Kornimate/medical-research-clean huggingface dataset:
epoetin beta in patients undergoing chemotherapy for solid tumors

Conditions: Anemia; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors. purpose: this clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

objectives: primary * identify factors predictive of treatment failure in patients with solid tumors treated with epoetin beta while undergoing chemotherapy. secondary * evaluate the impact of achieving target hemoglobin levels (i.e., hemoglobin \> 11 g/dl) after 8 weeks of treatment with epoetin beta. * evaluate changes in hemoglobin levels from baseline to after 8 weeks of treatment with epoetin beta. * evaluate the tolerability of epoetin beta in these patients. * evaluate the quality of life of these patients. outline: this is a multicenter study. patients receive epoetin beta subcutaneously once a week for ≥ 8 weeks in the absence of disease progression or unacceptable toxicity. patients complete a quality-of-life questionnaire (fact-an) at baseline and after 8 weeks of treatment.

Eligibility criteria:
inclusion criteria : * age \> 18 years * hemoglobin levels between \[ \> 9g/dl - \< 11 g/dl \] . * patient requiring erythropoietine beta treatment for a foreseeable duration of at least 8 weeks under the same chemotherapy protocol. * patient with cancer undergoing chemotherapy * patient without epo within 6 months prior to current chemotherapy. * who 2 performance status (appendix 1). * patient information and signature of informed consent or legal representative exclusion criteria : * hemoglobin \ 11 g/dl * patient with cancer not treated with chemotherapy (targeted therapy, hormone therapy, etc...) * patient with cancer treated with concomitant radiation chemotherapy. * co-treated with epo beta and scheduled transfusion prior to inclusion. * hypersensitivity to the active substance or one of the neorecormon excipients® * poorly controlled high blood pressure * pregnant woman, likely to be pregnant or breastfeeding, * persons deprived of liberty or under guardianship, * unable to undergo medical follow-up for geographic, social or psychological reasons.

Keywords: anemia unspecified adult solid tumor, protocol specific
hybrid closed loop system for patients on multiple daily insulin injections

Conditions: Type 1 Diabetes

Summary: the objective of this study is to assess structured group education onboarding protocol of the 670 g hybrid closed loop (hcl) systems in achieving glucose control of patients on multiple daily insulin injections (mdi).

goal the objective of this study is to assess structured group education onboarding protocol of the 670 g hybrid closed loop systems in achieving glucose control of patients on mdi. methods this study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on hcl insulin pump (minimed 670g) in a period of 3 months. a total of 40 subjects (age 18-65) will be enrolled in order to reach 34 subjects who will complete the hcl study. the investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. hba1c, derived from continuous glucose monitoring (cgm) will be performed at baseline and at the end of the 3-month study period. the following parameters will be analyzed" % patients achieving glucose readings time in range (tir) \> 67% in (70-180 mg/dl); % patients achieving \ 67% and \<3% time below range.collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via hospital electronic medical file (cerner millennium) and will be kept as electronic data on a separate research server.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes. diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not required. 2. hba1c \< 12.5% 3. age18-65 years at the initiation of the 670g system 4. multiple daily injections (basal bolus therapy) with total daily insulin use of great than 8.0 units per day over a 1 week period 5. willing and able (access to internet from home) to download information into the medtronic carelink software 6. clinically planning to and be able to start the medtronic 670g hcl system 7. history of 3 clinic visits in the last year 8. with history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist. exclusion criteria: 1. diabetic ketoacidosis in the 6 months prior to screening visit 2. type 2 diabetes 3. hyperthyroidism at time of screening 4. using pramlintide, dipeptidyl peptidase 4 (dpp-4) inhibitor, glucagon-like peptide-1 (glp-1) agonists, metformin, sodium-glucose transport protein 2 (sglt2) inhibitors at time of screening. 5. has taken any oral, injectable, or intravenous (iv) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or iv steroids during the course of the study.

Keywords: time in range hybrid closed loop system multiple daily insulin injection
opting in vs opting out

Conditions: Influenza Vaccination

Summary: the purpose of this study is to compare methods for consenting (opting in vs opting out) on influenza vaccine uptake rate in pregnant women. this study is designed to learn about the impact of influenza vaccination in pregnant women. this study will help gather knowledge about influenza vaccine side effects (if given) and whether the vaccine reduces the number of respiratory infection in mothers and their infants.

pregnant women who present for routine prenatal care when influenza vaccine is available would be eligible. enrolled women would be randomized to either the opting in (obtaining written consent to administer the vaccine) or opting out (signing only to refuse the vaccine) study group (part 1). vaccine uptake rate and reason for refusal will be captured for enrollees. at the end of this clinic visit, enrollees will be asked if they are interested in participating in part 2 and 3 of the study. if yes, consent will be obtained. part 2 of the study, a random sample of 50 women will be called 2 days after enrollment to determine 1) vaccine side effects 2) recall of information provided in consent and 3) to confirm next followup visit with obstetrician. during part 3, at 6 weeks post edd (estimated due date), data about episodes of respiratory illness in the mothers and their infants occuring between the time when influenza vaccine was offered (part 1) and 6 weeks post-edd will be abstracted using a standard form. data will be collected retrospectively by research nurses.

