Kornimate/medical-research-clean huggingface dataset:
calf circumference adjusted for body composition to assess muscle mass

Conditions: Muscle Mass; Obesity and Overweight

Summary: muscle mass is a critical indicator for malnutrition and sarcopenia assessment. anthropometric measurements like calf circumference (cc) could be a simple and cost-effective alternative when gold standard methods are not available. however, cc is probably less accurate for estimating muscle mass in female patients and patients with obesity. this study investigates whether adjusting cc using mid-upper arm circumference (muac) improves muscle mass estimation in patients with obesity. if validated, this correction method would serve as a simple clinical tool for muscle mass assessment.

the patient's demographic data including age, sex, primary diagnosis, and diagnoses of co-morbidities are found by the investigator in the medical history (ehl). the researcher codes the current main diagnosis and its severity: we use the world health organization's icd-11 classification (icd.who.int/browse11/l-m/en) and a three-point scale where 1 is mild and 3 is severe. the patient will be interviewed for changes in body weight and food intake. anthropometric measurements will be recorded, including height, weight, body mass index (bmi), mid upper arm circumference, calf circumference, and waist circumference. the accurate muscle mass measurement will be done using total body densitometry (dexa) scan, that was already ordered for other purposes. bone mineral density (bmd) from dexa scan will be recorded. this allows us to see if calf circumference can be used for estimating bone mineral density. patients will be followed up one year after data collection. follow up will involve calling the patients and asking them questions from the sarqol (sarcopenia quality of life questionnaire) calf circumference will be measured using non-elastic tape at the widest part of the dominant calf in the seated position with the weight evenly distributed on both feet (1). mid upper arm circumference will be measured at the midpoint between the acromial surface of the scapula and the olecranon process of the elbow over the dominant arm when bent at 90 degrees. waist circumference will be measured using measuring tape 2.5 cm above the umbilicus in a standing position. waist circumference is used to define obesity as it is a marker of abdominal obesity (2). we aim to keep the interview no longer than 10 minutes. demographic and anthropometric data will be analyzed using descriptive statistics. the sensitivity, specificity of muscle mass measurements will be calculated. corrected calf circumference will be compared to dexa (gold standard diagnostic tool) and new cutoffs will be defined by using receiver operating characteristic curves. statistical analyses will be performed using r.

Eligibility criteria:
inclusion criteria: booked to undergo bone density scanning (dexa) at tartu university hospital exclusion criteria: isolation for infectious disease pregnancy and lactation unable to understand or follow study protocol
study to evaluate the safety, tolerability, and pharmacokinetics of mk-3281 in healthy and hepatitis c infected male participants (mk-3281-002)

Conditions: Hepatitis C

Summary: this study will examine the safety, tolerability and plasma pharmacokinetics of multiple doses of mk-3281 in healthy male participants in part i, and in hepatitis c virus (hcv)-infected male participants in part ii. the clinical efficacy of mk-3281, as measured by viral load reduction, will also be assessed in part ii. the primary hypothesis is that twice daily administration of mk-3281 for 10 days in healthy adult male participants and for 7 days in hcv-infected male participants is sufficiently safe and well tolerated, based on assessment of clinical and laboratory adverse experiences, to permit continued clinical investigation. the results of this study will guide dose selection for future studies in both healthy participants and hcv-infected participants.


Eligibility criteria:
inclusion criteria: * participant is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug * participant has no clinically significant abnormality on electrocardiogram (ecg) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug * participants with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug * participant has a clinical diagnosis of chronic hcv infection (for part ii only). exclusion criteria: * participant has a history of stroke, chronic seizures, or major neurological disorder * participant has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases * participant has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment * participant has positive hepatitis b surface antigen (or other evidence of active hepatitis b infection) at the prescreening (study) visit * for healthy panel (part i), participant has evidence of chronic hepatitis c virus infection at the prescreening (study) visit * participant has a history of documented human immunodeficiency virus (hiv) infection
resveratrol in patients with non-alcoholic fatty liver disease

Conditions: Fatty Liver

Summary: non-alcoholic fatty liver disease (nafld) and fatty liver hepatitis (nash) are very common in the western world and strongly associated with obesity. no known effective treatment is known. from animal studies, it is known that the compound resveratrol perhaps has the potential to neutralize obesity-induced diseases. resveratrol is already widely used as a food supplement though the precise effects are unknown. this project focuses on the effect of resveratrol on fatty liver disease. the researchers plan to investigate the effects of resveratrol or placebo treatment for 6 months on nafld/nash in obese patients.

