Kornimate/medical-research-clean huggingface dataset:
β-galactosidase producing probiotic strains to improve lactose digestion

Conditions: Lactose Intolerance

Summary: the purpose of this study is to assess that two β-galactosidase producing probiotic strains help improve lactose digestion in subjects with lactose maldigestion.

the trial will be cross over, randomized in incomplete blocks, controlled, double-blind: each subject will be administered 3 products out of 4 (positive control, probiotic streptococcus (s.) thermophilus, probiotic bifidobacterium (b.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge. the total sample size is 42 enrolled subjects/37 completed patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.

Eligibility criteria:
inclusion criteria: 1. hbt\> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests 2. having signed the informed consent or having provide his/her legal representative's informed consent exclusion criteria: 1. known food allergy 2. any obstructive (copd, asthma...) or restrictive respiratory syndrome that may impact breath test measurements 3. any medically relevant malabsorption syndrome 4. any medically relevant chronic gut motility disorder other than irritable bowel syndrome (ibs), assessed with rome iii questionnaire 5. ongoing therapy with drugs known to affect gut motility 6. any general antibiotherapy taken during or within 4 weeks of study onset 7. use of lactase pill (eg. lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to visit 0b 8. subject who cannot be expected to comply with the study procedures 9. currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study. 10. to be a close collaborator to the investigators, either in terms of family relationship and/or professional relationship 11. pregnancy, based on anamnesis
periprosthetic plate over humeral nail

Conditions: Osteopenia, Osteoporosis

Summary: use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone

small im interlocking nail, such as humeral nail, could be used in femoral fixation in normal adolescent patients due to the advantages of the entry point lateral to tip of greater trochanter resulting in avoiding iatrogenic vascular injury and being the im locking device with smaller diameter and shorter length than conventional femoral nail which was appropriate for small-sized adolescent femoral anatom

Eligibility criteria:
inclusion criteria: * osteoporotic bone with femoral deformity. * osteogenesis imperfecta. --vitamin d deficiency ricket exclusion criteria: * uncooperative patient. -- skeletally immature * not receiving medical treatment. * patient with history of allergy to drugs used in the study. * neuromuscular pathology, previous trauma, or surgery to the leg

Keywords: deformity osteoporosis
prepare-calc-combo: severely calcified coronary lesions prepared with rotational atherectomy and modified balloons

Conditions: Coronary Artery Disease

Summary: a prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

a prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

Eligibility criteria:
inclusion criteria: clinical inclusion criteria 1. age above 18 years and consentable 2. angiographically proven coronary artery disease 3. anginal symptoms and/or reproducible ischemia in the target area by ecg, functional stress testing or fractional flow reserve 4. written informed consent angiographic inclusion criteria 1. de-novo lesion in a native coronary artery 2. target reference vessel diameter between 2.25 and 4.0 mm by visual estimation 3. luminal diameter reduction of 50-100% by visual estimation 4. severe calcification of the target lesion (for definition see appendix) exclusion criteria: clinical exclusion criteria 1. myocardial infarction (within 1 week) 2. decompensated heart failure 3. limited long term prognosis due to other conditions angiographic exclusion criteria 1. target lesion is in a coronary artery bypass graft 2. target lesion is an in-stent restenosis 3. target vessel thrombus

Keywords: calcified coronary lesions
digital pcr for quantifying periodontal pathobionts

Conditions: Periodontal Diseases

Summary: comparison of quantitative polymerase chain reaction (qpcr) and digital polimerase chain reaction (dpcr) quantification of subgingival plaque samples.


Eligibility criteria:
for inclusion, each subject had to be systemically healthy and aged 20 to 80 years. subjects were excluded if they: had less than 5 teeth in each jaw quadrant, regularly used a mouthwash as part of their oral hygiene routine, had received antibiotics during the last 6 months or during the study period, were pregnant or lactating, had a known systemic illness (i.e. hiv/aids, diabetes mellitus, cancer, diseases of bone metabolism, diseases affecting wound healing) or were treated with immunosuppressants, chemotherapy, radiation, calcium antagonists, antiepileptics and non-steroidal anti-inflammatory drugs.
a study of ly3502970 in chinese participants with obesity or are overweight with weight-related comorbidities

Conditions: Overweight; Obesity

Summary: the main purpose of this study is to learn about the safety and tolerability of ly3502970 when given to chinese participants with obesity or overweight with weight-related comorbidities. blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. each enrolled participant will receive ly3502970, or placebo given orally. for each participant, the study will last about approximately 22- and 30-weeks for both cohort 1 and 2, respectively including screening period.


