Kornimate/medical-research-clean huggingface dataset:
therapeutic study of bevacizumab injection directly inside the keloid tissue

Conditions: Keloid

Summary: keloid is chronic skin conditions that results in formation of tumor like growths on the skin. despite its benign nature, keloid can cause severe aesthetic and, in some cases, functional problem which negatively impacts person's quality of life. keloids do not regress on their own and results of most available treatments such as surgery, injecting keloids with steroids, chemotherapy injections, or even radiation therapy, have mostly proven disappointing. some laboratory studies have shown that there is excessive amount of a protein called "vascular endothelial growth factor (vegf)" in keloid tissue. this may play role in the formation and evolution of keloid. bevacizumab is a drug that works by targeting vascular endothelial growth factor (vegf) which helps new blood vessels form. without new blood vessels, the growth of the keloid may be slowed based on presence of excess amount of vegf in keloid tissue, we hypothesize that bevacizumab will be effective in treatment of keloids. this exploratory clinical trial is to confirm or reject this hypothesis.

sixty eligible patients will be enrolled in the study. this will be a two stage design trial. in stage i of the trial, 21 patients will be treated with intralesional bevacizumab. keloids that fail to respond to 4 injections will not be treated any longer with bevacizumab and all such patients will be removed from the trial. if 5 or more patients show some degree of objective response to treatment in at least one treated keloid, the trial will continue to enroll another 45 patients to a total of 66 patients, otherwise, the trial will stop in its entirety.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of a flat keloid. 2. age 18 to 50 3. a signed informed consent document (icd) 4. able and willing to receive bevacizumab women of child-bearing potential must have a negative pregnancy test during screening. the effects of bevacizumab on the developing human fetus are unknown. for this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. exclusion criteria: 1. pedunculated keloid 2. diastolic blood pressure of 90 mm hg or above 3. history of any degree of hypertension, even medically controlled hypertension 4. history of any form of cardiovascular disease or stroke 5. history of any form of thromboembolic event 6. history of renal dysfunction or proteinuria 7. history of recent (past 12 month) or planned (next 3 months) major surgery, 8. men and women who plan to have children within 6 months of their last treatment 9. psychological illness that may result in non compliance with treatment 10. pregnancy and breast feeding

Keywords: keloid
efficacy study of chemoradiotherapy with or without paclitaxel in squamous-cell anal carcinoma patients

Conditions: Anus Neoplasms; Carcinoma, Squamous Cell; Anus Diseases; Neoplasms; Neoplasms, Squamous Cell; Carcinoma

Summary: the purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (imrt) in patients with squamous-cell anal cancer.

this trial aims to investigate the efficacy of chemoradiotherapy with or without paclitaxel in squamous-cell anal cancer. this is a prospective multicenter open-label randomized phase iii clinical trial. patients will be randomized using an online randomization system to receive either standard imrt with capecitabine and mitomycin or imrt with capecitabine, mitomycin and paclitaxel. a stratification will be performed based on t stage, n stage and clinical center. doses of capecitabine and mitomycin in experimental group were reduced for better treatment tolerance. the target accrual is 157 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 15% 3-yr disease-free survival (70% vs 85%), α=0,05, power 80% in the experimental arm. an interim analysis is planned after 50% of the patients will reach a 3-year followup. pelvic magnetic resonance imaging (mri) is performed in all patients for staging and followup. pelvic mri and histological diagnosis are subject to central review. conduction of this study and data collection are controlled by a local institutional board.

Eligibility criteria:
inclusion criteria: * informed consent * histologically verified squamous-cell anal cancer * stage i-iiib (union for international cancer control (uicc) tnm classification v7) * eastern cooperative oncology group (ecog) status 0-2 * hiv (human immunodeficiency virus) negative * haemoglobin (hgb) \> 90 g/l * platelet count (plt) \> 120x10\*9/l * serum creatinine \< 150 µmol/l * total bilirubin \< 25 µmol/l exclusion criteria: * inability to obtain informed consent * distant metastases * synchronous or metachronous tumors * previous chemotherapy or radiotherapy * clinically significant cardiovascular disorders (myocardial infarction \ 160/100 mm hg * clinically significant neurological disorders * previous neuropathy 2 or higher * current infection or heavy systemic disease * pregnancy, breastfeeding * ulcerative colitis * individual intolerance to treatment components * proven dihydropyrimidine dehydrogenase (dpd) deficiency * participation in other clinical trials * psychiatric disorders, which render patient unable to follow instructions or understand his/her condition * technical inability to perform pelvic mri * inability of long-term followup of the patient

Keywords: anal cancer chemoradiation intensity-modulated radiotherapy paclitaxel
comparison of two immunosuppressive regimens in kidney transplant recipients with deceased donors with the aim of preventing the development of fibrosis / atrophy of reducing the incidence of cytomegalovirus infection

Conditions: Disorder of Transplanted Kidney; Cytomegalovirus Infections

Summary: the aim of this the study is to the assess whether the graft and patient survival, rejection rates and renal graft function after the first year will not differ between both study arms. the investigators will also the evaluate the reduction in the incidence of cytomegalovirus the and improvement of renal function of the everolimus after 1 year.