obesity is associated with non-alcoholic fatty liver disease (nafld) and steatohepatitis (nash) and recently, low-grade inflammation has been hypothesized to be the causative link. from animal studies, it is known that the compound resveratrol (res) has strong anti-inflammatory and antioxidant effects and perhaps the potential to neutralize obesity-induced diseases. res is already widely used as a food supplement though the precise effects are unknown. this project focuses on the effect of res on fatty liver disease. in a double-blind controlled clinical trial, the researchers investigate the effects of res 500 mg or placebo treatment x 3 daily for 6 months on nafld/nash in 48 obese patients in a double-blind, randomised, controlled clinical trial. the researchers hypothesize that res improves the alt levels and reduces liver fat and inflammation assessed by mr spectroscopy and histological evaluation.

Eligibility criteria:
inclusion criteria: * alt ≥70 u/l for men and ≥45 u/l for women * steatosis of the liver, assessed by ultrasonography * one of the following: * waist circumference ≥102 cm for men and ≥88 for women * hypertension: bp ≥130/80 mmhg * raised triglycerides ≥1,7 mmol/l * reduced hdl cholesterol ≤1.0 mmol/l * bmi ≥ 25 kg/m² exclusion criteria: * weight \> 130 kg * comorbidity such as diabetes, cancer, metabolic or coagulation disorder, or significant liver-, heart- or kidney disease * mri contraindication * treatment with glucocorticoids or methotrexate * alcohol intake \>20g/daily for men and \>12 for women

Keywords: non-alcoholic fatty liver disease non-alcoholic steatohepatitis resveratrol human study
a study of ly3454738 in adults with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: the reason for this study is to see if the study drug ly3454738 is safe and effective as treatment for participants with hives that are caused by chronic spontaneous urticaria (csu) and that are not controlled with h1-antihistamines.


Eligibility criteria:
inclusion criteria: * must agree to use appropriate birth control throughout the study * must have a diagnosis of csu for at least 6 months * must have csu symptoms for at least 8 consecutive weeks despite taking anti-histamines * must agree to take an anti-histamine every day during the trial * must be willing to enter information about symptoms in an electronic diary twice a day exclusion criteria: * must not have a cause, other than csu, for itching, hives, and/or angioedema (swelling beneath the skin) * must not have a current or recent active infection requiring antibiotics * must not have a history of anaphylaxis (severe, life threatening allergic reaction) * must not have asthma requiring medications other than short acting beta agonists (albuterol, etc.) * must not have received prior treatment with omalizumab, ligelizumab, or other experimental biologic for csu
a study of the breast-q react tool for people having breast surgery

Conditions: Breast Conserving Surgery; Mastectomy With Reconstruction

Summary: the researchers are doing this study to find out whether it is practical (feasible) to conduct a larger study looking at the effects of the breast-q real-time engagement and communication tool (react) on people's quality of life, interactions with their doctors, and medical interventions after undergoing routine breast conserving surgery or mastectomy. the breast-q react tool shows scores from standard questionnaires completed before and after breast surgery about overall physical wellbeing, arm pain or tightness, the ability to move the arms and perform everyday tasks, and any symptoms related to the arms, and provides feedback including recommendations and detailed information that help explain these scores and guide topics for people and their doctor to discuss.


Eligibility criteria:
inclusion criteria: * scheduled to undergo bcs or mastectomy followed by breast reconstruction with tissue expander, autologous tissues, or direct-to-implant, regardless of neoadjuvant chemotherapy or radiation history * female sex * able to speak and understand english * ≥18 years of age * able to access the patient portal online exclusion criteria: * patient is male * younger than 18 years of age * cannot communicate in english * recurrent breast cancer * patients without access to the internet.

Keywords: breast-q react assessments quality of life 24-184
evaluation of sleep mode within the respironics simplygo portable oxygen concentrator

Conditions: Lung Disease

Summary: the simplygo study is a single site, cross-over study which aims to enroll a maximum of 30 participants (to allow for 20 completed data sets) with a prescription for nocturnal oxygen, and meeting all eligibility criteria.

all participants will undergo a single night polysomnography testing in a sleep lab while they're oxygen saturation (spo2) is monitored. the study has a cross-over design, in which participants will receive their oxygen prescription in two different modes at different times during the night. the assignment (sleep vs. continuous mode) to which participants will initiate the night will be randomized, and all participants will utilize each of the two modes during the study. the hypothesis of this study is that there will not be a significant difference in spo2 for participants while they use the simplygo portable oxygen concentrator, set in 'sleep mode', or pulsed oxygen flow, as compared to their spo2 while on continuous flow oxygen during sleep during the course of the one night sleep study.

