Kornimate/medical-research-clean huggingface dataset:
alzheimer disease : rehabilitation's intervention at home

Conditions: Alzheimer's Disease

Summary: alzheimer's disease (ad) is the most common cause of dementia among elderly patients. by its prevalence and its medical and social consequences, ad represents a dual challenge to public health and society. the elderly want to stay in their homes even when their lives are altered by a chronic progressive disease. their caregivers claim in turn a support at home. but this desire is questioned because of the characteristics of the disease, e.g. the altered relational function by the cognitive impairment and the behavioural disorders associated. outpatients non-drug therapies represent a potential support that adapts to patient with an ad or mixed dementia, especially in their milder forms. the aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention at home and its acceptability by both the patient and the caregiver. the study of its efficiency in terms of autonomy will be the next step.

the protocol is based on weekly rehabilitation's intervention at home. all home visits and assessments of the patient and his caregiver will be made by the rehabilitation's therapist himself. twelve weekly interventions at home are planed. the first five are needed to define a realistic and achievable goal of treatment which is accepted by the dyad and the therapist. the following seven interventions will achieve this goal by rehabilitation's intervention (e.g. occupational therapy, psychomotor approach). four filmed sessions for dyad's assessment are planned (at inclusion, at weeks 5 and 12 after inclusion and 3 months after the last intervention).

Eligibility criteria:
patient's inclusion criteria: * aged 65 and over * ad or mixed dementia (dsm iv tr criteria), documented by a neuropsychological assessment and a brain imaging * living at home * having a caregiver (more than 2 visits per week) * agreement for the study caregiver's inclusion criteria : * more than 2 patient's visits per week * agreement for the study patient's exclusion criteria: * life expectancy less than 1 year * guardianship * already having a rehabilitation program's therapy * participation in a pharmacological study caregiver's exclusion criteria: - medical condition requiring regular care

Keywords: home care, rehabilitation therapy, alzheimer's disease
study to evaluate postoperative analgesia in subjects undergoing hemorrhoidectomy

Conditions: Hemorrhoids

Summary: effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Eligibility criteria:
inclusion criteria: * male or female equal or greater than 18 years of age at screening * female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy. * scheduled to undergo 2-or3-column excisional hemorrhoidectomy * american society of anesthesiology (asa) physical class 1-4 * able and willing to complete with all study visits and procedures * able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments * willing and capable of provide written informed consent. exclusion criteria: * pregnant, nursing or planning to become pregnant during the study period * use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery. * concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments. * single-column hemorrhoidectomy * body weight less than 50 kg (110 pounds) * history of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in marcaine with epinephrine) * contraindication to epinephrine * contraindication to any of the pain-control agents planned for postoperative use * administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration * history of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years. * uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance. * significant medical conditions or laboratory results that indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial. * any clinically significant event or condition uncovered during surgery * a cumulative incision length less than 3 cm

Keywords: hemorrhoids
comparison of adalimumab and tofacitinib in the treatment of active takayasu arteritis

Conditions: Takayasu Arteritis

Summary: this is a prospective,open-labelled,multi-center,randomized clinical trial.it compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active takayasu's arteritis patients.

in this study, 100 relapse takayasu's arteritis patients will be enrolled. patients are randomized into the adalimumab treatment group and tofacitinib treatment.patients will also be treated with reduced dose of glucocorticoid at the same time. the primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78. the efficacy will be evaluated at week 12, 24, 36, 52 and 78. if the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. safety is also monitored during the study.

Eligibility criteria:
inclusion criteria: 1. patients aged between 18-65 years old; 2. fulfilled the classification criteria of takayasu's arteritis by acr 1990; 3. relapse active tak: defined by the definition of active disease in the recommendations released by eular in 2018; 4. patients who signed the informed consent form. exclusion criteria: 1. patients who failed or intolerant to either adalimumab or tofacitinib; 2. patients with severe liver disease defined by the serum alt or ast elevated more than 2 times the upper limits; 3. not well controlled diabetes; 4. uncontrolled heart failure od renal dysfunction(egfr\<30ml/min); 5. patients with active infection,including tuberculosis, hepatitis b and c,hiv infection, bacteria or fungal infection; 6. upper gi bleeding 3 months before enrolement; 7. refractory hypertension; 8. pregnant or intended to be pregnant 3 months after the trial; 9. severe coronary artery involvement demonstrated by cta; 10. severe cranial or cervical or renal artery diseases that need surgery; 11. patients that should not be included by the investigator.
safety evaluation of the vibrating capsule

Conditions: Constipation

Summary: the study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.

healthy volunteers will be followed for safety for 7 days after taking the capsule. constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. safety and efficacy will be evaluated.

