Kornimate/medical-research-clean huggingface dataset:
quality of life study using gabapentin versus venlafaxine in treating hot flashes in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to assess the change in quality of life over a 6 month period between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.

60 evaluable patients with prostate cancer currently receiving androgen ablation therapy or who have had an orchiectomy will be enrolled in this study. all patients will be randomized 1:1 (30 patients per treatment arm) to either receive gabapentin or venlafaxine. treatment duration will be a total of 6 months. during those 6 months, study staff will evaluate frequency and intensity of hot flashes using hot flash score from hot flash diary every 28 days. patients will also record side effects associated with either gabapentin or venlafaxine on their medication diaries. study staff will record the severity of all adverse events reported. patients will also complete the quality of life functional assessment of cancer therapy-prostate (fact-p) form at baseline, cycle 3, and cycle 6/off study.

Eligibility criteria:
inclusion criteria: * men 18 years or older with histologically proven adenocarcinoma of the prostate * prior or current androgen deprivation for at least 6 months prior to study entry with either bilateral orchiectomy or being maintained on a stable dose of lhrh (luteinizing hormone-releasing hormone) agonist or antagonist * hot flash frequency of an average of 2 or more per day (average of 14 hot flash episodes per week) exclusion criteria: * cannot currently be taking serotonin reuptake inhibitors (ssris), serotonin-norepinephrine reuptake inhibitors (snris) or monoamine oxidase inhibitors (maois) * cannot have uncontrolled hypertension * cannot have history of past or current of epilepsy, epilepsy syndrome or other seizure disorder * cannot have psychiatric history of mania, hypomania, bipolar disorder or anorexia nervosa * cannot be receiving concurrent treatment with amy medications or herbal products being used with the express purpose of treating hot flashes.

Keywords: hot flashes prostate cancer
video-based exercise for individuals with social isolation due to coronavirus (covid-19)

Conditions: Healthy Lifestyle

Summary: in december 2019, new coronavirus pneumonia (covid-19) broke out in wuhan (hubei, china), and it spread rapidly from one city to the whole country in just 30 days, and then worldwide cases began to appear. all the countries of the world take some precautions to prevent the spread of this epidemic disease, which who declared as "pandemic". apart from compulsory situations, non-home and social isolation are the primary measures. however, not leaving the house and social isolation brings with it the restriction of physical activity. according to world health organization (who), in order to obtain health benefits, adult individuals between the ages of 18-64 should perform at least 150 minutes of physical activity per week (30 minutes a day for 5 days a week) or intensive physical activity for at least 75 minutes a week. for additional health benefits, adults should increase their moderate-intensity physical activities to at least 300 minutes a week or equivalent. physical activity; it is directly related to the prevention of chronic diseases, increasing fitness, strengthening the muscles and increasing the quality of life. it is reported that one of the ten main risk factors in terms of mortality in the world is insufficient physical activity. the effects of social isolation are related to physical inactivity, smoking and the possibility of having both health risk behaviors together. practical and innovative interventions are needed to reduce physical performance and decrease in muscle mass, strength and physical performance in the aging population. considering today's conditions and current covid-19 pandemic, technology-supported exercise programs are effective in increasing the motivation for physical activity. the purpose of this study; in order to prevent the spread of the covid-19 pandemic, social isolation, which is one of the measures taken in our country, is to evaluate the physical activity level of adults and to investigate the effectiveness of home exercises. it is aimed to use a model based on the video supported by a home-based exercise program.


