Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of four escalating dose regimens of tpi asm8 in patients with allergic asthma

Conditions: Asthma

Summary: during this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of tpi asm8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.

the early and late asthmatic response were both significantly attenuated by the highest dose of asm8. the methacholine challenge and other parameters (ecp, mrna knockdown on ccr3 and b-chain of il-3-il-5 and gmcsf were attenuated by asm8.

Eligibility criteria:
inclusion criteria: * men and women 18 to 65 years of age * generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ats criteria * history of episodic wheeze and shortness of breath * forced expiratory volume in one second (fev1) at baseline ≥ 70% of the predicted value * able to comprehend and follow all required study procedures; willing and able to sign an informed consent form. exclusion criteria: * significant acute or chronic medical or psychiatric illness * known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks * use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).
a study to investigate the safety, tolerability, and pharmacokinetics of memp1972a in patients with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: this is a phase ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (pk) of memp1972a.


Eligibility criteria:
inclusion criteria: * diagnosis of allergic rhinitis * in good health, determined by no clinically significant findings from medical history, 12-lead ecg, and vital signs * males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug exclusion criteria: * history or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders * history of anaphylaxis, hypersensitivity or drug allergies * use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing * use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing * positive blood test for chronic viral infections by: hepatitis b surface antigen, hepatitis c virus antibody, or hiv antibody
evaluation of attitudes about fertility

Conditions: Breast Cancer

Summary: * assess the attitudes and feelings of premenopausal latin american women towards the risk of loss their fertility by adjuvant chemotherapy. * correlate the attitudes with other variables including age at diagnosis, already having children, number of children, level of instruction, marital status, frequency of menstrual cycle.

eligibility criteria: * latin american women with evidence of cancer diagnosis at premenopausal status * over 18 years * agree to sign the informed consent * no evidence of infertility.

Eligibility criteria:
inclusion criteria: * women with breast cancer diagnosis in premenopausal * over 18 years * signed informed consent exclusion criteria: * evidence of infertility at diagnosis

Keywords: fertility chemotherapy breast cancer latin american women pre menopausal
does obesity influence women cardiorespiratory fitness and daily physical activities? (activob)

Conditions: Obesity

Summary: many obese individuals experience difficulties in executing household activities. in this study, we investigate the cardiorespiratory fitness (crf) of obese vs. non-obese women, and the impact of obesity on cardiorespiratory functioning during daily household activities.

methods: on 48 sedentary female subjects will be assessed by cardiorespiratory exercise testing with evaluation of peak oxygen uptake (⩒o2), heart rate (hr) and maximal cycling power output. next, cardiorespiratory functioning will be assessed during household activities such as ironing (a1), cleaning floor (a2), walking and climbing stairs (a3).

Eligibility criteria:
inclusion criteria: * body mass index (bmi = weight in kilograms/(height in meters) x (height in meters)) as: healthy obese (ob group (ob); bmi between 30 to 39.9 kg.m-2; n = 20), and healthy non obese (no group (no); bmi between 18.5 to 24.9 kg.m-2; n = 28). exclusion criteria: * comorbidities (other than obesity) : 1. history of systemic hypertension or antihypertensive medication, diabetes mellitus, cardiovascular or respiratory disease, systemic disease, smoking; 2. any drugs; 3. bmi \>40 kg.m-2; 4. having a regular physical activity.

Keywords: obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women
a trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered nnc0148-0287 (insulin 287) in subjects with type 2 diabetes

Conditions: Diabetes; Type 2 Diabetes Mellitus

Summary: this trial is conducted in europe. the aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered nnc0148-0287 (insulin 287) in subjects with type 2 diabetes


