cyrilzakka/clinical-trials huggingface dataset:
Volumetric Intensity Modulated Arc Therapy vs. Conventional Radiotherapy for Cancer Pain

This study compares the use of conventional radiotherapy technique with volumetric intensity-modulated radiotherapy (VMAT) in the treatment of painful cancer metastases. Half of the patients will receive radiotherapy using a conventional technique, while the other half will receive their treatment using a the VMAT technique.

Radiotherapy to painful sites of metastasis can provide pain relief.

Side-effects from radiotherapy is dependent on the volume and dose received by normal tissues. Conventional radiotherapy techniques delivers similar doses of radiation to the targeted cancer lesion and the normal tissues along the entrance and exit paths of the radiation.

Volumetric intensity-modulated arc therapy (VMAT) is an advanced technique of radiotherapy that spares normal tissues from receiving high-dose irradiation. However, VMAT increases the volume of normal tissues receiving low-dose irradiation.

This study aims at comparing the quality of life and side-effect profiles of patients treated by palliative radiotherapy using the conventional technique vs. VMAT.

Eligibility Criteria:
Inclusion Criteria:

1. Pain (SF-BPI score ≥1) should be related to metastases (bone or others) or to the tumor itself
2. Capable of providing the full list of analgesic medication being used
3. Capable of completing the SF-BPI and EORTC questionnaires without any help
4. Life expectancy of at least 3 month
5. KPS greater or equal to 50
6. Radiotherapy to 1 site pain
7. Site of treatment not previously irradiated
8. No planned changes in analgesic within 7 days before and after treatment

   • Patient may be started on Dexamethasone on the first day of radiotherapy
9. No planned chemotherapy, radiotherapy or surgery within 7 days before and after treatment
10. Patient provided informed consent to participate in this study

Exclusion Criteria:

1. Major mental or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
2. Treatment to upper and lower limb
3. Treatment to 2 or more sites of pain
4. Re-irradiation of the site of treatment
5. Women who are pregnant
6. Life expectancy less than 3 month
Improving Follow-Up Adherence in a Primary Eye Care Setting

This study aims to examine the effectiveness of three different ways of helping patients attend their recommended eye care appointments.

The three ways are 1) usual care, which involves a standard reminder letter; 2) automated telephone calls, which utilizes a machine to automatically call patients one month prior to their recommended follow-up date; 3)personalized telephone calls, which utilizes a staff member to personally call patients and offer them the opportunity to schedule at the time of the telephone call.

Eligibility Criteria:
Inclusion Criteria:

* Age: Over 18 years
* Primary Eye Care Patients who were recommended for a 6-month, 12-month, or 24-month follow-up appointment during September 2013 through November 2013.
* Access to a telephone

Exclusion Criteria:

* Does not speak English
The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome

The study aim is to investigate the Bio-electrical Impedance (BIA) parameters in general, and phase angle (PhA) in particular in Irritable bowel syndrome (IBS) patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.

The role and significance of bio-electrical impedance analysis (BIA) has not been studied in IBS. Therefore, The investigators designed this exploratory study to assess its potential role in the diagnosis and follow-up of treatment in IBS. The study aim is to investigate the BIA parameters in general, and PhA in particular in IBS patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.

The primary objective is to compare the BIA parameters including PhA between IBS and healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 - 75 years;
* Fulfilling the ROME IV criteria for IBS (only for patients);

Exclusion Criteria:

* Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);
* Known inflammatory bowel disorder;
* Known major intestinal motility disorder;
* Alcohol (defined as more than 14 U per week) or other substance abuse;
* Active psychiatric disorder;
* Known systemic or auto-immune disorder with implication for the GI system;
* Prior abdominal surgery (with the exception of cholecystectomy or ap-pendectomy);
* Any prior diagnosis of cancer other than basocellular carcinoma;
* Current chemotherapy;
* History of gastro-enteritis in the past 12 weeks;
* Dietary supplements unless taken at a stable dose for more than 12 weeks;
* Treatment with neuromodulators (one neuromodulator taken at a sta-ble dose for more than 12 weeks is allowed);
* Pregnancy.
Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography

The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.

The study will be performed in two phases: Image Accrual and Image Reading.