Eligibility criteria:
inclusion criteria: * being between 40-60 years old * being in social isolation due to covid-19 virus * not having any physical disability that prevents them from doing physical activities * being in social isolation due to covid-19 virus * having access to exercise videos exclusion criteria: * having a serious cognitive impairment * having serious hearing and vision problems * having vestibular disorders that can cause loss of balance * having diabetes and/or hypertension or a neurological disease

Keywords: social isolation exercises physical inactivity health benefits
study of op-1 putty in uninstrumented posterolateral fusions

Conditions: Degenerative Lumbar Spondylolisthesis

Summary: this study is to provide additional data to support the safety and efficacy of op-1 putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.

follow-up study 06-uplf-01 was a prospective collection of longer-term data on the patient population from pivotal study s01-01us, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of op-1 putty in uninstrumented posterolateral fusion (plf) as compared to autograft

Eligibility criteria:
inclusion criteria: 1. the patient was treated in stryker biotech clinical protocol s01-01us (pivotal ide study) and not a retreatment failure at the time of completion. 2. the patient or legal guardian is willing and able to understand, sign and date the study specific patient informed consent. 3. the patient agrees to complete the necessary clinical and radiographic evaluations. exclusion criteria: 1. there are no exclusion criteria for participation in this protocol.

Keywords: degenerative disc disease
efficacy of nac for the prevention and relief of pipn in women with ovarian, tubal, and peritoneal cancer

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: ovarian cancer is third most common gynecologic cancer in thai woman, treatment including surgery followed by chemotherapy. patient usually received paclitaxel every 3 week for 6 cycles, paclitaxel induce peripheral neuropathy is common dose dependent side effect which can disturb quality of life, result in chemotherapy dose reduction or discontinuation leading to poor prognosis and decreased survival mechanism of pipn including inflammation, promotion of microtubule polymerization and inhibition of depolymerization, and oxidative stress n-acetylcysteine is acetylated form of l-cysteine, might reduce oxidative stress. nac can restore glutathione level, which is potent natural antioxidant. nac might reduce pipn

this study was designed to evaluate the effect of nac on the incidence and severity of pipn in woman with ovarian, tubal, and peritoneal cancer who treated with paclitaxel for 3 cycles. (pippn is developed after cumulative doses 250 mg/m2 or more) patient in controlled group, received paclitaxel only. patient in intervention group divided to two groups. first group received nac 2400 mg/day for one week after received paclitaxel each cycle for 3 cycles. second group received nac 2400 mg/day for 9 weeks evaluate incidence and severity of pipn before start cmt, and every visit after received cmt each cycle using common terminology criteria for adverse event (ctcae) ver.5, functional assessment of cancer therapy/gynecologic oncology group-neurotoxicity (fact/gog-ntx), and patient neurotoxicity questionnaire (pnq)

Eligibility criteria:
inclusion criteria: * female patient aged 18 years old or more with ovarian, tubal, and peritoneal cancer who received paclitaxel first course after surgery * eastern cooperative oncology group (ecog) 0-1 * normal laboratory testing * hemoglobin ≥10 g/dl, leukocyte count ≥ 3,000/ml, absolute neutrophil count ≥1,500/ml, platelet count ≥100,000/ml * serum creatinine ≤1.5 mg/dl * bilirubin ≤1.5 upper limit of normal * alkaline phosphatase and serum glutamic oxaloacetate transaminase ≤3 upper limit of normal exclusion criteria: * patient with symptoms of peripheral neuropathy before study * allergy to n-acetylcysteine * psychiatric disorders * pregnant woman * history of treated with other chemotherapy or radiotherapy before study
mechanism study of metabolic response and health benefit induced by exercise

Conditions: Prediabetes

Summary: this study is a single-arm, self-control, single-center study to investigate the mechanism under exercise inducing metabolic response and health benefit. 40 overweight/obese patients with prediabetes will be recruited in this study and instructed to participate in an 8-week exercise program. we aim to investigate 1) the changes of phenotypes such as body weight, body fat, laboratory values, appetite, resting energy expenditure, myokine-adipokine before and after exercise 2) the changes of serum metabolomics 3) search for potential biomarkers of exercise through multi-omics integrated analysis of metabolomics, metagenomics, phenomics, single-cell transcriptome, etc.