Eligibility criteria:
inclusion criteria: * pregnant female age \>17 years * presenting for routine pnc at ut houston or ut galveston * pregnant during influenza season * pregnant when influenza vaccine available exclusion criteria: * influenza vaccine contraindication

Keywords: influenza vaccination rates
an enhanced medication monitoring program

Conditions: Medication Adherence; Hypertension

Summary: the goal of the enhanced medication management program (emmp) being developed by medminder systems, inc. is to increase the ability of frail elders to adhere to complex medication regimens for chronic conditions. adherence will facilitate effective self-care and decrease personal and societal costs associated with disease progression and loss of independence. multiple studies have shown that more frequent personal follow-up is the most effective way to maximize medication adherence, but such personal care is too costly to translate well to real life in a world of limited healthcare resources. currently available "smart pillboxes" are too expensive, too limited in the number and types of medications delivered, and too technically complex for the large majority of senior citizens. the emmp is designed to deliver prompts and reminders to the user, to be remotely programmable by caregivers, to allow the option of using pre-filled medication trays, to provide electronic adherence reports to family/caregivers and to provide personalized reinforcing phone calls from professional caregivers, all at a modest cost. the in-home reminder will use a familiar pillbox layout (4 doses/day for 7 days) and allow easy removal of medication cups by elderly, rheumatic fingers. installation will require only an electrical outlet (no modems or dedicated phone lines). once plugged in, the built-in pager will continuously download remotely programmed visual and/or aural prompts and reminders from a central server (remotemind). it will continuously upload the date and time when each medi-cation cup is removed and when weekly refill is carried out, enabling remote adherence monitoring, alerts to caregivers, and follow-up intervention(s) from personal and/or professional caregivers as needed. the hypothesis to be tested in this 2 year sbir phase i work plan is that the emmp will significantly im-prove adherence and clinical outcome (blood pressure control) in a population of frail elderly who are hyper-tensive. sbir phase ii will determine the minimum level of intervention needed to achieve sustained medication adherence and control of blood pressure in a larger group of hypertensive elders.


Eligibility criteria:
inclusion criteria: * persons aged 55 years and older who are coming in for routine outpatient visits * speaks and reads english * history of high blood pressure * systolic blood pressure ≥ 130 mm hg * using antihypertensive medication * using 2 or more prescription medications * plans to stay in area for the 9 months of study exclusion criteria: * receives personal help or reminders to take medication * has moderate to severe dementia (mmse score\<18) * has severe hearing or vision deficiency
full-mouth electronic toothbrush vs. conventional electronic toothbrush

Conditions: Toothbrush; Gingivitis; Plaque

Summary: the goal of this randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (fmet). the three arms are: 1) fmet + american dental association (ada) approved dentifrice, 2) conventional electronic toothbrush (etb) + ada dentifrice and 3) fmet + foam system.

the primary purpose is to compare the fmet + ada dentifrice to the conventional etb + ada dentifrice. the exploratory aim is to compare the fmet + foam system to both the fmet + ada dentifrice and conventional etb + ada dentifrice. baseline and 30-day outcome measures will be collected to evaluate the impact on clinical indicators of gingivitis, plaque, and patient perceptions.

Eligibility criteria:
inclusion criteria: * university of minnesota school of dentistry patient of record who is 18 years of age or older. * documented periodontal classification of mild to moderate gingivitis (\>10% bop) or documented gingivitis on an intact, reduce, or stable with a history of periodontitis in axium electronic health record (ehr) \>10% bop. * a minimum of 25% plaque measured o'leary plaque score. * a minimum of five natural teeth in each quadrant (excluding third molars, dental implants or teeth with more that ½ of natural surface restored). * be willing to abstain from all professional oral hygiene care (prophy/periodontal maintenance) during the study. * be willing to abstain from the use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.) during the study. * access to personal email account and a device connected to the internet to complete questionnaires and communicate with study team. exclusion criteria: * presence of aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition. * presence of any physical limitation or restriction that might preclude normal oral hygiene procedures (i.e. need another individual to perform oral self-care). * fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment. * any medication that may impact periodontal conditions (i.e., phenytoin, calcium antagonists, cyclosporin, warfarin, antimicrobials, or steroids). * have any uncontrolled medical condition or immunocompromised that may impact the study (i.e. uncontrolled diabetes hba1c \> 7, hiv). * pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported) * ≥2 weeks of antibiotic use in the past three months. or antibiotic use in the last six weeks. * cigarette use within the last year * unable to comply with the study protocol
dry needling for spasticity in stroke

