cyrilzakka/clinical-trials huggingface dataset:
Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.

OUTLINE:

Patients receive standard of care radium Ra 223 dichloride given by intravenous (IV) bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.

After completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be \>= 18 years of age
* Patient must have histopathologic diagnosis of prostate cancer
* Patient must have castration-resistant prostate cancer
* Patient must have radiographic evidence of bone metastasis
* Patients must be symptomatic from prostate cancer
* Patient must have plans to undergo treatment with radium-223
* Patient must have a PSA level \>= 10 ng/mL
* Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening
* Patient must have anticipated survival \> 3 months
* Patient must be willing and able to authorize consent
* Patient must be willing and able to comply with the protocol, including follow-up visits

Exclusion Criteria:

* Patient must not have visceral metastasis
* Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded

  \* Bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed
* Patients who have received prior radium-223
* Patients who have received prior platinum containing chemotherapy
* Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L
* Hemoglobin (HB) \< 9 g/dL
* Platelets (PLT) \< 100 x 10\^9/L
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Cefaly® Device in the Treatment of Patients With Fibromyalgia.

The objective of this pilot open trial was to assess the efficacy and safety of external trigeminal nerve stimulation (e-TNS) with the Cefaly® device in fibromyalgia.

The main objective of this clinical pilot trial was to evaluate the use of external trigeminal nerve stimulation (e-TNS) with the Cefaly® neurostimulator device as a new therapeutic treatment for fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from18 to 65 years (on the day of signing the informed consent form).
2. Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010).
3. Having a minimum pain score of at least 4 on the 0-10 Fibromyalgia Impact Questionnaire-revised (FIQR) pain scale at screening and baseline.

Exclusion Criteria:

1. Women: Pregnant, lactating or \<6 months post partum.
2. Episodic or Chronic Migraine according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine 1, having two or more attacks per month.
3. Change in any medication acting on the central nervous system (CNS) within 28 days before start of the study or during the study.
4. Severe depression i.e. having a Beck Depression Inventory-Fast Screen (BDI-FS) score \>12.
5. Botox injection within 4 months before baseline or during the study.
6. Psychiatric disorders that could interfere with study participation: bipolar disorder, psychotic disorders and dementia.
7. Suicidal behavior and/or ideation i.e. having a Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 4 during the preceding 2 years.
8. Patients currently taking any opioid medication.
9. Patients currently taking medically prescribed marijuana.
10. Current or history during the preceding year of alcohol or substance abuse including marijuana.
11. Widespread rheumatic diseases (other than fibromyalgia), evidence of inflammatory rheumatic disease.
12. Any unstable medical condition in the judgment of the investigator that would interfere with study participation or study assessments.
13. Implanted active metal or electrical devices in the head.
14. Cardiac pacemaker or implanted or wearable defibrillator.
15. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program).
Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care

This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes and their associated mechanisms of change.

Background: Most patients with chronic pain obtain their treatment in primary care settings, where evidence-based behavioral interventions are not typically provided, despite robust evidence for treatments like Acceptance and Commitment Therapy.

Objective: This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes and their associated mechanisms of change.

Design: Mixed-methods pilot randomized controlled trial. Active participants completed one 30-minute individual Focused Acceptance and Commitment Therapy (FACT) visit followed by 3 weekly 60-minute group visits and a booster visit 2 months later. An enhanced treatment as usual (ETAU) control group received 4 handouts about pain management based on cognitive behavioral science. Follow-up research visits occurred during and after treatment, at 12 weeks (booster visit), and at 6 months. Semi-structured interviews were conducted after the last research visit.

