Kornimate/medical-research-clean huggingface dataset:
s-1 in combination with abraxane in treating cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: this phase ii study was designed to evaluate the efficacy and safety of s-1 plus abraxane as second-line treatment for cholangiocarcinoma.

there are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. the efficacy of s-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. the impact study showed that abraxane plus gemcitabine provide better survival than gemcitabine alone. since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that s-1 plus abraxane is effective and safe in treating cholangiocarcinoma.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of cholangiocarcinoma * not eligible for curative surgery * progressed after first-line gemcitabine-based chemotherapy * eastern cooperative oncology group (ecog) performance status of 2 or better * no serious or uncontrolled concomitant medical illness * adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: \> or equal to 8 mg/dl, total bilirubin: \< or equal to 1.5 x institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 ml/min (calculated by the cockcroft and gault method). exclusion criteria: * uncontrolled infection or severe active comorbid disease * previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer * pregnancy or lactating women
human papillomavirus and rate of pregnancy achieved via medically assisted procreation

Conditions: Infertility; Sub-fertility; Papillomavirus Infections

Summary: the main objective of this study is to investigate the association between the presence of hpv infection in one or both members of infertile/sub-infertile couples and the outcome of pregnancies obtained by assisted reproduction. the success of assisted medical procreation is defined as achieving a pregnancy resulting in the birth of a living, viable child.

the secondary objectives of this study are: a. to study the alterations of sperm present in infertile men according to the presence of hpv in semen. b. identify the specific hpv genotypes involved. c. to study a potential link between hpv and embryonic characteristics (as classified by giorgetti) d. to study a potential link between hpv and survival of the conceptus: products of miscarriage or stillbirth, duration of pregnancy, birth weight. e. to study a potential link between hpv and fetal malformations.

Eligibility criteria:
inclusion criteria: * both members of each couple must have given their free and informed consent and signed the consent * both members of each couple must be members or beneficiaries of a health insurance plan * the patient (woman) is available for follow-up after a possible pregnancy * the patient (woman) is under 43 years of age * the patient (man) is under 60 years of age * couple consulting for infertility services in the participating reproductive medicine centers exclusion criteria: * one or both members of the couple are involved in another study * one or both members of the couple are in an exclusion period determined by a previous study * one or both members of the couple are under judicial protection or under any kind of guardianship * one or both members of the couple refuse to sign the consent * it is impossible to correctly inform one or both members of the couple * the patient (woman) has a contra-indication (or an incompatible combination therapy) for treatment necessary for this study * the source of sperm is a donor (i.e. it is not possible to obtain a sperm sample from the biological father for use in hpv testing).

Keywords: medically assisted procreation assisted reproductive technology human papilloma virus
efficacy of high-intensity laser therapy (hilt) in the patients with cervical disc herniation

Conditions: Cervical Disc Herniation

Summary: the worldwide prevalence of neck pain is between 16.7-75.1%, it has been seen at an increasing rate in recent years due to sedentary living conditions. pharmacological treatment, neck collar, traction, manual therapy, interventional injection techniques, surgical treatment and conventional physical therapy methods such as hotpack, ultrasound, tens (transcutaneous electrical nerve stimulation), vacuum interference, exercise are applied in the treatment of neck pain. in recent years, high intensity laser therapy (hilt) has been used as a painless and non-invasive physical therapy agent. it received fda approval in 2002 for hilt in the treatment of variety of musculoskeletal disorders. there are a few studies in the literature investigating the efficacy of hilt in chronic neck pain. there is only one study investigating the efficacy of hilt in cervical disc herniation. in this study, the efficacy of hilt and ultrasound-tens in the treatment of neck pain caused by cervical disc herniation has been compared, but the results of the exercise control group and long-term follow-up were not available. the aim of this randomized controlled trial is to evaluate the short and long-term efficacy of hilt treatment using improvement in the pain, range of motion, activities of daily living and functionality of the cervical spine in patients with cervical disc herniation. in group 1, only exercises will be applied; in the group 2, hilt will be applied in addition to exercise; in the group 3, hotpack, tens, ultrasound will be applied in addition to exercises.


