cyrilzakka/clinical-trials huggingface dataset:
Patient Navigation and Tailored Treatment Planning in Latina Patients With Breast Cancer

This research trial studies how well patient navigation and tailored treatment planning work in Latina patients with breast cancer. Patient navigation and tailored treatment planning may provide extra support by guiding patients through the healthcare system, remove barriers to care and provide ease of access to essential resources, encourage patient participation in their care, provide in-language summaries and plans for follow-up care, improve patient access to needed supportive care services and may improve general healthcare experience in Latina patients with breast cancer.

PRIMARY OBJECTIVES:

I. Successful navigation of patients being screened or treated for breast cancer through the continuum of their care (from visit to visit; from surgical care to radiologic care to oncologic care; from oncologic care to supportive care; etc).

II. Supply individualized in-language treatment summaries and follow-up care plans to enrolled patients.

III. Supply tailored in-language survivorship plan summaries to enrolled patients.

OUTLINE:

Patients receive treatment summaries and plan report that captures patient data through the use of an "intake checklist" completed during the initial consultation with the breast oncology team and used to guide referrals to existing services and programmed with generic information related to disease and treatment management plan. Additional elements, such as psycho-social services, exercise, and/or nutrition, identified by the patient self-report, will be incorporated. Patients also complete 3 questionnaires at each clinic visit.

After completion of study, patients are followed up at 6 months or 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving ongoing care at LAC+USC
* Self-identified as Latina (or Hispanic)
* Known or suspected breast cancer
* Being seen in a breast cancer high risk, screening or prevention program or clinic or in one of the breast cancer clinics (surgical or medical oncology)

Exclusion Criteria:

* Inability to sign informed consent or complete questionnaires and forms
* Self-identified as non-Latina (or non-Hispanic)
A Phase II, Multi-Center, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Sorafenib Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma

The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

Issues on "Safety" outcomes are addressed in the Adverse Event section.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced, metastatic, histologically confirmed melanoma, for whom treatment with dacarbazine is considered medically acceptable
* Age \>= 18 years
* Subject has measurable and evaluable disease defined as at least one metastatic lesion that can be accurately and serially measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan as per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Cutaneous lesions measuring at least 20mm in longest diameter can be considered measurable (and therefore target lesions) via color photography including a ruler
* Subject has biopsiable disease at baseline and is willing to provide biopsy samples, or does not have biopsiable disease at baseline
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Primary ocular or mucosal melanoma (cutaneous vulval melanoma is permitted)
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry
* (Active coronary artery disease or ischemia (myocardial infarction more than 6 months prior to study entry is allowed)
* Uncontrolled hypertension (\> grade 2 National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0)
* Active, clinically serious infections (\> grade 2 NCI-CTCAE version 3.0)
* Subjects with seizure disorder requiring medication are excluded
* History of or suspected Human Immunodeficiency Virus (HIV) infection, or chronic hepatitis B or C
* Symptomatic metastatic brain or meningeal tumors unless the subject is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. Also the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies)
* Pregnant or breast-feeding subjects
Personalized Active Immunotherapy (Vaccine Therapy) and Sargramostim Given After Standard of Care Treatment With Rituximab and Chemotherapy for Initial Treatment With Lymphoma

The treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. Personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. Sargramostim (a.k.a. GM-CSF) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy.

This approach has previously been studied in patients with follicular Non-Hodgkin's lymphoma and other B-cell malignancies. Encouraging efficacy results and a favorable safety profile have been seen to date in these studies.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Previously untreated follicular NHL
3. Stage III or IV disease requiring treatment
4. Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin)
5. Able to provide tumor sample adequate for Id-KLH manufacture
6. ≥ 18 years of age
7. At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan
Graston Technique Versus Kinesio Taping on Myofascial Pain Syndrome After Neck Dissection Surgery

This study was conducted to investigate the effect of Graston technique versus Kinesiotaping on myofascial pain syndrome after neck dissection surgery.

Fifty two patients from both genders who had cervical Myofascial pain syndrome following a neck dissection surgery participated in this Study. Their ages ranged from 30 to 50 years. They had been selected from the National Cancer Institute, Cairo University. They were assigned randomly into two groups (A) and (B), equal in number. Group (A) received Graston technique (IASTM), in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 12 Sessions performed in a period of 4 weeks (three times weekly). While Group (B) Received kinesiotaping, in addition to traditional treatment (range of motion exercises, stretching exercises and strengthening exercises) for 8 sessions performed in a period of 4 weeks (twice weekly). Pressure pain threshold, visual analogue scale and cervical lateral flexion and rotation were measured pre and post 4 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* The subjects were selected according to the following criteria:

The patient's ages ranged from 30 to 50 years participated in this study. Both genders participated in this study. All patients had a history of MPS at UTM from 3 to 5 months. All patients had moderate to severe pain (VAS score \>4). Informed consent was obtained from every patient enrolled in the trial. All patients had myofascial pain syndrome after unilateral modified radical neck dissection surgery.

