cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib

Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.
* Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.
* Patients scheduled for treatment with everolimus.
* Patients with at least one measurable lesion at baseline as per RECIST v1.1.

Exclusion Criteria:

* Patients who have received \>1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.
* Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
* Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
* Patients unwilling or unable to comply with the protocol.
Effect of Bariatric Surgery on Brain Insulin Sensitivity

Adiposity is associated with prediabetes and type 2 diabetes. In very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. So far the molecular mechanisms that lead to an improvement of type 2 diabetes after bariatric surgery are not fully understood. It is planned to characterize the metabolic and neuroendocrine changes in subjects before and after bariatric surgery. One special focus of the study is brain insulin resistance, a condition known to be associated with obesity with impact on the brain and whole body metabolism.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years
* planned bariatric surgery (laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy)
* stable medication 10 weeks before begin of the study

Exclusion Criteria:

* persons who wear non-removable metal parts in or on the body.
* persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
* cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
* persons with hearing impairment or increased sensitivity to loud noises
* people with claustrophobia
* minors or non-consenting subjects are also excluded
* subjects with an operation less than 3 months
* neurological and psychiatric disorders
* subjects with hemoglobin Hb \<11 g / dl
* hypersensitivity to any of the substances used
Urine-DNA Biomarkers in Detecting Bladder Cancer

DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. Many genetic alterations have been identified in the urinary DNA. However, not all bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach satisfactory sensitivity and specificity a new diagnostic test should include multiple biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross hematuria for cystoscope.

Urinary DNA representative of the tumour genome provide a promising resource as a liquid biopsy for non-invasive genomic profiling of urothelial bladder cancers. Voided urine samples will be collected prior to cystoscopy. Cell free DNA and cellular DNA will both be extracted and analyzed. A blood sample will be taken. In patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken and submitted for histopathology examination, according to clinical standard practice. Next generation sequencing will be applied and hotspots mutations in DNA from urine, blood and tumor. Logistic regression was used to analyze the association between predictor variables and bladder cancer. The investigators will confirm a couple of common mutations occured in urine-DNA and blood-derived DNA simultaneously and verify the specificity and sensitivity of individual variance or mutation combinations to establish an predictive model with optimal robustness in diagnosis of bladder cancer. Moreover, external consistency test will be performed on subsequent patients collection.

Eligibility Criteria:
Inclusion Criteria:

* patients with gross hematuria or other clinical sympton suspected of bladder cancer.
* male or female patients aged \>= 18 years.
* available tumor tissue, urine and blood sample.
* signed informed consent form.

Exclusion Criteria:

* prior diagnosis of cancer except bladder cancer
* age under 18 years
* individuals unwilling to sign the IRB-approved consent form
* comorbidities that would prohibit or make serial urine collection and cystoscopy examine difficult or impossible.
Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System

The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.


Eligibility Criteria:
Key Inclusion Criteria:

* At least 21 years old
* Underwent a 1. primary total knee replacement (TKR), 2. secondary/revision TKR or 3. Partial/unicompartmental knee replacement (PKR)
* Knee pain directly resulting from Knee Replacement surgery in affected knee

Key Exclusion Criteria:

* Current high opioid use
* Body Mass Index (BMI) \> 40 kg/m2
* Conditions with increased risk of infection
* Implanted electronic device
* History of bleeding or clotting disorder.
* Uncontrolled Diabetes Mellitus Types I or II
* Pregnancy
[11C]NOP-1A and Cocaine Use Disorders

The goal of this study is to compared \[C-11\]NOP-1A binding in recently abstinent cocaine use disorders and controls.

This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse of cocaine in humans.

Eligibility Criteria:
\[A\]Cocaine use disorders

Inclusion criteria:

1. Males or Females 18-50
2. Fulfill DSM-5 Diagnosis for Cocaine use disorder
3. Medically Healthy

Major exclusion criteria:

1. Pregnancy or lactation
2. Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use)
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain (e.g., morphine, suboxone, SSRIs, etc.)

\[B\] Healthy controls

Inclusion criteria:

1. Males or Females 18-50
2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
3. A negative urine drug screen
4. Medically Healthy

Major exclusion criteria

1. Pregnancy or lactation
2. Medical, psychiatric or drug \& alcohol use disorders
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain
6. Family history of a psychotic disorder, manic episode, drug use disorders in first-degree relatives.
Prehospital Provider Training With Augmented Reality (AR)

The goal is to evaluate the acceptance of Augmented Reality (AR) simulation as a learning modality for prehospital providers. The simulation itself is grounded in traditional best practices for simulation delivery and design as well as prior literature on simulation training for prehospital providers; the focus of this study is the participants' experiential interaction with AR and the simulation resources.


