Kornimate/medical-research-clean huggingface dataset:
a phase 1/2 study of cs7017, an oral pparγ agonist, in combination with paclitaxel

Conditions: Anaplastic Thyroid Cancer

Summary: the phase i/ii study will be conducted as an open label, multiple center study of cs-7017, an experimental drug and paclitaxel chemotherapy in subjects with advanced anaplastic thyroid cancer. biopsies will be obtained from patients with accessible tumor at baseline, two-weeks after the first cs-7017 dosage (prior to the start of combination therapy) and at the end of the first study cycle (week 3 of combination therapy), in order to evaluate the effects of the study drug alone and in combination with the chemotherapy agent on the tumor. treatment will continue until disease progression or the development of intolerable toxicities.


Eligibility criteria:
during the phase 1 and phase 2 portions of the study, participant eligibility criteria are identical except for prior treatment for anaplastic thyroid cancer (atc). during phase 1, eligible participants may have received prior chemotherapy while during phase 2, eligible participants must be chemotherapy naïve. inclusion criteria: * histologically or cytologically diagnosed, advanced atc * measurable lesion(s) * lesion(s) (primary or metastatic) with viable tumor tissue accessible for repeated biopsy * age equal to or older than 18 years * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * adequate organ and bone marrow function * agreement to use effective contraception while on treatment and for equal to or greater than 3 months after end of treatment * pregnant or breastfeeding exclusion criteria: * medical history of diabetes mellitus requiring treatment with insulin or oral agents; no pleural or pericardial effusion or clinically significant pulmonary or cardiovascular disease. * clinically active brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis * clinically significant active infection requiring antibiotic or antiretroviral therapy * concomitant use of other thiazolidinediones (tzds)

Keywords: anaplastic thyroid cancer neoplasm tumor anti-neoplastic agent first-line treatment of advanced anaplastic thyroid cancer
eval 3-drug therapy diethylcarbamize, albendazole and ivermectin that could accelerate lf elimination outside of africa

Conditions: Lymphatic Filariasis

Summary: this study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (lf) due to wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. the three drugs used together are called albendazole (alb), ivermectin (ivm) and diethylcarbamazine (dec). the usual treatment in papua new guinea (png) for lymphatic filariasis are dec and alb. a combination of these 3 drugs has not been previously used to treat lf.

this study will determine whether a single dose of the triple drug regimen of dec/iver/alb is non-inferior to annual treatments with dec/alb in inducing sustained clearance of mf in lf infected subjects (\>50 mf/ml) at 36 months post-treatment. this study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of dec/alb. there will be 3 treatment arms as follows: 1. the comparator (standard treatment) dec 6 mg/kg + alb 400 mg administered annually (at 0, 12, and 24 months). 2. dec 6 mg/kg + alb 400 mg given once 3. dec 6 mg/kg + alb 400 mg + iver 200 µg/kg administered once only at the beginning of the rct (0 month).

Eligibility criteria:
inclusion criteria: * men and women 18-65 years * \>50 mf/ml in finger stick blood samples * willing to give informed consent exclusion criteria: * prior treatment for lf within last 5 years * pregnant (do pregnancy test) * hemoglobin \< 7 g/dl * permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension * ast/alt and creatinine \> 1.5 upper limit of normal. * urine dipstick with glucose ≥ 2+ and/or protein ≥ 2+

Keywords: diethycarbamazine albendazole ivermectin lymphatic filariasis
emergency department acupuncture for acute musculoskeletal pain management

Conditions: Musculoskeletal Pain

Summary: the purpose of this project is to determine the feasibility, acceptability and effectiveness of acupuncture in the emergency department (ed) for treating acute musculoskeletal pain. the overall goal is to reduce acute and subacute opioid use by improving acute pain, anxiety and disability with non-pharmacologic treatment options at a critical entry point for patients into the healthcare system. this full-scale randomized controlled trial (rct) has been statistically powered to test the effectiveness of ed-based acupuncture for both one-hour (stage 1) and one-month (stage 2) pain reduction outcomes. the feasibility will be assessed based on patient recruitment and retention rates, while the acceptability will be assessed using patient reported outcomes and qualitative semi-structured interviews. stage 1 is a 2-phase study design. phase (1): enrolled subjects will be randomized to auricular (ear) acupuncture, peripheral acupuncture, or the control group receiving no acupuncture. subjects assigned to an acupuncture arm will receive information and access to acupuncture in an outpatient clinic for the 4 weeks following ed visit. subjects may also have a blood draw for biomarker analysis during their ed visit. a planned interim analysis of the first 60 patients (2/3 of the phase 1 arm completed) will be completed to select the more effective and/or acceptable arm for phase 2. at interim analysis, it was determined by the dsmb that neither arm was superior, so the recommendation was to continue stage 1 phase 2 unchanged with 3 arms. stage 1 is complete, and we will proceed with stage 2 powered to the 4-week pain score outcome. stage 2 will proceed with the same procedures as stage 1, only powered to a different outcome.