Exclusion Criteria:

* The potential participants were excluded if they meet one of the following criteria:

A wound in the affected area A cervical disk lesion Myelopathy or radiculopathy Cervical spine fracture or spondylolisthesis Rheumatoid arthritis Epilepsy or any psychological disorders Contraindications to IASTM. Contraindications to Kinesiotaping. Coagulopathy. Hemophilia or other clotting disorders.
Study of Oral Papillomavirus In Teens and Twenties

Recently human papillomavirus (HPV) has been recognized to cause some oropharyngeal (tonsil) cancer. But very little is known about oral HPV infection and risk factors. This study will evaluate how common oral HPV infection is, what sexual behaviors are associated with risk for infection, and how long infections tend to last.

18-25 year old individuals are being recruited from STD clinics in Baltimore County and followed every three months for this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 -26 years

Exclusion Criteria:

* Never received HPV vaccine (Gardasil or Cervarix)
An Open-Label Treatment Protocol to Provide Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

This is an open-label study to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy. This study intends to provide guidance to investigators with respect to identification of appropriate subjects for metreleptin treatment, guidance on metreleptin dosing, and collection of safety and efficacy data following metreleptin treatment in this population


Eligibility Criteria:
Inclusion Criteria:

* Is male or female ≥5 years old
* If female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):

  1. Not breastfeeding
  2. Negative pregnancy test result
  3. Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (Double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.)
* Has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation
* Has been diagnosed with at least one of the following 2 metabolic disorders:

  1. Diabetes Mellitus
  2. Hypertriglyceridemia as defined by fasting triglyceride concentrations \>200 mg/dL
* If ≥18 years of age, is able to read, understand, and sign the Informed Consent Form (ICF) and an Authorization to Use and Disclose Protected Health Information form, communicate with the investigator, and understand and comply with protocol requirements
* If \<18 years of age, has a parent or legal guardian to read and understand the ICF and Child Assent Form, communicate with the investigator, and understand and comply with protocol requirements. Adolescent subjects must also read and understand the Child Assent Form; if the child is too young or unable to read, then the Child Assent Form must be explained to the child.

Exclusion Criteria:

* Has been diagnosed with HIV infection
* Has known infectious liver disease
* Has known allergies to E. coli-derived proteins or hypersensitivity to any component of study treatment
High Light and Low Light Dose PDT in Glioma

RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.

PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic therapy using porfimer sodium to compare how well they work in treating patients who are undergoing surgery for recurrent malignant astrocytoma.

OBJECTIVES:

* Compare survival of patients undergoing surgical resection for recurrent high-grade malignant supratentorial astrocytoma treated with intraoperative high vs low light dose photodynamic therapy using porfimer sodium.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.

* Arm I: During surgery, patients receive low light dose photodynamic therapy.
* Arm II: During surgery, patients receive high light dose photodynamic therapy. After completion of study treatment, patients are followed at 1 day, 6 weeks, and 3 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 4-5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant supratentorial astrocytoma, glioblastoma, or mixed oligo-astrocytoma

  * Grade 3 or 4 tumor, defined as presence of ≥ 2 of the following features:

    * Nuclear atypia
    * Mitosis
    * Endothelial proliferation
    * Necrosis
* Recurrent disease

  * Failed prior surgery and radiotherapy
* Tumor suitable for radical resection by imaging studies

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 60-100%

Life expectancy

* At least 3 months

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* Willing to avoid direct sun-light exposure for 6 weeks after photodynamic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics

Surgery

* See Disease Characteristics
The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.

Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.

In this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal Tecnis ZLB00 IOL, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation Procedure was performed 1, 3, 6 months postoperatively. Main Outcome Measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.

Eligibility Criteria:
Inclusion Criteria:

* corneal astigmatism less than 1 diopter

Exclusion Criteria:

* ocular pathology others than cataract
Determine If the Stress That Comes With Not Developing an Erection Affects Tadalafil Effects

To determine if patients who are distressed over having problems getting or maintaining an erection react differently to the medication than those who are not stressed over the issue.


Eligibility Criteria:
Inclusion Criteria:

* 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* Nitrate use
* Participated in previous tadalafil study or have a current tadalafil prescription
* Heart attack within the last 90 days
* Kidney problems
* Certain heart problems
Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Teleangiectasia Patients

The study has the aim to evaluate the improvement in CNS symptoms measured by International Co-operative Ataxia Rating Scale (ICARS) in patients with ataxia teleangectasia (AT), during a period of treatment with ERY-DEX (dexamethasone sodium phosphate ex vivo encapsulated into human autologous erythrocytes).

This is a multi-centre, single arm, open label, 6 months, phase II study to evaluate the effect of ERY-DEX in improving Central Nervous System (CNS) symptoms in patients with Ataxia Teleangectasia (AT). The study consists of a screening period (max duration of 30 days) and a treatment period (duration 6 months).

