Kornimate/medical-research-clean huggingface dataset:
long-term follow-up of subjects treated with car t cells

Conditions: Long Term Adverse Effects; CAR-T; Duty to Follow Up; Adult; Progression-Free Survival; Disease-Free Survival; Overall Survival

Summary: this is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for phase 1 studies that evaluate the safety and efficacy of car t cells: nct05660369 (df/hcc# 22-175) and nct06026319 (df/hcc# 23-474).

this is a long-term safety and efficacy follow-up study for subjects who have been treated with car t cells in corresponding phase i main studies that evaluated the safety and efficacy of car t cells in subjects. no investigational treatment will be administered in this study. the fda (2020) recommends long-term follow up for subjects treated with gene therapy drug products to monitor for delayed adverse events (aes), as well as durability of clinical response. therefore, after monitoring of subjects in the main studies has been completed (24 months after car t cells infusion, or \<24 months after car t cells infusion if subject terminated early due to disease progression or due to discontinuing corresponding main study for any reason), subjects will be asked to participate in a long-term follow-up study (ltfu). subjects will be followed for up to 15 years following their last car t cells infusion in the corresponding main study.

Eligibility criteria:
inclusion criteria: subjects will be asked to participate leading up to the last df/hcc corresponding main study visit. subjects meeting the following criteria are eligible for study participation: * provision of voluntary written informed consent by subject * car t cells were administered in df/hcc irb corresponding main study exclusion criteria: subjects meeting the following criterion are to be excluded from study participation: - subject unable to comply with study requirements

Keywords: long-term follow-up to car-t cells follow-up studies
empathy in action: sunshine calls for life with diabetes

Conditions: Diabetes Mellitus, Type 2; Diabetes; Mental Health; Health Behavior

Summary: randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a federally qualified health center (fqhc) against usual care.

in this study, we will assess the effectiveness of a 6-month program delivered by phone by lightly-trained lay people to individuals with diabetes, with the goal of empathetic relationship building and engagement to support day-to-day challenges of managing diabetes and working towards self-management goals. we will recruit from a collaborating federally qualified health center (fqhc) and use a randomized controlled trial, comparing program to usual care. telephone callers will be lay people (no formal health training) who will be recruited for authentic interest and empathetic skills and lightly trained on conversational skills, cultural nuances, and how best to support people's individual lifestyle goals on nutrition, exercise, sleep and medication adherence. callers will encourage participants to seek additional help from their clinic or specific social services as needs arise that benefit from early escalation.

Eligibility criteria:
inclusion criteria: * hba1c ≥ 7.5% at baseline measurement and 8.0% at least one time 12 months prior to study enrollment. * at least one visit with lone star circle of care within the past 12 months (in person or telehealth) * willing to answer the phq-9 form in its entirety at baseline data collection (due to stratified randomization design). exclusion criteria: * hba1c \< 7.5% at baseline measurement. * refusal to answer the phq-9 form in its entirety at baseline data collection. * moderate to severe cognitive impairment * currently pregnant (if of female sex) * undergoing cancer treatment * having diagnosis of end-stage renal disease or serious mental illness * having moderate to severe cognitive impairment * receiving systemic treatment with prednisone or immunosuppressant therapy following an organ transplant

Keywords: telephone empathy layperson self-management incentives
spd489 adult major depressive disorder (mdd) open-label safety and tolerability rollover extension study

Conditions: Major Depressive Disorder

Summary: this study is an optional continuation of previous short-term adult major depressive disorder (mdd) augmentation studies. patients may only take part in this long-term, open-label research study if they completed a previous double-blind mdd augmentation study using spd489.


Eligibility criteria:
inclusion criteria: * subject has completed 1 of the respective short-term antecedent spd489 mdd studies and did not experience any clinically significant aes in the antecedent study that would preclude exposure to spd489. exclusion criteria: * subject has any current co-morbid axis i or axis ii psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol
c2p mobilization intervention (pilot)

Conditions: HIV Infections

Summary: connect to protect (c2p): partnerships for youth prevention interventions is a multi-site, three-phase project developed by the adolescent medicine trials network for hiv/aids interventions (atn). the overall goal of the project is to ultimately reduce hiv incidence and prevalence in youth 12-24 years old through a community mobilization intervention. this protocol (atn 040) describes part one of phase iii. part two of phase iii will be submitted as a separate protocol (atn 041).

