expanded Disability Status Scale (EDSS) \>=score 3.5 (Appendix B).
* Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
* Laboratory values within the following limits:
* Creatinine 1 . 5 x high normal.
* Hemoglobin

Exclusion Criteria:

* Subjects currently prescribed Campath or Lemtrada
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

The purpose of this study is to compare a minimally invasive surgical procedure and medication management in stroke patients with Atrial Fibrillation. The two treatment options are a minimally invasive surgical procedure or the use of medications.

Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of stroke and paroxysmal, persistent or permanent AF.
* Ischemic stroke or TIA with documented paroxysmal or persistent atrial fibrillation. A TIA will meet inclusion criteria as a sudden-onset focal neurological symptom or sign lasting at least 10 minutes but less than 24 hours with or without evidence of acute brain ischemia on diffusion weighted MRI imaging.
* Eligible symptoms INCLUDE hemiplegia or hemiparesis, monoplegia, or language disturbance other than isolated dysarthria.
* Symptoms that will NOT QUALIFY AS TIA INCLUDE transient monocular blindness in both eyes, dysarthria, vertigo,isolated sensory symptoms, confusion, memory loss, nonspecific complaints of dizziness, or syncope.

Exclusion Criteria:

* Recent stroke (\< 1 month).
* Age \< 18 or \> 80 years; Ejection Fraction \< 25%• Presence of left atrial appendage thrombus on CT or echocardiography
* Previous empyema or thoracic surgery, preventing access to the pulmonary veins via thoracoscopy.
* Left Atrial Diameter \> 55mm.
* Contraindication to anticoagulation with Coumadin.
* Mitral insufficiency (\> 2+)
* • • Contraindications to MRI
* •Artificial heart valve prosthesis
* Aneurysm clips
* Implanted drug infusion device or pump
* Any type of neurotranstimulator
* Any type of bone growth stimulator
* Cochlear implants or inner ear prosthesis
* Any intravascular coils, filters, or stents
* Shrapnel or bullets
* Other metallic implants or devices specify which
* Permanently tattooed eyeliner
* Are you pregnant or suspect to be pregnant?