Kornimate/medical-research-clean huggingface dataset:
continuing lamivudine versus switching to entecavir in patients who achieved undetectable hepatitis b virus dna

Conditions: Hepatitis B, Chronic

Summary: this is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg qd from lamivudine versus maintaining lamivudine 100mg qd treatment in chb patients currently receiving lamivudine monotherapy.

entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of lamivudine in nucleoside-naïve chb patients. the switch from lamivudine to entecavir in patients who have undetectable hepatitis b virus dna (hbv dna \< 60 iu/ml) may lead to more prolonged viral suppression to undetectable level by pcr method, compared to patients with continuous lamivudine treatment. the results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from lam to etv.

Eligibility criteria:
inclusion criteria: * adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic hbv infection for at least 6 months with \< hbv dna 60 iu/ml level and hbeag positive status. exclusion criteria: * subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study. * subjects should have alt \< 10 x uln, and no evidence of hepatocellular carcinoma. * subjects should be without serological evidence of co-infection with hcv, hiv, or hdv. * subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Keywords: chronic hepatitis b lamivudine entecavir
heart failure patients registry

Conditions: Heart Failure

Summary: this study is a multicenter non-interventional observational prospective registry. this non-interventional study (nis) does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation. the study will include only those patients who sign the informed consent form (icf) after explanation of the study objectives and methods by the study physician. planned study population consists of 20 000 adult outpatients with hf. all patients with hf who signed an icf will be included to this study. planned number of study sites is 150 outpatient centers in about 50 regions (in order to describe characteristics of outpatients with hf in different regions in the most comprehensive way). expected inclusion period duration - 24 months or reaching 20 000 patients, if this takes less than 24 months. planned follow-up period duration for 1 patient is about 52 weeks (12 months), which includes 3 visits (visit 1 - inclusion; visit 2 - approximately 6 months after inclusion; visit 3 - approximately 12 months after inclusion)


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at the time of inclusion; 2. signed and dated written informed consent in accordance with ich gcp and local law prior to inclusion in the study; 3. documented diagnosis of hf (according to clinical guidelines "chronic heart failure", 2020, approved by moh of rf) with typical symptoms/signs of hf consistent with i-iv functional classes of hf according to nyha classification. exclusion criteria: 1. the absence of signed icf; 2. the participation in any randomised controlled trial within 3 months before the inclusion in this study or during the participation in this study.

Keywords: heart failure
evaluation of bleeding on brushing using neem extract mouthwash versus chlorhexidine mouthwash

Conditions: Gingival Bleeding

Summary: i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of egyptian children.

1. first , we will select the patients according to the inclusion criteria. 2. we will take sulcus bleeding index which is defined as an index of gingival inflammation in which bleeding is measured from four gingival units using a periodontal probe. the scoring is ranging around eight anterior teeth from 0 to 5.in this study, we will take only score 2 which is bleeding on probing, change in colour and no edema in order to reduce variability. 3. 2%neem extract will be used to prepare mouthwash while, chlorhexidine will be used as positive control. 4. chlorhexidine will be coded with the letter "a" and the mouthwash of 2%neem extract with the letter "b". 5. the participants included will be allocated into 2 groups by drawing of sealed and opaque envelopes containing the codes "a" and "b" 6. the intra and extraoral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and who probe. all materials will be packaged in sterilization wraps and autoclaved, following the required biosafety standards. 7. the rinses will be performed twice daily, which will be supervised by the parents legal guardians previously instructed. kits containing toothpaste an brush will be provided, so that the patients will use the same toothpaste, avoiding any interference with the results. 8. after 3 weeks, we will ask the patient if there is any gingival bleeding in addition we will measure the sulcus bleeding index.

