Kornimate/medical-research-clean huggingface dataset:
a study to learn about the study medicine called infliximab (genetical recombination)[infliximab biosimilar 3] in people with rheumatoid arthritis, ulcerative colitis, crohn's disease, or psoriasis

Conditions: Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Psoriasis

Summary: the purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (ra), ulcerative colitis (uc, crohn's disease, or psoriasis. ra is a kind of joint disease that causes pain and swelling. uc causes inflammation and sores (also called ulcers), in the lining of the rectum and colon. chron's disease is a disease that lasts for a long time and causes severe irritation in your digestive tract. psoriasis is a skin disease that gives you a dry, scaly rash. the study includes patient's data from the database who: * have at least 90 days of look-back period * have any of these diseases (ra, uc, crohn's disease, or psoriasis) in the 90-day look back period * are 15 years of age or older at the time of first dosing all the patient's data included in this study would have received infliximab as intravenous (into veins) injection.


Eligibility criteria:
inclusion criteria 1. have at least 90 days of look-back period 2. have diagnostic code of indicated diseases (rheumatoid arthritis, ulcerative colitis, crohn's disease, or psoriasis) in the 90-day look-back period. patients with \>1 indication will be summarized as a separate group from each sub-cohort. an inpatient or outpatient visit assigned a diagnosis code consistent with either rheumatoid arthritis, ulcerative colitis, crohn's disease, or psoriasis using icd-10 coding. 3. 15 years of age or older at the time of index date exclusion criteria 1. patients with pre-existing safety outcome event during the 90-day look-back period will be excluded from the study cohort for that specific outcome event as this study is observing incident cases.

Keywords: tumor necrosis factor, tnf infliximab biosimilar
obstructive sleep apnea (osa) and sex-specific responses to n-acetylcysteine (nac)

Conditions: Obstructive Sleep Apnea

Summary: this is a randomized controlled trial (rct) of 4 weeks of study supplement n-acetylcysteine (nac) versus placebo in persons with significant obstructive sleep apnea (osa) who are receiving positive airway pressure therapy (pap), the standard of care therapy. the purpose of the study is to determine if nac is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with osa.


Eligibility criteria:
inclusion criteria: * apnea-hypopnea index ≥15 events/hr on portable sleep monitoring * hba1c \<6.5% exclusion criteria: * body mass index (bmi) ≥40 kg/m2; * diagnosis of diabetes mellitus, defined as the use of any diabetes medication (including glucagon like peptide \[glp\]-1 agonists) currently or in the previous three months or hba1c ≥6.5%; * shift work (i.e., working hours that routinely cause sleep initiation after 1:00 a.m.); * another major sleep disorder (i.e., circadian rhythm disorder, any history of narcolepsy, concurrently diagnosed or medication-treated restless legs syndrome, concurrently diagnosed or medication-treated chronic insomnia with the exception of antidepressant therapy); * regular use (more than twice/week) of an opioid/narcotic, benzodiazepine, or prescription sleep medication other than antidepressants currently or within the last month; * the use of n-acetylcysteine in any form (oral, intravenous, inhaled) in the last seven days * the use of other over-the-counter antioxidant therapies including vitamin c or vitamin e in the preceding 10 days * history of reduced ejection fraction heart failure, or chronic cardiac arrhythmia requiring medication or treatment; * unstable or uncontrolled medical or psychiatric comorbidity requiring hospitalization or change in medication during the previous three months; * use of biologics or immune modulators in the last year; * use of systemic steroids during the previous three months; * current tobacco smoking; * inability to sign informed consent; * currently use of positive airway pressure therapy or another osa treatment (e.g., hypoglossal nerve stimulator, oral device); * recent history of alcoholism or drug abuse (within the last three months) * neurological condition that requires ongoing pharmacological therapy (e.g., parkinson's disease, alzheimer's dementia, multiple sclerosis, other degenerative neurological disease). * pregnancy
venetoclax resistance landscape in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia; CLL; Progressive Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Relapsed Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to collect medical informations and samples from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms.

the purpose of this study is to collect medical informations and samples (blood, bone marrow and/or lymph node) from refractory and/or relapsed chronic lymphocytic leukemia during or after venetoclax treatment, in order to evaluate the frequency of resistance mechanisms (bcl2 mutations, over-expression of other members of the bcl2 protein family and energy metabolism changes).

