Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability and efficacy of ilb in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a phase 2a single-centre, open single-arm study in patients with amyotrophic lateral sclerosis (als) of intermediate progression rate. eligible subjects will be administered weekly doses of ilb. a total of 5 subcutaneous (s.c.) doses will be administered at the study clinic. the study consists of 10 visits; one 2-part screening visit, 5 ilb administration visits, and 3 follow-up visits. each individual patient's study participation will be 4 months, including the screening and follow-up visits. fifteen patients are planned to be included. the primary objective of the study is to evaluate the safety and tolerability of ilb in patients diagnosed with als. ilb is a solution for subcutaneous (s.c.) injection in saline solution. the dose administered will depend on the subject's body weight at the second study visit, prior to the first ilb administration. no formal sample size calculation has been performed for this study. the proposed sample size is considered sufficient in this early phase 2 development to provide adequate information on the patients. categorical data will be presented as counts and percentages. continuous data will be summarised using descriptive statistics.


Eligibility criteria:
inclusion criteria: 1. willing and able to give written informed consent for participation in the study. 2. clinical diagnosis of amyotrophic lateral sclerosis (als). 3. male or female patients between 18 to 80 years (inclusive). 4. forced vital capacity (fvc) 65% of predicted value for gender, height and age at screening. 5. evaluated with alsfrs-r and norris clinical rating scales for at least the past 4 weeks before study drug administration. exclusion criteria 1. unable to understand information about the study or are expected not to collaborate with the study team. 2. concurrent serious disease, other than als, at the discretion of the nvestigator. 3. pregnancy. 4. patients of childbearing potential not willing to use adequate double contraception with less than 1 percentage failure rate after the screening visit until the last visit. 5. addiction to drugs or alcohol. 6. confirmed hiv, hepatitis b or hepatitis c. 7. known bleeding disorders or abnormal bleeding events. 8. treatment with anticoagulant drugs warfarin and novel oral anticoagulants (noac) within the last 14 days prior to screening. 9. treatment with riluzole or lamotrigine within the last 28 days prior to study drug administration. 10. hypersensitivity to dextran sulfate. 11. poor venous access. 12. patients with clinically significant abnormal pk-inr, fibrinogen, von willebrand factor and activated partial thromboplastin time (aptt) at screening.
clinical trial of humax-cd4, a new drug to treat early stage t-cell lymphoma in the skin.

Conditions: Cutaneous T-Cell Lymphoma

Summary: the purpose of this trial is to determine the effect of humax-cd4 as a treatment for early stage cutaneous t-cell lymphoma (ctcl). almost all participants who are affected by ctcl have cancerous cells which bear a receptor called cd4. humax-cd4 is an investigational drug directed against this receptor. there is no placebo in this trial; all participants will be treated with humax-cd4. during the trial, the response rates, duration of responses, relief of symptoms, and safety profile of humax-cd4 will be evaluated.


Eligibility criteria:
inclusion criteria * medical diagnosis of ctcl, and positivity for the cd4 receptor. * early stage ctcl * have received at least two prior therapies with inadequate effect, including phototherapy and/or electron beam, and/or chemotherapy. * histopathological evidence of large cell transformation or poorly differentiated tumors or prior treatment with anti-cd4 monoclonal antibodies excluded participants from inclusion in the study. exclusion criteria * certain rare types of ctcl. * previous treatment with other anti-cd4 medications. * more than two previous treatments with systemic chemotherapy. * certain anti-psoriasis or anti-cancer therapies within the last 4 weeks before entering this trial. * some types of steroid treatments less than two weeks before entering the trial. * prolonged exposure to sunlight or uv light during the trial. * other cancer diseases, except certain skin cancers or cervix cancer. * chronic infectious disease requiring medication. * certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases. * pregnant or breast-feeding women. * women of childbearing age who are unable or unwilling to use an iud or hormonal birth control during the whole trial. * if you are participating in another trial with a different new drug 4 weeks before you enter this trial. note: other protocol defined inclusion and exclusion criteria may apply.

