Kornimate/medical-research-clean huggingface dataset:
induction chemotherapy plus radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to compare induction chemotherapy (tpf or gp) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (la-npc).


Eligibility criteria:
inclusion criteria: * newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie who type ii or iii). * age ≥ 18 and ≤ 65 years old. * tumor staged as iii/iva (according to the 8th ajcc edition). * no evidence of distant metastasis (m0). * satisfactory performance status: karnofsky scale (kps) ≥ 70. * adequate marrow: white blood cells (wbc) ≥ 4 × 10\^9/l, hemoglobin (hgb) ≥ 90 g/l, platelets (plt) ≥ 100 × 10\^9/l (or within the normal range of the laboratory) * normal liver function test: alanine aminotransferase (alt), aspartate aminotransferase (ast) \< 1.5×upper limit of normal (uln) concomitant with alkaline phosphatase (alp) ≤ 2.5×uln, and bilirubin ≤ uln. * adequate renal function: creatinine clearance ≥ 60 ml/min. * written informed consent. exclusion criteria: * who type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * age \> 65 or \< 18. * treatment with palliative intent. * previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer. * pregnancy or lactation. * history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * any other serious diseases, which may bring greater risk or affect the compliance of the test, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×uln), and emotional disturbance.

Keywords: nasopharyngeal carcinoma induction chemotherapy concurrent chemoradiotherapy
elderly primary insomnia polysomnographic study (0928-002)(terminated)

Conditions: Primary Insomnia

Summary: the purpose of the study is to test the safety and effectiveness of an investigational drug on insomnia in the elderly.


Eligibility criteria:
inclusion criteria: * elderly patients with a diagnosis of primary insomnia and in good physical and mental health
multiparametric scores for prediction of myocardial fibrosis in patients with mitral valve prolapse

Conditions: Mitral Valve Prolapse

Summary: this is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by cmr in patients with mvp; 2) to identify specific features that may predispose to ≥ mild vas or scd in patients with mvp.

patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. a minority of patients with mvp suffers from ventricular arrhythmias. different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the mv were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance. as cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views exclusion criteria: * age\< 18 years * coexistence of other cardiomyopathies or other ≥ moderate valve diseases * scarce acoustic transthoracic echocardiographic window * usual contraindications for cardiac magnetic resonance
naltrexone sr and fluoxetine combination therapy in subjects with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to determine if the combination of naltrexone sr and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (ocd)than either fluoxetine alone or naltrexone sr alone.


Eligibility criteria:
inclusion criteria: * male or female subjects, 18 to 60 years of age (inclusive) * outpatients with a current diagnosis of ocd that have received previous therapy * negative serum pregnancy test as screening in women of child-bearing potential * if a woman of child-bearing potential, must agreed to use an acceptable and effective form of contraception * no clinically significant abnormality on electrocardiogram (ecg) * no clinically significant laboratory abnormality at screening * negative urine drug screen * must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule exclusion criteria: * diagnosis of substance dependence * diagnosis of substance abuse (except for nicotine and caffeine) * serious or unstable medical illnesses * lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, anorexia nervosa, pervasive developmental disorder (pdd), asperger's syndrome or the presence of antisocial or borderline personality disorder * diagnosis of tic disorder or tourette's syndrome * subjects diagnosed with impulse control disorder * known sensitivity or allergic reaction to either naltrexone or fluoxetine * any condition which in the opinion of the investigator or sponsor makes the subject unsuitable for inclusion in the study * immediate family of investigators, study personnel or sponsor representatives

Keywords: ocd, naltrexone, fluoxetine, obsessive-compulsive disorder
use of leucocyte- and platelet-rich fibrin membranes in single implant

Conditions: Tooth Loss; Recession, Gingival

Summary: the objective of this randomized controlled clinical trial is to evaluate the increase of soft tissue thickness around single implants installed in maxillary esthetic area with the use of leucocyte-platelet rich fibrin (l-prf) membranes. the sample is of 42 individuals, where the control group (n = 21) will receive single implant placement only, while the test group will receive single implant placement with l-prf membranes.

the greatest challenge in implantology is to achieve a satisfactory esthetic result. a new platelet concentrate protocol, named leucocyte and platelet-rich fibrin (l-prf), has been developed in france. research has shown positive results using l-prf during implant placement, as improving soft tissue healing and bone formation, leading to higher esthetic level and greater implant stability. the aim of this study is to evaluate if the use of prf associated to implant placement in esthetic area presents superior aesthetic result and soft tissue thickness increase when compared to implant placement without graft. forty-two patients requiring single implant placement in the esthetic area of the maxilla will be randomly divided into test group (implant + l-prf) and control group (implant without graft). surgical procedures will be performed by a single operator. the rates of soft tissue thickness, esthetic and comfort will be evaluated at baseline and 3 months after the procedure.