Eligibility criteria:
inclusion criteria: * patients with bmi below 30, * first transplants with pra \< 30, * no contraindication for induction thymoglobuline, * age 18 years or younger than 70 years. exclusion criteria: * patients with a bmi above 30 * retransplantation * patients hypersensitized with pra \> 30 * compared with thymoglobulina indication for induction * age under 18 or over 70 years

Keywords: immunosuppression cytomegalovirus renal transplant atrophy/interstitial conversion of tacrolimus everolimus
a multiple dose study to evaluate safety, tolerability, pk, and efficacy of ser-155 in adults undergoing hsct

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Summary: an open-label and randomized, double-blind, placebo-controlled, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of ser-155 in adults undergoing hematopoietic stem cell transplantation to reduce the risk of infection and graft vs. host disease

this is a phase 1b randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the safety, efficacy, and microbiome alterations associated with ser-155 dosing, after microbiome conditioning with oral vancomycin, in adult subjects aged ≥18 years who are undergoing hematopoietic stem cell transplantation (hsct).

Eligibility criteria:
inclusion criteria: * male and female subjects ≥ 18 years of age undergoing hsct. * planning to undergo allogeneic hematopoietic stem cell transplantation from a human leukocyte antigen matched related donor, haploidentical related donor, hla-matched unrelated donor, or hla 1-antigen mismatched unrelated or related donor, with either bone marrow or peripheral blood stem cells as a graft source, and with any conditioning regimen exclusion criteria: * severe colitis of any etiology or active/currently-treated inflammatory bowel disease (ibd) or total colectomy. * evidence of relapse or progression of hematologic malignancy (minimal residual disease is allowed). * transplant using umbilical cord blood or ex vivo t-cell-depleted hsct * receipt of chimeric antigen receptor t-cell (car-t) therapy. * received a fecal microbiota transplant (fmt) or any live microbial therapeutic within 3 months prior to screening. * known allergy or intolerance to oral vancomycin. * concomitant participation or participation within 14 days or 5 half-lives of another investigational unapproved treatment, whichever is longer.

Keywords: microbiome stem cell transplant
the effects of ergonomics awareness education and exercise

Conditions: Ergonomics; Telerehabilitation; Musculoskeletal System Disorder; Quality of Life

Summary: this study aims to determine the effects of asynchronous and synchronous exercises, which are added to ergonomics awareness education, on musculoskeletal disorders, physical activity and quality of life.


Eligibility criteria:
inclusion criteria: * aged between 18-45 * working at home at least 5 hours a day * not having one or more diagnosed musculoskeletal disorders exclusion criteria: * limited access to technology or not being able to actively use the technology * had musculoskeletal trauma or surgery * pregnancy
vision in preschoolers study (vip study)

Conditions: Amblyopia; Strabismus; Refractive Error

Summary: to identify vision-screening tests that can accurately predict those three- and four-year old preschoolers who would benefit from a comprehensive vision examination because of signs of amblyopia, strabismus, and/or significant refractive error.

the vision in preschoolers (vip) study is a multi-center, multidisciplinary, prospective clinical study to evaluate screening tests for identifying preschool children in need of comprehensive eye examinations. the primary goal of the vip study is to identify an effective and efficient battery of screening tests that has high sensitivity and specificity in identifying preschoolers in need of further evaluation for amblyopia, strabismus and/or significant refractive error. the vip study is designed in three-phases. phase i activities will establish which screening tests perform well when administered by licensed eye care professionals (pediatric optometrists and pediatric ophthalmologists) in a population of 1000 head start preschoolers at high risk for the targeted vision disorders. phase ii activities will provide evaluation of the tests' performance when administered by pediatric nurses and lay people on a high risk population of 1000 head start preschoolers. each child will be tested twice with each screening test - once by a pediatric nurse and once by a lay screener. tests selected for phase ii will be determined by the outcome of phase i. phase iii activities will evaluate the performance of the tests in identifying individuals with specific vision disorders in a general population of (6400) head start preschoolers. the category of screening personnel and the specific screening tests used in phase iii will be determined by the outcome of phases i and ii.

Eligibility criteria:
children enrolled in head start who are between the ages of 3 years 0 months and 4 years 11 months of age.

