Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of clbs03 in adolescents with recent onset type 1 diabetes (the sanford project t-rex study)

Conditions: Diabetes Mellitus

Summary: this clinical trial will explore the safety and effect of autologous ex vivo expanded polyclonal regulatory t-cells on beta cell function in patients, aged 8 to 17, with recent onset t1dm. other measures of diabetes severity and the autoimmune response underlying t1dm will also be explored. eligible subjects will receive a single infusion of clbs03 (high or low dose) or placebo.


Eligibility criteria:
inclusion criteria: * male and females aged 8 to 17 years of age * diagnosis of t1dm within 100 days of receipt of study drug * positive for at least one islet cell autoantibody * peak mmtt-stimulated c-peptide level \> 0.2 pmol/ml (at the screening visit) * weight of ≥30 kg * must agree to use a reliable and acceptable method of contraception for the duration of participation * willing and medically acceptable to postpone live vaccine immunizations for one year after infusion * written informed consent and written assent exclusion criteria: * hemoglobin less than the lower limit of normal * leukocytes \<3,000/μl; neutrophils \<1,500/μl; lymphocytes \<800/μl; platelets \<100,000/μl * regulatory t-cells present in peripheral blood at \<20 cells per μl * current or ongoing use of non-insulin pharmaceuticals (that may affect glycemic control) * current or anticipated use of systemic corticosteroids or other immunomodulatory drugs * recent serious bacterial, viral, fungal, or other opportunistic infections * history of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease * serologic evidence of current or past viral infection: human immunodeficiency virus (hiv), hepatitis b, hepatitis c, and human t-lymphotropic virus (htlv) 1/2 * positive quantiferon® tuberculosis (tb) test, purified protein derivative (ppd) skin test, history of tuberculosis, or active tb infection * active infection with epstein-barr virus or cytomegalovirus * liver disease * pregnant or breast-feeding * vaccination with a live virus within 8 weeks of receipt of study drug * vaccination with a killed virus within 2 weeks of receipt of study drug * participation in an investigational drug study within 90 days prior to screening * previously treated with a t-reg based cell therapy * history of allergy to gentamicin

Keywords: t1dm type 1 diabetes mellitus t regulatory cell immunotherapy cell therapy t-reg
a study of hlx07 + hlx10 with or without chemotherapy versus hlx10 with chemotherapy in first line sqnsclc

Conditions: Squamous Non-small-cell Lung Cancer

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of hlx07 in combination with hlx10 with or without chemotherapy versus hlx10 with chemotherapy in first line recurrent or metastatic squamous non-small cell lung cancer.this study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of previously untreated, recurrent or metastatic squamous non-small cell lung cancer * egfr immunohistochemistry (ihc) h score ≥200 assessed by central lab * has measurable disease as defined by recist 1.1 as determined by the irrc * has a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance scale * has a life expectancy of greater than 12 weeks * has adequate organ function exclusion criteria: * histologically non-squamous nsclc must be exclused. for non-small-cell histology, if has squamous components be allowed * has history of such as pd-1/pd-l1、egfr、 ctla4 targeted therapy * egfr sensitivity mutation or alk or ros1 gene rearrangement need to be excluded * has had other active malignancies within 5 years or at the same time * has uncontrolled pleural effusion、pericardial effusion or ascites
carbon-11 labeled sarcosine in prostate cancer

Conditions: Prostate Cancer

Summary: men with and without prostate cancer will have a pet/ct scan that measures the level of the amino acid sarcosine. pet is a scanning method that uses short lived radioactivity.

tissue levels of the amino acid sarcosine are elevated in prostate cancer compared to normal prostate tissues and further increased in metastases from prostate cancer. this research project is designed to test whether 11c-sarcosine (a chemical that is linked to short lived radioactivity) would be useful to detect prostate cancer in men using pet/ct imaging. the uptake and distribution of 11c-sarcosine in men with known or suspected prostate cancer will be determined and compared with results from 11c-choline pet/ct.

Eligibility criteria:
inclusion criteria: * males 40 years of age or older * confirmed or suspected prostate cancer and will undergo a planned tissue biopsy of the known or suspected tumor (prostate cancer group 1 only) exclusion criteria: * active malignancy (except basal cell or squamous cell skin cancer) within the last 2 years * body weight \> 350 lbs (158 kg) * prisoners * subject not willing or able to sign informed consent

Keywords: prostate cancer biopsy pet
assessment of needs of moisturizers after various laser treatments

Conditions: Dermatologic Disorders; Injury Due to Laser

Summary: assessment of needs of moisturizers after various laser treatments

the investigators would like to assess of needs of moisturizers after various laser treatment : by investigating the changes in the skin barrier function after fractional carbon dioxide laser and fractional er:glass laser in mice and human skin

Eligibility criteria:
inclusion criteria: * at least 18 years of age without any dermatologic diseases exclusion criteria: * taking other known dermatologic disease * others who are shown pigmented lesion on treated-area * who have allergy or history of hypersensitivity reaction to moisturizers * who have other definitive cutaneous findings

Keywords: moisturizer, laser
minimize radioactive iodine ablation of remnant thyroid in differentiated thyroid cancer

Conditions: Thyroid Neoplasms

Summary: the researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.


Eligibility criteria:
inclusion criteria: * patients with differentiated thyroid cancer * recently underwent total thyroidectomy (within 6 months) * pathological criteria 1. t1bn0 : tumor size 1-2cm with no microscopic extension with multifocality (within three foci) 2. t3n0 : tumor size \<=2cm with microscopic extension (less than strap muscle) 3. t1-3n1a : 3 or less micrometastatic lymph node exclusion criteria: * differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer * gross extension (strap muscle or more) * thyroid cancer with distant metastasis * previous remote history of thyroid cancer surgery * history of cervical external beam radiation therapy * previous history of comorbid cancer within 5 years * renal insufficiency (ccr \<30ml/min) * women with pregnancy or breast feeding

Keywords: radioactive iodine therapy ablation thyroid cancer
eap (expanded access protocol) of lapatinib combined with capecitabine in metastatic breast cancer

Conditions: Neoplasms, Breast

Summary: this study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies


Eligibility criteria:
inclusion criteria: * may have received prior lapatinib in another trial. previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted. * prior treatment with hormonal therapy is allowed. * must have advanced or metastatic breast cancer with progression (as assessed by modified recist) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting. * must have tumors that overexpress erbb2 defined as +3 by ihc or fish positive for erbb2 gene amplification. the status of erbb2 expression must be documented prior to study entry. * must be \>/= 18 years of age * life expectancy of \> 8 weeks * must have recovered from side effects of previous treatment * patients with cns mets are eligible provided treatment with prohibited medications as listed in the protocol are not required * cardiac ejection fraction must be within the institutional range of normal as measured by echo. muga scans are allowed if echos cannot be performed * able to swallow and retain oral medications * must have adequate hematologic, hepatic and renal function exclusion criteria: * pregnant or lactating females * malabsorption syndrome, disease significantly affecting gi function, or resection of the stomach or bowel, or ulcerative colitis * concurrent disease or condition that would make the patient inappropriate for study participation * unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment * uncontrolled infection * active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; mi \< 6 months from study entry; uncontrolled or symptomatic chf; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient * receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. concurrent therapy with bisphosphonates is allowed * history of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients * history of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients * known dpd deficiency

Keywords: advanced tykerb her2 positive stage iiic erbb2 positive gw572016 metastatic stage iiib breast cancer
clinial application of park et al.(the knee 27 (2020) 1577-1584)'s study

Conditions: Knee Osteoarthritis

Summary: the goal of this study was to perform pulsed radiofrequency ablation with a modified target suggested in the cadaver study by park et al. (the knee 27 (2020) 1577-1584) on knee osteoarthritis patients, and to evaluate the effect of reducing the frequency of intravascular injection and reducing pain.


Eligibility criteria:
inclusion criteria: 1. chronic knee pain that does not respond to conservative treatment (physiotherapy, oral analgesic, steroid intra-articular injection, hyruan injection) for more than 6 months 2. a score of 6 or higher (out of 10) on the target knee's numerical rating scale 3. knee osteoarthritis 1-4 confirmed in knee x ray within 6 months of study enrollment exclusion criteria: 1. systemic inflammatory diseases such as rheumatic diseases 2. uncontrolled diabetes 3. malignant tumor 4. if the target knee has a previous surgical history (arthroscopy, arthroscopy, autologous or allograft osteochondral transplantation and autologous cartilage cell transplantation, osteotomy, arthritis surgery) 5. patients with lidocaine and contrast agent allergy 6. history of nerve block in the target knee within 2 weeks 7. body mass index over 40 kg/m2 8. bleeding disorder 9. pregnant/lactating women 10. inability to understand informed consent and respond to research questionnaires due to cognitive impairment 11. unable to read consent form (e.g. illiterate, foreigner, etc.)
blinding assessment of manual therapy interventions of the back in swiss graduate students

Conditions: Back Pain; Back Disorder; Back Pain, Low

Summary: there is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. in other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. this feasibility trial was conducted as part of a doctoral epidemiology course at the university of zurich, switzerland. within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). the investigators also aimed to assess blinding among outcome assessors.

manual therapy remains a guideline-compliant, first-line therapeutic option for back pain. yet, maintaining methodological quality in randomized controlled trials of manual therapy interventions poses challenges, particularly concerning: (a) the design of adequate 'sham' controls and (b) the blinding status of participants and outcome assessors. optimal implementation of large-scale manual therapy trials requires testing the feasibility of control manual therapy interventions and effective blinding of participants and outcome assessors. even when conducted in healthy populations and non-clinical settings, blinding feasibility trials remain an opportunity for methodological advancement in the field of manual medicine, and a research priority for unbiased treatment effect estimation in future trials. the primary objective of this methodological trial was to quantitatively assess blinding feasibility among participants (graduate students enrolled in an epidemiology ph.d. course) assigned to an active or control intervention immediately after a one-time intervention session. the secondary objective was to assess blinding feasibility among outcome assessors and explore factors influencing perceptions about intervention assignment among participants and outcome assessors. these two objectives contributed to obtaining valuable preliminary measures of blinding (blinding indices) for a future methodological blinding feasibility trial to be carried out in a real-world clinical setting.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * enrolled in a doctoral-level epidemiology course at the university of zurich, switzerland. exclusion criteria: * serious pathology (i.e., cancer, severe scoliosis, inflammatory disease, infection, cauda equina syndrome or progressive motor deficit) * history of spine surgery * obvious contraindication to manual therapy (i.e., spinal fracture)

Keywords: methods manual therapy randomised trial back pain feasibility blinding assessment
radiosurgery for the treatment of refractory ventricular extrasystoles and tachycardias

Conditions: Ventricular Tachycardia

Summary: patients with refractory ventricular extrasystoles or tachycardia not eligible for catheter ablation will receive single fraction stereotactic body radiation therapy (cardiac radiosurgery) with 25 gy. investigators initiated this study to demonstrate that in at least 70% of the patients the planned cardiac radiosurgery may be performed without any interruption or treatment related interventional events within the first 30 days after treatment.

primary endpoint: 30-day post-intervention safety defined as presence of both, radiosurgery delivery of the planned dose to the intended target area, and no possibly treatment related serious adverse events in the first 30 days after treatment. secondary endpoints: evaluated at 1 year * changes in ventricular tachycardia episodes and icd shocks * changes in antiarrhythmic medication due to treatment effects * occurrence of possibly treatment related adverse events in the first year after treatment * changes in patient-reported quality of life * overall survival * safety profile

Eligibility criteria:
inclusion criteria: * patients with structural heart disease and implantable cardioverter defibrillator (icd) * age \> 18 years * either 1. recurring symptomatic monomorphic ventricular tachycardia that requires icd intervention (e.g. shock or anti-tachycardia stimulation). at least 3 episodes within the 3 months prior to inclusion or 2. induction of symptomatic monomorphic ventricular tachycardia that requires icd intervention (e.g. shock or anti-tachycardia stimulation). induction triggered by icd or during electrophysiology studies (eps) or both, a) and b) * refractory to antiarrhythmic combination therapy * beside the cardiac conditions: no competing illness that would additionally limit the life expectancy to less than 6 months * no prior radiation therapy in the thorax area * no pregnancy and no active breastfeeding * ability to consent and consent to study participation exclusion criteria: * icd electrode malfunction of icd readings outside reference range * lack of evidence of a myocardial scar (computer tomography or magnetic resonance tomography for mri-capable icd aggregates or electrophysiological measurement) * no possible induction of symptomatic monomorphic ventricular tachycardia non-persistent or persistent with delivery of icd therapies such as antitachycardic pacing or shock * contraindication to radiosurgery (e.g. precise target volume definition not possible due to image artifacts created from a left ventricular assist device (lvad)) * inability to consent or missing or withdrawn consent

Keywords: ventricular tachycardia stereotactic body radiation therapy radiosurgery
non-interventional study of patients with pn nf1 starting selumetinib in russia

Conditions: Neurofibroma

Summary: the purpose of this study is to evaluate the effectiveness, safety of selumetinib and patient's parameters of symptomatic inoperable pn nf1 in real clinical practice in russia

this study will be non-interventional retrospective and prospective study. assessment of parameters will be carried out as if a patient is treated in real-life clinical setting. the patients should be enrolled into this project after evaluation of eligibility criteria by an investigator 10 clinical sites. no additional procedures besides those already used in the routine clinical practice will be applied to the patients. study population will consist of pediatric patients aged 3 years and older with nf1 and symptomatic inoperable pn who were prescribed with selumetinib

Eligibility criteria:
inclusion criteria: * nf1 diagnosed (according to the criteria for evaluating nf1), * symptomatic inoperable pn, * patients receiving therapy with selumetinib. for newly treated patients - registration on the first day of starting treatment with selumetinib, * age at starting of selumetinib treatment ≥ 3 to ≤ 18 years old (included in the study or started the therapy at the age of 18 years old), * patients whose parents or guardians have signed a consent form. exclusion criteria: * patients currently participating in an interventional study/clinical trial, * patients are excluded if there is evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy, * patients who receive other antitumor treatment options on optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer. if the patient on selumetinib treatment develop optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer, he can continue selumetinib therapy +\\- other treatment options on physician decision, * female patients above 12 age who are pregnant /plan to become pregnant or at breast feeding.

Keywords: non-interventional selumetinib
to evaluate the introduction of a public health approach to peripheral arterial disease (pad) using national centre for sport and exercise medicine facilities.

Conditions: Peripheral Arterial Disease

Summary: the aim of the project is to investigate the clinical and patient centred outcomes of people with peripheral arterial disease (pad) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. the podiatry clinic will be delivered from the move more centre (ncsem) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced bmi, and the success of any smoking cessation. quality of life and patient satisfaction with the programme will also be assessed.


Eligibility criteria:
inclusion criteria: 1. adult patient between the ages of 50-90 years, 2. patient attending for podiatry treatment 3. diagnosis of pad or is showing signs of symptoms of pad 4. wishes to take part in the study. exclusion criteria: 1. anyone unable to give informed consent due to lack of mental capacity. 2. anyone who would be unable to participate in increased activity due to other co-morbidities
adding magnesium sulfate to bupivacaine for ilioinguinal and iliohypogastric nerve block

Conditions: Magnesium Sulfate Causing Adverse Effects in Therapeutic Use

Summary: regional block of ilioinguinal and iliohypogastric (iiih) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. magnesium sulfate (mgso4) blocks n-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (la) in different anesthetic approaches. although the prolongation in postoperative duration resulting from the addition of mgso4 to la was significant in some literature studies, it was insignificant in others. this study was designed to investigate the adjunctive effect of mgso4 when added to bupivacaine for iiih blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (vrs) scores, analgesic consumption, and hemodynamics as secondary outcomes.

regional block of ilioinguinal and iliohypogastric (iiih) nerves has been applied to provide postoperative analgesia after inguinal hernia repair. magnesium sulfate (mgso4) blocks n-methyl-d-aspartate receptors, and that is why, it was used as an adjuvant to the local anesthetic (la) in different anesthetic approaches. although the prolongation in postoperative duration resulting from the addition of mgso4 to la was significant in some literature studies, it was insignificant in others. this study was designed to investigate the adjunctive effect of mgso4 when added to bupivacaine for iiih blockade on the postoperative analgesic duration as a primary outcome and on the verbal rating scale (vrs) scores, analgesic consumption, and hemodynamics as secondary outcomes. patients were divided into two groups of 45 patients each by means of coded envelopes according to the la used for iiih blockade. in the first group (control group), patients received 10 ml 0.5% isobaric bupivacaine plus 1 ml normal saline for iiih blockade, whereas in the second group (mgso4 group), 10 ml 0.5% isobaric bupivacaine and 1 ml of mgso4 10% were prepared. all the patients received intrathecal 3 ml 0.5% hyperbaric bupivacaine, and then, iiih blockade was performed under ultrasound guidance according to the group. postoperatively, vrs scores,analgesic duration, and any complication were recorded.

Eligibility criteria:
inclusion criteria: * adult male * american society of anesthesiologists physical status i or ii exclusion criteria: * patients with body mass index greater than or equal to 35 kg/m2 * allergy to the study drugs * on chronic analgesics or drug containing magnesium