Eligibility criteria:
inclusion criteria: * patients of at least 20 years of age, systemically healthy, with satisfactory oral hygiene assessed by plaque index and gingival index of less than 25% (o'leay et al. 1972). * patients requiring single implant placement in anterior maxilla (premolar to premolar) * buccal soft tissue thickness of at least 2mm * patients who agreed to participate in the study and signed a written consent (resolution nº196 of october 1996 and the code of professional ethics dental - c.f.o. - 179/93) exclusion criteria: * smokers * patients with parafunctional habits, such as bruxism * patients who need other types of rehabilitation, such as removable prostheses * pregnant or lactating * patients with uncontrolled systemic diseases (cardiovascular alterations, blood disorders, diseases that affect bone metabolism, immunodeficiencies, diabetes) * patients who use drugs that interfere with wound healing or contraindicate the surgical procedure, such as gingival growth related drugs * implants in adjacent regions * sites requiring bone augmentation procedure * patients in orthodontic treatment

Keywords: platelet-rich fibrin dental implant
evaluation of the effects of two dietary supplement formulations on the lipid profile in mild hypercholesterolemia

Conditions: Hypercholesterolemia and Hyperlipidemia; Supplementation

Summary: a single-center, randomized, parallel-group, double-blind, placebo-controlled clinical study followed by an open-label phase to evaluate the effects of a new formulation of a supplement on lipid profile in subjects with mild hypercholesterolemia who are non-responsive to the mediterranean diet. the study population consists of 99 subjects with mild hypercholesterolemia who are non-responsive to the mediterranean diet. the participants will be divided into three groups: group a: test product a (study product) group b: test product b (comparative product) placebo group: placebo the following visits are scheduled during the study: t-2 (day -35) - screening visit, 5 weeks before t0 t-1 (day -28) - enrollment visit, 4 weeks before t0 t0 (day 0) - randomization visit, baseline t1 (day 56) - interim visit, 8 weeks after t0 t2 (day 112) - final visit, 16 weeks after t0 after the first 8 weeks of the study (double-blind), all three groups will continue with only product a for an additional 8 weeks. this experimental design aims to highlight whether any differences between test product a and test product b observed during the first 8 weeks can be minimized when both arms receive the same treatment. additionally, the effect of product a will be observed at 8 and 16 weeks, thus providing efficacy data over a longer treatment period. this may also provide insights into the potential achievement of a plateau. regarding the placebo group, it will be possible to distinguish the effect of the diet alone from the combined effect of the diet and supplementation with test product a.


Eligibility criteria:
inclusion criteria: * prevention of cardiovascular disease * low cardiovascular risk (\< 5%) * sub-optimal serum levels of ldl-c (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-hdl-c (160-190 mg/dl; 4.14-4.92 mmol/l) at t-2 * signature of informed consent. exclusion criteria: * patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \>/= 5) * diabetes mellitus * taking hypolipemiants, supplements or drugs that may involve lipid metabolism * hypertension treatment not stabilized for at least 3 months * history of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease * any medical-surgical treatment that may limit adherence to the study protocol * pregnant and/or breastfeeding women

Keywords: mild hypercholesterolemia supplement lipid profile dietary supplement
feasibility, acceptability, and effectiveness of an individualized plant-based (iplant) diet plan in colorectal cancer: mixed method embedded design

Conditions: Colorectal Cancer; Nutrition Poor; Gastrointestinal Complication; Quality of Life

Summary: the goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. the main questions to answer are: 1. what are the current eating trends in colorectal cancer patients? 2. what are the common perceptions of adopting a plant-based diet in colorectal cancer? 3. does iplant diet plan improve nutritional indices of colorectal cancer patients? 4. does iplant diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status? participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling. the researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.


Eligibility criteria:
inclusion criteria: * diagnosed with colorectal cancer, including the sites of caecum, appendix, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, and rectum * tnm stage ii to iv * receiving chemotherapy * able to take food orally exclusion criteria: * have cognitive impairments or mental disorders * diagnosed with severe illness, such as chronic kidney disease and chronic obstructive pulmonary disease * within 4 weeks of bowel resection * terminally ill or receive hospice care * receiving enteral or total parenteral nutrition * having inflammatory bowel diseases * having gastrointestinal bleeding or obstruction * pregnancy or breastfeeding * severe anemia (\<0.8g/dl) * ecog performance score \>2 * high stoma output (\>1500ml per day)
elective internal mammary node irradiation in women with node-positive breast cancer

Conditions: Breast Neoplasms

Summary: the aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.

this is a multicenter, prospective, randomized phase 3 trial. patients with node-positive breast cancer without distant metastases were included. all patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either imni or no imni.

