Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy and safety of common sage in controlling hot flashes in prostate cancer patients treated by androgen deprivation

Conditions: Prostate Cancer

Summary: the purpose of this clinical phase i study is to measure the efficacy and side effects of common sage in the treatment of hot flashes in 10 patients with prostate cancer who receive androgen deprivation (ad) (exclusively or as part of a multimodality treatment) for a period of minimum 6 months. concomitant use of a non-steroidal anti-androgen during the first month of the ad is permitted to prevent the flair-up phenomenon. however, the inclusion of patients in the study will only start at least 2 weeks after the cessation of the anti-androgen. this is done to exclude a possible influence of the anti-androgen on the severity and frequency of hot flashes. once the informed consent is signed, the patient receives the study diary to note the daily frequency and severity of hot flashes and their effect on daily quality of life. the severity of the hot flashes is measured by the moyad scoring scale. the effect on daily quality of life is measured using the hot flash related daily interference scale (hfrdis). the patient will be instructed in detail how to use the diary. after week 1, the patient returns the diary to the responsible physician. in return the patient receives the study medication (common sage, product) and a diary for the next week (=week 2). this procedure will be repeated until the end of the observation period (2 months after enrollment in the study). the common sage will be provided in tablets. the suggested dose of common sage is 3 tablets a day (morning - noon - evening). to be sure that the effect of common sage is not due to an inhibition of the effect of the lhrh analogue, the related hormones (testosterone, fsh, lh, free testosterone and shbg) will be tested at three fixed moments: day of study enrollment, 1 month after study enrollment and at the end of the study. in order to check the level of hemoglobin and cholesterol, every 2 weeks a blood count will be performed. it has been shown that lhrh analogues can induce anemia and hypercholesterolemia. the investigators want to measure a possible effect of common sage on both. there are no known side-effects of the use of common sage. all symptoms that could be related to the use of common sage will be recorded in detail. therefore, a clinical examination including blood pressure registration will be performed by the responsible physician on a weekly base.


Eligibility criteria:
inclusion criteria: * prostate cancer patients treated with androgen deprivation and experiencing hot flashes. * karnofsky performance status ≥70% * age ≥18 years * informed consent obtained, signed and dated before specific protocol procedures exclusion criteria: * other therapy for hot flashes * mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study * patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to complete the diary, inability to return for follow-up visits, and unlikely to complete the study.
special drug use-results survey of duodopa enteral solution in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to assess the safety and efficacy of long-term use of duodopa in patients with parkinkon's disease in actual usage


Eligibility criteria:
inclusion criteria: 1. patients with parkinson's disease using duodopa for the purpose of improving circadian change (wearing-off phenomenon) of symptoms of parkinson's disease in which sufficient effect cannot be obtained with existing drug therapy including levodopa-containing drugs. exclusion criteria: na

Keywords: quality of life
effect of prebiotics on function and pain in patients with osteoarthritis and obesity

Conditions: Osteo Arthritis Knee; Obesity

Summary: the purpose of the present study is to determine if prebiotic supplementation can, through changes in the intestinal gut microbiota, lead to improvements in knee function and physical performance and reduce knee pain in adults with obesity and idiopathic metabolic knee osteoarthritis. we hypothesize that prebiotics will reduce systemic and local (knee joint) inflammation, thus improving knee function, lower pain medication use, and enhance performance of daily life activities.

primary outcome: 1. to determine the change in knee joint function and physical performance in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo. secondary outcomes: 1. to determine the change in knee pain in adults with obesity and knee osteoarthritis treated for 6 months with oligofructose-enriched inulin or placebo. 2. to examine the change in body composition (fat mass and lean mass) in participants treated with oligofructose-enriched inulin or placebo. 3. to evaluate the change in quality of life in participants treated with oligofructose-enriched inulin or placebo. 4. to gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic oa through examination of gut microbiota composition and short-chain fatty acid concentrations. 5. to gain a mechanistic understanding of the influence of oligofructose-enriched inulin supplementation in metabolic oa through examination of serum inflammatory and metabolomics markers.

Eligibility criteria:
inclusion criteria: * male and female adults aged 30-75 years of age. * bmi greater than 30kg/m2. * diagnosis via x-ray of knee oa grade ii and iii (kellgren and lawrence). exclusion criteria: * knee oa resulting from a traumatic injury. * previous knee surgery. * concomitant use of any weight loss medication, previous bariatric or other intestinal surgery * presence of active infection, pregnancy or lactation. * regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment. * antibiotic use within 3 months prior to enrollment * uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections.