Keywords: skin cancer lymphoma mycosis fungoides sezary syndrome
outcome of steroid therapy for myocardial inflammation in scleroderma

Conditions: Myocardial Inflammation

Summary: primary myocardial involvement is common in scleroderma, effected to pericardium, vascular, conducting defect and especially myocardium. cardiac mri is widely used for assessment of cardiac involvement in scleroderma, both structural and functional pathology. cardiac mri has a diagnostic accuracy of 85% for the detection of myocardial inflammation. nowadays, the treatment of myocardial inflammation in scleroderma is uncertain. the investigator's study aims to define the cardiac outcome after moderate dose steroid therapy in the patients who have myocardial inflammation detection by cardiac mri.


Eligibility criteria:
inclusion criteria: • the adult scleroderma patients who were defined as having myocardial inflammation by cardiac mri. exclusion criteria: * current infection that needs systemic antibiotic therapy * active viral hepatitis b or c * uncontrolled diabetes mellitus
clinical application value of remazolam combined with sugammadex sodium in anesthesia for endotracheal surgery under bronchoscopy

Conditions: Endobronchial Metastases; Bronchoesophageal Fistula; General Anesthetic Drug Adverse Reaction

Summary: this study is a prospective, randomized, controlled trial. in this study, 30 patients who underwent endotracheal tumor resection under rigid bronchoscope or stent placement for acquired tracheoesophageal fistula were selected as the subjects. the patients were randomly divided into remazolam general anesthesia group (r group) and propofol general anesthesia control group (p group). remazolam general anesthesia group (r group): remazolam 0.4 mg/kg, oxycodone 0.2 mg/kg and rocuronium 0.9 mg/kg were given for anesthesia induction. propofol general anesthesia control group (p group): propofol 1.5mg/kg, oxycodone 0.2mg/kg and rocuronium 0.9mg/kg were given for induction of anesthesia. after induction, high-frequency jet ventilation was used in both groups, the respiratory rate was 30-60 times/min, the inspiratory-to-breath ratio was 1:2, and the driving pressure was 0.8-1.0 kpa. group r was given remazolam 1mg/kg/h and remifentanil 6-8ug/kg/h for maintenance. group p was given propofol 4-8 mg/kg/h and remifentanil 6-8ug/kg/h for anesthesia maintenance. the dosage of propofol or remazolam was adjusted according to bis and intraoperative hemodynamic changes. rocuronium bromide 10 mg was added every half hour. intraoperative application of vasoactive drugs to maintain mean arterial pressure above 60mmhg to avoid perioperative hypotension. blood oxygen saturation and end-tidal carbon dioxide were monitored to avoid perioperative hypoxemia and hypercapnia, and warm measures were used to maintain the patient's intraoperative body temperature above 36.0°c. after surgery, group r was treated with sugammadex sodium 2-4 mg/kg to antagonize rocuronium bromide, and 0.5 mg of flumazenil was used to antagonize remazolam by intravenous injection; group p was treated with sugammadex 2-4 mg/kg to antagonize rocuronium.


Eligibility criteria:
inclusion criteria: * patients undergoing bronchoscopy endotracheal tumor resection or stenting of acquired tracheoesophageal fistula within a limited time * \>18 years * asa ⅱ-ⅳ exclusion criteria: * \<18years * refuse to participate * a history of schizophrenia, epilepsy, parkinson's disease or myasthenia gravis; * severe hepatic dysfunction (child-pugh class c) * severe renal dysfunction (requiring dialysis) * patients with asa grade ⅴ and above * emergency surgery
virtual reality intervention for skill acquisition support in autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: a randomized controlled phase ii study to assess the efficacy of floreo vr (virtual reality) building social connections as treatment for social skills in children with autism spectrum disorder (asd)

in this randomized controlled phase ii study, 30 eligible subjects aged 4-10 years old with documented asd diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs control group. the floreo vr building social connections intervention is designed to be administered for 12 weeks, with three treatment visits per week, for a total of 36 treatment visits.