Eligibility criteria:
inclusion criteria: 1. women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed. exclusion criteria: 1. neoadjuvant chemotherapy 2. bilateral breast cancer 3. distant metastasis 4. history of other malignancy 5. involvement of supraclavicular nodes or internal mammary nodes at diagnosis
otoacoustic emissions in different blood types

Conditions: Hearing Loss, Cochlear

Summary: the objective of this study is to examine whether abo and rhesus (rh) blood group systems have an association with distortion product otoacoustic emission (dpoae) and transient otoacoustic emission (teoae) amplitudes with the hypothesis of blood groups may affect hearing thresholds.

many factors have a significant impact on otoacoustic emission (oae) measurement and quality of analysis. race, age and gender are among the non-pathological factors. to date there is clear data to demonstrate the association of blood types with oaes. the aim of our research is to investigate the relation of different blood groups (abo) and rh factors on transient evoked oae and distortion product oae amplitudes and inner ear potentials, differences between ears and to contribute to the limited literature on cochlear hearing loss susceptibility and blood groups with the hypothesis that blood groups may be associated with hearing thresholds.

Eligibility criteria:
inclusion criteria: * not having hearing loss * having a blood group card obtained from health institutions exclusion criteria: * not meeting inclusion criteria

Keywords: otoacoustic emissions blood type
study to gather information about the proper dosing of the oral fxia inhibitor bay 2433334 and to compare the safety of the study drug to apixaban, a non-vitamin k oral anticoagulant (noac) in patients with irregular heartbeat (atrial fibrillation) that can lead to heart-related complications.

Conditions: Atrial Fibrillation (AF)

Summary: the purpose of this study is to try to find the best dose of the new drug bay 2433334 to give to participants and to look at how well bay 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. in addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin k oral anticoagulant (noac) in patients with atrial fibrillation. this study is also done to learn how the drug in this study moves into, through and out of the body. bay 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral fxia inhibitor. apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin k oral anticoagulant (noac). thinning the blood can prevent you from blood clots which can cause a stroke.


Eligibility criteria:
inclusion criteria: * participant must be 45 years of age or older at the time of signing the informed consent. * participant with af documented by ecg evidence with * cha2ds2-vasc score ≥ 2 if male or cha2ds2-vasc score ≥ 3 if female * indication for treatment with an oral anticoagulant in * any participant currently not treated with an oral anticoagulant (e.g. treatment naïve) or alternatively, * participant on a noac in case of at least one bleeding risk feature (history of a prior bleed within the last 12 months requiring medical attention and / or moderate renal dysfunction with egfr 30-50 ml/min and / or current clinically indicated antiplatelet therapy with acetylsalicylic acid(asa) ≤ 100 mg) * written informed consent exclusion criteria: * mechanical heart valve prosthesis * any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral stenosis * atrial fibrillation due to a reversible cause, participants in sinus rhythm after successful ablation, or plan for cardioversion or ablation during study conduct * requirement for chronic anticoagulation (for a different indication than af) or antiplatelet therapy (up to 100 mg asa is allowed). anticipated need for chronic therapy with nonsteroidal anti-inflammatory drugs (nsaids) * treated with a vitamin k antagonist in the 30 days prior to screening
ropinirole for the treatment of muscle cramps in patients with cirrhosis

Conditions: Muscle Cramp; Cirrhosis

Summary: the investigator's aim is to compare the efficacy of ropinirole (requip) to vitamin e in the treatment of muscle cramps in cirrhotic patients.

muscle cramps are common in liver disease, especially in patients with cirrhosis. despite the association of muscle cramps with liver disease, there is a paucity of information regarding treatment in these patients. many treatment options have been reported in the literature but no standard of treatment has been established. oral vitamin e replacement has been used successfully in the management of nocturnal muscle cramps in cirrhotic patients. ropinirole is primarily used for treatment of restless leg syndrome. an off label trial of low dose ropinirole in clinical practice has shown some success in providing relief of muscle cramps in patients with cirrhosis. this study will compare ropinirole to vitamin e treatment in a prospective cross-over study.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age in the vanderbilt medical center hepatology practice * diagnosis of cirrhosis * self report regular muscle cramping exclusion criteria: * patients without cirrhosis * patients under the age of 18 * pregnant women
actipatch plantar fasciitis clinical trial

Conditions: Plantar Fasciitis; Plantar Fasciopathy

Summary: plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. it can be disabling. there is no single accepted treatment course that is recommended in the literature. the use of pulsed radio-frequency electromagnetic (prfe) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation. the proposed study will investigate the efficacy of the use of a prfe device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.


Eligibility criteria:
inclusion criteria: * all patients with diagnosis of plantar fasciitis agreeing to participate * over 18 years old * able to wear unit and keep data up-to-date records of use * agree to forgo additional treatments during the study period exclusion criteria: * patients who have refused, are unable to give or have withdrawn consent * patients with heel pain present less than 3 months
development of distress management algorithms using mobile device based health logs in breast cancer survivors

Conditions: Breast Cancer; Quality of Life

Summary: distress monitoring is an important issue in cancer survivors. however, conventional distress screening is very difficult to perform. this study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.


Eligibility criteria:
inclusion criteria: * stage 0-iii breast cancer exclusion criteria: * stage iv breast cancer * breast cancer recurrence or metastasis * severe medical illness

Keywords: distress exercise wearable device smartphone