Kornimate/medical-research-clean huggingface dataset:
assessment of safety, tolerability and efficacy of 1% gpb cream versus qbrexza® (glycopyrronium) cloth 2.4% under maximum-use conditions in subjects with primary axillary hyperhidrosis

Conditions: Primary Axillary Hyperhidrosis

Summary: the aim of this study is to investigate the safety, tolerability and efficacy of 1% gpb cream compared to qbrexza® (glycopyrronium) cloth, 2.4%, for topical use under maximum use conditions.


Eligibility criteria:
inclusion criteria: * diagnosis of severe primary axillary hyperhidrosis with a hdss score of 3 or 4 * at least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes (patients should have acclimatized to that room for at least 30 minutes) * men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg/m2 * able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects * willing and able to provide written informed consent exclusion criteria: * known allergy to any of the components in the investigational product. * hypersensitivity against glycopyrrolate * secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis. * previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery. * botulinum toxin treatment in the prior 4 months. * angle closure glaucoma or its precipitation (narrow angle). * mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla. * any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation in the study

Keywords: excessive sweating
static balance in children with autism vs. neurotypical peers

Conditions: Autism; Autism Spectrum Disorder

Summary: the virtual reality rehabilitation system (vrrs) is an innovative and sophisticated technology, aimed to generate immersive and interactive settings intended for therapeutic and evaluative objectives. through the utilization of virtual reality technology, it constructs diverse scenarios, tasks, and activities in a controlled digital environment, fostering engagement. primarily crafted for rehabilitation purposes, the vrrs features adaptable programs addressing various therapeutic requirements, encompassing motor skill enhancement, cognitive challenges, and assessments related to balance.understanding the nuanced motor abilities in children, particularly those with neurodevelopmental conditions like autism, is a critical area of research in pediatric rehabilitation. the significance of this research lies in comprehending the specific balance challenges experienced by children with autism spectrum disorder (asd), a population often noted for motor coordination and balance difficulties. because vrrs offers a controlled and engaging environment, this study seeks to provide a detailed analysis of static balance abilities in capabilities in children diagnosed with asd in comparison to typically developing (td) children. the study also wants to explore the efficacy of vrrs as an assessment tool for pediatric balance evaluations.the primary objective of this study is to highlight the distinctions in postural control between asd and td children, utilizing an objective quantification tool to delineate the differences between the two groups. this will be achieved through a group comparison study involving two distinct cohorts. the first group will comprise 30 school-aged children with asd, while the second group will consist of 30 td school-aged children. to evaluate postural control, both groups will participate in an activity utilizing the vrrs in conjunction with a stabilometric balance platform. during the assessment task, participants will stand on the balance platform with their eyes open, focusing on a fixed point displayed on the vrrs screen for a duration of one minute. this process will be repeated three times for each participant. the combined use of vrrs and the stabilometric balance platform aims to provide a comprehensive evaluation of postural control abilities in both groups, allowing for the observation and measurement of potential differences in stability and balance performance between children with asd and their neurotypical counterparts.


Eligibility criteria:
inclusion criteria: * diagnosis of autism; qi ≥ 75 exclusion criteria: * motor deficits due to another clinical condition

Keywords: autism virtual reality virtual reality rehabilitation system postural control
handling medium for icsi with ionomycin and latrunculin a

Conditions: Infertility

Summary: using latrunculin a and ionomycin would improve the outcome of icsi if the handling medium during the icsi procedure has them.


Eligibility criteria:
inclusion criteria: * indication for icsi exclusion criteria: -
myoinositol for the treatment of ovarian and psychiatric disorder in polycystic ovary syndrome (pcos) patients

