Kornimate/medical-research-clean huggingface dataset:
direct acting anti-viral's in chronic hcv patients

Conditions: Safety Issues

Summary: the objective of the study is to determine the safety of daa's among chronic hcv patients. the outcomes of the study are; to determine the frequency of adverse events while receiving daas with or without rbv and/or pegylated interferon to calculate the percentage of patients with severity of medical event as per karch and lasagna classification to determine the percentage of patient having serious adverse event as per ich classification

the cross sectional survey data will be collected on a pre-defined questionnaire from gastroenterologist and hepatologist. the questionnaire will provide us information on demographics, relevant patient history, concomitant medication, ongoing treatment plan recommended for chronic hcv and adverse event details. the questions related to pharmacovigilance and safety assessment includes the international nonproprietary names (inn) unless it is prescribed brand of getz pharma. all adverse events associated with the prescribed treatment will be recorded. data on outcome assessment will be based on action taken due to ae and other reported details. seriousness of adverse event will also be recorded as per the ich classification and severity of medical event will be assessed as per karch and lasagna classification. all the information will be recorded by the healthcare professionals on the questionnaire during direct interaction with the patients. patients' written authorization to use and/or disclose the patient's personal and/or health data will be obtained. however, patient data secrecy will follow ich gcp requirements.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. male or female patient 3. age of patient ≥18 years 4. patients already diagnosed with hcv and on daas therapy. exclusion criteria: 1. written informed consent 2. male or female patient 3. age of patient ≥18 years 4. patients already diagnosed with hcv and on daas therapy.

Keywords: adverse events chronic hepatitis direct acting antivirals
the effect of fine motor skills training through telerehabilitation in children with diplegic cerebral palsy

Conditions: Diplegia, Spastic

Summary: the aim of this study is to compare the effect of occupational therapy intervention through two-way video call, versus occupational therapy home program in written form; on handwriting skills, occupational performance, fine motor and hand skills in children with diplegic cerebral palsy.


Eligibility criteria:
inclusion criteria: * being diagnosed with diplegic cerebral palsy * being between the ages of 7-12 * being able to read and write * to be at level i-iii in the manual ability classification system (macs) * to have the necessary devices (phone, tablet or computer) for video calling * not being able to come to the faculty to conduct the first evaluation face to face * not receiving occupational therapy in any special education center exclusion criteria: * presence of another neurological and/or psychiatric disease * not giving consent to the study individuals included in the study will be randomly assigned to the intervention and control groups. it is planned to keep the number of individuals in the intervention and control groups equal.

Keywords: cerebral palsy handwriting occupational therapy
18f-fluciclovine pet amino acid evaluation of brain metastasis treated with stereotactic radiosurgery

Conditions: Brain Metastases; Brain Metastases, Adult; Brain Cancer

Summary: this is a pilot imaging study in participants treated with stereotactic radiosurgery (srs) to treat brain metastasis. the purpose of this study is to see whether 18f-fluciclovine positron emission tomography (pet) can be used as a biomarker to measure response or progression of brain metastasis after srs.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer with radiographic finding of brain metastasis * any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension * planned treatment with srs as per the treating physician team * eastern cooperative oncology group (ecog) performance status 0-2 * individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18f-fluciclovine pet exclusion criteria: * prior anaphylactic reaction to 18f-fluciclovine * radiographic evidence of leptomeningeal disease * prior whole-brain radiation therapy * inability to undergo mri (e.g., due to safety reasons, such as presence of a pacemaker) * pregnant or positive serum pregnancy test within 14 days of registration * individuals expecting to be breastfeeding at the time of 18f-fluciclovine and unwilling to stop breast-feeding for 24 hours. temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed. * major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol and/or preclude informed consent\* * a legally authorized representative (lar) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.

Keywords: stereotactic radiosurgery 18f-flucicloivine pet imaging
effect of pioglitazone on oxidative load, inflammatory end-points and vascular reactivity in obese non-diabetic patients: a dose ranging study

Conditions: Inflammation

Summary: pioglitazone decreases oxidative load, inflammatory end points and improves vascular reactivity in obese patients in a dose dependent manner and that this effect is independent of its glucose lowering effects.