Eligibility Criteria:
Inclusion Criteria:

* Trainees/ faculty working and/or volunteering at LPCH/SHC facilities as well as community based prehospital providers
* 18 years and older

Exclusion Criteria:

* Participants who do not consent
* Have a history of severe motion sickness
* Currently have nausea
* History of seizures
* Are clinically unstable
* Currently using corrective glasses (not compatible with AR headset)
* Currently pregnant
Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital

Background: Nicotine contained in tobacco is highly addictive and tobacco use is a major risk factor for cardiovascular and respiratory diseases. Every year, more than 8 million people die from tobacco use.

Smoking-related mortality is significantly higher in people with serious mental illness. Is estimated that half of all deaths among individuals with mental illnesses are attributable to tobacco use. People with serious mental illness have greater daily tobacco consumption, nicotine dependence, and smoking relapse. While significant progress has been made in reducing tobacco use within the general population, rates of tobacco use remain high among individuals with mental illness. Smoking cessation often requires numerous attempts by these people. Thus, smokers with mental health illnesses may find it more difficult to quit, although highly motivated to quit.

Smoking cessation during hospitalization (total or partial) is cost-effective, as it reduces hospital readmissions, and mortality, and improves smokers' quality of life. Available quitting aids are both safe and effective in supporting cessation in tobacco users with mental illness and stopping smoking is associated with an improvement in mental health.

The investigators aimed to evaluate the feasibility and efficacy of adding an intensive smoking intervention to the usual treatment for patients with psychiatric disorders attending a day hospital of a tertiary hospital.

The investigators will perform a quasi-experimental, longitudinal, and prospective study in the mental health day hospital of the Hospital Clinic of Barcelona.

Adults attending the day hospital and willing to participate, under informed consent, will be invited to participate. Consecutive eligible individuals will be recruited and will be assigned to two groups, the control group, and the experimental group. Initially, patients will be recruited for the control group, once the control group is completed the experimental group will begin.

An assessment will be conducted at baseline (admission) and in the discharge. Sociodemographic and clinical data will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Mental health day hospital inpatient.
* Smoker of at least 1 cigarette per day, electronic cigarette, or heated tobacco product daily for at least 1 month.
* Individuals who accept to participate in the study and give informed consent.

Exclusion Criteria:

* Cognitive impairment, dementia, or brain damage.
* Medically unstable.
* Explicitly demanding tobacco treatment.
* Trying to quit smoking using another intervention.
* Insufficient comprehension skills in Spanish or Catalan.
Blood Glucose Monitoring Systems: Discounter Versus Brand

This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, with clinical indication for blood glucose measurement
* Signed informed consent form
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study.

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute disease (at the study physician's discretion)
* Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion)
* Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
* A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197)
* Being unable to give informed consent
* \< 18 years
* Legally incompetent
Study Comparing Remission Rates, in Patients With Major Depressive Disorder (MDD)

Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's response to treatment. The purpose of this study is the evaluation of the remission rates for patients with MDD. The evaluation will involve the use of HAM-D 17, and HAM-D 7 questionnaires and the comparison of those questionnaires.

12 weeks random

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* 18-75 years old
* Patients diagnosed with MDD according to DSM IV without psychotic symptoms
* HAM-D17 \> or = 18 on inclusion
* Patients receiving treatment for the first time or changing treatment based on their doctor's decision

Exclusion Criteria:

* Subjects with potentially problematic compliance
* Subjects participating in an interventional trial within the last 3 months
Evaluation of The Accuracy of CAD-CAM Custom Made Titanium Miniplates In Positioning of the Genial Segment in Computer Guided Genioplasty

In patients with chin deformeties, will using a custom made titanium plate in the positioning of the genial segments give an accurate results in comparison to the preoperative planned osteotomy and move of the Genioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients with genial deformeties that require surgical correction.
* Patients with chin asymmetry.
* Patients older than 18 years old.

Exclusion Criteria:

* Patients with uncontrolled systemic disease (Diabetes Mellitus).
* Previous Radiotherapy to the area of interest.
* Patients on bisphosphonates therapy.
* Patients underwent previous or concomitant mandibular orthognathic surgery.
Women's Quality of Life, Sexual Life and Psychological State in Patients Undergoing Embryo Transfers

Women's quality of life, sexual life and psychological state would affect the success of embryo transfer. The primary purpose of the study is to compare women's quality of life, sexual life and psychological state using validated forms between those undergoing fresh embryo transfer and those undergoing frozen embryo transfer.