Setting: A small integrated primary care clinic in southwestern U.S. affiliated with an academic medical center

Eligibility Criteria:
Inclusion Criteria:

* age 18 and older
* at least one non-cancer pain condition persisting for 12 weeks or more
* a current primary care clinician at the study clinic
* ongoing treatment for a non-cancer chronic pain condition

Exclusion Criteria:

* social anxiety or unwillingness to participate in a class setting
* presence of symptoms of psychosis and/or delirium
* a medical condition or life circumstance that would contraindicate or prevent participating (e.g. upcoming surgery)
* inability to comprehend the informed consent process or study instructions.
Motivational Interviewing in Women's Pelvic Wellness Education

This pilot study will assess the feasibility and acceptability of an educational workshop on pelvic floor disorders and its potential impact on decisional conflict.

Pelvic floor disorders can significantly affect a woman's quality of life, yet many feel uncomfortable openly discussing these topics. Treatments include lifestyle modification, medications, and/or surgery. "Decisional conflict" arises when patients have difficulty choosing between several viable treatment options. Factors contributing to decisional conflict include biased information, poor peer support, and unaddressed fears. Effective counselling may help address these factors.

There are few studies on how decision coaching can help women with prolapse and incontinence reach a satisfactory decision about treatment. This study aims to use the principals of shared decision making to address decisional conflict surrounding treatment for pelvic floor disorders. Specifically, the investigators will evaluate the feasibility and acceptability of small group workshops on pelvic organ prolapse and urinary incontinence led by a nurse continence advisor and a psychologist (decision coach).

Results of this study will inform future development of interdisciplinary, patient-centered approaches to enhanced decision making in women's health.

Eligibility Criteria:
Inclusion Criteria:

* Women ages \>18 years old
* Urinary incontinence and/or pelvic organ prolapse
* First visit with urogynecologist

Exclusion Criteria:

* Anal incontinence
* Previous pelvic radiation therapy
* Requirement for a Substitute Decision Maker
* Inability to attend the workshop
* Unwilling to attend an English-language workshop
* Unwilling to complete English-language surveys
Neoadjuvant Immunotherapy in Advanced NSCLC

A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. One such example would be to evaluate either single agent or an immunotherapy combination with chemotherapy. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.

A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. \[The Power Life Sciences Investigative Team\](https://www.withpower.com) is running a study to evaluate either single agent or an immunotherapy combination with chemotherapy. Patients can contact a site administrator via the information below, or enroll directly via \<a href="https://www.withpower.com/trial/phase-4-2019-e67c1"\>https://www.withpower.com/trial/phase-4-2019-e67c1\</a\>. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 Years of Age
* Informed consent is provided
* Histologically confirmed resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Epidermal growth factor receptor (EGFR) mutation negative and anaplastic lymphoma kinase (ALK) translocation negative

Exclusion Criteria:

* EGFR mutation positive and ALK translocation positive
* Active central nervous system (CNS) metastases
* Autoimmune diseases
* Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
* Patients with interstitial lung disease will not be included if they have symptomatic interstitial lung disease (ILD) - Grade 3-4
* Women who are breast feeding or pregnant
* Sexually active women or men of childbearing potential who are not willing to use an effective contraceptive method during the study
Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017 (OBE PRACTITIONERS UHC 2017)

Regarding 30 to 50% of occupational blood exposure (OBE) are underreporting among health professionals, it's to highlight that the part of medical professionals in OBE reporting is among the lowest (1996 to 2016). The current study is aiming to evaluate the underreporting of this specific occupational accident among medical staff for the year 2017. The investigators are supposing this is declining and the part of OBE reporting is better than before. So the current situation concerning OBE underreporting for medical staff in an University Hospital Center (UHC), 20 years after the first study, is our main purpose.


Eligibility Criteria:
Inclusion Criteria:

* Any medical or surgical health professional
* practitioner and resident
* working in an UHC
* without distinction of medical or surgical specialty
* having a professional mailbox

Exclusion Criteria:

* All paramedical health professionals (example: nurses) and pharmacists
* Any medical or surgical health professional working full-time outside an UHC
* Any medical or surgical health professional with exclusive liberal activity outside an UHC
* Administrative and technical staff of an UHC
Senior-COVID-Rea Multicentric Survey

With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be adapted continuously in response to the emergency. The first publications from the Chinese experience demonstrate an increase in the incidence of COVID-19 infections in patients over 60 years of age, a higher frequency of severe forms of the disease and therefore theoretical indications of orientation towards resuscitative care.