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old; * chronic lymphocytic leukemia diagnosis according to iwcll criteria; * refractory and/or relapsed disease during or after venetoclax treatment; * tumor samples available. * relapse might be progressive chronic lymphocytic leukemia or transformation into richter syndrome. * patients must be able to express their opposition to be enrolled in this study, if need be. * patients must be affiliated at the french social security system exclusion criteria: patients of their legal guardians refusing to participate -

Keywords: venetoclax venetoclax resistance resistance mechanism
the effects of trichosanthes root on blood sugar in patients with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: diabetes mellitus (dm) locates fifth of ten leading death etiology, the population of diabetic patients has a tendency of increase. trichosanthes root is called as tian hua fen, according to traditional chinese writing record that trichosanthes root has the action of downbear fire, moisten dryness, and slippery phlegm, and release thirst. the trichosanthes root may lower blood sugar levels in the modern study. the investigators designed a double blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar were divided into treatment and control groups, and each group was 30 patients. in the treatment group, oral administration of trichosanthes root 1.5 g, bid/day for 84 days continuously; in the control group, oral administration of trichosanthes root placebo 1.5 g, bid/day for 84 days continuously. the main outcome measure was the changes of plasma blood sugar and glycated hemoglobin a1c (hba1c) levels changed before and after trichosanthes root treatment. the investigators predict the results of the present study indicated that trichosanthes root can improve plasma blood sugar and glycated hemoglobin a1c levels.


Eligibility criteria:
inclusion criteria: 1. early diagnosis type ⅱ diabetic patients who glycated hemoglobin a1c level between 7.0% and 9.0% (including) , and after three months of diet and exercise control. 2. the subject who was taking hypoglycemic drugs metformin, the maximum total amount of ≦ 1500 mg / day. 3. age ranged between 20 and 80 years (including). exclusion criteria: 1. pregnancy or breast-finding. 2. allergy to test medicine. 3. type i diabetic patients. 4. bleeding tendency. 5. the participants who suffered from serious disorders, such as congestive heart failure, myocardial infarction, chronic obstructive pulmonary disease, renal failure, cancer or stroke etc. 6. irritable or anxious patients who cannot be assessed. 7. refuse to sign the agreement. 8. the values of sgot and sgpt levels were more than normal limit triple, or the value of creatinine level was more than normal limit. 9. plasm glucose(glucose ac) level in fasting state ≧ 300 mg / dl.

Keywords: trichosanthes root traditional chinese medicine clinical trial
an investigator-initiated, explorative trial evaluating the effect of sat-008 in healthy adults

Conditions: Allergy and Immunology

Summary: the purpose of this exploratory study is to evaluate the efficacy, safety, and feasibility of a novel digital device called sat-008 in healthy adults.

this clinical study was designed as a single institution, open, controlled, and investigator-led clinical trial to evaluate the efficacy, safety, and feasibility of a novel digital device called sat-008 in healthy adults.

Eligibility criteria:
inclusion criteria: * healthy adults aged 19 to 50 years * received influenza vaccination the previous year * scheduled to receive the influenza vaccine * voluntarily agrees with a consent form exclusion criteria: * current infectious disease * history of autoimmune diseases * current immunological compromised diseases.
whodas-ii for patients with nonspecific low back pain

Conditions: Low Back Pain

Summary: the main purpose of this study is to determine the measurement characteristics of whodas-ii (world health organization disability assessment schedule), as well as to analyze its correlation with low back pain (visual analog scale, vas), disability (spanish version of the roland morris questionnaire, rmq), fear avoidance beliefs and attitudes (spanish version of the fab questionnaire, fabq) and quality of life (sf-12). measurements will be taken at baseline and 6 days later (day 7).


Eligibility criteria:
inclusion criteria: * patients seen for nonspecific low back pain, with or without referred pain * able to read and write * have signed the informed consent form exclusion criteria: * central nervous system pathology (with or without treatment) * diagnosis of rheumatic inflammatory disease or fibromyalgia * red flags for underlying systemic disease * criteria for diagnosis of symptomatic herniated disc or symptomatic spinal stenosis

Keywords: nonspecific low back pain disability fear avoidance beliefs quality of life
comparison of se-tap, m-tapa, and rectus sheath block in abdominal surgeries

Conditions: Postoperative Pain

Summary: the aim of this randomised controlled study is to compare the effects of three different fascial plane block \[subcostal exterior semilunaris transverses abdominis plane (se-tap) block, modified thoracoabdominal nerves block through perichondrial approach (m-tapa), and rectus sheath block (rsb)\] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.

in last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (tap) block and rectus sheath block (rsb) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. furthermore, the number of newly defined block techniques is daily increasing like m-tapa and se-tap block. the rectus sheath block (rsb) is an old technique that suite midline incisions and provides analgesia for somatic pain. the local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. it has been suggested that both anterior and lateral branches of the t5-t12 thoracoabdominal nerves are blockade in m-tapa and se-tap blocks. so, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. however, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge. patients and methods: this is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. while the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. at the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral se-tap block in group s, bilateral rsb in group r, and bilateral m-tapa block in group m will be performed under ultrasound guidance. patient controlled analgesia with intravenous morphine will be started at the recovery room. postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology physical classification i-iii * scheduled for elective laparotomy with a midline incision exclusion criteria: * not agree to participate in the study * have mental status disorders * inability to communicate * known bleeding and/or coagulation disorders * infection at injection site * chronic opioid intake

