Kornimate/medical-research-clean huggingface dataset:
neoadjuvant study of nab-paclitaxel plus carboplatin in breast cancer

Conditions: Breast Cancer

Summary: this is a single-center, prospective, single arm phase ii study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for her-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. the primary objective is pcr. the secondary objectives include orr, 3-yr dfs, os and safety. the sample size is 30.


Eligibility criteria:
inclusion criteria: * female, between 18 and 70 years old * life expectancy is more than 12 months * breast mri or ultrasound confirmd tumor over 3cm and biopsy comfirned invasive breast caner of stage ii-iii (inflammatory breast cancer excluded) * not accompanied with other malignancies（except for controlled carcinoma in situ of the cervix or skin basal-cell carcinoma） * a normal bone marrow: absolute neutrophil count≥1.5\*10e9/l, hemoglobin≥100g/l, plt≥100\*10e9/l * normal liver and renal functions: ast≤60u/l, total biliruin≤1.5\*upper limit of normal, serum creatinine≤110umol/l, urea nitrogen≤7.1mmol/l * normal blood coagulation function * ecog performance status of 0-1 * willing to coordinate with a punch biopsy before treatment and accept neoadjuvant therapy * women of child-producing potential must agree to use effective contraceptive methods during the study, and a negative serum or urine pregnancy test must be obtained within 7 days prior to administration of the drugs * written informed consent * for her-2 positive patients, the her-2 status must be determined by ich +++ or fish/cish. for patients treated with trastuzumb, lvef≥55% by ultrasonic cardiogram or muga scan exclusion criteria: * previous systematic or local therapy including chemotherapy for breast cancer * distant metastases of breast cancer are observed * concurrent uncontrolled lung disease, severe sepsis, active peptic ulcer requring treatment, blood coagulation disorders, serious uncontrolled diabetes, connective tissue disease or bone marrow depression, unable to tolerate neoadjuvant therapy and related treatment * \>grade 1 peripheral neuropathy caused by any reason * history of chf, uncontrolled symptomatic angina, history of arrhythmias or myocardial infarction, poorly controlled hypertension (systolic pressure \> 180mmhg or diastlic pressure \> 100 mmhg) * lactational or gestational breast cancer * not willing to accept a punch biopsy before treatment and neoadjuvant therapy * psychopath or any other reasons that would preclude compliane with treatment * known serious allergy to any of the study drugs or excipients * participation in another study requiring administration of an in investigational drug or biological agent at present or recently (within the last 30 days prior to screening visit)
a study to evaluate the efficacy and safety of astegolimab in participants with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (copd) maintenance therapy in patients with copd who are former or current smokers and have a history of frequent exacerbations.


Eligibility criteria:
inclusion criteria * documented physician diagnosis of copd for at least 12 months * history of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening * post-bronchodilator fev1 \>=20 and \<80% of predicted normal value at screening * modified medical research council (dyspnea scale) (mmrc) score \>=2 * current or former smoker with a minimum of 10 pack-year history * history of one of the following combinations of optimized, stable, standard-of-care copd maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: inhaled corticosteroid (ics) plus long-acting beta-agonist (laba); long-acting muscarinic antagonist (lama) plus laba; ics plus lama plus laba exclusion criteria * current documented diagnosis of asthma according to the global initiative for asthma guidelines or other accepted guidelines within 5 years prior to screening * history of clinically significant pulmonary disease other than copd * history of long-term treatment with oxygen at \>4.0 liters/minute * lung volume reduction surgery or procedure within 12 months prior to screening * participation in or planned participation in a new pulmonary rehabilitation program. patients who are in the maintenance phase of a rehabilitation program are eligible * history of lung transplant * occurrence of moderate or severe copd exacerbation, covid-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug * treatment with oral, iv, or im corticosteroids within 4 weeks prior to initiation of study drug * initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or pde4 inhibitor within 4 weeks prior to screening * unstable cardiac disease, myocardial infarction, or new york heart association class iii or iv heart failure within 12 months prior to screening

Keywords: chronic obstructive pulmonary disease copd
evaluation of acell hydrated wound dressing for autogenous skin donor sites

Conditions: Burns

Summary: the purpose of this study is to see if treating a donor site wound with the acell dressing is as good as or better than the dressings we currently treat harvested donor sites with. this will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds. hypothesis: the mean healing time for wounds treated with the acell dressing will be less than the mean healing time for wounds treated with the standard of care dressing.

this is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the acell dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently xeroform.

Eligibility criteria:
inclusion criteria: * less than 30% total body surface area burn * burn wounds do not involve the donor site harvesting areas * requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces. * the scheduled excision and grafting procedure is the first such operation for the subject * subject agrees to participate in follow-up evaluations exclusion criteria: * critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability * major acute or chronic medical illness that could affect wound healing * cellulitis or other infection of the potential donor sites * donor site has been previously harvested for grafting * subjects who are pregnant * religious objections or allergy to porcine products

Keywords: burns acell donor site
bmac nerve allograft study

Conditions: Peripheral Nerve Injury Upper Limb

Summary: this study is a prospective, multi-center, proof of principle, phase i human safety study evaluating the sequential treatments of the avance nerve graft, a commercially available decellularized processed peripheral nerve allograft, with autologous bone marrow aspirate concentrate (bmac), a source of stem cells, for the repair of peripheral nerve injuries up to 7 cm in length. the purpose of this study is to establish a knowledge product, evaluating the safety profile of the avance nerve graft, followed by the application of bmac to support further investment into the promising area of using stem cells in conjunction with scaffolds.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female 18 to 74 years of age. * undergoing peripheral nerve exploration or grafting with allograft in the upper extremity. * subjects must be inpatients or scheduled for surgery at the time of study enrollment. * has nerve conduction block injuries to the ulnar, median, radial or musculocutaneous nerve of either upper extremities that is less than two years from injury. * be willing to undergo tension free end-to-end nerve graft coaptation on both the proximal and distal portion of the nerve gap with the avance nerve graft. * be willing to have bone marrow harvested from own body, concentrated, and applied to the site of nerve injury following the insertion of the avance nerve graft. * be willing to participate and able to comply with all aspects of the treatment and evaluation schedule over a 18-month duration. * capable of giving their own consent to participate in the study, and willing to sign and date an irb-approved written informed consent prior to initiation of any study procedures. * nerve conduction injury affecting sensory and motor function or solely motor function in the upper extremity. * nerve gaps following resection, up to 7 cm, inclusive. exclusion criteria: * subjects with type 1 diabetes mellitus or type 2 diabetes mellitus requiring regular insulin therapy. * subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular system. * history of neurodegenerative disease, neuropathy, or diabetic neuropathy. * history of chronic ischemic condition of the upper extremity. * cognitive limitation or mental illness preventing informed consent. * nerve injuries \>2 years post initial injury. * any participant who at the discretion of the investigator is not suitable for inclusion in the study.
the effects of laparoscopic guided transversus abdominis plane (tap) block in sleeve gastrectomy procedure.

Conditions: Obesity, Morbid; Postoperative Pain; Postoperative Nausea and Vomiting

Summary: sleeve gastrectomy is the most performed bariatric procedure worldwide. postoperative pain management is a challenging issue. in this trial, the investigators aimed to explore the effects of laparoscopic guided transversus abdominis plane (tap) block on postoperative pain management in patient those were performed laparoscopic sleeve gastrectomy.

tap block is a regional anesthesia technique which could be performed easily especially by laparoscopy and are used in various surgical procedures. in that technique, blockade of the plane between internal oblique muscle and transversus abdominis muscle is performed by infiltration of local anesthesics drugs. therefore , reduction of postoperative pain could be lead to decrease in postoperative complications.

Eligibility criteria:
inclusion criteria: * patients between 18-65 * undergo laparoscopic sleeve gastrectomy exclusion criteria: * bupivacaine allergy * having chronic pain or taking pain management * asa ( the american society of anesthesiologists physical classification system) class 4 or * patients who were performed additional procedures including cholecystectomy, hiatal hernia repair or abdominal hernia repair

Keywords: sleeve gastrectomy transversus abdominis plane block postoperative pain management
the influence of helicobacter pylori eradication on gastric pathology: a long-term, prospective cohort study

Conditions: Helicobacter Pylori; the Operative Link on Gastric Intestinal Metaplasia; Operative Link on Gastric Intestinal Assessment

Summary: helicobacter pylori (h. pylori) infection, affecting an estimated 50% of the global population, is a main cause of chronic gastritis, peptic ulcers and gastric cancer. by causing progressive damage to the stomach and may eventually result in gastric atrophy, h. pylori infection has been demonstrated to be responsible for more than 95% of gastric malignancies


Eligibility criteria:
inclusion criteria: * patients with h. pylori infection; * aged 18-65 years. exclusion criteria: * patients with gastrectomy, acute gi bleeding and advanced gastric cancer; * conditions unsuitable for performance of gastroscopy, such as coagulopathy, impaired renal function; * pregnancy or breastfeeding; * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
the observation about the effects of internal carotid artery stenosis on fundus vessels and the changes of fundus vessels after interventional therapy

Conditions: Internal Carotid Artery Stenosis

Summary: the investigators plan to collect 30 participants with internal carotid artery stenosis to observed the relationship between the degree of internal carotid artery stenosis and fundus vessels （and blood flow）density before operation, and compared with participants without internal carotid artery stenosis.the fundus blood flow density will be observed after intervention operation in order to see whether the operation is effective to improve the density of fundus vessels and blood flow or not.


Eligibility criteria:
inclusion criteria: 1. patients who have been diagnosed with carotid artery stenosis and need surgery; 2. patients whose vision won't get worse soon; 3. patients have not had any eye surgeries; 4. patients with complete profile. exclusion criteria: 1. patients with severe systemic disease; 2. patients with poor dioptric stroma; 3. patients with nystagmus; 4. patients with incomplete profile.
limbal relaxing incision versus toric intraocular lens for corneal astigmatism during cataract surgery.

Conditions: Astigmatism; Cataract

Summary: this study will compare toric intra-ocular lens (iol) with limbal relaxing incisions (lri) in correcting astigmatism in patient undergoing standard cataract surgery. astigmatism is unequal curvature of the eye; the eye is oval rather than spherical. uncorrected astigmatism of greater than approximately 0.75 diopters (d) can cause visual blurring, ghosting of images or halos. over 20% of patients undergoing cataract surgery have astigmatism which is likely to have been corrected by spectacles. cataract surgery involves the replacement of the natural opacifying crystalline lens with a clear artificial plastic intra-ocular lens (iol). the lens power can be selected to correct the patient's glasses prescription. the most widely used iols only correct glasses at one distance i.e. either near or distance. residual astigmatism after cataract surgery will need glasses for correction which is undesirable for many patients. limbal relaxing incisions (lri) are circumferential partial thickness cuts to the clear window of the eye (cornea) during surgery. these lris can correct corneal astigmatism and have no additional risk of complications. alternatively, toric iols are available which correct astigmatism inside the eye. they have been available for routine use in the last few years; technology has markedly improved and the lenses have become cheaper. studies have suggested toric iols provide better vision after cataract surgery than the regular iols. toric iol are widely used in the private practice and increasingly in the national health service (nhs). lris are cost effective for treating astigmatism however their predictability is believed to be lower than toric iols. as there are no randomised controlled trials comparing the outcomes between lris and toric iols. this research will address this gap in knowledge and accordingly from this research future practice will be able to provide treatment to patients with information about the best outcomes.


Eligibility criteria:
inclusion criteria: 1. symptomatic cataract for which the patient desires surgery 2. corneal astigmatism of greater than or equal to 0.75 d and lesser than or equal to 2.5d. 3. no significant ophthalmic co-morbidity which would affect the postoperative visual outcomes. exclusion criteria: 1. \<18 years of age 2. significant ophthalmic comorbidity detrimental to final visual outcomes 3. not competent to give consent 4. concurrent use of ocular medications including lubricants 5. unable to attend follow ups at 1, 3, 6 and 12 months.
a study of shr-4394 injection in subjects with prostate cancer

Conditions: Prostate Cancer

Summary: this is an open label, multi-center, multiple dose phase i study to evaluate the safety, tolerability, pharmacokinetics and efficacy of shr-4394 injection in subjects with prostate cancer.


Eligibility criteria:
inclusion criteria: 1. age range: 18-85 years old, male; 2. ecog score for physical condition is 0-1 points; 3. expected survival period ≥ 6 months; 4. prostate adenocarcinoma confirmed by histological or cytological examination; 5. patients with at least one metastasis lesion; 6. disease progression on or after the most-recent prior regimen; 7. continuous treatment with luteinizing hormone releasing hormone analogues (lhrha) or previous bilateral orchidectomy; 8. testosterone was at castration level; 9. adequate organ function. exclusion criteria: 1. received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment; 2. unresolved to ctcae 5.0\>=grade 2 toxicities from previous anticancer therapy; 3. meningeal metastasis history or clinical symptoms of central nervous system metastasis; 4. uncontrollable tumor-related pain; 5. uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms; 6. other serious concomitant disease; 7. previous or co-existing malignancies; 8. history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of shr-4394; 9. active hepatitis b or active hepatitis c; 10. other inappropriate situation considered by the investigator.
single ascending dose study of the safety, tolerability, and pharmacokinetics of gap-134 administered intravenously

Conditions: Arrhythmia

Summary: the study will assess the safety, tolerability and pharmacokinetics of single intravenous (iv) doses of gap-134 in healthy subjects. gap-134 will be administered as a 24-hour infusion.