Keywords: pain gut microbiota prebiotic
bio-hpp vs cast co-cr as implant framework

Conditions: Edentulous Alveolar Ridge

Summary: the purpose of this study was to assess the effect of bio-hpp versus co-cr custom abutments in fixed-detachable implant-supported mandibular partial dentures clinically and radiographically in class i kennedy classification (split-mouth study)

participants with bilateral partial edentulism in the posterior mandible received two implants at the positions of the second premolar and second molar on both sides; one side was restored with biohpp based screw-retained fdp (test group) and the other side was restored with co-cr based screw-retained fdp (control group). all patients were clinically examined at the time of prosthesis insertion, and 6,12 months later for fracture of implant or framework, fracture, or looseness of the screw, veneer chipping, and fractures, modified bleeding index, modified plaque index, peri-implant probing depth, as well as radiographically for marginal bone loss

Eligibility criteria:
inclusion criteria: * mandibular posterior edentulous with the first premolar as the last standing abutment tooth bilaterally. * all patients were edentulous for at least 6 months from the last extraction. * the bone height of the alveolar ridge was not less than 12 mm above the inferior alveolar canal and the buccolingual width of the alveolar ridge at the prospective implant site was not less than 6 mm. * the opposing arch was almost dentulous, and any missing teeth were restored using a fixed partial denture. * adequate interarch space at least 5mm between the opposing dentition and the mandibular edentulous space. * remaining teeth were in good periodontal condition. * maintaining good oral hygiene and were ready to cooperate throughout the study. exclusion criteria: * patients with active infection or inflammation or flabby tissue in the areas intended for implant placement. * those patients with systemic diseases that may influence soft or hard tissue healing. * patients with a history of radiation therapy in the head and neck region. * neurological or psychiatric handicap patients that could interfere with good oral hygiene. * heavy smokers and drug abusers. * patients with severe clenching or bruxism.

Keywords: bio-hpp peek screw-retained implant framework
prospective evaluation of ultrasound-guided percutaneous cholecystostomy with the trocar technique

Conditions: Cholecystitis, Acute; Cholecystitis

Summary: the purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (us)-guided percutaneous cholecystostomy (pc) with the trocar technique by the patient's bedside.

this clinical study will include patients who will undergo us-guided pc with the trocar technique. the study will include all cases requiring pc regardless of the underlying cause, while those requiring computed tomography (ct) guidance and those with uncontrolled coagulation disorders will be excluded. patient demographics, height, weight, and body mass index (bmi), comorbidities, asa score, presence or absence of stones, presence or absence of gallbladder perforation at diagnosis, presence or absence of concomitant ascitic effusion, days of preoperative antibiotic treatment, imaging modality used to establish the diagnosis, technical details of the procedure, laboratory values (before and after surgery), and contact information for patient monitoring will be recorded. the technical success of the method as well as its complications during hospitalization and during a 3-month follow-up period will be calculated. in addition, the anatomical access route during the pc (transhepatic/transperitoneal and intercostal/subcostal), the duration of the operation, the intraoperative and postoperative pain, and the clinical success of the method will be recorded. after the operation, the patients will be monitored clinically and with laboratory test and, if deemed necessary, us, ct or both imaging will be performed. before discharge, written instructions will be given regarding the management and care of the catheter. this study will not burden the hospital financially, as the clinical, laboratory, and imaging tests required for the diagnosis of the underlying etiology that leads to the need to perform the procedure, the technique used to perform the procedure, as well as the monitoring of the patients and the possible complications of the procedure, are part of the hospital's routine.

Eligibility criteria:
inclusion criteria: * all patients requiring pc, irrespective of the underlying cause and indication, are suitable for inclusion in the study. exclusion criteria: * patients are going to be excluded from the study if they are younger than 18 years, if they require pc catheter placement under ct guidance (according to the operator's judgement), or if they suffer from severe uncontrollable coagulopathy.

Keywords: cholecystostomy percutaneous trocar ultrasound guided technique seldinger transhepatic transperitoneal subcostal intercostal technical success complications
effect of combined aerobic and resisted exercise in breast cancer survivors

Conditions: Breast Cancer; Exercise; Physical Function

Summary: the purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors.

cancer and cancer treatment side effects are associated with fatigue, pain, decreased cardiovascular fitness and muscle strength, and overall quality of life. furthermore, cancer survivors are at increased risk for cancer recurrence and for secondary effect such as cardiovascular disease, diabetes, obesity, osteoporosis, and functional decline. increase physical activity or exercise is proposed to overcome the negative psychological and physiological effects. preliminary research evidence shows that exercise in cancer survivors improves quality of life, cardiorespiratory fitness, physical functioning, and decrease of fatigue. however, the best exercise mode and intensity has not been well established. little is known regarding the long term effect. no study investigated impact of exercise for breast cancer survivors on upper extremity function, and correlation between fitness, upper extremity function and quality of life.

