cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost

Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT \& hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.


Eligibility Criteria:
Inclusion Criteria:

* minimum age 18
* expectance of life at least 6 months
* Karnofsky-Score \> 50
* 1-3 vertebral body metastases
* Up to 5 other, macroscopic metastases
* effective contraception
* geographic reachability of patients
* Signed study-specific consent form prior to therapy
* no on-treatment participation on other trials

Exclusion Criteria:

* initial required neurosurgical decompression
* rapid, neurological deterioration
* prior radiotherapy of region for planned radiation
* conditions that preclude the application of magnetic resonance tomography
* malignancy: multiple myeloma or lymphoma
* technical conditions preclude stereotactic irradiation (technical limitations of device)
* pregnant or nursing women
* Fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients that are not able or willing to behave according to study protocol
* absent attendance for personal, disease related data storage and transfer
* on-treatment participation on other trials
Photoallergy Potential of Dapsone Gel in Healthy Volunteers

This study will evaluate the potential of dapsone gel and its vehicle to cause a photoallergic reaction after repeated application and irradiation to the skin of healthy volunteers under controlled conditions.


Eligibility Criteria:
Inclusion Criteria:

-Healthy adults.

Exclusion Criteria:

* Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application
* Sensitivity to adhesive bandages or tape.
Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)

This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).


Eligibility Criteria:
Inclusion Criteria:

* Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
* Patient has measurable disease
* Patient has accessible tumor and consents to undergo a tumor biopsy \[Part II only\]
* Patient is 18 years of age or older
* Patient has a performance status of 0-2 on ECOG scale
* Women of childbearing potential have a negative pregnancy test
* Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
* Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease

Exclusion Criteria:

* Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
* Patient has not recovered from adverse events from previous therapy within 4 weeks
* Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
* Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
* Patient has untreated brain metastases
* Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
* Patient is taking part in another clinical study
* Patient abuses drugs or alcohol
* Patient is pregnant or breastfeeding
* Subject is HIV positive
* Patient has active hepatitis
* Patient is using growth hormone or growth hormone inhibitors
* Patient has poorly controlled diabetes mellitus
Repetitive Transcranial Stimulation (r-TMS) Treatment for Patients With Parkinson's Disease

The purpose of this study is to test the effects of deep rTMS using the novel H-coil on the motor, affective and cognitive deficits in patients with Parkinson's disease (PD) and to establish its safety in this population.

Study rational:We anticipate that reaching deeper brain layers and larger volume of activation with the novel H-coil may induce significantly better therapeutic effects in patients with PD and will pave the way for establishing a novel and effective treatment for this disorder.

Design:A prospective, double blind sham-controled study. No. of centers:1 One: Tel-Hashomer Medical Center, affiliated to Sackler school of Medicine, Tel -Aviv University, Israel.

Study Population:Forty patients with idiopathic PD, Hoehn and Yahr stages II to IV, on stable antiparkinsonian therapy, with partial response.

Study Duration:Two years

Eligibility Criteria:
Inclusion Criteria:

* PD patients aged 40 years or older, diagnosed as idiopathic PD according to the UK Brain Bank criteria, with Hoehn \& Yahr stages II - IV while "off". Participants on antidepressants should be at least 2 months on stable therapy.

Exclusion Criteria:

* Patients who have concomitant epilepsy, a history of seizure or heat convulsion or history of epilepsy in first degree relative.
* Patients on neuroleptics.
* Patients with dementia or any unstable medical disorder.
* History or current hypertension.
* History of head injury or neurosurgical interventions.
* History of any metal in the head (outside the mouth).
* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
* History of migraine or frequent or severe headaches.
* History of hearing loss.
* The presence of cochlear implants
* History of drug abuse or alcoholism.
* Pregnancy or not using a reliable method of birth control.
* Participation in current clinical study or clinical study within 30 days prior to this study.
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other

This study will determine whether a specialized Web site geared for the guardians of children whose one parent has murdered the other can increase guardian capabilities, reduce guardian stress, and improve child behavior and mental health.

