Kornimate/medical-research-clean huggingface dataset:
hilotherapy for prevention of chemotherapy-induced peripheral polyneuropathy

Conditions: Equipment and Supplies

Summary: prospective study of hilotherapy of hands and feet as prevention of chemotherapy-induced peripheral polyneuropathy induced by taxan-based chemotherapy regimen that are used in the therapy of breast cancer and genital malignoma of the women.

in this trial, patients receiving taxan-based chemotherapy regimen e.g. paclitaxel, nab-paclitaxel or docetaxel in gynecological malignancies such as ovarian cnacer, breast cancer, endometrial cancer or cervical cancer will either receive cooling of hands and feet during the application of above-mentioned substances or not. the cooling will be provided by a machine called hilotherm chemocare unit and will be administered constantly at a temperature of 15-17°c. randomization will be 50:50. if a patient is randomized in the non-interventional arm, no cooling is allowed during the application of the chemotherapy. to assess the occurance and the extent of peripheral neuropathy, a neurological examination will take place before the start of chemotherapy, in the middle of the planned cycles of chemotherapy and after the completion of the regimen. quality of life and the subjective impacts of peripheral neuropathy will be evaluated via questionnaires.

Eligibility criteria:
inclusion criteria: * written consent for participation in this trail * age ≥18 years * female * breast or genital cancer of the woman * planned application of a taxan-based chemotherapy regimen (paclitaxel, nab-paclitaxel, docetaxel) independent of the therapy line * taxan- and platin-naivity * sufficient knowledge of the german language to assure an adequat survey of patient's history exclusion criteria: * pre-existing peripheral polyneuropathy * chemotherapy with taxan- and/or carboplatin-based regimens in a preceding therapy * existence of one of the following diseases: diabetes mellitus (of any type), neurological diseases that are involving peripheral nerve damage (e.g. multiple sclerosis, amytrophic lateral sclerosis, parkinson's disease), chronic pain syndrome, cryoglobulinemia, cold hemagglutination, cold hives / cold contact hives, raynaud's disease, significant peripheral artery disease, * lack of knowledge of german * males

Keywords: chemo-induced peripheral polyneuropathy taxan hilotherapy
a study to compare the effects of two anti-hiv drug combinations on the immune systems of hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to examine how the immune systems of hiv-infected patients react to 2 anti-hiv drug combinations.

patients are randomized to two study arms for at least 48 weeks of treatment. arm a receives sqv sgc plus rtv plus two nrtis of choice. arm b receives efv plus two nrtis of choice. nrtis approved for study use are stavudine (d4t), didanosine (ddi), zidovudine (azt), lamivudine (3tc), combivir, and zalcitabine (ddc). abacavir is excluded. the following immunology variables and hiv-1 viral characteristics will be evaluated during study visits: cd4 and cd8 cell counts; naive and memory t-cells; t-cell activation markers (hla-dr and cd38); t-cells expressing t helper 1- (th1-) and t helper 2- (th2-) associated intracytoplasmic cytokines; anti-cd3 t-cell activation responses; t-cell receptor v beta repertoire; cytotoxic t-lymphocyte (ctl) activity levels; lymph node histology (optional); hiv-1 qualitative microcultures and viral phenotyping for non-syncytium-inducing (nsi) and syncytium-inducing (si) viral isolates. laboratory determinations, adverse effects, neurological exams (including mental status evaluations), and lipodystrophy parameters (including fasting lipid profile and physical parameters) also are evaluated.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have a viral load of at least 5,000 copies/ml and a cd4 cell count greater than 75 cells/mm3. * are at least 16 (need consent of parent or guardian if under 18). * are able to complete the study. exclusion criteria patients will not be eligible for this study if they: * have ever taken anti-hiv medications. * are pregnant or breast-feeding.