Conditions: Depression; PCOS

Summary: polycystic ovary syndrome (pcos) is one of the most common reproductive disorders affecting 5-10% of women of reproductive age. beside impairments on reproductive functions (oligomenorrhea/amenorrhea), it also affects metabolism (insulin resistance, type 2 diabetes mellitus and cardiovascular risk) and psychology (increased anxiety, depression and eating disorders). recently, several studies have shown that there is an increased risk of mood disorders in women with pcos, with major depression and bipolar disorder as the most frequent diagnosis. myo-inositol is classified as a member of the vitamin b complex and it works as a second messenger system of several neurotransmitter receptors; furthermore, inositol, when administrated at pharmacological doses, crosses the blood-brain barrier. studies from the 90s showed that inositol, alone or in combination with other antidepressant drugs (mainly serotonin reuptake inhibitors), is able to induce improvement of the hamilton depression rating scale. recently, inositol has been proposed as treatment to improve clinical, metabolic and endocrinal status in pcos patients. administration of myo-inositol to pcos patients resulted in several beneficial effects, such as decrease of circulating insulin and serum total testosterone as well as a restored ovulation. in this proposed study, the investigators aim to evaluate in a double blind randomized trial whether inositol alone has beneficial effects on mental health disorders associated with pcos. in particular, 60 women in reproductive age that will be diagnosed of pcos, according to rotterdam 2003 criteria, will be recruited and randomly assigned to the inositol or placebo group. both groups will go through ultrasonic evaluation of the ovaries and serum hormonal levels (fsh, lh, testosterone, estradiol and insulin) will be evaluated. furthermore, with the help of psychiatrics, patients will be interviewed in order to test the presence of any mental health disorders using validated tests such as: hamilton anxiety scale (ham-a), hamilton rating scale for depression (ham-d), health assessment questionnaire (haq), short form of mc gill pain questionnaire (sf-mpq). women assigned to the inositol group will receive 12g of inositol during the day in three different administrations for a period of 4weeks. at the end of treatment period patients will be interviewed by psychiatrics and will go through ultrasonic evaluation of the ovaries and hormonal levels will be tested


Eligibility criteria:
inclusion criteria: * women diagnosed of pcos according to rotterdam 2003 criteria exclusion criteria: * bmi \>30 * pharmacological treatment in the last 3 moths * use of contraceptive pill
a two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of krp203 in patients undergoing stem cell transplant for hematological malignancies

Conditions: Hematological Malignancies

Summary: two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in part 2 only) of krp203 in patients undergoing allogeneic hemopoietic stem cell transplant for hematological malignancies


Eligibility criteria:
inclusion criteria * patients aged 18 to 65 years, inclusive * patients must have a hematological malignancy that as per standard medical practice requires myeloablative conditioning (including short term myeloablative reduced intensity conditioning) followed by allogeneic hematopoetic stem cell transplant * karnofsky performance status ≥60%. * suitable stem cell source available according to the graft selection algorithm using t-cell replete peripheral stem cells as a graft source exclusion criteria: * resting heart rate below 55 * significant cardiac disease (such as arrhytmia, heart failure) or any significant condition which in the investigators opinion would make the patient ineligible * previous allogeneic hsct * any drug required that is not compatible with krp203 (e.g. beta-blockers or anti-thymocyte globulin)
low-chlorine vs high-chlorine crystalloids in septic shock adults

Conditions: Septic Shock

Summary: fluid resuscitation is an important treatment in septic shock patients, however whether crystalloid composition affects septic shock patients outcomes remains unclear. according to previous studies, low-chlorine crystalloids could significantly reduce the incidence of kidney injury and 30-day mortality compared with high-chlorine crystalloids in critically ill adults. therefore, we hypothesized that the use of low-chlorine crystalloids would result in a lower incidence of major adverse kidney events within 30 days (make 30: overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction) than high-chlorine crystalloids in septic shock adults.


Eligibility criteria:
inclusion criteria: 1. 18 years old \<age ≤ 85 years old; 2. diagnosis of septic shock within 24 hours (sepsis 3.0); 3. needing fluid resuscitation judged by clinicians; 4. the patient or the patient's legally acceptable representative signs the informed consent (signs within 24h of enrollment) exclusion criteria: 1. pregnant or lactating period; 2. renal replacement therapy has been received or expected to receive within 6 hours; 3. those who were previously enrolled in the study; 4. estimated death within 24 hours; 5. other situations that not suitable for enrollment judged by researchers.

Keywords: crystalloids, septic shock, make30
cerebellar transcranial direct current stimulation in spinocerebellar ataxia 38

Conditions: Spinocerebellar Ataxias

Summary: spinocerebellar ataxia 38 (sca 38) is a very rare autosomal dominant inherited disorder caused by a mutation in elov5 gene, specifically expressed in cerebellar purkinje cells, encoding an enzyme involved in the synthesis of fatty acids. the present study aimed to assess the effect of cerebellar anodal transcranial direct current stimulation (tdcs) administered employing deltoid (cd-tdcs) and spinal (cs-tdcs) cathodal montage. clinical evaluation was performed at baseline (t0), after 15 sessions of tdcs (t1) and after one month of follow-up (t2).


