Kornimate/medical-research-clean huggingface dataset:
diphenhydramine ointment for knee osteoarthritis

Conditions: Osteoarthritis

Summary: the main purpose of this study is to evaluate whether recruitment rates are adequate to power a future rct. the secondary aims are to obtain preliminary information about safety and efficacy of topical diphenhydramine 5% ointment in patients with knee oa.


Eligibility criteria:
inclusion criteria: 1. acr clinical criteria of knee oa 2. radiographic knee oa (kellgren-lawrence grade \>1) 3. age ≥ 50 years 4. vas pain \>= 40/100 mm at baseline 5. non-use of nsaids one week before the baseline 6. symptoms present on most days for at least 3 months exclusion criteria: 1. any form of inflammatory arthritis 2. use of another topical product at the application site 3. treatment with intraarticular hyaluronic acid within 6 months 4. treatment with intraarticular glucocorticoid within 2 months 5. knee injury/surgery or diagnostic arthroscopy within 3 months 6. allergic reaction to diphenhydramine or any component of the formulation 7. participant has clinical signs and symptoms suggestive of covid-19, eg, fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening

Keywords: osteoarthritis knee pain antihistamines
gabapentin for the control of hot flashes in women with breast cancer

Conditions: Anxiety Disorder; Breast Cancer; Depression; Hot Flashes

Summary: rationale: gabapentin may be effective for the control of hot flashes. it is not yet known if gabapentin is effective in treating hot flashes. purpose: randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.

objectives: * compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer. * compare quality of life, anxiety, and depression in patients treated with these regimens. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). patients are randomized to 1 of 3 arms. * arm i: patients receive oral placebo 3 times a day. * arm ii: patients receive oral gabapentin at a low dose 3 times a day. * arm iii: patients receive oral gabapentin as in arm ii for 3 days and then at a high dose 3 times a day. treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. after week 8, patients may receive open-label gabapentin at the discretion of their physicians. hot flashes are assessed at baseline and then during weeks 3 and 7 of the study. quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8. patients are followed at week 12. projected accrual: a total of 408 patients (136 per arm) will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * experiencing 2 or more hot flashes per day for at least 1 week * hormone receptor status: * not specified patient characteristics: age: * not specified sex: * female menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * bilirubin normal * sgot no greater than 2 times upper limit of normal (uln) renal: * creatinine no greater than 1.25 times uln cardiovascular: * no coronary insufficiency * no myocardial infarction within the past 3 months * no symptomatic cardiac disease * no peripheral vascular disease * no cerebrovascular disease or stroke * no syncope or symptomatic hypotension other: * no history of allergic or other adverse reaction to gabapentin * not pregnant or nursing * fertile patients must use effective contraception during and for 1 week after study prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * no other concurrent anticonvulsant medication * no concurrent clonidine or venlafaxine

Keywords: stage i breast cancer stage ii breast cancer stage iv breast cancer stage iiia breast cancer recurrent breast cancer stage iiib breast cancer stage iiic breast cancer anxiety disorder depression hot flashes
treatment of myeloma in patients = 50% after hsc autotransplant by allogenic transplant genoidentical or phenoidentical after reduced intensity conditioning

Conditions: Myeloma

Summary: donor mobilization : donor will be mobilized with g-csf (granocyte) sub-cutaneous 10 µg/kg/day during 5 to 6 days. hematopoïetic stem cell harvest: by 1, 2, or 3 aphaeresis, a number of 4 x 106 cellules cd34+ /kg is required. if the cd34+ \>= 2 and \<= 4x106/kg: the center must decide on the strategy decision. in case of insufficient graft : a bone marrow harvest is recommended conditioning : fludarabine - busulfan - atg * d-5 : fludarabine (30 mg/m²) * d-4 : fludarabine (30 mg/m²)+ busilvex (0,8 mg/kg every 6 h) * d-3 : fludarabine (30 mg/m²)+ busilvex (0,8 mg/kg every 6 h) * d-2 : fludarabine (30 mg/m²) + atg (genzyme) (2.5 mg/kg) * d-1 : fludarabine (30 mg/m²) + atg (genzyme) (2.5 mg/kg) gvhd prophylaxis: csa alone at 3 mg/ kg + methotrexate d1, d3 and d6 only in case of minor abo incompatibility and with an anti a/b antibodies titer\> 1/32. transplant : hsc at d0 • 3 months after transplantation : disease evaluation : * if cr : supervision. then if progression: 4 cycles of bortezomib. * if no cr : bortezomib (4 cycles) • evaluation after bortezomib cycles * if cr : supervision. then, if progression and no gvhd : dli if no rc and no gvhd : dli


Eligibility criteria:
inclusion criteria: * major patients not under guardianship * myeloma with high b2 microglobulin level (\> 3 mg/l) and/or chromosome 13 deletion, and/or translocation t(4;14) stage i ds with high evolutive potential or stage ii, iii ds. and * with response \>= 50% and \<= 90% after the first autohsct (ifm 2005 01). the evaluation must be performed within 2 months after the first autohsct. * with an hla identical related or unrelated donor ( match 10/10). * donor and recipient must have signed a written informed consent.

Keywords: myeloma rict conditioning allograft
open suction vs. closed suction in ards

Conditions: Acute Respiratory Distress Syndrome

Summary: the alveoli tend to collapse in patients with ards. endotracheal aspiration may increase alveolar collapse by decreasing the end-expiratory lung volume. the hypothesis is that closed endotracheal aspiration led to less end-expiratory volume loss when compared to open endotracheal aspiration.


Eligibility criteria:
inclusion criteria: mechanically ventilated due to ards exclusion criteria: hemodynamically unstable air leaks syndrome (pneumothorax) higher level of fio2 (\>60%) chronic obstructive pulmonary disease

Keywords: endotracheal aspiration, electric impedance tomography
pilot study of oligonol supplementation to promote cardiovascular health

Conditions: Cardiovascular Health

Summary: the investigators hypothesize that acute consumption of oligonol, a patented lychee fruit extract (amino up chemical co.) particularly rich in low molecular weight flavanols, will improve endothelial function, reduce platelet reactivity and increase circulating levels of flavonoids after a single intake.

the investigators have demonstrated from previous studies at uc davis that a single dose of a high-flavanol supplement from cocoa can improve endothelial function, measured by increased blood flow from peripheral arterial tonometry (pat), reduce platelet reactivity, and increase circulating levels of flavonoids in the blood. the investigators seek with this proposal to determine if a similar response can be noted with a different high-flavanol supplement in normal, healthy people.

Eligibility criteria:
inclusion criteria: * age 18-50 yrs. * healthy, not taking prescription medications * subject is willing and able to comply with the study protocols. * subject is willing to consume the oligonol extract drink or placebo once a week for each of three weeks. exclusion criteria: * physical signs of health impairment. * abnormal clinical laboratory (cbc, chemistry, liver, etc.) values if determined to be clinically significant by dr. eric gershwin * inflammatory disorders (e.g. rheumatoid arthritis) * malabsorption * treatment with corticosteroids, hypolipidemic and anti-inflammatory drugs * renal or liver disease * heart disease, which includes cardiovascular events and stroke * cushing's syndrome * history of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year. * anti-anxiety medications * routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, cox-2 inhibitors, antihistamines, corticosteroids, ace-inhibitors, and beta-blockers, erectile dysfunction drugs. * asthma (can be worsened by mild to moderate food allergies). * indications of substance or alcohol abuse within the last 3 years * undergoing nicotine cessation therapy * multi-vitamin and mineral use other than a one-a-day type formula * current, consistent use of herbal or plant-based supplements; omega-3 fatty acids, and fish or unwilling to discontinue use while participating in the study. * alcohol consumption \> 1 oz/day (2 beers/day or 2 glasses of wine/ day, 1 drink of hard liquor/day) * chronic high-intensity exercise * smoking

Keywords: flavanols cardiovascular
early post-marketing study of daclatasvir (daklinza) in the treatment of chronic hepatitis c (chc) in adults

Conditions: Hepatitis C

Summary: this early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of chronic hepatitis c at participating sentinel sites for the cnfv in mexico.


Eligibility criteria:
inclusion criteria: 1. this study will include patients greater than or equal to 18 years of age with chronic hepatitis c, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (ifn) with or without cirrhosis, hiv/hcv coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic hepatitis c during the specified 24-month study period. exclusion criteria: 1. subjects who received daclatasvir as part of a clinical trial. 2. subjects who received daclatasvir for any indication other than local approved. 3. contraindications included in the approved mexican prescribing information.
vowel segmentation for classification of chronic obstructive pulmonary disease using machine learning

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this work aims to evaluate whether the segmentation of vowel recordings collected from patients diagnosed with copd and healthy control groups can increase the classification precision of machine learning techniques.

voice data and sociodemographic data on gender and age will be collected through the "voicediganostic" application from the company voice diagnostic. collected vowel recordings will be segmented and tested to determine whether some segments contain more information for the discrimination of copd from healthy control groups. each segment will be transformed into mathematical vocal measures called voice features. a dataset consisting of voice features in conjunction with demographics and health data will be constructed for each segment which in turn will be evaluated for classification performance using several machine learning algorithms. descriptive statistical analysis will be held on attributes containing information on input data and gained outcomes from ml algorithms. the achieved results will be presented in the form of summary tables and graphs.

Eligibility criteria:
inclusion criteria: * being 18 years old and older. exclusion criteria: * being under 18 years old and older.

Keywords: segmentation classification copd machine learning
post-market study of the iconacy hip system

Conditions: Degenerative Joint Disease

Summary: the purpose of this study is to evaluate the use and efficacy of the iconacy hip system for total hip replacement surgery.


Eligibility criteria:
inclusion criteria: * this must be a primary hip replacement on this hip * patient is 30 years of age or older * have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis * patient is likely to be available for evaluation for the duration of the study * able and willing to sign the informed consent and follow study procedures exclusion criteria: * is younger than 30 years of age * if there has been a total hip replacement on this hip in the past (no revisions allowed in study) * infection, or history of infection, acute or chronic, local or systemic * alcoholism or other addictions * muscular, neurological or vascular deficiencies which compromise the affected extremity * obesity(bmi\>45) * insufficient bone quality * loss of ligamentous structures * high levels of physical activity * materials sensitivity * prisoner * mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements * patient is pregnant * is not able to read english language

Keywords: hip arthroplasty arthroplasties prosthesis iconacy osteoarthritis arthritis tha thr djd
the effect of virtual reality glasses applied during emergency surgical intervention

Conditions: Anxiety

Summary: this randomized controlled trial evaluates the effect of virtual reality glasses applied during emergency surgical intervention with local anesthesia on patients anxiety. this study hypothesizes that virtual reality glasses reduces anxiety.

the sample of this study consisted of 138 patients in the experimental (n=69) and control groups (n=69). virtual reality (vr) application will be applied to the experimental group during the emergency surgical intervention under local anesthesia. anxiety level will be assessed with the spielberger state anxiety scale and measured by physiological responses of anxiety such as systolic blood pressure (sbp), diastolic blood pressure (dbp), heart rate (hr), respiratory rate (rr) and peripheral oxygen saturation (spo2) before and after vr application. in the control group, no application will be made except for standard care only.

Eligibility criteria:
inclusion criteria: * emergency surgical intervention with local anesthesia, * between the ages of 18-65, * conscious, oriented and cooperative, * able to read and understand turkish, * agree to participate in the study * does not have physical problems that will prevent the application of virtual reality glasses, * no previous experience with virtual reality glasses, * not diagnosed with anxiety, * does not use drugs for anxiety, * does not use alcohol and/or drugs, * no mental illness * patients who signed the informed consent form/written consent form exclusion criteria: * no emergency surgical intervention with local anesthesia, * those under the age of 18, over the age of 65, * unconscious, oriented and uncooperative, * can't read and understand turkish, * those who do not agree to participate in the study, * having a physical problem that will prevent the application of virtual reality glasses, * diagnosed with anxiety, * using drugs for anxiety (anxiolytic, antidepressant, antipsychotic, etc.), * using alcohol and/or drugs, * having a mental disorder, * patients who did not sign the informed consent form/written consent form

Keywords: anxiety virtual reality glasses emergency surgery
quality of life analysis of treatment in patients with prostate cancer on adjuvant zoladex therapy

Conditions: Prostate Cancer

Summary: this is an open label, non-interventional quality of life analysis for zoladex treated prostate cancer patients by investigator's questionnaire


Eligibility criteria:
inclusion criteria: * provision of informed consent * early or locally-advanced prostate cancer patients on androgen deprivation therapy * investigators are requested to recruit patients only with at least 1 month prior zoladex treatment. exclusion criteria: * allergy to substance of medication * prostate cancer patients with advanced disease

Keywords: quality of life
mito-5: weekly carboplatin and paclitaxel as first line chemotherapy for elderly patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage ic-iv.

this is a phase ii multicenter study. the experimental treatment is carboplatin (auc 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.

Eligibility criteria:
inclusion criteria: * age 70 years or greater * cytologic / histologic diagnosis ovarian cancer * stage of disease at diagnosis ic -iv * performance status (ecog) \< 3 * indication for chemotherapy treatment * written informed consent exclusion criteria: * previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * cerebral metastases * neutrophils \< 1000/mm3, platelets \< 100000/mm3, hemoglobin \< 8g/dl * creatinine \> o = 1.25 times the upper normal limit * got or gpt \> o = 1.25 times the upper normal limit, except in case of liver metastases) * patient's inability to comply with followup

Keywords: ovarian cancer elderly weekly chemotherapy first-line
longitudinal study of behavioral changes, economic and sociological after cancer

Conditions: Breast Cancer; Melanoma

Summary: generally, french studies concerned with the quality of life of cancer patients focus on the period of treatment (up to 2 years post diagnosis). however, studies about quality of life "after" cancer are relatively rare (= long-term quality of life, or from 5 years post diagnosis). these studies mainly concern the most common cancers (breast and prostate). or changes in quality of life after treatment could be different depending on the type of cancer. in addition, there is a significant influence of sociodemographic variables on the quality of life in remission. similarly using remote diagnostics, quality of life questionnaires related to health, must be reassessed because too often developed for situations in process. based on these findings, "elcca ii" study proposes to study for five years, the evolution of the impacts of two types of cancer (breast and melanoma) on quality of life (overall and related to the subjective health), socioeconomic status, and behavioral and emotional dimensions (post-traumatic development, coping, anxiety-depression) of those treated.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer (breast or melanoma) since less than 1 month * no metastasis * inform consent form signed exclusion criteria: * severe psychiatric disorder (depression, psychosis, etc.) * addictive pathology * longtime antidepressant treatment (\> 3 months) * patient pregnant or breastfeeding
vibration for pain reduction during trigger point injection

Conditions: Myofascial Pain Syndromes

Summary: the aim of this study is to evaluate the effects of vibration anesthesia for reducing pain induced by trigger point injection of gastrocnemius. sixty patients were randomized into the vibration or placebo group. in vibration groups, vibrator head was applied (100hz) on the popliteal fossa, during the trigger point injection. in placebo group, same vibrator head was applied with switch-off sate. then, a visual analog scale to evaluate the pain of trigger point injection and a five-point likert scale for patients satisfaction were compared between the two groups.


Eligibility criteria:
inclusion criteria: * patients who have the trigger point in the gastrocnemius and show referred pain. exclusion criteria: * those with prior history of trigger point injection * those with taking anti-platelet agent * those with hemorrhage tendency * pregnancy * acute infection * those who were unable to understand a visual analog scale (vas) or a likert scale

Keywords: myofascial pain syndromes, gastrocnemius, trigger points, injections, vibration
in vivo versus augmented reality exposure for small animal phobia

Conditions: Phobic Disorders

Summary: the aim of this study is to explore the differential efficacy of in vivo exposure versus augmented reality exposure in the treatment of specific phobia (small animals). the hypothesis is: there will not be significant statistical differences in the efficacy of in vivo exposure therapy versus augmented reality exposure in the treatment of specific phobia (small animals).

among anxiety disorders, specific phobias are highly prevalent (around 7.2% and 11.3% in the general population). cockroach or spider phobia is a type of specific phobia, animal type. the gold standard for the treatment of specific phobia (included small animal phobia) is in vivo exposure. most phobia sufferers (60-80%) never seek treatment. besides, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention or drop out (around 25%) when they are informed about the intervention procedure. information and communication technologies (ict) like virtual reality (vr) and augmented reality (ar) are pioneer applications that can improve treatment adherence and acceptance. there exist some studies offering preliminary evidence of the efficacy of ar for the treatment of small animal phobia. however, there are not any controlled study exploring the differential efficacy of ict-based exposure interventions versus in vivo exposure. in the present study the differential efficacy of ar exposure versus in vivo exposure for the treatment of small animal phobia is explored with a between subject randomized controlled trial. a pre-treatment assessment will be conducted in order to establish the diagnosis and evaluate the main outcome measures. all participants will receive an intensive exposure session following öst guidelines, (in vivo exposure in one experimental condition and ar exposure in the other experimental condition). after the treatment a post-treatment assessment will be carried out as well as follow-up assessments at 3- and 12-month after treatment completion.

Eligibility criteria:
inclusion criteria: * be between 18-65 years of age. * to meet current dsm-iv-tr criteria for specific phobia (animal type) * have as the major presenting complaint anxiety in, and avoidance of, a large range of situations involving spiders or cockroaches. * a minimum of 1 year duration of the phobia. * to have scores over 4 in phobic avoidance (on a scale of 0 to 8). * express a willingness to participate in the study. exclusion criteria: * to be able to put a hand inside the container with a spider or cockroach during the behavioral test. * have other psychiatric problem in immediate need of treatment. * have psychotic or organic symptoms. * have heart or lung disease. * current alcohol or drug dependence or medication.

Keywords: virtual reality augmented reality in vivo exposure one session treatment ict efficacy specific phobia anxiety disorders