cyrilzakka/clinical-trials huggingface dataset:
A 12-Gene Blood-Based Signature for Detecting Metastatic Bladder Cancer

The purposes of this study is to evaluate a new genetic-based test which will identify patients diagnosed with muscle-invasive bladder cancer before their surgery, who might have specific genes, which will increase their chances of recurrence of cancer after their surgery.

Some patients who are diagnosed with bladder cancer and have their had bladder removed, will have a recurrence of cancer sometime after their surgery. This recurrence is usually caused by tumor cells that originated from the bladder tumor and traveled to other parts of the body, which is called metastatic cancer. Some patients are more likely than others to have metastatic disease. This test may help in identifying these patients who might develop metastases from having these specific genes.


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom pelvic lymph node dissection can be performed;
* Any male and/or female, who is ≥18 years of age;
* Pathological diagnosis of urothelial carcinoma of the bladder;
* Localized muscle-invasive disease defined as clinical stage T2-4aN0M0 tumors;
* Did not receive neoadjuvant therapy;
* No radiographic evidence of metastatic disease on CT scans of the abdomen and pelvis, chest x-ray, or bone scan;
* Informed consent before study participation

Exclusion Criteria:

* Prior systemic chemotherapy;
* Prior radiation therapy;
* A history of another ongoing malignancy within the past 5 years other than basal cell carcinoma of the skin
Burnout Preventions, Professionalism Heightening, and Enhancing Resiliency (BUPHER)

Due to their difficult and stressful work surgeons are under continuous physical and mental stress exposing them to increased risk for burnout and lack of professionalism. The present intervention focuses on providing time and a safe space to debrief and explore personal and group experiences and dilemmas, as well as acquire coping skills related to burnout, communication and professionalism.


Eligibility Criteria:
Inclusion Criteria:

* All physicians (residents and experts) of the Surgical Division at Tel Aviv Sourasky Medical Center.
* All medical students studying at the Sackler Faculty of Medicine, Tel Aviv University, and attending a surgery round at the Surgical Division at Tel Aviv Sourasky Medical Center.
* Patients (and/or family members) in the Surgical Division at Tel Aviv Sourasky Medical Center following their surgery.

Exclusion Criteria:

* The research will not include children and/or judgment-impaired patients;
* population not met by inclusion criteria;
* non-Hebrew speaking patients;
* ventilated patients;
* patients in surgical intensive care;
* patients medically defined as suffering from clouding of conscious or delirium;
* subjects who decided to stop their participation in the study.
Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

Depression related vulnerabilities are highly comorbid with smoking behavior and dramatically reduce cessation rates among both community and clinical samples. Previous research has examined the efficacy of cognitive-behavioral treatment for individuals with a history of major depressive disorder (MDD) in standard cessation treatment. A broader health impact can be achieved by targeting individuals with current elevated depressive symptoms to address their association with cessation failure. Thus the objective of the present proposal is to conduct a Stage II randomized controlled trial (RCT) comparing the behavioral activation intervention to standard treatment among a similar community sample of 200 adult smokers with elevated depressive symptoms. Participants will be followed over 52 weeks post-quit date and the larger sample size will allow for more complex analysis of cessation outcomes.

This will be a Stage II randomized control trial to examine the efficacy of behavioral activation treatment for smoking (BATS) vs. standard smoking cessation treatment (ST). We will recruit 200 smokers with elevated depressive symptoms who will be randomized into one of two treatment groups. Treatment will be delivered in group format across both the BATS (n = 100) and ST condition (n = 100). All participants will receive 8 weeks of transdermal nicotine patch in addition to their assigned treatment group. We intend to compare the BA treatment for smoking (BATS) to a standard smoking cessation intervention (ST)on abstinence and relapse outcomes. In addition we will examine to what extent depressive symptoms and reward sensitivity prior to quit date will mediate the effects of BATS on improved smoking cessation outcomes relative to ST.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years of age
* A regular smoker for at least one year
* Currently smoking an average of at least 10 cigarettes per day
* Want to quit smoking
* Report current elevated depressive symptoms

Exclusion Criteria:

* Current Axis I disorder
* Psychoactive substance dependence (excluding nicotine dependence) within the past 6 months
* Current use of psychotropic medication or participation in any form of psychotherapy
* A history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness
* Current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt
Effects of COVID-19 Lockdown in Exercising Early Postmenopausal Women

While "conditioning" by exercise training has been widely evaluated, the available literature on "passive deconditioning" (i.e. forced deconditioning) is predominately limited to studies with or with almost complete mechanical and/or metabolic immobilization/sedation of the respective functional system (e.g. paralysis, bedriddenness). Vice versa, the effects of moderately long interruptions of dedicated types of exercise while maintaining everyday activity are rarely addressed. However, this topic is of high relevance, e.g. considering that breaks of health-related exercise programs due to increased family/occupational stress, vacation or temporary orthopedic limitation are rather frequent in everyday life. In the present project we aimed to determine the effects of 3 months of physical deconditioning due to COVID-19 induced lockdown after 13 month of high intensity endurance and resistance exercise in early postmenopausal women on parameters related to health and physical fitness.


