Kornimate/medical-research-clean huggingface dataset:
optimizing mental health for infants exposed to early adversity: a comparison of breaking the cycle and maxxine wright

Conditions: Mother-Child Relations; Substance Use

Summary: the goal of this clinical trial is to compare the effectiveness of the breaking the cycle (btc) and maxxine wright (mw) programs in substance-involved mothers and their children. one key difference between the two programs is that the btc program contains an infant mental health component while the mw program primarily focuses on the mothers. the main questions the trial aims to answer are: * do children at btc demonstrate enhanced infant mental health compared to children at mw up to 2 years post-intervention? * do mother-child dyads at btc experience more decreases in child adverse childhood experiences (ace), maternal stress, and mental health symptoms and have better home environment scores, parenting attitudes, and mother-child relationship scores compared to mother-child dyads at mw? * are enhanced infant mental health outcomes associated with children's lower psychosocial risk scores and mothers with lower ace scores, lower depression and anxiety scores, and lower maternal stress? * are the associations between treatment dose and infant mental health scores mediated by parenting attitudes and the mother-child relationship? does child exposure to psychosocial risk moderate the association between treatment dose and child outcomes? * how do the mechanisms of change lead to the effectiveness of btc? what are the potential lifetime health and non-health outcomes of at-risk children at btc? what is the long-term social return on investment (sroi) of btc? participants will complete several questionnaires at three timepoints while receiving services at either btc or mw: during the intake phase, 12 months after their engagement in services and 24 months after their engagement in services. given that the two programs serve a similar demographic of women, researchers will compare the btc group and the mw group to establish the comparative effectiveness and mechanisms of change of the infant mental health component of btc.


Eligibility criteria:
inclusion criteria: * receiving services at either btc or mw * having a child under the age of 6 years * being able to answer a questionnaire in english exclusion criteria: -
epidemiology of infections in pediatric cancer patients

Conditions: Infections

Summary: infections are common causes of morbidity and mortality in pediatric cancer patients. today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. moreover, little data exist on the epidemiology of infections among pediatric patients with solid tumors. the objectives of the present study are to define the incidence, categories of infections by organ systems, etiologic agents and risk factors for infections in different pediatric malignancies. the results of this study will help the investigators to better understand the epidemiology of infections in the different types of pediatric malignancies, enable the investigators to identify high risk patients, and design a better approach to empiric treatment of these patients. a prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across israel (rambam medical center, haemek medical center, schneider children's medical center, hadassah medical center, soroka medical center). all children aged 0-18 years of age, newly diagnosed with cancer and admitted to day care or inpatient departments with fever of \>38.0 c will be included in the study. demographic, clinical and microbiological figures will be collected in each center by a research assistant supervised by the infectious disease specialist. data will be collected according to a pre-defined patient data form and entered into an electronic data base that will be analyzed accordingly. in each event of febrile episode during chemotherapy, the following data will be collected by a research assistant using a patient data form and computerized software: * demographic data: age, gender, ethnicity. * clinical data: underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event. * imaging data * microbiological data * outcome the statistical analysis will be performed by an epidemiologist and statistician using the spss 12.0 software.


Eligibility criteria:
inclusion criteria: * pediatric cancer patients admitted to hospital with fever

Keywords: to define the incidence, categories of infections by organ systems, etiologic agents and risk
the long-term effect of perinatal tissue mesenchyme stem cells in the treatment for caesarean section scars

Conditions: Cicatrix

Summary: the study is to investigate the long-term efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.

this trial is a continuation of the investigators' previous clinical trial (nct02772289). in the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased. some studies have suggested that it usually took 18-24 months for a typical scar matures. in this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.

