Kornimate/medical-research-clean huggingface dataset:
haloperidol for pain control in patients with acute musculoskeletal back pain in the emergency department

Conditions: Back Pain; Chronic Pain

Summary: single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ed) with a chief complaint of back pain. a total of 150 patients age 18-65 presenting to the emergency department with chief complaint of backpain will be enrolled from april 2024 - april 2025. patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. follow-up will be performed by telephone at 24 hours.


Eligibility criteria:
inclusion criteria: * age 18 - 65 years old * presenting to the bronson ed with a chief complaint of acute, non-traumatic back pain * vas score \>5 cm exclusion criteria: * back pain due to traumatic injury * experiencing saddle anesthesia * has bowel or bladder dysfunction * has an abnormal neurological exam * requires imaging in ed * has a glascow coma score \<15 * has one or more abnormal vital signs: hr\>120, sbp\>180 or \ 38°, o2 saturation\<92% * has an allergy to ketorolac or haloperidol * has a known diagnosis of lewy body dementia * has a known diagnosis of glaucoma. * is known to be pregnant or breastfeeding * is a prisoner or ward of the state * is unable to consent for themselves/ non-english speaking * in the opinion of the attending physician or investigator the patient should not participate in the research

Keywords: haloperidol chronic pain back pain
identification of new inborn errors of immunity

Conditions: Primary Immune Deficiency Disorder

Summary: analysis of dna samples of patients with molecularly undetermined pid by whole exome/genome sequencing. transcriptome analysis of patients with molecularly undetermined pid.


Eligibility criteria:
inclusion criteria: * patients with primary immunodeficiency (pid) * male and female participants 0 years to adult age (any) * written informed consent by the participant after information about the research project exclusion criteria: * secondary immunodeficiency * refusal to enter the study
a study to evaluate the pharmacokinetics and the safety after administration of "br1015" and co-administration of "br1015-1" and "br1015-2" under fasting conditions in healthy volunteers

Conditions: Hypertension

Summary: the purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "br1015" and co-administration of "br1015-1" and "br1015-2" under fasting conditions in healthy volunteers


Eligibility criteria:
inclusion criteria: * those who weigh 50 kg or more and have body mass index (bmi) within the range of 18.0 to 30.0kg/m2 at screening visit. * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of the first administration of the investigational products to 14 days after the last administration and disagrees to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs) * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (except for simple appendectomy, hernia surgery) * in the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
pilot study of methadone patient access to collaborative treatment: a heal initiative

Conditions: Opioid Substitution Treatment Clinics; Patients; Staff

Summary: examine the preliminary effect of the mpact intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. the study will also explore the relationship between staff trauma symptoms and mpact implementation.

specific aims: aim 1: develop mpact through multilevel, iterative planning with otp staff and people with recent mmt experience. aim 2: conduct a 4-month mpact pilot test in two az otps: mesa (urban) with 50 patients and 22 staff, and sierra vista (rural-serving) with 50 patients and 8 staff to: 1. determine mpact implementation feasibility, acceptability, and preliminary effect on mmt practice change and culture. 2. determine mpact preliminary effect on mmt retention, in-mmt overdose, and patient ptss. 3. characterize staff trauma history, ptss and vicarious trauma, and explore their relationship with mpact acceptability and implementation fidelity. aim 3: characterize mpact acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 otps.

Eligibility criteria:
inclusion criteria: * staff of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment * patients receiving methadone at these locations exclusion criteria: * patients not receiving methadone at these locations * staff not involved in methadone treatment at these locations

Keywords: implementation science methadone treatment opioid use disorder opioid use disorder treatment workforce development vicarious trauma posttraumatic stress treatment retention
cardiovascular disease risk factors in chinese american immigrants

Conditions: Hypertension; Cardiovascular Diseases; Diabetes Mellitus; Metabolic Syndrome X

Summary: the chinese population is currently the fastest growing ethnic group in new york city (nyc). research has shown that chinese immigrants living in nyc have higher rates of cardiovascular disease (cvd) than individuals in china. this study will evaluate the effect that acculturation has on health habits and cvd risk factors in chinese immigrants living in nyc.