Eligibility Criteria:
Inclusion Criteria:

* (early)postmenopausal women, ( normal menopause, 1-5 years post)
* Osteopenia and osteoporosis (Bone Mineral Density \<-1.0 SD T-Score)

Exclusion Criteria:

* BMD \<-4.0 SD T-Score
* Prevalent clinical, low-trauma fractures
* Diseases and drugs with relevant effects on bone and muscle metabolism (e.g. glucocorticoids \>7.5 mg/d or bisphosphonate therapy); individual case assessment
* Diseases and drugs with relevant effects on cardiometabolic risk factors (e.g. severe hypertension with corresponding medical therapy); individual case assessment
* Severe cardiovascular events (e.g. stroke, coronary infarction) in the past.
* Other conditions, diseases that exclude exercise training or testing
Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients

The purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* hip fracture
* aged between 35 and 90 years old

Exclusion Criteria:

* contraindications for spinal anesthesia and PENG block
* impaired cognition or dementia
* multiple fractures
* any previous analgesic administration during the last 12 hours
Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)

Gene fusions are defined as two separate genes joined together (gene 1, gene 2), generating a novel fusion gene. NRG1 fusions are rare and complex with regard to the fusion/fusion partner. The specific NRG1 gene fusion will be identified by a specialized molecular testing lab.

Afatinib is provided on a single-patient protocol basis to patients suffering from tumors harboring NRG1 fusions, a disease for which no satisfactory authorised alternative therapy exists.

In the context of this mechanism it is planned to collect and analyze limited clinical data in order to investigate the safety and efficacy of afatinib in patients with advanced and/or metastatic solid tumours harboring NRG1 gene fusions.

Eligibility Criteria:
Inclusion Criteria to participate in this program:

* Confirmed diagnosis of an advanced, unresectable and/or metastatic tumor harboring NRG1 gene fusions characterized as follows:

  * Gene 1: NRG1 (prerequisite: conservation of the epidermal growth factor (EGF) domain - this will be identified by the lab performing the molecular testing)
  * Gene 2: All fusion partners are allowed (prerequisite: the region must be a coding region - this will be identified by the lab performing the molecular testing)
* Patient must have measurable or evaluable lesions (according to RECIST 1.1).
* At least 18 years of age at the time of consent.

Exclusion Criteria:

* Treatment with a systemic anti-cancer therapy or investigational drug within 14 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.
* Tumors carrying additional gene mutations other than NRG1 fusion where FDA-approved targeted therapy is available
* Prior treatment with a therapy targeting erythroblastic leukemia viral oncogene homologue receptors (ErbB)
* Any patient considered ineligible by the treating physician.
Positioning During Colonoscopy

Colonoscopy is the gold standard investigation in the screening of colorectal neoplasms. The investigators hypothesise that visualisation of the colonic mucosa on extubation may be improved by changing patient position as follows: left lateral position for the right colon, supine for the transverse colon and right lateral position for the left colon(fixed positioning). The investigators aim to validate our hypothesis by performing a randomised control study, comparing mucosal visualisation in patients placed in the 'routine' positions at the discretion of the endoscopist with visualisation in those placed in the above described positions. The hypothesis is that fixed positioning confers an advantage.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring colonoscopy

Exclusion Criteria:

* Polyp surveillance
* Cancer surveillance
* Infirmity
* Pregnancy
* Colectomy
* Poor tolerance
* Failed colonoscopy
* Poor bowel preparation
The Effect of Bedside Whiteboard Use on Anxiety, Depression and Nursing Care in Chronic Obstructive Pulmonary Patients