Approximately 800 women who fulfill all inclusion and exclusion criteria will be enrolled in chronological order from up to 3 different US sites with one study investigator for each site. Two cohorts of patients will be enrolled (i.e., Biopsy and Screening Cohorts). Paired sets of a standard 4-view exam will be collected both from Philips Tomosynthesis system (Tomosynthesis and synthetic 2D images) and a FDA-cleared FFDM system. All enrolled cases will be quality controlled for completeness of image and patient information.

The reading portion of the study will include approximately 300 normal cases (including some cases determined to be normal after call back after screening mammography), 65 cancer cases, and 40 biopsy proven benign cases.

The primary objective of the study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system (Tomosynthesis and synthetic 2D) images to conventional 2D mammography images (FFDM).

Eligibility Criteria:
Inclusion Criteria:

* Patient is female and at least 40 years of age
* No contraindication for routine bilateral mammography

Screening Cohort

* Patient presents for a routine screening mammogram Biopsy Cohort
* Patient is scheduled for a biopsy
* Patient has a screening detected abnormality

Exclusion Criteria:

* Patient is pregnant or believes she may be pregnant; OR,
* Patient is breast feeding; OR
* Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR,
* Patient has breast implants; OR
* Patient has previous surgical biopsy; OR
* Patient has previous breast cancer; OR
* Patient presented to screening with clinical symptoms (e.g. palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)
Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.

DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. We have determined the HLA-A\*2402 restricted epitope peptides derived from DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A\*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the safety and efficacy of novel vaccination for the advanced bladder cancer patients who already showed resistance to standard chemotherapies or radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

1. advanced bladder cancer which already showed resistance to standard treatments
2. Protein expression of MPHOSPH1 and DEPDC1 on the tumor

PATIENTS CHARACTERISTICS

1. Patients who showed resistance to standard chemotherapies or radiotherapy
2. Histological diagnosis is transitional cell carcinoma
3. HLA-A\*2402
4. ECOG performance status of 0 to 1
5. Age ≥ 20 years, ≤80 years
6. WBC≥ 2,000/mm³, ≤15000/mm³ Platelet count ≥ 75000/mm³ AST, ALT ≤150 IU/l Total bilirubin ≤ 3.0 mg/dl Creatinine ≤ 3.0 mg/dl
7. lesion of bladder cancer must express MPHOSPH1 or DEPDC1
8. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breastfeeding
3. Patients willing to childbearing ( Refusal or inability to use effective means of contraception)
4. Serious infections requiring antibiotics
5. Concomitant treatment with steroids or immunosuppressing agent
6. Other malignancy difficult to control.
7. Decision of unsuitableness by principal investigator or physician-in-charge
Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)

A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation.


Eligibility Criteria:
Inclusion Criteria:

* Males or females (of non-childbearing potential) between the ages of 18 to 70
* Participants have been diagnosed with Type 2 Diabetes
* Participants are nonsmokers for at least 6 months

Exclusion Criteria:

* Participant should not be diagnosed with Type 1 diabetes
* Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
* Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
* Participant has been diagnosed with glaucoma or is blind
* Participant has had trauma to one or both eyes
* Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
* Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months
Predictors of Asthma Exacerbations in Children

The purpose of this study is to determine whether parameters of the pulmonary function tests and the bronchial hyperresponsiveness to methacholine are predictors of asthma exacerbations.

Preliminary investigations from our own research group showed that lung function parameters (FEV1, the FEV1/FVC ratio and a moderate to severe hyperresponsiveness to methacholine challenge were risk factors of asthma exacerbations (OR 11.3). In the present study, these parameters will be evaluated in prospective design.

One hundred children will be included in the study. Baseline parameters will be collected in a healthy interval (visit 1), then the children will be followed up for 1 year. If the patients fulfill the criteria for an exacerbation the children will present in our department. We expect that 44% of the children have an exacerbation. All children will present at a second visit after one year (visit 2).

