Kornimate/medical-research-clean huggingface dataset:
shockwave therapy (swt)

Conditions: Gynoid Lipodystrophy

Summary: the purpose of the present study is to evaluate the effects of six sessions of aerobic exercise associated with shock waves therapy in the severity of gynoid lipodystrophy.

the gynoid lipodystrophy (gl) is considered to be a subcutaneous tissue disorder that causes changes in visible skin topography in the form of protrusions and depressions, mainly located in the lower limbs and abdominal region. it is a non-inflammatory and degenerative condition whose etiology has not been fully elucidated until now, although it can be explained by varied theories: the hormonal ,that is related to estrogen, the morphological one, based on alterations of the adipose tissue that is related to the interlobular septa of connective tissue that interconnects the subcutaneous adipose lobes, these septa are thin and have perpendicular projections, which favors the deposition of adipose tissue and its expansion to the surface of the dermis. the last one is about microcirculation deficits that can lead to intracellular edema and reduction of lymphatic drainage. shock wave therapy appears to be a safe and effective therapy to act in this disorder. it generates mechanical pressure waves in the tissues, promoting cavitation phenomena that produces lipolysis by destroying the cell membrane of adipocytes, increasing blood flow in the region, and stimulating lymphatic drainage. on the other hand, there are studies that report that improvement in the appearance of gl is associated with a decrease in subcutaneous adipose tissue. physiologically, aerobic physical exercise has the capacity to decrease body fat, taking into account that the oxidation reactions of fatty acids are enhanced, with moderate intensity exercise. in this sense, it may be beneficial to associate shockwave therapy and physical exercise to reduce gl severity, so this study aims to analyze the effect of radial shock wave therapy in association with the performance of an aerobic exercise program, in female subjects, in the degree of gl severity in the gluteal region and ⅓ proximal posterior of the thighs.

Eligibility criteria:
inclusion criteria: * participants with a moderate and severe degree of cellulitis, according to an css, in the region of the buttocks and ⅓ proximal posterior of the thighs; exclusion criteria: * unstable weight during the last 6 months, with a variation of less than or equal to 2 kg has been initiated; * hormonal treatment (contraceptive pill, intrauterine device, other) changed in the last 6 months; * participants with food restrictions; * pregnant women or post childbirth during the last year;

Keywords: gynoid lipodystrophy shock wave therapy aerobic exercise
helium-oxygen gas mixtures delivered by a high flow nasal cannula in bronchiolitis

Conditions: Bronchiolitis; Heliox; Pediatrics

Summary: the aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (hfnc) system (vapotherm precision flow heliox) in children ages 0-24 months with severe bronchiolitis.

respiratory syncytial virus associated bronchiolitis is a leading cause of global infant morbidity and mortality \[1\], yet care remains largely supportive. several recent studies show that a helium-oxygen gas mixture (heliox) improves outcomes in children with moderate to severe bronchiolitis \[2-5, 7\]. heliox is a safe, inert gas with no biological effects and very low density \[6\]. by improving laminar flow, heliox improves gas exchange in conditions where airway resistance is increased, such as asthma, croup and bronchiolitis \[6\]. recent data shows that infants with moderate to severe bronchiolitis have a reduced length of hospital stay when heliox is delivered via facemask or cpap, as compared to heliox via nasal cannula \[2\]. limitations to this study include the small number of patients (84/319 \[26%\]) who tolerated the facemask therapy and the fact that nasal cannula heliox was delivered at low flows (3 lpm). oxygen is increasingly being delivered with a heated, humidified, high flow nasal cannula (hfnc) system to infants with moderate to severe bronchiolitis in our picu. to date, there are no definitive randomized controlled trials that show the hfnc system is an effective treatment in bronchiolitis. however, there are several retrospective, prospective and pilot interventional studies showing clinical improvement in this patient population treated with the hfnc system \[8-11\]. we hypothesize that delivering heliox via a heated, humidified, high flow nasal cannula will be well tolerated, safe and effective. specific aim #1: the aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (hfnc) system (vapotherm precision flow heliox) in children ages 0-24 months with severe bronchiolitis. hypothesis #1: clinical and physiologic markers of respiratory distress will be improved in patients receiving heliox via hfnc compared to standard therapy following separation from mechanical ventilation.

