cyrilzakka/clinical-trials huggingface dataset:
An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy

The purpose of this study is to determine the therapeutic activity of different concentrations of PRX302 at increasing volumes and/or number of deposits per gram of prostate. Therapeutic activity will be determined based on changes in PSA levels, PSA velocity, PSA doubling time and tumor burden following treatment.


Eligibility Criteria:
Inclusion Criteria:

* Completed a full course of radiation therapy for prostate cancer at least 2 years before enrollment.
* Biochemical failure at screening as determined by either the ASTRO or the Phoenix definitions.
* At least 5 available PSA readings after completion of radiation therapy and prior to screening.
* PSA level of not greater than 10 ng/mL.
* PSA doubling time of at least 9 months at screening.
* Biopsy-proven recurrent localized prostate cancer.
* Tumor stage T1C to T2C.
* Prostate volume estimated at 40 mL or less as determined by TRUS.
* ECOG performance score 0 to 2.
* Serum testosterone of at least 1 ng/dL.

Exclusion Criteria:

* Prior history of metastatic prostate cancer.
* Salvage external beam therapy and/or salvage brachytherapy prior to enrollment.
* Biological, immunological, chemotherapeutic treatment or cryotherapy after completing radiation.
* Androgen ablation therapy within 12 months prior to enrollment.
* Recurrence of prostate cancer within 18 months of definitive primary radiotherapy.
* Other medication for prostate cancer.
* Presence of active malignancy other than prostate cancer.
* Treatment with other investigational therapies within 12 months prior to enrolment.
* Presence of a chronic indwelling Foley catheter for obstructive uropathy.
* Previous transurethral resection of the prostate (TURP), transurethral resection of the bladder neck, photo-selective vaporization of the prostate (PVP) or other resection surgery in the urinary tract.
* Previous treatment with PRX302.
* Any evidence of metastatic disease on bone scan, CT or magnetic resonance imaging (MRI) within 3 months prior to enrollment.
Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

Multi-centre, international, non-interventional, prospective survey

To assess after 84 days, on a large scale patient population, the evaluation of ocular surface diseases and the satisfaction of dry eye disease (DED) treatment naïve patients or those who had to switch for tolerance, dissatisfaction or efficacy reasons to Thealoz® Duo.

Eligibility Criteria:
Inclusion Criteria:

* All dry eye patients who require artificial tears or need to change their current artificial tears for any reason (i.e. due to dissatisfaction or low efficacy, etc...)
* Outpatients of either sex, aged at least 18 years
* Patients informed of the objectives of the survey and agreeing to participate.

Exclusion Criteria:

* Use of cyclosporine, lifitegrast, tacrolimus, sirolimus within last 3 months and during the survey
* Use of topical ophthalmological treatments (glaucoma, etc...)
* Use of lacrimal plugs
* Ocular surgery in the last 12 months
* Concomitant use of corticosteroids
* Concomitant use of autologous serum or any blood derivatives
* Severe blepharitis
* Severe dry eye associated to

  * Eyelid malposition
  * Corneal dystrophy
  * Ocular neoplasia
  * Sjogren syndrome
  * Any systemic pathologies
* Pregnancy/lactation
Investigating the Clinical Utility of the MDS

The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS).

The purpose of this study is to establish the clinical utility of the MDS while continuing to evaluate the safety and performance of the MDS in patients with skin lesions who are referred to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.

Eligibility Criteria:
Inclusion Criteria:

1. Lesion has one or more of the ABCDE features and is recommended for excision.
2. Lesion has at least 1 cm of skin around it that is accessible to the MDS.
3. Patient is at least 18 years old.
4. Patient is capable of giving written informed consent.
5. Lesion is scheduled for primary excision.

Exclusion Criteria:

1. Lesion is less than one centimetre from the eyes.
2. Lesion is on the palms of the hands or soles of the feet.
3. Lesion is mucosal.
4. Lesion is ulcerated.
5. Patient is pregnant.
6. Low patient study procedure compliance.
7. Patient who is mentally or physically unable to comply with all aspects of the study.
8. Patient is undergoing chemotherapy.
9. Patient has known sensitivity to fluorescent dyes.
10. Ink marking on or adjacent to lesion.
11. Lesions larger than 20mm or too large to allow imaging.
Safer Warfarin Treatment

The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* \>18 years of age
* included in the study at the onset of warfarin treatment
* target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)
* standard indications for warfarin treatment

Exclusion Criteria:

* Non-caucasian
* Clinical significant liver affection
* Heart failure, NYHA class III-IV
* Non-compliant - not able to accomplish protocol demands
* Not able to give informed consent
* Long-term antibiotic therapy
* Malabsorption conditions and inflammatory bowel disease
EXtension of Tablo TrEatmeNt Duration Registry

Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours.


