Kornimate/medical-research-clean huggingface dataset:
pilot study of iv and ip chemotherapy plus abdominal hyperthermia for ovarian ca

Conditions: Ovarian Cancer

Summary: this is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.

day 1 of each 21 day cycle: paclitaxel 175 mg/m2 iv (infused over 3 hours) day 1 or 2 of each cycle adequate iv hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion of 500 ml normal saline through the ip port. cisplatin 75 mg/m2 reconstituted in 500 ml ns warmed to 37 degrees celsius is infused ip (30 minute infusion)followed immediately by whole abdominal hyperthermia abdominal hyperthermia will be delivered using the bsd 2000 ellipse system to target temperatures of 40-42 degrees celsius monitored via rectally and vaginally continuing for no greater than 60 minutes after maximal 30 minute warm-up phase. total duration of hyperthermia will be no greater than 90 minutes. day 8: paclitaxel 60 mg/m2 ip. paclitaxel will be diluted and filtered initially in 1000 ml of normal saline or d5w warmed to 37 degrees celsius. for ip administration, the patient must receive an additional 1000 ml of normal saline degrees celsius in the peritoneal cavity. cycles will be repeated every 3 weeks x 6 cycles. patients will be followed until disease progression/recurrence or death.

Eligibility criteria:
inclusion criteria: * histologically diagnosed stage iii or stage iv advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer * optimal debulking (\< 1cm residual disease) of their disease within 6 weeks of the start of the study * patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy * gog performance status 0, 1, or 2 * patients must have normal organ and marrow function defined as: * absolute neutrophil count \>1,500/mcl * platelets \>100,000/mcl * total bilirubin and creatinine \<1.5 x institutional upper limit of normal(uln) * ast(sgot)/alt(sgpt)\<3 x institutional uln exclusion criteria: * patients with biochemical recurrences or evidence of measurable disease * patients with suboptimal (\>1 cm) residual disease * patients who have had chemotherapy within 4 weeks prior * receiving any investigational agents * known brain metastases * epithelial ovarian carcinoma of low malignant potential (borderline carcinomas) * uncontrolled intercurrent illness * prior radiation therapy * history of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years

Keywords: ovarian debulked recurrent stage iii stage iv
a phase iv, multi-center, open-label trial of sibutramine in combination with a hypocaloric diet in obese and overweight thai subjects.

Conditions: Obesity

Summary: the purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.


Eligibility criteria:
inclusion criteria: * subject has nutritional obesity and bmi \>30 kg/m exclusion criteria: * type 1 or type 2 diabetes mellitus * inadequately controlled hypertension * history of gilles de la tourette's syndrome. * use of any maois, ssris, amino acids, antimigraine drugs, opioids * hypothyroidism or hyperthyroidism. * history of: * benign prostatic hyperplasia * neurological disorders * psychiatric illness * severe renal or hepatic impairments * narrow-angle glaucoma * history of cardiovascular disease or cerebrovascular disease * persistent tachycardia at rest * pulmonary hypertension * phaeochromocytoma

Keywords: sibutramine obesity
the implantable cardioverter-defibrillators (icd)/device expectations, adaptations, and successes study

Conditions: Depression; Anxiety; Post-traumatic Stress Disorder

Summary: the introduction of pacemakers and implantable cardioverter-defibrillators (icds) has substantially changed the medical and surgical management of patients with cardiac rhythm disease. in the case of patients with icds, these devices are programmed to deliver a strong electrical shocks. in adults, multiple studies have suggested that patients at risk of receiving shocks from their device have an increased prevalence of anxiety and depression. very few studies have looked at this question in children. we propose to evaluate a cohort of patients age 6 to 20 with icds, compared to a cohort of patients with pacemakers, assessing each group for the presence of depressive and anxiety disorders, including post-traumatic stress disorder (ptsd).


Eligibility criteria:
inclusion criteria: * age 6 through 20 at the time of enrollment for patients. * age ≥18 for caregiver * functioning pacemaker or icd (explanted or inoperative devices do not qualify) * informed consent of parent or guardian as well as assent of study participant exclusion criteria: * lack of english language fluency in patient and caregiver * hospitalization within 4 weeks of visit * first implantation of icd or pacemaker within 6 months of study enrollment

Keywords: pacemaker implantable cardioverter-defibrillator
community-based approaches to treating hypertension and colon cancer prevention

Conditions: Hypertension; Colon Cancer

Summary: black men constitute the demographic group with the greatest burden of premature death and disability from hypertension (htn) in the united states. but while the disproportionately high rate of hypertension-related morbidity and mortality is well documented, the epidemic of colorectal cancer (crc) among black men is comparatively under-appreciated. for example, crc is a leading cause of cancer death in black men with a death rate 50% higher than in white men. low rates of screening for crc in this population contribute significantly to this problem. the purpose of this randomized controlled trial (rct) is to evaluate the effect of a lifestyle intervention delivered through telephone-based motivational interviewing (mint) versus a patient navigation intervention on blood pressure reduction and crc screening.