Intraparental homicide (IPH), when one parent kills the other, leaves approximately 4,000 children bereaved each year, adding to a total of 70,000 currently in the United States. Although few studies have focused on this phenomenon, available data indicate children of IPH suffer short- and long-term mental health consequences, including post-traumatic stress disorder (PTSD). Prior research also indicates that guardians, often family members under stress themselves, do not know how to help the children. No interventions directed at guardians of child survivors of IPH are found in scientific and clinical literature. Use of a specialized Web site called an Interactive Healthcare Communication Application (IHCA) has been found effective in treating multiple health conditions, including breast cancer in women and asthma in children. This study aims to refine an IHCA Web site for use by guardians of child survivors of IPH, to determine the safety and effectiveness of this Web site, and to determine how it is used by targeted guardians.

In the first phase of this study researchers will develop the IHCA based on feedback from a small focus group of guardians of child survivors of IPH. Then guardians of survivors of IPH up to 16 years old will be randomly assigned either to receive access to the IHCA created for them or to have access only to generally available Internet information. The IHCA will have six components: (1) an Instant Library of articles on topics of interest; (2) a resource directory of both national and local support and service organizations; (3) access to a peer communication system; (4) a Frequently Asked Questions section, updated with responses to user generated questions; (5) an "Ask an Expert" system staffed by researchers; and (6) personal stories of others dealing with IPH. Participants with access to the IHCA will receive print and phone instructions explaining the Web site and have their usage monitored by tracking software. Those in the control group will be directed to a Web site linking to publically available, pre-existing support Web sites. After 16 weeks of unlimited access to the IHCA or control group Web sites from their home computers, all participants will complete four evaluation reviews: the Family Crisis Oriented Personal Evaluation Scales, the Parenting Stress Index, the Child Behavior Checklist, and the Child PTSD Inventory - Parent.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and read English at a 7th grade level
* Guardian of a child survivor of parental homicide aged 0 to 16 years

Exclusion Criteria:

* None
Immunotherapy in Uncommon and 20ins EGFR-mut Lung Cancers

Immunotherapy effectiveness and optimal combination strategy in lung cancers with EGFR uncommon and 20ins mutations was unclear. Based on 627 lung adenocarcinoma patients harboring EGFR mutations and receiving immunotherapy, we reported that patients with EGFR uncommon mutations had better response to immunotherapy, than EGFR 19del/L858R or 20in mutations. Immunotherapy monotherapy or plus chemotherapy was identified as better combination strategy for EGFR uncommon or 20ins mutations, respectively. Higher tumor mutation burden, more M1 macrophage, less Tregs and M2 macrophages infiltration, but not PD-L1 expression was found to be associated with EGFR uncommon mutations, compared to EGFR 19del/L858R or 20in mutations. These findings revealed diverse response and optimal combination strategy of lung adenocarcinoma patients harboring EGFR mutation subtypes, promoting rethinking about current immunotherapy application and prolonging survivals of them.


Eligibility Criteria:
Inclusion Criteria:

1. age≥18 years,
2. advanced or recurrent LUAD confirmed by pathology,
3. harboring EGFR mutations confirmed by super amplification refractory mutation system (super-ARMS) or next-generation sequencing (NGS),
4. receiving anti-PD-(L)1 antibody therapy at least once,
5. Radiologically evaluable according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)

Exclusion Criteria:

-
Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response

The purpose of this study is to see if new techniques of measuring HNSCC tumors with magnetic resonance imaging (MRI) can help predict how well the tumors will respond to combined chemotherapy and radiation treatment. The investigators hope to find a reliable method to determine whether or not a patient's cancer is responding to chemo-radiation early in their treatment using an MRI, such that that cancer treatments could be tailored to the individual more effective in the future. The MRI techniques include dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), diffusion-weighted magnetic resonance imaging (DW-MRI), and magnetic resonance spectroscopy (MRS). Participants will be subjected to two sessions of MRI scans: one before the initiation of their regular treatment and the second before their second cycle of chemotherapy. Each scanning session will last approximately 45 minutes.