Eligibility criteria:
inclusion criteria 1. males and females, ages 21-80 2. current prescription for supplemental oxygen at night; can be pulsed dose or continuous 3. willing and able to provide informed consent exclusion criteria 1. medically unstable participants per discretion of the principal investigator 2. diagnosis of sleep apnea, per chart review, self report or rated high risk based on the berlin questionnaire 3. participants unable or unwilling to spend one night in a sleep lab 4. nocturnal oxygen requirements \> 5 liters per minute 5. currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products 6. employee or family member that is affiliated with philips

Keywords: oxygen
adherence to mesalamine profile for patients with inflammatory bowel disease

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: hypothesis: mesalamine is commonly used to induce and maintain remission in patients with inflammatory bowel disease (ibd). behavioral and psycho-social barriers to mesalamine adherence exist in patients with ibd. these factors can be identified using qualitative testing in order to develop a validated instrument to measure the "adherence profile" of an individual patient, and design appropriate behavioral interventions to reduce non-adherence. objectives: to test a novel interview instrument that determines the medication adherence profile of patients with ibd prescribed mesalamine by correlating with objective measures of adherence

specific aims: 1. to test a novel interview instrument to classify patients into "adherence profiles" 2. to validate this instrument with quantitative scores of mesalamine adherence and objective testing. study design rationale: qualitative research design and prospective validation

Eligibility criteria:
inclusion criteria: * adult patient (age \>18) * diagnosis of ibd (confirmed by endoscopy and histology) \> 3 months * in clinical remission (based on simple colitis activity index score \<2.5) * on mesalamine compound for maintenance of remission * stable mesalamine dose for 1 month exclusion criteria: * not receiving primary gi care at bidmc
impact of glenosphere size on range of motion in female patients undergoing reverse shoulder arthroplasty

Conditions: Rotator Cuff Tear Arthropathy; Massive Irreparable Rotator Cuff Tear

Summary: the purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (rsa) to determine if a larger glenosphere allows greater range of motion without an impact on complications.

a current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (rom) following rsa. some researchers have shown an association between increased glenosphere size and improved rom, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. this is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. most studies have shown an increased rom with larger glenosphere sizes.1 because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited rom. the purpose of this study is to determine if a larger glenosphere allows for greater rom in female patients undergoing rsa.

Eligibility criteria:
inclusion criteria: * female sex * diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty * no history of prior shoulder arthroplasty * consent to study participation by signing the informed consent and the protected health information (phi) form (attachment b and c) * ability to speak, read and write english exclusion criteria: * male sex * any impairment that would prevent answering the surveys * no children or adolescents under the age of 18 years old * no prisoners, pregnant women, or mentally disabled persons * no workers' compensation cases
safety and efficacy study of tnx-102 sl in subjects with military-related ptsd and related conditions

Conditions: PTSD

Summary: this is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of tnx-102 sl -a sublingual formulation of cyclobenzaprine. following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 65 years of age * diagnosed with current ptsd as defined by the clinician-administered ptsd scale for dsm-5 (caps-5), * for patients with a qualifying index trauma(s) resulting in ptsd that occurred during military service, military contractor, department of homeland security or law enforcement * willing and able to withdraw and refrain from specific therapies (ask pi) * use medically acceptable form of contraception (female only) * signed informed consent exclusion criteria: * significant traumatic brain injury * severe depression * bipolar and psychotic disorders * increase risk of suicide * significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for hep b, hep c, hiv) * unable to wash-out specific medications (ask pi) * history of violent behavior within past 2 years, unrelated to work duties * history of drug or alcohol abuse within past 6 months * positive illegal substance test * known hypersensitivity to cyclobenzaprine * others: seizure disorders, uncontrolled sleep apnea, bmi\>40 * participation in an investigational study in past 30 days * in the process of litigating for compensation for a psychiatric disorder * females that are pregnant or breastfeeding

Keywords: ptsd military-related ptsd and other related conditions
effectiveness of iliopsoas positional release versus conventional exercises in the management of sub-acute back pain.