Eligibility criteria:
inclusion criteria: * patients with cervical disc herniation diagnosed by mri whose symptoms started for at least 3 months ago * not receiving physical therapy and rehabilitation in the last 3 months * not taking any medications such as analgesics, anti-inflammatoires or muscle relaxants for the treatment of symptoms. exclusion criteria: * patients with major psychiatric disease, cervical spine surgery and rheumatological disease; pacemaker users; those who were injected with local corticosteroids; pregnant women; cancer patients
vaccine therapy in treating patients with stage i or stage ii pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: vaccines made from a person's cancer cells may make the body build an immune response to and kill tumor cells. combining vaccine therapy with surgery may be an effective treatment for pancreatic cancer. purpose: phase i trial to study the effectiveness of vaccine therapy in treating patients with stage i or stage ii pancreatic cancer that has been surgically removed.

objectives: i. study the safety of autologous tumor derived gp96 heat shock protein peptide complex (hsppc-96) in patients with resected pancreatic adenocarcinoma. ii. examine the immune response to hsppc-96 in this group of patients. outline: this is a dose escalation study. six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex (hsppc-96) subcutaneously once a week for 4 weeks. five patients are initially enrolled at each of two dose levels. an additional three patients may be enrolled at each dose level to determine the optimal dose of hsppc-96. patients are followed at weeks 1, 4, and 12 after treatment. projected accrual: a maximum of 16 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven, resected, stage i or ii pancreatic adenocarcinoma patient characteristics: age: 18 and over performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: wbc at least 3000/mm3 lymphocyte count at least 700/mm3 platelet count at least 100,000/mm3 hepatic: not specified renal: creatinine no greater than 2.0 mg/dl cardiovascular: no clinically significant heart disease other: no other serious illness no active infections requiring antibiotics within past 2 weeks not pregnant or nursing fertile patients must use effective birth control no known immunodeficiency no active bleeding prior concurrent therapy: biologic therapy: no prior immunotherapy chemotherapy: no prior chemotherapy endocrine therapy: no concurrent corticosteroids radiotherapy: no prior radiation therapy surgery: must undergo whipple procedure or distal pancreatectomy at memorial hospital must not have undergone splenectomy other: no investigational treatment within 2 months of surgery no immunosuppressive therapies

Keywords: stage i pancreatic cancer stage ii pancreatic cancer adenocarcinoma of the pancreas
benefits of using various starting doses of atorvastatin on achievement of cholesterol targets

Conditions: Coronary Arteriosclerosis; Diabetes Mellitus, Type 2; Cerebrovascular Accident; Dyslipidemia; Peripheral Vascular Disease

Summary: european physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. the study evaluates if selecting the starting dose based on baseline and target ldl-c cholesterol would provide better results (ie proportion of subjects resching target)


Eligibility criteria:
inclusion criteria: * high cholesterol blood levels (ldl-cholesterol above 100 mg/dl up to 220 mg/dl. * triglycerides up to 600 mg/dl. * history of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events. exclusion criteria: * pregnancy or lactation, use of high statin doses (\>40mg) at baseline, liver or renal problems * use of other drugs that would interfere with evaluation of efficacy or cause safety problems * uncontrolled hypertension, diabetes or hypothyroidism * recent cardiac event of procedure * high baseline cpk levels
evaluation of the effectiveness of a spa therapy to "neyrac-les-bains" to the old subject (60-80 years old) with a chronic low back pain.

Conditions: Chronic Low Back Pain

Summary: low back pain is considered to be chronic if it has been present for longer than three months. this pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. thus she is frequently met in general medicine, in particular to the ageing subject. it is the 2nd motive for consultation. the chronic low back pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals. the primary objective of this study is to determine the impact of a 3 months spa therapy on the chronic low back pain in older adults (from 60 to 80 years old) realizing a spa therapy of 3 weeks to "neyrac-les-bains".

realization of the protocol : 1. selection of the patients (realized during the consultation of programming in the beginning of the spa therapy). they are 2 thermal doctors of "neyrac-les-bains" (1 general practitioner with formation of thermal medicine and a rheumatologist) which include the eligible patients in this study during the visit of the beginning of spa therapy. 2. they will put back to the patients the inform consent form, the form of non-opposition and the 1st questionnaire (j0). the nurse of the spa therapy will be at their disposal to help them to fill the questionnaire if need. an urn will be arranged in the entrance hall of neyrac- les-bains to get back the filled questionnaires (j0 and j21). patients will follow the conventional spa therapy of 3 weeks without a specific changes or modification of the care provided. feedback : assessments conducted by the using of self - questionnaires: * delivered in the issue of the visit of inclusion and at the end of the spa therapy ; * sent by mail at 3 and 6 months the expectations and fears will be evaluated by means of individual interview or focus groups. to avoid the biases bound to the questionnaire, the patients questioned in qualitative are different from patients receiving the questionnaire (not over the same period of spa therapy).