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age \>3 and \<7 years
* Diagnosis of intermittent asthma
* In the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist Singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist Singulair ®)
* The ability to perform three reproducible spirometries
* Examination in infection-free interval (\> 4 weeks infection-free)
* Minimum distance to the following asthma medications:
* Short-acting beta 2-agonists: 8 hours
* Ipratropium bromide: 24 hours
* Long-acting beta 2-agonists: 24 hours
* steroids: 4 weeks
* leukotriene antagonist: 4 weeks

Exclusion Criteria:

* Age older than 6 years or younger than 4
* The inability to perform spirometry
* Other chronic diseases or infections (eg. HIV, tuberculosis, malignancy)
* Participation in another study
Steady Feet: Preventing Falls in the Community

The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program.

Participants aged 60 or older, at high risk of falls, with Short Physical Performance Battery (SPPB) scores between 7 and 11, and without significant cognitive or vision impairment, were recruited for a non-randomized, two-arm study. They were evaluated at baseline and the third month. The intervention group (IG) underwent Steady Feet and CGH's standard care for fall prevention, while the control group (CG) received CGH's standard care for fall prevention. Feasibility was assessed across Bowen's domains, including acceptability, demand, implementation, practicality, adaptation, and limited efficacy. Measurements included SPPB, Timed Up and Go, the 6-minute walk test, the Four-Square Step Test, the CONFbal scale, and a satisfaction survey administered to IG participants. Between-groups statistical analyses will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years and above
* At high risk of falls according to the FROP-COM
* Short Physical Performance Battery (SPPB) score of 7 to 11
* Able to ambulate without wheelchairs or walkers
* Able to understand basic instructions.

Exclusion Criteria:

* Possess significant cognitive impairment (Abbreviated Mental Test \< 5)
* Had visual impairment, as determined by not passing at least 2 out of 3 Vision Function Test(s) (Logarithm of the Minimum Angle of Resolution (LogMar) vision, Stereoscopic vision, and Melbourne Edge Test (MET)
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia.

PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.

OBJECTIVES:

* To determine the difference in nephrotoxicity between low-dose and weight-based intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients with neutropenia.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
* Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment continues for approximately 2 weeks unless clinical herpes simplex virus infection is confirmed or the patient is no longer neutropenic.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older.
* Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
* Receiving chemotherapy or have received chemotherapy within the past 2 weeks
* Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
* Creatinine clearance ≥ 50 mL/min
* Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption)

Exclusion Criteria:

* Pregnant or nursing
* Hypersensitivity to acyclovir sodium
* High tumor burden (i.e., WBC \> 50,000/mm\^3 at admission)
* Neutropenic, defined as one of the following:
* ANC \< 500/mm\^3
* ANC \< 1,000/mm\^3 with a predicted decrease to 500/mm\^3
* Active HSV infection, as evidenced by any of the following:
* Positive HSV cultures
* Oral lesions
* Receiving 5 mg/kg acyclovir sodium every 8 hours
Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus

The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and comply with the protocol and provide informed consent.
* Speaks English.
* Age ≥ 18 years.
* Clinical diagnosis of discoid lupus as assessed by the PI.
* At least one active (inflamed) discoid lesion with an IGA score of ≥ 3 and with a diameter ≥ 1cm at screening and baseline. Two lesions with equal scores will be necessary if consenting to pre-and post-treatment biopsies.
* Maximum body surface area of 20%.

Exclusion Criteria:

* Unwillingness or inability to complete informed consent process or comply with the study protocol.
* Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study.
* History of coagulopathy, pulmonary embolism or deep venous thrombosis.
* History of cutaneous squamous cell carcinoma localized to the treatment area.
* Serum creatinine \> 1.5 mg/dL, or alanine aminotransferase or aspartate aminotransferase \> 1.5 × upper limit of normal.
* Other dermatologic disease besides discoid lupus whose presence or treatments could complicate assessments.
* Other diseases besides dermatologic disorders whose treatment could complicate assessments. Subjects with systemic lupus erythematosus are permitted as long as they do not have unstable disease and meet all other criteria, including the exclusion criteria for systemic immunosuppressive or immunomodulating drugs (below).
* Topical treatments for discoid lupus within 2 weeks of Visit 2.
* Systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) other than antimalarials (hydroxychloroquine, chloroquine, quinacrine) within 4 weeks or 5 half-lives of Visit 2 (whichever is longer).
* Potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before Visit 2 (topical agents with limited systemic availability are permitted).
* Prior use of JAK inhibitors, systemic or topical, within the last 12 months.
* Ultraviolet (UV) therapy or tanning within 2 weeks prior to Visit 2 or during the duration of the treatment period.
* Any systemic or local infection that, in the opinion of the investigator, may compromise the safety of the subject or complicate assessments.
* Subjects allergic to lidocaine or with a history of keloids will not be allowed to provide an optional skin biopsy, but will be eligible for the remainder of the study.
* Electrocardiogram (ECG) changes on baseline screening consistent with high risk for a major adverse cardiovascular event (MACE).
Application of Preoperative Axillary Lymph Node Marking With Nano-Carbon in Breast Cancer Patients Before Neoadjuvant Chemotherapy

