Kornimate/medical-research-clean huggingface dataset:
effects of maternal anti-hiv treatment on infants born to hiv-infected women

Conditions: HIV Infections

Summary: in clinical trials being conducted throughout the world, pregnant hiv-infected women are given anti-hiv drugs before, during, and after they give birth to prevent mother-to-child transmission of hiv. however, the effects of this anti-hiv treatment on infants is unknown. the purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-hiv treatment on infants born to these hiv-infected women. study hypothesis: specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. these regimens are associated with reduction of mother-to-child hiv transmission.

many hiv-infected women outside the united states enroll in clinical trials that provide them antiretroviral therapy (art) to prevent mother-to-child transmission of hiv. however, data are limited on the safety, toxicity, and adverse effects that maternal art may have on infants born to hiv-infected women. this study will monitor the adverse effects and potential benefits of maternal art on these infants. no antiretrovirals will be given in this study. this study will last 18 months. infants will be enrolled in the study within 48 hours of birth. there will be 6 study visits starting at study entry and every 6 weeks thereafter. infants will undergo blood and urine collection, and medical history assessments will occur at every visit. mothers will also be evaluated at these visits.

Eligibility criteria:
inclusion criteria: * infant born to hiv-1 infected mother enrolled in nih-sponsored, international antiretroviral treatment trial and who has had either in utero or postpartum antiretroviral exposure * parent or guardian willing to provide informed consent exclusion criteria: * infant with no exposure to antiretrovirals or who received only intrapartum antiretroviral exposure

Keywords: perinatal transmission mother-to-child transmission
an open-label, extension study evaluating the safety, toleration, and efficacy of sildenafil in women with sexual arousal disorder

Conditions: Sexual Dysfunctions, Psychological; Sexual Arousal Disorder

Summary: the purpose of this study is to evaluate the safety and toleration of oral sildenafil administered as required by women with female sexual arousal disorder (fsad) who successfully complete one of the following pfizer-sponsored, 12-week, double-blinded clinical trials: a1481082 or a1481123. addition of this 52-week open-label extension will increase the total duration of sildenafil exposure to 64 weeks. sustained efficacy will also be evaluated after 3 and 6 months of open-label therapy.


Eligibility criteria:
inclusion criteria: * included were subjects who completed pfizer study a1481082 or a1481123 without a major protocol violation and with all treatment-related adverse events resolved prior to crossover into the open-label study. * for subjects receiving hormone replacement therapy and/or selective serotonin reuptake inhibitor treatment, dosage of these must be stable at the start of this extension study and remain stable throughout. * subjects should continue to maintain a stable sexual relationship throughout the study. exclusion criteria: * excluded were subjects who experienced either treatment-related serious adverse events or significant treatment-related laboratory abnormalities in the previous study, and subjects who misused study medication and/or failed to adequately account for study medication in the previous study, or who were non-compliant with visits. * also excluded were subjects who were currently prescribed and/or taking nitrates or nitric oxide donors in any form (oral, sublingual, buccal, transdermal, inhalational or aerosols).
monitoring of dialysis vascular accesses during angioplasty under echodoppler

Conditions: Arteriovenous Fistula Stenosis

Summary: dialysis vascular accesses called arteriovenous fistulas ( avf) are essential to ensure extra-renal purification by hemodialysis for patients with chronic end-stage renal disease. complications of dialysis avf cause significant morbidity and hospitalization. dialysis avf angioplasties are frequently used to treat stenosis, the 1st complication concerning them and which announces the complete thrombosis which may be the definitive loss of the avf. historically performed under x-ray, the progression in the quality of ultrasound scanners allows today to perform this procedure under echo-doppler guidance and thus to avoid both radiation and the injection of iodinated contrast products and their complications. it is thus possible to preserve residual renal function, a situation with a better prognosis, or to help the maturation of the avf without precipitating the patient towards dialysis. the procedure can then be less costly, requiring a much lighter infrastructure. the complication rates of ultrasound angioplasty remain poorly known because only a few series have been published. in addition, the evolution of the echo-doppler parameters of the avf is unknown during angioplasty and it is difficult to know which are the most reliable to distinguish during the procedure a "good angioplasty gesture" from an incomplete angioplasty to be continued. the proposed study would provide initial insight into the question posed.