Eligibility criteria:
inclusion criteria: 1. participants must be age 50 years or older, 2. self-identify as a black or african american male, 3. have uncontrolled hypertension as defined by systolic blood pressure (sbp) \> 135 mmhg or diastolic blood pressure (dbp) \> 85 mmhg and sbp \> 130 or dbp \> 80 mmhg (in those with diabetes at the screening). exclusion criteria: 1. inability to comply with the study protocol (either self-selected or by indicating during screening that he could not complete all requested tasks).

Keywords: hypertension colon cancer screening african american men motivational interviewing patient navigation
multi centre study comparing osseospeed tx with osseospeed

Conditions: Partial Edentulism; Edentulism Nos

Summary: to compare marginal bone level alterations, implant stability and implant survival between osseospeed och osseospeed tx


Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. female/male aged 18 years and over 3. history of edentulism in the study area of at least 3 months 4. in need for implant(s) replacing missing tooth/teeth in the maxilla 5. deemed by the investigator to be suitable for one stage surgery 6. deemed by the investigator to be suitable for loading after 10-12 weeks 7. deemed by the investigator as likely to present an initially stable implant situation. 8. deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants. exclusion criteria: 1. unlikely to be able to comply with study procedures, as judged by the investigator 2. uncontrolled pathological processes in the oral cavity 3. known or suspected current malignancy 4. history of radiation therapy in the head and neck region 5. history of chemotherapy within 5 years prior to surgery 6. systemic or local disease or condition that would compromise post-operative healing and/or osseointegration 7. uncontrolled diabetes mellitus 8. corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration 9. present alcohol and/or drug abuse 10. current need for bone grafting and/or augmentation in the planned implant area 11. involvement in the planning and conduct of the study (applies to both astra tech staff and staff at the study site) 12. previous enrolment in the present study. 13. simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.

Keywords: edentulism in the upper jaw
the effects of acute caloric deprivation on odour identification and food reward

Conditions: Olfaction; Diet; Exercise; Energy Depletion; Food Hedonics; Food Reward

Summary: the purpose of this study is to determine how the modality of energy depletion can differently impact appetite hormones, ad libitum food intake, food hedonics, and olfaction.

the objectives of the current randomized controlled study were to examine how the modality of an acute 3 day isocaloric -25% energy depletion by dieting alone or by aerobic exercise alone differently impacts appetite and appetite-related hormones, ad libitum energy intake (ei), food hedonics and food reward, and olfaction. it was hypothesized that independent of modality of depletion, that relative to the control, there would be increased ad libitum feeding and food reward, improvements in smell performance, and a decline in fasting leptin and increase in fasting total ghrelin. it was also hypothesized that the increased food reward would prove to be a predictor of ad libitum ei and that relative to the depletion by aerobic exercise alone, the depletion by diet alone would produce greater compensatory increases in appetite, ad libitum ei, and food reward. statistics to test for differences in body weight, plasma hormone concentrations, relative-reinforcing value of food (rrvf), and olfaction across each condition of the study, repeated measures anova controlling for day 1 as a covariate was employed. pairwise comparisons at day 4 using sidak adjustment to account for multiple comparisons are reported when the anova was significant. one way repeated measures anovas with sidak adjustments for multiple comparisons were used to test for differences in variables measured only at day 4: body composition (fat mas, %fat, and fat free mass), appetite, palatability, and ad libitum ei.

Eligibility criteria:
inclusion criteria: * free from any illness that could influence outcome of the experiment * weight-stable for \>6months * aged between 18-40 years exclusion criteria: * diabetic * smoker * medication
clinical procedures to support research in als

Conditions: Amyotrophic Lateral Sclerosis; ALS-Frontotemporal Dementia; Primary Lateral Sclerosis; Progressive Muscular Atrophy

Summary: the purpose of the clinical procedures to support research (capture) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (als) and related disorders.

the study will consent patients with als or related disorders that are receiving care at a clinical center in the create consortium that uses epic as its electronic health record (ehr) system. the study aims to systematically gather a clinical dataset through the ehr using a standardized approach to characterize the natural history of als and related diseases.