Eligibility criteria:
inclusion criteria: * males and females aged 4 years to 10 years 11 months of age (up to 11th birthday at randomization). * patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. participants must provide informed assent as clinically appropriate. * a diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to dsm-5 criteria, supported by either the autism diagnostic observation schedule or the autism diagnostic interview-revised. * participants must receive aba therapy at cortica, with scheduled aba sessions in clinic at least 3 times per week. * participants must be able to tolerate vr therapy in the judgement of parent or caregiver and study staff exclusion criteria: * a history of photosensitive epilepsy, or photoparoxysmal response on electroencephalogram (eeg) * active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome), not adequately controlled * history of balance disorder including vertigo, motion sensitivity, or balance disorder * primary sensory impairment (blindness, deafness) * motor disorder that would interfere with vr engagement

Keywords: asd virtual reality vr social communication applied behavior analysis therapy
trip-patch vs the rigiscan

Conditions: Erectile Dysfunction

Summary: in men without erectile problems, night time erections occur during the rem-sleep. for this study the current diagnostic test, the rigiscan is compared, with the data from the trip-patch during the night. to validate discriminating sensor-readings between flaccid state and full rigidity of the penis. eventually, to have a validated device, a patch in the size of a postage stamp, that easily measures erectile function at home. furthermore the temperature on the outside of the thigh will be measured.

background of the study: erectile dysfunction (ed) is defined as the persistent or recurrent inability to attain and maintain an erection sufficient to perform sexual activity. ed has an effect on physical and psychosocial well-being. the current diagnostic test, the rigiscan to measure night time erections, has a lot of disadvantages. when an erection occurs and there is no inflow and outflow in the corpora cavernosa it is expected that the saturation will drop. as known with low flow priapism. from a study from solnick, the mean skin temperature in younger male (19-33 years old) increases from 33,8°c to 36.2°c during arousal. a penile oximeter and temperature sensor was developed, to measure saturation and temperature of the penis during the night. the trip-patch (transdermal rigidity assessment via ischemia of the penis) is expected to continuously measure saturation levels in the corpora cavernosa by real time monitoring with a photodiodes and leds and the sensor has a temperature logger. objective of the study: see above study design: observational study study population: healthy volunteers are asked to participate after informed consent. age between 18 and 40 years. both sensors and the rigiscan will be placed at the same time, when 10 patients have night time erections with the rigiscan, the study is complete.

Eligibility criteria:
inclusion criteria: * healthy volunteers without (a history of) erectile dysfunction * signed informed consent * male * between 18-40 year exclusion criteria: * volunteers who are unwilling to sign written informed consent * volunteers with sickle cell anemia because this could affect the accuracy of the measurements * volunteers with erectile dysfunction

Keywords: rigiscan nocturnal erection temperature saturation
regenexx™ pl-disc versus steroid epidurals for lumbar radiculopathy

Conditions: Radiculopathy; Herniated Disc; Disc Degeneration

Summary: the primary objective of this study is to compare the improvement in subject-reported clinical outcomes for regenexx pl-disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months. secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

prospective, single-blinded, randomized, controlled to include 25 subjects treated with regenexx pl-disc and 25 subjects treated with steroid epidural injection with the steroid epidural group crossing over to the pl-disc injection group at 3 months. subjects will have symptoms consistent with lumbar radiculopathy confirmed by physical examination. subjects will be enrolled within 60 days prior to injection and take part in follow-up visits for one year following treatment. a preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months and 12 months post injection. subjects will remain blinded to the treatment allocation through at least the 3 month primary endpoint. control subjects not improving after the 3 month visit will be unblinded and given the opportunity to cross-over to the pl-disc group. subjects will complete the study following the 1 year follow-up visit.

Eligibility criteria:
inclusion criteria: * pain, spasm, or functional disability in the low back and diagnosed as radiculopathy having failed conservative treatment (e.g. nsaids, physician initiated physical therapy) for at least 3 months and not longer than 2 years * significant functional disability related to pain, lack of strength, or other back or leg symptoms * physical examination consistent with lumbar radiculopathy * lumbar disc bulge, herniation, and/or kader grade 2 or greater multifidus atrophy evident on mri and consistent with physical exam findings * is independent, ambulatory, and can comply with all post-operative evaluations and visits exclusion criteria: * symptomatic central or foraminal stenosis * previous low back surgery * prior epidural steroid injection or other low back injection therapy within the past year * \>50% loss of disc height at the symptomatic level * spondylolisthesis * inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout) * quinolone or statin induced myopathy/tendinopathy * severe neurogenic inflammation of the cutaneous nerves * condition represents a worker's compensation case * currently involved in a health-related litigation procedure * is pregnant * bleeding disorders * currently taking anticoagulant or immunosuppressive medication * allergy or intolerance to study medication * use of chronic opioid, * documented history of drug abuse within six months of treatment

Keywords: lumbar radiculopathy disc bulge disc herniation disc degeneration
statstrip a glucose/creatinine meter system lay user study evaluation

Conditions: Diabete Mellitus; CKD; ESRD

Summary: the primary objective of this study is to assess the performance of the nova statstrip a glucose/creatinine meter system in the hands of the subject (lay user) and compare the result to an accepted glucose/creatinine reference method in the hands of a trained technician.

to assess the performance of the statstrip a glucose/creatinine assay in the hands of lay users on capillary whole blood obtained by finger stick and compare with the performance characteristics to a central laboratory traceable reference method. to assess the ease of use of the statstrip glucose / creatinine meter system in the hands of the intended lay users. lay users will be provided with all package insert sheets, a quick reference guide and instructions for use (ifu) manual. no training, coaching, or prompting will be provided to the lay users other than clarifying the protocol.

Eligibility criteria:
inclusion criteria: * adult subjects (≥ 18 years old) with diabetes. * adult subjects (≥ 18 years old) with kidney diseases (ckd, esrd) and/or in dialysis. * adult subjects (≥ 18 years old) that are healthy. * subjects willing to complete all study procedures. * subjects whose pre-screen glucose or creatinine medical history is deemed of value by the study site * subjects able to read, write, speak in english. exclusion criteria: * subjects unable to consent to participating in the study. * subjects possessing a cognitive disorder or other condition, which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study. * subjects taking prescription anticoagulants (such as warfarin or heparin) or has clotting problems that may prolong bleeding. * subjects having hemophilia or any other bleeding disorder. * subjects having an infection with a blood borne pathogen (e.g. hiv, hepatitis). * subjects working for a medical device or diagnostic company.

Keywords: diabetes ckd esrd poct
pulmonary protection of transcutaneous electrical acupoint stimulation in gynecologic laparoscopic surgery

Conditions: Reperfusion Injury

Summary: teas might protect against postoperative pulmonary such as ischemia-reperfusion injury (iri) and atelectasis. we tested the hypothesis that transcutaneous electrical acupoint stimulation protects against postoperative pulmonary complications in patients who are receiving mechanical ventilation during general anesthesia for gynecologic laparoscopic surgery.

participants: 100 patients who underwent elective gynecologic laparoscopic surgery methods: we recruited 100 patients who are planned for gynecologic laparoscopic surgery. patients were enrolled from march 1, 2015. we randomly allocated patients into two groups: controlled group ( patients treated without transcutaneous electrical acupoint stimulation) and teas group (patients treated with teas on feishu, hegu, chize half an hour before the surgery). blood ph, pco2, po2 and oxygen saturation were measured by an automatic blood gas analyzer immediately after obtaining the samples from the aorta. sample all the patients blood before and after the surgery. and then measure the level of tnf-α, il-1β, and il-6.

