Kornimate/medical-research-clean huggingface dataset:
a study to determine the safety and efficacy of rilpivirine in treatment-naive indian participants with human immunodeficiency virus type 1 (hiv-1) infection

Conditions: Human Immunodeficiency Virus Infections

Summary: the primary purpose of the study is to evaluate the efficacy of rilpivirine (rpv)-based regimen in human immunodeficiency virus type 1 (hiv-1) infected, antiretroviral (arv) treatment-naive participants, as determined by the percentage of virologic responders defined as having hiv-1 ribonucleic acid (rna) less than 400 copies/ milliliter (ml) at week 24.


Eligibility criteria:
inclusion criteria: * must have documented human immunodeficiency virus type 1 (hiv-1) infection * must be antiretroviral (arv) treatment-naïve * have plasma hiv-1 ribonucleic acid (rna) less than (\<) 100,000 copies/milliliter (ml) at screening visit * have cluster of cd4+ t-cell count (greater than) \>200/ cubic millimeter (mm\^3) at screening visit * women of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta hcg\]) pregnancy test at screening; and a negative urine (or serum, if required by local regulations) pregnancy test before the first dose of study exclusion criteria: * history of any primary nucleo(t)side reverse transcriptase inhibitor (n\[t\]rti) or non-nucleoside reverse transcriptase inhibitor (nnrti) mutations (if testing performed locally, and results are available), as defined by the current international aids (acquired immunodeficiency syndrome) society-united states (usa) (international antiviral society-usa) 2017 guidelines * has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency) * diagnosed with acute viral hepatitis at screening or before baseline * infected with mycobacterium tuberculosis which is likely to require rifampicin-based treatment during the study * has a grade 3 or 4 laboratory abnormality as defined by the division of aids (daids) for grading the severity of adult and pediatric adverse events criteria with the following exceptions unless clinical assessment foresees an immediate health risk to the participant: (a) preexisting diabetes or with asymptomatic glucose grade 3 or 4 elevations (b) asymptomatic triglyceride or cholesterol elevations of grade 3 or 4

Keywords: treatment-naive rilpivirine india
biorhythms in metabolic tissues

Conditions: Sleep Deprivation; Metabolic Disturbance; Biological Clocks; Healthy

Summary: metabolism is increasingly recognized as being highly regulated by anticipatory biological rhythms (circadian rhythms or "biorhythms"), which are driven by molecular feedback loops, and which are approximately 24 hours long ("circa diem"). these circadian rhythms exist both centrally, in the brain, but also in the periphery, and are specific to many tissues depending on their main biological function or functions. whereas these circadian rhythms have been thoroughly characterized in other organisms, their role in humans remain poorly understood, partly because of the difficulty in studying these rhythms in peripheral tissues. the investigators therefore aim to characterize these rhythms in primarily skeletal muscle and adipose tissue in healthy young volunteers (using the so-called constant routine paradigm), and how these rhythms interact with one another at various genetic and molecular levels. at the same time, the investigators aim to study how an unhealthy vs. healthy diet can alter these circadian rhythms, and how they interact with circadian rhythms in other tissue compartments such as those expressed by blood cells.


Eligibility criteria:
inclusion criteria: * age 18-33 yr * healthy (self-reported) and not on medication * bmi 18-28 kg/m2 (and waist circumference \<102 cm), and weight stable (±5% body weight in past 6 months) * non-smoker and non-nicotine user * regular sleep-wake pattern, with sleep duration of 7-9.25 hrs per night * sedentary to moderately active with regular exercise habits the last 2 months * regular daily meal pattern with 3 main meals exclusion criteria: * major or chronic illness, e.g. diabetes, renal disease or inflammatory bowel disease * current or history of endocrine or metabolic disorders * psychiatric or neurological disorders (e.g. bipolar disorder, epilepsy) * frequent gastrointestinal symptoms * chronic medication * any sleep disorder (e.g. irregular bedtimes, symptoms of insomnia) * any issues with or allergies against the provided food items or utilized anesthesia * shift work in the preceding three months or for a long duration * time travel over two time zones in the preceding month * too much weight gain or weight loss in the preceding 6 months * pregnancy
efficacy study of a novel skin health product to reduce an uvb induced erythema

Conditions: Erythema; Sun Damaged Skin; Skin Inflammation

Summary: the aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product.