The primary aim of this prospective, multicentre study is to determine whether the involved node can be marked using black carbon dye and successfully identified at the time of surgery. The secondary aims are to determine the concordance between the tattooed node and sentinel node, migration of black dye into other nodes, and false-negative rate of tattooed node (in patients undergoing ALND after NACT).

Pretreatment evaluation of axillary lymph nodes and marking of biopsied nodes in patients with newly diagnosed breast cancer is becoming routine practice. Tagging of biopsied axillary lymph nodes with metal markers, similar to what is done for suspicious breast lesions, is being adopted in clinical practice. The need to mark a positive axillary lymph node becomes especially relevant in cases where neoadjuvant chemotherapy (NACT) is anticipated so that these nodes may be identified at the time of surgery. Measures that improve both the accuracy of nodal evaluation after NACT and the ability to assess treatment response are desirable in order to tailor therapies for breast cancer treatment. The investigators sought to test tattooing of biopsied axillary lymph nodes with a sterile black carbon suspension.

Eligibility Criteria:
Inclusion Criteria:

1. Female; 2. Aged \>=18 years; 3. With invasive breast cancer; 4. Patients to be treated with neoadjuvant chemotherapy; 5. Patients scheduled to undergo routine fine needle aspiration (FNA) or core biopsy of abnormal axillary lymph node; 6. Patients with operable breast cancer; 7. Heart, lung, liver and kidney function well, suitable for patients undergoing surgery; 8. Informed consent patients.

Exclusion Criteria:

* 1. Patients who do not plan or are unable to operate; 2. Patients with distant metastasis were excluded; 3. Patients without invasive cancer components in DCIS alone; 4. Patients who are unable to cooperate with the doctor's recommended surgical treatment (breast conserving surgery or radical surgery) due to personal or family factors; 5. Patients with serious cardiopulmonary diseases, uncontrolled infectious diseases and other non tumor related diseases who can not tolerate comprehensive treatment such as surgery and chemotherapy; 6. Patients with mental illness or other reasons unable to sign informed consent; 7. Patients with poor medical compliance who cannot complete the trial treatment process and follow-up according to the standard according to the researcher's opinion.
Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers

The duration of the autonomic (sympathetic) block will last longer than the sensory block. The duration of the increased perfusion index will last longer than either the sympathetic or sensory block.

The Masimo SpHb™ (SpHb) is a device used to monitor the blood hemoglobin level via a sticky sensor connected to a finger. Our results from 2 recent studies undertaken with this device concluded: 1) that it is not always accurate when the finger is cold such as during surgical blood loss, and 2) a local nerve block to the finger improved the finger temperature and the accuracy of the device.

Our purpose is to investigate the duration of effect of two local nerve blocking drugs (lidocaine and bupivacaine - both FDA approved drugs in routine use) in a finger on each hand. Having a better understanding of how long the nerve block lasts could help determine when an additional block might be necessary to maintain the accuracy of the device during surgical blood loss.

We previously listed the primary outcome for this study as the time until return to baseline finger temperature. However, in blinded looks at the data it became clear that defining time until return to baseline from the serial temperature measurements in an objective fashion would be extremely difficult and potentially controversial. We have modified the primary outcome to be the change in the average temperature from baseline to post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers

Exclusion Criteria:

* History of allergic response to local anesthetics
* BMI \>25
* Pregnant of nursing
* Current smokers or past smokers of \> 1 pack year history
* Neurological deficit and/or injury in the upper extremities
* Current respiratory infection
* Per investigator judgement, would not be suitable for study