Kornimate/medical-research-clean huggingface dataset:
p53 gene therapy for head and neck malignant tumors in advanced stage

Conditions: Neoplasms

Summary: this is multicenter, open-label, randomized, active-controled, phase iv study of local direct intra-tumor injection of rad-p53 monotherapy, with concurrent chemotherapy , with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage .

primary objectives of this study is to determine the efficacy profiles of rad-p53 intra-tumor injection alone, with concurrent chemotherapy, with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage (stage iii or iv) including target lesion complete response rate (lcr) and overall target lesion response rate (olr), response duration (rd), and progress-free survival (pfs). the secondary objectives of this study is to investigate overall response rate (opcr) and overall complete response rate (ocr), overall survival (os), ecog, and safety of rad-p53 monotherapy and combined with chemotherapy, radiotherapy or surgery.

Eligibility criteria:
inclusion criteria: 1. advanced stages of head and neck malignant tumors (stage iii and vi) 2. at least one target tumor can be injected with study drug, the largest diameter greater than 2 cm 3. histologically confirmed head and neck malignant tumors 4. no prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks 5. age: 18-85 years old 6. expected to survive more 12 weeks 7. ecog:0-2 8. neutrophils≥1.5×109/l,platelet≥ 80×109/l, hb≥80g/l, bilitubin≤2mg/dl,alt and ast ≤2×institutional upper limit of normal, cr ≤1.5×institutional upper limit of normal,coagulation tests (ptt and inr) within normal range 9. subject provided signed informed consent exclusion criteria: 1. hypersensitive to study drug 2. tumor(s) locate very close to important blood vessels and nerves, which affect injection 3. with a coagulation and bleeding disorder 4. with uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness 5. local infection close to injection site or systemic infection 6. pregnant or lactating 7. principle investigator consider not suitable

Keywords: p53 gene head and neck malignent tumors gene therapy
baclofen in preventing postoperative nausea and vomiting after bariatric surgery

Conditions: Postoperative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy; Morbid Obesity

Summary: this study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

. a total of 100 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. the patients will be selected from those attending gastrointestinal and laparoscopic surgery unit, general surgery department, tanta university hospital, tanta, egypt. the participants will be randomized into four groups by closed envelop method

Eligibility criteria:
inclusion criteria: * morbidly obese patients scheduled for sleeve gastrectomy with bmi ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes. * morbidly obese patients scheduled for sleeve gastrectomy with bmi ≥ 40 kg/m2 without comorbidity. * patients fit for anesthesia and surgery. exclusion criteria: * patients with bmi \>55 kg/m2. * patients with previous procedures for the treatment of obesity. * pregnant females and lactating women. * patients with psychological or psychiatric disease * administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery * patients who experienced vomiting within 24 hours before surgery. * patients with history of alcohol or drug abuse. * patients with hypersensitivity or contraindications to any of the drugs used in this study.

Keywords: postoperative nausea and vomiting laparoscopic sleeve gastrectomy baclofen morbid obesity
a multicenter placebo-controlled double blind study to evaluate the efficacy and safety of sandostatin ( sms 201-995 ) in patients with acquired immunodeficiency related diarrhea who were either "responders" or "non-responders" in a prior placebo-controlled double-blind sandostatin study.

Conditions: Diarrhea; HIV Infections

Summary: the primary objective of this study is to determine the relapse rate in patients with aids-related diarrhea who were found to be "responders" in a previous placebo-controlled, double-blind study of sandostatin (study #d203 - fda 102a). the secondary objectives include: 1) to evaluate clinical efficacy and safety of open-label sandostatin in patients who were "non-responders" in study #d203 - fda 102a; 2) to evaluate the efficacy and safety of sandostatin during prolonged open-label treatment in "responders" from study #d03 - fda 102a.


Eligibility criteria:
inclusion criteria patients must have the following: * only patients who have completed the duration of study d203, fda 102a will be eligible for this study. * each of these patients must give written informed consent to participate in study d204, fda 102b as well.

Keywords: octreotide diarrhea acquired immunodeficiency syndrome aids-related complex
a feasibility study followed by a randomized phase ii study of yoga for radiation therapy side effects in prostate cancer

Conditions: Prostate Cancer

Summary: this study will ascertain the feasibility and effect of eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage i /ii prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.

the feasibility study refers to the ability to recruit patients willing to participate in the eischens yoga interventional arm. those who are recruited during the feasibility study are seemlessly move to the phase ii study, and for this reason the feasibility study and eischens yoga interventional arms are reported simply as the eischens yoga interventional arm.