Eligibility criteria:
inclusion criteria: * written informed consent to participate in the study * willingness to actively participate in the study and to come to the scheduled visits * female and/or male * from 18 to 65 years of age * uniform skin color and no erythema or dark pigmentation in the test area * ita° \> 28 in the test area exclusion criteria: * female subjects: pregnancy or lactation * drug addicts, alcoholics * aids, hiv-positive or infectious hepatitis * conditions which exclude a participation or might influence the test reaction/evaluation * participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area * one of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases * cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years * insulin-dependent diabetes mellitus * electronic implant (e.g. pace maker, insulin pump, hearing aid, and the like) that cannot be removed during irradiation * documented allergies to cosmetic products and/or ingredients * active skin disease at the test area * irregularly tanned skin in the test area * medical history of dysplastic nevi, melanoma or other skin carcinoma * medical history of abnormal response to sunlight * regular use of tanning beds (more than 10 times within the last 6 months) * wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation * usage of medication with known photo-toxic and/or photo-sensitizing potential (e.g. some antibiotics, blood pressure regulating agents and antidepressants agents; hypericum perforatum) within the last 14 days prior to the start of the study and/or throughout the entire course of the study * any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study * systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and/or throughout the entire course of the study * systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study and/or throughout the entire course of the study
posterior minimally invasive plate osteosynthesis (mipo) for humerus diaphyseal fractures

Conditions: Humerus Fracture

Summary: the primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior mipo for humerus diaphyseal fractures with extra-articular distal humeral anatomical plate.

the primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior mipo for humerus diaphyseal fractures with extra-articular distal humeral anatomical plate. clinical * pain * rom functional * constant score * meps * quickdash radiological - bone union complications * infection * nerve injury

Eligibility criteria:
inclusion criteria: * closed diaphyseal humerus fracture at the junction of the middle third with distal exclusion criteria: * open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma

Keywords: humerus fracture osteosynthesis
clinical trail of tang-min-ling pills in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: this is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to evaluate the efficacy of tang-min-ling pills in the treatment of type 2 diabetes mellitus.

type 2 diabetes mellitus combined liver-stomach heat retension syndrome were recruited, which were divided into 3 groups .the patients were randomly taken with high-dosage (12g tang-min-ling pills every time), low-dosage (6g tang-min-ling pills every time), placebo by 3 times every day for 12 weeks.

Eligibility criteria:
inclusion criteria: * initial treatment type 2 diabetic patient * liver-stomach heat retention syndrome * bmi ≥24kg/m2 * aged 30-65 years * after screening stage(lifestyle intervention),hba1c≥7.0%,fpg7.0-13.3mmol/l or pg2h\>11.1mmol/l; * voluntary signs the informed consent exclusion criteria: * have used anti-diabetes drug before more than 1 month * used drug to control the blood sugar with 3 weeks * diabetic ketosis,keto-acidosis,serious infection or trauma,major surgery within 1 month * liver or kidney insufficiency,lung insufficiency,heart failure,acute myocardial infarction or other serious primary disease * sbp/dbp \>160mmhg/100 mmhg * serious chronic diabetic complication * chronic stomach-intestine disease,bad condition of the whole body * pregnancy,preparing to pregnant,or breast-feed stage women * allergic to tcm component * mental disease * allergic habitus * attending to other clinical test * attended this test before * bibulosity and/or mental active drug,drug abuse or depend * usually change the working environment,unstable live environment,etc.which will complied the inclusion * unstable dose or type of anti-hypertension drug * taking the drug or health food which will change the body weight

Keywords: tang-min lin pills type 2 diabetes liver and stomach heat retention evaluate the safety and efficacy of tang-min lin pills
cytokine and eicosanoid mediators in coronavirus disease 2019 (covid-19)

Conditions: COVID-19

Summary: this study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe covid-19 admitted to the hospital; and (2) correlate the dynamic changes in eicosanoid mediators with available patient clinical status, including measures of severity of illness, routine laboratory tests, and outcomes.


Eligibility criteria:
inclusion criteria: 1. admitted to a hospital with symptoms suggestive of covid-19. 2. confirmed infection with sars-cov-2 as determined by polymerase chain reaction (pcr) or other commercial or public health assay in the 72 hours prior to hospital admission or any time during hospital admission. 3. subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 4. understands and agrees to comply with planned study procedures. 5. agrees to the collection of whole blood samples. exclusion criteria: 1. inability to obtain informed consent. 2. anticipated transfer to another hospital which is not a study site within 48 hours. 3. inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access). 4. obstetric patients. 5. prisoners.

