Kornimate/medical-research-clean huggingface dataset:
a study to investigate the safety, tolerability, pharmacokinetics of single and multiple doses of hepenofovir fumarate tablets in healthy volunteers.

Conditions: Chronic Hepatitis b

Summary: a study to investigate the safety, tolerability, pharmacokinetics of single and multiple doses of hepenofovir fumarate tablets in healthy volunteers

it's a single-center,randomized, double-blind, placebo-controlled study. it will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of hepenofovir fumarate tablets in healthy adult subjects.

Eligibility criteria:
inclusion criteria: * able to understand the nature of the study, comply with the protocol, and provide informed consent. * subjects willing to adhere to protocol requirements and to finish the study. * subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration. * subjects aged between 18 and 55 years (both inclusive). * subject's weight within normal range according to normal values for body mass index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale. * subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range. exclusion criteria: * history or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug). * hypersensitivity to different kinds of drugs and food. * presence of significant alcoholism or drug abuse. * volunteer who have donated blood or lose blood(\>450ml)within past 90 days prior to the first dose of the study drug. * any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study. * use of any prescribed medication or otc medicinal products during the last 14 days prior to dosing of the study. * consumption of spcial food(including gragon fruit, mango, grapefruits) or strenuous excercise,or other factors which may effect the absorption,distribution,metabolism,excretion of drugs for within 2 weeks prior to dosing of the study. * any treatment which could bring about induction or inhibition of cyp3a4. * volunteer who have participation in a drug research study within past 90 days prior to the first dose of the study drug. * difficulty in swallowing or other gastrointestinal disease or disorder. * presence of an abnormal electrocardiogram (ecg), which was clinically significant. * female subjects who were breast-feeding or had a positive pregnancy test at screening or at any time during the study. * subjects with abnormal health as determined by personal medical history, clinical examination and laboratory examinations,which was clinically significant. * subjects who, in the opinion of the investigator, should not participate in the study.
combination iodine 125 seed implants and lhrh agonists for locally advanced (stage t3) prostate cancer

Conditions: Prostate Cancer

Summary: patients with prostate cancer should have the following examination including biopsy, serum psa volume, prostate ct scan or mri, bone scan, abdomen ultrasound, chest x ray, blood biochemistry, blood rout, ecg and testosterone. two groups: first group:30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal prostate implant +zoladex 3.6mg im 1/28d (lhrh agonist, 3.6mg subcutaneous injection 1/4weeks). second group: 30 cases should be treated with zoladex 3.6mg im 1/28d (lhrh agonist, 3.6mg subcutaneous injection 1/4weeks). pfs and psa level will be the primary variables.


Eligibility criteria:
inclusion criteria: 1. provision of written informed consent 2. t2c-t3b n0 m0 (biopsy、 bone scan、 ct、 mri) 3. no metastasis (bone scan、 ct、 mri) 4. psa level\>10ng/ml 5. histological or cytological confirmation of prostate cancer 6. able to understand and comply with the requirements of the study exclusion criteria: 1. having been treated with external radiation therapy or chemistry therapy. 2. clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs. 3. alanine amino transferase (alt) or aspartate amino transferase (ast) greater than 2 times the upper limit of normal (uln) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s) 4. in the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease). 5. contra-indications (eg, known or suspected allergy) to gnrh antagonists or excipients(non-active ingredients of investigational product). 6. treatment with a non-approved or investigational drug within 30 days before study entry. 7. bibulosity or drug abuse.

Keywords: to detective the effect of the treatment of combination iodine 125 seed implants and lhrh agonists for the patients with locally advanced prostate cancer.
manuka honey sinus rinse study

Conditions: Cystic Fibrosis; Infection, Bacterial

Summary: a trial investigating the effect of a sinus rinse in people with cf

people with with cf often have bacterial infection in their air ways. there is great interest in the different types of bacteria found within these infections. this clinical trial looks at whether a novel sinus rinse device (that incorporates manuka honey) could help clear infection or reduce the amount and/or types of bacteria found within the upper airway. this study assesses the changes in the sino-nasal outcome test (snot-22) scores along with any changes in quality of life, before and after the use of a sinus rinse device for 30 days. in addition to this, the amount and types of bacteria found in nasal swabs, the sinus rinse solution, and sputum samples, before and after using the sinus rinse device will be investigated. sputum samples will also be monitored for changes in composition before and after using the sinus rinse.