ABSTRACT Chronic obstructive pulmonary disease (COPD) is a disease characterized by the inability of the body to adequately exchange gases, resulting in progressive shortness of breath that can form secretions and compromise the performance of daily activities. COPD is reported as the third most common cause of death worldwide, with 3.23 million deaths in 2019. Anxiety and depression are common in individuals with COPD. However, COPD is more common in patients with other chronic diseases such as hypertension, diabetes, cancer or musculoskeletal disorders. Communication is a key component in interprofessional care as well as in improving patient care outcomes. Strategies to address gaps in the quality of information and communication between patients, caregivers and professionals improve patient safety as well as quality of care. One of these strategies is the use of whiteboards at the bedside. The use of whiteboards at the bedside has emerged as a strategy to improve interprofessional team participation, communication and information sharing with care teams, patients and families. This study will be conducted in randomized controlled single blind parallel groups to examine the effect of bedside whiteboard use on anxiety, depression and nursing care satisfaction in COPD patients. The research will consist of patients who are hospitalized in Atatürk University Research Hospital Chest Diseases Clinic and who meet the inclusion criteria. In the results of the research, it is thought that the use of whiteboard will affect the communication between health care team members.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Having a medical diagnosis of COPD
* To be in a condition to be followed up with at least 7 days

Exclusion Criteria:

* - Having strong reading and comprehension skills
Sodium Valproate-loaded Nanospanlastics in Patchy Alopecia Areata in Comparison to Topical Steroids

the aim of this study is to assess the efficacy and safety of sodium valproate-loaded nanospanlastic in the treatment of patchy AA, in comparison to conventional therapy with topical steroids

Alpopecia Areata (AA) is the second common cause of non-scarring hair loss, the disease has huge negative impact on patients' quality of life, social and psychological status. The underlying pathogenesis of AA is not fully characterized, Yet the collapse of immune privilege and generation of autoimmune attack against unknown follicular antigens are the most agreed-upon theories behind the disease. In spite of various therapeutic armamentariums available for AA, no single agent has been proven efficacious regarding reversing hair loss and establishing long-term response.

keeping in mind the burden of the disease together with lacking effective treatments, a need for further therapies is colossal.

Wnt-b catenin pathway is one of the crucial signalling pathways that regulate hair cycling. An increasing body of evidence is supporting the fact that wnt-b catenin pathway is inhibited in AA, and therefore contributing to the hair loss that characteize the disease.

Sodium valproate (SV), a well-known anti-epileptic drug, was found to inhibit Glycogen synthase kinase-3beta (GSK3β) in neuronal cells as one of the possible antiepileptic mechanisms of SV. GSK3B is a well-known inhibitor of β-catenin activity in dermal papilla cells (DPCs), and thus induces catagen-like changes in these cells. So the idea of using topical SV to promote hair regrowth via activation of b catenin came up and attracted the interests of investigators. recently an optimized sodium valproate-loaded nanospanlastics topical formula promisingly achieved clinical equivalence with 5% minoxidil lotion in AGA, with a superior safety profile to minoxidil

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate patchy alopecia areata, which is defined as less than 50% involvement of the entire scalp
* Age above 12 years.
* Both genders.
* Patients with patchy alopecia areata, with 2 patches or more

Exclusion Criteria:

* Patients having single patch alopecia areata (at least 2 patches are required, as one patch will be left untreated to exclude the possibility of spontaneous remission)
* Affection of more than 50% of the scalp area
* Patients with alopecia totalis or universalis
* Patients with ophiasis
* Age: Less than 12 years old.
* Pregnant or lactating females
* Patients with history of or existing scalp skin diseases, infections or skin cancer
* Severe systemic illness (as uncontrolled DM or hypertension, liver or renal diseases) and immune-compromised patients
* Patients with concomitant autoimmune diseases as suspected by history or confirmed by previous investigations
* Diagnosis or history of local dermatological disease in the scalp apart from AA such as eczema, seborrheic dermatitis, psoriasis.
* Any psychiatric illness or psychological state impairing future compliance or influencing expectations of the patient
Russian Extremely Severe Ulcerative Colitis Study

The purpose of this study is prove the need to selection of a extremely severe ulcerative colitis, to identify predictors of colectomy, which will reduce the optimal time for surgery.

Acute severe ulcerative colitis is a life threatening disease,total mortality rate can reach 17%, and the frequency of surgical treatment approximately 40%. Standard conservative therapy in these patients is often ineffective and the optimal timing of the surgical treatment has not yet been established.

In the Russian clinical guidelines for the treatment of ulcerative colitis, the extremely severe ulcerative colitis is added to the classification of the severity.

The extremely severe ulcerative colitis is a severe, according to the criteria of Truelove, Witts and the endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction.

