Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of kaletra in arv therapy experienced patients

Conditions: Human Immunodeficiency Virus

Summary: to demonstrate that patients treated with kaletra have an improvement in their quality of life compared to the quality of life they had with their previous nrti therapy.


Eligibility criteria:
inclusion criteria: * hiv infected subjects * subjects failing in current hiv treatment, or * subjects with a viral load \< 400 copies/ml and not tolerating their current hiv treatment. exclusion criteria: * subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit * subject is pregnant

Keywords: kaletra
cardiovascular function in adult survivors of childhood malignancies

Conditions: Childhood Cancers

Summary: anthracyclines have been used commonly to treat children with solid tumours and haematological malignancies and have led to their increased survival. nonetheless, anthracycline has the side effect of cardiotoxicity. the purpose of this study is to assess the impact of anthracycline therapy on heart deformation and fibrosis, heart-vessel interaction, usefulness of circulating biomarkers in the assessment of heart function and potential genetic predisposition to heart failure in adult survivors of childhood cancers.

incorporation of anthracyclines into chemotherapy protocols has improved the survival of children with solid tumours and haematological malignancies. nonetheless, longitudinal studies have implicated the absence of a safe anthracycline dose that is free of cardiotoxicity. substantial risk for cardiovascular disease has been shown recently in large cohorts of adult survivors of childhood and adolescent survivors. serial monitoring of cardiac function is hence of paramount importance in childhood cancer survivors for early detection of myocardial damage and timely institution of interventions. the optimal monitoring of cardiac function in the long term in these at-risk patients remains to be established. novel noninvasive imaging modalities including echocardiography and cardiac magnetic resonance allow interrogation of myocardial deformation and fibrosis, while circulating biomarkers are increasingly used to monitor the cardiac status in heart failure patients. additionally, genetics of heart failure are increasingly unveiled.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 35 years old * history of acute leukaemia diagnosed before 18 years old * completion of cancer directed therapy for at least 5 years. exclusion criteria: * history of congenital heart disease * presence of syndromal disorder such as down syndrome, neurofibromatosis, etc, * hypothyroidism not on replacement therapy * claustrophobia or other reasons rendering mri assessment not feasible.

Keywords: anthracycline cardiac function echocardiography biomarkers
comparing wound area reduction of non-healing dfus using moleculight i:x versus standard of care

Conditions: Non Healing Diabetic Foot Ulcer

Summary: this is a 12 week, randomized controlled trial. there are 2 arms and 20 patients with non healing diabetic foot ulcer allocated in each arm. one arm receives i:x guided treatment and the other arm receives standard of care treatment. our primary objective is to compare the wound area reduction in both arms.


Eligibility criteria:
inclusion criteria: * male or female patients presenting with chronic dfu * the chronic dfu has a surface area that has reduced \<25% in the previous 4 weeks1 prior to first study visit * patient has been receiving treatment for their dfu for less than 12 weeks. * the chronic dfu is \> 1 cm2 in area and less than 15 cm in length (max. diameter) * 18 years or older * willing and able to make all required study visits exclusion criteria: * • patients categorized as having a maintenance wound * use of skin substitutes or hyperbaric oxygen therapy or surgical intervention * treatment with an investigational drug within 1 month of enrolment * presents with chronic (\>10 mg/kg for \>30 days) systemic corticoids before enrolment * has abi \<0.5 (measured within 3 months of randomisation) * undergoing chemotherapy or is immunocompromised * diagnosed with charcot disease or ulcers from electrical, chemical or radiation burns, or presents with collagen vascular disease, ulcer malignancy, untreated osteomyelitis or cellulitis * recombinant or autologous growth factors or skin/dermal substitutes within 30 days of enrollment * inability or unwillingness to consent
a study to evaluate the effect of slimbiotics l. fermentum k8 postbiotic on weight management and metabolic health outcomes

Conditions: Metabolic Health; Weight Loss; Stress; Well-Being, Psychological; Sleep; Healthy Eating

Summary: this study is to evaluate the efficacy of a postbiotic supplement on weight management and metabolic health. this study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. two groups will be included: the intervention (slimbiotics postbiotic) and placebo. the slimbiotics postbiotic formula is the first plant-based postbiotic targeting weight management and metabolic health. other competing postbiotics are isolated from humans (feces) but the strains in slimbiotics were isolated from a fermented plant (millet porridge cereal) this product contains l. fermentum k8 postbiotic.


Eligibility criteria:
inclusion criteria: * women \& men * 18+ * bmi between 25-32 (average bmi of subjects shall not exceed 30) * generally healthy - don't live with any uncontrolled chronic disease * own a sleep-tracking device (smart watch etc.) exclusion criteria: * any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * anyone with known severe allergic reactions. * women who are pregnant, breastfeeding or attempting to become pregnant * unwilling to follow the study protocol. * subjects currently enrolled in another clinical study * subjects having finished another clinical study within the last 4 weeks before inclusion * hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum) * condition after implantation of a cardiac pacemaker or other active implants * sulfonylurea treatment * any disease or condition which might significantly compromise the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria * history of or present liver deficiency as defined by quick \< 70% * regular medical treatment including over-the-counter, which may have an impact on the study aims (e.g. probiotics containing supplements, laxatives, steroids etc.) * history of hepatitis b, c, hiv * subjects who are scheduled to undergo any diagnostic intervention or hospitalization which - may cause protocol deviations * simultaneous study participation by members of the same household * pregnancy and lactation * ascites as assessed by sonography * any diet to lose body weight * eating disorders or vegan diet * anorexia drugs present drug abuse or alcoholism
assessment of the impact of whole body cryostimulation on skin physiological indicators

Conditions: Quality of Life; Atopic Dermatitis

Summary: the aim of the planned study will be to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of patients with atopic dermatitis (ad). the aim of the study will be also to measure the oiling, hydration and ph of the skin of patients with ad after a series of treatments in a cryogenic chamber. each participant will complete a brief questionnaire on quality of life, life satisfaction index, self evaluation questionnare and dermatology life quality index (before and after the wbc procedures).

in this research project will be performed 15 treatments in cryogenic chamber (1 once a day, every day, with a break on saturdays and sundays). cryostimulation will be conducted in a cryochamber located in the małopolska cryotherapy centre in kraków, poland (polish: małopolskie centrum krioterapii). the whole body cryostimulation (wbc) exposure will be administered in a special temperature-controlled unit which consists of two rooms (-60° and -120°c). persons with any contraindications (both with ad and healthy) for whole body cryostimulation will be excluded from the study. patients with ad in treatment by phototherapy, cyclosporin a, oral corticosteroids, which are topical calcineurin inhibitors such as pimecrolimus and tacrolimus and patients during or after immunotherapy, children and adolescents under 18 years of age, breast-feeding mothers and pregnant, patients with inflammatory diseases, infectious, autoimmune and cancer will be excluded from research. the participants will be informed about how they should breathe and move in the cryochamber. entry to the cryochamber will be preceded by a 30s acclimatization period in the vestibule at a temperature of -60° c, after which the subjects will go directly to the proper chamber (-120° c) for three minutes. during the procedure, all participants will be clothed in shorts, wool socks, gloves and hats or headbands for protection from frostbite, as well as wooden clogs. additionally, participants will wear surgical masks with a layer of gauze over the mouth and nose for protection. throughout the session, the participants will be under direct supervision of qualified doctor.

Eligibility criteria:
inclusion criteria: * informed consent for research; * equal age and above 18 years of age; * no contraindications to cryostimulation procedures; * clinically diagnosed atopic dermatitis (people with ad); exclusion criteria: * lack of informed consent for research * patients with ad in treatment by phototherapy, cyclosporin a, oral corticosteroids, which are topical calcineurin inhibitors such as pimecrolimus and tacrolimus and patients during or after immunotherapy, * children and adolescents under 18 years of age, * breast-feeding mothers and pregnant, * patients with inflammatory diseases, infectious, autoimmune and cancer

Keywords: ad patients whole body cryostimulation
efficacy and safety of romiplostim in adult subjects with persistent or chronic immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia

Summary: the objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (itp).


Eligibility criteria:
inclusion criteria: * diagnosed with immune thrombocytopenia (itp) for at least 6 months prior to signing the informed consent form (icf). * subject is ≥ 18 years old while signing the icf. * patients who have no response or relapsed after splenectomy. or patients who have not been splenectomised and have no response or relapse to at least 1 prior treatment for immune thrombocytopenia (itp). * the mean of 3 scheduled platelet counts taken during the screening period must be: \ 35×10\^9/l. exclusion criteria: * any known history of bone marrow stem cell disorder. any abnormal bone marrow findings other than those typical of itp. * any active malignancy. if prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, and no treatment or active disease within 5 years prior to signing the icf.. * received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the icf. * received myeloproliferative leukemia (mpl) stimulation product other than the subject who had suspended recombinant human thrombopoietin (rhutpo) for injection for 4 weeks before signing icf. * received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the icf. * received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the icf. * less than 4 weeks since end of any clinical trials about therapeutic drug or device prior to signing the icf. * pregnant or breastfeeding. * in the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial.
outcome of icsi using cryopreserved testicular sperm from infertile men with varicocele-associated azoospermia

Conditions: ICSI AZOOSPERMIA VARICOCELE

Summary: this study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for icsi in an art program in sohag. patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

study approval: the study will be submitted for approval by research and ethical committees at faculty of medicine, sohag university. this study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for icsi in an art program in sohag . patients personal and medical history and socio-demographic data will be retrieved from their saved medical files. study design: prospective, controlled clinical study. control group: icsi cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. cases with known female factor infertility will be excluded. outcome measures: fertilization rate, embryo quality, chemical pregnancy and clinical pregnancy.

Eligibility criteria:
inclusion criteria: * cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for icsi in aى art program. * icsi cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. exclusion criteria: * cases with known female factor infertility

Keywords: varicocele-azoospermia-icsi
valsartan/hydrochlorothiazide combination in the treatment of severe hypertension

Conditions: Hypertension

Summary: the purpose of this study is to assess the potential of using valsartan/hctz as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.


Eligibility criteria:
inclusion criteria: * diagnosed severe hypertension exclusion criteria: * inability to discontinue all prior antihypertensive medications * heart failure of any kind * history of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm liver, kidney, or pancreas disease * diabetes with poor glucose control * allergy to certain medications used to treat high blood pressure other protocol-defined exclusion criteria may apply.

Keywords: hypertension high blood pressure valsartan/hydrochlorozide severe hypertension
accelerated treatment of endocarditis

Conditions: Endocarditis

Summary: existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks one or more types of intravenously administered antibiotics. the long hospitalization increases several risks for the patient, including mental strain and increased loss of function. furthermore, it poses a significant financial burden on the health systems. current guidelines fail to use available clinical and paraclinical, data collected from patients (echo, temperature, crp, leukocytes, procalcitonin etc.) to determine duration of treatment. a strategy including these data in treatment algorithms ensures an individualized treatment, targeting the individual patient's course and response to treatment. thus, the purpose of this open-label, prospective, non-inferiority, rct study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 475 patients, approx. 125 patients with each type of bacteria (streptococci; enterococcus faecalis; staphylococcus aureus).


Eligibility criteria:
inclusion criteria: * admitted with left-sided infectious endocarditis (duke criteria) * \< 14 days of relevant antibiotic treatment for endocarditis * one of the following bacteria: streptococci, enterococcus faecalis, staphylococcus aureus * \> 18 years old exclusion criteria: * known immune incompetency, * relapse endocarditis with 6 months, * unable to give informed concent
study to evaluate the efficacy and safety of abt-450/ritonavir/abt-267 (abt-450/r/abt-267) in japanese adults with subgenotype 1b chronic hepatitis c virus (hcv) infection

Conditions: Chronic Hepatitis C Infection

Summary: this is a phase 3, double-blinded, multicenter study. the study will consist of 2 substudies: substudy 1 (ss1) will be double-blinded and enroll non-cirrhotic subjects and substudy 2 (ss2) will be open label and enroll subjects with compensated cirrhosis.


