Kornimate/medical-research-clean huggingface dataset:
shr-a1811 alone or in combination with adebrelimab as neoadjuvant treatment in hr positive/her2 low breast cancer

Conditions: HR Positive/HER2 Low Breast Cancer

Summary: this is an open-label, phase ii study evaluating the efficacy and safety of shr-a1811 alone or in combination with adebrelimab in stage ii-iii hr positive/her2 low breast cancer. subjects will receive the neoadjuvant therapy of shr-a1811 alone or in combination with adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. efficacy will be assessed every 2 cycles.


Eligibility criteria:
inclusion criteria: 1. female patients aged ≥ 18 but ≤ 75 years 2. histologically confirmed to be hr+/her2-low invasive breast cancer 3. treatment-naive patients with stage ii-iii 4. eastern cooperative oncology group (ecog) score is 0 or 1 5. good level of organ function 6. subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits exclusion criteria: 1. previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. received any other anti-tumor therapy at the same time 3. bilateral breast cancer, inflammatory breast cancer or occult breast cancer 4. stage iv breast cancer 5. not confirmed by histopathology 6. with a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer 7. participated in other drug clinical trials within 4 weeks before enrollment 8. known allergic history of the drug components of this protocol 9. history of immunodeficiency 10. clinically significant cardiovascular diseases 11. known or suspected interstitial lung disease 12. active hepatitis and liver cirrhosis 13. known hereditary or acquired bleeding thrombotic tendency 14. history of neurological or psychiatric disorders

Keywords: shr-a1811 adebrelimab neoadjuvant hr positive/her2 low breast cancer
exoskeleton use in acute rehab post spinal cord injury; a safety and feasibility study

Conditions: Spinal Cord Injuries

Summary: this study will examine the safety and feasibility of using an exoskeleton in subjects who are less than 6 months post spinal cord injury (sci).

study participants with acute sci (\<6 months post injury) will be involved in an indoor, overground walking program. locomotor training will include 90 minute sessions (including time to don and doff the device) for 30 training hours (90 minutes, 2-3 times weekly for 8 weeks.)

Eligibility criteria:
inclusion criteria: * individuals aged 15 and older with acute sci (\<6 months post) etiology of sci can be traumatic or non traumatic includes motor complete (ais a,b) and motor incomplete (ais c,d) at c7 or below. participants must be able to follow 2 step commands participants must be deemed medically stable by responsible physician or physiatrist * spine considered stable by surgeon * surgical wound is approximated and surrounding tissue appears healthy * participant does not require supplemental oxygen * participant is able to have any iv or other lines disconnected. must meet manufacturer's requirements for use of ekso gt: exclusion criteria: * range of motion (rom) restrictions that would prevent a patient from achieving a normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions spinal instability untreated deep vein thrombosis (dvt) decreased standing tolerance due to orthostatic hypotension significant osteoporosis that prevents safe standing or may increase the risk of fracture caused by standing or walking uncontrolled spasticity - score of 3 or higher on modified ashworth scale uncontrolled autonomic dysreflexia (ad) skin integrity issues on contact surfaces of the device or on surfaces that would prohibit sitting (sacrum, greater trochanter, proximal tibia) upper leg length discrepancy greater than half an inch (\> .5") or lower leg discrepancy greater than three-quarters of an inch (\>.75") cognitive impairments resulting in motor planning or impulsivity concerns pregnancy
a study of arq 501 in patients with squamous cell carcinoma of the head and neck

Conditions: Head and Neck Neoplasms; Carcinoma, Squamous Cell

Summary: this is a phase 2, multi-center, open label study of arq 501 in patients with locally advanced, recurrent or metastatic squamous cell cancer of the head and neck (scchn).


Eligibility criteria:
inclusion criteria: 1. able to provide signed and dated informed consent document prior to study-specific screening procedures. 2. histologically or cytologically confirmed locally advanced, recurrent or metastatic scchn. 3. measurable disease per recist. 4. ≥ 18 years old. 5. karnofsky performance status (kps) ≥ 70%. 6. male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of arq 501. 7. hemoglobin (hgb) ≥ 10 g/dl. 8. absolute neutrophil count (anc) ≥ 1.5 x 10\^9/l (≥ 1,500/mm³). 9. platelet count ≥ 100 x 10\^9/l ( ≥ 100,000/mm³). 10. total bilirubin less than or equal to 1.5 x upper limit of normal (uln) or less than or equal to 3.0 x uln with metastatic liver disease. 11. aspartate aminotransferase (ast) and alanine aminotransferase (alt) less than or equal to 2.5 x uln or less than or equal to 5.0 x uln with metastatic liver disease. 12. creatinine less than or equal to 1.5 x uln. exclusion criteria: 1. primary tumor of nasopharyngeal origin. 2. eligible for curative surgery or radiotherapy. 3. received three or more systemic anticancer regimens. 4. have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. 5. have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion. 6. surgery within two weeks of first infusion. 7. have symptomatic or untreated central nervous system (cns) involvement. 8. are pregnant or lactating. 9. previous exposure to arq 501.

