Kornimate/medical-research-clean huggingface dataset:
a study to monitor patients with primary or early hiv infection

Conditions: HIV Infections

Summary: the purpose of this study is to monitor patients who recently have been infected with hiv in order to learn how their immune systems respond to hiv infection and to study how the virus acts in their bodies. primary hiv infection occurs within 20 days to 8 weeks following exposure to hiv. the symptoms of primary hiv infection are usually fever, tiredness, headache, or muscle aches. however, symptoms vary greatly from person to person, and some people might not experience any symptoms at all. because these symptoms also resemble the cold or the flu, it is difficult to identify patients with primary hiv infection. information gathered from this study will help doctors decide what kind of treatment is best to give patients who recently have been infected.

primary hiv-1 infection is frequently identified as a nonspecific viral syndrome occurring within 20 days to 8 weeks following a documented hiv exposure. however, symptoms vary from person to person, and some people undergo asymptomatic seroconversion. because of the difficulty identifying patients with either acute hiv infection (within 30 days of initial infection) or early infection (within 12 months of initial infection), no systematic review of viral dynamics or immunodynamics in this patient population has been undertaken. a better understanding of the virologic and immunologic parameters during acute and early hiv infection should provide information relevant to the optimal design of future clinical therapeutic trials. the only patient intervention is obtaining blood, lymph node tissue, csf, and semen or vaginal secretion specimens at designated intervals according to the schedule of evaluations. patients are followed for 5 years. patients may elect to start or discontinue antiretroviral therapy at any time; however, no antiretroviral therapy is administered as part of this study. descriptive analysis includes tolerance and toxicity, magnitude and durability of rna suppression, magnitude and durability of immunologic responses (cd4 and cd8 cells), and decay and emergence of resistant virus in tissue reservoirs (csf, genital secretions, and lymph nodes).

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 13 years old (consent of parent or guardian required if under 18). * have acute or early hiv infection. the stage of hiv infection will depend on the results of certain lab tests.

Keywords: semen hiv-1 immunity, cellular lymph nodes viremia antibodies, viral vagina viral load acute infection
efficacy and safety of susu zhike granules for treating acute cough due to common cold with cold-cough syndrome in children

Conditions: Cough

Summary: this protocol is designed with the aim of exploring the efficacy of susu on shortening duration and reducing severity of cough, and observe the safety used in children.

susu used to be a clinical experienced chinese herb formula for treating acute cough caused by common cold. the ingredients includes hua ju hong, qiao rui su, zi su ye, jie geng, gan cao,which relieving cold and cough, resolving phlegm in traditional chinese medicine theory. this prescription was used for a long time in clinical for treatingacute cough caused by common cold as an herb formula. to standardize the quality and make it easier to take, we reproduced it into a patent medicine and design this trial for evaluating it.

Eligibility criteria:
inclusion criteria: * diagnosed as common cold standard, and vas score of daytime or night-time cough \>= 40mm; * diagnosed as wind cold cough syndrome; * aged 6-14 ( \< 14) years; * the course of cough is \<= 48 hours; * the maximum temperature is \<= 38 degree c within 24 hours before visit; * the informed consent process complies with the requirement,and the legal representative and the child (\>= 8 years old) sign the informed consent form. exclusion criteria: * accompanied by sore throat, obvious fever; * the white blood cell count(wbc), absolute value of neutrophils(neu) and c-reactive protein(crp) all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection; * with complication, such as otitis media, sinusitis, acute bronchitis, pneumonia; * acute bronchitis, pneumonia have been cured less than 8 weeks; * with a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection; * patients with severe malnutrition; * patients with other serious systemic diseases of the cardiovascular, brain, liver, kidney and hematopoietic systems, any anatomical or respiratory abnormalities or mental disorders; * allergic to the experimental drugs; * received antihistamines or any cough medicine, oral or inhaled steroid preparation before enrollment; * the investigator considers it inappropriate to participate in this clinical trial.

Keywords: susu zhike granules
influence of a dietary supplement as treatment of migraine in children and adolescents

Conditions: Migraine

Summary: migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.during migraine attacks inflammation is an important issue. based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).

children or adolescents with migraine and both parents are informed in detail about the study.probands are advised to fill in a special childrens´ diary for migraine daily. after a 4 week-run-in period they start to take the dietary supplement (powder to be dissolved in water)plus a capsule with omega-3-fatty acids from fish oil for 12 weeks daily. afterwards there is a follow-up without supplement treatment for another 12 weeks.76 participants will be included in the trial for statistical evaluation.