Eligibility criteria:
inclusion criteria: * diagnosis of als or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy). * receiving care at a clinical center that uses epic as its ehr. * able and willing to provide informed consent (or informed consent obtainable from a designated proxy). exclusion criteria: * inability to understand english and/or spanish
pharmacokinetic study of livalo® fixed combination drug in healthy subjects

Conditions: Hyperlipidemia; Hypertension

Summary: the purpose of this study is to compare pharmacokinetics between pitavastatin and valsartan co-administration and livalo fixed combination drug in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male volunteers * age 20-55 years at the time of screening * bmi 19-26 kg/m2 at the time of screening exclusion criteria: * received other investigational drug within 90 days prior to the first dose of study drug

Keywords: pitavastatin valsartan
multinational monitoring of trends and determinants in cardiovascular disease (monica)

Conditions: Atherosclerosis; Cardiovascular Diseases; Cerebrovascular Accident; Coronary Disease; Heart Diseases

Summary: to foster collaboration between the world health organization monica project and the nhlbi study of atherosclerosis risk in communities (aric). to ensure that valid comparisons could made between findings in monica and aric by supporting activities to standardize coding, classification, and analysis of coronary and stroke events, risk factors, and medical care according to monica protocol.

background: the monica project was undertaken by the world health organization (who) as a ten year international effort to measure the trends in cardiovascular mortality and coronary heart disease and cerebrovascular disease morbidity and to assess the extent to which these trends were related to changes in known risk factors, daily living habits, or major socioeconomic features. pilot studies were completed in 1981 in four countries and by 1985 there were 41 monica's in defined communities in 27 countries. each study site covered a population of around 300,000 persons and was expected to be studied for a decade. the centers measured the incidence of cardiovascular disease--particularly coronary heart disease and cerebrovascular diseases--and assessed the extent to which these trends were related to changes in known risk factors (smoking, blood lipids, blood pressure, diet), daily living habits, health care, and major socioeconomic factors in the study populations. monica was also expected to introduce, in the countries concerned, new health statistical methods that would lead to more effective use of national health information systems. as an associate member of monica, nhlbi received copies of unclassified project documentation and was represented at meetings of monica principal investigators. however, central data analysis and quality control evaluations were not available to associate members. under this contract, nhlbi received summary tabulations of: population demographics and vital statistics including the numbers of total deaths and of cardiovascular, coronary heart disease and stroke deaths among residents of each reporting unit; fatal and non-fatal coronary and stroke events; ecg abnormalities, chest pain symptoms, and cardiac enzyme measurements; population survey prevalence rates and distributions of risk factors including but not limited to blood pressure, total cholesterol, other lipids and lipoproteins, height, weight, and cigarette consumption; hospitalizations and medical care for cardiovascular conditions; case fatality rates within 28 days of onset of a heart attack, stroke, or other cardiovascular event. the nhlbi also received reports on the quality of the data and performance at each site based on the circulation and evaluation of test case histories.

Eligibility criteria:
no eligibility criteria
clinicopathological and molecular correlation of acrochordon in relation to human papillomavirus infection

Conditions: Acrochordon; Skin Tag; Soft Fibroma; Human Papillomavirus; HPV

Summary: acrochordon, or soft fibroma, is a common benign skin tumor which is generally regarded as a sign of cutaneous aging or as a reaction to friction since it occurs in the intertriginous areas. recent studies have shown the presence of human papillomaviruses, especially the mucosal types, on some of the intertriginous lesions. this study is to analyze the different clinical presentations of acrochordon and correlate them with pathologic and molecular human papillomavirus findings. further goal is to improve the ability to differentiate acrochordon and its possible prevention and treatment. also, it may have an implication on the transmission and prevention of cervical carcinoma.

acrochordon, also called soft fibroma, skin tag or fibroepithelial polyp, is a common cutaneous disorder characterized by a polypoid growth composed of fibroblasts in a loose collagenous stroma, sometimes with proliferation of blood vessels. they appear as soft, skin-colored or light brownish skin tumors. three types of lesions may occur, (1) multiple small, furrowed papules, especially on the neck and in the axillae, (2) single or multiple filiform smooth growths in various locations, and (3) solitary bag-like pedunculated growth, seen most commonly on the lower trunk. most regard them as a sign of cutaneous aging. the presence of human papillomaviruses (hpvs), especially the mucosal types, has been demonstrated in acrochordon. our previous experience on hpv typing of skin tags also confirms this finding. though hpv is a ubiquitous virus, the presence of mucosal type hpv in non-mucosal sites is exceptional. this investigation is trying to correlate the clinicopathological and hpv molecular typing of acrochordons. a better understanding of acrochordon and its relation to hpv infection may improve the ability to prevent and treat.