Eligibility criteria:
inclusion criteria: * the patient is willing and able to give informed consent. * the patient must be ≥ 18 years. * the patient must have an established diagnosis of cf (one or more of the following) sweat chloride \>60meq/l presence of two cf causing mutations. * the patient must have chronic symptoms of rhinosinusitis according to the criteria of the european position paper on rhinosinusitis (appendix a). * the patient scores greater ≥ 7 on their snot-22 questionnaire. exclusion criteria: * the patient has ever tested positive for the bacteria mycobacterium tuberculosis. * the patient is currently using a nasal rinse protocol. * the patient has undergone sinus surgery within 6 months. * the patient suffers from nasal bleeding. * the patient is currently undergoing systemic antibiotic therapy for infective exacerbation. * the patient is using overnight oxygen via nasal cannula. * the patient is participating in another clinical trial or has done so within the last 30 days. * the patient has a known allergy to bee products. * the patient has an objection to the use of bee products
multidisciplinary care after prostatectomy

Conditions: Prostate Cancer

Summary: this is a pilot, prostective, comparative, randomized, monocentric open-label study whose main objective is to determine whether appropriate psychological, nutritional and physical activity support can improve the quality of life of carrier patients. localized prostate cancer treated by prostatectomy

pilot study to demonstrate the benefits of a multimodal intervention (psychological and nutritional support and physical activity) on the recovery of patients treated by prostatectomy for localized prostate cancer. after inclusion of 100 patients, at week 6 will undergo a prostatectomy and then at week 9 will be randomized into two groups of 50 patients for each group. groupe intervention which will benefit from multidisciplinary care over 12 weeks (one apa session per week plus 5 workshops with the psychologist and a workshop with the dietician) plus a visit with the urologist. then after 3 months, 6 months and 12 months, the group benefit from an evaluation with the urologist, the teacher of adapted physical activity and the dietitian. -for the control group, it will be followed classically, a visit to the urologist, an assessment with the teacher of physical activity and the dietician, after prostatectomy, then at 3 months, 6 months and at 12 months.

Eligibility criteria:
inclusion criteria: who score 0 or 1 * adult patients with localized prostate cancer eligible for surgical treatment according to the afu criteria following the capra and d'amico classifications: low risk or risk intermediaries. these are patients under the age of 73, with clinical stage and or mri \< or = t3, psa \< or = 20 ng/ml, with assessment negative extension (bone scintigraphy, thoraco-abdomino-pelvic scanner, choline pet-scanner) * informed and written consent signed by the patient * person affiliated with social security or beneficiary of such a scheme exclusion criteria: who score greater than or equal to 2 * mmse score below 20 * persons referred to in articles l1121-5 to l1121-8 of the csp (corresponds to all protected persons: person deprived of liberty by judicial or administrative decision, person subject to a legal protective measure)
safety evaluation of adverse reactions in diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess the effects of incretin-based antidiabetic therapies (dpp-4 inhibitors and glp-1 agonists) on cardiovascular, gastrointestinal and renal system and to detail the mechanisms underlying their action in these systems.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * metformin monotherapy - stable dose during last 3 months * hba1c 48-75 mmol/mol (ifcc) * bmi 25-40 kg/m2 * age 35-70 years (women postmenopausal) * use of ace inhibitors or atii receptor blockers for at least 3 months before enrollment exclusion criteria: * egfr\<30 ml/min/1.73m2 (mdrd) * treatment with incretin mimetics during 3 months before enrollment * chronic insulin therapy * chronic use of loop diuretics, glucocorticoids, nsaid, immune suppressants, antimicrobial agents, chemotherapeutics, bile acid sequestrants (colestyramin, colesevelam) * history of pancreatic disease or impaired pancreatic function (defined as the need to use pancreatic enzymes) * active liver disease or a 3-fold elevation of liver transaminases (alt, ast) * active malignancy * history of severe cardiovascular disease including acute coronary syndrome, stroke or transient ischemic neurologic disorder during previous 6 months, atrial fibrillation or other arrhythmia requiring chronic antiarrhythmic medication, chronic heart failure (new york heart association grade iii/iv) * history of alcohol abuse, defined as \>4 units of alcohol/day (32 g or 40 ml of 100% alcohol) * history of allergy for glp-1 receptor agonists or dpp-4 inhibitors * any disease that could interfere with study procedures (e.g. decreased mobility, mental incapacity) * inability to give informed consent
rehabilitation with personalized strategies according to muscle volume before knee arthroplasty

Conditions: Gonarthrosis; Arthroplasty

Summary: preoperative rehabilitation before total knee arthroplasty (tka) has not been proven to be effective. latest meta-analyzes do not find any improvement of motor performance during gait 6 months after surgery. however, most of the previous studies did not specifically target muscle atrophy to design rehabilitation protocol. pre-operative muscle atrophy, although not systematic, is often observed. the preoperative muscles volumes of thigh muscles have been poorly identified and never used to adjust the pre operative rehabilitation strategy. as part of the "followknee" (rhu) project, which attempts to implement a personalized management of tka and its follow-up, this study wants to explore the potential effect of adapted treatment to improve muscle force and muscle volume before tka.