Eligibility criteria:
inclusion criteria: 1. han chinese 2. 5.6 mmol/l≤fasting blood glucose\<7 mmol/l, and/or 7.8 mmol/l≤2h-postload glucose\<11.1mmol/l, and/or 5.7% ≤hba1c\<6.5% without anti-hyperglycemic medicine treatment 3. voluntary participation and provide informed consent exclusion criteria: 1. participated in any clinical study in relation to weight-loss in the past 1 year 2. had a weight change of more than 10% present weight in the past 1 year 3. had a drug usage not suitable for this study in the past 3 months, such as hormone drug, orlistat, metformin, glp-1 receptor agonists, lipid-lowering agents, liver protection drug, etc 4. presence of diseases influencing glucose and lipid metabolism ,such as hyperthyroidism, hypothyroidism, cushing syndrome, etc 5. poorly controlled blood pressure: systolic blood pressure≥180mmhg, and/or diastolic blood pressure≥100mmhg 6. presence of serious heart, liver, kidney or systemic diseases 7. presence of skeletal and muscular diseases which make it difficult to exercise 8. received any kind of surgery in the past 1 year 9. covid-19 positive or recovery from covid-19 within 4 weeks 10. presence of eating disorders or have a history of eating disorders 11. presence of sleep disorders 12. work in disrupted circadian rhythms 13. pregnancy and breastfeeding women
novel self-adhesive composite hybrid versus conventional composite in restoration of carious primary teeth.

Conditions: Dental Caries in Children

Summary: the clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (surefil one) versus conventional composite(voco grandio) as restorative material for carious primary teeth.

composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? this randomized clinical trial is performed to discus and assess that hypothesis. a total of 120 class i restoration(60 surefil one novel self-adhesive composite hybrid \& 60 voco grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. the restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. both the procedure and follow up will done in the out-patient clinic, pediatric dentistry and dental public health department, faculty of dentistry, cairo university, cairo, egypt.

Eligibility criteria:
inclusion criteria: children: good general health and medically free patients. age ranges: from 4-7 years old. a provided informed consent by the parents. acceptable child cooperation. teeth: class i carious primary teeth. 2 contralateral or adjacent carious teeth. simple caries, extending to the dentin. no singe or symptom of pulp inflammation. normal radiographic examination. exclusion criteria: children: unable to attend follow-up visits. refusal of participation. teeth: symptom tooth. periapical pathosis. mobile primary tooth.
prophylactic negative pressure dressings for closed laparotomy wounds - a randomised, controlled, open label trial

Conditions: Infection

Summary: laparotomy wounds are associated with high rates of surgical site infections (ssi). the effect of prophylactic negative pressure dressing of closed incisional wounds on ssi rates is inconclusive.


Eligibility criteria:
inclusion criteria: * elective and emergency abdominal surgery exclusion criteria: -
navigated laparoscopic microwave ablation of tumor mimics in pig liver - an ex-vivo trial

Conditions: Liver Cancer; Surgery; Navigation, Spatial

Summary: in primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.it could be performed laparoscopically. under ultrasound control the microwave device is placed in the tumor.therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. during learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. targeting systems could optimize that. the casone-spot-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. in this study targeting precision using the spot-system should be compared to conventional laparoscopic ultrasound-guided microwave ablation. therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. the ablation procedures will be performed by two novices and two experienced surgeons. aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the spot-navigation system.


Eligibility criteria:
inclusion criteria: board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation exclusion criteria: * non

Keywords: laparoscopy navigation microwave ablation ultrasound guidance
study of bms-587101 in patients with moderate to severe psoriasis

Conditions: Psoriasis, Moderate to Severe

Summary: the purpose of this clinical research study is to learn if bms-587101 is effective on the treatment of moderate to severe psoriasis. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: otherwise healthy individuals with a diagnosis of plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may be enrolled). men and women not of child bearing potential (i.e. women who are postmenopausal or surgically sterile), women ages 18 to 75. - exclusion criteria: women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. known or suspected infection, including infection with human immunodeficiency virus (hiv), hepatitis b or c viruses. any recent infections requiring antibiotic treatment that completed within 4 weeks of enrollment. any known malignancy or history of malignancy within 5 years prior to enrollment, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised with no evidence of recurrence (squamous cell carcinoma of other locations is exclusionary). any history of guillane-barre syndrome. history of keloid formation. -
a study of mircera for the maintenance treatment of anemia in dialysis patients