Eligibility criteria:
inclusion criteria: * male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent * females of no childbearing potential \[if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by fsh (follicle-stimulating hormone) levels above 40 u/l\] * body mass index (bmi) between 20.0 and 35.0 kg/m\^2 (both inclusive) * type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months exclusion criteria: * known or suspected hypersensitivity to trial products or related products * receipt of any investigational medicinal products within 3 months before screening * use of oral antidiabetic drugs (oads) or glucagon-like peptide-1 (glp-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening
effectiveness and safety of biphasic insulin aspart 70/30 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. this is a clinical trial investigating the effectiveness of using biphasic insulin aspart 70/30 in two different treatment regiments for 6 months in subjects with type 2 diabetes, not well controlled on their current oral anti-diabetic drug therapy.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c = 7.5% * insulin naïve * current treatment by oral anti-diabetic drugs exclusion criteria: * severe medical conditions
effect of vitamin d supplementation on hemoglobin a1c in patients with uncontrolled type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine if daily supplementation with 2000 international units of vitamin d will improve hemoglobin a1c in uncontrolled type 2 diabetics.

vitamin d is typically understood to support musculoskeletal health when administered concomitantly with calcium. a number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. with the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin a1c are being sought to help prevent the costly and debilitating complications of this chronic disease.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * hemoglobin a1c \>7% measured in the 3 months prior to randomization * age 21 to 75 years exclusion criteria: * renal insufficiency (defined as crcl \<30ml/min) * gestational diabetes * malabsorption syndrome * patients taking vitamin d supplements at doses \>400 international units daily
support group program in improving quality of life in underserved urban latina breast cancer survivors

Conditions: Breast Carcinoma; Cancer Survivor

Summary: this randomized clinical trial studies a support group program in improving quality of life in underserved urban latina breast cancer survivors. a psychosocial support group program may help reduce distress and improve health-related quality of life in underserved urban latina breast cancer survivors.

primary objectives: i. evaluate the effect of the support program for latina breast cancer survivors using validated measures of health-related quality of life. ii. evaluate the effect of the support program for latina breast cancer survivors using validated measures of general distress. secondary objectives: i. a brief qualitative assessment will evaluate the perception of the program among intervention participants using a brief survey. outline: participants are randomized to 1 of 2 arms. arm i: participants attend support group sessions over 1-1.5 hours once weekly for 10 weeks. the sessions include facilitated discussions among participants about the following topics: stress management and emotional coping strategies, nutrition and physical activity, sexuality and body image, medical advocacy, self-care and social support. participants receive a binder in which the rationale for each topic, techniques learned, and activities completed during each session will be summarized and are shown a chair-robics digital video disc (dvd). arm ii: participants receive one phone call to arrange a follow-up with the promotora, a note acknowledging their participation in the study, and a community resource booklet. participants are then yoked into one of the 3 intervention groups and asked to attend a 30 minute session similar to arm i.

Eligibility criteria:
inclusion criteria: * latino * spanish-speaking * diagnosed with breast cancer * a current resident of either king, snohomish or pierce counties in washington state with the intent of remaining a resident for at least 3 months following study enrollment * additionally, at time of enrollment, participants must be post-treatment (with the exception of adjuvant therapy) for their primary cancer and not actively undergoing treatment for a secondary, metastatic, or recurrence of cancer (local or distant) * there will be no restrictions on time since diagnosis for participants
health communication in families

Conditions: Lung Cancer; Melanoma; Skin Cancer

Summary: there are two goals of this research study. first, we hope to develop a plan to guide family discussions that can help parents diagnosed with lung cancer talk about cancer risk with their adult children. second, we want to understand how families talk about cancer prevention.

in large part due to the advent of genetic testing, families have recently become a more central focus in cancer prevention. given the high concordance of health behaviors within families (kristeller et al., 1996), there is interest in developing family-wide behavior change interventions to reduce cancer risk. a cancer diagnosis represents a "teachable moment," in which a diagnosis may prompt health behavior change. although this phenomenon has been observed among cancer survivors, it has not been examined among a patient's family members. several critical questions exist about how families understand and communicate with regard to cancer risk information and what family processes facilitate or impede health behavior change. there is very little existent research in the area of cancer prevention among family members of cancer patients. results in this area could help us develop interventions for family members who are motivated to make health behavior changes, and to inform and guide others who may not be motivated at the time their family member is diagnosed. most importantly, the results could also help us intervene with family members of those who have been diagnosed with cancers where genetic and lifestyle components are important in the etiology of the illness, such as lung cancer and melanoma, and thus first-degree family members would benefit from strong messages to adopt healthy lifestyles. the research will rely on qualitative data collection and analysis. we will conduct qualitative interviews with 20 pairs of melanoma patients and one adult son or daughter, and 20 pairs of lung cancer patients and one adult child/sibling/or spouse. more specifically, for each pair of participants (i.e., the patient and his/her family member) we will conduct three interviews: an individual interview with the patient, an individual interview with the family member, and a joint interview where we will talk to the patient and family member at the same time. we will analyze interview data with a qualitative data computer analysis program, and identify themes and conclusions representing the core ideas in our data.