Keywords: drug therapy, combination hiv protease inhibitors ritonavir dosage forms saquinavir reverse transcriptase inhibitors anti-hiv agents efavirenz
the efficacy and safety of retrovir in patients infected with hiv who are asymptomatic (cdc group ii) or have persistent generalized lymphadenopathy (cdc group iii)

Conditions: Lymphatic Disease; HIV Infections

Summary: to evaluate the safety and tolerance of chronic administration of retrovir (azt) in hiv-infected adult patients without clinical manifestations of disease. to assess the efficacy of azt therapy in the treatment of hiv disease in these patients.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * prior history of a malignancy other than cutaneous basal cell or cervical carcinomas. * other significant, chronic underlying medical illness which would impair study completion. * liver dysfunction as demonstrated by lab results. * laboratory evidence of compromised bone marrow function. concurrent medication: excluded: * any other experimental agents. * any probenecid-containing product. patients are excluded if they have a history of symptoms characteristic of cdc class i or iv including any of the following: * unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks. * unexplained fever \> 38.5 degrees c on more than 14 consecutive days or on more than 15 days in the previous 30-day period. * unexplained diarrhea defined by = or \> 2 liquid stools per day persisting for = or \> 14 days or 15 days in any 30-day period. * or history of secondary infections associated with aids related complex (arc) including: * recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years. * herpes zoster infection within 3 years. * oral hairy leukoplakia at any time. * or history of opportunistic disease fulfilling the cdc surveillance definition of aids. * signs and symptoms at baseline characteristic of acute hiv disease (cdc group i). * evidence of significant neurologic dysfunction as currently defined by cdc following standard neurologic screening and aids dementia assessment. prior medication: excluded: - previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (azt). excluded within 4 weeks of study entry: - treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy. excluded within 3 months of study entry: - antiretroviral drugs or biologic response modifiers. excluded within 4 months of study entry: - systemic corticosteroids. patients must meet the following criteria: * hiv infection demonstrated by elisa and confirmed by western blot. * signs and symptoms of hiv disease limited to those characteristic of cdc groups ii (asymptomatic) and iii (persistent generalized lymphadenopathy - pgl). * ability to give informed consent. * willingness to be followed by the originating medical center for the entire 3-year duration of the study. active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

Keywords: acquired immunodeficiency syndrome zidovudine
investigation of sarcopenia and physical fitness levels of geriatric individuals living in nursing homes and at home

Conditions: Geriatric Individuals

Summary: to examine the sarcopenia and physical fitness levels of geriatric individuals living in nursing homes and at home. considering these aims, our working hypotheses are; h1: there is a difference in sarcopenia level between geriatric individuals living in a nursing home and at home. h2: there is a difference in dynapenia levels between geriatric individuals living in a nursing home and at home. h3: there is a difference in physical fitness between geriatric individuals living in a nursing home and at home.

geriatric individuals living in the nursing home and at home will be included in the research. within the scope of the study, anterior thigh thickness of geriatric individuals will be evaluated by ultrasonography and the presence of sarcopenia will be determined according to the sonographic t-high adjustment rate (star) method, and the presence of dynapenia will be determined according to hand grip strength in individuals without sarcopenia. additionally, the physical fitness of geriatric individuals in both groups will be evaluated with the senior fitness test. the study will be carried out with 100 geriatric individuals. as a result of the study, individuals in the groups will be compared in terms of the presence of sarcopenia and dynapenia and physical fitness.

Eligibility criteria:
inclusion criteria: * getting a score between 24 and 30 on the mini mental state exam * living in a nursing home for at least six months (for nursing home residents) * ability to stand without assistance for at least 90 seconds exclusion criteria: * inability to communicate verbally * using a walking aid * elderly people with severe visual impairment, neurological disorders and/or congestive heart failure * older adults for whom exercise is not recommended
study of the effect of diabetes on the incidence and the extent of coronary artery disease

Conditions: Patients Undergoing Coronary Angiography

Summary: in the present study the investigators will measure the extent of coronary artery disease via coronary angiography and the correlating risk factors.

in the present study the investigators will examine the risk factors determining the development, extent and the manifestation of coronary artery disease. the study will recruit patients undergoing coronary angiography for clinical purposes.

Eligibility criteria:
inclusion criteria: * any subject eligible for coronary angiography with or without known cv disease for clinical reasons. exclusion criteria: * patients revascularized in the past, with either coronary artery bypass grafting or percutaneous coronary intervention, will be excluded from the study since it is not possible to describe the extent of cad in these patients. * moderate or severe aortic stenosis.
cognitive rehabilitation for opioid abuse-related cognitive impairment

Conditions: Substance-Related Disorders

Summary: research has consistently found that cognitive impairment is common in persons with a history of substance abuse. the most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall. to develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. it is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.


Eligibility criteria:
inclusion criteria: * has completed the detoxification process * has completed at least 8 years of formal education * speaks and reads english fluently * is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse) exclusion criteria: * unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent) * past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia) * history of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (note: history of concussion, including brief loss of consciousness, is okay)
d-serine for enhancing cognitive retraining for the treatment of schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study will examine the effectiveness of d-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.

this study is based on the hypothesis that by increasing nmda receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining. patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either d-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * clinically stable * treated with antipsychotic medications for at least 6 months in the past, and on a stable dose of the same antipsychotic medication over the past month * not pregnant or lactating exclusion criteria: * other current or past dsm-iv axis i diagnosis * calgary depression scale score \>10 or simpson-angus rating scale score \> 20 * currently treated with clozapine, lamotrigine or carbamazepine, or defined as treatment refractory * substance abuse or dependence within the past 3 months, except for nicotine * wechsler adult intelligence scale-revised score \< 70 * significant recent (within past 3 months) risk of committing suicide * abnormal thyroid function tests within the last 6 months * previous treatment with d-serine * history of evidence of a medical or neurological condition that would expose the subject to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the trial * clinically significant abnormal laboratory test results at screening * ect treatment within the past two months
activity of mefloquine against urinary schistosomiasis

Conditions: Urinary Schistosomiasis

Summary: urinary schistosomiasis is a debilitating disease in central africa and pregnant women are frequently suffering from this condition. mefloquine is currently investigated as preventive treatment against malaria in pregnancy and mefloquine is also known to exert activity against schistosomiasis. the investigators want to test the hypothesis whether mefloquine may active against urinary schistosomiasis when used as preventive treatment against malaria in pregnancy.

objectives the principal aim of this clinical trial is to evaluate whether mefloquine - when given as intermittent preventive treatment against malaria in pregnancy - shows in vivo activity against concomitant schistosoma haematobium infection. this study is therefore a "proof of principle" study and is not intended to establish a clinically satisfying cure rate or to formally compare the efficacy of mefloquine with the standard therapy. hypothesis two underlying hypotheses have been formulated for this proof of principle study. primary hypothesis: mefloquine reduces egg excretion of schistosoma haematobium by 50% compared to sulfadoxine/pyrimethamine (s/p) treatment when given as iptp secondary hypothesis: mefloquine may lead to an adequate cure rates of schistosoma haematobium infections compared to s/p (\>80%) trial design the evaluation of mefloquine activity against s. haematobium will be evaluated in the course of an open label multicenter randomized controlled trial assessing the efficacy, tolerability, and safety of mefloquine iptp against malaria. this study is therefore a nested randomized controlled trial taking advantage of the randomization and treatment allocation procedures of the iptp trial and assessing the additional efficacy outcome of reduction of s. haematobium egg excretion.

Eligibility criteria:
inclusion criteria: * pregnant women after first trimester and before 28th week of pregnancy * hiv negative * egg excretion of schistosoma haematobium (mean \>10 eggs per ml urine) * asymptomatic (no signs of complicated schistosomiasis, no severe anemia) * ability to comply with study protocol exclusion criteria: * intake of anthelminthic or antimalarial drug within 2 months prior to inclusion * allergy to study drugs

Keywords: schistosomiasis, schistosoma haematobium
amg 102 in combination with mitoxantrone and prednisone in subjects with previously treated castrate resistant prostate cancer

Conditions: Cancer; Castrate-Resistant Prostate Cancer; Mestastatic Prostate Cancer; Prostate Cancer