Conditions: Back Pain

Summary: recommended treatment for chronic non-specific lbp is exercise therapy, behavioral therapy including pain management, or a combination of these; there is not enough evidence to establish recommendations for which one is the most appropriate. the primary objective of this study is to explore the effects of ilio-psoas release on sub-acute back pain, rom \& functional disability

following the screening, participants will be randomized to receive the experimental or the controlled treatment in a1:1 ratio. computer-generated random numbers will be used for randomization. after obtaining the basic information, a unique code will be provided to each included patient. the outcome assessor will be blinded to the type of treatment. patients and investigator could not be blinded due to the nature of treatment. group "a "(experimental group) will receive positional release technique on painful iliopsoas(both if necessary) group "b" (control group) will receive conventional physical therapy treatment consisting of hot pack, tens, ultra sound along with back strengthening exercises. all patients will be assessed for pain , rom and functional activities before and after treatment sessions. visual analogue scale(vas) and modified schober test will be used for pain and rom respectively. roland-morris questionnaire (rmq) will be used for functional activities.

Eligibility criteria:
inclusion criteria: * sub-acute (pain for \> 1.5 month) * age 18-40 years * willing to participate * both gender will be recruited. exclusion criteria: * any history related to spinal surgery * previous administration of epidural injections * lbp due to specific pathology * neurological deficits (like stroke) * clinical disorder contraindicated to exercise

Keywords: back ache manual therapy soft tissue techniques
valsartan intensified primary care reduction of blood pressure study

Conditions: Hypertension

Summary: this study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.


Eligibility criteria:
inclusion criteria: * newly diagnosed or currently treated hypertensive patients who have not attained their blood pressure target and require active pharmacological treatment as recommended by the local guidelines as judged by the general practitioner exclusion criteria: * significantly elevated blood pressure (severe hypertension) * requiring 3 or more antihypertensive drugs * severe kidney disease or dialyses * clinical diagnosis requiring concomitant therapy with antihypertensive treatment that would be outside the therapies allowed under study protocol other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension valsartan
tunnel technique with emdogain® in addition to connective tissue graft compared with connective tissue graft alone for the treatment of gingival recessions: a randomized clinical trial.

Conditions: Gingival Recession

Summary: microsurgical tunneling flap procedures using connective tissue grafts (ctg) are predictable for treating teeth with gingival recessions. enamel matrix derivatives (emd) can be used as an alternative to the aforementioned gold standard. the aim of this study is to evaluate clinically the use of tunnel technique with emd applied group in addition to ctg and the same technique with ctg group for the treatment of multiple gingival recessions.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * bilateral multiple gingival recessions in homologous teeth exclusion criteria: * full-mouth plaque index ≥ 20% (ainamo \& bay 1975) * full-mouth sulcus bleeding index ≥ 15% (mühlemann \& son 1971) * smoking * systemic diseases with compromised healing potential of infectious diseases * drugs affecting periodontal health / healing * pregnant and lactating females * previous periodontal surgery in the area
dextroamphetamine as an adjunct in cocaine treatment - 1

Conditions: Cocaine-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.


Eligibility criteria:
please contact site for information.

Keywords: cocaine dependence
the effectiveness of breathemax breathing device on secretion clearance

Conditions: Lung Disease

Summary: the purpose of this study is to determined effects of breathemax on secretion clearance.


Eligibility criteria:
inclusion criteria: * one sign of secretion accumulation in bronchi * stable cardiopulmonary function * good consciousness and good co-operation exclusion criteria: * massive hemoptysis * pneumothorax (untreated)

Keywords: breathemax breathing device secretion clearance ventilatory dependence intubated patients
a trial comparing ferumoxytol with iron sucrose for the treatment of iron deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: the purpose of the study is to evaluate the efficacy and safety of intravenous (iv) ferumoxytol compared to iv iron sucrose for the treatment of iron deficiency anemia (ida).


Eligibility criteria:
key inclusion criteria include: 1. males and females ≥18 years of age 2. participants with ida defined as having: 1. hemoglobin \<10.0 g/deciliter (dl) 2. transferrin saturation (tsat) \<20% 3. participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used 4. female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study key exclusion criteria include: 1. history of allergy to iv iron 2. allergy to two or more classes of drugs 3. participants on dialysis or with an estimated glomerular filtration rate \<30 ml/minute(min)/1.73 square meter (m\^2) 4. female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test 5. hemoglobin ≤7.0 g/dl 6. serum ferritin \>600 nanogram/ml

Keywords: iron deficiency anemia feraheme ferumoxytol iron sucrose venofer ida