Eligibility criteria:
inclusion criteria: * terminal stage gonarthrosis with total knee arthroplasty (tka) indication * tka indicated by the surgeon * body mass index \< 35 * acceptance to realize a preoperative rehabilitation in outpatient setting * adult between 18 and 80 years old * patient affiliated to social security * patient who signed an informed consent exclusion criteria: * functionally uncomfortable osteoarticular illness (disabling pain, functional limitation of joint amplitudes or muscle strength) of controlateral leg. * unable or refusal to consent * contraindication to electrostimulation (skin lesion, nearby implanted metallic material, implanted cardiac or neurologic electrostimulator, intolerance to muscle electrical stimulation) * unstable medical situation preventing the continuous realization of a program of at least 4 weeks
lorlatinib continuation study

Conditions: Non-Small-Cell Lung Cancer; NSCLC

Summary: the purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the pfizer sponsored lorlatinib parent studies that will be closed. additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention


Eligibility criteria:
inclusion criteria: 1 - any participant who is receiving study treatment and deriving clinical benefit (as determined by the principal investigator) in a pfizer-sponsored lorlatinib parent study. 2- participants must agree to follow the reproductive criteria. 3- adequate bone marrow, liver, renal, pancreatic function exclusion criteria: 1 - female participants who are pregnant or breastfeeding. 2- any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Keywords: alk anaplastic lymphoma kinase
the effect of insulin glulisine compared with insulin aspart on breakfast post prandial glucose levels in prepubertal children

Conditions: Type 1 Diabetes Mellitus

Summary: to determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.

this is a treatment, open label, crossover study comparing two and four hour breakfast post prandial blood glucose levels after receiving a dose of insulin glulisine or insulin aspart administered subcutaneously and consuming the breakfast meal from a prescribed menu containing 45, 60 or 75 grams of carbohydrate. each subject will receive insulin glulisine for ten days and insulin aspart for ten days.

Eligibility criteria:
inclusion criteria: * current patient in the helen devos children's hospital diabetes clinic; * ages 4-11 years; * prepubertal (tanner stage i); * diagnosed with type 1 diabetes mellitus with positive islet cell antibodies or presenting at time of diagnosis with positive serum or urine ketones and requiring insulin since diagnosis; * at least six months from date of diagnosis of type 1 diabetes mellitus; * tsh within reference range and negative transglutaminase iga antibodies within nine months of study start; * hba1c between 6.9 and 10% within 30 days of study start; parent or guardian able and willing to provide written informed consent prior to enrollment; * at time of study start, current insulin regimen includes multiple daily injections with insulin glargine as the basal insulin and insulin aspart or insulin lispro as the pre-meal rapid acting insulin exclusion criteria: * pubertal (tanner stage 2 or greater); * concurrent addison's disease, celiac disease or untreated hypothyroidism; - receiving oral, injectable or inhaled steroids or immunosuppressant medications; * receiving stimulants for treatment of attention deficit disorder or attention deficit hyperactivity disorder; * intercurrent illnesses such as a fever \> 101 degrees f, infection, or gastroenteritis; * use of any medication to treat diabetes other than those listed under in inclusion criteria; * potential for lack of compliance or any other issue which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Keywords: type 1 diabetes mellitus in children insulin glulisine insulin aspart post prandial
effects of mindfulness meditation on facial paralysis patients

Conditions: Facial Paralysis

Summary: currently, physicians have several options in addressing the anatomic and physiologic sequela of facial paralysis. however, strategies to address the psychologic and coping ability for patients have not been investigated. the goal is to investigate the effect of mindfulness meditation on social functioning in patients with facial paralysis. this study will also explore whether increasing social functioning in patients with facial paralysis will improve overall quality of life. these questions will be answered using a randomized controlled trial.

in this study population, facial paralysis was significantly associated with increased loneliness, decreased social function, decreased comfort with socializing, and worse quality of life scores. furthermore, prior studies have shown that facial paralysis increases the likelihood of depression as measured on validated psychometric instruments. currently, treating physicians have several options in addressing the anatomic and physiologic sequela of facial paralysis. however, strategies to address the psychologic and coping ability for patients have not been investigated. to better provide patient-centered care, physicians should consider the psychosocial impact of facial paralysis to identify patients who may benefit from additional support interventions to complement facial reanimation treatment plans. this is a prospective repeated measures study examining psychosocial status as measured by validated psychometric instruments. the intervention group will participate in mindfulness meditation using a phone application. assessment of social functioning and quality of life will be conducted using survey instruments.

Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * must have any-cause facial paralysis exclusion criteria: * patients younger than 18 years old * non-english speakers * patients without smart-phone access * patients with autism * patients with schizophrenia * patients with an affective psychiatric condition

Keywords: mindfulness meditation facial paralysis quality of life social functioning
effectiveness of menthol chewing gum in the management of thirst

Conditions: Thirst

Summary: the objective of this study was to compare the effectiveness of menthol chewing gum compared to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst during the preoperative period. the hypothesis of the study was that the use of menthol chewing gum in surgical patients in the preoperative period would be more effective than the maintenance of fasting with regard to the decrease in thirst and its discomforts.

there is evidence that chewing gum is effective in relieving thirst in the surgical patient in the preoperative period as it stimulates the salivary glands by means of mechano and chemoreceptors, increasing the salivary ph and flow, lubricating the oral cavity, acting in this way on peripheral thirst, which is triggered by dehydration of the oral mucosa. furthermore, menthol gum stimulates the cold receptors, known as trpm8, which are responsible for deactivating centers of thirst. thus, the risk of bronchoaspiration due to gastric fullness is avoided and the discomfort of a dry mouth is reduced.preliminary evidence indicates that the chewing gum strategy assists in the relief of a dry mouth and thirst in patients undergoing dialysis and head and neck radiotherapy. however, there is no scientific evidence of controlled studies with results that can be generalized regarding the use of chewing gum to reduce thirst and its discomforts in surgical patients in the preoperative period when they remain in a fasted state.

Eligibility criteria:
inclusion criteria: * elective surgeries; * aged between 12 and 65 years; * did not receive preanesthetic medication; * oriented in time and space; * present dentition (natural or artificial); * fasting for a minimum of three hours; * available for collection at least 3 hours prior to the scheduled surgical procedure; * verbalize thirst spontaneously or when questioned with an intensity greater than or equal to three on the verbal numerical scale (vns); exclusion criteria: * allergy to menthol; * chewing restriction; * swallowing restriction; * patients who presented nausea, vomiting, or pain; * patients with chronic xerostomia; * chronic renal patients;

Keywords: chewing gum artificial saliva saliva mastication salivary glands xerostomia
donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases

Conditions: Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer

Summary: this pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. when the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). giving cyclophosphamide after the transplant may stop this from happening.

primary objectives: i. to determine if haploidentical stem cell transplant using post-transplant cyclophosphamide results in 60% or better disease free survival (dfs) at 12 months at our institution. secondary objectives: i. to determine the rate of acute and chronic graft-versus-host disease (gvhd), non-relapse mortality, and relapse. outline: preparative regimen: patients receive fludarabine phosphate intravenously (iv) once daily (qd) on days -6 to -2. patients receiving myeloablative conditioning receive busulfan iv every 6 hours for 16 doses on days -7 to -4 and patients receiving reduced intensity conditioning receive busulfan iv every 6 hours for 8 doses on days -5 to -4. patients also receive cyclophosphamide iv qd on days -3 and -2 transplant: patients undergo stem cell transplant on day 0. gvhd prophylaxis: patients receive cyclophosphamide qd on days 3 and 4, tacrolimus on days 5-180, and mycophenolate mofetil on days 5-35. after completion of study treatment, patients are followed up periodically for 2 years.

Eligibility criteria:
inclusion criteria: * diagnosis of a hematological malignancy requiring an allogeneic stem cell transplant consistent with the standard of care * remission of any acute hematologic malignancy or adequate disease control for chronic malignancies. * ages 18-69 years old. * available familial haploidentical (4 to 6 out of 8 hla loci-matched) donor exclusion criteria: * significant organ dysfunction defined as: lv ef \ 2.5 x uln, bilirubin \> 1.5 x uln, serum creatinine \> 2mg/dl, dialysis, or prior renal transplant * hiv positive (recipients who are positive for hepatitis b (hbv), hepatitis c (hcv) or human t-cell lymphotropic virus (htlv-i/ii) are not excluded from participation) * positive pregnancy test for women of childbearing age. * major anticipated illness or organ failure incompatible with survival form transplant. * severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible.