Kornimate/medical-research-clean huggingface dataset:
care to caregiver: the effect of reflexology on sleep and anxiety of cancer caregiver

Conditions: Sleep; Anxiety

Summary: introduction and aim: with the increase in life expectancy in cancer, it gains importance in the care process and the problems experienced by caregivers. however, the problems experienced by individuals caring for cancer patients are often ignored. the most common problems faced by cancer caregivers are sadness, anxiety, sleep disorders, and fatigue. although reflexology has positive effects on sleep and anxiety in different patient groups, there is no study on its effectiveness in cancer caregivers. the aim of this study was to evaluate the effectiveness of reflexology on sleep and anxiety of caregivers. materials and methods: the study was conducted as a double-blind placebo-controlled design. after the groups were determined with block randomization, the reflexology investigation was applied to the experimental group for three consecutive days, while for the placebo group, the hands was moved around the foot for the same periods but no deep stimulation was applied. on the fourth day, a sociodemographic diagnostic form, state anxiety scale and richard-campbell sleep scale were administered to the participants by a blinded researcher. data were analyzed with spss 25.0 package program. written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

introduction and aim: with the increase in life expectancy in cancer, it gains importance in the care process and the problems experienced by caregivers. however, the problems experienced by individuals caring for cancer patients are often ignored. the most common problems faced by cancer caregivers are sadness, anxiety, sleep disorders, and fatigue. although reflexology has positive effects on sleep and anxiety in different patient groups, there is no study on its effectiveness in cancer caregivers. the aim of this study was to evaluate the effectiveness of reflexology on sleep and anxiety of caregivers. materials and methods: the study was conducted as a double-blind placebo-controlled design. after the groups were determined with block randomization, the reflexology investigation was applied to the experimental group for three consecutive days, while for the placebo group, the hands were moved around the foot for the same periods but no deep stimulation was applied. on the fourth day, a sociodemographic diagnostic form, state anxiety scale, and richard-campbell sleep scale were administered to the participants by a blinded researcher. data were analyzed with spss 25.0 package program. written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study.

Eligibility criteria:
inclusion criteria: * care to cancer patients at least for 6 months exclusion criteria: * decline to participate in study
preheated composites vs. conventional composites in noncarious cervical lesions

Conditions: Noncarious Cervical Lesions

Summary: preheating resin composites is the warming of resin composites by using a heating device (composite warmer) before its placement. preheating increases the flow properties and allows better adaptation to cavity preparation. the high thermal energy also improves polymerization rate, thereby reducing microleakage. conventional composites resin is used as one-paste light-cured systems, which are built up in increments to overcome the effects of setting shrinkage and to ensure thorough curing. several studies report failure of cervical restorations of noncarious cervical lesions and an incessant search for the most suitable restorative material. therefore, this study aims to evaluate the clinical performance of conventional resin composites compared with preheated resin composites in the treatment of noncarious cervical lesions. our null hypothesis states that there is no difference between the clinical performance of preheated resin composites and conventional resin composites in the treatment of noncarious cervical lesions. this study will be conducted at the conservative and endodontics department in polyclinic b, faculty of dentistry, manipal university college malaysia (mucm). it involves forty-six randomly selected patients with two similar noncarious cervical lesions, each on a canine, first premolar, second premolar or first molar on the contralateral side of the maxillary arch. one lesion will be restored with preheated resin composite (3m™ filtek™ z350 xt universal restorative) while the other lesion will be restored with conventional resin composite (3m™ filtek™ z350 xt universal restorative). both restorations will be done on each patient's first visit. the patients will be recalled 1,3 and 6 months later for assessment of the restorations, using modified us public health service (usphs) criteria: marginal integrity, marginal discoloration, wear, retention, secondary caries and postoperative sensitivity.


Eligibility criteria:
inclusion criteria: * patients who are systemically healthy (asa i and asa ii )44 and have satisfactory oral hygiene (ohi-s score of 0 to 3.0). * participants must have two noncarious cervical lesions (abrasion/abfraction), each on a canine, 1st premolar, 2nd premolar or 1st molar on the contralateral side of same dental arch (maxillary arch) with similar depth and width. * both nccls are in contact with antagonist teeth as well. exclusion criteria: * participants requiring dental prostheses of the target teeth. * participants have a diagnosis of caries coincident with the cervical lesion, or an indication for irreversible endodontic treatment of the target teeth. * existence of periodontal damage with respect to the target teeth.
a trial to evaluate the potential impact of renal impairment on the pharmacokinetics and safety of cpx-351

Conditions: Hematologic Malignancy; Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes

Summary: this study evaluates the pharmacokinetics and safety of cpx-351 in patients with moderate or severe renal impairment.


Eligibility criteria:
inclusion criteria: 1. ability to understand and voluntarily give informed consent. 2. male or female patients, age ≥18 years at the time of consent. 3. diagnosis of hematologic malignancy including, but not limited to, aml, all, and mds. patients may be newly diagnosed, refractory to initial treatment, or in relapse. 4. patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (crcl)) using the cockcroft-gault formula. 5. consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of cpx-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of cpx-351. 6. male patients must be willing to refrain from sperm donation for 6 months following the last dose of cpx-351and must use adequate contraception throughout the entire study period and for 6 months following the last dose of cpx-351. exclusion criteria: 1. prior treatment with cpx-351 ≤ to 1 month before the start of cpx-351 in this study. 2. patients with active (uncontrolled, metastatic) second malignancies are excluded. 3. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent. 4. patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products. 5. female patients who are pregnant, nursing, or lactating. 6. participation in another clinical trial of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to enrollment in this study. 7. any other condition that would cause a risk to patients if they participate in the trial.
re-read study to compare the brain uptake of [18f]flutemetamol with brain neuritic plaque density determined postmortem

Conditions: Cognitive Impairment

Summary: data from subjects who had previously been dosed with flutemetamol (18f) injection and imaged in study ge-067-007, and who died on or before 10 june 2013, will be analyzed. the pet brain images previously obtained in study ge-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). the numbers of images in each category will be used to calculate sensitivity and specificity.


Eligibility criteria:
inclusion criteria: * the subject was enrolled in prior study ge067-007. * the subject died on or before 10 june 2013. * the subject's brain is judged to be of suitable quality for analysis, including all regions necessary for analysis. exclusion criteria: * not applicable
intranasal cooling for cluster headache and migraine

Conditions: Migraine; Cluster Headache

Summary: this study will be looking at the clinical efficacy of using a intranasal evaporative cooling device in providing relief of the symptoms of migraine and cluster headache. it will involve using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates and removes heat from the tissue, thereby cooling the tissue and the blood vessels which supply blood to the brain. this cooling effect will cause the blood vessels to constrict and it is thought that this may provide symptomatic relief in both these forms of headache. 10 migraine patients and 5 cluster headache patients will be enrolled in the study and will receive 10 treatments each, for a maximum of 20 minutes at a time. they will be monitored during the treatment and for two hours afterwards to assess headache severity and side effects. there will be a further follow up 2 months after the last treatment to assess for longer term side effects from the treatment.


Eligibility criteria:
inclusion criteria: * \>18 years old. * meets criteria for nice guidelines diagnosis of cluster headache or chronic migraine * has not responded satisfactorily to migraine prophylaxis or standard analgesia * capable of giving informed consent exclusion criteria: * \< 18 years of age * subject has history of other severe co-morbid illness which would prevent full participation in the study * inability to insert the nasal cannulae * known temperature sensitive disorder such as reynauds, cryoglobulinaemia * known oxygen dependency to maintain sao2 \>95%

Keywords: migraine cluster headache headache
a study to assess the safety and tolerability of lucerastat in subjects with fabry disease

Conditions: Fabry Disease

Summary: the primary purpose of this study was to assess the safety and tolerability of lucerastat in adults with fabry disease receiving enzyme replacement therapy (ert). the secondary objectives were to investigate the effects of lucerastat on plasma and urine levels of biomarkers, to assess its effects on renal and cardiac functions and to determine the pharmacokinetic profile of lucerastat at steady-state.


Eligibility criteria:
inclusion criteria: * signed informed consent form * male and female adult subjects with a diagnosis of fabry disease (fd) based on historical assessments (residual α-gal a activity level below lower limit of normal for males and presence of a galactosidase alpha mutation for females) and a history of clinical symptoms of fd * on ert for at least 24 months without any change in dose within the last 6 months prior to screening exclusion criteria: * severe renal function impairment * severe residual neurologic deficit * clinically significant unstable cardiac disease * any circumstances or conditions, which, in the opinion of the investigator, may have affected full participation in the study or compliance with the protocol

Keywords: fabry disease lucerastat
co-administration of methotrexate and cp-690,550

Conditions: Rheumatoid Arthritis

Summary: this study was designed to estimate the effects of methotrexate (mtx) on the pharmacokinetics (pk) of cp-690,550 when administered to subjects with rheumatoid arthritis (ra), to estimate the effects of cp-690,550 on the pk of mtx and to evaluate the short-term safety and tolerability of co-administration of cp-690,550 and mtx.


Eligibility criteria:
inclusion criteria: * adults diagnosed with moderate to severe ra (rheumatoid arthritis) * diagnosis of ra based on the american college of rheumatology 1987 revised criteria. * treatment with an oral stable weekly dose of methotrexate (mtx) (15-25 mg/week, administered as a single dose \[sd\]) for a minimum of 4 doses (4 weeks) exclusion criteria: * blood dyscrasias including confirmed: hemoglobin \<9 g/dl or hematocrit \<30%; white blood cell count \<3.0 x 109/l; absolute neutrophil count \<1.2 x 109/l; platelet count \<100 x 109/l * evidence or history of clinically significant infections within the past 6 months (eg, those requiring hospitalization, requiring parenteral antimicrobial therapy, or those with recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the trial. * total bilirubin, ast (aspartate aminotransferase) or alt (alanine aminotransferase) more than 1.2 times the upper limit of normal at the screening visit, or a history of clinically significant elevated liver function tests (lfts) while on current mtx dose or chronic liver disease, recent or active hepatitis.

Keywords: pharmacokinetics oral jak inhibitor methotrexate (mtx) rheumatoid arthritis (ra)
black adolescent & entertainment study

Conditions: Obesity, Childhood

Summary: the study is being conducted to obtain adolescent girls' thoughts and opinions on relationship and communication styles are shown on television.


Eligibility criteria:
inclusion criteria: 1. female, 2. self-identify as african american or black, 3. 12 to 17 years of age at the start of the study, 4. presence of obesity by virtue of a body mass index (bmi) ≥ 95th percentile for age and sex or non-overweight by virtue of a bmi of at least the5th percentile, but below the 85th percentile, for age and sex,118 and 5. english speaking. exclusion criteria: 1. reports of the presence of a major chronic medical illness: renal, hepatic, gastrointestinal, endocrinologic (e.g., cushing syndrome, hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication), 2. individuals who self-report major depressive disorder, psychoses, current substance or alcohol use disorder, or any other psychiatric disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. 3. current, regular use of prescription medications that affect appetite, mood, or body weight: currently prescribed serotonin re-uptake inhibitors (ssris), neuroleptics, tricyclics, stimulants, or any other medication known to affect appetite, mood, or body weight. oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before the study visit, 4. failure to provide a rating of 6 or more on at least 50% of food items on the food preferences questionnaire (appendix f); exceptions may be given for restrictions due to religious practices or food allergies, if food items can be replaced with items of equivalent macronutrient content.
efficacy of combination therapy for prevention of effects of malaria during pregnancy

Conditions: Malaria

Summary: this study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (sp) treatment regimens and intermittent sulfadoxine/pyrimethamine (sp) + artesunate (sp/as) treatment of hiv negative and positive mothers in clearing placental parasitemia at delivery. if intermittent protective sp/as treatment is equally efficacious and safe as intermittent protective sp, such a regimen could be adapted for programmatic use as a potentially more durable alternative to sp monotherapy in areas of increasing sp resistance.


Eligibility criteria:
inclusion criteria: * women 15 years of age or older * first or second pregnancy between 16 and 36 weeks gestation exclusion criteria: * pregnancy prior to 16 weeks or after 36 weeks gestation * third or later pregnancy; * report previous allergic reactions to sp, as, or unknown antimalarials; * if the distance to their home is too great or too inaccessible for follow-up; * child's father refuses the woman's participation

Keywords: malaria birthweight placental malaria intermittent protective treatment sulfadoxine/ pyrimethamine artesuate combination therapy pregnancy
clomiphene citrate for the treatment of obesity related male hypogonadism

Conditions: Obesity; Hypoandrogenism

Summary: hypogonadism is a clinical condition that can be associated with obesity in man. controversy exists regarding if its a condition that needs to be treated. the standard testosterone therapy is associated with increase in cardiovascular risks, according to some studies, and leads to infertility. the use of clomiphene citrate in this sub population of obese man as an alternative treatment option is not well studied. the aim of this protocol is to evaluate the cardiovascular risks, metabolic and hormonal parameters in a double blinded randomized placebo trial.

hypogonadism (low testosterone level) in obese man is a clinical condition which treatment is controversial. most of this controversy remains regarding the association between cardiovascular risk elevation and testosterone replacement therapy in some studies. this protocol is a double blinded randomized placebo trial and 2 groups will be followed. the primary end-point of this research is the correlation between the serum testosterone and flow-mediated dilatation of the brachial artery (fmdab), circulating levels of sicam-1, svcam-1, e-selectin and progenitor endothelial cells. the secondary end-points include: (1) the evaluation of metabolic parameters: weight, abdominal circumference, glycaemia, total cholesterol, fractions and triglycerides, homeostasis model assessment index (homa) and bioelectrical impedance parameters; and (2) hormonal parameters: total testosterone levels, sex hormone-binding globulin (shbg), luteinizing hormone (lh) , follicle stimulating hormone (fsh) and estradiol.

Eligibility criteria:
inclusion criteria: * adam questionnaire positive for 3 or more questions * total serum testosterone lower than 300 ng/dl in two different occasions, within a 1-week minimum interval. this blood sample must be collected between 8 and 11 a.m. * low or inappropriate normal serum luteinizing hormone (lh) level * atp iii metabolic syndrome criteria * obesity - bmi over 30 kg/m2 exclusion criteria: * systemic illness, such rheumatoid arthritis, cushing disease, liver insufficiency or renal insufficiency. -use of certain medications (opiates, high-dose glucocorticoid therapy, methadone) * eating disorders * testicular volume below 4 ml * use of recreational drugs * excessive exercise practice * men in treatment for prostatic cancer * hyperprolactinaemia * hemochromatosis * history of headache * systolic blood pressure lower than 100 mmhg * previous adverse reactions to nitrate compounds * diabetes over 10 years of diagnosis

Keywords: flow-mediated dilatation clomiphene citrate sicam-1 svcam-1 se- selectin endothelial function cardiovascular risk endocrine system diseases selective estrogen receptor modulators estrogen receptor modulators infertility, male endothelial progenitor cells obesity testosterone
immunotherapy after surgery in treating patients with breast cancer, colon cancer, or melanoma

Conditions: Breast Cancer; Colorectal Cancer; Melanoma (Skin)

Summary: rationale: immunotherapy uses different ways to stimulate the immune system and stop cancer cells from growing. immunotherapy biological extracts may be useful as adjuvant therapy in treating patients who have had surgery for breast cancer, colon cancer, or melanoma. purpose: phase iii trial to study the effectiveness of corynebacterium granulosum extract as maintenance immunotherapy following surgery in treating patients with breast cancer, colon cancer, or melanoma.

objectives: * determine the survival of patients with colon cancer, breast cancer, or melanoma with minimal residual disease after surgical resection treated with maintenance immunotherapy using corynebacterium granulosum p40. * determine leucocyte adherence inhibition, an indication of metastases, over time in patients treated with this regimen. outline: this is a multicenter study. patients are stratified by center and are matched with case-controls by disease type and stage. beginning 2 weeks after surgical resection, patients receive corynebacterium granulosum p40 subcutaneously weekly for 6 weeks, followed by rest for 3 months. treatment continues for life. patients are followed for survival. projected accrual: not specified

Eligibility criteria:
disease characteristics: * diagnosis of colon cancer, breast cancer, or melanoma with minimal residual disease (at least 90% of tumor mass resected) after surgical resection * hormone receptor status: * not specified patient characteristics: age: * 20 to 80 sex: * not specified menopausal status: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * see disease characteristics

Keywords: stage i colon cancer stage ii colon cancer stage iii colon cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer recurrent breast cancer recurrent colon cancer stage i melanoma stage ii melanoma stage iii melanoma recurrent melanoma