Conditions: Anemia

Summary: this 2 arm study will compare the efficacy and safety of mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (ckd) who are on hemodialysis. eligible patients receiving once-weekly intravenous (iv) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia; * hemodialysis 3 times weekly for \>=12 weeks before screening, and during screening/baseline period; * receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period. exclusion criteria: * overt gastrointestinal bleeding within 8 weeks before screening or during screening/baseline period; * transfusion of red blood cells within 8 weeks before screening or during screening/baseline period; * active malignancy;
a phase i/ii clinical trial of vidaza with abraxane in patients with advanced/metastatic solid tumors and breast cancer

Conditions: Advanced or Metastatic Solid Tumors; Advanced or Metastatic Breast Cancer

Summary: the purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with abraxane plus vidaza is safe and results in good tumor response. all patients enrolling in this study will receive treatment with abraxane and vidaza. safety will be assessed by adverse events, laboratory results and performance status. tumor response will be measured by recist criteria.

the phase i part of the study will enroll patients with advanced or metastatic solid tumors who have failed at least one previous treatment. the purpose of the phase i part is to assess the safety of the investigational treatment and select the recommended phase ii dose-regimen. the phase ii part of the study will enroll patients with advanced or metastatic her2-negative breast cancer who have not received treatment for their metastatic disease. the purpose of the phase ii part of the study is to assess safety and efficacy of the investigational treatment in breast cancer. the study doctor will determine what phase patients will be enrolled in.

Eligibility criteria:
inclusion criteria: 1. for phase i, any solid tumors, including lymphoma, that progressed or were stable as best response on at least one previous therapy and are evaluable. 2. for phase ii, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer. 3. her-2/neu negative (phase ii) 4. negative pregnancy test for female subjects 5. women of childbearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. investigator. 6. male or female for phase i and female for phase ii, \>19 years of age and any race. exclusion criteria: 1. major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1 2. known brain metastases 3. prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase ii) 4. active infection requiring antibiotic therapy 5. history of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane 6. grade 2 or greater motor or sensory neuropathy 7. prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase ii portion) 8. uncontrolled hypertension, arrhythmia, congestive heart failure or angina. patients who have had a myocardial infarction or cardiac surgery should be at least 6 months from the event and free of active symptoms. 9. known or suspected hypersensitivity to azacitidine or mannitol 10. pregnant or breast feeding 11. patients with advanced malignant hepatic tumors 12. malignancy other than breast carcinoma (phase ii) 13. known hiv infection or chronic hepatitis b or c
first-in-human study of eos884448 in participants with advanced cancers.

Conditions: Advanced Cancer

Summary: io-002 study is a multicenter, open-label, dose-escalation phase i/iia clinical study to evaluate the safety and tolerability, pk, pd, and antitumor activity of eos884448 in participants with advanced cancers.

multicenter, open-label, dose-escalation phase i/iia clinical study to evaluate the safety and tolerability, pk, pd, and antitumor activity of eos884448 in participants with advanced cancers. the study will consist in a dose-escalation phase to determine the mtd, the rp2d, and the safety of eos884448 in participants with advanced cancers.

Eligibility criteria:
inclusion criteria: 1. be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of eos884448 2. be more than18 years of age on day of signing informed consent. 3. have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available 4. have evaluable disease, per recist v1.1 for solid tumor escalation or other criteria if indicated 5. have an ecog performance status of grade 0 to 1. 6. have adequate organ function. 7. agree to use adequate contraception during the treatment if required. exclusion criteria: 1. has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose. 2. has undergone major surgery within 5 weeks before initiating treatment. 3. has received prior radiotherapy within 2 weeks of start of ip. 4. has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or grade 1, or deemed irreversible. 5. has known cns metastases. 6. has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids. 7. has uncontrolled or significant cardiovascular disease. 8. has received vaccine containing live virus within 4 weeks. 9. has known active or chronic viral hepatitis. 10. has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements.