Kornimate/medical-research-clean huggingface dataset:
clinical impact of bactek-r in subject with mild pneumonia due to covid-19 infection

Conditions: COVID-19

Summary: the purpose of the study is to confirm if bactek-r (mv130) provides clinical benefit in subject with mild pneumonia (curb-65≤2) by covid-19 admitted to the hospital.

this is a prospective, open-label, randomized pilot study to evaluate the efficacy and safety of bactek-r (mv130) in subject with mild pneumonia due to covid-19 infection.

Eligibility criteria:
inclusion criteria: 1. - subjects who voluntarily sign informed consent forms 2. - both genders. 3. - subjects aged between 18 and 70 years. 4. -subjects capable of complying with the treatment 5. - subjects admitted to hospital with non-severe pneumonia (curb-65≤2) by covid-19 6. - confirmatory test for covid-19 infection exclusion criteria: 1. - subjects who has not signed informed consent forms 2. - subjects included in another clinical trial. 3. - subjects under treatment with immunosuppressants. 4. - subjects in treatment with another type of immunotherapy. 5. - subjects who are or have been undergoing treatment with metformin. 6. - subjects who are or have been treated with statins. 7. - subjects who are or have been under treatment with sertraline. 8. - pregnant women. 9. - subjects who cannot offer cooperation and / or have serious psychiatric disorders. 10. -subjects who are allergic to any of the components of bactek-r (mv130). 11. - subjects with pathologies described in the charlson index
lidocaine-prilocaine (emla) cream as analgesia in hysterosalpingography practice

Conditions: Gynecological Pathology

Summary: the purpose of this study is to demonstrate that lidocaine-prilocaine cream decrease pain during hysterosalpingography diagnostic practice.


Eligibility criteria:
inclusion criteria: * patients that must perform a hysterosalpingography * acceptance to participate in the study signed informed consent exclusion criteria: * hypersensitivity or allergy to anesthetics * refusal of the patient * patients under age 18 years old and pregnant * unbearable pain that involves other analgesic measures

Keywords: hysterosalpingography prilocaine local anaesthetic pain relief gynecological pathology
pilot study of stellate ganglion injection to provide relief from hot flushes

Conditions: Hot Flashes; Menopause

Summary: this study is being done to determine whether stellate ganglion injection with local anesthetic (the study procedure) can reduce the number and severity of hot flashes in women who have hot flashes. hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue and irritability during the day. hot flashes are the most common reason that women seek hormonal therapy. however, for many women, including breast cancer survivors, this is rarely an option, and these women seek alternatives to hormonal therapy to treat hot flashes. the study procedure has been in clinical use for more than fifty years in treating certain disease states and chronic pain. the study procedure has not been used to relieve hot flashes and the use of the study procedure with local anesthetic for the reduction of hot flushes is considered experimental.


Eligibility criteria:
inclusion criteria: * women surgically or naturally menopausal, * experiencing moderate to severe hot flushes, and * elect to undergo stellate ganglion block procedure. exclusion criteria: * subjects who are currently sick, * subjects have acute infections or cardiac compromise, * subjects who have local infections of the anterior neck region, severe * subjects who have pulmonary disease, * subjects who are anticoagulated, * subjects who are on hormone therapy, * subjects who have a blood clotting disorder, * subjects who have an american society of anesthesiologists (asa) physical status score of 3 or higher (severe systemic disease, not incapacitating), * subjects who have allergic reactions to local anesthetics and/or contrast dyes, * subjects who have past or present diagnosis of psychosis, * subjects who have current diagnosis of depression, or * subjects who have current substance or alcohol abuse.

Keywords: hot flushes (vasomotor symptoms)
study to evaluate the efficacy of octenisept® in patients with chronic wounds

Conditions: Ulcus Cruris

Summary: this is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. the study will be conducted at a single center with a total of 70 patients. patients will be randomized to either the octenisept® group or to the placebo group.

randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. the study will be conducted at a single center with a total of 70 patients. patients will be randomized to either the octenisept® group or to the placebo group. primary objectives: antimicrobial efficacy of octenisept® compared to placebo. secondary objectives: subjective tolerance of octenisept®, evaluation of wound parameters.