Eligibility criteria:
inclusion criteria: * aged from 65 to 75 * the american society of anesthesiologists (american society of anesthesiology, asa) class ⅱ \~ iii * scheduled for gynecologic laparoscopic surgery under general anesthesia exclusion criteria: * pre-existing lung or caridac disease * impaired kidney or liver function * history of bronchial asthma or chronic obstructive pulmonary disease * history of smoking * respiratory infection in the previous 2 weeks * preoperative use of bronchodilator, or a steroid

Keywords: postoperative pulmonary complications transcutaneous electric acupoint stimulation pulmonary protection
a study to compare efficacy and safety of tenofovir used alone or in combination with pegylated interferon alpha-2b in participants with chronic hepatitis b and elevated alanine aminotransferase (mk-4031-384)

Conditions: Hepatitis B

Summary: this study will compare monotherapy with tenofovir to sequential therapy with pegylated interferon alpha-2b (pegifn-2b) followed by tenofovir, and to combination therapy with pegifn-2b + tenofovir, in participants with hepatitis b e antigen (hbeag)-positive chronic hepatitis b and elevated alanine aminotransferase (alt). all enrolled participants will be be administered tenofovir alone for 8 weeks and then will be randomly assigned to 1 of the 3 treatment arms.


Eligibility criteria:
inclusion criteria: * chronic hepatitis b (hepatitis b surface antigen \[hbsag\]-positive for \>6 months or evidence of chronic hepatitis b in liver biopsy) * elevated serum alt level * liver biopsy or a non-invasive investigation within 12 months prior to randomization with chronic hepatitis b * treatment naïve or history of interferon for not more than 1 month, taken at least 6 months before enrollment * compensated liver disease exclusion criteria: * known hypersensitivity to tenofovir, interferon alpha-2b, and/or any other component of the study products * co-infection with hepatitis c virus (hcv), hepatitis d virus (hdv) or human immunodeficiency virus (hiv) * need for prolonged or frequent use of systemic acyclovir or famciclovir * previously received lamivudine or an investigational anti-hepatitis b virus (hbv) nucleoside or nucleotide analog and were resistant to these drugs * history of variceal bleeding or other gi bleeding due to portal hypertension, hepatic encephalopathy, spontaneous bacterial peritonitis, grade iii and iv esophageal varices unless banded or other clinical signs of hepatic decompensation * history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc * need for potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, and anti-tuberculosis regimens) or nephrotoxic drugs (e.g. frequent nonsteroidal anti-inflammatories, aminoglycosides, amphotericin b, and foscarnet) * one or more additional known primary or secondary causes of liver disease, other than hepatitis b * history of clinical pancreatitis * pregnant or breastfeeding * female participants of childbearing potential and male participants must be willing to use acceptable method of birth control. * medical condition that requires frequent or prolonged use of systemic corticosteroids * use of warfarin or other anticoagulants during 30 days prior to screening or if expected to be needed during the study period
nivolumab and ipilimumab in classical kaposi sarcoma (cks)

Conditions: Classic Kaposi Sarcoma

Summary: a phase 2 study of nivolumab plus ipilimumab in previously treated classical kaposi sarcoma (cks)

a prospective, single arm, interventional study. all patients will receive iv nivolumab 3mg/kg every two weeks and ipilimumab 1mg/kg every 6 weeks. patients will be treated until disease progression or intolerable toxicity for a maximal period of two years, with an option to re-initiate therapy upon progression in patients with prior documented response to investigational therapy (unless treatment was held for progression of disease).

Eligibility criteria:
inclusion criteria: * pathologically confirmed ks * age \> 18 * ecog ps \< 2 * at least one prior treatment modality (palliative radiation or chemotherapy) * measurable disease as defined by recist version 1.1 by physical exam and/or pet-ct (previously irradiated lesions should not be counted as target lesions). exclusion criteria: * patients with hiv-related ks or hiv positive serology. * ongoing immunosuppressive therapy * active autoimmune disease. subjects with type i diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.