Eligibility criteria:
inclusion criteria: * - both sexes * 60-80 years old * realizing a spa therapy of 3 weeks. * presenting a mechanical pain of the rachis lumbar vertebra \> 3 months * possible irradiation up to the knee (cruralgia / sciatalgie truncated) * cooperation and understanding allowing to conform in a strict way to the conditions planned by the study * acceptance to participate in the study (non-opposition) exclusion criteria: * - \ 80 years * inflammatory, tumoral, traumatic or infectious rheumatism * surgery of the back * spa therapy dating less than 6 months * evolutionary slipped disc * disorders(confusions) of the concentration or the compression of the written or oral french language making impossible the realization of the study * the pain estimated by the digital scale = 0 in the inclusion

Keywords: chronic low back pain old subject spa therapy pain function expectations fears
music therapy to address patients' journeys with chronic illness, outcomes, and readmission

Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: conduct a pilot study (n = 20) to explore the feasibility and acceptability of the major chord music therapy (mt) intervention (i.e., two in-person mt sessions prior to discharge and two virtual mt sessions post-discharge) and collection of patient-reported outcomes through 30 days after hospital discharge. the investigators will uncover any potential modifications that need to be made to the intervention and data collection process prior to initiating the randomized trial.


Eligibility criteria:
inclusion criteria: * age range: ≥40 to ≤89 years * hospitalized at uh cleveland medical center (uhcmc) with anticipated length of stay following recruitment ≥ 2 days as documented in electronic health record (ehr) * diagnosed (i.e., icd-10 code within the ehr) with either copd (j44) or hf (i50) with confirmed icd-10 code in ehr * able to read and understand english * screening positive for depression and/or anxiety as evidenced by: gad-7 anxiety score ≥ 10 and phq-9 depression score ≥ 10 * access to wifi, active email address \& laptop, tablet, and/or pc with videoconferencing capabilities * has reliable support person who can be available to respond in case of a medical emergency at any time * has reliable access to a mobile device with active data plan exclusion criteria: * significant hearing and/or visual impairment as documented in ehr * unable to independently provide consent (i.e., no proxy consent) * active suicidal ideation documented in inpatient psychiatry note during current hospital admission or expressed at any point verbally or in writing to study staff * severe psychological comorbidity (e.g., psychosis, schizophrenia) that would prevent patient from engaging fully in intervention as documented in ehr * currently admitted to intensive care unit * receiving active cancer treatment (e.g., chemotherapy, radiation, immunotherapy) as documented in ehr * diagnosed with medical condition likely to be terminal within 24 weeks as documented in ehr * on wait list for heart transplantation or ventricular assist device (vad) as documented in ehr * nyha stage iv hf or end-stage copd as documented in ehr * receiving hospice care as documented in ehr * active substance abuse as documented in ehr

Keywords: music therapy chronic obstructive pulmonary disease heart failure in-person virtual
study on therapeutic mechanism of natural psychotherapy for neurosis

Conditions: Obsessive-Compulsive Disorder

Summary: explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

1. to evaluate the cognitive function, cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population. 2. investigate the pathological mechanism of neurotic patients from the aspects of electroencephalic graph/functional magnetic resonance imaging (eeg/fmri) and biology. 3. to investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. in order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.

Eligibility criteria:
inclusion criteria: * have a diagnosis of obsessive-compulsive disorder or compulsive behavior * duration of symptoms for not less than 12 months * age 15-60 years old. * you can participate in the whole experiment and offline assessment in beijing exclusion criteria: * documented disease of physical diseases including, but not limited to stroke, tumor, parkinson's disease, huntington's disease, seizure, epilepsy, history of brain trauma * subjects who suffered from alcohol or illegal drug abuse/dependence

Keywords: obsessive-compulsive disorder natural psychotherapy
pharmaceutical care and clinical outcomes for the elderly taking potentially inappropriate medication

Conditions: Elderly; Chronic Disease

Summary: the investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.


Eligibility criteria:
inclusion criteria: * hospitalized patients aged at least 65 years * taking at least six prescribed medicines regularly, including at least one potential inappropriate medication exclusion criteria: * patients who refused informed consent * discharged before consent could be obtained * cognitive impaired

Keywords: adverse drug reaction inappropriate medication pharmacist pharmaceutical care
cortical excitability and decision making after total sleep deprivation and sleep restriction

Conditions: Acute and Partial Sleep Deprivation

Summary: the investigators examine changes in decision making, vigilance and cortical excitability in healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand, and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night) on the other hand, in a cross over controlled manner. the investigators hypothesize that total sleep deprivation, as well as partial sleep restriction lead to impairments in decision making and vigilance, and enhanced cortical excitability. beside these three primary outcomes, the investigators also assess changes in sleep by eeg, dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory, and also collect saliva samples.