Eligibility criteria:
inclusion criteria: * 1. children aged 8-10 years old with gingivitis 2. cooperative children 3.both genders 4.medically free 5. sulcus bleeding index score is 2 exclusion criteria: * 1. children undergoing orthodontic treatment 2.children undergoing any other oral hygiene aid other than routine teeth brushing 3.children with known history of allergy to any mouthwash or drug 4.parents unable to give informed consent 5.children taking antibiotic or antiseptic in previous two months

Keywords: bleeding on brushing
inhaled interferon α2b treatment in mild-to-moderate covid-19 infected children

Conditions: COVID-19; Children

Summary: in the covid-19 pandemic era, a convenient and effective treatment for pediatric patients is unavailable. a multi-center chinese clinical trials with the aim to using interferon-α2b spray inhalation to develop new treatment strategies for the treatment of pediatric patients with mild or moderate type of covid-19. the purpose of this study is to determine the safety and efficacy for interferon α2b spray inhalation as first line treatment.

this project aims to improve the treatment of pediatric patients infected with covid-19. interferon has antiviral property and is approved to be used in treatment in hepatitis b and hepatitis c virus infections. interferon α2b, β1a and lambda are under evaluation in clinical trials for the treatment of covid-19 in adult. as upper respiratory tract infection is the dominant characteristic of most infected children, topical treatment may be a better way to increase the safety and efficacy than oral or intravenous medication. this study aims to obtain essential data regarding the efficacy and safety of inhaled interferon α2b in children with mild to moderate covid-19 infection. subjects will be enrolled with covid-19 infection diagnoses by orf1ab gene and n gene pcr test. standard evaluation process will be applied to identify mild and moderate patients. patients will be randomized into interferon group and non-interferon group. patients in interferon group will receive inhalation treatment within the first five days since the symptom onset. patients will receive daily pcr test. cycle threshold (ct) values over 35 is considered as de-isolation criterion. days requiring isolation (from symptom onset to de-isolation time point) is the major index to evaluate efficacy. clinical manifestations and test results from clinical recording system will be collected to evaluate the side effects.

Eligibility criteria:
inclusion criteria: * patients diagnosed as mild to moderate covid-19 infection with positive pcr test and symptoms (ct \< 35) * parents and patients comprehend and welling to participate in this study. * agree to the collection of nasal swabs per day as protocol. exclusion criteria: * patients evaluated as severe or critically severe type of covid-19 infection (individuals who have spo2 \<94% on room air, oxygen treatment is necessary, respiratory failure, septic shock, and/or multiple organ dysfunction). * patients with comorbidities * decline to participate by parents or children * allergy to any study medication or usage of any kind of interferon treatment within 14 days before test * children cannot tolerate the inhalation treatment * any situation where the program cannot be carried out safely.

Keywords: interferon α2b inhaled treatment
development of a novel stress testing protocol to define the relationship between coronary microvascular dysfunction and diastology in women with angina but no evidence of obstructive coronary artery disease

Conditions: Microvascular Coronary Dysfunction

Summary: microvascular coronary dysfunction (mcd) (abnormities in small blood vessels/arteries in heart) with symptoms of persistent chest pain, primarily impacts women. there are an estimated 2-3 million women in the us with mcd and about 100,000 new cases annually. recent data from our research group suggests that coronary microvascular disease impairs the way the heart relaxes. this pilot study will attempt to exacerbate this phenotype in an effort to better understand the pathophysiology of the disease. the investigators will recruit 30 volunteers total (10 healthy calibration subjects, 10 women with microvascular disease, and 10 age-match women for the group with microvascular disease). subjects will undergo a series of "stress" maneuvers in conjunction with advanced cardiac magnetic resonance imaging.


Eligibility criteria:
inclusion criteria: 1. fully understanding and willing to undergo study procedures 2. male or female greater than or equal to 18 years of age 3. understanding and willing to sign consent form. exclusion criteria: 1. history of cardiovascular, pulmonary, or neurological disease 2. hypertension (sitting blood pressure \>140/90 mmhg, with measurements recorded on at least 2 occasions) 3. diabetes 4. unable to give informed consent; 5. contra-indication to cmri testing, including claustrophobia and metallic implants 6. adherence or retention issues; 7. women who are pregnant. 8. allergy to animal dander.
safety and feasibility of reversible induction strategy

Conditions: Patients With Uncertain Difficult Airway; Colon Cancer; Gastric Cancer; Prostatic Cancer

Summary: this study would explore the safety and feasibility of a reversible induction strategy for uncertain difficult airway. this reversible induction strategy would include high flow nasal canular oxygenation support, short-term effect anesthetic including propofol and remifentanil for sedation and analgesia and sugammadex would be used for reverse the muscle relaxant.


Eligibility criteria:
inclusion criteria: * \>18 years old,\<65 years old * signed informed consent * undergoing selective operation （ time of operation is over two hours） * asa classification i-ii * mallampati classification 3-4 * suspicious difficult airway, but the anesthetists decide to try to rapid induction exclusion criteria: * patients with several dysfunctions of liver, kidney or heart) * patients with a full stomach or have other risk factors of reflux aspiration * any medicine was taken before surgery, which might enhance or mitigate the effects of muscle relaxant * infection of the mouth or nose * allergy history of any medicine which would be used in this study * pregnant and lactating women * patients with neuromuscular disease

Keywords: thrive uncertain difficult airway reversible induction strategy
single dose monurol for treatment of acute cystitis

Conditions: Urinary Tract Infection

Summary: urinary tract infecton (uti) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. one of the most common antibiotics used to treat utis is trimethoprim-sulfamethoxazole (tmp-smx), usually for total of three days. however, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for uti. an alternative antibiotic which is also fda approved for the treatment of utis is fosfomycin (monurol). the effectiveness of fosfomycin in curing utis when given as a single dose is not well studied. the purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of tmp-smx.

procedures subjects will undergo once they have read and signed the consent are: questions about their medical and sexual history and current symptoms of uti. they will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.they will be given a sheet to record symptoms at home. they will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapy.follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Eligibility criteria:
inclusion criteria: * non pregnant women in good health with symptoms of acute cystitis for less than 7 days exclusion criteria: * pregnant, lactating, or not regularly contracepting * history of chronic conditions such as diabetes * known anatomic abnormalities of the urinary tract * use of prophylactic antibiotics * history of allergy or intolerance to any of the study drugs * recent (\> 2 weeks)exposure to oral or parenteral antimicrobial * history of uti in previous 1 month

Keywords: uti
evaluation of the use of various assessments of common cold symptoms for proof of efficacy of coldzyme mouth spray

Conditions: Common Cold

Summary: this study evaluates the use of various assessments of common cold symptoms for proof of efficacy of coldzyme mouth spray on naturally acquired common colds. half of the participants will receive coldzyme® mouth spray while the other half may use optional care as needed.


Eligibility criteria:
inclusion criteria: 1. men and women 2. age 18 to 70 years old 3. increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to v1) but generally in good health 4. readiness to comply with trial procedures: * use of ip as recommended (verum group) * filling in diary * keeping habitual diet and physical activity level 5. women of child-bearing potential: * have to agree to use appropriate contraception methods * negative pregnancy testing (beta human chorionic gonadotropin test in urine) at v1 participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study. exclusion criteria: 1. known allergy or hypersensitivity to the components of the investigational product 2. history and/or presence of clinically significant condition/ disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.: * nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or reconstructive surgery * acute/chronic airways disease/disorder (e.g. chronic obstructive lung disease, asthma, chronic cough of any origin) * acute psychiatric disorders * any other acute/chronic serious organ or systemic diseases 3. influenza vaccination within the last 3 months prior to v1 and during the study 4. regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/antirheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to v1 and during the study (except for the defined optional care) 5. pregnancy or nursing 6. history of (in the past 12 months prior to v1) or current abuse of drugs, alcohol or medication 7. participation in the present study of a person living in the same household as the subject 8. inability to comply with study requirements according to investigator's judgement 9. participation in another clinical study in the 30 days prior to v1 and during the study
a study of wr 6026 in the treatment of pneumocystis carinii pneumonia (pcp) in hiv-infected patients

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to evaluate the efficacy of wr 6026 once daily in the treatment of mild pcp. to evaluate the safety and tolerance of wr 6026. to assess the correlation between plasma wr 6026 concentrations and outcome/toxicity.

all patients will receive an initial loading dose of wr 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of wr 6026 taken in a fasting state for 3 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * any medications not listed as excluded will be permitted on study. \[ as per amendment 4/11/97:pcp prophylaxis is permitted if initiated after the day 21 evaluation has been completed.\] patients must have: * documented hiv infection. * documented pcp. * on a room air abg, the po2 value greater than or equal to 70 mm hg and the (a-a) do2 less than 35 mm hg. * signed informed consent from parent or legal guardian for those patients less than 18 years of age. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known hypersensitivity to quinolines. * if patient is unwilling or unable to discontinue other medications with anti-pcp activity during the treatment period of this study. concurrent medication: excluded: * any patient unwilling or unable to discontinue other medications with anti-pcp activity during the treatment period of this study (e.g., tmp/smx, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine). * methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites). patients with the following prior conditions or symptoms are excluded: * history of g6pd deficiency, hemoglobin m abnormality, or nad methemoglobin reductase deficiency. prior medication: excluded: * more than 24 hours receipt of anti-pcp treatment for the current episode of pcp. receipt of prior pcp prophylaxis is permitted, as long as it is discontinued at study entry.