cvd includes diseases that affect the heart and blood vessels. the underlying cause of cvd is atherosclerosis, in which fatty plaques develop on the inner walls of arteries. there are many risk factors for cvd, including inflammation, high blood pressure, high cholesterol, and obesity. research has shown that cvd mortality rates differ greatly between chinese immigrants living in nyc and individuals living in china. because of this difference, it is important to understand the impact of immigration and acculturation on health habits and psychosocial factors, which may influence the development of cvd. this study will gather information from chinese immigrants in nyc to identify the impact of immigration and acculturation on behavior and cvd risk factors. in addition, results from this study may provide insight into the cvd risk patterns in other immigrant groups. this study will enroll chinese immigrants living in nyc. participants will attend one study visit and will complete questionnaires to assess their health habits (diet, physical activity, and smoking), stress levels, and socioeconomic status. participants will also undergo a physical examination and blood collection.

Eligibility criteria:
inclusion criteria: * chinese immigrant * currently residing in nyc exclusion criteria: * under 18 years of age * not of chinese dissent * born outside mainland china

Keywords: blood pressure, high obesity tobacco use disorder
one year clinical evaluation of e-max cad and lava ultimate laminate veneers

Conditions: Discoloration, Tooth

Summary: restoration of anterior teeth using conservative approach allows clinicians to provide porcelain laminate veneers with excellent esthetics without extensive tooth structure removal. laminate veneers need the use of etch-able ceramics like glass ceramics (e.max) and hybrid ceramics (lava ultimate). the aim of this study is to compare both e.max and lava ultimate veneers clinically.

the use of e-max cad well documented in the literatures as successful restoration modality which has superior optical and mechanical properties. the introduction of hybrid ceramic materials combined the advantages of both glass ceramics and composite resin. resin nano-ceramic is a mixture of a resin composite matrix and nano-ceramic fillers of approximately 80% by weight. the main advantages of this material over the glass ceramics are the stress absorbing action or stress distribution by having modulus of elasticity near to the tooth dentin and can be individualized intra-orally or extra-orally, either before or after definitive cementation. yet there are no studies for clinical evaluation of both mentioned laminate veneers restorations. this study is conducted to compare between both materials clinically according to modified usphs criteria in terms of marginal adaptation, fracture, debonding, marginal discoloration and patient satisfaction.

Eligibility criteria:
inclusion criteria: 1. from 18-50 years old, be able to read and sign the informed consent document. 2. be physically and psychologically able to tolerate conventional restorative procedures. 3. have no active periodontal or pulpal diseases, have teeth with good restorations. 4. patients with teeth problems indicated for laminate veneer (e.g. discoloration, defect not involve more than 60% enamel loss, mild malposition, anterior upper....). 5. be willing to return for follow-up examinations and evaluation. exclusion criteria: 1. patients in the growth stage with partially erupted teeth. 2. patient with fractured teeth of more than 60% enamel loss. 3. patients with poor oral hygiene and motivation. 4. pregnant women. 5. psychiatric problems or unrealistic expectations. 6. lack of opposite occluding dentition in the area intended for restoration.
comparison of short-term efficacy and long-term prognosis for reduction surgery and radical resection in almost-ccr rectal cancer patients

Conditions: Almost-cCR; Surgery; Rectal Cancer

Summary: the aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-ccr). all almost clinical complete response(almost-ccrs) were entered into two groups randomly. the estimated sample size of the minimal operation group was 221, and 221 in the mile's group. three years' progression-free survival(pfs) and overall survival(os) were compared.

patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of xelox at the interval. all almost-ccrs after neoadjuvant treatment were randomly divided into minimal operation group or mile's group. all ccrs were treated with "watch and wait". patients after local recurrence were randomly divided into minimal operation group or mile's group. if pathological result was pathological staging 3 after neoadjuvant therapy（ypt3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (apr). with 3 years follow-up，the main research goals are 3 years of progression-free survival(pfs) and overall survival(os). secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.

