Kornimate/medical-research-clean huggingface dataset:
hypofractionated radiotherapy for prostate cancer

Conditions: Prostate Cancer

Summary: external beam radiotherapy (rt) is one of the standard curative treatment options for patients with prostate cancer (pc). several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. nowadays, rt for pc commonly consists of delivering 74-80 gy in 2 gy fractions, resulting in an overall treatment time of 7-8 weeks. the sensitivity of different tissues to fractionation changes can be quantified through the alpha/beta ratio in the linear-quadratic model. dose-response analysis of pc patients treated with both external beam rt and brachytherapy has led to the hypothesis that the alpha/beta ratio of pc is lower than for most other tumors and approaches a value characteristic of late responding tissues. values between 1.2 and 3.9 gy have been calculated. if the alpha/beta ratio of pc is indeed low, then hypofractionating rt treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.the advantages in terms of patient convenience and treatment cost are obvious. there is level i evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation rt schedules. results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. in this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. the incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. the study will be performed in 2 stages. for stage 1, sample size was calculated to rule out an upper limit of 40% of patients with rtog grade 2 or worse bowel (gi) complications with an expected rate of 25%, based on a one-stage fleming-a'hern design. a power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). if 22 or more patients out of 72 had grade 2 or worse gi complications, then the study arm was to be rejected. to allow for a dropout of 10%, 160 patients were included in stage 1. sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with rtog grade 2 or worse gi complications with an expected rate of 25%. when including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. if 45 or more patients out of 155 had grade 2 or worse gi complications, then the study arm was to be rejected. the sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.


Eligibility criteria:
inclusion criteria: * patients with t1-4 n0 m0 prostate cancer exclusion criteria: * other no skin cancer diagnosed within 5 years prior to enrolment * no informed consent
histology and ultrasound pilot study of ha gels adipose tissue

Conditions: Atrophy

Summary: this study is a single-blind intra-individual comparative study to evaluate the short and medium term tissue response after the injection of 2 brands of hyaluronic acid gels (ha), designed for deep injection, that have been used for several years on a worldwide scale.

the study will be disclosed to patients who present with an indication for either abdominoplasty or bilateral breast reduction with a wise pattern skin excision (inverted t inframammary scar) informed consent will be obtained from volunteers at their next consultation, during which the preoperative preparation is finalised and the surgery is booked. participants will receive injections for the first time three weeks to four months before the operation and for the second time five to nine days before the operation, in tissue that will be removed during the surgery. in each session, through one single access point, a linear retrograde, subcutaneous injection will be performed with 0,5 ml of each of the studied hyaluronic acid gels, each in an opposite direction, each parallel to the skin surface. both sessions will be monitored by ultrasound examination. after the injections, the 2 cm of injected area which is most remote from the entrance point of the cannula will be remodelled by finger pressure and tissue pinching, to simulate remodelling as commonly performed after filler injection. at the beginning of the operation, the injected subcutaneous fat will be removed with the overlying skin, to be sent for histologic examination. the objective of the histologic examination is to assess the tissue response at one week versus three weeks to four months after the injection, as well as to assess the spread of the products, with and without remodelling after injection.

Eligibility criteria:
inclusion criteria: * patients eligible for and requesting abdominoplasty * patients eligible for and requesting bilateral breast reduction exclusion criteria: * patients prone to hypertrophic scarring or keloids * hypersensitivity to hyaluronic acid * hypersensitivity to lidocaine or amide type local anaesthetics * autoimmune disease * severe, multiple allergies or anaphylactic shock * epilepsy * heart rhythm disorders * porphyria, congenital methemoglobinemia, glucose-6 phosphate dehydrogenase deficiencies, treatment with methaemoglobin-inducing substances. * previous streptococcal disease (acute rheumatic fever whether or not with heart valve involvement) * patients on medication which slows hepatic metabolism (such as cimetidine, beta-blockers) * diabetes requiring insulin treatment * major system disease. * coagulation disorders. anticoagulation therapy. chronic use of acetylsalicylic acid. * previous surgery in the areas eligible for injections. * all contraindications to their surgical treatment (such as pregnancy or lactation).