Eligibility Criteria:
Inclusion Criteria:

* Participant weighs ≥ 34kg.
* Participant is hospitalized and has dialysis dependent End-Stage Kidney Disease or Acute Kidney Injury and is prescribed renal replacement therapy \> 12 hours.

Exclusion Criteria:

* Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.
Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection

Patients with Supratentorial tumor undergoing craniotomy have a higher risk of postoperative pain, which will affect their postoperative quality of recovery (QoR). Although scalp nerve block (SNB) can alleviate postoperative pain, the effect on postoperative QoR in patients with supratentorial tumor undergoing craniotomy is still unclear. This study is aimed to explore the effect of SNB on postoperative QoR in this population. To explore the effect, we design a randomized controlled trial in which 84 patients with supratentorial tumor will be randomly assigned to either the SNB group or control group. The primary outcome is 15-item QoR score at 24 h after surgery. The secondary outcomes include 15-item QoR scores at 72 h after surgery, Riker Sedation-Agitation Scale, nausea and vomiting, intraoperative opioids and propofol consumption, perioperative heart rate and mean artery pressure, the duration of anesthesia and surgery, time to extubation, PACU duration, the length of postoperative days, adverse events within 72h and total medical expenses.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65;
* the diagnosis was supratentorial tumor;
* scheduled for elective supratentorial craniotomy with general anesthesia ;
* the American Society of Anesthesiologists physical status I-III;

Exclusion Criteria:

* the BMI≦18kg/m2 or BMI≧30kg/m2;
* refusing to sign written informed consent;
* anticipated surgery duration is too short (\<2 h) or too long (\>6 h);
* liver or kidney dysfunction, severe cardiopulmonary failure or nervous system disease ;
* with other malignancies ;
* severe hematological disease and / or abnormal coagulation function;
* fever, systemic and / or scalp infection;
* tumors are metastases, aneurysms, hemangioma, or located in the skull base, or located in functional brain areas such as language and movement;
* allergy to any drug used in this study;
* a history of craniotomy tumor resection;
* preoperative usage of antiinflammatory agents or analgesics;
* pregnant women, lactating women, illiterate people, people with cognitive impairment, a history of mental illness, unable to communicate and complete the scale assessment;
* patients with severe hemodynamic disturbances or other life-threatening complications during the operation, or those transferred to the intensive care unit (ICU) after surgery.
Southampton Mealtime Assistance Study

The primary objective of the study is to determine if the use of volunteers employed specifically to focus on mealtime assistance can increase food and nutrient intake of patients admitted to an acute Care of the Elderly ward. The sustainability of providing helpers to increase dietary intake over a year will be assessed and linked to actual dietary intake. The secondary objectives are to assess the association between dietary intake resulting from mealtime assistance and patient satisfaction, malnutrition risk, body composition, grip strength, length of hospital stay and hospital mortality.

Poor nutritional status in older people acutely admitted to hospital is common with the risk of malnutrition estimated to be greater than 40%. Malnutrition is associated with major adverse clinical outcomes such as increased mortality, morbidity and length of stay at enormous cost to individuals and the health service. There is growing recognition that malnutrition is often unrecognised and untreated, and that many patients are discharged from hospital in a more malnourished state than when they were admitted. It is not surprising that complaints about nutrition and food services are amongst the commonest complaints in NHS hospitals.

The standard of mealtime care in UK hospitals has been an issue of concern for a number of years. A report last year from the Healthcare Commission found that one in five patients who wanted help eating did not get it. A secondary analysis of data provided by the Health Care Commission suggests that in some hospitals two out of five patients who wanted help with eating did not get it. Consistent with this, the recent Hungry to be Heard report found that nine out of ten nurses indicated they did not always have time to help ensure patients ate properly. They also suggested that some patients were not given appropriate assistance to eat. This problem is not unique to the UK and has been reported in other countries such as Australia and the USA.