Eligibility criteria:
inclusion criteria: 1. histology is confirmed as rectal adenocarcinoma. 2. 18 to 75 years old. 3. preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（ct3cn1m0）. 4. the anus couldn't be retained after tme. 5. almost-ccr or ccr recurrence during observation. exclusion criteria: 1. patients were unable to tolerate the operation. 2. preoperative stage: t4b or progress during the treatment. 3. hiv infection stage or chronic hepatitis b. 4. active clinical severe infections. 5. evil liquid state or decompensation of organ function. 6. other malignant tumor history in five years. 7. other primary carcinoma. 8. unstable condition and incompliance of the patient
an study to evaluate the safety and efficacy of copanlisib in combination with nivolumab in patients with advanced solid tumors

Conditions: Non-small Cell Lung Cancer (NSCLC); Head and Neck Squamous Cell Carcinoma (HNSCC); Hepatocellular Carcinoma (HCC)

Summary: the purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. the maximum tolerated dose will then be used in phase 2 (dose expansion) of the study.

study was originally designed with both phase i and phase ii part, but sponsor decided not to conduct phase 2 part due to strategic portfolio re-prioritization.

Eligibility criteria:
inclusion criteria: * participants with a histologically confirmed diagnosis of: phase 1b: * advanced solid tumors where nivolumab is indicated as per the latest nivolumab prescribing information, phase 2: * metastatic nsclc, progressing on or after prior pembrolizumab therapy with or without chemotherapy, irrespective of pd-l1 expression patients with egfr or alk genomic tumor aberrations should have disease progression on fda-approved therapy for these aberrations. * recurrent or metastatic hnscc progressing on or after prior pembrolizumab therapy with or without chemotherapy * hcc progressing after any prior therapy. exclusion criteria: * active, known or suspected autoimmune disease. participants with vitiligo, type i diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * major surgery, open biopsy or significant traumatic injury ≤ 28 days prior to first administration of study intervention. central line surgery is not considered major surgery * symptomatic metastatic brain or meningeal carcinomatosis or tumors unless the participant is \> 6 months from definitive therapy (surgery or radiotherapy), has no evidence of tumor growth on an imaging study and is clinically stable with respect to the tumor at the start of study intervention. * other malignancy within the last 5 years except for the following, which are permitted: * curatively treated basal cell/squamous cell skin cancer, * carcinoma in situ of the cervix, * superficial transitional cell bladder carcinoma (if bcg \[bacillus calmette-guerin\] treatment was given, there should be a minimum of 6 months between last dose and enrollment), * in situ ductal carcinoma of the breast after complete resection, * participants with localized, resected and/or low-risk prostate cancer may be eligible after discussion with the sponsor's designated medical representative and sponsor's approval. * other protocol inclusion/exclusion criteria may apply
dose escalating study with bay43-9006 with carboplatin, paclitaxel and bevacizumab in untreated stage iiib non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung; Lung Cancer

Summary: to determine the tolerability, maximum tolerated dose and pharmacokinetics of this drug.


Eligibility criteria:
inclusion criteria: * patients must have stage iiib (with malignant pleural effusions) or stage iv histological or cytological confirmation of non-small cell carcinoma (excluding squamous) * age \>/= 18 years old * patients must have at least 1 evaluable lesion. lesions must be evaluated by ct scan or mri * ecog performance status of 0 to 1 * adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose: * hemoglobin \>/= 9.0 g/dl * white blood cell (wbc) count \>/= 2,500/mm3 * absolute neutrophil count (anc) \>/= 1,500/mm3 * platelet count \>/= 100,000/mm3 * total bilirubin \</= 1.5 times the upper limit of normal (uln) * alt and ast \</= 2.5 x uln (\</= 5 x uln for patients with liver involvement) * inr \</= 1.5 and aptt within normal limits * serum creatinine \ /= 45 ml/min (crcl = wt (kg) x (140-age)/72 x cr level, female x 0.85) for patients with creatinine levels above institutional normal * urinalysis (ua) must show less than 1+ protein in urine, or the patient will require a repeat ua. if repeat ua shows 1+ protein or more, a 24 hour urine collection will be required and must show total protein \</= 1000 mg/24 hour to be eligible exclusion criteria: * patients with squamous histology * cardiac disease: congestive heart failure \> class ii nyha; active coronary artery disease (mi more than 6 months prior to study entry is allowed); or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) * uncontrolled hypertension defined as systolic blood pressure \> 150 mmhg or diastolic pressure \> 90 mmhg despite optimal medical management * hiv infection or chronic hepatitis b or c * active clinically serious infections (\> grade 2 nci-ctc version 3.0) * evidence or history of cns disease, including primary brain tumors, seizures disorders, or any brain metastasis