DCE-MRI, DW-MRI, MRS have the potential to measure early cellular changes that occur in response to successful therapies, such as chemoradiation, and have been demonstrated to be early predictors not only of therapeutic response, but also of overall survival for other malignancies. Our long-term goal is to use these imaging techniques to develop non-invasive functional imaging methodologies that would be better predictors of pathological response than the current clinical standard.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of loco-regionally advanced (stage III or IV) squamous cell carcinoma of the head and neck (oropharynx, hypopharynx and larynx)
* Age \> 18 years
* No prior surgery, chemotherapy or radiation therapy for head and neck cancer
* Scheduled to receive chemoradiation for definitive therapy

Exclusion Criteria:

* Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia)
* Contraindications to gadolinium
* Severe, active co-morbidity
* Major medical illnesses or psychiatric impairments
* Pregnant or nursing women
Beliefs, Attitudes, and Response to Genetic Testing in SarcomaPatients

Genomic research has shown that a portion of leiomyosarcomas can be attributed to an underlying cancer predisposition syndrome. However, the optimal approach for incorporating germline testing into the care of these patients. This study is assessing the beliefs about the heritability of leiomyosarcoma and other cancer risks, and attitudes towards germline testing among leiomyosarcoma patients.

This is a descriptive study to explore attitudes to genomics and return of genetic information and examine the cognitive and affective impact of receiving germline genetic information among LMS patients and their family members.The present study will aim to do the following:

* Assess leiomyosarcoma (LMS) patients' beliefs and attitudes about the heritability of LMS and their interest in genetic testing.
* Among LMS patients who undergo genetic testing, evaluate the cognitive, affective, and communication outcomes of genetic testing in LMS patients found to have actionable germline germline pathogenic variants (PVs).
* Evaluate family members' beliefs and attitudes about the heritability of reasons for undergoing genetic testing and responses.

Prior studies of cancer patients have found a strong interest in genetic testing so at-risk relatives will have the opportunity to have increased cancer screening or take risk-reducing measures to prevent cancer. However, the genes most strongly associated with LMS are tumor protein 53 (TP53) gene and Retinoblastoma 1 (Rb1) gene. These genes cause risks for cancers that families may be less familiar with and that have less well-established approaches for screening and prevention.

LMS may not be the most significant cancer risk related to the syndrome associated with the PV identified. The finding of risk for other non-LMS cancers may be unexpected and incongruent with the family's experience or focus on the LMS being treated. Screening recommendations for relatives testing positive for these PV will generally be given cancer screening recommendations targeted towards risks for cancers other than LMS.

Patients beginning or in the midst of cancer treatment may be less able to share and effectively communicate about genetic test results to patients. We need to better understand how patients and family members respond to findings to maximize the clinical benefit of this information and support family communication.

LMS patients will be identified by querying the enterprise data warehouse (EDW) and Huntsman Tumor Registry and prospectively by reviewing clinic and tumor board lists.

Eligibility Criteria:
Inclusion LMS Proband

* Actionable germline PV detected in the research context
* Living
* No prior germline testing for this PV
* Able to speak and read English
* Mentally competent
* Age 18 or older

Relative of LMS Proband

* 25-50% chance for having inherited the PV
* No prior germline testing for this PV
* Able to speak and read English
* Mentally competent
* Age 18 or older

Exclusion (both cohorts)

* \<18 years
* Unable to read or write
The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence

Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.

Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.

Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation.

Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.

Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.