Eligibility criteria:
inclusion criteria: * stage 0 to ii breast cancer diagnosed within 5 years * complete adjuvant therapy \> 2 months, except hormone therapy * \> 18 years exclusion criteria: * disease in progress, recurrent, or metastasis * medical or musculoskeletal condition which resistance exercise is contraindicated * medication which may alter exercise response

Keywords: breast cancer exercise upper extremity function quality of life
meaning-centered psychotherapy in advanced cancer

Conditions: Lymphoma, Non-Hodgkin; Neoplasms

Summary: we have developed an 8-week meaning-centered group psychotherapy designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the limitations of their cancer illness. this project's overall aim is to explore the feasibility and efficacy of this new and unique psychotherapy intervention for advanced cancer patients in enhancing psychological and spiritual well-being and quality of life by comparing it with a standard supportive group psychotherapy.

as per brief summary

Eligibility criteria:
inclusion criteria: * 21 years of age or older; * english speaking; * stage iii or iv solid-tumor or non-hodgkin's lymphoma; * receiving ambulatory care at memorial sloan-kettering cancer center in new york city; exclusion criteria: * significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention; * presence of cognitive impairment disorder, such as delirium or dementia that is sufficient, in the investigator's opinion, to preclude meaningful participation and/or informed consent; * karnofsky performance rating scale below 50 or physical limitations or illness severity sufficient to preclude participation in outpatient group psychotherapy.

Keywords: stage 3 cancer; stage 4 cancer; solid tumor cancer; non-hodgkin's lymphoma; solid tumors; end-stage cancer; group psychotherapy; psychotherapy; emotional support; support groups
a randomized crossover trial of bright light therapy in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome (IBS); Circadian Misalignment

Summary: the purpose of this research study is to assess whether morning bright light therapy (blt) using a wearable device called a re-timer could potentially improve irritable bowel syndrome (ibs) symptoms and decrease intestinal permeability (leaky gut). morning bright light therapy will be administrated through a safe-wearable glasses device called a re-timer. the re-timer glasses are lightweight and deliver blue-green light at 500nm, mimicking exposure to natural light.

the hypothesis of this study is that morning bright light therapy (blt) using re-timer™ glasses in irritable bowel syndrome (ibs) patients with circadian misalignment (cm), will improve ibs symptom severity, improve circadian misalignment, decrease intestinal permeability and improve stool microbial diversity. our overall objective is to assess the effects of morning bright light therapy on ibs symptom severity, circadian misalignment, intestinal permeability and intestinal microbiota. we propose to conduct a 6-week, single center, randomized, crossover pilot trial involving 30 subjects with active ibs symptoms (ibs-sss \>75), and circadian misalignment (cm) based on late chronotype (munich chronotype questionnaire, corrected midpoint of sleep \> 4:00h). subjects will be randomized to blt or placebo with a 2-week washout between each condition. all subjects will have assessments at two timepoints: after 2 weeks of blt, and after 2 weeks of placebo.

Eligibility criteria:
inclusion criteria * 18-65 years old * irritable bowel syndrome based on rome iv diagnostic criteria * mild to severe ibs symptom severity based on ibs-sss greater than or equal to 75 17. * late chronotype based on the munich chronotype questionnaire (corrected midpoint of sleep \> 4:00h) 18 exclusion criteria * subject that are pregnant or plan to become pregnant. * night shift workers or people who have crossed more than 2 time zones in the previous 4 weeks. * regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, nsaids, beta blockers, antibiotics, psychotropic medications, hypnotics and exogenous melatonin products during 4 weeks prior to the study. * any major organ disease - known renal impairment, diabetes, liver disease, or significant cardiac failure (ny classification stage iii/iv), inflammatory bowel disease or celiac disease per chart review and/or medical history. * diagnosis of narrow angle glaucoma or retinal disorders or demonstrated symptoms indicative of these diagnosis during the eligibility screening. * moderate to severe depression (score ≥ 21 or any endorsement of suicidal intent on the beck depression inventory) 19 * sleep apnea (score high risk in 2 or more categories of the berlin questionnaire) 20 * restless leg syndrome (score ≥ 15 on the irls study group rating scale) 21 * inability or unwillingness of subject to sign an informed consent

Keywords: stomach irritable bowel syndrome circadian misalignment
prospective, multicentric study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by tomotherapy +/-chemotherapy.