Eligibility criteria:
inclusion criteria: * male and female patients of at least 18 years at the time of consent * patients with a venous leg ulcer (ulcus cruris) * patients with a chronic leg ulcer * females of childbearing potential who are willing to comply with any applicable contraceptive requirements of the protocol * negative pregnancy test * satisfactory medical assessment * ability to provide written informed consent * signed declaration of consent * willingness to co-operate exclusion criteria: * pregnant or lactating women and women not using contraception * known history of alcohol or drug abuse * use of any antibiotic medication within the last 7 days prior to the first dose * patients with serious concomitant disease * patients with a coagulation disorder * known history of allergic reactions attributed to octenisept® or one of its compounds * participation in another clinical trial within the last 30 days before randomization * concomitant treatment with other preparations that interfere with the trial preparation or the disease * absence of declaration of consent * doubt about willingness to co-operate * non-fulfilment of the inclusion criteria

Keywords: ulcus cruris chronic wounds octenisept®
different treatment modality in necrotic primary molars

Conditions: Primary Teeth; Dental Pulp Regeneration

Summary: necrotic primary molars in preschool children will be treated with the regeneration concept to provide a healthy biological environment within the root canal system and regression in clinical signs and symptoms which are the primary outcomes of regeneration treatment.

a convenient sample of preschool children have a necrotic primary second molar randomly allocated to one of the 3 study groups which are: group a (control) treated by the conventional treatment ( pulpectomy followed by stainless steel crown ssc), group b: treated by regeneration using triple antibiotic paste followed by ssc), group 3:(treated by regeneration using calcium hydroxide with iodoform(metapex) followed by ssc. the 3 groups were evaluated at baseline, 6 months and 12 months for clinical and radiographic success.

Eligibility criteria:
inclusion criteria: * a child with one or more necrotic primary teeth * presence of abscess/fistula * sensitivity to percussion * presence of maximum grade 2 mobility ( not more than 1 mm) * increases of the dental lamina dura * cooperative patients exclusion criteria: * medically compromised children * patient allergic to any of the used materials * presence of pathologic root resorption (internal-external) or more than 1/3 of the apical root. * presence of vitality in the canals * presence of grade 3 mobility * non-restorable teeth

Keywords: triple antibiotic paste
development of dysphagia protocol in ankara city hospital stroke patients

Conditions: Stroke, Acute

Summary: stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.the aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.fifty-five patients with acute stroke and dysphagia who were admitted to ankara city hospital neurology clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. when the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge.

stroke, also called cerebrovascular disease, is a sudden-onset neurological disorder that causes a regional or general dysfunction in the brain due to vascular causes. dysphagia, one of the common complications of stroke, is associated with increased morbidity and mortality.the aim of this study is to evaluate the clinical evaluation of swallowing in stroke patients and to determine the factors affecting the severity and prognosis of dysphagia in patients with dysphagia.fifty-five patients with acute stroke and dysphagia who were admitted to ankara city hospital neurology clinic and diagnosed with stroke by neurology and who did not meet the exclusion criteria will be included in this study. when the patients are admitted to the neurology clinic and will be discharged, they will be evaluated three times, in the first month after discharge. clinical evaluations will be made by the responsible investigator in the examination room. patients will be evaluated with a bedside swallowing screening test. patients will be divided into 3 groups as mild, moderate and severe dysphagia according to the test. the patients will be evaluated while they are in the neurology clinic and 1 month after the treatment is given.

Eligibility criteria:
inclusion criteria: * diagnosed with acute stroke by neurology * having trouble swallowing * 18-85 years old, volunteers exclusion criteria: * unconscious * uncooperative * those with oropharyngeal structural damage * patients with malignancies involving the head and neck region
evaluation of a psychological capital intervention to alleviate burnout and regulate immunity among oncology nurses

Conditions: Burnout; Psychological

Summary: burnout appears to be highly prevalent among oncology nurses, which was a problem not only for the nurses themselves but for the patients for whom they provide care. how to mitigate and prevent burnout and improve nursing performance outcomes is an urgent problem for nursing manager. in a sample of 99 oncology nurses, immunological characteristics were compared to burnout scores. in a randomized trial, 90 oncology nurses suffering burnout were randomized to receive psychological capital intervention or routine psychological care. participants were assessed before and after treatment using measures of burnout, psychological capital and immunological characteristics.

burnout appears to be highly prevalent among oncology nurses, which was a problem not only for the nurses themselves but for the patients for whom they provide care. and burnout-associated biomarkers remain controversial, and their potential roles in burnout are still unclear. this study was a randomized controlled trial in which the independent variable was group psychological intervention, while the dependent variables were pre- and post-intervention scores on the maslach burnout inventory and on the psychological capital scale, as well as values for various immunological indicators. in stage 1 of the study, recruited subjects completed the psychological capital questionnaire and blood was sampled. in stage 2, the research team administered a custom-designed psychological capital intervention (pci) to part of the sample, while the other part received routine care . the pci group received 1 h of counseling twice weekly for a total of 24 weeks in total. in stage 3, the pci and control groups completed the questionnaires again and provided blood samples.

Eligibility criteria:
inclusion criteria: * subjects were officially employed and licensed nurses who had been working in the cancer hospital for at least 2 years. exclusion criteria: * subjects had recently suffered personal health problems or significant negative life events, such as the death or serious illness of a family member, or if they were on maternity leave or other types of leave from their nursing job.

Keywords: burnout oncology nurses positive psychology capital intervention immune variables
exhaled carbon monoxide as a marker of hemolysis in sickle cell disease- an exploratory study

Conditions: Sickle Cell Disease

Summary: the investigators propose to evaluate etco in patients with hbss, hbsc, and hbs-beta thalassemia during routine clinic visits, and longitudinally. our goal is to know whether etco differs amongst subjects with different sickle cell syndrome genotypes, and whether it is a stable marker of hemolytic rate, as reflected in routine labs obtained for clinical care (including total hemoglobin, reticulocyte count, lactate dehydrogenase, and, when sampled, total and direct bilirubin). we hope to establish whether this inexpensive and non-invasive test faithfully reflects hemolytic parameters in sickle cell syndromes.

this is an observational study of sickle cell patients with the aim to measure exhaled carbon monoxide levels and to correlate with genotype and standard clinical markers of hemolysis. upon enrollment and at each subsequent visit, if acceptable to the patient, each subject will undergo measurement of exhaled carbon monoxide utilizing a hand held carbon monoxide monitor, microco/smoke check. subsequent evaluations may be obtained during a routine visit, while hospitalized for a vasocclusive crises (voc) episode, or when evaluated in the acute care clinic. the principal study objective is to assess if exhaled carbon monoxide levels are a non-invasive marker of hemolysis in subjects with sickle cell disease (scd). the secondary study objective is to assess exhaled carbon monoxide levels serially in subjects with scd, relative to vasocclusive crises, transfusion requirements, and pain syndromes. the one inclusion criteria is for all adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions. the exclusion criteria are a recent (2 week) history of lung infection, asthma, acute chest syndrome, or copd exacerbation and/or a significant pulmonary dysfunction in the recent (3-6 month) past.

Eligibility criteria:
inclusion criteria: all adult sickle patients presenting for follow up at the outpatient sickle cell clinic who are capable of following simple instructions. exclusion criteria: a recent (2 week) history of lung infection, asthma, acute chest syndrome, or copd exacerbation and/or a significant pulmonary dysfunction in the recent (3-6 month) past.

Keywords: carbon mono oxide sickle cell hemolysis
a phase 1 study of kbp-5209 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to determine the maximum tolerated dose of kbp-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

this is a phase 1, open-label, multicenter study of kbp-5209 administered orally once daily (qd) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. this study is designed to determine the mtd or rp2d and to characterize the safety, tolerability, and pk profile of kbp-5209.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists. * patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by recist v1.1 * eastern cooperative oncology group performance score 0 to 2; exclusion criteria: * patients with symptomatic cns metastases; * patients who have a known history of hepatitis c or chronic active hepatitis b or a known diagnosis of hiv * any significant ophthalmologic abnormality * patients who have any severe and/or uncontrolled medical conditions * significant gastrointestinal abnormalities, * patients who have impaired cardiac function or clinically significant cardiac diseases, * chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on day 1 or have not recovered from the side effects of such therapy; * treatment with third generation egfr inhibitors * major surgery/surgical therapy for any cause within 4 weeks of screening;

Keywords: cancer advanced solid tumors egfr her2 her3 her4 alk mutations irreversible tyrosine kinase inhibitor metastatic non small cell lung cancer gastric cancer colorectal cancer
nutritional support and telemedicine

Conditions: Malnutrition

Summary: the aim of this clinical trial is to assess the implementation of an app to track the nutritional status and diet habits of "chronic complex patients"(ccp) in order to improve their nutritional status and evaluate the level of adherence to dietetic counseling.