The aim of the present study is to investigate if the use of volunteers employed specifically to focus on mealtime assistance in a Care of the Elderly Ward can increase food and nutrient intake, impact on body composition and improve clinical outcomes. The findings will inform service development in the nutritional care of older people across the Trust and wider.

Eligibility Criteria:
Inclusion Criteria:

Patients will be recruited in a consecutive prospective manner.

* emergency admissions to acute medical wards and
* ability to gain consent from patient or relatives

Exclusion Criteria:

* Patient acutely unwell or palliative care
* Patient lacking capacity to consent and no assent given by relatives
* Patients who are tube fed or nil-by-mouth
Interdisciplinary Rehabilitation of Patients With Glioma During Anti-cancer Treatment

The results of the present RCT study will add to the growing body of literature investigating the potential role of exercise as a supportive therapeutic intervention for patient with glioma.

Gliomas are the most frequent primary neoplasm in the CNS and according to the World Health Organization histologically categorized into low-grade glioma (LGG) (WHO grades I/II) or high-grade glioma (HGG) (WHO grades III/IV). Gliomas are among the biggest challenges within the field of neuro-rehabilitation and oncology, and optimising treatment by improving QoL, function and cognition is of major clinical importance in this population. Because the majority of patients cannot be cured, clinical cancer research traditionally have focused on prolonging survival, exposing relapse or optimising the response to the medical treatment. Today there is a general consensus that health-related quality of life (HRQoL) is important in the evaluation of new treatments. However, research in HRQoL among patients with gliomas is scarce compared to the other categories of patients with tumors. In recent years have exercise become an important part of cancer treatment. The effects is well documented in studies among other cancer patients than gliomas and includes improvements of quality of life, physical function, reduce fatigue and thereby supports daily activities among cancer patients'. Inpatient rehabilitation studies among glioma patients have also indicated improved HRQoL and functional measurements such as activity of daily life, mobility and cognition. Despite of this rehabilitation efforts is still not emphasized in this population and recent literature concludes that there are no well-designed clinical studies examining the effect of multidisciplinary rehabilitation among Glioma patients. This study is the first to investigate the effect of an intensive specialised interdisciplinary outpatient rehabilitation program among gliomas patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary glioma (WHO grades I-IV)
* Age ≥ 18
* Reference with diagnosis or treatment at Odense University Hospital
* Karnofsky performance score (KPS) ≥70
* Ability to understand Danish.

Exclusion Criteria:

* Pregnancy
* Known psychiatric diagnosis or substance abuse
* Heart problems excluding intense exercise (NYHA group III and IV)
* Pronounced impressive/expressive aphasia
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia

The purpose of this study is to characterize the effect of Minoxidil 2% Solution and Botanical Hair Solution Regimen in women with thinning hair and female pattern hair loss/androgenic alopecia (Ludwig I and II).


Eligibility Criteria:
Key Inclusion Criteria:

1. Female patients age 18 to 60 years at the time of enrollment.
2. Women who have self-perceived thinning hair.
3. Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II).

Key Exclusion Criteria:

1. History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
2. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.

3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.

4. Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.

5. Subjects who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study.

6. Pregnant or breast-feeding females or women planning to become pregnant during the course of the study
Gut Permeability, Sensitivity and Symptomatology

To better understand the relationship between gut barrier function and the symptomatology and pathophysiology of irritable bowel syndrome (IBS).


Eligibility Criteria:
Inclusion criteria

* Age 18 to 70 years
* No abdominal surgery (except appendectomy, cholecystectomy, hernia repair, hysterectomy, and C-section).
* Written informed consent

Exclusion criteria

* Females who are pregnant or breastfeeding
* Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
* Use of NSAIDs or aspirin within the past week (since NSAIDs affect intestinal permeability)
* Use of oral corticosteroids within the previous 6 weeks
* Ingestion of artificial sweeteners such as Splenda (sucralose), Nutrasweet (aspartame), lactulose or mannitol 2 days before the study tests begins, e.g. foods to be avoided are sugarless gyms or mints and diet soda.
* Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before the study begins.
* Proton pump inhibitors.
* Antibiotics for the preceding 60 days before the start of the study.
* (vii) Alcohol intake beyond the recommended safe limit (\<21 unites per week)
* Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies.
* Known allergy to fluorescein
* Inflammatory bowel diseases, celiac disease.
Pain Perception During Chorionic Villus Sampling

Chorionic villous sampling is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Currently there is no randomized study to evaluate the efficacy of analgesia for pain reduction during chorionic villous sampling. Multiple studies have been published suggesting that analgesia during the similar procedure of amniocentesis does not significantly reduce pain scores.