Eligibility criteria:
inclusion criteria: * at least 3 days of migraine per month exclusion criteria: * not able to communicate in german or english language * any disease that forbids the participation in the trial according to the investigators assessment * pregnancy * no willingness to participate in the trial * known allergy to fish or soya

Keywords: migraine children dietary supplement q10 prevention
a single dose, 4-period, 2-treatment replicate design bioequivalency study of granisetron hydrochloride 1 mg tablets under fed conditions

Conditions: Nausea; Vomiting

Summary: the objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with roche laboratories' 1 mg granisetron tablet, kytril, following a single 1 mg dose, under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to granisetron or any other comparable or similar product.

Keywords: prevention of nausea and vomiting associated with radiation or chemotherapy
a new non-invasive marker to detect silent hypoxia in patients undergoing cardiac surgery

Conditions: Cardiac Surgical Procedures; High-risk Surgical Patient; Anaerobic Threshold

Summary: in patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. this phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. by measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. the investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.


Eligibility criteria:
inclusion criteria: * age \> 18 yo * cardiac surgical procedure under cardiopulmonary bypass * high-risk surgical patient fulfilling one of the following items: * euroscore \>= 6 * ejection fraction \< 40% * creatinine clearance \< 40ml/min * pulmonary arterial pressure \> 45mmhg * signed informed consent * social security affiliation exclusion criteria: * emergency situation * patient on ecmo * pregnancy or lactation
ipragliflozin add-on long-term study in japanese participants with type 2 diabetes mellitus on sitagliptin (mk-0431j-849)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in japanese participants with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.


Eligibility criteria:
inclusion criteria: * has type 2 diabetes mellitus * has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy * hemoglobin a1c (hba1c) ≥7.0% and ≤10.0% before study participation exclusion criteria: * history of type 1 diabetes mellitus or a history of ketoacidosis * history of any of the following medications: thiazolidinediones (tzd) and/or insulin within 12 weeks prior to study participation, sodium glucose cotransporter 2 (sglt2) inhibitors anytime * currently has a urinary tract infection or genital infection with subjective symptom
cystatin c as an early marker of contrast-medium nephropathy in cardiac catheterization patients

Conditions: Contrast Induced Nephropathy; Acute Renal Failure

Summary: hypothesis: cystatin c compared with creatinine is a better and earlier marker of contrast-induced nephropathy in high and intermedium risk cardiac catheterization patients. primary objective: establish if cystatin c is superior detecting contrast-induced nephropathy than creatinine in high and intermedium risk cardiac catheterization patients.

contrast induced-nephropathy is a complication that is underestimated in clinical practice after cardiac catheterization. during the last 30 years, because of the increasing use of contrast medium for diagnostic and therapeutic procedures, this has become the third in-hospital cause of acute renal failure (12%). that's why, it is necessary to establish an earlier marker of renal dysfunction that can help us in the diagnosis and allow us to initiate the appropriate therapeutics, because depending on the severity of the renal damage, it can increase the cardiovascular risk and morbidity. the risk of contrast medium nephropathy is still present even with the use of low osmolarity contrast media, and many patients increase their in-hospital days, costs and hemodialysis requirement. cystatin c is a non glucosylated protein produced in nucleated cells in a constant rate, and because of its low molecular weight it's filtered through the glomerular membrane without restriction and it's fully reabsorbed in the proximal tubule, that's why it's considered an excellent marker evaluating the glomerular filtration rate in patients with acute renal failure during the first 24-48 hours. we propose that cystatin c can be useful as an earlier and superior marker of contrast-induced nephropathy in high and intermedium cardiac catheterization patients.

Eligibility criteria:
inclusion criteria: * age over 20 years old * indication for coronariography and/or percutaneous coronary intervention * voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial * a mehran contrast-induced nephropathy score from six to fifteen. exclusion criteria: * n-acetylcystein and fenoldopam pre-medication * low risk patients according mehran classification * cardiogenic and septic shock * acute renal failure by any other cause * patients with chronic kidney failure requiring any kind of dialysis * patients unable to complete follow-up * exposure to contrast media 48 hours prior to study * patients unable to give consent * receiving contrast media other than non-ionic

Keywords: contrast-induced nephropathy cystatin c contrast media creatinine cardiac catheterization
safety and efficacy study of mdv3100 in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy

Conditions: Castration-Resistant Prostate Cancer

Summary: this is a phase 3 study to compare the clinical benefit of mdv3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.