Eligibility criteria:
inclusion criteria: * chronic hcv-infection prior to study enrollment * screening laboratory result indicating hcv subgenotype 1b infection * subject has plasma hcv rna level greater than 10,000 iu/ml at screening * voluntarily sign an informed consent * females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile exclusion criteria: * co-infection of hepatitis b virus (hbv), human immunodeficiency virus (hiv) or any hcv genotype other than subgenotype 1b * prior therapy with direct acting antiviral agents for the treatment of hcv, including telaprevir, simeprevir and boceprevir * any cause of liver disease other than chronic hcv-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease; clinically significant laboratory abnormalities; uncontrolled clinically significant disease, disorder or medical illness

Keywords: hepatitis c genotype 1b cirrhotic treatment experienced treatment naive japanese ombitasvir paritaprevir ritonavir viekirax combination tablets
geriatric hiv cohort in sub sahara africa

Conditions: HIV Infections; Non Communicable Diseases; Aging

Summary: the overall goal of the proposal is to improve capacity for detection and management of non-communicable diseases and geriatric syndromes in the aging hiv population in sub-saharan africa

the establishment and scale up of solid and sustainable hiv programs in sub-saharan africa (ssa) has led to a reduction in mortality and morbidity from hiv related opportunistic infections and some hiv related cancers. this improved survival has resulted in two phenomena: the first is the surfacing of non-communicable diseases (ncds) in the hiv population, especially in those on long-term art, and the second is increased longevity leading to increasing numbers of elderly hiv infected individuals

Eligibility criteria:
inclusion criteria: age 60 years and above * evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * any clinical (physical and psychiatric) condition which prevents the patients to participate safely in the study procedures according to the judgments of a physician. * subjects already enrolled in experimental clinical trial.
the effect of child position on the results of hyperventilation during routine electroencephalography

Conditions: Epilepsy

Summary: electroencephalograhy (eeg) is used as a tool for diagnosing epilepsy/convulsions. during the recording, especially for childen who are suspected of having abbcence epilepsy the investigators will perform an eeg recording including a provocation test of hyperventilation in order to induce epileptic discharges. there is no clear instruction about the position of the child during performing this hyperventilation provocation. clinical observations showed that this provocation is more effective when it's performed in the siiting position. no study was previously performed to investigate this issue

the study will include 30 patients at the age of 4-10 years old of both sexes. after signing an informed concent, every child, suspected of having absence seizures, will undergoe an eeg recording including a provocation of hyperventilation. the study will include two groups: 1. a group of 15 children who will undergoe an eeg recording with 3 minutes of hyperventilation in the prone position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. finally the participants will performed additional 3 minutes of hyperventilation in the sitting position 2. a group of 15 children who will undergoe an eeg recording with 3 minutes of hyperventilation in the sitting position, followed by 5 minutes of rest, then after another 5-10 minutes of recording with normal breathing. . finally the participants will performed additional 3 minutes of hyperventilation in the prone position. participants who will not be able to perform all the steps of the study will be excluded the analysis of the study results will be performed by a specialist in pediatric neurology and pediatric epilepsy who will confirm whether the eeg recording show epileptic discharge (sharp waves, slow waves, combination of sharp and slow waves, spikes or combination of spikes and slow waves)

Eligibility criteria:
inclusion criteria: * children suspected of having absence seizures in the ages mentioned above. * legal guardian approval exclusion criteria: * inability to perform hyperventilation * children who have absence seizure under anti-convulsive treatment
rapid diagnostic assay for gonorrhea and chlamydia

Conditions: Urethritis; Cervicitis; Sexually Transmitted Infections

Summary: this study is a pilot randomized controlled trial evaluating the use of either a) rapid 30-minute desktop assay or b) point-of-care gram stain (current standard of care) to guide the clinical management of patients with symptomatic urethritis or cervicitis evaluated in the massachusetts general hospital sexual health clinic. patients presenting with symptoms of urethritis or cervicitis and meeting inclusion criteria will be randomized to have diagnostic specimens tested during the clinical encounter using either the 30-minute desktop assay or point-of-care gram stain. patients randomized to the intervention arm of the study will also have a gram stain created, which will be held for interpretation by the clinician following the clinical encounter. patients will not be followed longitudinally. recruitment will conclude when 100 participants enroll in the study.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * presenting with symptoms of acute urethritis or cervicitis * willing to provide urine or additional vaginal swab specimen exclusion criteria: * younger than 18 years old * presenting with symptoms not consistent with urethritis or cervicitis * unwilling or unable to provide urine or vaginal swab specimen * pregnant * contact of index patients with gonorrhea or chlamydia * known exposure to gonorrhea or chlamydia * reporting concurrent symptoms at a non-genital site * suspected or confirmed to have monkeypox