Keywords: hyaluronic acid histology ultrasound subcutaneous adipose tissue
extension study of ionis-ghr-lrx administered to participants with acromegaly being treated with long-acting somatostatin receptor ligands

Conditions: Acromegaly

Summary: the purpose of this study is to assess the safety and efficacy of extended dosing with ionis ghr-lrx in participants with acromegaly as add-on to somatostatin receptor ligands (srl) therapy.

this extension study will include participants up to 60 participants with acromegaly from study nct03548415. all participants will remain on the same dose from the previous study and receive ionis ghr-lrx (sc) injection once every 28 days as add-on to srl therapy for 53 weeks. at the end of 53 weeks, participants will enter a 14-week post-treatment (pt) evaluation period.

Eligibility criteria:
inclusion criteria: * randomized in index trial (cs2) and completed the entire study, or completion of the treatment period for cs2 and completed or plan to complete ptwk5 visit with an acceptable safety profile, per investigator judgment * participants with confirmed stable monthly regimen of srl for 3 months prior to screening * able and willing to participate in a 53-week treatment and 14-week post-treatment study exclusion criteria: * treatment with any other acromegaly medications taken prior to day 1 within the time period: bromocriptine: 2 weeks, carbergoline: 4 weeks, quinagolide: 4 weeks, pegvisomant: 4 weeks and pasireotide: 4 months * participant who received surgery for pituitary adenoma in the last 3 months prior to screening and participants needing and/or planning to receive surgery for the pituitary adenoma during the trial * unwilling to comply with required study procedures during the treatment and post-treatment periods

Keywords: acromegaly, ionis-ghr-lrx
superb microvascular imaging ultrasonography of lacrimal gland in patients with sjögren syndrome

Conditions: Inflammation; Sjogren's Syndrome; Gland; Inflammation

Summary: a prospective study will be conducted to evaluate inflammatory activity in lacrimal glands due to sjögren's syndrome on superb microvascular imaging (smi), gray scale ultrasound (us), color doppler us and power doppler us.

in the disease activity index recommended by eular, the european rheumatology association, to evaluate the disease activity of patients with sjögren's syndrome, it is recommended to measure the swelling in the gland by performing a clinical examination for glandular activity. however, it is not practical to measure the size of these glands due to their location. in studies in which lacrimal glands were evaluated by ultrasonographic methods, parameters such as gland size measurement, gland heterogeneity and doppler activity were reported to be very successful in differentiating patients from healthy controls. determining the presence and characteristics of vascular flow is an important part of ultrasonographic examinations. however, small vessels and low velocities are not always possible to detect with conventional color and power doppler ultrasound. sonographic examination will be inconclusive, especially if the presence of vascular flow or activity needs to be addressed as a basis for diagnosis and follow-up. superb microvascular imaging (smi) is a new vascular imaging mode that provides low speed and visualization of microvascular flow. smi uses an algorithm that can suppress parasitic reverberations to extract flow signals and displays this information as a color overlay image or a monochromatic or color flow map.there are studies that report that superb microvascular imaging (smi), a new and up-to-date ultrasonography technology, is more sensitive in detecting the activity of rheumatic diseases. in this respect, there are no studies evaluating the inflammatory activity of lacrimal glands with smi method. therefore, a prospective study will be conducted to evaluate the inflammation detecting performance of smi, gray scale us, color doppler us and power doppler us. the null hypothesis that there is no difference between doppler us and smi methods in the detection of increased inflammatory activity in sjögren's syndrome patients.

Eligibility criteria:
for the first group: inclusion criteria: * patients diagnosed with sjögren's syndrome * age between 18-65 exclusion criteria: * history of eye or face trauma or surgery * diabetes mellitus * pregnancy for the second group: inclusion criteria: * asymptomatic eye (no dry eye or dry mouth), * no previous trauma or surgery on face or eye, * no history of systemic inflammatory disorders. exclusion criteria: * history of eye or face trauma or surgery * diabetes mellitus * pregnancy * rheumatological diseases

Keywords: superb microvascular imaging microvascularization sjogren's syndrome disease activitiy
repetitive transcranial magnetic stimulation of the posterior parietal cortex in patients suffering from gilles de la tourette syndrome

Conditions: Gilles de la Tourette Syndrome; Tics

Summary: repetitive transcranial stimulation (rtms) of the posterior parietal cortex will be applied daily over five days in adult gilles de la tourette patients. this approach aims at reducing premonitory sensations believed to induce tics. patients will be randomized to an active or placebo (sham) group in a crossover design.