Eligibility criteria:
inclusion criteria: * children 0-24 months * admission to the pediatric intensive care unit * diagnosis of bronchiolitis, with respiratory syncytial virus infection confirmed by laboratory testing * mechanical ventilation exclusion criteria: * inclusion in another clinical trial * significant cardiac disease * anatomically abnormal airway * neurologic disease * immunodeficiency * history of chronic lung disease * craniofacial anomaly * chromosomal anomalies * known or suspected dysphagia
phase 2 study of vx-950, pegasys and copegus in hepatitis c

Conditions: Hepatitis C

Summary: to assess the safety of the combination of vx-950, pegasys and copegus in subjects with hepatitis c.


Eligibility criteria:
inclusion criteria: * infected with hepatitis c virus exclusion criteria: * contraindications to peginterferon or ribavirin therapy.
a short-term study to examine the effects of athx-105 phosphate on weight loss and safety

Conditions: Obesity

Summary: this primary purpose of this study is to determine if athx-105 phosphate causes weight loss over a 12-week period.

the rate of obesity in adults continues to increase. obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. to date, the medication options to treat obesity have been limited. this study will examine if a new investigational drug, athx-105 phosphate, may cause weight loss in humans over a 12-week period.

Eligibility criteria:
inclusion criteria: * obese adults with a body mass index of 30-45 kg/m2 exclusion criteria: * pregnancy * diabetes * adults with serious or unstable current or past medical conditions

Keywords: weight loss weight-loss drugs obesity overweight body weight diet metabolic disorder nutrition disorder
effect of different approaches of delivering local dental anesthesia on pain perception in children.

Conditions: Pain; Local Anesthetics; Epinephrine; Vibration

Summary: the aim of the study is to compare the efficacy of three different approaches of local anesthesia (la) administration (warm\[37°c\] la, buffered la, and buzzy device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and wong-baker fpr scales.

pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage.in pediatric dentistry, the injection of local anesthesia is the most common cause of fear and expected to be painful.so, an effective pain control significantly contributes to an optimal dental treatment in pediatric dentistry.proper pain prevention may enhance the child's cooperation by building dentist-child trust and reducing fear and/or anxiety during the current or future visit(s). the purpose of this study is to compare the efficacy of three different approaches of la administration(warm\[37°c\] la, buffered la, and buzzy device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and wong-baker fpr scales. this study will be conducted on 80 children aged between 6-12 years from pediatric dental clinic, faculty of dentistry, mansoura university. children will be divided to 4 equal groups, 20 children each. three experimental groups, and a (control group) . the 4 groups will be randomly allocated for each technique using block technique of simple random sampling .randomized block designs are constructed to reduce noise or variance in the data. every block will include the equal number of the four groups (three experimental and one control).

Eligibility criteria:
inclusion criteria: 1. children requiring maxillary infiltration la for dental treatment. 2. cooperative children (positive or definitely positive on frankel's scale). 3. children are in apparently good health and not taking any medications that will alter their pain perception. 4. children have no history of allergy to mepivacaine exclusion criteria: 1. the person responsible does not authorize the participation of the child as a research volunteer. 2. be using pain modulating drugs. 3. patients with a history of hypersensitivity to local anesthetics. 4. patients with a history of systemic diseases.
a study to assess the safety of myozyme® and of aldurazyme® in male and female participants of any age group with pompe disease or with mucopolysaccharidosis type i (mps i) in a home-care setting

Conditions: Pompe Disease; Mucopolysaccharidosis Type I (MPS I)

Summary: primary objective: to obtain data pertaining to the safety and tolerability of alglucosidase alfa and laronidase treatments administered in a home-care infusion setting. secondary objectives: * to evaluate personal satisfaction of both cohorts of patients treated in a home-care infusion setting. * to evaluate the infusion compliance in both cohorts of patients treated in a home-care infusion setting.

prospective observation duration for each patient: at least 12 months (from enrollment)

Eligibility criteria:
inclusion criteria: * signed, informed consent obtained prior to being enrolled into the study and prior to starting any data collection. consent of a legally authorized guardian is required for legally minor patients as defined by local regulation. if the patient is legally minor, signed written consent shall be obtained from parent(s)/legal guardian and assent obtained from the patient, if applicable. * pompe disease patients with confirmed acid alpha-glucosidase (gaa) enzyme deficiency treated with myozyme® in home infusion setting according to authorized clinical practice and the approved risk management plan document (cohort a) or * mps i patients with confirmed deficiency of the lysosomal enzyme, alpha-l-iduronidase treated with aldurazyme® in home infusion setting according to authorized clinical practice and the approved risk management plan document (cohort b). exclusion criteria: * participation in another clinical trial with any investigational agent within the 12 weeks preceding enrolment. * any condition (e.g. medical concern) which, in the opinion of the investigator, would make the participant unsuitable for the study. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
effects of lactobacillus reuteri plus vitamin d3 in children with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate in a randomized, double-blinded, controlled trial, whether a new food supplement containing lactobacillus reuteri dsm 17938 and vitamin d3 (reuterin® d3) may improve the scorad in pediatric patients with mild to moderate atopic dermatitis

recent evidence suggests that childhood allergy development can be linked to an imbalance of the intestinal microbiota. the probiotic bacteria, which contribute to the balance of the intestinal microflora, may play a key role in the modulation of the immune response, looking as a potential resource in the prevention or treatment of allergic disorders. in this study the investigators will recruit pediatric patients with atopic dermatitis of mild-to-moderate degree, for which the standard treatment consists in using an emollient cream and topical steroids in case of exacerbation. the investigators assume that participants can receive significant benefits from the addition to their standard treatment of a food supplement containing l. reuteri dsm 17938 and vitamin d3, which, thanks to their beneficial effects on intestinal microbiota and on modulation of the immune response, may compensate for the inadequate capacity of these patients to produce antimicrobial peptides in response to cutaneous aggressions, improving, therefore, the severity of the disease. 88 children of both sexes, between 1 and 4 years old, with a scorad of 25-50 will be selected as a part of routine outpatient visits at the pediatric allergy department of the university hospital of verona. the study product (active or placebo) will be administered for 3 months, with a follow-up period of further 3 months. from all participants, at time 0 and after 3 months, blood and stool samples will be collected for the analysis of vitamin d and cathelicidin levels and for the analysis of microflora respectively.

Eligibility criteria:
inclusion criteria: * diagnosis of atopic dermatitis of mild to moderate grade (scorad 25-50) * signature of the informed consent from both parents or a legal representative exclusion criteria: * presence of autoimmune diseases, immunodeficiency, inflammatory bowel diseases, cystic fibrosis, metabolic diseases * use of immunosuppressive drugs and/or systemic corticosteroids in the previous 2 months * use of antibiotics in the last 4 weeks * use of probiotics and/or prebiotics in the last 2 weeks * use of vitamin d in the last 4 weeks * participation in other clinical trials

Keywords: atopic dermatitis, probiotics, vitamin d3, l. reuteri
correlation between pre-transplant ici exposure and post-transplant graft rejection

Conditions: Graft Rejection; Hepatocellular Carcinoma; Immunotherapy; Immune Checkpoint Inhibitor

Summary: immune checkpoint inhibitors (icis) have revolutionized the treatment of advanced hcc. the combination of the ici and other treatment regimens (anti-vegf, locoregional therapies et al) produced superior results in patients with advanced-stage hcc compared to those treated with traditional therapeutic regimens. liver transplantation (lt) offers excellent long-term outcomes for certain patients with hcc. however, the immune-stimulating property of icis may lead to rejection and even graft loss, damping their use in treating hcc before liver transplantation. therefore, it is worthwhile to explore the relationship between exposure to icis before lt and the incidence of graft rejection and rejection-related death or graft loss after lt.

this will be a retrospective and observational study, which will analyze the correlation between the use of icis and incidences of graft rejection and rejection-related death or graft loss after lt in consecutive recipients with lt for hcc at the organ transplantation center of sun yat-sen memorial hospital of sun yat-sen university. the primary aim of this study is to analyze the correlation between pretransplant exposure to icis and incidences of graft rejection and rejection-related death or graft loss within 1 year after liver transplantation. the secondary aim is to analyze the risk factors for graft rejection and to explore the correlation between ici exposure and posttransplantation complication, such as incidences of early allograft dysfunction (ead), bleeding, infection, biliary and vascular complications et al. the exploratory aim is to identify potential biomarkers in predicting graft rejection, such as subsets of lymphocytes and cytokines et al.

Eligibility criteria:
inclusion criteria 1. written informed consent must be obtained prior to any data collection. 2. patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma based on the aasld practice guidelines. 3. all patients receiving liver transplantation for hcc. exclusion criteria 1. cholangiocellular carcinoma, combined hepatocellular and cholangiocarcinoma, and other rare types of liver cancer that are confirmed by histology/cytology. 2. patients with incomplete follow-up data

Keywords: hepatocellular carcinoma liver transplantation immune checkpoint inhibitor graft rejection
a phase i, open label, non randomized, multicenter, dose escalation clinical study to investigate safety and tolerability of opb(otsuka pharmaceutical biwa)-111077 in subjects with advanced hcc(hepatocellular carcinoma)

Conditions: Advanced Hepatocellular Carcinoma

Summary: this is a phase i, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of opb-111077 administered orally, once daily in subjects with advanced hcc.


Eligibility criteria:
inclusion criteria: 1. histopathologically or clinically diagnosed hcc by korean liver cancer study group (klcsg) guidelines. 2. subject who has advanced hcc 3. documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment 4. male or female subject, age at consent ≥20 years and ≤75 years. 5. life expectancy ≥12 weeks. 6. subjects who agree that they or their partner(s) will practice contraception during the study period and 3 months (12 weeks) after the completion of study treatment. 7. subjects informed of the diagnosis of advanced hcc who are fully informed about the content of the study by the investigator using the written consent form, and give written consent to participate in the study of their own free will. exclusion criteria: 1. past liver transplantation 2. uncontrollable hepatic encephalopathy or ascites 3. presence of brain metastases 4. clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding. 5. primary malignancy other than hcc 6. human immunodeficiency virus (hiv) infection 7. severe or poorly controlled complication that may affect the conduct or results of the study. 8. use of interferon preparation within 4 weeks (28 days) before start of study treatment in the present study. 9. pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period 10. other cases judged by the investigator to be ineligible for participation in the study.
selective estrogen receptor modulators (serms) - a potential treatment for psychotic symptoms of schizophrenia in men?

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the aim of this project is to investigate the effect of raloxifene 120mg in men with schizophrenia. this trial will adopt a 12 week randomised controlled model. hypotheses 1: that the men receiving adjunctive selective estrogen receptor modulators (serm) will have a significantly greater reduction in psychosis symptoms over the course of the study than men receiving adjunctive placebo. hypotheses 2: that the men receiving adjunctive serm will have a significantly greater improvement in cognitive function than men receiving adjunctive placebo

with the recent advent of selective estrogen receptor modulators (serms), such as raloxifene hydrochloride, there is the potential to harness the positive estrogenic effect on central nervous system (cns) neurotransmitter systems. while the cns effects of raloxifene have not been fully studied, its actions are mediated through binding to estrogen receptors and can thereby regulate gene expression that is ligand, tissue or gene specific. by inference then, raloxifene would be expected to impact on dopamine and serotonin pathways in a similar fashion to unconjugated estrogen. this study aims to examine the impact of adjunctive serm (120mg oral raloxifene daily) treatment on the psychopathology and cognition of men with schizophrenia and related disorders

Eligibility criteria:
inclusion criteria: * physically well * dsm-iv diagnosis of schizophrenia, schizoaffective or schizophreniform * 18- 45 years * able to give informed consent * panss total score \> 60 (1 - 7 scale) and a score of 4 (moderate) or more on two or more of the following panss items: delusions, hallucinatory behaviour, conceptual disorganization or suspiciousness exclusion criteria: * patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event. * patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilization. * patients whose psychotic illness is directly related to illicit substance use or who have a history of substance abuse or dependence during the last six months, or consumption of more than 30gm of alcohol (three standard drinks) per day * smoking more than 20 cigarettes per day. * use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet.

Keywords: schizophrenia mental illness serm raloxifene