Conditions: Stroke

Summary: stroke is the leading cause of physical disability due to the presence of spasticity. different needling techniques, including botulinum toxin a are proposed for management of spasticity; however results are conflicting. the presence of spasticity in the upper extremity implies several impairments for daily life activities. no study has investigated the effects of deep dry needling inserted into the targeted spastic musculature of the shoulder region in patients who had suffered a stroke. the investigators will conduct a randomized controlled trial investigating the effects of the inclusion of deep dry needling into a rehabilitation program over the musculature of the shoulder region, pressure pain hyperalgesia and range of motion in individuals with chronic stroke. the investigators hypothesize that patients receiving dry needling into the spastic shoulder musculature would exhibit greater improvements in spasticity, pressure sensitivity and range of motion than those who will not receive the intervention.


Eligibility criteria:
inclusion criteria: * first-ever unilateral stroke; * hemiplegia resulting from stroke; * age between 40 and 65 years old; * presence of hypertonicity in the upper extremity; * restricted range of motion of the shoulder exclusion criteria: * recurrent stroke; * previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time; * previous treatment with btx-a in the 6 months prior the study; * severe cognitive deficits; 5, progressive or severe neurologic diseases, e.g., heart conditions, unstable hypertension, fracture or implants in the lower extremity; * fear to needles; * any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.

Keywords: dry needling spasticity pain
simple breath test to examine phenylalanine metabolism

Conditions: Phenylketonuria (PKU)

Summary: phenylketonuria(pku)is a rare condition caused by the body's inability to properly breakdown an amino acid called phenylalanine(phe), due to a missing enzyme, phenylalanine hydroxylase(pah). when the enzyme is missing and/or not functioning properly, it increases the level of phe in the body. high levels of phe can cause severe brain damage or nerve damage unless the children are on a strict low phe diet. a low phe diet restricts the intake of protein rich foods and can pose a significant burden to both the patient and the family. investigators at the university of british columbia and british columbia children's hospital will examine the phenylalanine metabolism in children with pku using a simple breath test. patients (5-18y) receiving standard clinical care at the bc children's hospital's biochemical diseases clinic will be enrolled.the study will be conducted twice on each patient. baseline measurements will be performed at the beginning of each study for each patient.the physician in charge will then prescribe the standard dose of sapropterin dihydrochloride (kuvan®) (20mg/kg/d) or otherwise as deemed appropriate by the physician-in-charge. the test will be repeated a week (minimum) after the beginning of treatment with the prescribed dose. the investigators propose that children who are responsive to sapropterin dihydrochloride (kuvan®) will have increased 13co2 in breath after treatment, and those who do not respond will have no change in the 13co2 in the breath before and after treatment. as a comparison to the experimental group, age and gender matched healthy controls will also be studied. the test in healthy controls will be performed once without any intervention, and is only used as a comparative value.


Eligibility criteria:
inclusion criteria: study subjects: 1. children (4-18y)diagnosed with pku 2. parent(s) or guardian(s) willing and able to provide informed signed consent. 3. parent(s) or guardian(s) willing and able to comply with all study procedures healthy controls: 1. healthy children (4-18y) with no health condition 2. willing to go through an initial screening for age and gender match 3. parents or guardians willing and able to provide informed signed consent. 4. parents or guardians willing and able to comply with study procedures exclusion criteria: study subjects: 1. children \< 4y of age diagnosed with pku, as it may be challenging to collect breath samples and perform indirect calorimeter in very young children 2. children (4-18y)who are diagnosed with pku, but are currently ill, with a fever, cold, vomiting or diarrhea healthy controls: 1. healthy children \< 4y of age , as it may be challenging to collect breath samples and perform indirect calorimeter in very young children. 2. healthy children (4-18y), but are currently ill, with a fever, cold, vomiting or diarrhea.