There are two types of embryo transfers; fresh and frozen embryo transfers. Studies have been conducted to compare success rates between fresh and frozen embryo transfers. However, most studies have not taken into consideration women's quality of life, sexual life and psychological state in comparing fresh embryo transfer with frozen embryo transfers. These all parameters are confounding factors that may influence the success of embryo transfer. The purpose of this study is to compare women's quality of life, sexual life and psychological state using validated forms between those undergoing fresh embryo transfer and those undergoing frozen embryo transfer. The following forms will be used: expanded version of the inventory of depression and anxiety symptoms (IDAS-II), Beck Anxiety inventory (BAI), Short Form Survey (SF-36) and Female Sexual Function Index (FSFI. This study can provide evidence regarding the association between women's quality of life, sexual life and psychological state and embryo transfer success.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 - 39 years
* Body mass index between 18 -3 5 kg/m2
* Anti-mullerian hormone levele \>1.1 ng/ml or antral follicle count \> 8
* fresh or frozen embryo transfer using middle-quality or good-quality day 3 or 5 embryos

Exclusion Criteria:

* Age below 20 or over 39 years
* Uterine malformations
* Hypo or hyperthyroidism
* Diabetes mellitus
* Previous history of psychiatric disorders
* Use of psychiatric medications
* Systemic disorders (hypertension, chronic liver/kidney/heart problems)
Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder.

Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity.

Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9).

Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.


Eligibility Criteria:
Inclusion Criteria:

* All patients involved in this clinical trial will have symptomatic OLP

Exclusion Criteria:

* Smokers or tobacco users will be excluded from this clinical trial.
* Pregnant and lactating females.
* Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study.
* Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded.
* Any patients presenting with extra oral lichen planus lesions will be excluded.
* Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded.
* Vitamin administration intake within the last 3 months
FAmily CEntered (FACE) Advance Care Planning for Teens With Cancer

Advance Care Planning (ACP) prepares patients and their loved ones for future health care decisions, including end-of-life decisions. Yet, the needs of adolescent oncology patients for participation in ACP, despite its priority, is not well studied. Our goal is to test a model of ACP that anticipates these issues, fully empowers the family and adolescent, and keeps the key role of health care professionals central, building on our earlier work. We hypothesized FAmily CEntered (FACE) ACP, would: (1) increase congruence in treatment preferences between adolescents and surrogates; (2) decrease decisional conflict for adolescents; and (3) increase quality of communication compared with controls.

Condition The purpose of the FACE intervention is to facilitate conversations about EOL care between adolescents and their legal guardians or surrogates in order to increase congruence in treatment preferences, to decrease decisional conflict, while supporting plans and actions, psychological adjustment and quality of life. This intervention will consist of three 60 to 90-minute sessions in a dyadic format with a trained/certified interviewer. Each session will be followed by a 15 minute assessment, using process measures to assess participants' ratings of the quality of the communication with the facilitator and satisfaction (negative and positive emotions in response to session) on a Likert scale. A research assistant, not the facilitator, will conduct the immediate post evaluation sessions. A Standard of Care comparison condition will also be assessed and measures administered at the same time intervals: at baseline, one week intervals for three weeks for process measures and Statement of Treatment Preferences, and at 3 month-post intervention follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥14.0 years and \<21.0 years for adolescents at enrollment;
* Age ≥ 21.0 years for surrogates at enrollment;
* IQ \> 70 or not known to be developmentally delayed;
* Depression score on Beck Depression Inventory, Second Edition (BDI-II) Total Score \< 26;
* Primary language English

Exclusion Criteria:

* In foster care;
* Developmentally delayed;
* Suicidal or homicidal or psychotic at time of screening;
* Not understand or speak English; and
* Failure on mini mental status exam
Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit?

There is little research on the effect of oral screening campaigns for improving oral health in older people. Therefore, the aim of this study is to investigate the effect of a low-threshold contact with an oral health professional, including an oral health examination, on dental attendance of older people (65 years of age or older).

The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.

In the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions.

In this way, we want to find out whether the presence of a dental professional with tailored advice is crucial to motivate an elderly person to good oral care.

Eligibility Criteria:
Inclusion criteria:

* 65 years of age or older
* home-dwelling within the selected regions (ELZ RITS en ELZ Scheldekracht)
* Dutch speaking
* no dental check-up in the last 12 months
* sufficient cognitive ability to answer the questions

Exclusion criteria:

- Failure to meet inclusion criteria
Inflammatory Myopathies in Primary Sjögren's Syndrome

The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS).

Muscle disease is associated with pSS, but this association is not well defined. The AMISS study, a retrospective observational multicentric study, will recruit patients with pSS and muscle involvement in order to characterize in details the features of this association (epidemiological aspects, clinical presentation, biological, radiological and histological findings, treatments and outcomes).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Primary Sjögren's syndrome according to the ACR/EULAR classification criteria
* inflammatory muscle involvement, as diagnosed by the treating physician

Exclusion Criteria:

* Diagnosis of inflammatory myopathy before the diagnosis of pSS