Eligibility criteria:
inclusion criteria: * adults age 18 or older * clinical diagnosis of acute (≤7 days) musculoskeletal pain as determined by an ed provider * able to read and understand the consent form in english exclusion criteria: * unable to receive acupuncture due to injury or infection of acupuncture sites * unwilling or unable to attend the follow-up outpatient acupuncture clinic * severe hearing or speech impairment * cognitive impairment, including evidence of drug, medication or alcohol intoxication, that would prevent comprehension of consent procedures or study measures and procedures * critical illness * deformity * medical condition that would contraindicate safe participation as determine by an ed provider

Keywords: acupuncture pain emergency department
hmgb1 release from hemorrhagic shock patients

Conditions: Intensive Care Unit; Hemorrhagic Shock; Adult Disease

Summary: it is reported that high mobility group box 1 (hmgb1), a non-histone nuclear protein, can serve as an alarmin with damage associated molecular patterns to activate immune responses in the early stages of hemorrhagic shock (hs). however, the origin of hmgb1 and how it is released following hs is poorly understood. in this study, we teased out this mechanism. we try to record the concentration of serum hmgb1 protein following hs in clinical patients.

the study was approved by the first people's hospital of chenzhou, hunan, p.r. china. consent was obtained from patients in their hospital course. eighteen patients were enrolled for each group. in addition, acute physiological and chronic health evaluation ii (apache ii) score was used to evaluate the severity and morbidity of hs patients serial blood samples were collected at indicated time points on hospital admission for hs patients (0, 2, 4, 8, 24, and 72 h following hs). levels of hmgb1 were detected by elisa according to the kit manufacturer's instructions.

Eligibility criteria:
inclusion criteria: hemorrhagic shock (hs) was defined as out-of-hospital systolic blood pressure (sbp) of 70 mmhg or less or sbp ranging 71 to 90 mmhg with a heart rate of 108 beats/min or more. exclusion criteria: pregnancy, \<18 years old, more than 2,000 ml of intravenous fluids or blood before enrollment, hypothermia, drowning, asphyxia, burns, isolated penetrating head injury, time of call received by dispatch to study intervention longer than 4 h, known prisoners, and transfer from another hospital

Keywords: hemorrhagic shock hmgb1
study of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant/refractory ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.

ovarian cancer is the leading cause of death for patients with gynecologic malignancies. approximately 75% of patients are diagnosed at an advanced stage will eventually experience disease recurrence. the overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. the 5-year overall survival rates are less than 20%. therefore, it is important to seek alternative agent that can improve the outcome. fludarabine is a purine nucleoside analog prodrug that upon phosphorylation is toxic to dividing and quiescent lymphocytes and monocytes, exerting its effects through dna synthesis interference and apoptosis. the preclinical studies suggest fludarabine may be effective in other cancers such as ovarian cancer. therefore, the purpose of this study is to test the efficacy and safety of the study drug fludarabine combined with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.

Eligibility criteria:
inclusion criteria: * histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary. * platinum resistant or refractory ovarian cancer * at least treated with one line of platinum-based chemotherapy * female, age ≥18 years and ≤70 years, signed informed consent. * eastern cooperative oncology group (ecog) performance status 0-2 * measurable disease according to response evaluation criteria in solid tumors (recist) 1.1 version * patients must have a life expectancy of at least 3 months. * patients must have adequate organ function as defined by the following criteria: * white blood cell count ≥ 3 x 10\^9/l, absolute neutrophil count (anc) (≥ 1.0 x 10\^9/l), hemoglobin of ≥ 80 g/l, platelets ≥ 80 x 10\^9/l * total bilirubin ≤ 1 x upper limit of normal (uln), ast and alt ≤ 2.5 x uln * serum creatinine ≤ 1 x uln * symptomatic central nervous system (cns) metastasis exclusion critera: * has known allergies to any of the excipients. * prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin * lvef (left ventricular ejection fraction) \<50% * had disease recurrence/progression within 6 months after the administration of doxorubicin chemotherapy * history of myocardial infarction, or unstable angina, or new york heart association (nyha) grade iii-iv within 6 months prior to day 1. * known significant chronic liver disease, such as cirrhosis or active hepatitis * uncontrollable active infection