Keywords: pku phenylketonuria phenylalanine children stable isotopes sapropterin dihydrochloride responsiveness
clinical investigation to evaluate the safety and performance of connettivinabio plus cream compared to connettivinabio cream in the management of wounds in patients at high risk of infection

Conditions: Wounds

Summary: the clinical investigation plan will include a screening/baseline visit (v1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. screened and eligible patients will be randomly assigned in one of the two groups: group 1 will receive connettivinabio plus cream whereas group 2 will receive connettivinabio cream. lesions will be cleaned and a photo will be acquired with a digital camera. in both groups, the schedule treatment will consist of daily medication changes. wound bed score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the levine's technique, eq-5d questionnaire to the patient will be assessed on day 1 (v1, baseline visit), 7 (v2), 14 (v3), 21 (v4) and 28 (v5) post-baseline. treatments in both groups (connettivinabio plus or connettivinabio) will be applied for a maximum period of 28 days. the easiness of treatment application will be also recorded at v5.


Eligibility criteria:
inclusion criteria: * signed written informed consent. * male or female ≥ 18 years * having wounds (both chronic or acute wounds regardless of etiology), with the following characteristics: * non infected * wound bed score ≥4 and \<13 * wound area ≤ 100 cm2 * patient having one or more factors associated with increased risk of wound infection (iwii, 2016) * patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing, able and ensuring to comply with the study requirements for the whole study period. exclusion criteria: * absence of factors associated with increased risk of wound infection * infected wounds - where infection is defined by: for chronic wounds: a combination of three or more signs or symptoms of local infection: periwound skin erythema, local heat, persistent pain, oedema of wound.s edge, malodour, pus and heavy exudation (cutting kf, 1994; trial c, 2010); for acute wounds: cellulitis or pus or abscess, delayed healing, erythema, hardening of edge, serous-purulent drainage, malodour * non-vital tissue greater than 25% of the total wound area * heavily exuding wounds * presence of fistula * history of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, sjögren's syndrome or mixed connective tissue disease * active malignant disease * active sickle cell disease * radiation therapy * known allergy to any of the devices' constituents * pregnant and breastfeeding women * subjects unable to understand informed consent or having a high probability of non- compliance with the study procedures and or non-completion of the study according to investigator's judgement.
the impact of a redesigned handout for robotic sacrocolpopexy on patient preoperative preparedness and satisfaction

Conditions: Pelvic Organ Prolapse; Patient Satisfaction

Summary: the goal of this clinical trial is to learn if a new preoperative handout for patients undergoing robotic sacrocolpopexy will improve patient sense of preparedness and satisfaction in comparison to the previously used handout. the main questions it aims to answer are: * does the new preoperative handout for patients undergoing robotic sacrocolpopexy improve patient preparedness and satisfaction? * will the new preoperative handout for patients undergoing robotic sacrocolpopexy impact postoperative queries in the form of phone calls and messages to the clinic? participants will: * receive routine counseling regarding robotic sacrocolpopexy from their surgeon * be randomized to the new or old preoperative handout * undergo robotic sacrocolpopexy * complete a questionnaire at their 4 week postoperative follow up visit regarding their sense of preparedness for surgery and overall satisfaction


Eligibility criteria:
inclusion criteria: * women who were to undergo robotic sacrocolpopexy with or without supracervical hysterectomy, rectopexy, salpingectomy, urinary incontinence procedures, or other minor procedures. exclusion criteria: * patients unable to provide informed consent, those undergoing other concomitant major abdominal surgeries, patients less than 18 years old, pregnant patients, non-english speaking patients, and patients planning postoperative follow up at an outside facility.

Keywords: robotic sacrocolpopexy handout study
efficacy of a web-based weight loss program

Conditions: Overweight; Obese

Summary: since overweight and obesity, a risk factor for various diseases, is a prevalent problem in the modern society, it is important to search for new strategies to counteract this. in contrast to in person support, the internet provides a low cost opportunity, which is able to reach a large part of the population. therefore a web-based weight loss program may be an adequate mean for many people. now it is hypothesised that a web-based weight loss program is able to support a reduction of body weight and weight-related cardiovascular risk factors effectively and to promote a healthier lifestyle. it is expected that program use, compared to a control group, results in greater reductions in body weight and cardiovascular risk.


Eligibility criteria:
inclusion criteria: * age 30-65 years * body mass index: 27-39,9 kg/m2 * ecog-performance status degree 0 or 1 * basal internet skills * private internet access * signed informed consent exclusion criteria: * malign diseases * major organ diseases * inflammatory bowel diseases * insulin - dependent diabetes mellitus * pregnancy, breast feeding * treatment of eating disorders (e.g. bulimia, anorexia nervosa) within past 5 years * parallel participation in other weight loss programs or other trials * weight loss \> 5% within past 6 month * chronic therapy with glucocorticoids * subjects treated because of psychiatric disorders (e.g. schizophrenia, bipolar disorder) in the past * subjects with expected non-compliance to protocol guidelines

Keywords: weight reduction web-based intervention cost-effective overweight obesity cardiovascular risk