Kornimate/medical-research-clean huggingface dataset:
treatment evaluation of neuromodulation for tinnitus - stage a2

Conditions: Tinnitus

Summary: this is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

participants with chronic tinnitus will be provided with a ce marked neuromodulation device. participants are randomized to one of four different treatment arms. the treatment period is intended for 12 weeks of use. based on the clinical investigation plan, participants are informed that their stimulation settings can change between the first and second halves of the treatment period and that the differences may be perceptually noticeable. differences in tinnitus severity scores will be compared between and within treatment arms.

Eligibility criteria:
inclusion criteria: * 18 to 70 years of age * ability to read and understand english * willing and able to provide informed consent * willing to commit to the full duration of the study * baseline tinnitus handicap inventory (thi) score of \>= 38 points * subjective tinnitus of 3 months to 10 years * maximum ac pure-tone audiometry hearing loss of 80 db hl in any test frequency in the set {2,3,4,6,8}khz or 40 db hl in the set {250,500,1000}hz either unilaterally or bilaterally * baseline minimum masking level (mml) of 20 to 80 db hl * tonal tinnitus exclusion criteria: * diagnosed with objective tinnitus * commenced usage of hearing aid within the last 90 days * cases where pulsatility is the dominant feature of tinnitus * patients whose tinnitus cannot be masked during minimum masking level (mml) assessment * meniere's disease * significantly severe loudness discomfort level (ldl, less than 30 db sl) * depression or neuro-psychological condition, previously diagnosed or identified from the state-trait anxiety inventory (stai) with score greater than 120 * diagnosed with somatic tinnitus resulting from head or neck injury * temporomandibular joint disorder (tmj) * current or previous involvement in medico-legal cases * pregnancy * oral piercings * neurological condition that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ent consultant * severe cognitive impairment based on mini mental state examination (mmse, less than 20) * patient with a pacemaker or other electro-active implanted device * have used neuromod devices products in the past * participants currently prescribed drugs for a central nervous system pathology, i.e. epilepsy, multiple sclerosis (ms), parkinson's, bi-polar disorder * the site principal investigator does not deem the candidate to be suitable for the study for other reasons not listed above * self-reporting episodes of auditory hallucinations * abnormal otoscopy as assessed by the audiologist, including active otitis media, perforation and hearing loss that is identified as completely conductive * abnormal tympanometry as assessed by the audiologist
a safety and tolerability study of neural stem cells (nr1) in subjects with chronic ischemic subcortical stroke (iss)

Conditions: Ischemic Stroke

Summary: evaluation of the safety and tolerability of escalating doses of nr1 administered intracerebrally at a single time-point post-injury to subjects with chronic iss with or without cortical stroke.

evaluation of the safety and tolerability of escalating doses of nr1 administered intracerebrally at a single time-point post-injury to subjects with chronic iss with or without cortical stroke. the study will be a dose escalation using up to 4 cohorts each at a single dose level, of intracerebral administration of nr1 cells. secondary objectives are to evaluate clinical and radiologic responses as well as utility of efficacy measurement tools.

Eligibility criteria:
inclusion criteria: * age 18 - 75 years * history of ischemic subcortical stroke in the middle cerebral artery and/or lenticulostriate artery 6 to 60 months from time of stroke * ability of subject to understand and provide written informed consent * willing to take tacrolimus (prograf) 2 days before and for 2 months after transplant exclusion criteria: * stroke lesion less than 1 cubic centimeter or greater than 100 cubic centimeters measured by mri * index stroke is lacunar infarct less than 1 year old * history or presence of any major neurological disease * history of active cancer other than basal or squamous cell skin cancers * history of seizures * pregnant or breast-feeding
the effects of type 1 diabetes mellitus and increased weight on gut microbiome and urine metabolome profiles in children

Conditions: Obesity; Overweight; Type 1 Diabetes Mellitus

Summary: this study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (t1d).

the investigators will obtain stool and urine samples from subjects aged 7-17 years in 4 groups: * group 1: obese or overweight children within 3 years of diagnosis of t1d * group 2: normal weight children within 3 years of diagnosis of t1d * group 3: obese or overweight children without t1d * group 4: normal weight children without t1d type 1 diabetes will be defined according to american diabetes association criteria along with the presence of pancreatic autoantibodies (gad65, ica512, or insulin autoantibodies). obese and overweight status will be defined by bmi \>85th percentile for age and gender according to cdc criteria. all subjects will provide one-time stool and first morning urine sample. overweight or obese subjects will additionally have a point of care blood glucose and hemoglobin a1c measurement to ensure that they do not have diabetes. the investigators will perform 16s rrna sequencing of stool bacteria and mass spectrometry measurement of urine metabolites.

Eligibility criteria:
inclusion criteria: * age 7 to 17 years * diagnosis of diabetes will be defined by current american diabetes association criteria ° (fasting glucose \> 126 mg/dl, 2 hour ogtt glucose \> 200 mg/dl; random glucose \> 200 with symptoms of hyperglycemia; or hba1c \> 6.5%) * diabetes duration \< 3 years * presence of pancreatic autoimmunity (gad65, ica512, or insulin autoantibody positivity) * adult caregiver willing to actively support study participation * signed parental informed consent form and minor child informed assent form exclusion criteria: * other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation
goals of care discussion for patients with advanced lung and gastrointestinal cancer in the emergency department of a comprehensive cancer center

Conditions: Lung Cancer; Gastrointestinal Cancer

Summary: to improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.

primary objective: to compare overall percentage of days spent in an acute care setting over the 30-day period from time of the index emergency department (ed), referred to as acute cancer care center (accc), visit for patients who receive the emergency department-based goc intervention and those who do not. secondary objective: to obtain data on rates of admission to the icu, death in the hospital setting, symptom improvement for participants hospitalized, hospice referral, survival, and 30-day care costs for participants who receive the goc intervention in the accc and those who do not.

Eligibility criteria:
inclusion criteria: 1. participant is at least 18 years old presenting to the triage area of the mdacc accc for treatment 2. participant has advanced lung or gi cancer. advanced cancer patient defined as: locally recurrent or metastatic for which there is no curative treatment available. 3. participant screens positive for at least 2 of 3 triple threat conditions (dyspnea, altered mental status, or poor performance status) 4. participant has the ability to speak and write in english 5. participant has the ability to provide consent or is accompanied by a lar able to provide consent exclusion criteria: 1. participant is already enrolled in hospice 2. participant is comatose 3. participant has severe intellectual disability 4. participant has a history of dementia documented in the medical records 5. participant has baseline communication barriers such as aphasia or deafness 6. participant is new to mdacc, without established oncology care at our institution at time of accc arrival 7. participant is 18 years or older, currently cared for by pediatrics service 8. pregnant women 9. prisoners
neuropsychology of financial capacity

Conditions: Parkinson Disease; Brain Tumor; Stroke

Summary: the present project aims to investigate the financial capacity in patients diagnosed with parkinson's disease or parkinsonism, brain tumor (glioma or meningioma) and cerebrovascular lesion (stroke), in order to evaluate the presence and degree of impairment, and the role of some factors as potential predictors of financial incapacity. the term 'financial capacity' means both operations relating, for example, to asset management or investing money, and activities of daily life such as shopping or using small sums of money; these activities are mediated by different cognitive functions, from numerical and arithmetic skills to decision making. financial capacity is, in fact, an instrumental activity of daily life (i.e. instrumental activity of daily living, i-adl) whose impairment negatively affects the functional autonomy of the individual, so as to be subject to legal protection. to assess financial capacity, the numerical activities of daily living - financial (nadl-f; arcara et al., 2017) will be administered, a battery of tests aimed at investigating both financial performance and financial competence according to the most recent neuropsychological models proposed in the literature.


Eligibility criteria:
inclusion criteria: * age \> 18 years * clinical diagnosis of interest for clinical groups * for stroke patients: disease duration \> 1 month exclusion criteria: * other brain disorders different from those of interest * sensory-motor deficits that could prevent neuropsychological assessment * language disorders that could prevent neuropsychological assessment * global cognitive impairment as indexed by moca \< 26 or mmp \< 22.85
monitoring of erythroid lineage specific chimerism following allogeneic hematopoietic transplantation for thalassemia major

Conditions: Thalassemia Major

Summary: the purpose of this study is to collect peripheral blood and bone marrow aspirate samples from thalassemia patients in tehran, in a collaborative effort to develop an erythroid lineage specific chimerism assay applicable to patients with thalassemia. development of such an assay would be useful both for identification of the exact mutation causing the disease, as well as for providing a direct method to measure and monitor the kinetics of donor erythropoiesis in this patient population following transplant.

* in the first phase of the study we will develop a panel of reagents designed to identify predominant thalassemia mutations in the iranian population, as well as alternative highly variable erythroid specific polymorphisms. to determine how informative this panel is, these reagents will be applied to samples collected from patients homozygous for the disorder, and compared to patients with thalassemia trait and normal iranian donors. * in the second phase, we propose to serially measure and compare erythroid lineage chimerism with overall genomic chimerism following transplant. samples will be collected from participants before and at 1, 2, 3, 6 and 12 months following transplant and cryopreserved. peripheral blood from the stem cell donor will also be collected and cryopreserved. participants will undergo myeloablative or nonmyeloablative transplant.

Eligibility criteria:
inclusion criteria: * thalassemia patients being treated at shariati hospital in tehran.

Keywords: chimerism allogenic hematopoietic transplantation assay
cmv glycoprotein b (gb) vaccine long term antibody response

Conditions: Viraemia

Summary: the purpose of this study is to see how well the antibody levels found months to years after patients entered a previous randomised placebo-controlled trial of a glycoprotein b vaccine against cytomegalovirus have persisted and to have the previous samples retested using different methods which have been further developed in different laboratories. also, to prepare monoclonal antibodies from the b lymphocytes of these patients and define their strength. if potent antibodies are identified, the investigators would like to consider developing them further to see if they can protect future transplant patients against cytomegalovirus.

this is a follow up study to a randomised controlled trial comparing a cmv glycoprotein b vaccine with placebo (trial title: a phase ii immunogenicity trial of cytomegalovirus glycoprotein b vaccine in allograft candidate recipients; cta ref no 20363/0238/001-0010; rec ref no 5476; ucl sponsor no 05/009) in participants with chronic renal or liver deficiency sufficient to require transplantation. the study provided encouraging results (data now unblinded and analysed) by reducing the amount of cytomegalovirus that vaccinated patients excreted in blood post transplant (griffiths et al lancet 2011). the titre of antibody made against glycoprotein b was a correlate of protection against duration of viraemia (i.e. reduction in cmv levels). 100% of patients given vaccine produced antibody against glycoprotein b although the titres decreased with time. the titres of cmv neutralising antibody were boosted in those with prior natural immunity. the titres of neutralising antibody were low among those who were initially seronegative. however, improved assays for cmv neutralising antibodies have now become available, so we wish to have the samples retested using these different methods. we will also send the blood samples taken in the previous study to the same labs for enzyme immunoassay for antibodies against glycoprotein b. this trial will approach patients that took part in the above referenced study for one further blood sample to determine their current antibody titres and to obtain their consent to test the samples taken in that previous study using these new improved antibody assays. monoclonal antibodies will be made from purified b lymphocytes to study how these may bind and neutralise cytomegalovirus in the laboratory in order to develop antibodies as potential therapeutic agents.

Eligibility criteria:
inclusion criteria: 1. recipient of imp (investigational medicinal product) (cmv gb vaccine or placebo) in trial 'phase ii immunogenicity trial of cytomegalovirus glycoprotein b vaccine in allograft candidate recipients study' (cta ref no 20363/0238/001-0010; rec ref no 5476; ucl sponsor no 05/009). 2. informed consent must be obtained from the patient. exclusion criteria: 1. patient unable or unwilling to provide and sign an informed consent.

Keywords: cytomegalovirus
vaginal elasticity assessment before and after vaginal carbon dioxide laser treatment.

Conditions: Laser Burn

Summary: female patients with either stress urinary incontinence (sui) or vaginal wall weakness and prolapse will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after carbon dioxide laser treatment.

patients will be recruited and sign a consent form. the patients included are patients with sui or vaginal wall weakness and prolapse. each participant undergoes 3 laser treatments 4 weeks apart. assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points: * before the first treatment session (baseline). * before and after each treatment session. * 3 months post final treatment. every patient will serve as her own control. demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility criteria:
inclusion criteria: * any woman undergoing vaginal carbon dioxide laser treatment. exclusion criteria: * women that are not in the age range.
a phase 1 study of pln-101095 in adults with advanced or metastatic solid tumors

Conditions: Metastatic Solid Tumor

Summary: this is a phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, pk, pd, and preliminary evidence of antitumor activity of pln-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab. the study will consist of 2 main parts: * part 1: consecutive dose-escalation cohorts using a bayesian optimal interval (boin) dose escalation design * part 2: dose-expansion cohorts using simon's 2-stage design


Eligibility criteria:
inclusion criteria: 1. has histologically or cytologically confirmed advanced solid tumor 2. has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab. 3. at least 1 measurable lesion, as defined by recist v1.1 4. estimated survival of ≥3 months 5. no effective therapeutic options available (eg, has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy) exclusion criteria: 1. any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab 2. previous treatment with pembrolizumab \<21 days prior to the first dose of combination therapy of pembrolizumab and pln-101095 3. received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of pln-101095 4. received radiotherapy (rt) within 1 week for palliative bone-directed therapy and 4 weeks for all other types, prior to the first dose of pln-101095 5. received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of pln-101095 6. received a cell therapy within the last 12 months prior to the first dose of pln-101095 7. known active central nervous system (cns) metastases (brain and/or leptomeningeal metastases) 8. pregnant or lactating female participant

Keywords: advanced solid tumors cancer head and neck squamous cell cancer colorectal cancer urothelial carcinoma gastro-esophageal junction cancers esophageal cancer cervical cancer hepatocellular carcinoma renal cell carcinoma endometrial cancer cutaneous squamous cell carcinoma triple negative breast cancer melanoma non-squamous cell lung cancer
high-intensity interval training versus moderate continuous training in heart transplant recipients.

Conditions: Heart Transplant Recipients

Summary: the aim of this study was to examine the effects of high intensity aerobic interval training (ait) versus moderate continuous training (con) in heart transplant recipients.

clinically stable heart transplant recipients \> 12 month or more after htx, age \> 18 years, willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months were included from the heart centre, rigshospitalet, copenhagen university hospital. patients were excluded due to unstable condition or postoperative complications, recent severe rejection episodes (\>h1r \< 3 month), physical disabilities which prevent participation and re-transplantation or multi-organtransplantation.

Eligibility criteria:
inclusion criteria: -stable heart transplant recipients \> 12 month or more after htx, age \> 18 years,\< 80. willing and capable of giving written informed consent for study participation. exclusion criteria: unstable condition postoperative complications, recent severe rejection episodes (\>h1r \< 3 month), re-transplantation or multi-organtransplantation.

Keywords: heart transplant recipients exercise capacity endothelial function quality of life
prevalence of angle closure in caucasian hyperopes

Conditions: Chronic Angle Closure Glaucoma

Summary: the primary purpose of this study is to assess the prevalence of asymptomatic chronic angle closure in high risk caucasian individuals, namely those with hyperopia. a secondary purpose is to assess whether specific demographic or ocular-anatomic parameters in this population are associated with a higher risk for angle closure.

caucasian subjects aged \> 40 years with hyperopia will undergo complete eye examination including subjective refraction and gonioscopy. in addition we will measure axial length, anterior chamber depth and lens thickness using ultrasound biometry.

Eligibility criteria:
inclusion criteria: * age greater than 40 years * hyperopia greater then +1.00 d spherical equivalent exclusion criteria: * any identifiable eye disease or previous eye surgery that can affect the anatomy of the irido-corneal angle

Keywords: chronic angle closure hyperopia
overweighed children´s health - studies of the effect of lifestyle and food habits

Conditions: Overweight; Obesity

Summary: the aim is to investigate the development of overweight and obesity from infancy to school age, and to evaluate an intervention to prevent further development of overweight and obesity among children. a follow-up study will be conducted on 267 children and will allow comparison between children that developed overweight with the ones who did not. subjects will be requited at 10 years of age from a previous project. these children have been studied when they were 6-18 months old and a follow-up was conducted at 4 years of age. sixteen percent of the children were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids and anthropometric measurements exists. in the present follow-up data regarding food and physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids, igf1 will be collected. an intervention study will be conducted on 80-120 overweight children that will be randomized into one intervention and one control group. an intervention during two years will encourage long term healthy habits regarding diet and physical activity through group meetings and supervision. information about food habits will be collected through questionnaires, interviews and diaries. measurement of physical activity and energy expenditure will be made with sense wear and double labeled water, and will be used to validate reported food intake. further, anthropometric measurements and blood samples will be collected.


Eligibility criteria:
inclusion criteria for selfh intervention study: * age and gender adjusted body mass index (bmi) \> 25 * born in 1995-1998 * living in or nearby the northern city of umea, sweden exclusion criteria for selfh intervention study: * no chronic disease that could influence metabolic parameters * no attention deficit disorders * no access to internet

Keywords: children overweight obesity food habits dietary assessment physical activity