Eligibility criteria:
inclusion criteria: * gilles de la tourette syndrome as defined by dsm iv-r * yale global tics severity scale (ygtss) score between 30 et 60 * premonitory sensations (" urge to move ") * affiliated to the french social security regime * ability to give informed consent exclusion criteria: * rtms : epilepsy, craniotomy scar, pacemaker or neural stimulator, metal implants or foreign bodies, claustrophobia, pregnancy * cognitive impairment (mms ≤ 24/30) * axis i disorders according to dsm iv-r : psychosis or history of psychosis, bipolar illness, major depressive disorder, addictions (except to nicotine) * impulse control disorders * other chronic debilitating illnesses * unability to give informed consent * participation in another clinical trial

Keywords: gilles de la tourette syndrome tics transcranial magnetic stimulation
the effect of dilution and prolonged injection time on dexamethasone-induced perineal irritation

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the efficacy of dilution with glucose and prolonged injection time on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. the major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. some patients undergo spontaneous remission, while others develop into severe pain or pruritus. in clinical practice, dexamethasone is always diluted with glucose in many cases, but diluted dexamethasone in relieving dexamethasone induced perineal irritation has not been studied yet. the aim of this study was to investigate the efficacy of dilution with glucose on dexamethasone induced perineal irritation.

Eligibility criteria:
inclusion criteria: * aged 18-65 years * asa physical status i-ii exclusion criteria: * on regular use of analgesic * contraindication or allergy to steroid or glucose * drug or alcohol abuse * diagnosed with paresthesia or mental diseases * communication disorders * pregnancy or nursing

Keywords: dexamethasone 21-phosphate pain pruritus glucose
cognitive behavioral therapy for post-traumatic stress disorder in homeless women

Conditions: Post-Traumatic Stress Disorder

Summary: this study will determine the effectiveness of cognitive behavioral therapy in treating post-traumatic stress disorder in homeless women.

exposure to traumatic events may lead to mental health problems, such as post-traumatic stress disorder (ptsd). ptsd is a type of anxiety disorder that is characterized by the presence of persistent frightening thoughts and memories of the traumatic event. additionally, people with ptsd often feel emotionally numb, and they may experience sleep problems or be easily startled. homeless people, in particular, are at risk for experiencing a variety of traumas. homeless women tend to experience more traumatic events and develop ptsd at higher rates than housed women. although effective treatments for ptsd are available, homeless women are unlikely to seek them out. there is a need for ptsd treatment approaches that are specifically designed for these women. this study will develop a cognitive-behavioral therapy treatment that will be adapted to best serve the needs of homeless women. the study will then determine the therapy's effectiveness in treating a group of homeless women with ptsd. this study will consist of three phases. the first phase will be used to gather and analyze information about ptsd in homeless women and methods of treating the disorder in this population. focus groups consisting of homeless women, shelter directors, case managers, and mental health service providers will be used to obtain the necessary information. phase two of this study will consist of developing an adaptation of an existing ptsd treatment manual to make it relevant to the lives of homeless women. the third and final phase of this study will recruit 32 homeless women with symptoms of ptsd, and who did not participate in either of the first two phases of the study. participants in this 4-week study will be randomly assigned to receive either the adapted cognitive behavioral therapy treatment or no treatment at all (assessment-only). the treatment group will attend twice weekly sessions for a total of 4 weeks. all participants will be evaluated immediately prior to the start of treatment and 1 week after treatment ends. outcomes will include ptsd symptoms and depression symptoms.

Eligibility criteria:
inclusion criteria: * sub-diagnostic threshold ptsd symptoms * currently resides in a transitional homeless shelter in los angeles county * trauma that is related to ptsd symptoms occurred at least 1 month prior to study entry * understands, speaks, and reads english * planned departure date from the shelter is at least 1 month after study entry exclusion criteria: * significant cognitive impairment

Keywords: cognitive behavioral therapy cbt homeless women
ledipasvir/sofosbuvir fixed-dose combination and vedroprevir with or without ribavirin in treatment-experienced participants with chronic genotype 1 hcv infection and cirrhosis

Conditions: Hepatitis C Virus Infection

Summary: this study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) + vedroprevir (vdv) ± ribavirin (rbv) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis c virus (hcv) infection and cirrhosis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years, with chronic hcv genotype 1 infection * documentation as treatment-experienced having received pegylated interferon (peg-ifn) + rbv ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (svr) * presence of compensated cirrhosis * screening laboratory values within defined thresholds * must use specific contraceptive methods if female of childbearing potential or sexually active male * not pregnant or a nursing female exclusion criteria: * co-infection with hiv or hepatitis b virus (hbv) * current or prior history of clinical hepatic decompensation * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Keywords: hepatitis c gilead gs-9451
prospective, observational study of biomarkers in liver cancer - identification of actionable events

Conditions: Hepatocellular Carcinoma

Summary: to collect tumor tissue from patients with liver masses suspicious for primary liver cancer. the research biopsy will be used to identify biomarkers in future studies.

in this study patients are referred to the department of radiology for an image-guided (either ct or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. a written informed consent will be obtained for the clinical biopsy per standard protocol. additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. the additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.