Eligibility criteria:
inclusion criteria: patients * prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). prior or concurrent androgen deprivation therapy is permitted. * patients of age \>18 years, and all races will be included in the study. * patients must have an ecog performance score ≤ 1 * all patients must sign an informed consent form caregivers * subject is age \>18 years * subject is english-speaking * subject must sign an informed consent form exclusion criteria patients * patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ecog performance status score. * active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (smokers that have been smoke-free for 6 months may be included) * patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months). * patients who are undergoing chemotherapy for any reason * patients with evidence of metastatic disease caregivers * subjects that are unwilling or unable to provide informed consent * subjects with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions * active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (smokers that have been smoke-free for 6 months may be included) * patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
hamstring stretching effective on nonspecific low back pain

Conditions: Low Back Pain

Summary: low back pain is one of the most common complaints in the world and can be considered a universal health problem for humanity. low back pain is a multifactorial disease with multiple etiologies. risk factors are difficult to identify. it is reported in the literature that 70-80% of the world's population has low back pain at some point in their lives, and 95% of this pain is mechanical. mechanical low back pain (mba) can be described as a clinical picture that develops as a result of overuse, strain, traumatization or deformation of the structures that make up the spine. in order to define low back pain mechanically, all organic causes such as inflammatory, infectious, tumoral, metabolic causes, fractures and pain reflected from internal organs must be excluded. the most common diseases that cause low back pain are; they are caused by mechanical factors and degenerative diseases. mechanical and static stresses can lead to joint blockage, restricting the range of motion of the joint along with pain. non-specific many factors affect low back pain. kim and shin reported that asymmetry of hip extension range of motion of both hip joints was associated with nonspecific low back pain rather than simple hip extension range of motion, and they found that limiting hip extension was compensatory.


Eligibility criteria:
inclusion criteria: * patients with complaints of low back pain, * nlbp for at least 12 weeks, * finger-to-ground distance greater than 0 cm; a passive straight-leg raising -(slr) angle of less than 80°, measured with a hand-held goniometer; * normal mobility of the hip; * passive knee extension ≥25°, * vas score between 3 and 7 will be included. exclusion criteria: * people with a history of hamstring injury in the last two years, * fractures in the spine or lower extremities, * pregnancy, * leg length difference of more than 2 cm, * and obesity will be excluded from the study.
dehydroepiandrosterone (dhea)supplementation pre-ivf(in vitro fertilization) cycles

Conditions: Infertility

Summary: the purpose of this study is to compare the effect of pre-ivf cycles treatment with and without dhea(dehydroepiandrosterone) on the ovarian reserve markers, the number of oocytes obtained and ivf(in vitro fertilization) outcomes of dor(diminished ovarian reserve) patients and the expression of bmp-15(bone morphogenetic protein 15),gdf-9（growth differentiation factor 9) and igf-i(insulin-like growth factors-1) in follicular fluid.

78 patients were enrolled according to the inclusion criterion. they were randomized into two groups, 40 were in dhea group and 38 were in control group. the dhea group received dhea (lab hercules™) 25mg three times a day continuing more than 12 weeks prior to the start of ivf treatment till the day of egg collection and the control group got without any dhea treatment. all of the ivf women patients were given cc(clomifene citrate)+hmg(human menopausal gonadotropin) protocol for controlled ovarian hyperstimulation. hormonal profile including e2(estradiol),fsh(follicle-stimulating hormone) ,p(progesterone) ,lh (luteinizing hormone),t(testosterone),afc(antral follicle account),serum and follicle amh(anti-mullerian hormone)levels will be repeated in follicular phase (d2 or 3) of cycle followed by an ivf treatment using cc+hmg protocol based on our standard departmental regimen. improvement of ovarian reserve markers would be assessed by the change in serum and follicle amh levels. cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for the test of dhea-s(dehydroepiandrosterone sulfate) and igf-i. bmp-15 and gdf-9 expression in the follicular fluid were detected with western blot.

Eligibility criteria:
inclusion criteria: * patients with antral follicle count \<5 or amh\<1.1ng/ml and a previous poor ovarian reserve (por)(\</= 3 oocytes with a conventional stimulation protocol using at least 150 iu fsh per day,at least two episodes) exclusion criteria: * patients with polycystic ovary or polycystic ovary syndrome, patients who had previous chemotherapy, pelvic irradiation or ovarian surgery and patients on hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or dhea).