Eligibility criteria:
inclusion criteria * generally healthy men and women of nonchildbearing potential (woncbp), aged 18 to 50 years. * body mass index (bmi) range of 18 to 30 kg/m2. * blood serum creatinine levels less than or equal to the upper limit of normal. exclusion criteria * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * any history of clinically important cardiac arrhythmias and familial history of long qt syndrome or unexpected cardiac death. * history of drug and alcohol abuse, positive hiv, hcv, and/or hbs ag test, and any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ecgs, or clinical laboratory test results.
a natural history study in chinese male patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this is a multicenter, prospective, single cohort study designed to describe the natural history of dmd in chinese male patients. a total of approximately 330 subjects will be enrolled with the target number of subjects in each group as below: * group 1, ambulatory subjects aged \<6 years, approximately 100 subjects; * group 2, ambulatory subjects aged \>=6 years, approximately 180 subjects; * group 3, non-ambulatory subjects, approximately 50 subjects. subjects will visit sites every 6 months. each subject will be observed for at least 24 months. all subjects will remain enrolled until the study completion date, such that some will have data collected after month 24. subjects, who complete visit 5/month 24 at least 6 months prior to study completion, will be asked to complete an additional visit at month 30.


Eligibility criteria:
inclusion criteria: 1. chinese male patients with any age, diagnosed with dmd. diagnosis must be confirmed in subject's medical history and by genetic testing obtained during routine clinical care for diagnostic purposes as reported from an appropriate regulated laboratory using a clinically validated genetic test (genetic testing is not provided by the sponsor). 2. subjects who are \>=4 years old must be receiving glucocorticosteroids for a minimum of 6 months prior to signing informed consent. there should be no significant change (\ 4 years will be exempt from this requirement; those not taking gc will be eligible if the initiation of gc treatment in these subjects is considered inappropriate in the opinion of investigators. exclusion criteria: 1. any injury which may impact functional testing. previous injuries must be fully healed prior to consenting. prior lower limb fractures must be fully healed and at least 3 months from injury date. 2. presence or history of other musculoskeletal or neurologic disease or somatic disorder not related to dmd including pulmonary, cardiac, and cognitive diseases. 3. subjects \>=4 years old who have not completed the varicella vaccination. 4. participation in other studies involving investigational drug(s) for a minimum of 90 days prior to signing the informed consent and/or during study participation.
treatment of social anxiety disorder and selective mutism

Conditions: Social Anxiety Disorder; Selective Mutism

Summary: this study is to assess the efficacy of a brief, 11-week, manualized taming sneaky fears for social anxiety disorder (sad) and/or selective mutism (sm) child and parent group cognitive behavioural therapy (cbt) treatment protocol. children 4 to 7 years old (n = 88) meeting criteria for sad and/or sm, and their parents are recruited from the psychiatry outpatient program and participants will be randomized to either the taming sneaky fears group or a parent psycho-education and child socialization group. trained clinicians blinded to all measures and treatment assignment will administer pre, post and 6-month follow-up outcome measures. investigators assess within-the-child and within-the-parent/environment factors that predict treatment outcomes.

this study utilizes a repeated measures, longitudinal, randomized controlled trial design to compare the efficacy of two interventions in the treatment of children aged 4 to 7 years with sm and/or sad. participants are randomized into either the: 1. taming sneaky fears for sad and/or sm parent and child group cbt treatment, or 2. the parent psycho-education and child socialization comparison program. both programs run for 10 consecutive weeks (plus one additional introduction week). to control for the nonspecific factors associated with treatment, such as the support, attention and expectation of improvement, parents and children in both treatment protocols receive comparable levels of attention from therapists (i.e., same duration of group sessions and total number of sessions with a therapist) and comparable opportunities for socialization (e.g., for the children: invitation to discuss how the previous week went, snack time, story time; for the parents: discussion of specific topics at each session). however, parents and children in the comparison group are not taught cbt strategies.

Eligibility criteria:
inclusion criteria: * 4 to 7 year old children who meet diagnostic criteria for a primary diagnosis of selective mutism (sm) and/or social anxiety disorder (sad) through a clinical and semi-structured diagnostic interview . * presence of other anxiety disorders/symptoms is not an exclusion criterion as long as the main concern (primary diagnosis) is sad and/or sm. exclusion criteria: * presence of autism spectrum disorder, brain injury, or significant developmental delays (based on medical history and clinical assessment). * children and parents not fluent in english.

Keywords: social anxiety disorder selective mutism cbt preschool anxiety disorders