Eligibility criteria:
inclusion criteria: * adult patients with multiple acrochordon on non-anogenital sites who ask to remove the lesions and have signed consent to surgery will be asked to participate in the study exclusion criteria: * no special exclusion criteria
effect of motor control exercise combined with laser or tens on pain, range of motion, and functional disability on obese patients with low back pain

Conditions: Back Pain; Obesity; Motor Control Exercises; Laser Therapy

Summary: this randomized study aimed to assess the impact of mce in conjunction with lllt and mce in conjunction with tens on pain levels, rom, and functional disability in obese patients with lbp.

sixty obese male and female patients with lbp participated in this study. after providing informed consent, they were randomly divided into two equal groups, with group a receiving mce combined with lllt and group b receiving mce combined with tens.

Eligibility criteria:
inclusion criteria: the inclusion criteria were the following: * patients aged 40 to 77 years * non-athletic, have a bmi \> 25 * complaining of lbp. exclusion criteria: the exclusion criteria were the following: * vertebral fractures * surgical spinal fixation * rheumatic disorders * any underlying medical condition that may be causing back pain, including: * malignancy * viscerogenic causes * infection, systemic disease of the muscles and skeletal system, * sensory dysfunction * neuromuscular diseases like multiple sclerosis.
optimizing the diagnosis of pneumocystis in immunocompromised patients

Conditions: Pneumocystis; Immunocompromised Patients

Summary: evaluate new diagnostic methods using qpcr on non-invasive samples, compared with reference techniques for the positive diagnosis of pneumocystis (pcp) in immunocompromised patients


Eligibility criteria:
inclusion criteria: * adult patients with suspected pneumocystis * with an indication for bronchial fibroscopy for bal or induced sputum * no opposition to the research from the adult patient or his or her next of kin research for patients unable to express their non-opposition exclusion criteria: * pneumocystis treated for more than 72 hours * pregnancy/breast-feeding * adult patients deprived of liberty, protected

Keywords: immunocompromised patients pneumocystis
multiple electrode aggregometry to assess platelet function in patients undergoing hip joint alloplasty with and without bone cement

Conditions: Arthroplasty; Methylmethacrylate Embolism; Platelet Aggregation

Summary: the aim of the study is to assess blood platelet function and activation in patients undergoing both cement and non cement hip joint total alloplasty. bone cement is used as a special biomaterial to help fix a hip prosthesis in place but is associated with bone cement implantation syndrome causing such complications as hypotension, cardiac arrhythmias. the pathophysiology of bone cement implantation syndrome is not fully known but one theory supports formation of clots in the bloodstream. this directly would activate platelets but no such study has been performed in humans. as bone reaming could potentially cause platelet activation even without bone cement, the study involves a control group of patients undergoing non cemented joint alloplasty.


Eligibility criteria:
inclusion criteria: * patients qualified for hip arthroplasty * signed consent for study * no abnormality in coagulation screen * not taking regular antiplatelet medication except small dose of acetylsalicylic acid exclusion criteria: * lack of consent * low platelet count (\<100 thousand) in standard preoperative full blood count * on regular antiplatelet medication (except 75mg acetylsalicylic acid)

Keywords: hip joint alloplasty bone cements impedance aggregometry platelet activation
family caregivers in underserved populations providing complex cancer care

Conditions: Malignant Female Reproductive System Neoplasm; Stage 0 Lung Cancer AJCC v8; Stage I Lung Cancer AJCC v8; Stage IA1 Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8

Summary: this clinical trial develops and tests a model of family caregiver education focused on the role of underserved family caregivers as providers of complex care in the home. cancer patients have symptoms from their cancer or treatment and are then supported by family caregivers at home with tasks requiring technical skill. family caregivers are often asked to provide complex care whether it involves decisions about managing symptoms or providing technical care for ports/pumps, tubes, or devices. family caregivers often are not given enough information on how to provide care for patients at home needing complex care. the results from this study may help researchers refine and improve the intervention for caregivers through future research for caregivers on a much larger scale.

primary objectives: i. develop methods of assessing and supporting family caregiving skills in providing complex care. ii. develop family caregiver (fcg) teaching materials and methods of instruction to enhance skills preparedness. iii. pilot test the intervention in a cohort of underserved fcgs. outline: participants attend 2 teaching sessions with a research nurse. participants also complete questionnaires at baseline, 3, and 7 weeks.

Eligibility criteria:
inclusion criteria: * patient: diagnosis of any stage lung or gynecologic (gyn) cancer * patient: read and understand english * patient: requires either complex physical care or complex decision making regarding symptoms * patient: age 18 years or older * fcg: designated by the patient as their caregiver * fcg: read and understand english * fcg: age 18 years or older * fcg: providing complex care and/or complex decision-making exclusion criteria: * inability to read and understand english