Eligibility criteria:
inclusion criteria: * primiparous women receiving cesarean delivery * ages between 21-35 years * gestation ages ≥ 37 weeks and \< 42 weeks * willing to give and sign an informed consent form and a photographic release form * willing to comply with study dosing and complete the entire course of the study exclusion criteria: * any systemic uncontrolled disease * recent or current cancer * history or presenting with a keloid formation * wounds or local disease in treatment area * planning any other cosmetic procedure to the study area during the study period * smoking

Keywords: mesenchyme stem cells cesarean section scars
feasibility of positive links for youth care engagement intervention

Conditions: HIV Antibody Positivity

Summary: a small pilot study to assess feasibility and acceptability of the pl4y intervention.

after completing enrollment and informed consent, participants will be randomly assigned to pl4y in a 2:1 fashion (intervention:control) with a target enrollment of 40 receiving the intervention and 20 in the control arm for a total of 60 participants. there is no blinding in this study protocol.

Eligibility criteria:
inclusion criteria: * confirmed hiv infection * recent diagnosis of hiv (within the past 6 months) or be virologically unsuppressed (\>1000 copies/ml) or disengaged from hiv care (\ 90 days apart) exclusion criteria: * cannot consent * unwilling to come to visits * unwilling to be in san antonio for a year

Keywords: positive links youth emerging adults
pharmacokinetics and pharmacodynamics of trv130, morphine, and placebo in healthy subjects

Conditions: Pain, Acute

Summary: this study is designed to compare trv130 to placebo and morphine to learn about its effects on pain relief and side effects.

this study will explore the pharmacokinetics, pharmacodynamics (pd), safety and tolerability of trv130.

Eligibility criteria:
inclusion criteria: * informed consent * healthy adult males age 18 - 50 years, bmi 19-32 kg/m2 * acceptable duration of cold pain test results at screening exclusion criteria: * clinically significant medical illness or physical exam findings * active dermatological conditions or skin trauma on the non-dominant hand, or peripheral vascular disease * partial blindness, keratoconus, nystagmus or any other ophthalmic condition which could interfere with pupillometry * use of tobacco or nicotine within 6 months prior to screening * history of recent (within 6 months) drug or alcohol abuse, as defined in dsm-iv-tr

Keywords: acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
group music therapy intervention with informal carers of elderly dependents

Conditions: Care Burden; Anxiety; Depression; Coping Strategies; Quality of Life

Summary: to evaluate the effects of a group music therapy intervention with informal caregivers of elderly people on clinical psychological symptoms, taking into account variables such as caregiver burden, anxiety and depression.


Eligibility criteria:
inclusion criteria: * to be the main informal caregiver of an elderly dependant * the dependant person has to be over 60 years of age * to be over 18 years of age * having signed the informed consent form accepting the assessment and intervention exclusion criteria: * not residing in spain * being under 18 years * having uncompensated sensory deficits that prevented the administration of the assessment protocol; * illiteracy.

Keywords: group music therapy informal caregivers health-related quality of life (hrqol) anxiety depression
optimum insufflation capacity in nmd

Conditions: Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Chronic Respiratory Insufficiency

Summary: patients with underlying neuromuscular disorder (nmd) often suffer from weakness in the inspiratory and expiratory muscles. consequently they do not have the strength to generate the minimum flow of 160 to 300 liters/minute for an efficient cough function. the restricted cough function allows secretion to accumulate, which in turn causes narrowing of the airway lumen and makes ventilation of the neuromuscular patient even more difficult. the patient's susceptibility to infection increases again and the vicious circle repeats itself. severe secretion retention may even lead to ventilator failure. effective secretion and cough management instead reduces the risk for stay in hospital. therefore, secretion and cough management is a mandatory part of the therapeutic concept for treating patients with neuromuscular disease. the therapeutic efficacy of the lung insufflation assist maneuver(lia) integrated in the ventilator ventilogic ls-plus manufactured by weinmann gmbh+co kg was studied in a pilot study carried out by the dep. for pediatric pulmonology and sleep medicine at the university hospital of essen/germany in cooperation with research \& development at weinmann gmbh \&co kg, germany . the objective of the pilot study was to examine the therapeutic efficacy of liam as a cough support function in patients with neuromuscular disease and indications for mechanical ventilation. we hypothesized that i) a certain insufflation maneuver pressure may be optimal to achieve the highest individual peak cough flow and ii) that this pressure is below the pressure needed to achieve the maximum insufflation capacity. we define the lowest insufflation capacity at which the best individual pcf can be achieved as optimum insufflation capacity (oic). the study was performed using two different techniques in order to demonstrate that findings are not dependent on maneuver details but are rather based on effects of maneuver pressure. the protocol was limited to techniques which do not require breath stacking: i) insufflation with an intermittend positive pressure (ippb) device and ii) with the ventilogic ls using liam.


Eligibility criteria:
inclusion criteria: * neuromuscular disorder * respiratory insufficiency * use of home mechanical ventilation exclusion criteria: * acute illness * history of pneumothorax

Keywords: cough augmentation peak cough flow hyperinsufflation
human papilloma virus (hpv) self-collection and women adherence

Conditions: Cervical Cancer; HPV Infection

Summary: despite declining mortality in high-income countries, cervical cancer continues to be a public health problem in low and middle -income countries. hpv tests have shown a better sensibility and a higher capacity of reducing mortality than cytology based-screening. greater participation has been demonstrated with the use of hpv self-testing when it is offered to women with a poor screening history; however, it is not clear whether getting tested necessarily translates into a greater adherence to the entire clinical protocol, including diagnosis and treatment of precancerous lesions. the aim of this study is to evaluate the effect of the self-testing techniques on the participation and adherence of women to cervical cancer screening.

the investigators will perform a randomized clinical trial with three arms including: regular hpv with cytology triage, colpo/biopsy, and treatment if indicated; hpv self-collection without cytology triage but with colpo/biopsy and treatment if indicated, hpv self-collection with immediate treatment for women with positive test results. this study will be carried out in two different settings with differential access to diagnosis and treatment. two methods will be used for inviting women and collecting samples: mail and door-to-door. participation (screening uptake) and adherence to the clinical protocol (compliance with diagnosis and treatment) will be evaluated.

Eligibility criteria:
inclusion criteria: * women 30-65 years old * no history of cytology or any other screening test for cancer of the cervix in the past 5 years * be linked to one of the health providing entities participating in the study * women who sign the informed consent. exclusion criteria: * women 30-65 years old * no history of cytology or any other screening test for cancer of the cervix in the past 5 years * be linked to one of the health providing entities participating in the study * women who sign the informed consent.

Keywords: cervical cancer screening programs hpv tests
stress management intervention in inner city adolescents with asthma

Conditions: Asthma; Psychosocial Stress

Summary: the study will utilize a stress management program delivered over 10 sessions that is hypothesized to result in decreased stress levels and improved coping strategies in an inner city adolescent asthma population. participants will include adolescents ages 10-15 years with physician diagnosed asthma. the outcome measures will be obtained via psychosocial questionnaires and spirometry.


Eligibility criteria:
inclusion criteria: * ages 8-15 years of age * physician diagnosed asthma based on nhbli guidelines * english speaking * child assent/parental consent exclusion criteria: * refusal of child assent/parental consent * non-english speaking * history of psychiatric illness, autoimmune disease, hiv/aids, smoking history.

Keywords: adolescents
evaluation of nexpowder application to prevent delayed bleeding after colorectal endoscopic mucosal resection

Conditions: Colorectal Cancer

Summary: delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. in addition, preventive hemostasis with clips is difficult and costly. a newly developed endoscopic hemostatic powder generating gelation effect (nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (emr) for large superficial colorectal lesions.


Eligibility criteria:
inclusion criteria: * more than 18 years old * indication of emr for a superficial nonpedunculated colorectal lesion * higher risk of bleeding (score gseed re2 ≥ 7\*) \*score gseed re2 (albeniz et al gie 2020): * proximal location (cecum to transverse included) : 3 points * antiplatelets or anticoagulation use: 3 points * lesion size ≥ 40 mm: 1 point * asa iii-iv or major comorbidity: 1 point exclusion criteria: * patients susceptible to allergic reactions to certain substances in nexpowder * more than one colorectal lesion * suspicion of invasive cancer (kudo v, sano iiib, connect iii), macronodular more than 1 cm, depressed area (paris iic) * pedunculated polyps (ip from paris classification) or ulcerated polyps (iii) * recurrent or residual lesion after endoscopic or surgical resection * poor bowel preparation quality (boston score \< 6) * inflammatory bowel disease (ibd) * patients with a platelet count of 50,000/mm3 or less * patients with acquired (non-medicated) or inherited bleeding disorders * patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement) * contraindication to general anesthesia * women who are pregnant or who wish to become pregnant during the study or women who are breastfeeding. * children, immunocompromised persons and persons over 90 years of age * patients already participating or scheduled to participate in other clinical trials * lesion previously resected by endoscopy * patient with an initial metastatic lesion before colonoscopy * patient unable to give personal consent * lack of signed informed consent

Keywords: colorectal polypectomy endoscopic mucosal resection hemostatic powder
portal hypetension and bariatric surgery (bariaportal)

Conditions: Bariatric Surgery Candidate; Obesity, Morbid; Portal Hypertension

Summary: the worldwide obesity epidemic has led to an increase in the proportion of patients with chronic liver disease due to non-alcoholic fatty liver disease (nafld) and in the prevalence of obesity in patients with cirrhosis of all etiologies. the reported prevalence of obesity in patients with cirrhosis is of 30% which appears similar to that of the general population. bariatric surgery is currently considered as the most effective and durable means for the management of morbid obesity as it is associated with the remission and/or improvement of many obesity associated comorbidities as well as improved quality and expectancy of life. however, the surgical risk is increased compared to individuals without cirrhosis, and determining the risk/benefit ratio of bariatric surgery in the setting of cirrhosis is a complex task further hampered by the lack of randomized controlled trials. the nationwide inpatient sample study reported a slightly increased rate of mortality of bariatric surgery in the setting of compensated cirrhosis compared to individuals without cirrhosis (0.9% vs 0.3%). interestingly, this risk was as high as 16.3% in individuals with decompensated cirrhosis (16.3%). however, this study has been published more than 10 years ago and the mortality of bariatric surgery has decreased significantly and is around 0.1%. furthermore, the introduction of transient elastography in clinical practice has allowed the early identification of patients with chronic liver disease (cld) at risk of developing clinically significant portal hypertension (csph). a few series including a limited number of patients have been published indicating that csph should not be considered as a formal contraindication for bariatric surgery. this study is meant to assess the outcomes of bariatric surgery in patients with morbid obesity and compensated advanced chronic liver disease (cacld) (currently synonymous of the term "compensated cirrhosis'') associated with clinically significant portal hypertension (csph) in a large multicentric, multinational series.


Eligibility criteria:
inclusion criteria: * individuals with morbid obesity (bmi \> 40 or 35 with at least one comorbidity) undergoing bariatric surgery and csph (defined as hvpg \> 10 mmhg and/or cross-sectional imaging showing collateral circulation, and/or varices at esophagogastroduodenoscopy. * information available to determine postoperative mortality (at least first postoperative month of any duration in case of primary hospitalization longer than 1 month) exclusion criteria: * absence of preoperative evidence of csph in spite of evidence liver cirrhosis. * absence of information to determine at least postoperative mortality.
a study of pf-05212384 plus folfiri versus bevacizumab plus folfiri in metastatic colorectal cancer

Conditions: Metastatic Colorectal Carcinoma

Summary: this is a multicenter, open label phase 1b/2 study in patients with metastatic colorectal carcinoma. the phase 1b will identify the dose of the combination of pf-05212384 plus folfiri. the randomized, two-arm phase 2 portion will compare the efficacy and safety of pf-05212384 plus folfiri to that of bevacizumab plus folfiri. the study population will consist of patients with mcrc previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.


Eligibility criteria:
inclusion criteria: * advanced colorectal carcinoma. * progression on prior oxaliplatin-containing regimen used in 1st line setting for mcrc or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting. * tumor tissue available at time of screening for molecular profiling. * adequate performance status. * adequate glucose control, bone marrow, kidney, liver, and heart function. exclusion criteria: * participation in other studies involving investigational drug(s) (phases 1-4) before the current study begins and/or during study participation. * prior irinotecan treatment. * prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting. * history of gilbert's syndrome. * active brain metastases. * deep vein thrombosis in the preceding 2 months. * history of interstitial lung disease. * ras (kras/nras) wild type mcrc not previously treated with an anti-egfr containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).