Eligibility criteria:
inclusion criteria: * patients age 18-60 years * ability of subject to understand character and individual consequences of clinical trial * written informed consent must be available before enrollment in the trial * for women with childbearing potential, adequate contraception exclusion criteria: * patient with diverticulosis * patient must not use protocol-defined prohibited medicine * history of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ecg such as changes in st segment and t waves, and / or q wave) * clinical evidence of significant (as judged by the investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions * presents of pacemakers * history of or current eating disorder such as anorexia or bulimia or compulsory overeating. * diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia. * actively participating in another clinical trial

Keywords: constipation gastro vibrating capsule safety
a clinical trial to compare efficacy and tolerability of fulvestrant 250mg, 250mg (plus 250mg loading regimen) and 500mg

Conditions: Advanced Breast Cancer; Metastatic Breast Cancer

Summary: this study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.


Eligibility criteria:
inclusion criteria: * breast cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor * requiring hormonal treatment * postmenopausal women defined as a woman who has stopped having menstrual periods exclusion criteria: * treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer * treatment with more than one previous regimen of endocrine therapy for advanced breast cancer * an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures

Keywords: oncology cancer breast cancer
stroke arrhythmia monitoring database

Conditions: Acute Stroke

Summary: cardiac arrhythmia are frequently observed after stroke. they may on one hand be causative for the stroke mainly in case of atrial fibrillation but on the other hand present severe complications of the stroke. in addition, cardiac comorbidity as well as acute myocardial infarction are frequently found in acute stroke patients. diagnostics to identify cardiac arrhythmia in the acute phase of stroke care thus have an important role not only for adjusting the correct secondary prevention but also to prevent cardiac complications potentially reducing morbidity and mortality. the aim of the samba-study is to systematically assess the prevalence of higher grade arrhythmias after stroke using a standardized reading of 72h telemetric monitoring in the first days after stroke onset. in addition, it evaluates different strategies to identify paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patients treated on the stroke unit * patients with telemetric monitoring exclusion criteria: * none

Keywords: stroke cardiac monitoring
characterisation of fundamental decision making in people suffering from a characterised depressive episode

Conditions: Depressive Episode

Summary: the investigators will include patients suffering from major depressive disorder (mdd), in episode. the patients will undertake neuropsychological tasks evaluating executive function and clinical assessment related to depressive symptoms, anxiety, transdiagnostic symptoms and psychological skills.

the investigators will include patients suffering from mdd, in episode. the patients will be evaluated with the mini-7 interview. then, the participants will undertake different neuropsychological tasks evaluating executive function: the stroop task, the d2 tasks, the finger tapping test and the mindpulse. the participants will also undertake clinical evaluation the madrs, the transdiagnostic skills scale, the symptomatic transdiagnostic test, the stai and the severity insomnia indexes. the investigators will perform correlational analysis between the neuropsychological tasks and the clinical evaluations. the investigators will also compare the predictive power of the different neuropsychological tasks on depressive symptoms.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * diagnosis of a depressive episode according to dsm-5 criteria, confirmed by the mini international neuropsychiatric interview (mini 7.0 according to dsm-5). * no evidence of bipolar disorder or schizophrenia, confirmed by the mini. * no dementing neurological disease. * no guardianship or trusteeship exclusion criteria: * opposition to data processing * depressive episode in the context of a known bipolar disorder or schizophrenic illness

Keywords: depression fundamental decision computerised cognitive performance test
a phase 1a/1b study of actm-838 in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this is a first in human (fih) 2-part study using actm-838 in patients with advanced solid tumors resistant to standard of care treatment. part 1a will evaluate dose escalation and part 1b will evaluate dose expansion.

this study has 2 parts. part 1a will evaluate the safety and tolerability and activity of escalating doses of actm-838 to estimate the maximum tolerated dose (mtd) and/or the optimum biological dose (obd) for actm-838 as a monotherapy and determine the dose recommended for part 1b. part 1b will further evaluate actm-838 in patients with advanced specific tumor types (defined pathologically, clinically and/or molecularly) based on data emerging from the phase 1a and the pre-clinical program. the details on the phase 1b dose expansion part will be incorporated in a future protocol amendment.