Eligibility criteria:
inclusion criteria: * progressive prostate cancer * medical or surgical castration with testosterone less than 50 ng/dl * one or two prior chemotherapy regimens. at least one chemotherapy regimen must have contained docetaxel * eastern cooperative oncology group (ecog) performance status 0-2 * adequate bone marrow, hepatic, and renal function * able to swallow the study drug and comply with study requirements * informed consent exclusion criteria: * metastases in the brain or active epidural disease * another malignancy within the previous 5 years * clinically significant cardiovascular disease * gastrointestinal disorder affecting absorption

Keywords: prostate cancer castration-resistant
a smartphone app for women with primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: with a randomized, pragmatic study the effectiveness of a smartphone app for menstrual pain in 18-34-year-old women with primary dysmenorrhea will be investigated.

smartphone apps may be useful to guide and support individuals in self-management strategies. primary dysmenorrhea is a very common problem for women. with a randomized, pragmatic study the investigators aim to evaluate whether a smartphone app for women with menstrual pain is effective in reducing menstrual pain in 18-34-year-old women with primary dysmenorrhea. for this the investigators compare the complete smartphone app with two control versions of this app. the complete app provides evidence-based self-care information and instructions for self-acupressure in menstrual pain, the control intervention i includes self-care information, but no instructions for self-acupressure, and control intervention ii includes instructions for self-acupressure, but no self-care information. the investigators aim to observe 594 women with primary dysmenorrhea over 12 menstruation cycles. the primary outcome is the mean pain intensity on the days with pain during the 6th menstruation after randomization using a numerical rating scale (nrs; 0=no pain; 10=strongest pain imaginable). women are eligible when they suffer from primary dysmenorrhea, are between 18 and 34 years old, not pregnant and do not plan to be pregnant within the next 12 months.

Eligibility criteria:
inclusion criteria: * female, aged 18-34 years * dysmenorrhea, defined as self-reported menstrual cramps or pain during every menstrual cycle which started during the teenage years * no prior history of a gynecological disease that is known to be a reason for the dysmenorrhea * not more than 5 days with menstrual pain outside the menstrual period itself * menstruation within the last six weeks and a cycle length of 3 to 6 weeks * moderate or severe pain, defined as a score equal to or higher than 6 on a numeric rating scale (nrs, 0 to 10) for the worst pain intensity during the last menstruation * informed consent * possession of an iphone * willingness and ability to input and share anonymous data through the study app * the willingness to see a doctor when 1) pain is getting worse than usual, 2) pain medication is not helping, and 3) when the pain is still present well before or well after the period. exclusion criteria: * known pregnancy * pregnancy already planned for the forthcoming 12 months

Keywords: mhealth dysmenorrhea acupressure self-management self-care
trial using cogwatch for tea making training in stroke apraxia and action disorganisation syndrome

Conditions: Stroke; Apraxias

Summary: apraxia and action disorganization syndrome after stroke can disrupt activities of daily living (adl). occupational therapy has been effective in improving adl performance, however, inclusion of multiple tasks means it is unclear which therapy elements contribute to improvement. this study evaluates the efficacy of a task model approach to adl rehabilitation, comparing training in making a cup of tea with a gait training control condition.

apraxia and action disorganization syndrome (aads) after stroke can disrupt activities of daily living (adls). occupational therapy has been effective in improving adl performance, however, inclusion of multiple tasks means it is unclear which therapy elements contribute to improvement. this trial evaluates the efficacy of a task model approach to adl rehabilitation, comparing training in making a cup of tea with a stepping training control condition. stroke survivors with aads participate in a cross-over randomized controlled study. participants attend five 1-hour tea making training sessions in which progress is monitored and feedback given using a computer-based system which implements a markov decision process (mdp) task model (cogwatch). in a control condition participants receive five 1-hour stepping sessions. analysis compares tea making training with stepping training effects on error reduction and time taken in making 4 different tea types. a complex tea preparation task (making two different cups of tea simultaneously) is used to test for generalisation of training effects.