Keywords: lung cancer nsclc
ivig for drug and device refractory gastrointestinal auto-immune neuropathy

Conditions: Gastrointestinal Motility Disorder; Gastroparesis; Neuropathy

Summary: patients with the symptoms of generalized gi dysmotility, including gastroparesis, are sometimes refractory to available medications, devices and other interventions/ some of these patients have serologic and/or endo organ abnormalities and findings consistent with autoimmune neuropathies, primarily involving the gi tract. these disorders have been known as autoimmune gastrointestinal neuropathies (gain) or also as autoimmune gastrointestinal dysmotility (agid), among other terms. some patients respond to intravenous immunoglobulin (ivig) and this study, which is an observational clinical series, documents the patients, their findings and standardized responses to therapy with ivig.

gastrointestinal dysmotility disorders encompass a large group of patients including a subset with autoimmune findings, either on serologic testing and/or end organ anatomic and physiologic effects. the identification of patients with autoimmune gastrointestinal neuropathies (gain) or also as autoimmune gastrointestinal dysmotility (agid), has led to trial with autoimmune therapies. most promising therapy has been intravenous immunoglobulin (ivig) and this, usually given in 12-week courses with standard dosing, has helped a number of patient's refractory to other available therapies including diet, drugs, devices and enteral diversions/disruptions.this observational study documents clinical observations in consecutive patients meeting entry criteria who received ivig. patients will have their gastrointestinal (gi) symptoms documented by a standardized patient reported outcome (pro) survey at baseline and use the same assessment tools after at least one course of ivig therapy.

Eligibility criteria:
inclusion criteria: patient with otherwise refractory symptoms of gastrointestinal (gi) motor disorders. - exclusion criteria: inability to receive intravenous immunoglobulin. -

Keywords: gastroparesis nausea vomiting abdominal pain neuropathy
erector spinae plane block versus rectus sheath block for postoperative analgesia after supraumbilical surgery

Conditions: Post Operative Pain

Summary: objectives: to compare the effectiveness of erector spinae plane block (espb) and rectus sheath block (rsb) in providing postoperative analgesia after supraumbilical surgery in adult patients and their impact on the patient's outcomes. background: supraumbilical surgery for hernia repair is the second-most-popular after surgical inguinal hernia repair and is accompanied by moderate to severe postoperative pain, so patients always require large doses of opioids within the first postoperative day. because opioids have several adverse effects such as drowsiness, pruritus, nausea, and vomiting, regional analgesic techniques are an essential component of postoperative opioid-sparing analgesia. previous studies have shown that regional analgesic techniques after abdominal wall surgeries can be an essential element of a postoperative pain management strategy with minimal adverse effects and hemodynamic responses. espb provides both somatic and visceral analgesia to the abdominal wall, through the blockade of the anterior rami of spinal nerves and the rami communicants involving sympathetic nerve fibers. rsb provides analgesia to the anterior abdominal wall from the xiphoid process to the symphysis pubis, through the blockade of the anterior rami of the 7th to 12th intercostal nerves. the dermatomal distribution of espb and rsb makes them ideal regional analgesic techniques after abdominal surgery, and to our knowledge, there were no previous trials that studied the difference between them. patients and methods: this was a prospective, randomized (1:1), double-blind clinical trial on 60 patients scheduled for elective supraumbilical surgery under general anesthesia at our hospital. patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group e; general anesthesia with postoperative bilateral ultrasound-guided espb, whereas in group r; general anesthesia with postoperative bilateral ultrasound-guided rsb.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status ≤ ii * age from 21 to 60 years * body mass index (bmi) \< 35 kg/m² exclusion criteria: * american society of anesthesiologists (asa) physical status \> ii * age \ 60 years * body mass index (bmi) ≥ 35 * local infection at the puncture site * altered mental status * pregnant women * allergy to study drugs * chronic pain * coagulation abnormalities or on anticoagulants * severe hepatic or kidney disease

Keywords: erector spinae plane block rectus sheath block regional analgesia