this is a single center, open labeled study. a total of 24 obese patients will be recruited to participate in this study. the study will have three groups of 8 patients each. subjects will be enrolled into each group by alternate recruitment. subjects in group one will receive 15mg of pioglitazone; subjects in group two will receive 30 mg of pioglitazone; subjects in group three will receive placebo. all subjects will receive pioglitazone or placebo for 6 weeks, followed by a 6-week observation period off pioglitazone/placebo. at baseline, and at week 1, week 2, week 4, week 6 and month 3 all patients will have blood drawn for tbars, ortho and meta-tyrosine, 9-hode and 13-hode, nf, ikb, tnf-a, icam-1, vcam-1, pai-1, ap-1, egr-1, mmp-2, mmp-9, timp, crp-1, e-selectin, p-selectin, asymmetric dimethylarginine (adma), papp-a, saa, mcp-1, il-6, ros generation, insulin levels, and crp. post-ischemic dilation of the brachial artery will be used as an index of endothelium-mediated vasodilation. all subjects will have an oral glucose tolerance test (gtt) with 75gm of glucose at day 0 and at day 42. vascular reactivity will be assessed at 0, 6, and at 12 weeks.

Eligibility criteria:
inclusion criteria: * • obese (bmi\>=30) * age: 20 to 65 years of age inclusive * without established clinical coronary artery disease (documented history or myocardial infarction, typical angina and an exercise ecg positive for ischemia or angiographic evidence of cad) * good health as evidence by history and physical exam * female subjects must be: postmenopausal for at least one year or surgically incapable of childbearing (i.e. have had a hysterectomy or tubal ligation) or, if capable of childbearing a subject, must be practicing an acceptable method of contraception. • subject will be available for duration of the study and willing to comply with all study requirements. exclusion criteria: * • diabetes mellitus * allergy or sensitivity to pioglitazone * current use of insulin therapy. * coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks * hepatic disease (transaminase \> 3 times normal) * renal impairment (creatinine clearance \< 50 ml/min) * history of drug or alcohol abuse * copd * participation in any other concurrent clinical trial * any other life-threatening, non-cardiac disease * use of an investigational agent or therapeutic regimen within 30 days of study * pregnancy or nursing
effect of grapes in inflammatory bowel disease

Conditions: Crohn Disease

Summary: the overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the california table grape commission) on the gut microbiotacomposition in adult patients with the ibd subtype crohn's disease (cd).

this protocol is designed to investigate the effect of grape powder consumption in inflammatory bowel disease (ibd), in particular how grape powder consumption (provided as 46g/day grape powder; equivalent to 1.5 cups fresh grapes) alters the gut microbiota (gm) composition in humans with ibd. the investigators will focus on studying ibd patients affected with cd as a proof of principle that could be tested later in other ibd subtype (ulcerative colitis or others specific surgical conditions). the overall objective of this pilot intervention study is to determine the impact of grape powder (46g/day freeze dried whole grape powder provided by the california table grape commission) on the gm composition in adult patients with the ibd subtype crohn's disease (cd). an 28 day pilot study in adult cd patients at the digestive health institutes (dhi) of university hospitals cleveland medical center (uhcmc). table participation in this study will last for a maximum of 28 days and will consist of two phases. phase i (baseline period - 7 days) where all grapes and berries will be removed from the diet, and phase ii (intervention period - 21 days) where participants will be supplemented with 46g/d freeze-dried grape powder consumed as 22.5g packets twice daily. the dose of 46g/day of grape powder is equivalent to 1.5 cups of grapes. participants will be asked to avoid consumption of all other grapes/berries during phase ii. the investigators will compare the before and after changes in gut microbiota composition.

Eligibility criteria:
inclusion criteria: * documented diagnosis of crohns disease. cd outpatients in remission * harvey bradshaw-index in remission (\<6 score) * capable of providing consent to participate. * able to complete daily surveys and take oral nutrition * able to record daily meal intake exclusion criteria: * short bowel syndrome. * hospitalized patients. * individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients. * known drug abuse. * known parasitic disease of the digestive system. * symptomatic intestinal stricture. * presence of an ostomy. * other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study. * well-founded doubt about the patients cooperation. * existing pregnancy or lactation. * history of \<1 natural bowel movements per day. * unable to access to technology that permits the daily completion of study related activities. * change in ibd medication within past 4 weeks. * body mass index \<16 kg/m or ≥35. * documented c.difficile colitis within four weeks of screening. * known berry or grape allergy * no probiotic or antibiotic use for the previous 14 days
efficacy of early stage alzheimer's support groups

Conditions: Memory Loss; Alzheimer's Disease; Dementia

Summary: the purpose of this study is to evaluate the impact of an early stage memory loss support group (essg) and education seminar (es) on quality of life, mood, social support, distress about memory loss, and interpersonal relationships of memory loss participants and their caregivers.