Eligibility criteria:
inclusion criteria: * greater than 2 months post stroke; medically stable; failing at least one of four praxis items in the birmingham cognitive screen (bcos) or a document filing task. exclusion criteria: * recent stroke (less than 2 months post stroke); not medically stable

Keywords: activity of daily living stroke apraxia action of daily living cup of tea
acute effects of various aerobic exercise in allergic rhinitis.

Conditions: Allergic Rhinitis

Summary: this study was to investigate the comparison among acute effects of various aerobic exercise on symptoms in allergic rhinitis patients.

fifteen patients with allergic rhinitis aged 18 - 45 years old. the experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. the participant perform moderate intensity exercise 30 minutes/time. physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. the dependent variables between pre-test and post-test were analyzed by a paired t-test. the dependent variables between groups were analyzed by independent t-test. one way repeated measures anova was used to compare the variables among exercise. differences were considered to be significant at p \< 0.05.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of allergic rhinitis diseases * clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week. * positive skin prick test (wheal diameter\>3 mm.) to house dust mite (d. pteronyssinus) and using normal saline as the negative control. * stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine. exclusion criteria: * asthma, chronic rhino-sinusitis, hypertension, cardiovascular diseases * a smoking habit

Keywords: allergic rhinits cytokines aerobic exercise rhinitis symptoms
pract to investigate controlling alcohol related harms in a low-income setting; emergency department bis in tanzania

Conditions: Alcohol Use Disorder; Injury Traumatic; Trauma

Summary: alcohol use is rapidly increasing in low- and middle-income countries, where it is inexpensive, readily available, poorly regulated, and there are few resources devoted to promoting safe alcohol use. a brief intervention based on a motivational interviewing framework has been shown to reduce alcohol use and alcohol-related harms. the investigators have translated and adapted a brief intervention for alcohol to the tanzanian context and swahili language called "punguza pombe kwa afya yako (ppkay)/ reduce alcohol for your health." this project will evaluate this intervention in injury patients presenting for care at the kilimanjaro christian medical center in moshi, tanzania. by using innovative adaptive clinical trial methods, the investigators will expedite the development of the most effective way to integrate this intervention into clinical care. by the end of this project, investigators will have identified the most effective brief intervention components and be able to characterize the intervention's effect overall. additionally, investigators will standardize adaptive trial methods to revolutionize the science of clinical trials for behavioral sciences in low-resource settings.


Eligibility criteria:
inclusion criteria: * ≥18 years of age) * present seeking initial care at the kcmc ed for an acute (\<24 hours) injury * not clinically intoxicated (i.e., have capacity to consent). * one or more of the following: 1) disclosed alcohol use prior to injury, 2) scored ≥8 on the audit, 3) test positive (\>0.0 g/dl) by alcohol breathalyzer. exclusion criteria: * do not speak the native swahili language * too ill or unable to communicate * prior enrollment in this study * decline informed consent.
study evaluating efficacy and safety of froniglutide (pf1801) in patients with idiopathic inflammatory myopathy

Conditions: Dermatomyositis; Polymyositis; Idiopathic Inflammatory Myopathies

Summary: this is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and pharmacokinetics of froniglutide in patients with idiopathic inflammatory myopathy ("froniglutide study")


Eligibility criteria:
key inclusion criteria: * diagnosis of iim (dm or polymyositis \[pm\]) as per bohan and peter classification criteria * mmt-8 ≤125 units and two out of the following csm items, or mmt-8 \>125 units and three out of the following csm items, together with verifiable muscular weakness a. pga vas ≥2 cm b. sga vas ≥2 cm c. haq-di ≥0.25 d. extramuscular activity (mdaat) ≥2 cm e. increase in one or more muscle enzyme (ck, ldh, ast, alt, aldolase) values (must be ≥1.3 × uln) * on treatment with standard of care (immunosuppressants and/or corticosteroids) for \>12 weeks and on stable therapy for at least 4 weeks key exclusion criteria: * inclusion body myositis (ibm) or amyopathic dm * severe muscle damage (myositis damage index \[mdi\] \>7/10 cm). permanent deterioration caused by reasons other than pm/dm, or myositis with cardiac involvement * clinically significant renal/hepatic impairment * severe interstitial lung disease requiring supportive oxygen therapy