However, the first published data from Hubei province suggest a low benefit of resuscitation for patients between 70 and 80 years of age and null in patients over 80 years of age. These data question the individual benefit / risk balance of an orientation towards resuscitation for this category of patients, their quality of life and the concept of unreasonable obstinacy.

Among the covariates associated with resuscitation mortality described in the data published to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine, lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the entry into resuscitation have been identified.

The objective of this multicentric observational study is to determine the clinical and biological covariates predictive of mortality in the population of patients over 60 years of age admitted in intensive care unit, in particular by integrating functional and nutritional data from patients 1 month before COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 60
* sent to the intensive care unit
* whose COVID diagnosis has been established (RT-PCR and / or chest scanner)

Exclusion Criteria:

* Refusal of the patient or his support person to participate in the study
Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients

The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients

A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.

Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.

Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.

Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.

The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Liver transplant recipient at increased risk for infection increased risk include any of the following:
* retransplantation
* renal replacement therapy (dialysis),
* post transplant abdominal surgery (within 21days)
* receipt of corticosteroids for greater than 14 days within the 4 weeks -preceding transplant
* ICU care for greater than 48 hours at the time of transplantation
* colonization with Candida sps within 4 weeks of transplantation
* requirement of 15 units or greater of packed red cell transfusions
* Intraoperative time exceeding 6 hours

Exclusion Criteria:

* Hypersensitivity to azole or echinocandin antifungal agents
* receipt of systemic antifungal therapy within 4 weeks prior to transplantation
Efficacy of Pythagorean Self-Awareness Intervention for Major Depressive Disorder

The present study explored the effects of the implementation of the Pythagorean Self Awarenes Intervention (PSAI) on patients diagnosed with major depressive disorder. The primary aim was to evaluate the effectiveness of PSAI compared to the usual care provided for adults with major depressive disorder with respect to the reduction of depressive symptoms. Secondary aims of this study included reduction of stress and anxiety, enhancement of healthy lifestyle and improvement of affect, sleep quality and cognitive functions of patients.

Study design This randomized controlled trial was conducted at the Mental Health Center of Peristeri, department of the Psychiatric Hospital of Attica, Greece, from December 2018 to January 2020. The study protocol was approved by the School of Medicine, National and Kapodistrian University of Athens (Protocol n. 1718038002/30/07/2018) and the center's directorate and was consistent with the Declaration of Helsinki. All participants were enlisted in the study only after being fully informed by the researcher about the aims and procedures of the research and submitting written consent.

Procedures Patients eligible for the above mentioned criteria were randomized in two groups: the intervention group, receiving PSAI, and the control group, receiving the usual care provided by the center for patients with MDD, namely medical treatment and counselling. Randomization was conducted based on random numbers generated by an online random number generator (https://www.sealedenvelope.com/simple-randomiser/v1/lists). This study was non-blinded, as patients and researchers were aware of the group assignment.

Eligibility Criteria:
Inclusion Criteria:

* major depressive disorder diagnosis conducted by a psychiatrist of the center according to the DSM-V criteria
* residency in Attica
* ability to speak and write fluently in the Greek language

Exclusion Criteria:

* antecedent psychotic or manic episode
* current feeding or eating disorder, obsessive-compulsive disorder, self-harming behaviors or recent suicide attempt and current drug abuse or addiction
* current treatment with Cognitive-Behavioral Therapy
* denial to participate in the research
Photobiomodulation Therapy for the Prevention of Acute Radiodermatitis in Breast Cancer Patients Undergoing Radiotherapy

Radiodermatitis (RD), an inflammatory skin reaction, occurs in more than 90 percent of cancer patients treated with radiotherapy (RT). This is the result of the radiation causing damage to the epidermal basal skin stem cells. Based on the severity of the skin symptoms, acute RD can be categorized into four grades ranging from red and dry skin to moist desquamation, necrosis, and eventually ulceration. Acute RD can be distressing, negatively influencing the patients' quality of life (QOL). In cases of severe RD, RT might be interrupted, affecting the treatment outcome.