Eligibility criteria:
inclusion criteria: 1. advanced solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit, or they must be ineligible to receive or refuse to receive such therapy 2. at least one measurable lesion per response evaluation criteria in solid tumors (recist ) v1.1; amenable for biopsy, and radiographically apparent on computed tomography (ct) or magnetic resonance imaging (mri ) 3. eastern cooperative oncology group (ecog) 0-1 4. adequate hematologic, hepatic, pulmonary, and cardiac function 5. cd4 count \>500/ml at screening 6. additional protocol defined inclusion criteria may apply exclusion criteria: 1. active autoimmune disease requiring systemic treatment (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drug) within the past 6 months prior to dosing of investigational product. 2. history of permanent artificial implants (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopaedic screw\[s\], metal plate\[s\], bone graft\[s\], or other exogenous implant\[s\] 3. known history of cholelithiasis or urolithiasis 4. history of valvular disease, arterial aneurisms or arterial or venous malformation 5. known active brain metastases 6. documented active salmonella infection or vaccination with salmonella typhi within 6 months prior to investigational product dosing 7. additional protocol defined inclusion/exclusion criteria may apply

Keywords: non-small cell lung cancer head and neck cancer esophageal cancer ovarian cancer cervical cancer stomach cancer thyroid cancer renal cell cancer mesothelioma breast cancer pancreatic cancer colorectal cancer sarcoma immunotherapy melanoma bladder cancer cholangiocarcinoma bile duct cancer
mk0431 monotherapy study in patients with type 2 diabetes mellitus (0431-040)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients have type 2 diabetes mellitus and have laboratory results that are within the values established by the study such as an hemoglobin a1c (hba1c) \>=7.5% and \ =130 mg/dl and \<=280 mg/dl exclusion criteria : * patients have type 1 diabetes mellitus or required insulin therapy within the past 12 months
comparative study between thrombosis prophylaxis protocols

Conditions: Prophylaxis of Deep Vein Thrombosis

Summary: background: compare the american and brazilian protocols for prophylaxis of deep vein thrombosis (dvt), seeking to draft a new protocol, more comprehensive and applicable. methods: a prospective study was conducted over a year, covering 212 patients, comparing the protocols on the stratification of risk of dvt, and the type of prophylaxis indicated. a new protocol was proposed, applied and compared to previous.

not desired

Eligibility criteria:
inclusion criteria: patients who underwent plastic surgery in the hospital of the medical school of botucatu, in the period of one year exclusion criteria: refusal to participate in the research protocol
the impact of maternal obesity on pregnancy outcomes in el-minia locality

Conditions: Obesity During Pregnancy in Clinical Practice

Summary: a study will carried out over a period of one year , all obese pregnant women as diagnosed with bmi at the time of 1st anc visit and before labor ,observation of events during both intra-partum \&postpartum periods it will be recorded.outcome will compared with normal other pregnant women

it is known that obesity during pregnancy has drawbacks for both maternal and foetal outcome the aim of this study is to evaluate and measure the proportion of the adverse pregnancy outcomes attributable to maternal obesity and so reaching to recommendations in order to improve the outcomes and wellbeing of these women and their children.patient will be divided into two groups control group with normal bmi and study group and both compared as regard foetal and maternal outcome the assessed fetal variables will be: fetal birthweight \& incubators admission. data will be retrieved from patients before labor and from investigator observation both intrapartum and postpartum.

Eligibility criteria:
inclusion criteria: * obese * pregnant * age 18 -40 * single viable cephalic foetus exclusion criteria: less than 18 years more than 40 years associated medical disorders patient refusal non cephalic presentation -

Keywords: obesity , pregnancy , maternal and fetal outcome
study evaluating the safety and tolerability of sca-136 in healthy japanese male subjects

Conditions: Schizophrenia

Summary: this study is being conducted to assess the safety and tolerability of ascending multiple oral doses of sca-136 administered to healthy japanese male subjects.