Eligibility criteria:
inclusion criteria: * lung cancer patients must have a history of smoking. * family members of lung cancer patients must be active smokers in order to participate in the study. * all participants must be more than 18 years of age and be fluent in english. * patients must have received a diagnosis of either lung cancer or melanoma within the past 3 to 18 months.

Keywords: lung skin melanoma
cardiopulmonary fitness, lung function, muscular oxygen saturation, and quality of life in t1dm

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to compare the differences of 1. cardiopulmonary fitness 2. lung function 3. muscular oxygen saturation 4. quality of life between type 1 diabetes mellitus and healthy adults.

this study is also to investigate the relationships between cardiopulmonary fitness, lung function, muscular oxygen saturation, glycemic control, and quality of life in patients with type 1 diabetes mellitus.

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes mellitus ≥2 years (diabetic group) * age-, gender-, and bmi-matched healthy subjects (control group) exclusion criteria: * cardiac or respiratory disease * pregnancy * hospitalization due to any medical condition in recent 6 months * any other condition affecting exercise performance or lung function.

Keywords: diabetes mellitus cardiopulmonary fitness lung function muscular oxygenation
faslodex post marketing surveillance

Conditions: Breast Cancer

Summary: this pms aims to assess the efficacy, the safety and tolerability profile of faslodex in everyday practice. secondary objective of this pms is to identify the frequency of serious adverse events or any unknown adverse events of faslodex.


Eligibility criteria:
inclusion criteria: * postmenopausal women * patients who have failed 2 or more prior hormone therapies (the prior hormone therapies should contain both antiestrogen and non-steroidal aromatase inhibitor) * patients who were intolerant to prior hormone therapy and have no endocrine therapeutic options (the prior hormone therapies should contain both antiestrogen and non-steroidal aromatase inhibitor) exclusion criteria: * the patients who received faslodex treatment before

Keywords: efficacy profile safety profile faslodex
comparison of pharmacokinetic, safety, tolerability of alpha-1 mp and prolastin in alpha1-antitrypsin deficient adults

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the purpose of this clinical study (champ - comparability pharmacokinetics of alpha-1 modified process) is to compare the pharmacokinetic, safety and tolerability of alpha-1 proteinase inhibitor (human), modified process (alpha-1 mp) and prolastin in adult alpha1-antitrypsin deficient patients. patients will be infused intravenously with study drug on a weekly schedule for 24 weeks.

the objective of this study is to demonstrate the pharmacokinetic comparability of alpha-1 mp to prolastin® in subjects with alpha1-antitrypsin deficiency. this study is divided into three 8-week treatment sequences including an initial 8-week double-blind treatment period (with one of the 2 study drugs), a second 8-week double-blind treatment period (with the other study drug), and a third 8-week open-label treatment period (with alpha-1 mp).

Eligibility criteria:
inclusion criteria: * documented diagnosis of congenital alpha1-antitrypsin deficiency * must be receiving augmentation therapy with plasma-derived (human) alpha1-proteinase inhibitor (prolastin®) for at least one month prior to study entry. * signed written informed consent prior to initiation of any study related procedures exclusion criteria: * females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study * use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis). * subjects who have had exacerbations of their disease within one month of trial entry.