Keywords: squamous cell carcinoma of the head and neck
effects of coenzyme q10 supplement on cardiovascular risk factors in subjects at high risk of metabolic syndrome

Conditions: Metabolic Syndrome; Cardiovascular Diseases

Summary: this study aims to evaluate the ameliorating effect of coenzyme q10 supplementation on cardiovascular risk factors in high risk population for metabolic syndrome, including blood lipid metabolism, insulin resistance, blood pressure regulation, platelet function, endothelial function, cardiorespiratory fitness and muscle function.


Eligibility criteria:
inclusion criteria: * metabolic syndrome or high-risk groups with metabolic syndrome are defined as subjects with metabolic syndrome according to the international diabetes federation (idf) chinese adult criteria, and high-risk groups are defined as those who meet at least two mets risk factors. the specific criteria are as follows: 1. aged 30-90 years old; 2. two or more of following are acceptable: 1. abdominal obesity (central obesity): waist circumference \>=90 cm for men and \>=80cm for women; 2. hyperglycemia: fasting blood glucose ≥ 5.6mmol/l or taking hypoglycemic drugs; 3. hypertension: systolic blood pressure \>=130mmhg and (or) diastolic blood pressure \>=85mmhg or taking blood pressure medications; 4. fasting tg\>=1.70mmol/l or taking antihyperlipidemic drug; 5. fasting hdl-c\<1.04 mmol/l for men, \<1.29 mmol/l for women or taking antihyperlipidemic drug; 3) sign informed consent and insist on participating in the research. exclusion criteria: * 1) take drugs/dietary supplements, such as aspirin, fish oil and etc., that affect platelet function in recently six months; 2) blood system disease or infection; 3) blood pressure \>=160/100mmhg; 4) low platelet count (whole blood platelet\<100 x 10\^9/ml); 5) abnormal hemoglobin (male \<120g/l, female \<110g/l); 6) low hematocrit (male \<40%, female \<37%); 7) prothrombin time (pt) is outside the normal reference range; 8) pregnant women or nursing mothers; 9) abnormal menstrual cycle, taking birth control pills or hormone replacement therapy; 10) gastric ulcer, liver or kidney dysfunction.
iqp-cl-101 in ibs management

Conditions: Irritable Bowel Syndrome

Summary: after 2 weeks of run-in period, subjects are randomized to either iqp-cl-101 or a matching placebo. over 8 weeks, the subjects are monitored for improvements in ibs symptoms


Eligibility criteria:
inclusion criteria: * fulfils rome-iii criteria for ibs diagnosis * females' agreement to use appropriate birth control methods during the active study period for females of childbearing potential * subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply exclusion criteria: * known sensitivity to any of the ingredients of iqp-cl-101 * clinically relevant abnormalities in colonoscopy within the last 2 years prior to randomization * other causes of ibs symptoms such as inflammatory bowel disease (ibd), microscopic colitis, celiac disease, history of abdominal obstruction, cholecystitis, pancreatitis, ileus, or any gastrointestinal bleeding * use of medications that could influence gi functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals) within 1 month prior to randomization * clinically relevant excursions of safety parameters * any other conditions deemed relevant by the investigator(s)

Keywords: irritable bowel syndrome ibs
safety and tolerability of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal insufficiency (28 week extension)

Conditions: Diabetes Mellitus, Type 2; Renal Insufficiency

Summary: this clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (t2dm) and moderate or severe renal insufficiency


Eligibility criteria:
inclusion criteria: * complete the core study exclusion criteria: * did not comply with core study requirements

Keywords: type 2 diabetes, vildagliptin
a randomized comparative study of a weekly versus every other week nurse practitioner-led symptom management clinic for head and neck cancer patients undergoing concurrent chemotherapy and radiation

Conditions: Head and Neck Cancer

Summary: a retrospective chart review of patients receiving concurrent chemoradiotherapy for oropharynx cancer was performed to compare clinical data for patients treated prior to the initiation of the np clinic with those subsequently seen weekly in the np clinic. the variables studied included; rate of hospitalization, dose completion and dose reductions. the results revealed an overall improvement in all variables for those patients seen in the weekly np clinic. to further analyze this data a randomized, prospective study is proposed to validate the findings of the retrospective study. it is predicted that a weekly np led clinic will decrease costly hospitalizations, increase patient treatment completion and improve overall patient quality of life and satisfaction.