Keywords: vision screening
laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area

Conditions: Gastric Cancer Stage I

Summary: nowadays, while pursuing the eradication of tumor, how to maximize the preservation of normal anatomy and physiological functions of the stomach, reduce the surgical trauma caused by excessive debridement, and improve the quality of life of patients after surgery has become a more important concern in the treatment of early gastric cancer. this prospective multicenter randomized controlled clinical trial was designed to elucidate the oncologic safety of laparoscopic gastric preservation surgery compared to standard laparoscopic gastrectomy. the oncologic safety of laparoscopic gastric preservation surgery with anterior basal dissection (sbd) compared to standard laparoscopic gastrectomy. this trial is an investigator-initiated, multicenter, prospective, randomized, open, parallel-controlled with a non-inferiority design. patients diagnosed as distal gastric cancer with clinical stage t1n0m0, with a lesion diameter of 3 cm or less were eligible to participate in this study. patients will be randomized to either laparoscopic stomach-preserving surgery with sbd or standard surgery. the primary end-point is 3-year disease-free survival.


Eligibility criteria:
inclusion criteria： 1. single lesion detected by gastroscopy and clearly diagnosed histologically as gastric adenocarcinoma. 2. patients with gastric cancer with clinical stage t1n0m0 (based on the tnm stage of the 8th edition of ajcc) (t-stage assessed by ultrasound gastroscopy and n-stage and m-stage assessed by enhanced ct). 3. tumor length diameter less than 3 cm. 4. the lesion is located in the gastric sinus. 5. patient age greater than 20 years and less than 80 years. 6. ecog score of 0 or 1. 7. the patient voluntarily participated in this clinical study. exclusion criteria: 1. patients with gastric cancer suitable for endoscopic treatment (differentiated gastric cancer with tumor length diameter less than 2 cm and located within the mucosa). 2. cardiopulmonary dysfunction that cannot tolerate laparotomy. 3. pyloric duct gastric cancer. 4. previously undergone upper abdominal surgery. 5. other malignant tumors diagnosed within the previous five years. 6. pregnant women.

Keywords: gastric cancer
enhanced and attendance-based prize cm in community settings

Conditions: Cocaine Dependence

Summary: the purpose of this study is to address the conditions under which prize contingency management (cm) for abstinence and attendance may improve outcomes of cocaine-dependent patients. for patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate the efficacy of two cm procedures relative to standard, non-cm treatment. the two cm procedures will be provided as additions to standard care and will reinforce drug abstinence but will differ in expected magnitudes of prizes patients can earn, especially during early stages of abstinence. they will provide expected magnitudes of winning about $250 and $560, respectively. we expect that both cm conditions will improve retention and abstinence relative to the standard treatment, non-cm condition. if the enhanced cm condition engenders better outcomes than the $250 cm condition, this finding would suggest that patients initiating treatment while actively using cocaine may best be treated with relatively high reinforcement prize cm as an adjunct to standard care. for patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate the efficacy of a cm procedure that reinforces treatment attendance. the expected magnitude of winnings will be about $250, and again cm treatment will be in addition to standard care. this cm condition will be compared to standard treatment without cm as well as to a cm treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence. results from this study will inform an important clinical question of whether simply reinforcing attendance can improve clinical outcomes. increased retention may result in greater exposure to therapeutic processes that may reduce drug use, especially among patients who begin treatment having already achieved some abstinence. we will also evaluate the cost-effectiveness of cm by examining the effects of the interventions on hospitalizations, medical and psychiatric care, criminal justice costs, and productivity.


Eligibility criteria:
inclusion criteria: * age \> 18 years * current dsm-iv diagnosis of cocaine dependence * a cocaine-positive urine sample submitted during the first two scheduled treatment days at the center * willing to provide names, addresses and phone numbers of individuals to assist in locating the patient for follow-up evaluations * english speaking * willing to sign informed consent. exclusion criteria: * serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) * dementia (\<23 on the mini mental state exam; folstein et al. 1975) * in recovery from pathological gambling

Keywords: substance abuse contingency management
preoxygenation before prehospital tracheal intubation with niv versus balloon

Conditions: Preoxygenation

Summary: recent studies reports feasibility, effectiveness and even less complications of using niv for preoxygenation during tracheal intubation in icu and in operating room. none study has been done in emergency out-of-hospital medical rescue. this trial attempts to demonstrate same results or even more in that conditions.

this trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus niv.

Eligibility criteria:
inclusion criteria: * patients needing chest tube intubation exclusion criteria: * cardiac arrest * children * pregnancy * incompetents

Keywords: chest tube preoxygenation niv out-of-hospital patients needing tracheal chest tube managed by medical mobile emergency rescue services
extended release naltrexone for treating amphetamine dependence in iceland

Conditions: Amphetamine Dependence

Summary: until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. the primary aim of this pilot study is to replicate the findings of the swedish team that showed oral naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of vivitrol (naltrexone for extended-release injectable suspension) or vivitrol placebo. patients in each group will receive drug counseling. vivitrol is administered monthly and may be a better test of efficacy than tablets that must be taken daily.