Conservative treatment of patients with extremely severe ulcerative colitis worsens treatment outcomes only. The authors of the study want to prove that patients with a extremely severe ulcerative colitis need a colectomy in a short time.

Is there a need for long-term follow-up, conservative treatment of high-risk patients? Is it safe to perform early surgical treatment without long-term conservative treatment? This study will allow to answer these questions and help doctors in the treatment of such patients anywhere in Russia and not only.

Eligibility Criteria:
Inclusion Criteria:

* Acute Severe Colitis according to the Truelove and Witt's Criteria;
* Extremely severe activity according endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction (lower 31 g/l).

Exclusion Criteria:

* Pregnancy;
* Infectious, ischemic colitis;
* Transformation of diagnosis into Crohn's disease;
* Medical treatment failure before the admission.
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of one or more doses of AP30663 for cardioversion in adult participants with AF.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical indication for cardioversion of AF
* Current episode of symptomatic AF lasting between 3-hour and 7 days (inclusive) at randomization
* Adequate anticoagulation according to international and/or national guidelines

Key Exclusion Criteria:

* Significant clinical illness or surgical procedure within 4 weeks preceding the screening visit
* History of significant mental, renal or hepatic disorder, chronic obstructive pulmonary disease, sinus nodal disease, or other significant disease, as judged by the investigator.
* Any cardioversion attempt of AF or atrial flutter within 4 weeks preceding randomization
* Use of any antiarrhythmic drug class I and/or III within 6 months before randomisation

Other protocol defined Inclusion/Exclusion criteria may apply
Pathways Mediating Impaired Postural Control in Parkinson's Disease

The purpose of this project is to use transcranial magnetic stimulation (TMS) to explore the state of excitability of corticocortical and corticofugal (cortex to spinal cord, cortex to brainstem to spinal cord) pathways that project to muscles that control the legs and trunk in people with Parkinson's disease. The outcome variables will be further analyzed to understand their relationship to quantitative measures of postural instability and gait dysfunction. As such, the project can be classified as basic physiologic research. The protocol is not designed to determine if measures of corticocortical or corticofugal excitability can be used as a biomarker to predict disease progression.


Eligibility Criteria:
Inclusion Criteria:

Participants with Parkinson's disease

* Diagnosis of idiopathic PD or dystonia as determined by a movement disorders neurologist in accordance with the UK Society Brain Bank diagnostic criteria.
* Age 45-80 years.
* Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters.

Healthy Older Adults (Control participants)

* Age 45-80 years (this group will be age and sex-matched to the PD group)
* Able to ambulate independently without the use of an assistive device (cane or walker)

Healthy Young Adults

* Age 21-44 years (this group will be age and sex-matched to the PD group)
* Able to ambulate independently without the use of an assistive device (cane or walker)

Exclusion Criteria:

* Subjects who describe a history of a frequent vasovagal syncope (fainting) in response to blood, emotional stress, or sensory triggers.
* Subjects who are on anti-coagulant medications.
* Any musculoskeletal disorder that affects the ability to stand.
* History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
* Intracranial metallic or magnetic devices.
* Pacemaker or any implanted device.
* History of surgery on blood vessels, brain or heart.
* Unexplained, recurring headaches or concussion within the last six months.
* Moderate to severe hearing impairment.
* Subjects who are pregnant.
* Dementia diagnosis
* Other significant neurological disorders that may affect participation or performance in the study
* Implanted deep brain stimulator or other neurosurgeries to treat PD.
Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.

Upon determination of eligibility, all patients will receive the following treatment:

Gemcitabine + Carboplatin

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Locally advanced or metastatic breast cancer
* Measurable disease as per RECIST criteria
* No prior chemotherapy in the metastatic breast setting
* Prior chemotherapy and/or hormonal therapy for early stage breast cancer
* Adjuvant Herceptin is allowed
* Prior radiation therapy in either the metastatic or early stage setting
* Patients may have received any number of hormonal therapies
* Age \>18 years
* Only women are eligible for the study
* Able to perform activities of daily living with minimal assistance
* Normal organ and bone marrow function
* Patients who will be receiving Trastuzumab must have normal heart function
* Sign a written informed consent document

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Received prior chemotherapy for metastatic breast cancer
* Known leptomeningeal carcinomatosis
* Uncontrolled brain metastasis
* Uncontrolled intercurrent illness
* Pregnant or lactating
* History of other non-breast cancer malignancy
* Received prior chemotherapy for early stage breast cancer within 6 months

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.