Eligibility criteria:
inclusion criteria: * have a diagnosis of stage iii or iv hnc * are initiating concurrent chemotherapy and radiation * are able and willing to sign informed consent * ages 18 years or older * ecog (eastern cooperative oncology group) score of 0 or 1 (the ecog score attempt to quantify cancer patients' general well-being and activities of daily life) * able to read and complete the required survey exclusion criteria: * cannot provided informed consent * any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment. * have a history of prior cancer within past 5 years (excluding non-melanoma skin cancer) * are unwilling or unable to complete the required qol (quality of life) survey
longitudinal cortical demyelination in multiple sclerosis and related disorders

Conditions: Multiple Sclerosis; Neuromyelitis Optica; Demyelinating Autoimmune Diseases, CNS

Summary: in this protocol, a combination of mri, blood, and cerebrospinal fluid (csf) analysis will be used to understand the natural history, underlying immunologic mechanisms, and clinical implications of central nervous system (cns) lesions, in particular lesions in the cerebral cortex, in multiple sclerosis (ms) and other inflammatory and autoimmune disorders affecting the cns. patients with these disorders, as well as healthy controls, will undergo baseline clinical evaluation and testing, bloodwork, and mri, with follow up clinical evaluation, bloodwork, and mri at years 1, 3, and 6. additional mris may be performed in patients with possible new lesion formation or to compare mri techniques. lumbar puncture will be performed on participants who are not currently being treated with disease modifying therapies and who are willing to undergo the procedure.


Eligibility criteria:
inclusion criteria: * 18 years old * able to provide consent in english * able to undergo mri exclusion criteria: * contraindication to mri * pregnancy
a study to learn about the study medicine called pf-07976016 in adults with obesity

Conditions: Obesity

Summary: the purpose of this clinical trial is to learn about the safety and effects of the study medicine (called pf-07976016) for the potential treatment of obesity. the study will compare the experiences of participants taking the study medicine (pf-07976016) to those of participants who take placebo (a lookalike substance that contains no active study medicine). the aim is to measure the body's response to the study medicine, including any changes in participants' body weight and how well they tolerate the study medicine.


Eligibility criteria:
key inclusion criteria: * male or non-pregnant, non-breastfeeding female, 18 to 74 years of age at visit 1 * body mass index ≥30.0 kg/m2 at visit 1, with stable body weight, defined as \<5 kg change in the 12 weeks before visit 1 * eligible and willing to receive required background medicine * willing and able to comply with all study procedures key exclusion criteria: * any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes. * use of any prohibited prior or concomitant medication(s) * presence of specified abnormalities on diagnostic assessments including clinical laboratory tests at visit 1.

Keywords: obesity
efficacy of vitamin b1 in familial adenomatous polyposis patients.

Conditions: Familial Adenomatous Polyposis (FAP)

Summary: this study aimed to investigate the efficacy of vitamin b1 in patients with familial adenomatous polyposis, and to determine the inhibitory effect of vitamin b1 on the size and number of colorectal adenomas by administering oral vitamin b1 therapy for 1 year and colonoscopy follow-up every 3 months

we will mark a region with a diameter of no more than 5 cm, containing at least 3 polyps, each with a diameter of 5-15 mm. continuous video recording will be conducted throughout the colonoscopy procedure to provide baseline reference images of the colorectal polyps. patients with familial adenomatous polyposis were given 100mg bid dose of vitamin b1 orally for one year, and colonoscopies were followed every 3 months to observe changes in the size and number of polyps in the designated area.

Eligibility criteria:
inclusion criteria 1. patients with a confirmed diagnosis of classical familial adenomatous polyposis (fap) based on colonoscopy, histopathology, and genetic testing. 2. aged between 18 and 80 years, with no restriction on gender. 3. no history of total colectomy, with remaining bowel segments available for evaluation. 4. presence of more than 10 adenomatous polyps in the colon or rectum. 5. normal liver and kidney function. 6. willing to participate in vitamin b1 therapy and commit to regular follow-up appointments. exclusion criteria 1. use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect colorectal polyps, including aspirin, nonsteroidal anti-inflammatory drugs (nsaids), ω-3 polyunsaturated fatty acids, rapamycin, and curcumin. 2. use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect vitamin b1 absorption, metabolism, or excretion, including aminoglycoside antibiotics, thiazide diuretics, oral contraceptives, antiepileptic drugs, and antituberculosis drugs. 3. attenuated familial adenomatous polyposis (afap). 4. allergy to vitamin b1. 5. contraindications to vitamin b1, such as liver or kidney dysfunction, or severe neuropsychiatric disorders. 6. history of total colectomy, with no remaining bowel segments. 7. pregnant or breastfeeding individuals. 8. presence of advanced colorectal cancer or metastatic cancer in other locations. 9. previous radiotherapy, chemotherapy, or tumor immunotherapy. 10. history of alcohol or other substance abuse.

Keywords: familial adenomatous polyposis thiamin
to assess the level of adherence of subjects receiving saizen® via easypod™ in austria

Conditions: Growth Disorders

Summary: this is a national, multicentre, observational registry to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment from hospitals in austria and to assess the level of adherence of subjects receiving saizen® via easypod™.

subjects will be enrolled in a multicenter, longitudinal observational registry. parents/subjects will provide their informed consent/assent to upload their data for populationbased analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: - to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to identify adherence subject profiling * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to asses the impact of adherence on insulin-like growth factor 1 (igf1) (i.e. above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to the austrian summary of product characteristics (smpc) * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country. exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in another interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
safety study of isentress® + truvada® in post-exposure treatment of hiv infection

Conditions: HIV Infections

Summary: the objective are to assess the nature and incidence of drug intolerance observed with a new antiretroviral triple therapy, truvada® \[0-0-1\] + isentress® 400 mg tablets \[1-0-1\], prescribed in a setting of the treatment of individuals with recent exposure to a risk of transmission of hiv infection and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.


Eligibility criteria:
inclusion criteria * age 18 years or over * consultation immediately following exposure to the risk of transmission of hiv infection (less than 48 hours, except in the case of rape when this period may be increased to a maximum of 120 hours) * person capable of understanding the principle of the study and giving his/her informed consent exclusion criteria * subjects recently exposed to a risk of transmission of hiv infection in which the source patient is known to be infected with hiv and treated, and whose therapeutic history justifies the introduction of pet other than that proposed in this study * subjects with a contraindication to the prescription of truvada® and/or isentress® (renal impairment, allergy, etc.) * subjects previously treated with phenytoin, phenobarbital and rifampicin, since combination with raltegravir is contraindicated subjects known to be infected with hepatitis b virus, whether or not treated with lamivudine * subjects refusing to take part in the study * pregnant women

Keywords: tolerability of post exposure to hiv infection prophylaxis
a phase 3 study to evaluate the safety and efficacy of efgartigimod ph20 subcutaneous in adult patients with primary immune thrombocytopenia

Conditions: Primary Immune Thrombocytopenia

Summary: a phase 3 study to evaluate the safety and efficacy of efgartigimod ph20 subcutaneous in adult patients with primary immune thrombocytopenia


Eligibility criteria:
inclusion criteria: 1. ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits). 2. participants enrolled in the argx-113-2004 trial who completed the 24-week trial period. note: if a participant has had an sae during the argx-113-2004 trial, their eligibility should be evaluated by the investigator and the sponsor's trial physician. the decision of enrolling the participant will be evaluated case by case. 3a. agree to use contraceptives consistent with local regulations and the following: • female participants of childbearing potential must have a negative urine pregnancy test at baseline before receiving imp. in addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary itp or available through another patient program for patients with primary itp), the following criteria apply: 4. ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits). 5. participant has completed a 52-week treatment period. exclusion criteria: 1. introduction or continuation of nonpermitted medications during the argx-113-2004 trial (such as anti-cd20 therapy, romiplostim, monoclonal antibodies, fc fusion proteins, or live/live-attenuated vaccines) 2. use of any other investigational drug or participation in any other investigational trial 3. known hypersensitivity reaction to efgartigimod ph20 sc or any of its excipients 4. pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod ph20 sc