Keywords: ovarian cancer fludarabine pegylated liposomal doxorubicin chemotherapy
omega-3 fatty acids as regulators of brown adipose tissue during cold exposure

Conditions: Cold Exposure

Summary: this clinical trial will assess the whether fish oil supplementation can modulate brown fat activation, shivering, thermal comfort and skin blood flow during cold exposure.

this proof-of-concept study will be conducted as a randomized, double-blind, placebo controlled, parallel group clinical trial in which 30 healthy men and women (ages 18-40 years) will be randomly assigned to fish oil (n=20; 7.8 g/day total n-3 pufa: 3.75 g/day epa and 1.5 g/day dha) or placebo (n=20, olive oil) conditions for 12 weeks. before beginning supplementation, and at 6- and 12-weeks post-supplementation, whole-body thermoregulation will be assessed by progressively reducing air temperature (from 29°c→4°c, with a wind speed of 4.5 m/s) over a 125-minute period in an environmental chamber. this approach will allow for quantitative determination of fish oil supplementation on body temperature regulation during cold exposure. this approach is novel because it also permits comprehensive assessment of the regulation of core body temperature (rectal temperature) and objective quantification of both autonomic \[metabolic heat production (indirect calorimetry), bat activation (infrared thermography), shivering (accelerometry, electromyography), skin blood flow (laser doppler)\] and behavioral (voluntary control of local thermal comfort) thermoregulatory responses. the advantage of this methodology is that this approach will enable assessment of whether fish oil supplementation is beneficial during exposure to cold environments.

Eligibility criteria:
inclusion criteria: * male and female, between the ages of 18 to 40 years. * body mass index (bmi) of 18.5 to 24.9 kg/m2 * considered "moderately to highly active" by the international physical activity questionnaire (ipaq) and the physical activity readiness questionnaire (par-q+) exclusion criteria: * history of smoking or recreational smoking, hyperlipidemia, hypertension/cardiovascular disease, diabetes, renal disease, neurological disease, metabolic disease, and bleeding disorders or delayed clotting time. * taking ssri's (antidepressants and anxiety medication), add/adhd medication, and chronically consume pain medication (aleve, tylenol, cbd, etc). * have or have had chronic disorders of the rectum (e.g., cancer, surgery, active hemorrhoids, etc.) or who currently have related acute conditions (diarrhea, constipation, etc.). * have or have had a diagnosis of disorders related to immune suppression and/or autoimmune disease. * are pregnant or planning on being pregnant. * resting blood pressure of \> 130mmhg systolic or 90 mmhg diastolic. * resting pulse rate of \> 100 bpm. * history of regularly consuming fish oil supplements and/or regularly eating more than one fish meal per week. * consuming more than one fish meal per week during the study.

Keywords: brown fat fish oil cold
dexmetomedine for post operative delirium in elderly patients undergoing elective total knee replacement under spinal anesthesia

Conditions: Postoperative Delirium

Summary: postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate the use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries

on the day of surgery and after arrival to the theatre, all patients will have supplemental oxygen by nasal cannula at 5 l min-1 and will be connected to the standard monitoring non-invasive blood pressure, electrocardiography, and pulse oximetry. crystalloid 10mg/kg will be administered then all patients will receive spinal anaesthesia in the sitting position, under complete aseptic technique. the midline or para median spinal puncture will be performed. volume of 3 ml of hyperbaric bupivacaine (marcaine® spinal heavy 0.5%, astrazeneca) will be injected using a 25 g spinal needle . after establishment of spinal anesthesia , a loading dose of dexmetomedine (1 µg/kg) will be administered for 10 min for all the patients then three types of syringes will be prepared on 50 ml syringes group a: saline 50 ml, group b: a 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, and group c: a 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg. the patients then they will be randomized into 3 groups

Eligibility criteria:
inclusion criteria: * asa physical status i- ii * age from 65to 75 years old, * elective total knee arthroplasty under spinal anaesthesia. exclusion criteria: * bleeding disorders * allergy to any of the drugs used in the study * renal insufficiency * liver failure-neurological abnormalities -patients with hearing and visual impairment

Keywords: delirium , dexmetomedine
study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of azd0328 in elderly healthy subjects

Conditions: Alzheimer's Disease

Summary: the primary purpose of this study is to investigate the safety and tolerability of azd0328 following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum tolerated dose.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent * clinically normal physical findings, laboratory values, vital signs and resting ecg as judged by the investigator exclusion criteria: * history of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder * history of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity * intake of any prescribed medicine or st john's wort, except for occasional paracetamol and nasal anticongestant, within 3 weeks or use of over-the-counter drugs within 2 weeks before the first administration of study drug

Keywords: safety tolerability azd0328
effect of insulin glargine in insulin naïve subjects with type 2 diabetes on oral hypoglycemic agent(s)

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of this study is to compare the percentage of subjects who reach the target hba1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or nph human insulin.