Keywords: dehydroepiandrosterone（dhea） dor（diminished ovarian reserve) ivf(in vitro fertilization) bmp-15(bone morphogenetic protein 15)
study to evaluate markers of response in locally advanced breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to compare the association between image and certain molecular markers with complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy composed of bevacizumab, docetaxel and doxorubicin.

this is a pharmacogenomic phase ii, multicenter, prospective clinical trial whose main objective is to evaluate the association of molecular and imaging markers with the response to bevacizumab administration in combination with docetaxel and doxorubicin as neoadjuvant chemotherapy in patients diagnose with locally advanced breast cancer.

Eligibility criteria:
inclusion criteria: * female * signed informed consent form * ages between 18 and 70 * 12 months of life expectancy at least * histologically confirmed breast cancer * no previous treatment for locally advanced breast cancer * her2+ o her2- * disease measurable by pet and/or mri * ecog 0-1 * adequate organic function * negative pregnancy test; fertile women must use anticonceptive methods after icf and 30 days after last study drug administration * enough capability to follow the procedures and follow-up test included in the protocol exclusion criteria: * metastatic disease * inadequate health to receive the study chemotherapy * previous breast cancer treatment * pregnant or lactating women * major surgery or significative traumatic injure in the 28 days previous to inclusion, or during treatment. * minor surgery 24 hours before first bevacizumab infusion * concomitant or recent aspirin(\>325mg/day)or clopidogrel(\>75mg/day) treatment * concomitant or recent oral anticoagulant treatment * history or evidence or bleeding diathesis or hereditary coagulopathy with bleeding risk * uncontrolled arterial hypertension * clinical significative heart disease, or uncontrolled severe arrhythmia disorder * unhealed wounds, peptic ulcer or bone fracture * history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess, 6 months before inclusion * evidence of any other disease, neurological or metabolical disorder or physical examination or laboratory finding related with any disease that makes the subjet ineligible for the study treatment or that put the subject in risk because of the study treatment. * psychiatric disorders that may prevent the subject to complete the study treatment * current participation in any other trial involving an investigational drug, or participation in any kind of trial 28 days before inclusion * chronical corticosteroid treatment * hypersensitivity reaction to bevacizumab or any of its components or any of the other study drugs or components * patients diagnosed with different neoplasms the previous 5 years excluding non melanoma skin cancer and resected cervical cancer

Keywords: breast cancer pharmacogenomics bevacizumab
steady state study of codeine sulfate

Conditions: Pain

Summary: study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (m3g), and morphine-6-glucuronide (m6g) after oral administration of roxane laboratories' codeine sulfate tablets administered at a dose of 15 mg q4h x 5 days.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to codeine sulfate or any comparable or similar product.
effect of cbt microinterventions on mechanisms of behavior change among adults with aud

Conditions: Alcohol Use Disorder

Summary: this proposed r21, effect of cbt microinterventions on mechanisms of behavior change among adults with aud: using eye tracking to measure pre-post cognitive control, uses a translational team science approach to isolate and examine the effect of three different cognitive behavioral therapy (cbt) interventions (functional analysis (fa), cognitive restructuring for alcohol related thoughts (cr), and dealing with cravings (dc)) on specific hypothesized mechanisms (cognitive control, stimulus salience, or craving/arousal, respectively).

this r21 uses an innovative paradigm pairing a "microintervention" design with eye tracking laboratory tasks used successfully to show deficits of cognitive control over cocaine and nicotine cues, and to objectively measure stimulus salience and craving/arousal in response to alcohol cues. to achieve the study's two specific aims, participants with aud will be assessed with antisaccade (to measure cognitive control) and attentional bias (to measure stimulus salience and pupil diameter) eye tracking tasks. specific aim 1. to isolate and preliminarily assess the impact of specific cbt microinterventions on potentially malleable hypothesized mechanisms of change in drinking using a novel laboratory paradigm and conducted by a translational science team. specific aim 2. to test specificity of cbt interventions' effect on particular mechanisms of behavioral change, the investigators will test each microintervention's effects on all three purported mechanisms (as stated in "brief summary".)