Keywords: aids-related opportunistic infections pneumonia, pneumocystis carinii administration, oral wr 6026
effects of intra-uterine slow-release insemination on pregnancy rate in women designated for artificial insemination

Conditions: Infertility

Summary: a couple that does not achieve pregnancy though regular attempts for a year are defined infertile couple. this condition is caused by faulty functioning of the reproduction system of the husband or wife or both. if there are no organic defects and there is no definite injury to the reproductive system (ova or spermatozoa), the specialist doctor generally decides to put the couple into a fertility treatment program. artificial insemination is one of the important ways of achieving pregnancy. three common methods of artificial insemination: 1. placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution (cup insemination, ci) upon the cervix. 2. spermatozoa injection (after improvement) through the vagina to the cervix (intra-cervical insemination, ici). 3. spermatozoa injection (after improvement) directly into the uterus (iui-intra-uterine insemination). the evie - slow release insemination method: the slow release insemination is utilizing a grasby type ms16 pump for 3 hours. the release rate for motile spermatozoa is 50x103 per minute. advantages: * very close approximation of the natural procedure in which the spermatozoa arrive to the fertilization site over a long period. * an extended "window of opportunities" for meeting between the ovum and spermatozoa will be longer. * there is no loss of spermatozoa due to leaking as sometimes happens with single-time injection practiced in the iui method. primary endpoint: accumulation of 50 cycles of sri- slow release insemination (study group) in addition to 50 cycles of regular iui (control group). two weeks after insemination beta hcg test secondary endpoints: four weeks after insemination - us viability scan procedure: subjects will be women with fertility difficulties who are designated for iui treatment. 100 insemination cycles will be conducted. (50 regular iui and 50 evie-sri). subjects that were treated with the iui method and who does not become pregnant will then be treated with the evie-slow release method and vice versa.


Eligibility criteria:
inclusion criteria: * primary or secondary infertility designated for iui treatment. * age of candidates: 20-40 years. * normal uterus x-ray. * women suffering from infertility on a background of non-ovulation. * infertility on a background of male problems (over 10 million of motile sperm cells per sample). * infertility on background of unexplained problem * same sex patients / single patient * written informed consent exclusion criteria: * woman under the age of 20 or over the age of 40 years. * female infertility on mechanical background (different blockages, irregular uterus). * infertility on male background of medium to very low level of spermatozoa - less than 10 million motile sperm cells per sample. * men and women who are opposed to the random spermatozoa insemination method. * participants who are not willing to sign the consent form.

Keywords: infertility insemination slow release
t-cell receptor α/β depleted donor lymphocyte infusion

Conditions: Lymphoid Leukemia, Acute; Myeloid Malignancy; Plasma Cell Tumor

Summary: this pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a t-cell depleted allogeneic hematopoietic cell transplantation (tcd hsct). this study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. these cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.


Eligibility criteria:
inclusion criteria: * patients with hematologic malignancies that are candidates cd34+ selected, t-cell depleted allogeneic hematopoietic stem cell transplantation. * patients must have a karnofsky (adult) performance status of at least 70%. * patients must have adequate organ function measured by: * cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (lvef) at rest must be 50% and must improve with exercise. * hepatic: \< 3x upper limit of normal (uln) ast and \< 1.5 mg/dl total serum bilirubin, unless there is congenital benign hyperbilirubinemia. patients with higher bilirubin levels due to causes other than active liver disease is also eligible with pl approval (e.g., patients with pnh, gilbert's disease or other hemolytic disorders). * renal: serum creatinine: ≤ 1.2 mg/dl or if serum creatinine is outside the normal range, then creatinine clearance (crcl) \> 40 ml/min (measured or calculated/estimated). * pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (dlco) 50% of predicted (corrected for hemoglobin). * each patient must be willing to participate as a research subject and must sign an informed consent form. exclusion criteria: * patients with active acute gvhd.