with recent advances in diagnostic procedures and treatment options, many individuals with ad are now diagnosed early in the disease. early diagnosis has many benefits: treatment can be started sooner, legal and financial planning can be addressed while the individual is able to participate in decision-making, and support services can be mobilized earlier. however, early diagnosis may also have negative consequences for the diagnosed individual's quality of life. thus, diagnosis creates an obligation to help individuals and their families learn more about ad and cope with the impact of the diagnosis. many alzheimer's association chapters have begun providing early stage support groups that focus on enhancing quality of life for participants and their caregivers. anecdotal reports suggest that these groups improve quality of life of participants, but some individuals may also experience decreases in quality of life associated with stress, depression, or family conflict as a result of discussing current and future losses in the group. thus, there is a need to systematically evaluate the benefits of these groups. this study will evaluate and compare the efficacy of a structured, 8-session early stage support group intervention (essg) and a half-day education seminar (es). participants with early stage memory loss and their caregivers will be randomly assigned to either essg or es. both are presented by the alzheimer's association western \& central washington state chapter.

Eligibility criteria:
inclusion criteria: * dementia diagnosis confirmed by primary care physician * early stage dementia, defined as a mini mental state exam score of 18 or higher, and a clinical dementia rating of 1 or less * care partner who will attend groups and complete study assessments * aware of memory loss (verbally acknowledges memory loss and/or expresses concern about memory) * comfortable in a group separate from family members * no significant history of mental illness (no hospitalization or medication for psychotic disorder within the past 2 years) * consent to research participation (participant, care partner, legal representative) * remain in the community for the 6 month duration of the study

Keywords: memory alzheimer's disease dementia support group psychosocial
phase 1/2 study of can103 in subjects with gaucher disease

Conditions: Gaucher Disease, Type 1; Gaucher Disease, Type 3

Summary: gaucher disease is a rare lysosomal storage disorder caused by deficient activity of the enzyme acid β-glucosidase, causing glucosylceramide to accumulate within macrophages and leading to hepatosplenomegaly, anemia, thrombocytopenia, and bone disease. in the non-neuronpathic form (type 1), disease manifestations are mostly systemic, whereas in the neuronopathic forms, glucosylceramide also accumulates in the central nervous sysem and leads to acute (type 2) or chronic (type 3) neurodegeneration. the purpose of this phase 1/2 first-in-human study is to initially evaluate the safety and tolerability of two doses of can103, and then barring any safety concerns, to evaluate the efficacy and safety of the two doses administered intravenously every other week in treatment-naive subjects with gaucher disease type 1 or type 3.

phase 1: 4 newly treated subjects with type i gaucher disease (gd1). phase 2: 36 newly treated subjects with gd1 or type iii gaucher disease (gd3)

Eligibility criteria:
inclusion criteria: * subjects have a confirmed clinical, enzymatic, and genetic diagnosis of gaucher disease (type 1 or type 3); * phase 1: subjects with gd1 aged ≥18 years; phase 2: subjects with gd1 or gd3 aged ≥12 years; * subjects have not received enzyme replacement therapy (ert) or substrate replacement therapy (srt) within 3 months before screening; * subjects have gd-related anemia and one or more of the following disease manifestations: 1. spleen volume ≥2 mn as measured by mri, or 2. liver volume ≥1.5 mn as measured by mri, or 3. platelet count ≥20 × 10\^9/l and \<100×10\^9/l. exclusion criteria: * subjects have received or stopped treatment with other investigational drugs or devices within 30 days before screening or less than 5 half-lives, whichever is longer (drugs only); * subjects have anemia due to other causes during screening, including nutritional anemia. subjects whose nutritional anemia recovers with the treatment of iron, folic acid, or vitamin b12 may be rescreened; * subjects have received hepatectomy or splenectomy; * subjects have had an allergic reaction to imiglucerase or other erts and their components; * subjects have received treatment with erythropoietin, whole blood or packed red blood cell transfusions, or chronic systemic corticosteroids within 3 months before screening, or have received a platelet transfusion within 1 month before screening.

Keywords: can103 gaucher disease
pilot study: use of the saccadometer to detect characteristic saccadic peak velocity in myasthenia gravis patients

Conditions: Myasthenia Gravis

Summary: fast eye movements have been shown to demonstrate characteristics that are specific to myasthenia gravis that are not present in other eye movement disorders. it is possible to measure these eye movements and potentially identify these characteristics using new portable eye movement testing equipment. the aim of this pilot study is to discover if these characteristics can be identified using portable eye movement testing equipment in patients with a confirmed diagnosis of myasthenia gravis.

the diagnosis of myasthenia gravis (mg) can be challenging, particularly in its ocular manifestation with current clinical procedures. previous research has shown that fast eye movements in patients suffering with mg have quite specific characteristics that can be used to correctly diagnose the condition. the saccadometer is a portable eye movement testing device that may provide the ability to detect the characteristics of fast eye movements that myasthenia patients alone demonstrate - specifically these are hyperfast movements that are present when slower eye movements are impaired by the disease process. these fast movement characteristics are not present in defects of eye movements due to other aetiologies. saccadic properties of a small group of patients with a confirmed diagnosis of mg will be measured to identify if characteristic hyperfast saccades are present.