Currently, there is no generally accepted treatment available for RD. As such, the standard skincare treatment is hospital dependent. Photobiomodulation therapy (PBMT) can offer a solution, since the therapeutic use of (infra)red light induces photochemical reactions in the target cells, stimulating repair and healing processes, and reducing pain and inflammation.

Previous studies using PBMT to prevent RD showed promising results. However, these beneficial results need to be validated in a larger breast cancer patient population receiving an alternative RT regimen. The study hypothesizes that PBMT is a safe and effective strategy to prevent worsening of acute RD grade two or higher in breast cancer patients undergoing RT. The primary objective is to measure the degree of acute RD to detect changes during and after RT. Second, the patients' QOL and pain will be assessed. Finally, the third objective is to evaluate the safety of PBMT.

The results of this project will support the implementation of PBMT into the standard RD skincare program.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma
* Treatment with primary breast-sparing surgery (lumpectomy) and/or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal therapy
* Scheduled for postoperative radiotherapy at Ziekenhuis Oost-Limburg, Genk:
* Hypofractionated radiotherapy regimen (i.e. 16 daily fractions of 2.66 Gray to the whole breast followed by a boost of 5 fractions of 2.66 Gray to the tumor bed, 5x/week)

Exclusion Criteria:

* Scheduled for postoperative radiotherapy at Jessa Hospital, Hasselt, Belgium
* Previous irradiation to the same breast
* Metastatic disease
* Concurrent chemotherapy
* Required use of bolus material to deliver radiotherapy (i.e material placed on the to-be- irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose; mostly used for treatment of superficial tumors)
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psyschological disorders, dementia, etc. of the participant
* Seizure
* Disorders triggered by lighttake anticoagulants
* Hemorrhagic diatheses
* Pregnancy
* Suspected of carrying serious infectious disease
* HIV positive history
Preoperative Anemia Frequency

In our retrospective study, it was aimed to determine the frequency of anemia in non-emergency patients over the age of 18 who applied to the Anesthesiology and Reanimation Department of our hospital.


Eligibility Criteria:
Inclusion Criteria:

* -patient over 18 years old,
* Patients applying to the Department of Anesthesiology and Reanimation AD

Exclusion Criteria:

* Pregnant,
* under 18 years old,
* will undergo cardiac and emergency surgery
* Patients with Massive Bleeding
* Patients who underwent multiple surgeries during the study period
Insertion Technique in Large Volume Paracentesis

The purpose of this study is to compare two different methods that are used for inserting the needle during paracentesis. One method is called the "coaxial insertion technique" and the other is called the "z-tract technique". Researchers would like to see which method is better and leads to less problems like oozing from the needle insertion site and pain during the procedure. Both methods are approved and currently used methods for doing a paracentesis at the University of Virginia. Which method is used generally depends on physician preference. There have been no studies done to date that compare these two methods for needle insertion.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Agreement to participate
* Patients with cirrhosis (confirmed by liver biopsy or clinically diagnosed) and ascites
* Patients presenting to UVA Digestive Health Clinic for a scheduled therapeutic paracentesis who do not have any contraindications to the procedure
* Ability to be reliably contacted by phone 24 hours following paracentesis

Exclusion Criteria:

* Prisoners
* Non-english speaking
* Paracentesis with less than 5 liters of ascitic fluid removed. (If this occurs, the specific subject encounter will be removed from the study but the subject may be included if at their next regularly scheduled paracentesis 5 liters or greater of ascitic fluid is removed.)