Eligibility Criteria:
Inclusion Criteria:

* neurological signs of AT
* patients in autonomous gait or helped by a support
* proven molecular diagnosis of AT
* Males and females aged \> 3 years
* Body weight \>15 kg
* Plasma levels of Lymphocytes CD4+/mm3 \> 500 (for patients aged 3-6 years) or \> 200 (older than 6 years)
* written IC to participate.

Exclusion Criteria:

* Current or previous neoplastic disease
* History of severe impairment of the immunological system
* Chronic conditions representing a contraindication to the use of steroid drugs
* Non compliance with the study request
* Any previous steroid assumption within 30 days before starting ERY-DEX
* Have any other significant disease that in the Investigator's opinion would exclude the patient from the trial
* Females of childbearing potential who were pregnant, breast-feeding or were not using adequate contraceptive methods
Effects of Prostate Cancer on Brain Function

To explore whether the patients with prostate cancer have functional changes in specific brain areas and changes in psychological and mental characteristics compared with the patients without prostate cancer.

This study was intended to observe the functional changes of brain fMRI in patients with and without prostate cancer enrolled in the cohort of patients who planned to undergo prostate biopsy, in an attempt to discover specific brain region changes in patients with prostate cancer, and lay a foundation for further clarifying the relationship and mechanism between brain region function changes and prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 80
2. Patients with prostate biopsy;
3. No history of other malignant tumors;
4. Exclude other malignant tumors;
5. Fully understand the clinical trial protocol and sign informed consent;

Exclusion Criteria:

1. magnetic resonance contraindications;
2. symptomatic acute or chronic inflammation of the prostate;
3. Patients with brain trauma or brain disease;
4. Patients who have died of other malignancies in the past or are currently suffering from other malignancies;
5. Patients judged by the investigator to be unfit to participate in the clinical trial;
Game-based Pediatric Diabetes Education

The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D).

The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.

Youth with T1D who comply with inclusion criteria and provide consent will be randomized to either the treatment arm (will be given a tablet with the game) or the control arm (no tablet will be given, no exposure to the game). Participants in both arms will continue receiving standard of care treatment. Participants will be asked to maintain food and activity logs and answer questionnaires about lifestyle.

Participants will be evaluated at baseline and at 3 months with interim contact in between. Devices will be downloaded to collect app usage data (game telemetry). Exposure time will be tracked by the application. Survey to elicit barriers and challenges encountered during the study will also be conducted.

Eligibility Criteria:
For youth:

* Be between the age of 6 to 12 years.
* Have been diagnosed with type 1 diabetes for at least 1 year.
* Be currently taking insulin through multiple daily injections or an insulin pump.
* Check blood sugar with a meter at least 4 times per day or use a continuous glucose monitor.
* Be willing to comply with all study visits and procedures.

For Parent:

* Biological or adopted parent with custody and medical decision making of the patients
* Living with identified patients
* Over 18 years old
* Resident of Allegheny County

Exclusion Criteria:

-Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes.
Eye Drops for Early Morning-Associated Corneal Swelling of the Cornea

This study evaluates the efficacy of hyperosmolar eye drops on early morning edema of the cornea in patients with Fuchs' endothelial corneal dystrophy (FECD). Each participant will receive hyperosmolar eye drops in one eye and lubricating eye drops in the fellow eye.

Hyperosmolar eye drops are lubricating eye drops with 5% of sodium chloride. Hyperosmolar eye drops are thought to temporarily deswell the cornea.

During morning hours, patients with Fuchs' endothelial corneal dystrophy (FECD) typically report poor vision and disturbing glare because of corneal edema. To improve vision in advanced stages of the disease, corneal endothelial transplantation has become the treatment of choice. Many patients with Fuchs' endothelial corneal dystrophy (FECD) use hyperosmolar eye drops before transplantation. At present, it is unclear, how much hyperosmolar eye drops help reducing corneal edema in Fuchs' endothelial corneal dystrophy (FECD). Based on our previous work that determined the amount of additional corneal edema in the morning in patients with Fuchs' endothelial corneal dystrophy (FECD), the investigators will assess if hyperosmolar eye drops speed up the deswelling process.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced Fuchs' endothelial corneal dystrophy (FECD)
* Indication for corneal endothelial transplantation (Descemet Membrane Endothelial Keratoplasty - DMEK)
* Must be able to speak and understand German or English.

Exclusion Criteria:

* Other corneal diseases (i.e. epithelial defects except for bullae caused by Fuchs' endothelial corneal dystrophy (FECD), corneal scars, postoperative / bullous keratopathy, corneal degenerations / dystrophies, corneal inflammation / infection)
* Regular use of drugs potentially affecting the cornea (i.e. amiodarone, chloroquine, triptan, isotretinoin, constant use of antihistamines, use of contact lenses in past four weeks, anesthetic eye drops, corticosteroid eye drops, antibiotic eye drops in past four weeks, glaucoma drops, hyperosmolar eye drops within the past 24 hours)
* Systemic diseases that affect the cornea (e.g. connective tissue disease, complicated diabetes mellitus)
* Lack of fixation during corneal tomography