Eligibility criteria:
inclusion criteria: patient participants * confirmed diagnosis of myasthenia gravis by either a positive acetylcholine antibody serum test (achr) and/or a positive single fibre electromyograph (sfemg) test. * patient participants must have also had at least one episode of diplopia and/or eye movement abnormality attributed to their diagnosis of mg. healthy participants: * must have no history of eye movement abnormality * no have no history of other auto-immune disease (specifically diabetes, thyroid eye disease and chronic external ophthalmoplegia). exclusion criteria: * patients without confirmed myasthenia gravis diagnosis by means of either a positive achr serum test and/or a positive sfemg test. * patients with confirmed myasthenia gravis who have not had at least one episode of diplopia and or ptosis. * patients with current or previous episodes of ocular motility dysfunction that have a confirmed diagnosis other than myasthenia gravis. * any healthy participant found to have an abnormality of vision or eye movement upon screening or a history of auto-immune disease.

Keywords: saccades
study to evaluate the effectiveness of the initial specimen diversion device when collected through peripheral intravenous catheters

Conditions: Septicemia

Summary: this is a randomized, open label study to evaluate the initial specimen diversion device (isdd) in reducing the contamination rate in blood culture analysis. blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. er, surgical, medical, etc.). only samples that are collected via pivc's may be included in this study. the isdd will be compared to current laboratory practices for the collection of blood for culture purposes. laboratory standard procedures (lsp) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.


Eligibility criteria:
inclusion criteria: * adults \>19 years old exclusion criteria: * not a good candidates for direct-to-media (dtm) technique

Keywords: septicemia blood culture contamination
presepsin in the diagnosis of sepsis in critically ill patients

Conditions: Sepsis; Infection

Summary: sepsis is one of the most common causes of death worldwide. it is caused by a complex of inadequate host responses to infection. sepsis remains a major challenge of modern intensive care medicine. despite recent improvements, the incidence of sepsis in critically ill patients increases steadily (25%) and mortality rates remain unacceptably high (30%). it is difficult to distinguish the sepsis from the non-infectious systemic inflammatory response syndrome. early identification of the origin of infection can help dramatically to improve outcome and reduce mortality. that is why clinicians need fast, reliable and specific biomarkers for sepsis recognition.

comparison between the detection of novel early inflammatory biomarker (psep) and the others normally used biomarkers (c-reactive protein - crp, interleukin 6 - il6, procalcitonin - pct) in the early diagnosing of sepsis in the critically ill patients a broad range of clinical and laboratory parameters are combined (surviving sepsis campaign, international guidelines) for early sepsis identification: white blood cells (wbc), c-reactive protein (crp), interleukin 6 (il-6), procalcitonin (pct). an ideal biomarker should be a fast and specific increase in sepsis, short half-life, rapid decrease after administration of an effective therapy and fast (bed-side) method of determination. none of the current biomarkers have all of these characteristics. we investigate the diagnostic accuracy of presepsin compared to other biomarkers (wbc, pct, il6, crp) for infection or sepsis, defined according to sepsis-3 definition (singer, jama 2016) in adult patients admitted to icu with suspected sepsis.

Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosis of sepsis from qsofa (quick subsequent organ failures assessment) * need of vasopressors for mean arterial pressure (map) ≥ 65 mmhg * lactate levels ≥ 2mmol/l despite adequate volume resuscitation exclusion criteria: * age below 18 years * terminal state of disease * pregnancy

Keywords: presepsin biomarkers sepsis diagnosis
the effect of sifrol® on tremor and depression in patients with idiopathic parkinson's disease

Conditions: Parkinson Disease

Summary: documentation of the effect of sifrol® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic parkinson's disease under routine conditions


Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease with tremor and/or depression requiring therapy with sifrol® or change of therapy to sifro®l and not under medication with neuroleptics were allowed to be observed during the study exclusion criteria: * patients who meet one or more of the general or specific contraindications mentioned in the summary of product characteristics (spc) for sifrol® * patients under treatment with neuroleptics should not be observed during this study