Keywords: coronavirus disease 2019 sars-cov-2 eicosanoids eicosanoid storm cytokine storm
pharmacogenetics of ace inhibitor-associated angioedema

Conditions: Hypertension; Diabetes Type 2

Summary: the investigators would like to find out if sitagliptin (dipeptidyl peptidase-4 or dpp4 inhibition), a drug to treat diabetes, affects blood vessel relaxation in healthy people receiving enalapril (angiotensin converting enzyme or ace inhibition), a blood pressure medicine. understanding how these drugs interact in healthy people will help us learn their potential effects in people who have diabetes.

to test the hypothesis that dppiv inhibition with sitagliptin potentiates the vasodilator response to substance p in the presence of ace inhibition with enalaprilat and to bnp and glp-1 even in the presence of ace inhibition. the aim promises to provide important new data regarding the mechanism of action of dppiv inhibitors and interactive effects of these two drug classes used in a growing population of diabetic patients.

Eligibility criteria:
inclusion criteria: * age 18 to 65 inclusive * men and women * black and white americans * bmi \<25 for female subjects: * postmenopausal status for at least 1 year * status post surgical sterilization * if childbearing potential, utilization of a barrier method of birth control and willingness to undergo blood b-hcg testing prior to drug treatment and on every study day exclusion criteria: * smoking * diabetes type 1 or 2, as defined by a fasting glucose of 126 mg/dl or greater or the use of anti-diabetic medication * hypertension as defined by an untreated seated sbp greater than 140 mmhg an untreated dbp greater than 90 mmhg or the use of antihypertensives * history of reported or recorded hypoglycemia (plasma glucose less than 70 mg/dl) * pregnancy * breast-feeding * use of hormone replacement therapy * the use of contraceptive therapy * use of any medication other than multivitamin * hematocrit \<35% * cardiovascular disease such as history of myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure(lv hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy * asthma * history of angioedema * history of cough or other side effect during ace inhibitor use * impaired renal function, as defined by an egfr\<60ml/min/1.73m2 * clinically significant gastrointestinal impairment that could interfere with drug absorption * impaired hepatic function (aspartate amino transaminase\[ast\] and/or alanine amino transferase \[alt\]\>2 x upper limit of normal range * history of alcohol or drug abuse * treatment with any investigational drug in the 1 month preceding the study * mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study * inability to comply with the protocol, e.g., uncooperative attitude, inability to return to follow-up visits, and the unlikelihood of completing the study

Keywords: dppiv inhibitors ace inhibitors bradykinin glucagon-like peptide (glp-1) bnp diabetes hypertension
tranexamic acid to decrease heavy menstrual bleeding in individuals anticoagulated for venous thromboembolism pilot study

Conditions: Venous Thromboembolism; Venous Thromboses; Heavy Menstrual Bleeding; Anticoagulants and Bleeding Disorders

Summary: t-rex hmb is a pilot randomized controlled trial (rct) designed to assess the feasibility of a full trial comparing tranexamic acid (txa) to placebo in decreasing hmb in premenopausal individuals anticoagulated for vte. strong data supports txa as an effective and safe agent at decreasing hmb in the general population, but its use in those with vte has been limited by a lack of data for its efficacy in anticoagulated individuals and theoretical concerns of its prothrombotic effects.


Eligibility criteria:
inclusion criteria: 1. adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days) 2. diagnosed with acute vte on objective imaging; 3. within two weeks of starting treatment with therapeutic dose anticoagulation; 4. planned treatment of at least 3 months of therapeutic dose anticoagulation. 5. written informed consent in accordance with federal, local and institutional guidelines. exclusion criteria: 1. hypersensitivity or allergy to txa 2. active major bleeding other than menstrual bleeding 3. use of hormonal contraceptives 4. known history of thrombosis and antiphospholipid syndrome (including those patients that are triple positive for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein i antibodies. 5. known renal insufficiency 6. pregnant or breastfeeding 7. use of other thrombotic agents 8. under 18 years of age 9. patient is unable to provide informed consent (lacking capacity, language etc)
a study to evaluate efficacy, safety, and tolerability of darigabat in participants with panic disorder

Conditions: Panic Disorder

Summary: the purpose of this trial is to measure the efficacy, safety, and tolerability of darigabat (25 milligrams \[mg\] twice daily \[bid\]) compared with placebo in participants with panic disorder.