this is an observational, retrospective study on data from routine care. all angioplasties concerning major patients, meeting the inclusion criteria and performed during the inclusion period will be taken into account. (for this purpose, a list of procedures performed at the vichy hospital will be established via the angioplasty procedure reports. in order to establish the evolution of the echographic parameters over time, the echographic data will also be collected from each follow-up report corresponding to each procedure until the end of the follow-up. these reports correspond to the normal post-intervention control ultrasounds at 1 month, 3 months and the annual visits. if intermediate ultrasounds are available, their reports will also be used. in the case of a patient having an emergency angioplasty, the data of the control ultrasound triggering the intervention will be used as pre-intervention data.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * patient undergoing whose fistula is treated by angioplasty under echo-doplerat the vichy hospital center between 01/01/2015 and 31/12/2019 exclusion criteria: * patients who are minors, * patients with an avf with a flow rate \< 100 ml/min. * patients with acute or chronic, segmental or total occlusion of an avf segment * patients with acute or chronic, segmental or total thrombosis of an avf segment * patients whose main obstacle is located on the arterial side. * intervention that required the use of x-rays.

Keywords: blood vessel repair arteriovenous fistula ultrasound angioplasty
caregiver depression in a low-resource setting: socio-demographic predictors of major depressive disorder among family caregivers of breast cancer patients in pakistan

Conditions: Major Depressive Disorder (MDD)

Summary: this cross-sectional study aims to assess the prevalence of depression among primary caregivers of breast cancer patients within low-resource country like pakistan. caregiving for individuals with breast cancer can be physically and emotionally demanding, often leading to psychological distress, including depression. however, there is limited data from low- and middle-income countries, including pakistan, where caregivers may face additional socioeconomic and systemic burdens. this study seeks to quantify the burden of depression in this population and explore associated sociodemographic and caregiving-related factors. findings will help inform psychosocial support strategies and interventions to improve caregiver well-being in resource-constrained environments.


Eligibility criteria:
inclusion criteria: 1. primary caregiver of a patient diagnosed with breast cancer at any stage 2. male or female caregiver 3. aged 15 years or older 4. providing physical, emotional, or financial support to the patient 5. willing to give informed consent exclusion criteria: 1. paid caregivers (professional or hired help) 2. age under 15 years 3. unwilling to provide consent or participate in the study 4. incomplete or missing essential data required for analysis
a study to compare the efficacy and safety of topical administration of fmx-101 for treatment of moderate-to-severe acne

Conditions: Acne Vulgaris

Summary: this is a phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of fmx-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.


Eligibility criteria:
inclusion criteria: * has facial acne vulgaris with: * 20 to 50 inflammatory lesions (papules, pustules, and nodules); * 25 to 100 noninflammatory lesions (open and closed comedones); * no more than 2 nodules on the face; and * iga score of moderate (3) to severe (4) * willing to use only the supplied non-medicated cleanser (cetaphil gentle skin cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study exclusion criteria: * acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations * sunburn on the face * severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results. * abnormal baseline laboratory values that are considered clinically significant * allergy to tetracycline-class antibiotics or to any ingredient in the study drug * pseudomembranous colitis or antibiotic-associated colitis

Keywords: acne
unilateral training of the uninjured limb on clinical outcomes in patients with surgically treated radius fracture

Conditions: Wrist Fractures; Distal Radius Fractures

Summary: the objective will be to determine the effectiveness of adding unilateral upper limb postoperative training to standard rehabilitation compared to standard rehabilitation on maximum grip strength and manual dexterity in patients aged 30-50 years with surgically treated distal radius fracture. it is presumed that the addition of unilateral upper limb training will significantly improve maximum grip strength and manual dexterity at the end of the intervention period compared to the group receiving only standard rehabilitation. patients who agree to participate in this research will be randomly assigned to a control group (standard rehabilitation with unilateral training with mobility exercises) or an experimental group (standard rehabilitation with unilateral high-intensity strength training). the duration of the postoperative intervention will be 12 weeks. the primary variables are maximum grip strength and manual dexterity. secondary variables are wrist mobility, forearm circumference, maximum voluntary isometric strength, functionality and health-related quality of life. results will be measured at 0, 6 and 12 weeks postoperative.


Eligibility criteria:
inclusion criteria: * age between 30-50 years * radiological diagnosis of unilateral distal radius fracture without concomitant fractures. * fracture treated surgically. exclusion criteria: * patients with lesion of the triangular fibrocartilage. * patients with distal radius fracture with consolidation disorders. * patients with health conditions that cause pain or affect the motor skills of the upper limb (radiocarpal osteoarthritis, carpal tunnel syndrome, quervain's tenosynovitis, neurodegenerative diseases, sequelae of stroke) * patients with multi-site pain or chronic polyarticular diseases such as osteoarthritis or rheumatoid arthritis. * unstable cardiovascular, respiratory, systemic or metabolic conditions that do not allow high-intensity physical exercise. * patients who are taking nutritional supplements that interfere with the regulation of skeletal muscle strength and mass (example: whey protein, creatine, etc.) * inability to understand, read and/or speak the spanish language.

Keywords: distal radius fracture cross-education rehabilitation exercise
the molecular mechanism of ras wild-type mcrc resistance to anti-egfr-antibody

Conditions: Colorectal Cancer

Summary: establishing the genetic map of primary and secondary resistance of chinese wild ras colorectal cancer received anti-egfr treatment through tissues and peripheral blood ngs testing. combination genetic data with clinical characteristics, prognosis and treatment data to explore the molecular mechanism of resistance of anti-egfr-antibody.

cetuximab is a chimeric (mouse/human) monoclonal antibody, an epidermal growth factor receptor (egfr) inhibitor. many large clinical trials demonstrated that for ras wild-type metastatic colorectal cancer (mcrc), especially left-sided ras wild-type mcrc, cetuximab can prolong os. but some of patients have primary resistance to cetuximab and for all patients received cetuximab will develop secondary resistance. cell-free or circulating tumour dna (ctdna) including primary site and metastatic site genetic information, which can avoid tumor heterogeneity. the results of paired test detection of tissue and ctdna showed there is 93% consistency in ras testing. therefore, dynamic monitoring ctdna during anti-egfr targeted treatment of ras wild-type mcrc patients can implement prognosis of efficacy and response evaluation in real-time. besides, it can monitor the variation features of resistance gene and find resistance gene in real-time. according the situation of gene change to find potential drug resistance mechanism and formulate individualization treatment plan.

Eligibility criteria:
inclusion criteria: 1. age≥18 years, ≤75 years, all gender; 2. histologically proven metastatic adenocarcinoma of colorectal cancer, no previous history of cancer; 3. the clinical data of patient is intact; 4. the data of patients after surgery is intact, and the prognosis follow-up data of patient is available. exclusion criteria: 1. previous history of cancer； 2. intact clinical data or diagnosis results of histopathology is unavailable; 3. time of progression disease after treatment and follow-up data are unavailable; 4. patient received blood transfusion within 3 months; 5. other situation that researchers think it will impact the results of trails or violate ethics.
study to assess pharmacokinetics, safety & efficacy of anidulafungin when treating children with invasive candidiasis

Conditions: Candidemia

Summary: prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \<18 years) with invasive candidiasis, including candidemia (icc).

prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \< 18 years) with invasive candidiasis, including candidemia (icc). to participate in the study, at the time of enrollment subjects must (1) have either a confirmed diagnosis of icc or mycological evidence highly suggestive of candida sp or (2) in infants 1 month to \< 2 years only, be at high risk of candidiasis. all subjects meeting screening criteria receive iv anidulafungin. subjects will be stratified by age (1 month - \< 2 years; 2 years - \< 5 years; 5 years - \< 18 years). subjects may be switched to oral fluconazole, provided that the pre-specified criteria are met. subjects with microbiologically confirmed icc must have a minimum total treatment duration of 14 days. the maximum allowed treatment duration of anidulafungin is 35 days; the maximum total treatment duration for the study is 49 days. at selected centers, anidulafungin pharmacokinetics will be assessed in the first 6 subjects age 1 month - \< 2 years to confirm the recommended dosage regimen. a population pk-pd analysis will be performed in all other enrolled subjects. subjects will be followed for safety through 6 week fu visit. efficacy for subjects with confirmed icc will be assessed at eoivt, eot, 2-week fu and 6-week fu visits.

Eligibility criteria:
inclusion criteria: * subject must be either (1) at high risk for candidiasis (1 month - \< 2 years only) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (icc) (all age groups) * male and female patients from 1 month to less than 18 years of age. exclusion criteria: * any patients with allergy to the drug; and any pregnant female or lactating. * failed previous antifungal therapy or expected to live \< 3 days. * patients with documented or suspected candida meningitis.

Keywords: anidulafungin pediatrics candidemia invasive candidiasis safety
effects of dietary supplements based on trace elements on voice parameters and some psychological and physiological parameters related to stress - single-center, comparative, cross-over, randomized, double-blind study versus placebo, in healthy subjects

Conditions: Stress

Summary: preliminary data obtained by the company pronutri, which produces food supplements based on trace metals, suggests that food supplements containing trace metal compounds could act by reducing stress, which could result in effects on various physiological parameters. trace elements are pure minerals essential to the functioning of our body, present in very small quantities. they have a precise and fundamental role in biological and information processes: a deficiency can lead to dysfunctions, often at the origin of our daily ailments. no scientific study has so far been carried out to measure the effects of these molecules on physiological and psychological parameters related to stress in healthy volunteers. the present study therefore aims to test the effects of these tablets containing metals and trace metals on the reduction of stress.


Eligibility criteria:
inclusion criteria: * male or female over 18 years of age * healthy (healthy volunteers) (no current treatment except contraception and no acute illness within 3 months) * affiliated to the social security system * signed consent exclusion criteria: * voice disorders: aphasia, dysphonia, aphonia... * presence of a cardiac pacemaker * person intolerant to lactose, or to any excipient present in the vx 1 product * person under legal protection or unable to give consent * minor * pregnant or post-pregnant woman under 6 months or of childbearing age without effective contraception * person deprived of liberty by a judicial or administrative decision or under psychiatric care

Keywords: stress trace elements voice parameters
effect of anti-histamine in prevention systolic hypotension after protamine

Conditions: Protamine Adverse Reaction

Summary: protamine remains the anticoagulant of choice for cardiopulmonary bypass (cpb). the process of protamine neutralization of heparin came with the side effects sometimes; it can be life threatening or fetal reaction. the adverse cardiopulmonary response of protamine has been observed during entire history of clinical cardiac surgery. the true mechanism reaction is difficult to defined and the complexity of the clinical situation the classification of protamine reaction has been divided in to main 3 types (transient systemic hypotension secondary to rapid administration, anaphylactic and anaphylactoid reaction and catastrophic pulmonary vasoconstriction. the reaction from pharmacologic histamine release is the most common type of reaction. protamine was believed to induce hypotension by this mechanism, and it was demonstrated to release histamine by degranulation of isolated mast cells from the hypothesis that the systemic hypotension cause by the released of histamine. the investigators will measure the serum tryptase which is the enzyme that released from degranulation of human mast cell. comparing the serum tryptase level of the patient at baseline, 30 min and 60 min after protamine was given. there for the hypothesis of this study is administrating of h1 and h2 blocker helps attenuate the drop in map after protamine is given.


Eligibility criteria:
inclusion criteria: * asa physical status 1-3 * schedule for open heart surgery exclusion criteria: * history of allergy to the study drugs or protamine * history of previous cardiac surgery or received protamine * history of diabetes with insulin therapy

Keywords: protamine antihistamine
evaluation of clinical perfectionism in parkinson disease

Conditions: Parkinson Disease

Summary: scientific studies show that almost half of the people with parkinson's disease (pd) suffer of depression and / or anxiety.

scientific studies show that almost half of the people with parkinson's disease (pd) suffer of depression and / or anxiety. also, clinicians reported that they exhibit specific personality traits (e.g., rigidity and perfectionism). to date, few studies used cognitive behavioural therapies (cbt) in people with parkinson's disease showing promising results. recently, perfectionism has received particular attention because of it association with many emotional disorders. thus, some psychometric tools have been developed in order to evaluate different aspects of perfectionism. yet, none of them has been used in people with parkinson's disease. the objective of this study is to investigate whether there is a direct link between parkinson's disease and perfectionism by using psychometric tools from the cbt literature. identifying such link would allow to justify the use of cbt in people with parkinson's disease with the goal in mind to improve their care and quality of life.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * score mini mental scale (mms) greater than 23 * for parkinsonian, parkinson disease be defined according to the criteria of the unified parkinson disease rating scale (updrs), with a hoehn and yahr stage 1, 2 or 3 * the control patients present dystonias not within the scope of parkinson * informed consent form signed * patient covered by social insurance exclusion criteria: * proven presence of neuropsychological disorders * patients with deep brain stimulation * diagnosis of somatic pathology diagnosed * private patient freedom or protected adult (under guardianship)

Keywords: parkinson perfectionism