Kornimate/medical-research-clean huggingface dataset:
dose-ranging study to evaluate antibody response to g17dt in patients with gastric cancer

Conditions: Gastric Cancer

Summary: an open, dose-ranging, multiple dose, multi-centre study in patients with stage i-iii or stage iv gastric cancer. twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.


Eligibility criteria:
inclusion criteria: stage i-iii criteria- * patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma. * absence of metastatic disease evident from: * physical examination * the most recent chest x-ray * abdominal ct or ultrasound scan * life expectancy of at least 3 months * who performance status of 0 to 1 * written informed consent given stage iv criteria- * patients aged 18 years or over with stage iv gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases * life expectancy of at least 3 months * who performance status of 0 to 2 * written informed consent given exclusion criteria: * history of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix recurrent gastric cancer following previous surgery presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection * previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies * concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids * females who were pregnant, planning to become pregnant or lactating * patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study * previous g17dt treatment * haematological indicators: * haemoglobin \<10.0g/dl * white blood cell count \<4.0 x 109/l * platelets \<100 x 109/l

Keywords: gastric cancer g17dt pas insegia gastrimmune
exercise capacity and dyspnea in obese patients with metabolic syndrome: effects of weight loss

Conditions: Obesity; Metabolic Syndrome

Summary: dyspnea is a common complaint in obese patients. the mechanisms behind this dyspnea and the effects of weight loss on dyspnea are not completely understood. the objectives of this study were to examine the relationships between exercise parameters and dyspnea in obesity and assess the effects of weight loss. the investigators compared pulmonary function, exercise performance and dyspnea in 34 patients with abdominal obesity and metabolic syndrome (ms) against 34 age and sex-matched controls. the study also assessed within-group changes in physiology and symptoms in a subset of patients following participation in a weight management program. because obesity is a heterogeneous condition, with variable genetic associations, co-morbidities and distributions of adipose tissue, the study focused on patients with abdominal obesity who met diagnostic criteria for metabolic syndrome.

the study has two parts: first, the investigators compared dyspnea, pulmonary function and exercise measurements between obese patients and control subjects with normal weight; then, the investigators assessed the effects of medical weight loss in the obese group on these parameters. baseline dyspnea was assessed using the baseline dyspnea index.the effect of weight loss on dyspnea was assessed using the transitional dyspnea index. the main physiologic measurement of interest was the inspiratory capacity (l, measured at rest and during exercise).

Eligibility criteria:
inclusion criteria: * individuals accepted into the behavioural weight management program at the ottawa hospital bariatric centre * age between 20 and 60 years * bmi greater than 30 * abdominal girth (for females) greater than 88 cm * abdominal girth (for males) greater than 102 cm * plus any two of the other criteria for metabolic syndrome: i.e. blood pressure greater or equal to 130/85; fasting glucose greater or equal to 6.1 mmol/l * controls-normal weight (nw) and sedentary exclusion criteria: * smoker * any medical conditions which would affect exercise performance * use of medications that could affect exercise performance (i.e. beta-blockers) * inability to pedal on a cycle ergometer and provide reproducible inspiratory capacity (ic) measurements

Keywords: obesity metabolic syndrome dyspnea pulmonary function exercise capacity
124i-fiau imaging in ebv and kshv associated cancers

Conditions: Hodgkin Lymphoma; Non Hodgkin Lymphoma; Kaposi's Sarcoma; Gastric Cancer; Nasopharyngeal Cancer

Summary: this research is being done to determine whether viral thymidine kinase (tk) expression in epstein-barr virus (ebv) and kaposi's sarcoma herpesvirus (kshv) virus-associated tumors is sufficient to image.

ebv and kshv are associated with a variety of malignancies including some lymphomas, carcinomas and other malignancies. we anticipate that viral tk expression will differ among tumor types and will be adjusted with standard chemotherapies and some investigational agents. this exploratory study is aimed in part at evaluating whether standard regimens or investigational regimens might bring about sufficient activation of the ebv-tk or kshv-tk in tumors to be therapeutically useful if used in conjunction with fiau as a radiopharmaceutical.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. ebv-positive or kshv-associated malignancy, including but not limited to: * ebv+ hodgkin lymphoma * ebv+ non-hodgkin lymphoma or lymphoproliferative disease * primary effusion lymphoma * kaposi's sarcoma * ebv+ gastric cancer * ebv+ nasopharyngeal cancer 3. measurable disease (at least one lesion measuring \> 2 cm in longest axis). 4. ecog performance status of 0, 1, or 2. 5. patients must be able to lie flat for at least 60 minutes and fit on pet-ct scanner. 6. for post-therapy imaging with fiau-pet, treatment with standard or investigational agents that can potentially activate herpesvirus tk, including but not limited to the following. concurrent radiation therapy is permissible: * platinum compounds (for example, cisplatin, carboplatin) * anthracyclines (for example, doxorubicin or pegylated doxorubicin) * tubulin disrupting agents (for example, vincristine, vinblastine) * rituximab * gemcitabine * cytarabine * histone deacetylase inhibitors * bortezomib note: patients who would not receive bortezomib as part of their usual care may receive a one-time dose of bortezomib for the purpose of imaging with 124i-fiau and fiau-pet-ct. 7. ast and alt \< 3 x upper limit of normal, unless attributed to tumor, obtained within 2 weeks prior to registration. 8. serum creatinine \< 2.0 mg/dl, within 2 weeks prior to registration. 9. in patients who will receive bortezomib for imaging purposes only: * total bilirubin \< 1.5 x upper limit of normal, obtained within 2 weeks prior to registration. * platelet count \> 70,000 / mm3 obtained within 2 weeks prior to registration. * no pre-existing peripheral neuropathy greater than grade 1. exclusion criteria: 1. end-stage liver disease unrelated to tumor. 2. known active or chronic hepatitis b or hepatitis c infection. 3. history of iodine hypersensitivity. 4. chronic renal insufficiency requiring dialysis. 5. women who are pregnant or breast feeding. 6. foreseen inability to comply with study requirements.

Keywords: ebv+ malignancies kshv+ malignancies hiv-associated lymphomas hodgkin lymphoma nonhodgkin lymphoma or nonhodgkins lymphoproliferative disease primary effusion lymphoma kaposi's sarcoma gastric cancer nasopharyngeal cancer
comparison of efficiency of closed kinetic chain exercises versus proprioceptive exercises patient with hemophilia

Conditions: Hemophilia A; Hemophilia B

Summary: hemophilia is a bleeding disorder caused by a deficiency of clotting factors in the blood. muscle and joint bleeding are frequently observed in patients with hemophilia. lower extremity bleeding can adversely affect balance, gait, and proprioception. the goal of this study; to compare the effectiveness of closed kinetic chain exercises and proprioceptive exercises on balance, proprioception and gait parameters in adolescent and young hemophilic individuals with lower extremity joint involvement. the main question it aims to answer is: are the effects of closed kinetic chain exercises and proprioceptive exercises different on balance and walking in hemophilic individuals?


Eligibility criteria:
inclusion criteria: * having been diagnosed with hemophilia a and hemophilia b * having a blood factor level below 5%, * between 13-25 years old * history of bleeding to the lower extremity and target joint * total lower extremity hemophilia joint health score ≥3 * using prophylaxis exclusion criteria: * having undergone lower extremity surgery in the last 6 months * having a body mass index over 30 kg/m2 * have an inhibitor * using a walking aid

Keywords: hemophilia exercise balance proprioception
the therapeutic effects of intermittent theta burst stimulation in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the investigator would like to investigate the impact of theta burst stimulation over right inferior frontal gyrus in autism spectrum disorder


Eligibility criteria:
inclusion criteria: * autism spectrum disorder, confirmed by ados exclusion criteria: * current and past systemic disease * current and past major psychiatric disorders including schizophrenia, bipolar affective disorder and major depressive disorder * current and past brain injuries * intelligence \< 70 * seizure history * pregnant
applications for methotrexate optimization in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the goal of this study is to enable the study sponsor to assess the impact of a marketed or validated blood test has on physicians' clinical treatment decision making when treating ra patients who have been taking methotrexate. ultimately, the blood test will allow treating physicians to modify current methotrexate therapy in partially responding rheumatoid arthritis (ra) patients' therapy, on an individualized basis, as a means of improving clinical outcomes. the study requires a blood sample from ra patients who have been on methotrexate therapy for a minimum of 3 months and are having an inadequate response to therapy. physicians will then be provided with the results of the test indicating the methotrexate polyglutamate (active metabolites of methotrexate) levels in the patient's red blood cells as a means to help determine whether a patient's exposure to methotrexate has been optimized.

this study is currently enrolling individuals who have an established diagnosis of ra and are receiving methotrexate as part of their therapy. patients are required to submit a blood sample. there is no cost to volunteers who participate.

Eligibility criteria:
inclusion criteria: * able to read, understand, and sign the informed consent form * able to read, write, and speak english * ≥18 years of age * diagnosed with ra within past 24 months (waiver) * taking oral methotrexate therapy for a minimum of 3 months * considered to have an insufficient response to methotrexate and therefore a candidate for change to therapy, including changing mtx dose or changing route of delivery, or adding or switching dmards (including but not limited to biologic dmards) exclusion criteria: * prior exposure of the study center, study physician or study patient to the avise pg laboratory test * patients with known abnormal hepatic and or hematological parameters * use of prednisone \>10mg/day (or its equivalent) * rheumatologic diagnosis other than primary ra
type 1 diabetes mellitus bone mineral density in childhood and adolescence

Conditions: Type 1 Diabetes Mellitus

Summary: type 1 diabetes mellitus is a disease that has an effect on bone mineral density. it is unclear how and when it effects the bone density. the investigators are studying the effects of diabetes on bone mass compared to children without diabetes.


Eligibility criteria:
inclusion criteria: * we will recruit children from age 5 to age 18 with a diagnosis of type 1 dm. children will have various lengths of time since diagnosis. exclusion criteria: * we will exclude children on anticonvulsants or steroids and children with other concomitant illnesses that interfere with bone mass accrual, except for hypothyroidism on treatment.

Keywords: diabetes
impact of catch-up hpv vaccination

Conditions: HPV; HPV Vaccination; Vaccine Preventable Disease; Cervical Lesion; Cervical Cancer

Summary: each year in france, more than 6000 new cases of hpv inducted cancers are recorded. the vaccinal cover stays insufficient since less than 30% of the french population is vaccinated. therefore french studies about vaccine efficacy and especially about the catch-up vaccine (done after 15years old) are needed. hpvac2 is a prospective, analytic and monocentric study designed to learn the impact of the catch-up hpv vaccination. women from 25 years old and born after 1984 may be included if they come to the brest chu to do their regular cervical smear. at this time, a survey will be given to know their vaccinal status. the aim of the study is to prove the efficacy of the catch up vaccination by analyzing the cervical smears results and by comparing the vaccinated group with the not-vaccinated group.


Eligibility criteria:
inclusion criteria: * age limit * patient must have done a hpv or smear test during the study period * consent necessary exclusion criteria: * age limit * no hpv or smear test done in the study period * patient not able to give her consent
safety, tolerability and pharmacokinetics of etelcalcetide in healthy male volunteers

Conditions: Hyperparathyroidism, Secondary

Summary: the purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.


Eligibility criteria:
inclusion criteria: * male between 18 and 45 years of age who have provided written informed consent * subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests exclusion criteria: * history or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator * history of any ongoing medical condition requiring treatment with prescription medication * history of asthma, severe allergies including skin reactions or prior anaphylactic type reactions * clinically significant abnormalities on screening clinical examination or laboratory safety tests * history of drug or alcohol abuse
effect of home exercise activity on cortisol and depression in copd during the pandemic covid

Conditions: Chronic Obstructive Pulmonary Disease

Summary: exercise activity during the covid pandemic is appreciated to be conducted in home especially for chronic chest diseases as chronic obstructive pulmonary disease (copd) to reduce the chance of viral contamination during the covid-19 pandemic.

40 copd men will be divided to exercise group (20 patients) and control group (20 patients): the exercise group will receive a exercise session contains a fifty minutes exercise training at home with moderate intensity on the available training devices as bicycle or treadmill in addition to 30 minutes of exercising of upper and lower limb, the session will be repeated three times per week for eight weeks. the control group will not be trained

Eligibility criteria:
inclusion criteria: * stable copd patients * patients who will have a training device as bicycle or treadmill in home exclusion criteria: * diabetic patients * renal patients. * liver diseases
evaluation of wirion™ eps in lower extremities arteries

Conditions: Peripheral Arterial Disease (PAD)

Summary: demonstrate the safety and performance of the wirion™ eps in subjects undergoing lower extremity atherectomy for the treatment of peripheral arterial disease (pad)


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age 2. subject or authorized representative, signed a written informed consent form to participate in the study, prior to any study related procedures 3. subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations 4. rutherford classification 2-4 5. has moderate to severe calcification visualized on angiogram in the femoropopliteal arteries 6. planned atherectomy of the native femoropopliteal arteries 7. reference vessel diameter for intended filter location must be visually estimated to be ≥3.5mm and ≤6.0mm 8. an adequate "landing zone" for placement of the wirion™ device distal to the target lesion of at least 30mm 9. a female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days and agrees to remain on birth control throughout the study exclusion criteria: 1. any planned surgical or endovascular intervention within 30 days before or after the index procedure 2. a lesion deemed not accessible by the wirion™ eps 3. inability to take aspirin or adp receptor antagonists 4. history of bleeding diathesis or coagulopathy or will refuse blood transfusion if deemed necessary 5. has perforation, dissection, or other injury of the access or target vessel requiring additional stenting or surgical intervention before enrollment 6. subject is enrolled in another drug or device study protocol that has not reached its primary endpoint (participating in registry studies is not excluded) 7. life expectancy less than 12 months 8. known severe renal insufficiency (egfr \<30 ml/min/1.72m2). 9. ≤1-vessel tibial run-off status
reach through equitable implementation of turtle island tales

Conditions: Obesity, Childhood; Obesity; Cancer

Summary: reach through equitable implementation of turtle island tales is a family-level obesity prevention intervention that aims to reinforce ai cultural values of family interaction and holistic wellness. the long-term objective of this research program is to increase the reach of existing evidence-based interventions (ebis) for cancer and obesity prevention among american indian (ai) families who live in persistent poverty census tracts.

turtle island tales is an obesity prevention program for ai families with young children (3-8 years) that was developed to address the gap in home-based, family wellness programs for this population. substantial research as been conducted on the effectiveness of this program for participating families. the primary aim of the current project is to investigate community-engaged dissemination to improve the reach of turtle island tales. dissemination strategies will be undertaken in partnership with community leaders and/or local supplemental nutrition assistance program education (snap-ed) agents who will disseminate the program through existing extension/snap-ed delivery mechanisms (snap-ed is commonly administered through extension programs of land-grant universities). turtle island tales was accepted as a snap-ed eligible program in 2022. as such, the program will be administered as part of usual/typical snap-ed delivery in participating communities and largely constitutes program evaluation. the primary research question is: what is the reach of the evidence-based turtle island tales wellness program intervention within ai communities? a secondary aim for this project is determining the effectiveness of turtle island tales among participating families using program evaluation survey data obtained via snap-ed program evaluation.

Eligibility criteria:
inclusion criteria: * residence in one of identified persistent poverty census tracts * person \>18 years of age caring for a child 3-8 years old exclusion criteria: * residence outside of identified persistent poverty census tracts * caregiver \<18 years of age * no child 3-8 years old living in household
effects of tdcs-enhanced cognitive control training on depression

Conditions: Depression Unipolar

Summary: deficient cognitive control (cc) is one of the central characteristics of major depression (md). hypoactivation of the dorsolateral prefrontal cortex (dlpfc) has been linked with this deficit. antidepressants and cognitive-behavioral therapies modify cc most-likely as a common mechanism of treatment. transcranial direct current stimulation (tdcs) is a safe, simple and effective non-invasive method to modulate the cortical excitability. it has been shown, that the activity of the dlpfc can be modulated by transcranial direct current stimulation (tdcs) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation. the goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tdcs-enhanced cc training (cct) on depressive symptom severity and compare the stimulation intensities 1ma, 2ma and sham tdcs. overall, the study will include 57 participants (n = 19 per group). each participant will complete 12 training sessions with online sham/ anodal tdcs. as a training task we will use an adaptive version of the paced auditory serial addition task (pasat). in the pasat, digits are presented auditive and participants have to add the current digit to the digit they heard before. in the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). the pasat is known to elicit frustration. participants have to exert cognitive control over these emotions to complete the task successfully. before, during and after the training symptom severity will be assessed. baseline and post-training performance in the pasat and in a transfer task (delayed working memory task, dwm) will be measured. to further explore variables that influence the effect of tdcs on depressive symptom severity we will measure brain activity (eeg, nirs), heart rate, global functioning (gaf), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors. sustainability of the training effects will be measured at a follow-up visit (3 months later).


Eligibility criteria:
inclusion criteria: * current major depressive episode * right handedness exclusion criteria: * history of seizures * intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed * pregnancy * use of mood stabilizers * diagnosed bipolar disorder * current substance abuse (nicotine excluded) * current substance addiction (nicotine excluded) * diagnosed psychotic diseases * diagnosed anorexia nervosa * diagnosed personality disorders: cluster a, antisocial personality disorder, * borderline personality disorder

Keywords: depression transcranial direct current stimulation (tdcs)
azd9164 single ascending dose study in healthy male subjects

Conditions: Healthy

Summary: the aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of azd9164 following single ascending dose administrations to healthy male subjects.


Eligibility criteria:
inclusion criteria: * provision of signed, written and dated informed consent prior to any study specific procedures * have a body mass index (bmi) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg * be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start exclusion criteria: * any clinically significant disease or disorder * any clinically significant abnormalities at screening examinations * use of any prescribed or non-prescribed medication

Keywords: safety tolerability healthy inhalation healthy males