Kornimate/medical-research-clean huggingface dataset:
dutch acute hcv in hiv study (dahhs)

Conditions: Hepatitis C; Human Immunodeficiency Virus

Summary: prospective open label proof of concept feasibility interventional clinical trial in which 60 acute hcv genotype 1 patients co-infected with hiv will receive 12 weeks of boceprevir in addition to standard of care peginterferon + ribavirin if they show a rapid viral responds at week 4. the primary hypothesis of this study is that the subset of patients with a rapid viral responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (p) and ribavirin (rvr4) can be successfully treated with a shorter 12-week triple therapy regimen.


Eligibility criteria:
inclusion criteria: 1. documented recent hcv genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below. 2. plan to start a standard of care therapy for acute hcv consisting of 24 weeks of peginterferon + ribavirin. hcv rna plasma viral load at screening \>1000 iu/ml. 3. a previously performed hcv rna plasma measurement can be used for screening if \<4 weeks old. 4. on haart at the time of screening. 5. minimum age 18 years. exclusion criteria: 1. disallowed co-medication that cannot be stopped or replaced: several potentially life-threatening drug-drug interactions (ddi) are possible when boceprevir is combined with other drugs. therefore all co-medication, including over-the-counter drugs should be checked for potential ddi with ddi table in the dutch summary of product characteristics (spc, appendix a). if the co-medication is not mentioned in the spc ddi table, www.hcv-druginteractions.org should be used. 2. contraindications for the use of full dose of peginterferon alpha-2b or ribavirin: neutrophils \<0,75×109/l or thrombocytes \< 100.000×109/l or a hb \<6.2mmol/l, creatinine clearance \<50ml/min). 3. history of liver cirrhosis or \>f1 fibrosis on fibroscan. inclusion of patients with a chronic well-controlled hbv (hbv-dna below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes \>f1 fibrosis. fibroscan reports \<2 years old can be used for screening. fibroscan is not required for other patients at screening. 4. haart was started \<4 weeks before baseline visit. 5. inability to switch to a haart regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + raltegravir (isentress®) 400mg bid or rilpivirine 25mg qd or atazanavir (reyataz®) 300mg qd + ritonavir (norvir®) 100mg qd. 6. patient that virologically failed haart in the past
adipokine genetic variations in predictingnafld progression to nash in egyptian patients

Conditions: NAFLD; NASH - Nonalcoholic Steatohepatitis

Summary: due to the limited data concerning egyptian population. authors aimed to investigate the differentadipokine gene polymorphism related to non alcoholic fatty liver disease incidence, prognosis and progression to steotosis and also to find different related factors including obesitu, diabetes and liver enzymes level


Eligibility criteria:
inclusion criteria: egyptian patients confirmed nafld diagnosis diabetic - exclusion criteria: * pregnancy and lactation, history of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day women), cirrhosis, autoimmune hepatitis and other causes of liver disease (viral hepatitis, hemochromatosis, wilson's disease), drug induced hepatitis, chronic enteropathies, chronic kidney disease

Keywords: egyptian population nafld nash dna extraction liver enzymes
equivalence study of specificity of ppd

Conditions: Tuberculosis Infection

Summary: determine if investigational products and reference standard produce similar responses.

primary: to determine if the 2 investigational products (aplisol formulated from the new tuberculin ppd drug substance and the reference standard ppd-s2) produce qualitatively similar responses (positive or negative) in subjects who are uninfected with m. tuberculosis (mtb) or other mycobacteria. secondary: 1. to determine if the 2 investigational products have equivalent specificity for detecting subjects currently or previously infected with mtb; 2. to assess the tolerability of the investigational products in terms of the local and systemic reactogenicity events.

Eligibility criteria:
inclusion criteria: * males or nonpregnant females, age 18 to 70 years * negligible risk of manifesting a positive ppd test as evidenced by: * prior history of negative ppd test or interferon gamma release assay (igra) within 14 months before screening * no history of bacillus calmette- guérin vaccination; or if vaccination status is uncertain, was born in the us and did not live outside the us as a child * no history of mtb or mtb therapy (including isoniazid, rifampin, ethambutol, pyrazinamide, or streptomycin) * no history of infection with atypical mycobacteria, including suspicious chest roentgenogram * no history of high risk medical conditions (eg, hiv infection or other immunosuppressive conditions, severe chronic renal disease \[as evidenced by a creatinine clearance \< 30 ml/min\], poorly controlled diabetes mellitus, silicosis, intravenous drug use, or alcohol abuse) * no known close contact to a confirmed mtb case (family or social setting) * no history of living or travelling in india, china, sub-saharan africa, or southeast asia in the past 6 months * no exposure (other than casual) to high-risk environments for mtb exposure (eg, prisons, homeless shelters); healthcare workers are allowed exclusion criteria: * subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating * history of anaphylactic type reaction or other severe reaction to ppd in the past, including a history of blistering or sloughing * presence of conditions that may suppress tst reactivity, including: protocol no. jhp-aplisol-03 confidential 04 may 2012 page 8 of 38 * acute viral infections, including measles, mumps, chicken pox, human immunodeficiency virus (hiv1, hiv2). mild viral syndromes are allowed. * acute bacterial infections including typhoid fever, brucellosis, typhus, leprosy, or pertussis * acute systemic fungal infection * live virus vaccinations within the past 6 weeks, including measles, mumps, polio, varicella, or flumist® * metabolic derangements (eg, poorly controlled diabetes, cushing syndrome, chronic renal failure \[as evidenced by a creatinine clearance \< 30 ml/min\])

Keywords: tb, aplisol
late-onset treatment study extension protocol

Conditions: Pompe Disease (Late-Onset); Glycogen Storage Disease Type II (GSD-II); Glycogenesis Type II; Acid Maltase Deficiency (AMD)

Summary: pompe disease (also known as glycogen storage disease type ii) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in patients with pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. the objective of this extension study is to assess the long-term safety and efficacy of alglucosidase alfa treatment in patients with late-onset pompe disease who were previously treated under the placebo-controlled, double-blind study aglu02704 (nct00158600).


Eligibility criteria:
inclusion criteria: * patient must have completed protocol aglu02704 (nct00158600) * patient must provide signed, informed consent prior to performing any study-related procedures * patient (and patient's legal guardian if patient is under 18 years of age) must have the ability to comply with the clinical protocol * a female patient of childbearing potential must have a negative pregnancy test at baseline. (note: all female patients of childbearing potential and sexually mature males must use a medically accepted method of contraception throughout the study.) exclusion criteria: * the patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, would preclude treatment with alglucosidase alfa.
intensive adjuvant therapy for tnbc with brca gene mutation

Conditions: Breast Carcinoma; BRCA Mutation; Adjuvant Drug Therapy

Summary: evaluation of the efficacy and safety of different adjuvant intensification regimens in early-stage brca1/2 mutant triple-negative breast cancer.


Eligibility criteria:
inclusion criteria: * ecog score 0-1 * tnbc * brca1/2 mutation * no distant metastases assessed by imaging after surgical treatment * breast cancer that is non-pcr after neoadjuvant therapy, or postoperative pathology suggestive of ≥pt2, or ≥pn1 * have completed postoperative adjuvant chemotherapy and/or radiotherapy * no major organ dysfunction exclusion criteria: * patients who are unable to take oral medication, or who refuse this medication regimen * already enrolled in another study, or less than or equal to 4 weeks from discontinuation of another medication * presence of severe dysfunction of vital organs * patients with other malignancies (with the exception of cured non-melanoma skin cancers, carcinoma in situ of the cervix and other tumours that have been cured for at least 5 years) * acute infectious disease or active chronic infectious disease * history of uncontrolled epilepsy, central nervous system disease or mental disorder
study b2c112060: a study of the efficacy and safety of vilanterol inhalation powder in adults and adolescents with persistent asthma

Conditions: Asthma

Summary: the objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.


Eligibility criteria:
inclusion criteria: * outpatient at least 12 years of age * both genders; females of childbearing potential must be willing to use birth control method * clinical diagnosis of asthma for ≥12 weeks * best pre-bronchodilator fev1 of 40%-90% predicted * reversibility of fev1 of at least 12% and 200mls * current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit * ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits exclusion criteria: * history of life-threatening asthma * respiratory infection within last 4 weeks leading to change in asthma management * asthma exacerbation within last 3 months * concurrent respiratory disease or other disease that would confound study participation or affect subject safety * allergies to study drugs, study drugs' excipients, or medications related to study drugs * taking another investigational medication or medication prohibited for use during the study. * previous participation in a vilanterol (gw642444) study

Keywords: asthma
role of cbc as a prognostic marker for dka patients

Conditions: Diabetic Ketoacidosis

Summary: 1. to evaluate that change of platelet-to-lymphocyte ratio affect the duration of hospital stay and mortality rate of dka patients 2. to assess the impact of red blood cell distribution width (rdw) on the prognosis of diabetic ketoacidosis patients 3. to evaluate the changes in hematological parameters (rbcs,hct,hb,mcv,plt,wbcs) and their correlations with acidosis level and dehydration during ketoacidosis treatment

diabetes mellitus (dm) is a serious threat to global health with an increasing prevalence and incidence rates,the number of people who had dm was 463 million in 2019,and according to international diabetes federation \[idf\] this number will have reached 700 million in 2045 (1). one of the most serious complication of dm is diabetic ketoacidosis (dka) which is a life-threatening acute copmlication of diabetes mellitus \[dm\], \[dka\] occur in patients with both type 1 and type 2 diabetes, for which type 1 and type 2 diabetes is responsible for 66% and 34% patients respectively (2,3). despite the development of improved treatment, dka remains at a high incidence of recurrence and a leading cause of mortality among patients with dm, resulting in an elevated burden for patients,hospitals,and healthcare providers(4,5). as a systemic metabolic disease,dka has been reported to be associated with the inflammatory response of the hyperglycaemic state(6,7). the inflammatory markers like (platelets-lymphocyte ratio, red blood cell distribution width) play an important role in the development of inflammation and affect prognosis of dka one of the most things that affected by diabetic ketoacidosis is hydration status, as dka can cause dehydration and some complications may result from that such as cerebral edema,coma or even death(8,9). there are many methods to estimate the hydration status such as clinical dehydration scale(cds), hematological parameters (rbc, hct , hb mcv, plt ,wbc) which are used as an alternative approach to estimate the extent of dehydration in dka patients(10,11).

Eligibility criteria:
inclusion criteria: * the study will include patient with type 1 or type 2 dm, patients \> 18 yrs, dka patients (based on the criteria of the american diabetes association (ada): plasma glucose \> 13.9 mmol/l (250 mg/dl), arterial ph \< 7.3 and a bicarbonate level \<18 meq/l, with ketonuria) exclusion criteria: * the study will exclude patients \<18 yrs , patients with history of hematological disease like(leukemia,hemophilia,thalassemia,sickle cell anaemia,polycythemia vera),patients with history of renal or cardiac or hepatic disease)

Keywords: cbc in dka patients
a study to investigate the effectiveness of an education support program on medication adherence in italian real life rheumatoid arthritis (ra) patients treated with subcutaneous (sc) abatacept

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to investigate whether an educational supported program (esp), including tight control procedures implemented through patient home care, has positive impact in terms of better adherence to the therapy with abatacept sc at 12 months after treatment start (1st injection). in the scope of this objective the adherence is measured by the medication adherence questionnaire (maq).


Eligibility criteria:
inclusion criteria: * informed consent to participate in the study signed by the patient * age ≥ 18 years at the date of consent subscription * diagnosis of active rheumatoid arthritis moderate to severe as per the 1987 american college of rheumatology (acr) criteria/2010 acr/ european league against rheumatism (eular) ra classification criteria * naïve of abatacept * initiated with abatacept sc either as 1st or 2nd line biologic treatment after inadequate response to previous therapy with one or more dmards according to summary of product characteristics (smpc) locally approved exclusion criteria: * participating in clinical trial or other non-interventional studies, excluding registries * inability to read and write * any condition that in the investigator's opinion might jeopardize the follow-up and the data collection for the entire study observation period (24 months)
virtual lifestyle medicine comparative effectiveness research

Conditions: Chronic Disease; Obesity; Sleep Disorder; Depression

Summary: this study evaluates the effectiveness of two online lifestyle medicine programs. participants will be randomized by residence, urban vs. rural, into one of two lifestyle medicine programs.

this study compares the effectiveness of two virtual lifestyle medicine programs across two settings: urban and rural. program materials include nutritional education, methods to reduce personal stress, and incorporation of physical activity in daily routine. bio-marker and subjective/self-reported survey measures will be collected at baseline, 5-weeks and six-months from baseline. study seeks to measure variations in participant outcomes across two lifestyle interventions, participant engagement and level of adherence.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * able to read and write english * access to high-speed internet * taking medication for at least one chronic disease condition such as high blood pressure, or are overweight (bmi of 25 or greater) * willing to provide blood samples at three time points * willing to complete online surveys at three time points exclusion criteria: * advised by physician to limit physical activity * previous experience with lifestyle medicine programs, specifically lifestyle medicine clinic, complete health improvement program, full plate diet * household includes someone who has previous experience with a lifestyle medicine program
study evaluating levonorgestrel/ethinyl estradiol (lng/ee) in pms

Conditions: Premenstrual Syndrome

Summary: the purpose of this study is to determine whether lng/ee is effective in the treatment of menstrual cycle related symptoms.


Eligibility criteria:
inclusion criteria: * healthy women aged 18 to 49 years * regular 21 to 35 day menstrual cycles for 3 months prior to study visit 1 * history of menstrual cycle related symptoms as determined by the investigator. exclusion criteria: * contraindication to combination oral contraceptives * depression requiring hospitalization or associated with suicidal ideation within the last 3 years * use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Keywords: levonorgestrel ethinyl estradiol premenstrual syndrome menstrual cycle related symptoms
zirconia bars for mandibular implant overdentures

Conditions: Edentulous Mouth

Summary: purpose: to assess the clinical and radiographic outcomes of computer-aided designed and manufactured (cad-cam) zirconia bars supporting mandibular implant-retained overdentures (iods) after a 3-year follow-up. methods: a prospective observational single-center study involving 30 edentulous patients rehabilitated with two mandibular implants and a mandibular implant overdenture supported by a computer-aided design - computer-assisted manufacturing zirconia bar with distal extensions was performed assessing clinical and radiographic parameters.


Eligibility criteria:
inclusion criteria: * edentulous individuals for more than one year. * individuals with sufficient anatomical bone conditions in the interforaminal area to place implants of 4.3mm in diameter and at least 10.0mm in length without bone augmentation needs. * written consent to participate and to attend the study and the yearly follow-ups. exclusion criteria: * individuals suffered from psychiatric problems. * history of cerebrovascular or cardiovascular accident within the last six months. * uncontrolled or insulin-dependent diabetes, immuno-compromised status, current chemotherapy, and leukocyte system diseases. * severe systemic health conditions do not allow surgical intervention with local anesthesia. * irradiated bone. * severe parafunctional habits * drugs or alcohol abuse. * insufficient oral hygiene. * unrealistic treatment demands. * smokers were not excluded, but a cessation protocol was suggested before the implant treatment. * unwillingness to participate in the study.

Keywords: cohort study edentulism implant overdentures zirconia prosthodontic maintenance dental implants
efficacy of intralesional prp +/- topical silymarin in the treatment of melasma

Conditions: Melasma

Summary: melasma is an acquired disorder of melanogenesis leading to hyperpigmentation and manifested by symmetrical brown to gray-black macules and patches with serrated irregular edges . it occurs especially in sun-exposed areas and affects young to middle-aged women. it is most commonly seen on the face and less commonly on the neck, arms, and chest . platelet rich plasma (prp) is defined as a small volume of autologous plasma that contains a high concentration of platelets obtained by centrifugation of autologous blood and subsequent suspension of platelets


Eligibility criteria:
inclusion criteria: * females in the reproductive age (18 years old and above) presented with melasma confirmed by wood's light. exclusion criteria: * pregnant and lactating. * systemic diseases that may cause facial hyperpigmentation (e.g: thyroid diseases, renal, hepatic or endocrinal disorders). * patients receiving depigmenting drugs oral or topical in previous 3 months, drugs that prolong bleeding as aspirin, hormone replacement therapy or contraceptive pills. * patients with anemia, thrombocytopenia, coagulopathies or patient on anticoagulant therapy and patients with iron deficiency. * patient with infections in the face e.g. herpes. * patients with history of scarring or keloid formation.
rhythmic risk of type 1 brugada syndrome and pulmonary infundibulum mapping

Conditions: Brugada Syndrome Type 1

Summary: brugada syndrome has been described as the association of a right bundle block with st segment elevation on the v1 to v3 electrocardiogram in patients with a structurally normal heart. the rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. in addition, the predictive value of ventricular pacing remains controversial; there is therefore currently no review to effectively assess rhythmic risk in patients with brugada type i syndrome. investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with brugada type 1 syndrome with a comparable ecg. the mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. only the catheter used differs from the usual procedure.


Eligibility criteria:
inclusion criteria: group 21 * brugada type 1 syndrome * age : 50-60 years old * asymptomatic * signed informed consent group2 * brugada type 1 syndrome * age \>18 years old * implantable defibrillator * having received at least 1 appropriate shock or a sudden sudden death * signed informed consent groups 1 and 2 exclusion criteria: * brugada type 2 or 3 syndrome * contraindication to electrophysiological exploration

Keywords: brugada syndrome ventricular arrhythmia sudden death
evaluation and implementation of mobile tracking devices to increase safety in hospitalized patients (monitor)

Conditions: Fitness Trackers; Hemodynamic Monitoring; Internet of Things; Postoperative Complications; Wearable Electronic Devices; Anesthesia; Surgery

Summary: the study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. in addition, patients' activity levels are recorded and correlated with various clinical parameters.


Eligibility criteria:
inclusion criteria: * patients with elective surgery (≥ 18 years). * written informed consent to participate in the study * planned invasive arterial blood pressure measurement exclusion criteria: * postoperative invasive ventilation * american society of anaesthesiologists (asa) class v * outpatient surgical procedure * previous participation in this study * patients unable to give consent or patients who do not have adequate german language skills * suspected lack of compliance * skin lesions of the forearms or inability to wear a tracking device * known allergy to latex/silicone/nickel