Eligibility criteria:
inclusion criteria: * male (in female subjects, menstrual cycle influences sleep) * age between 18-35 years * right-handedness * good general health * signed informed consent after being informed exclusion criteria: * contraindications on ethical grounds * clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc) * known or suspected non-compliance, drug or alcohol abuse (\> 5dl wine/ \>1l beer daily) * regular medication intake * enrolment into a clinical trial within last 4 weeks * history of seizure or a family history of epilepsy * diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases) * history of any moderate or heavy head trauma * sleep disorders (e.g. insomnia, sleep apnea, restless leg syndrome, narcolepsy, etc.) * sleep complaints in general or eds * irregular sleep-wake rhythm (e.g. shift working) * long (\> 9 hours per night) or short sleepers (\< 7hours per night) * sleep efficiency ≤ 80% * travelling with time lag less than 1 month ago (or planning to do so within 1 month prior to the study) * body mass index \ 30 kg/m2 * 5 drinks or food items containing caffeine per day * 10 cigarettes per day * student of one of the following subjects: mathematics, physics, computer science, economics, or psychology (since students of these subjects have profound knowledge of probability calculations, which could interfere with our measurements in decision making) * the following additional exclusion criteria apply only to subjects with tms sessions * history of frequent and/or heavy headache respectively migraine * history of claustrophobia * hearing disorder * magnetic resonance imaging (mri) contraindication (such as pacemaker implanted pumps, shrapnel, etc.; full mri screening form will be filled out - see -entrance questionnaires) * no clear tms evoked potential in the target area during the screening assessment * these subjects will be invited to participate in the study with no tms sessions, the other protocol being identical
the effects on physical activity on mitochondrial function in skin fibroblasts in patients with parkinson's disease.

Conditions: Parkinson's Disease

Summary: the aim of this study is to investigate the effect of physical activity on mitochondrial function in skin fibroblasts in patients with parkinson's disease.

a randomized double-blind clinical trial will be conducted to study the effects of physical activity on mitochondrial function in skin fibroblasts in patients with parkinson's disease. it is an intervention study, and twenty-four patients will be needed. once the subjects have been selected, they will be randomly assigned into three groups (eight patients in each group). the first group will perform basic physical training (bpt) based on strength and resistance, the second group will perform bpt combined with functional exercises (bptfe) with cognitive and motor training, and the third group will not carry out any activity program, serving as control. the interventions will last 60 minutes, with a frequency of 3 times a week, during 16 weeks. the control group will receive 4 months of pa from the program that has obtained the best results,in terms of symptoms and quality of life, after the last evaluation.

Eligibility criteria:
inclusion criteria: * patients with a medical diagnosis of idiopathic pd, hoehn and yahr scale stages of i-iii. * patients who score ≥26 on the montreal cognitive assessment (moca). * patients who have signed the ic. * patients with stable medication. * age between 50 and 70 years, and able to walk independently for 6 minutes. exclusion criteria: * patients with a pathology other than idiopathic pd. * patients with cognitive impairment (moca \<26 points). * patients with uncontrolled cardiovascular disease, visual impairment, or recent musculoskeletal disorders in the extremities. * patients who are performing another therapeutic exercise protocol. * patients who have undergone surgery to influence any symptom from the pd.

Keywords: parkinson's disease physical activity mitochondrial function skin fibroblasts
smart phone application in increasing physical activity in breast cancer survivors

Conditions: Breast Cancer

Summary: this pilot clinical trial studies how well a smart phone application works in increasing physical activity in breast cancer survivors. a smart phone application that increases physical activity may help reduce the likelihood of cancer coming back in breast cancer survivors.

primary objectives: i. to conduct a pilot study to inform the design of a mobile health application for smartphone that is targeted to increase physical activity and reduce risks associated with breast cancer.

Eligibility criteria:
inclusion criteria: * a participant is only able to participate in one phase, not both phases, of the research study * must have completed breast cancer treatment * those on adjuvant hormonal therapy are allowed to participate in the research study (either phase) exclusion criteria: * those who currently meet the centers for disease control and prevention (cdc)'s physical activity guidelines * those who do not currently use a smartphone (of any kind) * those who do not read and speak english