Eligibility criteria:
inclusion criteria: * primary diagnosis of panic disorder based on diagnostic and statistical manual of mental disorders, fifth edition text revision (dsm-5-tr), as confirmed by the standard mini international neuropsychiatric interview (mini) * participant has had a minimum of 8 panic attacks, with no week free of panic attacks, in the month prior to the screening visit. in the 2 weeks prior to the baseline visit, the participant must have had at least 4 panic attacks and no week free of panic attacks * participants with a pdss total score ≥12 at the screening and baseline visits * body mass index of 17.5 to 40.0 kilograms per meter square (kg/m2) and a total body weight \>48 kg at screening exclusion criteria: * participants who have a current significant psychiatric comorbidity * any newly initiated evidence-based psychotherapy, including cognitive behavioral therapy (cbt) * any exposure-based therapy is prohibited throughout the duration of the trial * participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease * participants who answer "yes" on the following c-ssrs suicidal ideation items (within the last 6 months) * suicidal ideation item 4 (active suicidal ideation with some intent to act, without specific plan) or * suicidal ideation item 5 (active suicidal ideation with specific plan and intent) or participants who answer "yes" on any of the 5 c-ssrs suicidal behavior items (within the last 2 years) * any of the suicidal behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) or * participants who, in the opinion of the investigator, present a serious risk of suicide note: other protocol-defined inclusion/exclusion criteria may apply
five point initiative: a bundled implementation strategy to address the hiv epidemic in black communities

Conditions: Hiv

Summary: the purpose of this study is to assess the effectiveness of the fpi bundled implementation strategy in increasing hiv testing, pre-exposure prophylaxis (prep) linkage (e.g., prescription) and knowledge, and condom use/access.


Eligibility criteria:
inclusion criteria: * any individual present during the community events at the "five points" (barbershop, hair/beauty salon store or salon, corner store/grocery/neighborhood restaurant, laundromats, car service provider \[e.g. gas station, mechanic, car wash\]) in predominantly black communities in miami where hiv prevalence is high. * pre- and post-assessment: individuals are only eligible to complete the survey one time during the pre-intervention and during the post-intervention phases. * intervention: individuals are only eligible to participate in the intervention phase of this study once every 6 months. exclusion criteria: * individuals who are unable to completely and fully understand the informed (verbal) consent process and the study procedures. * individuals who have previously completed the survey during the pre-intervention and post-intervention phases. * individuals who have participated in the intervention phase of this study within less than 6 months.

Keywords: hiv prevention hiv testing prep implementation science
patient reported outcome measures after treatment of skin cancers on the face

Conditions: Skin Cancer

Summary: this study is to evaluate the psychological well-being in patients diagnosed with skin cancer (melanoma and squamous cell carcinoma (scc) in the face) at the time of diagnosis and after treatment. patients diagnosed with primary melanoma and/or scc and/or infiltrative basal cell carcinoma on the face subjected to surgical treatment (excision or mohs surgery) will be included. all patients will receive questionnaires.


Eligibility criteria:
inclusion criteria: * individuals diagnosed with melanoma, scc and/or infiltrative basal cell carcinoma on the face for surgical treatment and planned for excision or mohs surgery * patients who are able to give informed consent exclusion criteria: * electrodesication and curettage of the tumour

Keywords: melanoma scc in the face infiltrative basal cell carcinoma on the face mohs surgery
physical activity and social engagement for persons with disabilities in an underserved community

Conditions: Disability Physical; Chronic Conditions, Multiple; Aging

Summary: using a community-based participatory approach, this project aims to evaluate the feasibility, acceptability, and preliminary efficacy of two technology-driven group activity programs on socioemotional health and physical activity in a local underserved community, tarrant, alabama. participants will complete two six-week programs, specifically lakeshore online fitness (online) and get active with virtual reality (vr).

this project will utilize a cross-over randomized design where participants will initially be randomized into either the online or vr intervention group. after completing the initial six weeks of the assigned intervention, participants will cross over and complete six weeks of the other intervention. no washout period is included due to several reasons, including no known washout period for certain socioemotional outcomes have been established by prior literature, ethical concerns in requiring return to baseline levels during washout, and a prolonged washout period would negatively impact participant adherence and retention to the study. psychosocial metrics will be collected at the end of each activity session through surveys.

Eligibility criteria:
inclusion criteria: * resident of tarrant, alabama * 18 years or older with a physical disability or chronic health condition or older than 60 years * fluent in english exclusion criteria: * visual impairment that interferes with television viewing