Keywords: alpha 1-antitrypsin deficiency alpha 1-antitrypsin pulmonary emphysema
the prevalence of metabolic syndrome in patients suffering from chronic pain

Conditions: Pain and Metabolic Syndrome

Summary: obesity is considered as the epidemic of the century. central obesity is one of the metabolic syndrome's features. it has been proven that obesity can cause back pain and headaches; thus, there might be a link between chronic pain and the syndrome. the objective of this study is to assess the prevalence of metabolic syndrome in patients suffering from chronic pain.

all patients will answer a questionnaire, their hip circumference will be measured, and their bmi will be calculated (weight/(height)2 ). the patients' blood pressure will be measured. the patients will be asked to bring their blood tests (lipids and glucose).

Eligibility criteria:
inclusion criteria: * patients over 18 that suffer from chronic pain and are being treated at the pain medicine unit exclusion criteria: * pregnant women, patients with abdominal wall defects

Keywords: chronic pain and metabolic syndrome
study of t-pred(tm) compared to pred forte(r) ii

Conditions: Cataract

Summary: study of t-pred(tm) compared to pred forte(r)

this study was a multi-center, randomized, double-masked, bioequivalence study. a total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with t-pred or pred forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point. the investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either t-pred or pred forte. the second eye received the other study treatment (rp if the first eye received t-pred; t-pred if the first eye received pred forte) at the time of the second cataract extraction.

Eligibility criteria:
inclusion criteria: * 18 years of age or older exclusion criteria: * no active or adverse disease
computer-assisted rehabilitation environment training after argus retinal prosthesis

Conditions: Retinitis Pigmentosa

Summary: the goal of the current project is to fill the unmet clinical needs around the objective assessment of visual function and develop outcome-oriented visual rehabilitation approach using the computer assisted rehabilitation environment (caren) system for argus recipients.


Eligibility criteria:
inclusion criteria: * recipient of the argus ii retinal prosthesis system * ability to provide informed consent * ability to follow two-step commands * ability to ambulate 300+ feet with or without visual assistance * able to tolerate argus device turned on for \>20 continuous minutes. exclusion criteria: * dementia * musculoskeletal contraindication to exercise or walking * cardiopulmonary contraindication exercise (i.e. uncontrolled heart failure, cardiac arrhythmia, or pulmonary disease).

Keywords: argus ii retinal prosthesis system rehabilitation
cochlear implant and vestibular function.

Conditions: Sensorineural Hearing Loss; Deafness; Hearing Loss

Summary: this study investigate weather one type of cochlear implant (ci) surgery (insertion of the electrode via paracentesis of the round window (rwa)) leads to less vertigo than another type of ci surgery (cochleostomy). the participants will be randomized into 2 groups: rwa or cochleostomy. they will be examined with a video head impulse test (vhit) before and after ci surgery to clarify their vestibular function.

cochlear implant is an advanced type of hearing advice. it consists of an outer microphone, which picks up sound and sends it through an electrode into the cochlear. with a cochlear implant people, that are profoundly deaf or have severe hearing loss, can get their hearing back. vertigo is one of the most common side effects to cochlear implant surgery. in this study we will investigate if one type of ci surgery (insertion of the electrode via paracentesis of the round window) leads to less vertigo than another type of ci surgery (cochleostomy). in the randomization there will be stratified according to age (60+/-), residual hearing (yes/no) and gain before surgery (+/-0,68). three different surgeons will do the surgeries. all technical aspect of the surgery, other than the insertion of the electrode into cochlea, is being done identically. electrodes from cochlear, medel and ab is being used. we will compare the findings from the vhit examination with the subject dizziness perceived of the patient. the patients will be examined before surgery, the day after their surgery and one month after their surgery. the same examinator will perform all the vhit tests. the test will be performed in continuation of the patient's other visits at the department of audiology and department of otorhinolaryngology -head and neck surgery.

Eligibility criteria:
inclusion criteria: * deaf or severe hard of hearing * normal or slightly affected vestibular function (gain \>0,50) exclusion criteria: * subjects with otosclerosis * subject who will have the ci surgery for preservation of the residual hearing

Keywords: hearing loss cochlear implant