Eligibility criteria:
inclusion criteria: * are native chinese males or females * have had a stable body weight for the 3 months prior to randomization (less than 5% body weight change) and body mass index of ≥ 30.0 kilograms per square meter (kg/m²) or between 27.0 up to 30.0 kg/m² with at least 1 of the following weight-related comorbidities including hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea exclusion criteria: * have any prior diagnosis of type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm), or rare forms of diabetes mellitus * have used or intend to use any prescription or over-the-counter medications or traditional chinese treatments within 3 months prior to screening, exception of medications for the treatment of concurrent medical conditions with a stable dose * have known allergies to glp-1ras, ly3502970, related compounds, any components of the formulation, or have a history of significant atopy * are overweight or have obesity induced by other endocrinological disorders, diagnosed monogenetic, or syndromic forms of obesity * have or plan to have a surgical, endoscopic or device-based treatment for obesity * have a history or presence of psychiatric disorder, a moderately severe or severe depression status, or a significantly risk for suicide * have a history of acute or chronic pancreatitis * have a known self or family history of multiple endocrine neoplasia type 2a or type 2b, thyroid c-cell hyperplasia, or medullary thyroid carcinoma * have other acute, chronic, or uncontrolled medical conditions, vital organ failure or abnormal laboratory value in the judgment of the investigator would make the participant inappropriate for entry into this study

Keywords: safety and tolerability chinese ly3502970
donor neutrophil subsets to predict the risk of agvhd

Conditions: Acute Graft-versus-Host Disease

Summary: this is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.

this study was a single-center, observational, prospective cohort study. the study lasted for 3 months, from 2023.12 to 2024.3, the clinical enrollment was completed, and from 2024.3 to 2024.6, the follow-up was completed. it is planned to enroll 260 subjects, divided into 130 donors and 130 patients. no randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate. all recipients will be followed for agvhd evaluation, relapse, cgvhd, leukemia relapse, disease-free survival (dfs), non-relapse mortality (nrm). agvhd and cgvhd were graded according to published guidelines. all recipients will be monitored every month until the study is completed.

Eligibility criteria:
inclusion criteria: donors 1. voluntarily sign the informed consent form; 2. age 16-65 years old 3. donors whose hla-matched or hla-mismatched to the corresponding recipients recipients 1. voluntarily sign the informed consent form 2. age 16-65 years old 3. willing to undergo hla-matched or hla-mismatched allo-hsct exclusion criteria: donors 1. have a history of other tumors 2. with poor compliance or mental disorders 3. infected with hiv and hcv 4. with uncontrolled hbv infection 5. with other autoimmune diseases 6. those who are judged by the researcher to be unsuitable to participate in this study recipients 1. have a history of other tumors 2. with poor compliance or mental disorders 3. infected with hiv and hcv 4. with uncontrolled hbv infection 5. with other autoimmune diseases 6. those who are judged by the researcher to be unsuitable to participate in this study
sentinel node in endometrial cancer

Conditions: Endometrial Cancer

Summary: phase ii, open-label, randomized pilot study. patients will be randomized (1:1) to receive for sentinel node screening: 1. radiotracer (rt) via cervical administration and tumir 2. combination of rt with indocyanine green (rt + icg) via cervical administration and tumir patients will be followed up to 1 month after the last administration of radiotracer 70 patients will be included into the study.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. histological diagnosis of endometrial cancer with criteria of high risk according to the following criteria: - unfavorable histology according to figo (adenocarcinoma serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion\> 50% by resonance magnetic (mr) or transvaginal ultrasound 3. women of childbearing age should have a transvaginal ultrasound who rule out pregnancy and must commit to using methods highly effective contraceptives (vasectomized couple and sexual abstinence) until the hysterectomy is performed. 4. patient who gives written informed consent. exclusion criteria: 1. pregnancy or lactation. 2. suspected lymph node or distant metastatic disease in the preoperative study. 3. history of previous surgery or radiotherapy in the pelvic and paraortic lymphatic drainage areas or nodal involvement of any other etiology. 4. body mass index (bmi) greater than 45 kg / m2. 5. patients who, in the researcher's opinion, are not suitable for participate, regardless of reason, including medical or clinical, or participants potentially at risk of not comply with the study procedures. 6. known hypersensitivity to some of the active substances or excipients from rt or icg (including previous history of hypersensitivity to products containing human albumin). 7. hypersensitivity to sodium iodide. 8. patients allergic to iodine. 9. patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal and autonomic disturbances of the gland thyroid.
a knowledge translation intervention for tb/hiv treatment adherence, in zomba district, malawi

Conditions: Tuberculosis

Summary: despite increased emphasis on evidence based practice in recent years a gap remains between evidence and practice, particularly in resource poor countries. few studies to date have examined the use of knowledge translation strategies to improve health care outcomes in low income countries. however, given that the majority of health care in these settings is provided by workers with less training and limited resources, the theoretical potential for knowledge translation strategies to improve health care delivery and outcomes by integrating best evidence into routine practice may be greatest in these settings. knowledge translation (kt) is an approach to changing health care provider behavior to reduce the gap between evidence and practice in health care delivery. there has been a tendency for knowledge translation interventions to employ generic, "off the shelf", strategies, and apply them to deal with specific issues. this generic approach, fails to recognize the variability in the specific characteristics of health care settings, in terms of their patient populations, health care systems, and health care providers. these characteristics, whether they function as barriers or facilitators to change, make a generalized approach to kt ineffective, where a tailored strategy, which specifically adjusts its approach to measured local barriers and facilitators may achieve better alignment of practice to evidence. this is likely to be particularly true in low income countries where the majority of health care is provided by non-physician health care workers, working within a wider range of health care systems, with variable and unique patient populations and resource constraints. given the potential to significantly impact health care outcomes at relatively low cost, further research is needed both to develop methods for identifying potential barriers and facilitators to kt strategies in specific resource poor settings, and to evaluate the effectiveness of kt strategies tailored to address the identified barriers. this study will assess the effectiveness of a two part knowledge translation intervention tailored to address factors identified in a previous study as functioning as barriers and facilitators to treatment adherence among patients on treatment for tuberculosis or combined tuberculosis and antiretroviral treatment, targeting improved patient adherence and health outcomes, in a specific low income country.


Eligibility criteria:
inclusion criteria: * all health centers in zomba district

Keywords: tuberculosis treatment adherence knowledge translation educational outreach
improving adult protective services client outcomes: a stepped-care social and mental health engagement program

Conditions: Depression in Old Age

Summary: the purpose of this study is to ascertain the feasibility and effectiveness of an 8-week social engagement program aimed at reducing depression and increasing social engagement among seniors who are transitioning out of adult protective services (aps) for either elder abuse or self-neglect.


Eligibility criteria:
inclusion criteria: older adults * an aps validated em/sn case * able to provide informed consent * able to speaks english or spanish, * community-dwelling, * able to hear sufficiently using the telephone * transitioning out of aps intervention (i.e. in the case closure phase of the aps service). student * college or university student * enrolled at one of the uthealth graduate programs in houston, university of houston, texas southern university, sam houston state university, or rice university * commit to making 8-weekly consecutive calls * complete the required 1-hour training and assessment. exclusion criteria: older adults * individuals needing a proxy to consent * suspected or confirmed decision-making capacity impairments or uncontrolled psychiatric illnesses such as schizophrenia, paranoia, delusion, or delirium * older adults transitioning to a nursing home, assisted-living, or residential care facility student -only engaging in the program to fulfill some educational requirement

Keywords: social engagement adult protective services (aps) elder abuse self neglect
a trial evaluating the efficacy and tolerability of ssr125543 in outpatients with major depressive disorder

Conditions: Major Depression

Summary: primary objective: * to evaluate the efficacy of three fixed doses of ssr125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (day -1) to day 56 in the 17-item hamilton depression rating scale (ham-d) total score. secondary objectives: * to evaluate the tolerability and safety of ssr125543 in outpatients with major depressive disorder * to evaluate plasma concentrations of ssr125543

this duration of this trial is 11 weeks.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of major depressive disorder, as defined by the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (296.3) and confirmed by the semi-structured mini international neuropsychiatric interview (mini). exclusion criteria: * inpatient hospitalization at screening * symptoms of depression present for \ 2 years * significant suicide risk * mild depression as measured by standard clinical research scales * history of failure to respond to antidepressant treatment * other psychiatric conditions that could obscure the results of the study * for women of child-bearing potential, the unwillingness to use highly effective means of birth control the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of ixekizumab (ly2439821) in participants with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.


Eligibility criteria:
inclusion criteria: * presents with established diagnosis of active psoriatic arthritis (psa) for at least 6 months, and currently meets classification for psoriatic arthritis (caspar) criteria * active psa defined as the presence of at least 3 tender and at least 3 swollen joints * presence of active psoriatic skin lesion or a history of plaque psoriasis (ps) * men must agree to use a reliable method of birth control or remain abstinent during the study * women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment * have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cdmards) * have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (tnf) inhibitors. the participant must have discontinued at least 1 tnf inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance. exclusion criteria: * current use of biologic agents for treatment of ps or psa * inadequate response to greater than 2 biologic dmards * current use of more than one cdmards * diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than psa * have received treatment with interleukin (il) -17 or il12/23 targeted monoclonal antibody (mab) therapy * serious disorder or illness other than psoriatic arthritis * serious infection within the last 3 months * breastfeeding or nursing (lactating) women
dating violence and hiv prevention in girls: adapting mental health interventions

Conditions: Dating Violence; HIV Infections

Summary: this project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure.

a growing body of research reveals that dating violence (dv) plays a significant role in adolescent girls' hiv risk. dating violence has been associated with less condom use, younger age at first intercourse, having multiple sex partners and alcohol use prior to sexual encounters. thus, prevention strategies that address dating violence and hiv risk may hold promise for reducing sexual risk behavior among a particularly at-risk population. in this study, a cognitive-behaviorally based intervention named "skills to manage aggression in relationships for teens" (date s.m.a.r.t.) is being developed and compared to a psychoeducational program for dating violence and hiv prevention. the program is being implemented with a sample of underserved youth, as economic disadvantage and minority status have been found to be related to increased rates of adolescent dating violence. a primary focus of the intervention is to address mental health problems (i.e. psychological distress and behavioral dysregulation) that underlie the development and maintenance of both dating violence and sexual risk behavior among adolescent girls.

Eligibility criteria:
inclusion criteria: * adolescent must be english-speaking * adolescent must have a lifetime history of physical dating violence perpetration or victimization exclusion criteria: * current enrollment in an intervention for dating violence or hiv prevention

Keywords: hiv prevention dating violence females romantic relationships adolescents sexuality underserved youth
post-transplant cyclophosphamide in wiskott-aldrich syndrome

Conditions: Wiskott-Aldrich Syndrome

Summary: a protocol named as "cip-2015" for patients with wiskott-aldrich syndrome may reduce the rate of gvhd. the details of the protocal followed with: 1. conditioning regimen busulfan 16 mg/kg in total, fludarabine 160 mg/m2 in total. 2. gvhd prophylaxis: rabbit antihuman thymocyte globulin 7.5 mg/kg post-transplant cyclophosphamide (cy) (50 mg/kg.d on days +3 and +4) cyclosporine or tacrolimus, mycophenolate mofetil, on days +5

patients were enrolled in cip-2015 protocol at the capital institute of pediatrics (beijing). the conditioning regimen consisted of fludarabine (40 mg/m2) from days -6 to -3, and busulfan was administered intravenously for 4 days, from days -5 to -2，using dose targeting based on therapeutic drug monitoring. thymoglobulin (sanoﬁ, cambridge, ma) 7.5 to 10 mg/kg (cumulative dose over 4 days) was administered over 4 days, from days -5 to -2. bone marrow (bm) and pbsc were infused on day 0, followed by post-transplant cy (50 mg/kg/day, on days +3 and +4). to protect against hemorrhagic cystitis, mesna (2-mercaptoethane sodium sulfonate) was administered at 150% of the cy dose. post grafting immunosuppression with mycophenolate mofetil and tacrolimus commenced on day +5 and extended until days +28 and +84, respectively. tacrolimus was tapered off by day +90 if there was no gvhd.

Eligibility criteria:
inclusion criteria: -patients diagnosed with wiskott-aldrich syndrome with indication of hematopoietic stem cell transplantation exclusion criteria: * without indication of hematopoietic stem cell transplantation