Eligibility criteria:
inclusion criteria: * healty japanese men willing to use a medically acceptable form of contraception. exclusion criteria: * any significant disease * positive urine drug screen * increased liver function tests * use of prescription drugs.
cord blood transplantation with myeloablative conditioning and post-transplant cyclophosphamide (compact study)

Conditions: Cord Blood Transplantation; Hematological Malignancies

Summary: despite anti-thymocyte globulin has a mainstay role in preventing gvhd (and non-relapse mortality) in cb transplantation, it also induces delayed immune recovery, increased risk of cytomegalovirus and epstein-barr virus reactivation, post-transplant lymphoproliferative diseases, overall accounting for increased transplant-related mortality and/or increased relapse incidence. all these findings support the use of alternative approaches for in vivo t cell depletion in the setting of cb transplantation.

study objectives. the primary objective is to evaluate neutrophil and platelet engraftment and day +100 cd4+ cell count in patients receiving matched cb unit transplant with a myeloablative conditioning regimen and a gvhd prophylaxis including post-transplant cyclophosphamide. secondary objective is to estimate the incidence and severity of acute and chronic gvhd. study endpoints. primary endpoints are hematopoietic engraftment and day +100 cd4+ cell count. secondary endpoints are acute and chronic gvhd

Eligibility criteria:
inclusion criteria: * age: ≥ 18 ≤ 75 years old * cb unit transplantation (tnc\> 2,0 x10\^7/kg and \> 4/6 loci hla matched) * myeloablative conditioning regimen consisting of either thiotepa/ busulfan/ fludarabine or tbi/ fludarabine * gvhd prophylaxis including pt-cy (30 mg/kg or more on days + 3and +5) csa and mmf * diagnosis of 1 of the following hematological malignancies: acute myeloid leukemia (aml), myelodysplastic syndrome, high risk acute lymphoblastic leukemia (all), bi phenotypic/undifferentiated leukemia, chronic myeloid leukemia resistant to tk inhibitors, ph-neg myeloproliferative neoplasms, resistant/relapsing non-hodgkin's lymphoma ineligible for an autologous transplant. exclusion criteria: * positive serologic markers for human immunodeficiency virus (hiv) * acute hepatitis b virus (hbv) or acute hepatitis c virus (hcv) infection
ginseng in treatment of fatigue in multiple sclerosis

Conditions: Fatigue

Summary: the purpose of this study was to evaluate the efficacy and safety of ginseng in treatment of fatigue and quality of life of ms patients.

multiple sclerosis (ms) is one of the most common non-traumatic causes of disability in the world. it is a chronic inflammatory and demyelinating disorder of the central nervous system (cns) which affects individuals in the productive ages and causes a large burden for years to come. fatigue is a common complaint and one of the least understood symptoms of ms

Eligibility criteria:
inclusion criteria: * definite diagnosis of relapsing-remitting ms (rrms) by the macdonald criteria with a baseline of expanded disability status score (edss)of less than 5.0 exclusion criteria: * prior use of ginseng or any other tonic agents, glucocorticoids, warfarin, digoxin, aspirin, furosemide, caffeine, ephedra and anti-platelet agents within one month prior to enrollment; * pregnancy or lactation; * history of renal failure; and, * lack of appropriate adherence to the study protocol.

Keywords: multiple sclerosis ginseng fatigue quality of life
an evaluation of yoga therapy for cervical spondylosis

Conditions: Cervical Spondylosis; Neck Pain

Summary: cervical spondylosis is a chronic degenerative condition, commonly affecting \>40-year-old adults worldwide. cervical spondylosis is an important cause of neck pain and low back pain, and seriously affects the physical health, mental health, patients quality of life. yoga has been most commonly used intervention for pain conditions. but its efficacy in cervical spondylosis has not yet been studied in clinical trials. the primary aim of the present study was to assess the efficacy of yoga chikitsa (therapy) compared with control intervention for neck pain caused by cervical spondylosis.


Eligibility criteria:
inclusion criteria: * neck pain of cs as per diagnostic criteria of international classification of diseases * cs supported by a physical examination, and cervical radiographic examination * history of neck pain longer than 3 months * willing to provide informed consent exclusion criteria: * history of neck trauma, fracture or surgery, * systematic disease of the neck or spine including bones and joints conditions, * pregnancy