the aim is to evaluate the usage of an app and track the nutritional status of "chronic complex patients"(ccp) in order to improve their nutritional status. this is a study of an experimental design, referring to a controlled randomized trial with ccp in the moises broggi hospital.in the first stage, there's been an elaboration of the contents of the app. for the assessment of the strategy of food education, two groups of patients will be defined(intervention group (ig) \& control group (cg)). in each group there will be 91 subjects, meaning a total of 182 patients. inclusion criteria: \>18 years old, ccp with either malnutrition, or risk of malnutrition (mna\<23,5), therapeutic profile \<3, living at home, with full accessibility and capable to use a smartphone, and usual internet consumers (patients or caregivers), and who need to sign the informative consent. the inclusion of this study, will be made through a random sampling and patients will be assigned to ig or cg. all patients will undergo an initial evaluation, a follow-up visit after the first 6 months, and then a final visit after 12 months. the intervention group will also contain an educational, and nutritional program by means of the app throughout the entire study, and data will be collected through a telematic questionnaire between visits. the variables to study are nutritional, diet, clinics, social and valorisation tools ict (ig).

Eligibility criteria:
inclusion criteria: * \>18 years old * polymorbidity * malnourished patient or patient at risk of malnutrition (mna≤23.5) * patient living at home, with access to and able to use a smartphone and regular internet users (patients or caregivers) * patient who agrees to participate in the study by signing the informed consent form exclusion criteria: * established artificial nutrition * advanced dementia * admission to a nursing home/social care for a period of \>1 month * patients not responding to the telematic visits on more than 2 occasions.

Keywords: telemedicine nutritional support polimorbidity patients
feasibility study of preimplantation genetic diagnosis for single-gene disorders

Conditions: Preimplantation Diagnosis

Summary: preimplantation genetic diagnosis (pgd) for monogenic diseases is usually performed by multiplex pcr combining polymorphic microsatellites familial analysis and, where possible, couple-specific mutation detection. single-cell multiplex pcr developments are costly and time-consuming. we propose to test and clinically validate a targeted next-generation sequencing approach for the pgd for cystic fibrosis. this technique would allow a pgd for probably almost every couple asking for it in our centre, without a previous couple-specific development (but only a preliminary familial analysis). it will be based on haplotyping using a large number of snps and mutation detection. a clinical validation will be performed by reanalysing non-transferable embryos obtained after pgd for cystic fibrosis, with couple's informed consent. concordance of the results between pgd and reanalysis by ngs will be achieved and if validated, this technique may be applied to future pgd for cystic fibrosis in our centre. the same technique may then be applied for other pgd indications for which a set-up is often needed.


Eligibility criteria:
inclusion criteria: * age\> or = 18 years * couples at risk of transmitting cystic fibrosis * asking for a pgd in strasbourg * dna samples available at the laboratory for: * the couple * a related with cftr status known * having signed an informed consent exclusion criteria: * inability to give informed consent (understanding difficulties...)

Keywords: preimplantation genetic diagnosis pgd next-generation sequencing ngs single-gene disorders cystic fibrosis cftr single-cell analysis pcr snp whole genome amplification
study of fk788 in subjects with chronic hepatitis c virus infection

Conditions: Hepatitis C

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4 weeks therapy with fk788 in subjects with chronic hepatitis c virus (hcv) infection. also, to assess the effect of fk788 on serum alt concentration and hepatitis c viral level during therapy and for four weeks following therapy.

this is a multi-center, randomized, investigator and subject blinded, placebo-controlled eight week study, including a four week treatment period and a four week follow-up period. three cohorts of hcv positive subjects will be studied in a sequential manner.

Eligibility criteria:
the following criteria is a brief summary of criterion required for trial participation. inclusion criteria * has chronic hepatitis c virus infection and has previously received at least three months of treatment with any approved therapy and failed to respond, relapsed or did not tolerate therapy * has positive hcv rna by rt-pcr * has abnormal alt levels (at least 2 x uln) * has liver biopsy within past 2 years consistent with chronic hepatitis, no evidence of non-alcoholic steatohepatitis or cirrhosis, and at least mild inflammation * has normal liver function indicated by: pt =\ = 3.5 g/dl, total bilirubin =\< 1.5 mg/dl * ana titer =\< 1:160 exclusion criteria * has positive skin test for tuberculosis * has alt value \>= 300 iu/l * has abnormal hematological parameters indicated by: anc \< 1500/mm3 and platelets \< 100,000/mm3 * has creatinine \> 1.5 x uln * afp \> 50 ng/ml and evidence of hepatocellular carcinoma on ultrasound * is a carrier of the hepatitis b surface antigen (hbsag), positive for hiv-1 and/or hiv-2 antibodies

Keywords: hcv