Eligibility criteria:
inclusion criteria: 1. age 18 or above; 2. diagnosis of amphetamine dependence as defined by dsm-iv-tr with 10 or more days of amphetamine use in the past month, and patient and clinician identify amphetamine dependence as the main problem; 3. abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines \[unless used to treat alcohol withdrawal\] for at least 7 days prior to receiving study drug or placebo; 4. provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly; 5. successfully complete 7-10 day assessment and study baseline measures at vogur exclusion criteria: 1. any liver test \>5 times the top limit of normal; physiologically dependent on opioids or other substances (nicotine excepted) at time of admission to vogur; 2. suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge: 3. schizophrenia, bipolar i or other non-substance related psychotic disorder; severely depressed, suicidal or homicidal: dementia: inability to understand the informed consent; 4. planning to move from the reykjavík area or enter jail within the next 12 months; 5. likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure; 6. known hypersensitivity to naltrexone, polyactide-co-glycolide (plg); carboxymethylcellulose, or any other component of the diluent; 7. female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control; 8. a body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment; 9. use of an investigational agent in the past 30 days

Keywords: amphetamine dependence amphetamine injection vivitrol/vivitrol placebo amphetamine craving
neoadjuvant hormonal treatment of postmenopausal women who have operable breast cancer

Conditions: Breast Cancer

Summary: efficacy of neoadjuvant endocrine therapy with anastrozole in pomenopausal women with er-positive breast cancer. flavia morales-vásquez, horacio noé lópez basave. background: neoadjuvant hormonal therapy (ht) is being used increasingly to downstage locally advanced and large operable breast cancer. following this treatment, inoperable breast cancer often becomes fully respectable and tumors requiring mastectomy may be successfully removed by breast-conserving surgery (bcs). methods: recruit postmenopausal women with er(+) and/or pgr (+) breast cancer (bc) t2,n1-2 to t3,n0-1 were assigned to ht with anastrozole 1 mgr daily for 4 months. the primary endpoint was to compare overall objective response (or) determined by clinical (palpation) and ultrasound. secondary endpoint was the number of patients who qualified for bcs plus radiotherapy.


Eligibility criteria:
inclusion criteria: * postmenopausal women who had primary breast cancer, histological confirmed, through a core needle biopsy, and who{s tumors positive for estrogens receptor er/pr. clinical stage iib or iiia tumor assessable by clinical exam, mammogram or and ultrasound adequate functional bone marrow documented evidence adequate renal function and liver function life expectancy for six months written inform consent exclusion criteria: * prior treatment with letrozole or tamoxifen uncontrol disorders patients with instable angina or uncontrol cardiac disease patient with bilateral breast tumors patients elegies for conservative breast surgery inflammatory breast cancer o distant metastases other concurrent malignancies, except carcinoma with in situ cono biopsy of uterine cervix or adequate treat skin cancer no melanoma concomitant cancer treatment such as chemotherapy, immunotherapy biological modulators, endocrinotherapy, biphosphonates therapy and radiotherapy. concomitant treatment with steroids others research drug whiting the last 30 days and concomitant use of research drugs history non compliance with medications schedules and patients consider potential unreliable.
ankylosed teeth treatment by bone orthodontic treatment

Conditions: Ankylosed Teeth

Summary: codify the treatment of teeth by stiff corticotomy technique. evaluate the duration of treatment and tooth movement.

codify the treatment of teeth by stiff corticotomy technique. evaluate the duration of treatment and tooth movement. during treatment the teeth by stiff corticotomy, millimeter measurements are performed on a cohort of patients with this pathology. these measures take place during normal clinical phases and on all media such as, plaster models, photographs and radiological examinations performed at the beginning, during and at the end of treatment.

Eligibility criteria:
inclusion criteria: * patient in need of orthodontic treatment and presenting one or more teeth stiff * can meet the requirement of orthodontic treatment (attendance, quality of brushing) * showing no indication against general surgery exclusion criteria: * a patient against indication for orthodontic treatment : root resorption of teeth adjacent to stiff teeth, dental anchoring deficiency by multiple agenesis or agenesis of the adjacent teeth to teeth stiff, loss of periodontal support or active periodontal disease * a patient against indication to treatment with corticotomy : general pathology against indicating surgery, proximity root with no possibility of improvement orthodontic preparation * inability to maintain a good level of oral hygiene and good cooperation.

Keywords: orthodontique bone stretching