The mid-urethral sling (MUS) has become the preferred procedure, as it is less invasive than the Burch colposuspension. However, the MUS procedure has a 5-20% failure rate and carries risks such as infection, voiding dysfunction, hemorrhage, pain, bladder or urethral injury, and mesh erosion.

Hence, there is a need for alternative efficacious, outpatient SUI treatments. Platelet-derived therapies are a growing trend across multiple medical and surgical specialties. Evidence suggests that platelets play an important role in tissue repair, vascular remodeling and inflammatory and immune responses through secretion of growth factors, cytokines, and chemokines.

These biologically active proteins include transforming growth factor-β, platelet-derived growth factor, platelet-derived epithelial growth factor, insulin-like growth factor, vascular endothelial growth factor. These growth factors are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation. The key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing.

One of the most well-described platelet-based therapies is autologous platelet-rich plasma (PRP). PRP is derived from the centrifugation of whole blood with a separator gel to remove the red and white blood cells. The resulting supernatant has a greater than four-fold increase in platelets and other plasma proteins. This concentrate is then administered via injection.

Eligibility Criteria:
Inclusion Criteria:

* Female patient with mild to moderate SUI

Exclusion Criteria:

* Under anti-platelet agent treatment
* Platelet dysfunction syndrome
* Critical thrombocytopenia
* Acute and chronic infections
* Anti-coagulation therapy
* History of malignancy
Effectiveness Gastric Balloon in Obese Adolescents

Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.


Eligibility Criteria:
Inclusion Criteria:

* Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI \> 3.5 SD)
* Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised

Exclusion Criteria

* Previous esophageal or gastric surgery or history of intestinal obstruction;
* History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis
* Hiatus hernia \>5 cm or \<5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion);
* History of significant psychological disorder (permission sought from lead care giver).
Examining the Effect of Mental Health Disorders on Vascular Function and Exercise Tolerance

Specific Aim #1: Examining the impact of mental health disorders (PTSD and GAD) on peripheral vascular function and sympathetic nervous system activity in young individuals.

Specific Aim #2: Examining the impact of mental health disorders (PTSD and GAD) on peripheral hemodynamics and metabolic byproducts during small muscle mass exercise in young individuals.

Specific Aim #3: Examining the impact of mental health disorders (PTSD and GAD) on exercise tolerance, peripheral hemodynamics and metabolic byproducts during large muscle mass exercise in young individuals.

Mental health disorders are highly prevalent and underdiagnosed and can cause perturbations in cardiovascular and metabolic function leading to substantial individual burden (increased health care cost, loss of work productivity). Post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD), two common mental health disorders, can cause increase cardiovascular disease risk due to chronic increases or fluctuations in heart rate, blood pressure, stress hormones, inflammation, and oxidative stress. Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by a persistent maladaptive reaction resulting from exposure to severe psychological stress. It has been revealed that individuals with PTSD, in addition to adverse mental health symptoms, also possess higher prevalence rates for physical comorbidities such as hypertension, obesity, diabetes, and metabolic syndrome. Taken together, these PTSD-induced comorbidities result in a significant increase in the likelihood of developing cardiovascular disease (CVD) when compared to individuals without PTSD. Anxiety disorders, the most prevalent mental health issue in the United States, is associated an increased incidence of hypertension and heart disease. This increased cardiovascular disease (CVD) risk is thought to derive from an overactivation of the sympathetic nervous system that results in a predominately pro-oxidant, pro-inflammatory cardiovascular environment. Peripheral vascular dysfunction, or the inability of the blood vessels to adequately respond to specific stimuli, is a factor closely related to CVD. Therefore, this study will focus on a younger population with PTSD or GAD in an attempt to ascertain the presence of peripheral vascular dysfunction and the magnitude to which two potential primary contributors (autonomic dysfunction, oxidative stress) are involved in this dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
* for PTSD group, a score of ≥ 33 on PCL-5 checklist
* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale

Exclusion Criteria:

* taking medications that could influence cardiovascular function
* limited English proficiency