Summary: the primary objectives of this study are the following: phase 1b: to identify a safe dose level of amg 102, up to 15 mg/kg q3w, to combine with mitoxantrone and prednisone (mp) phase 2: to estimate with adequate precision the effect of the addition of amg 102 to mp, compared with placebo plus mp, as assessed by the hazard ratio (hr) for overall survival (os) of previously treated subjects with castrate-resistant prostate cancer (crpc)


Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of the prostate * radiographic evidence of metastatic disease * progressive disease meeting at least one of the following criteria: 1. a sequence of at least 2 rising psa values measured at a minimum of 1 week apart with a 2 ng/ml minimum starting value, or 2. progression according to recist criteria for measurable lesions, or 3. appearance of 2 or more new lesions on bone scan. * history of prior taxane-based chemotherapy for metastatic prostate cancer * for patients without a history of surgical castration, continued gnrh analog administration is required * ecog performance status of 0 or 1 * life expectancy ≥ 3 months exclusion criteria: * treatment with external beam radiotherapy ≤ 14 days before enrollment or radiopharmaceutical ≤8 weeks * ≤ 4 weeks since receipt of most recent prior chemotherapy, non-gnrh analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and \<6 weeks since receipt of prior bevacizumab. * known cns metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area). * significant cardiovascular disease * lvef \< 50% by muga or echo * treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection) * concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed * major surgical procedure ≤30 days before enrollment or not yet recovered from prior major surgery * presence of peripheral edema \> grade 2 * known positive test for hiv, hepatitis c, chronic or active hepatitis b * serious or non-healing wound * unable to begin protocol specified treatment within 7 days after enrollment * other investigational procedures are excluded.

Keywords: crpc
a phase iia study of tas-205 for duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the objective of this study is to evaluate the efficacy after 24-week repeated oral doses of tas-205 in patients with duchenne muscular dystrophy (dmd) in an exploratory manner.

duchenne muscular dystrophy (dmd) is the most common fatal genetic disorder diagnosed in childhood, affecting approximately 1 in 3,500 lives male births. dmd patients suffer from a relentless decline in muscle strength that impairs the ability of walking and breathing, resulting in their lives with wheelchairs and then loss of upper body function. the main objective of this study is to evaluate the efficacy after 24-week repeated oral doses of tas-205 in patients with dmd in an exploratory manner. the objective of this study is also to evaluate the safety, the dose-response and the urinary excretion of pharmacodynamic (pd) marker after 24-week repeated oral doses of tas-205 in dmd patients.

Eligibility criteria:
inclusion criteria: * able to give an informed consent. if applicable, able to give an informed assent. * phenotypic evidence of dmd. * male and ≧5 years of age. * bodyweight ≧7.5 kg and \<60 kg. * able to complete the 6mwd test with a distance of at least 75 m. * able to take tablets. * if taking oral glucocorticoids no significant change in the total daily or dosing 6 months before enrollment. exclusion criteria: * any serious drug allergy. * a forced vital capacity (fvc) of \<50% of predicted value. * wearing a respirator continuously (except for the use during sleep). * a left ventricular ejection fraction (ef) of \<40% or fractional shortening (fs) of \<25% on echocardiogram. * clinically significant cardiac failure and respiratory failure. * ongoing immunosuppressive therapy (other than corticosteroids) . * surgical history or plan for surgery that may affect muscular strength or motor function. * any injury that may affect muscular strength or motor function. * with any systemic allergic disease or any chronic inflammatory disease. * previous gene therapy (exon skipping, or stop codon read through therapy), cell-based therapy, or any other investigational agents.
evaluation of some biochemical markers of bone turnover in childern and adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: type 1 diabetes is associated with many longterm complications as retinopathy,neuropathy and nephropathy. recently, several studies have linked type 1 diabetes to bone fragility.studies conducted on patients with type 1 diabetes have concluded that bone is negatively affected in type 1 diabetes with impaired bone density,increased fracture risk and impaired bone turnover markers.


Eligibility criteria:
inclusion criteria: * childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included exclusion criteria: * childern and adolescents with congenital bone disease, those with disorders of the parathyroid gland and those with chronic kidney disease.