Conditions: Breast Cancer Invasive

Summary: prospective, multicentric, non-randomized phase ii study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by tomotherapy +/-chemotherapy. patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study. the study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: tomotherapy +/-chemotherapy (radiation therapy alone or preceded by chemotherapy). the nature of the chemotherapy treatment will be decided according to the standards of each center. the patients will be followed for the study up to 36 months after the surgical procedure.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patient with a non-inflammatory and non-metastatic invasive mammary carcinoma. 3. indication of mastectomy and immediate prosthetic breast reconstruction. 4. patient wishing to have an immediate mammary reconstruction with prosthesis. 5. formal or presumptive pre-operative indication for adjuvant radiotherapy (+/- chemotherapy). 6. oms ≤ 2. 7. patient affiliated to a social health insurance in france. 8. patient must provide written informed consent prior to any study specific procedures. exclusion criteria: 1. metastatic breast cancer. 2. bilateral breast cancer. 3. inflammatory breast cancer (t4d). 4. history of breast cancer within 5 years. 5. not applicable according to the protocol version n°6 : previous neoadjuvant treatment for the ongoing disease. 6. pregnant or breastfeeding women. 7. any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure. 8. patient protected by law.

Keywords: breast cancer invasive tomotherapy immediate prosthetic breast reconstruction
study comparing the role of the laparoscopy surgical staging in the peritoneal carcinomatosis to laparotomic approach

Conditions: Colorectal Peritoneal Carcinomatosis

Summary: the peritoneum is the second most common site of recurrence in patients with colorectal cancer. cytoreductive surgery with hyperthermic intraperitoneal chemotherapy improve the prognosis of these patients and incorporates surgical removal of all visible disease followed by chemical destruction of microscopic disease through chemoperfusion. the most validated predictors of outcome are preoperative tumor burden measured in terms of the peritoneal carcinomatosis index (pci) and completeness of cytoreduction (cc score). diagnostic laparoscopy prior to resection is widely used in hepatopancreaticobiliary and colorectal cancer and has been shown to be effective in excluding unnecessary laparotomy associated with higher morbidity.


Eligibility criteria:
inclusion criteria: * patients with colorectal cancer with a resected minimal synchronous peritoneal carcinomatosis, or ovarian metastases, tumour rupture in the abdominal cavity. * patients received six months of systemic chemotherapy (currently the folfox-4 regimen which could be modified if the standard is modified) exclusion criteria: * none

Keywords: digestive peritoneal carcinomatosis laparoscopy laparotomy peritoneal cancer index (pci) staging
the turkish validity-reliability study of the european heart failure self-care behavior scale-caregivers version

Conditions: Heart Failure; Self Care

Summary: the aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the european heart failure self-care behavior questionnaire for caregivers.

this research will be of descriptive type. the population of the study will be heart failure patients who applied to the university hospital cardiology clinic and polyclinic. the sample of the study will consist of patients who meet the research criteria and agree to participate in the study. the data collection tools of the study are the patient questionnaire (17 questions), the european heart failure self-care behavior scale for caregivers (9 questions) and the caregiver contribution scale in heart failure self-care, which was conducted by the researchers by scanning the literature. english turkish translations will be made before starting the research. afterwards, expert opinion will be taken for the suitability of the scale items. then, the turkish scale items will be translated back into english and the linguist's opinion will be taken that the scale can be applied. language and content validity will be done for the scale form. the scale items will be translated into turkish and expert opinions will be taken. then, the turkish scale items will be translated back into english and the linguist's opinion will be taken that the scale can be applied. language validity and content validity will be done in the study. explanatory factor analysis will be applied for the validity of the questionnaire. kaiser meyer olkin(kmo) test, which measures the adequacy of sample size as antecedent tests, and bartlett's test for sphericity will be used to test sphericity. factor analysis principal component analysis method will be applied.

Eligibility criteria:
inclusion criteria: * be over 18 * to be a caregiver for patients with heart failure for at least 1 year. * volunteer to participate in the research. exclusion criteria: * having communication problems and mental problems. * be under the age of 18. * receiving hemodialysis treatment for less than 6 months.

Keywords: heart failure validity and reliability self care