Eligibility criteria:
inclusion criteria: 1. liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care 2. age ≥ 18 years. 3. ecog performance status 0-2 4. adequate organ and marrow function as defined below: inr ≤ 1.5 platelets ≥ 70,000/mcl 5. ability to understand and the willingness to sign a written informed consent 6. target liver mass not subcapsular in nature as determined by the participating biopsy team 7. child pugh turcotte score a or b exclusion criteria: 1. previous treatment for hcc 2. any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites
omalizumab in adult and adolescent patients with severe persistent allergic asthma

Conditions: Asthma

Summary: omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma. this study is not enrolling patients in the us.


Eligibility criteria:
inclusion criteria: patients who met the following criteria were included: * males or females of any race, who were 12-75 years of age * a body weight ≥ 20 kg and ≤ 150 kg and with a total serum ige level ≥ 30 to ≤ 700 iu/ml * a diagnosis of allergic asthma ≥ 1 year duration according to american thoracic society (ats) criteria and at screening a history consistent with gina (2204) step 3 or 4 clinical features * a positive prick skin test (diameter of wheal \>= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1 * increase in fev1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg * an fev1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization * receiving moderate to high dose inhaled corticosteroid ≥ 800 µg bdp or equivalent and a regular inhaled long acting b-2 agonists for at least 3 months prior to screening and \> 1000 µg (bdp) and a laba for at least 4 weeks during the run-in and at randomization * patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ics (≥ 800 µg bdp or equivalent) plus regular inhaled laba * evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation exclusion criteria: patients who met the following criteria were excluded: * had received systemic corticosteroids for reasons other than asthma within 4 weeks of visit 1 * a smoking history \>10 pack years * an active lung disease other than allergic asthma * elevated serum ige levels for reasons other than allergy * patients with significant underlying medical conditions

Keywords: asthma omalizumab severe persistent allergic asthma
treatment of tac-expressing cutaneous t-cell lymphoma (ctcl) and adult t-cell leukemia (atl) with yttrium-90 radiolabeled anti-tac

Conditions: Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous

Summary: the study purpose is to evaluate the clinical response to multidose administration of anti-tac monoclonal antibody conjugated with 10 mci 90y in patients with tac-expressing adult t-cell leukemia (atl).

the study purpose is to evaluate the clinical response to multidose administration of anti-tac monoclonal antibody conjugated with 10 mci 90y in patients with tac-expressing adult t-cell leukemia (atl). this study represents an extension of phase i trial (clinical project #90-c-0043, fda ind #3469) which permitted the administration of 5 mci, 10 mci, and 15mci 90y-anti-tac to patients with atl. we propose to administer 90y-anti-tac (10 mci doses) to patients with tac-expressing atl who are over 18 years of age and who fill the patient eligibility criteria.

Eligibility criteria:
disease characteristics: histologically confirmed adult t-cell leukemia/lymphoma (atl) or cutaneous t-cell lymphoma (ctcl). reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-tac as determined by immunofluorescent staining or soluble il-2 receptor level greater than 1,500 u required. all stages of tac-expressing t-cell leukemia and lymphoma eligible except stage i ctcl. all forms of atl eligible, including the "smoldering" type as well as aggressive disease. no symptomatic cns disease other than tropical spastic paraparesis. asymptomatic cns disease with demonstrable malignant cells in the csf allowed (such patients receive cns therapy, e.g., intrathecal methotrexate and/or cns irradiation, as appropriate). prior/concurrent therapy: biologic therapy: not specified. chemotherapy: ctcl must have failed initial chemotherapy. atl may or may not have had prior chemotherapy. at least 4 weeks since prior cytotoxic chemotherapy. endocrine therapy: not specified. radiotherapy: at least 4 weeks since prior radiotherapy. surgery: not specified. patient characteristics: age: 18 and over. performance status: not specified. life expectancy: greater than 1 month. hematopoietic: wbc at least 3,000, platelets at least 75,000. hepatic: not specified. renal: not specified. other: no pregnant women. negative pregnancy test required of fertile women.

Keywords: interleukin-2 receptor