Chorionic villous sampling (CVS) is a frequent procedure used for antenatal genetic testing. This procedure is associated with anxiety and fear of pain that can be expected during the procedure, often prejudicing patients against this definitive antenatal testing. It is important to determine if different approaches to pain and anxiety reduction are effective. Previous studies have not shown that local anesthesia affects pain experience during amniocentesis (1-5). There are no randomized studies evaluating interventions for pain reduction during chorionic villous sampling which constitutes an important evidence gap.

The study will be offered to women at \<13 weeks gestation, with a singleton fetus who are seen at Mount Sinai Medical Center for chorionic villous sampling. The eligible women will be randomized to one of two groups: use of analgesia using injectable lidocaine or ethyl chloride topical anesthetic spray. This study intends to show that local anesthesia during chorionic villous sampling will not decrease the perception of pain in patients undergoing this procedure.

This trial is trying to determine perception of pain based on use of injectable lidocaine or ethyl chloride anesthetic spray; it is noted that the form of anesthesia may be a factor in perception of pain. The investigators do not know if there is a difference in perception for topical or injectable. If the perceived pain is comparable in topical and injectable, this trial could conclude that both are viable options, and while both present minimal risk to patients, topical is less invasive.

Eligibility Criteria:
Inclusion Criteria:

* \<13 week gestation
* Singleton gestations undergoing CVS

Exclusion Criteria:

* Multiple gestations
* More than one attempt of needle insertion
* Allergy or hypersensitivity to local anesthesia
Bacterial Decolonization to Prevent Radiation Dermatitis

The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Diagnosis of a solid tumor of the breast or head and neck with plans for fractionated radiation therapy (≥ 15 fractions) with curative intent

Exclusion Criteria:

* Prior RT to the region of interest
* Existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds)
* Known allergy to chlorhexidine or mupirocin
Urinary Steroid Metabolites in Autism

Deviation of hormone formation within nerve cells and nerve system provides autism spectrum disorder and neurodevelopment retardation through interaction of steroids with neurotransmitter-receptors, calcium-channel receptors and genomic interaction via nuclear steroid receptors.

Urinary steroid metabolites will be compared between children with autism spectrum disorder and healthy controls.

Autism spectrum disorder presents many alterations in amino acid metabolism and in neurotransmitter systems (gamma amino acid system, glutamate-glutamine, nicotine-acid, serotonin-system) . Also alteration in gene activation within nerve cells and lymphocyte cultures encloses over 600 genes, affecting a wide field of enzymes , metabolic pathways and hormone formation. Male hormones and their precursors are often increased and their influence to nerve cell growth and spine formation is evident.

The diagnosis of autism spectrum disorder is made in accordance of criteria of the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) of the American Psychiatric Association by an experienced and specialised paediatrician or psychologist and /or by an Autism Diagnostic Interview-Revised (ADI-R) or Autism Diagnostic Observation Schedule (ADOS) .

Overnight urine with measurement of quantity and time will be collected and a little part of the urinary samples will be frozen for storage till analysis. Age, weight and length of the children at collection time will be ascertained.

Four stratified groups (autistic boys, girls, and healthy controls, boys and girls, each age 5-15) will be formed.

Urinary samples will further remain anonymous through an Identification-Number (ID).

Analysis of hormones and the most of the known metabolites excreted in urine will be performed by a specialised laboratory using gas chromatography-mass spectrometry (GC/MS) analysis (University Hospital Bern, Steroid Laboratory, Switzerland).

The statistical analysis, with age, gender, weight, diagnosis and hormone analysis results as factors , consists in linear regression analysis to detect deviation in hormone formation and metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Autism spectrum disorder
* Age 5-15 years

Exclusion Criteria:

* Epilepsia
* Psychotropic medication
* other severe illness
Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia

This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS (Central Nervous System) systemic embolism, and who consent to participate in the study.