Eligibility criteria:
inclusion criteria: * age 18 or older * current alcohol use disorder (aud) diagnosis * drank alcohol within 60 days prior to telephone screen * able to read and understand english at the 7th grade education level exclusion criteria: * participant diagnosed with schizophrenia or schizoaffective disorder * participant has a head injury with symptoms in the last 30 days * current inpatient or outpatient treatment for aud or drug use disorder (dud)
clinical study of autologous natural killer cells in multiple myeloma

Conditions: Multiple Myeloma

Summary: multiple myeloma (mm) is a lethal disease and at present no available treatment method seems to prevent the disease from progressing or relapsing in the long term. nk cells have a relatively high cytotoxic capacity and an anti tumour effect, suggesting a potential as a treatment of mm.this is a phase i, first-in-human, therapeutic exploratory study, where no benefits for the patients can be guaranteed. however, the theoretical implication is that the infused cells may have a positive antitumour effect for the participating individuals.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. above 18 years of age 3. mm diagnosis (stage i-iii according to the international staging system) 4. eligible for, and willing to undergo, high dose chemotherapy and asct 5. measurable monoclonal immunoglobulins 6. eastern cooperative oncology group (ecog) performance status 0-2 7. life expectancy of at least three months exclusion criteria: 1. non-secretory mm 2. malignancy, other than mm, treated with chemotherapy or radiation within the past six months 3. blood donation or other significant blood loss within three months from screening 4. any physical condition or laboratory results that contraindicate a blood donation to be performed within four weeks from screening 5. any physical condition or laboratory results that require the chemotherapy to start before there is available slot for blood donation 6. known or suspected allergic reactions to any ingredient of the ip 7. diagnosis or indication of any active autoimmune disease, such as rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosis or multiple sclerosis 8. uncontrolled or severe cardiovascular disease, such as myocardial infarction within six months from screening, heart failure (class iii or iv according to new york heart association), uncontrolled angina, clinically significant pericardial disease or cardiac amyloidosis 9. poorly controlled hypertension 10. poorly controlled diabetes mellitus, type i or ii 11. diagnosis or indication of any clinically relevant renal disease 12. diagnosis or indication of any clinically relevant hepatic disease 13. ongoing infection that is considered chronic 14. known or suspected drug or alcohol abuse, within 12 months from screening 15. pregnant, trying to become pregnant, or nursing 16. lack of, or unreliable contraceptive method, as judged by the investigator 17. medical history or any abnormal physical finding that is clinically relevant and could interfere with the safety or objectives of the study, as judged by the investigator 18. lack of suitability for participation in the trial, for any reason, as judged by the investigator

Keywords: nk cells consolidation
effects of body contouring surgery in obese patients

Conditions: Validation Study; Quality of Life

Summary: the aim of this study is twofold; 1) to assess the psychometric properties of the finnish version of the body-q questionnaire, 2) to assess the effects of body contouring surgery using patient-reported outcome measures.

the body-q is translated into finnish through forward and backward translation and a committee review. the preliminary version is pilot tested with 20 participants undergoing body contouring surgery. the study is of longitudinal design gathering data from participants undergoing body contouring surgery due to obesity. data collection takes place in the department of plastic surgery, helsinki university central hospital, helsinki, finland. the participants fill in three patient-reported outcome measures. the outcomes of the three patient-reported outcome measures are compared with each other and internal validity assessed. test-retest reliability is assessed after two weeks from the first completion of the questionnaires. with validated questionnaires the effects of body contouring surgery is assessed.

Eligibility criteria:
inclusion criteria: * body contouring surgery due to: a) massive weight loss b) postbariatric weight loss * patient age over 18 years exclusion criteria: * patient age under 18 years * no body contouring surgery * surgical intervention performed in another hospital than helsinki and uusimaa hospital district * no obesity
penetration of moxifloxacin into liver tissue of patients undergoing liver resection.

Conditions: Side-effect of Antibiotic

Summary: the aim of the study is to provide data on the pharmacokinetics (pk) of moxifloxacin (mxf) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.

after given informed consent, patients scheduled for planned liver resection are enrolled into the study. the patients receive mxf 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. blood and healthy liver tissue are sampled in 34 patients after administration of mxf. plasma is sampled concomitantly. in a subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36 and 48 h to establish the pk. the pharmacokinetic parameters of mxf are calculated applying a two-compartment model.

Eligibility criteria:
inclusion criteria: * age 18-80 years old * elective liver resection of liver tumor * in females: pregnancy test negative * subjects willing and able to give fully informed written consent exclusion criteria: * subjects with contra-indications to moxifloxacin * subjects under therapy with moxifloxacin within 2 weeks before recruitment

Keywords: pharmacokinetics liver resection