the objective of phase iii is to initiate and complete a community mobilization intervention aimed at ultimately reducing hiv incidence and prevalence among youth. the intervention will consist of guiding c2p coalitions through a strategic planning process that will result in the development and implementation of a local action plan. the action plan will focus on changing structural elements of the affected communities that are believed to be associated with youth hiv acquisition and transmission. each coalition's plan will include: (1) identification of potential community structural changes and specific steps for how to effect such changes; and (2) the selection of a community-level centers for disease control and prevention (cdc)-endorsed hiv prevention program. these activities will be described in this document. details related to the training, technical assistance, adaptation, and implementation of the selected cdc program will be subsequently submitted for irb review as part two of phase iii (atn 041). the intervention consists of community mobilization activities that are expected to lead to structural change and the adaptation and delivery of a cdc-endorsed hiv-prevention program. atn/c2p staff at each site, with training and technical assistance from a c2p national coordinating center, will engage in a strategic planning process with their coalition members that results in the development and implementation of a local action plan. the evaluation of the intervention will be within and across atn/c2p sites implementing this protocol. for assessing the overall efficacy of the community mobilization intervention, data will be collected and analyzed from: 1. atn/c2p site staff, in the form of systematic documentation of the community mobilization process and accomplishments (e.g., structural change achieved); and 2. local public health departments and other similar sources of epidemiological information, as was done for generating phase i epidemiologic profiles. duration: 4 years.

Eligibility criteria:
inclusion criteria: * community each atn/c2p site is attempting to mobilize exclusion criteria: * non-atn funded site

Keywords: hiv prevention hiv positive communities
effect of probiotics on patients with congenital heart disease following cardiopulmonary bypass

Conditions: Congenital Heart Disease; Intestinal Disease; Dysbiosis

Summary: a randomized, controlled study including infants with non-cyanosis congenital heart disease (chd) in need of surgical correction involving cardiopulmonary bypass (cpb) was established. infants aged 1 month to 1 years were enrolled between june 2021 and july 2022. the patients in treatment group were supplied with probiotics consisting of bifidobacterium infantis and lactobacillus perioperatively and patients in control group were provided with placebo. data concerning patients' clinical outcome such as diarrhea were collected. blood samples were collected for measurement of fatty acid binding protein 2 (fabp2), diamine oxidase (dao), d-lactic acid (d-la) and c-reactive protein (crp). stool samples were collected to investigate the changes of intestinal flora.


Eligibility criteria:
inclusion criteria: * a diagnosis of chd requiring surgical repair with the use of cpb * age greater than 37 weeks corrected gestational age and less than 1 year old exclusion criteria: * patients with inherited metabolic disease, history of intestinal surgery, preexisting gastrointestinal pathology (such as nec, ibs, inflammatory bowel disease, chronic intestinal obstruction or diarrhea), immunity dysfunction or received antibiotics, probiotics or hormone-replacement therapy within 2 months before enrollment were excluded from the study
evaluation of preoperative n1539 in total knee arthroplasty

Conditions: Pain, Postoperative

Summary: the primary objective of this study is to assess the effect of preoperative administration of n1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.


Eligibility criteria:
inclusion criteria: * voluntarily provide written informed consent. * be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral total knee arthroplasty (tka), and be expected to require iv analgesia, remain in an inpatient setting for ≥24 hours, and receive at least two doses of study drug. * asa physical status category 1, 2, or 3. * female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study. * have a body mass index \<40 kg/m\^2 exclusion criteria: * have a known allergy or hypersensitivity to any study treatment. * have a history of previous tka. * has plans for a concurrent surgical procedure (eg, bilateral tka). * has tka planned to be performed under general anesthesia. * have a history of myocardial infarction within the preceding 12 months. * have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation. * have active or recent (within 6 months) gastrointestinal ulceration or bleeding. * have a known bleeding disorder which may be worsened with the administration of an nsaid. * be currently receiving treatment with oral meloxicam (mobic®) or another nsaid within 48 hours prior to surgery. * have previously received n1539/iv meloxicam or received any investigational product within 30 days before dosing with study medication. * have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.

Keywords: total knee arthroplasty pain analgesia n1539 phase 3b knee replacement
comparison of vocal biomarkers for depression and anxiety to formal clinical assessments

Conditions: Depression/Anxiety

Summary: participants will be recruited to complete self reported surveys normally used as standards of care for screening and monitoring depression and anxiety symptom severity, provide a voice sample composed of an answer to open ended questions and then be assessed by a mental health professional using structured and clinically validated assessment tools for depression and anxiety. their voice will be analyzed by machine learning models that predict the severity of depression and anxiety symptoms. the models' performance will be compared to the clinician assessments and how that correlation compares to a similar comparison between the clinician assessments with the self reported surveys. it is hypothesized that the performance of the machine learning models in assessing the severity of depression and anxiety symptoms is no worse than the self reported surveys when both are compared to clinician assessments. it is also hypothesized that presence or absence of the diagnoses of major depressive disorder and generalized anxiety disorder can be predicted better than chance by the analysis of the participant's voice sample using machine learning models.


Eligibility criteria:
inclusion criteria: * native speaker or conversant in english * access to smartphone or computer with microphone * provision of esigned and dated informed consent form * willingness to adhere to the study protocol * to participate in the subsequent clinical interview portion of this study in addition to the above inclusion criteria, a participant must provide an evaluable and qualified voice sample. exclusion criteria: * speech impairments or other conditions that impact their ability to speak clearly * under the influence of recreational drugs or alcohol * ill or experiencing heavy allergies or temporary conditions affecting respiration, voice, or speaking.

Keywords: vocal biomarker depression anxiety structured clinical assessment
evaluating the effect of a written action plan on comfort and understanding of hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: this study is being conducted to evaluate if a written action plan for hidradenitis suppurativa (hs) will help patients with hidradenitis suppurativa gain a better understanding of the condition and how to manage the condition on a daily basis compared to a routine verbal consultation.


Eligibility criteria:
inclusion criteria: * this study will only enroll subjects between the ages of 18-years and 89-years of age. * diagnosis of hs by a board-certified dermatologist * able to read and comprehend study materials * no prior exposure to written hs action plans exclusion criteria: * those who do not fit the inclusion criteria
effect of periodontal treatment on visfatin, fetuin-a and sirtuin 1 of patients with periodontitis and type 2 diabetes

Conditions: Periodontal Diseases; Type 2 Diabetes; Periodontitis

Summary: the aim of this study is to determine the concentrations of visfatin, fetuin-a and sirtuin 1 in the gingival crevicular fluid and clinical periodontal parameters in diabetic and systemically healthy individuals and to determine whether non-surgical periodontal treatment had any effect on these biomarkers and periodontal clinical parameters at the end of a 3-month follow-up period. the hypothesis of our study is that gingival crevicular fluid visfatin, fetuin-a and sirtuin 1 concentrations will change with non-surgical periodontal treatment in type 2 diabetic and systemically healthy individuals and that this change will be associated with diabetes and clinical parameters.

sixty-six patients were divided into six equal groups; group 1: systemically and periodontally healthy individuals, group 2: systemically healthy individuals with periodontitis, group 3: controlled type 2 diabetes and periodontally healthy individuals, group 4: controlled type 2 diabetes and periodontitis, group 5: uncontrolled type 2 diabetes and periodontally healthy individuals, group 6: uncontrolled type 2 diabetes and periodontitis. the study was planned as a randomized, single-blind, parallel design. periodontal clinical parameters (silness-löe plaque index, löe-silness gingival index, probing pocket depth, clinical attachment level, bleeding on probing) were recorded clinically and concentrations of visfatin, fetuin-a and sirtuin 1 in gingival crevicular fluid were assessed biochemically. after baseline examinations, periodontal treatment was completed using a nonsurgical periodontal treatment protocol completed in 24 hours. periodontal clinical parameters and gingival crevicular fluid were recorded at baseline and 3 months after periodontal treatment. biochemical analysis and statistical evaluation were performed.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * to be over 18 years old * no periodontal treatment in the last 6 months * being systemically healthy except for type 2 diabetes * not taking medication for any reason except type 2 diabetes * hba1c \<7 in controlled type 2 diabetes group * hba1c ≥7 in uncontrolled type 2 diabetes group * not smoking or drinking alcohol exclusion criteria: * not volunteering to participate in the study * under 18 years of age * periodontal treatment in the last 6 months * having any systemic disease affecting the periodontal condition * having used local or systemic antibiotics in the last 3 months * use of anti-inflammatory, steroid drugs in the last 3 months * taking vitamin, mineral or antioxidant supplements in the last 3 months * being pregnant or lactating * regular use of mouthwash * smoking or drinking alcohol

Keywords: visfatin fetuin-a sirtuin 1 periodontitis type 2 diabetes non-surgical periodontal treatment gingival crevicular fluid
comparing the efficacy of intranasal midazolam versus intravenous diazepam for control of seizures in children

Conditions: Seizures

Summary: after approval , study will be conducted at the children hospital pims, islamabad. children 1-12 years presenting/admitted with seizures will be enrolled in the study after taking informed consent from the parents. children's name, age, sex will be recorded by the on duty doctor. patients will be randomly allocated to two equal groups. group a (ga) will receive single dose of intravenous diazepam (0.2mg/kg/dose)after passing cannula, while group b (gb) will receive single dose of intranasal midazolam (0.2mg/kg/dose).response to treatment will be assessed by recording the time required for termination of seizures in both gruops.the time required for gaining intravenous accessin group a will be recorded as well. data will be collected through a structured performa.

benzodiazepines are the first line of drugs for cessation of acute seizures.benzodizepines can be given intravenous,orally,per rectal and intranasal.conventional treatment of acute seizures is intravenous diazepam in most hospital settings which requires an iv access,which is not possible for parents to give at home.the main problem in an actively seizuring child is to reach the hospital and maintaining an intravenous line.midazolam is a water soluble benzodiazepine which is widely used as an anxiolytic and anticonvulsant ,can be given through intravenously,intramuscularly, oral,buccal and nasal mucosa as well.it becomes lipid soluble at physiologic ph levels and reaches the cns with a rapid onset and shorter duration of action.it is administered into nostril in a way that it comes into direct contact with nasal mucosa.it is given in a dose of 0.2mg\\kg and within a few minutes its level in serum are comparable to the injectables levels.it is a safe,cheap,easy to use and effective alternative to diazepam for use at home as well as in hospital settings.

Eligibility criteria:
inclusion criteria: * children 1-10 years both male and female visiting/admitted in children hospital pims with acute episode of seizure (febrile or afebrile) exclusion criteria: * children requiring emergency resuscitation * children with uncontrolled epilepsy
evolution of resistance to systemic therapies in patients with breast cancer

Conditions: Metastatic Breast Cancer

Summary: the objective of this study is to apply whole-body dw imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.


Eligibility criteria:
inclusion criteria: * age over 18 years. * first metastatic breast cancer relapse after treatment for early stage disease * a minimum of 10 evaluable lesions in the liver on routine x-ray ct imaging * patient prescribed cytotoxic, endocrine or biological therapies * patient physically and psychologically fit enough to consider sequential wb-- - dwi imaging alongside their standard disease monitoring * written informed consent exclusion criteria: * diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia * diagnosis of brain metastases. * contraindication to magnetic resonance mr imaging
web-based, interactive professional education for chronic obstructive pulmonary disease

Conditions: Education of Primary Care Clinicians

Summary: this study involves the development and evaluation of a web-based, interactive education program on chronic obstructive pulmonary disease (copd) for primary care clinicians. the research questions that this proposal addresses include: 1. can an interactive, web-based copd course be developed to disseminate evidence-based, best practice recommendations to primary care clinicians? 2. can assessment tools be developed to evaluate the impact of the program on clinician behavior in clinical practice and on patient care?


Eligibility criteria:
inclusion criteria: * primary care clinicians in training * willing to participate exclusion criteria: * specialists
clinical and genetic study of neurodegenerative disorders with cognitive impairment

Conditions: Alzheimer's Disease; Dementia; Neurodegenerative Disorders

Summary: patients with different types of dementia will be recruited and evaluated in national hospital departments for their usual neurological follow-ups. a blood sample will be proposed in the field of this research project, and the biological material will be stored at the dna and cell bank of institut de fédératif recherche (ifr) of neurosciences (pitié-salpêtrière hospital, paris). the clinical research network is already set up for alzheimer's disease and frontotemporal dementias, which permits an evaluation according to a clinical standardized protocol. among these disorders, a monogenic sub-group has been identified. in alzheimer's disease, it is associated with the app, psen1 and psen2 genes, which account only for 75% of the familial forms with early onset. in frontotemporal dementias, the tau gene mutations account only for 10% of the cases with an autosomal dominant inheritance. the identification of familial forms with a genetic inquiry in the relatives is essential for a greater knowledge of the molecular bases of forms not caused by the known genes, using linkage approaches and candidate gene analysis. the familial forms are also useful for identifying the modifier genes. in the multifactorial forms, the aim is to assemble a wide cohort of patients and controls matched for localizing and identifying susceptibility genetic factors. the strategies will use a candidate gene approach, and in the near future, studies of single nucleotide polymorphisms (snps) spread out in the whole genome. meanwhile, similar approaches, particularly with candidate genes, could be used for identifying predictive factors of tolerance and response to the treatment. finally, correlations will be performed with seric markers according to each kind of dementia. specialized clinical teams in diagnosis and follow-up in dementias are assembled for this project, and in the study of neurological disorders of genetic origin.


Eligibility criteria:
inclusion criteria: * patients presenting with a neurodegenerative disorder with cognitive impairment controls (without signs of the disease), matched with sex and age with the patients * relatives for the familial cases exclusion criteria: * pregnant women * minors * persons refusing to sign the informed consent

Keywords: alzheimer's disease dementia phenotype-genotype correlations candidate genes related disorders