Eligibility criteria:
inclusion criteria: * insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents * body mass index between 26 and 40 kg/m2 * hba1c between 7.5% and 10.0% * fasting plasma glucose \>7.8 mmol/l and fasting c-peptide \> or =0.25 nmol/l

Keywords: insulin naive
a study to evaluate two different surgical methods for treatment for abdominal wall diastasis

Conditions: Abdominal Hernias and Other Abdominal Wall Conditions; Post-operative Pain; Recurrence

Summary: this is a three armed prospective randomized trial that will compare two different surgical techniques for reconstruction of the abdominal wall diastasis with a conservative treatment procedure. the study hypothesis: which surgical approach provides the safest and best long term results for patients with abdominal wall diastasis either the insertion of net alternative with a double row suture or exercise alone?

the conservative control group will receive a special training program for abdominal muscle training for 3 months,and all groups wearing girdle for 3 months. all patients examined with a ct scan before randomization and then a biodex measurement of abdominal muscle strength. all patients must also complete the sf-36 (scientifically tested instruments to measure self-reported physical and mental health) and vhpq (ventral hernia pain questionnaire). two-thirds of patients receive surgery and followed up with a 3 month and 1-year control.at 1 year of control, all go through a ct scan and a biodex measurement of muscle strength. the control group followed up after one and half months and 3 months. in the surgery group, patients may not know what reconstruction they received before the final assessment after 1 year.

Eligibility criteria:
inclusion criteria: 1. abdominal wall diastasis\> 3 cm 2. discomfort or tenderness in the abdominal wall 3. desire for abdominal wall reconstruction 4. women have undergone at least one birth 5. smoking cessation 1 month pre-and 3 months post-operatively exclusion criteria: 1. \<18 years old 2. ongoing pregnancy 3. ongoing breastfeeding 4. current immunosuppressive therapy
study to investigate real life effectiveness of symbicort maintenance and reliever therapy in asthma patients across asia

Conditions: Asthma

Summary: the purpose of this study is to compare whether symbicort maintenance \& reliever therapy (smart) is more effective in uncontrolled asthmatic patients than their current therapy in a real life situation.


Eligibility criteria:
inclusion criteria: * provision of signed informed consent * asthma diagnosis at least 6 months before visit 1 of study * patients who have reversible airway obstruction continuous asthma treatment except symbicort at least within 4 weeks before visit 1 of study exclusion criteria: * known or suspected allergy to active ingredients of study medication or excipients * use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study * smoking, current or previous with a smoking history of ≥ 10 pack years

Keywords: symbicort smart
pilot study for patient-cooperative control strategies for actuated transfemoral prostheses

Conditions: Gait Disorder, Sensorimotor

Summary: this pilot study investigates the feasibility of novel control strategies for actuated transfemoral prostheses. several parameters from gait analysis (including motion-capture and ground reaction force measurements) are analyzed. the subjective perception of prosthetic functionality is captured with a questionnaire.

setting of the study: conventional prostheses for transfemoral amputees are mostly simple mechanic joints, or have micro-processor-controlled damping. the prototype tested in this study is equipped with a motor that can actively move the knee joint. therefore, movements like, for example, alternating stair climbing, are possible that cannot be realized with pure mechanical and actively damped prostheses. during level-ground walking, it is hypothesized that less compensatory movements are needed. we have developed an actuated prototypical prosthesis and new control strategies which should facilitate both level-ground walking and stair climbing. parts of the control strategies have been tested in able-bodied subjects \[1\]. this control strategy has been extended such that only biological stiffness modulation can be rendered \[2\]. hypothesis: subjects can use our transfemoral prosthesis to walk on level-ground, to climb several steps and to overcome small obstacles without prior training. the user-cooperative control is intuitive and easily learnable. objective of the study: this pilot study is meant to investigate the general feasibility of novel control strategies for actuated transfemoral prostheses. parameters of a standard gait analysis, like ground reaction forces and kinematics (using a motion capture system), will be recorded. from this data, gait symmetry, step length, walking speed, and other measures can be calculated. the subjective impression of the user will be evaluated with a questionnaire.

Eligibility criteria:
inclusion criteria: * at least 18 years old * written consent of participant * for amputees: regular use of a transfemoral prosthesis * for amputees: transfemoral amputation exclusion criteria: * bodymass \> 100 kg * for amputees: mobility class 1 * for amputees: no stable residual leg volume * for amputees: constrictive contractures