Eligibility criteria:
inclusion criteria: 1. age ≤ 80 and \> 18 years 2. diagnosis of sca 38 with the presence of clinical symptoms. exclusion criteria: 1. inability to understand and sign the informed consent 2. presence of other severe neurological disorders 3. presence of significant medical or psychiatric illnesses 4. pregnancy.

Keywords: gait ataxic symptoms dysarthric symptoms
analysis of molecular markers of drug resistance in tumor biopsies from previously untreated aggressive non-hodgkin's lymphoma

Conditions: Non-Hodgkin Lymphoma

Summary: although the cause(s) of clinical drug resistance in non-hodgkin's lymphomas (nhl) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. to further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets \[including but not restricted to bcl-2, bax, bcl-6, mib-1, p53, p21, p27, p16, cyclin d(1), cyclin a, cyclin e, mdm-2, cpp 32, mcl-1, eber-1, alk, and a panel of b, t and other cell lineage markers\], involving these pathways, with clinical outcome following treatment with combination chemotherapy. all clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. no new patients will be enrolled for this study.

although the cause(s) of clinical drug resistance in non-hodgkin's lymphomas (nhl) are unknown, in vitro studies suggest that abnormalities of the cell cycle and mechanisms of apoptosis may play an important role. clinical studies have now shown that p53, bcl-2 and tumor proliferation all have significant effects on clinical drug resistance. to further investigate the role of genes that control the cell cycle and apoptosis, we wish to correlate the expression of multiple molecular targets using immunohistochemistry and cdna microarray expression profiling (including but not restricted to bcl-2, bax, bcl-6, mib-1, p53, p21, p27, p16, cyclin d1, cyclin a, cyclin e, mdm-2, cpp 32, mcl-1, eber-1, alk, and a panel of b, t and other cell lineage markers), involving these pathways, with clinical outcome following treatment with combination chemotherapy. all clinical data and tissue samples for this study will come from patients who have been previously enrolled on two protocols for the initial treatment of aggressive lymphomas. no new patients will be enrolled for this study.

Eligibility criteria:
prior enrollment on the clinical trial of promace-cytabom versus promace-mopp (81-c-0166) or short course promace-cytabom (87-c-0180) for the treatment of previously untreated aggressive lymphomas. informed consent for participation in the above clinical trials. adequate biopsy material from initial biopsy and/or biopsies at relapse of disease.

Keywords: cell-cycle apoptosis molecular prognosis
gene therapy for achromatopsia (cngb3)

Conditions: Achromatopsia

Summary: a clinical trial of aav - cngb3 retinal gene therapy for patients with achromatopsia

cngb3 retinal gene therapy for patients with achromatopsia

Eligibility criteria:
inclusion criteria: * are aged 3 years or older * have achromatopsia confirmed by a retinal specialist (ci or pi) exclusion criteria: * are females who are pregnant or breastfeeding * have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months * have any other condition that the ci/pi considers makes them inappropriate for entry into the trial
cost-benefit evaluation of a transdiagnostic psychological treatment for emotional disorders in primary care

Conditions: Emotional Disorder; Depression; Somatoform Disorders; Anxiety Disorders

Summary: the aim of this study is to compare, in cost-effectiveness and cost-utility terms, a brief transdiagnostic cognitive-behavioural therapy in two different modes, individual and group, with the treatment usually administered in primary care (tau). participants between 18 and 65 years old and with, according to the pretreatment evaluation, mild to moderate emotional disorders will be randomly allocated to the three clusters. they will be assessed again immediately after treatment and 6 and 12 months later. the study hypotheses expect to find (h1) the individual treatment generally as effective as the group one, whereas (h2) the tau will be the least effective. (h3) the group therapy is expected to get the best results in terms of cost-effectiveness and (h4) the tau will get the worst cost-effectiveness results. furthermore, (h5) it is expected to find these results across the follow-up assessments too.


Eligibility criteria:
inclusion criteria: * mild/moderate emotional disorder exclusion criteria: * severe mental disorder (including severe depressive or anxiety disorders, not somatizations) * high level of impairment * recent, severe suicide attempt * no emotional disorder/below the instruments cut-off points

Keywords: transdiagnostic therapy emotional disorders primary care cost-benefit analysis brief psychological treatments randomized controlled trial depression anxiety disorders somatoform disorders
extension study of semapimod 60 mg iv x 3 days

Conditions: Crohn's Disease

Summary: study cni-1493-cd06 is an open, single-arm extension studies to cd03 and cd05. cdai is the only efficacy measure assessed in this study. the safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.


Eligibility criteria:
inclusion criteria: the study was open to patients who had satisfactorily completed either study cni-1493-cd-03 or cni-1493-cd-05. initial entry criteria were: 1. patients who satisfactorily completed either study cni-1493-cd-03 or cd-05 were eligible for participation in this study. satisfactory completion was defined as follows: 1. the patient completed 5 treatment courses in the previous trial. 2. the patient had responded to treatment, as defined by a decrease in cdai of at least 70 points from original baseline (prior to treatment on study cd-02 or cd-04) at the last assessment for study cd-03 or cd-05, respectively. the decrease had to be attributable to semapimod treatment. thus, patients whose response was attributable to other anti-crohn's disease therapy are not to be included. 3. the patient had no adverse event \>grade 2 felt to be probably or definitely related to study medication. 4. the patient did not meet any discontinuation criterion in previous trial. 2. patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, cni-1493-cd-02 or cd-03, and cni-1493-cd-04 or cd-05. 3. patients could not take any other investigational therapies during the course of this study. 4. men and women of childbearing potential had to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. it was strongly recommended that two forms be used. 5. patients had to be able to adhere to the study visit schedule and/or protocol requirements. exclusion criteria: could not have met any of the exclusion criteria for the cd02, 03, 04 or 05 studies.

Keywords: crohn's disease tnf-alpha inhibitor map kinase inhibitor cni-1493
a study to evaluate the pharmacokinetics and safety between hcp2303 and co-administration of each component in healthy volunteers under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetic characteristics and safety between hcp2303 and co-administration of each component in fed condition in healthy volunteers.


Eligibility criteria:
inclusion criteria: * age 19\~54 years in healthy volunteers * 18.5 kg/m\^2 ≤ bmi \< 30 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg * 90 mmhg ≤ sitsbp \<140 mmhg, 50 mmhg ≤ sitdbp \<90 mmhg * agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug * subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * subjects who cannot consume the high-fat meal provided during this clinical trial * subjects who judged ineligible by the investigator
problem solving and cardiovascular disease risk management in diabetic blacks

Conditions: Cardiovascular Diseases; Heart Diseases; Diabetes Mellitus, Type 2; Coronary Disease

Summary: the purpose of this study is to test a measurement tool and a new training intervention for problem solving in self-management of high cardiovascular disease (cvd) risk in african americans with type 2 diabetes.

background: african americans with type 2 diabetes carry a high burden of cvd risk and adverse vascular events such as stroke and peripheral vascular disease. cvd risk factors of suboptimal blood pressure, lipids, and glycemic control are controllable through medical management and lifestyle behavior modification. the traditional primary care medical management model for these chronic cvd risks is inadequate, and models are shifting toward increased disease-related decision-making and self-management on the part of the patient. yet, precise methods for: 1) identifying patients with ineffective disease-related problem-solving skills, and 2) providing patients with disease-related education that incorporates problem-solving and decision-making skills, have yet to be determined design narrative: the study will test a measurement tool and a novel training intervention for problem solving as applied to self-management of high cvd risk in african americans with type 2 diabetes. the specific aims are to: 1) assess the validity and reliability of an empirically derived assessment tool of effective versus ineffective cvd risk-related problem-solving ability (the health problem solving scale, hpss), 2) develop a novel intervention to teach cvd risk-related problem-solving skills to ineffective problem solvers, and 3) conduct a pilot study with a sample of african americans with type 2 diabetes who have a high cvd risk profile (suboptimal blood pressure, lipids, and/or hba1c) and ineffective cvd risk-related problem-solving skills, as measured by the hpss. the principal investigator is the recipient of a research scientist development award. her career goal is to become an independent researcher in self-management of cvd risk in high-risk african american populations, and to be a leader in the development and translation into practice of novel, theory-driven and empirically based interventions to improve patient self-management of cvd risks.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes * african american by self report * high cvd risk profile, defined as having one or more of the following:1) suboptimal a1c (greater than 7 percent); 2) suboptimal blood pressure (sbp greater than 130 mmhg and/or dbp greater than 80 mmhg); 3) suboptimal lipid control (ldl greater than 100 mg and/or hdl less than 40 mg) * willing and able to give informed consent exclusion criteria: * plan to leave area prior to study completion * severe diabetes complications that would interfere with the study * end-stage disease

Keywords: african americans