Keywords: fascial plane blocks postoperative pain opioid consumption quality of recovery abdominal surgery
influence of adherence to growth hormone therapy (ght) with norditropin® on near final height in patients with growth hormone deficiency (ghd) and born small for gestational age (sga)

Conditions: Growth Hormone Deficiency in Children; Born Small for Gestational Age

Summary: participants are free to decide if they want to take part in this study or not. the study will be conducted to collect information about the influence of adherence to growth hormone therapy with norditropin® in children and teenagers in daily practice in germany. this study will look mainly at the difference in near final height between children and teenagers who adhere to their therapy plan with norditropin® to non-adherent patients. participants will get norditropin® as prescribed to them by their doctor. the study will last as long as the therapy with growth hormone is seen necessary by the participants' doctors and the participants, up to a maximum of 10 years. during the visits at the participants' doctors participants will be asked to fill in a questionnaire.


Eligibility criteria:
inclusion criteria: * informed consent of parent or legally acceptable representative of subject and child assent, as age-appropriate must be obtained before any study-related activities. 1. the parent or legally acceptable representative of the child must sign and date the informed consent form (according to local requirements) and 2. the child must sign and date the child assent form or provide oral assent (if required according to local requirements). * the decision to initiate treatment with commercially available norditropin® flexpro® has been made by the treating physician and the patient's parents/legal guardian before and independently of the decision to include the patient in this study. * male or female, all age groups equal to or below 15 years with more than 2 years expected remaining treatment time until reaching nfh. patients who self-inject should be above 8 years of age in order to be able to fill in the questionnaire. * children being gh naïve at baseline with one of the following confirmed diagnoses 1. isolated growth hormone deficiency (ighd) 2. small for gestational age (sga) exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. * patients who have an expected future duration of therapy of less than 2 years are not eligible for the study.
alleviation of cedar pollen induced allergic symptoms by orally taken superfine beta-1,3-glucan

Conditions: Allergic Conjunctivitis

Summary: intravenous- injection of beta-1,3-glucan in human is known to induce t helper type 1 response, while oral uptake did not. it was examined whether superfine dispersed beta-1,3-glucan (sdg) contrived to absorbed by intestinal mucosa would alleviate allergic symptoms by per-oral ingestion

beta-1,3-glucan made from japanese mushroom is commercially available for healthy foodstuffs. allergy patients were orally administrated either sdg (n=30) or non-dispersed beta-1,3-glucan (ndg, n=30) and allergic symptoms were assessed clinically, by the double-blind, placebo-controlled, randomized study

Eligibility criteria:
inclusion criteria: * history of seasonal allergic conjunctivitis with or without rhinitis in spring (japanese cedar pollen season) every year * positive allergen specific ige (\> 30 iu/ml) or positive skin prick test result (wheal diameter \> 3mm) to japanese cedar, orchard grass pollen, or house dust-mite extract exclusion criteria: * patients who had undergone immunotherapy in the previous 5 years * a history of other immunological or medically relevant diseases

Keywords: allergy allergy conjunctivitis beta-1-3glucan th1/th2
obstructive sleep apnoea in ehlers-danlos syndrome

Conditions: Ehlers-Danlos Syndrome; Obstructive Sleep Apnea

Summary: ehlers-danlos syndrome (eds) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. eds features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (osa). there is evidence from studies based on questionnaires that eds patients might be more frequently affected by osa and sleep disturbances than the general population. however, the actual prevalence of osa in patients with eds is unknown. aortic root dilation and dissection are common complications of eds and little is known about the underlying risk factors. preliminary evidence suggests a link with osa but this has not yet been investigated. the primary objective of this study is to assess the prevalence of osa in eds-patients (100) compared to a matched control group (100). the secondary objective of this pioneer study is to assess whether there is a relationship between osa severity and aortic diame-ter/craniofacial abnormalities in eds patients.

ehlers-danlos syndrome (eds) is a clinically and genetically heterogeneous group of inherited connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. eds features such as genetically related cartilage defects, craniofacial abnormalities and increased pharyngeal collapsibility have been proposed to cause obstructive sleep apnoea (osa). there is evidence from studies based on questionnaires that eds patients might be more frequently affected by osa and sleep disturbances than the general population. however, the actual prevalence of osa in patients with eds is unclear. aortic dilation and dissection are complications associated with eds and little is known about the underlying risk factors. preliminary evidence suggests a link with osa but this has not yet been investigated. the primary objective of this study is to assess the prevalence of osa in eds-patients compared to a matched control group. the secondary objective of the study is to assess whether there is a relationship between osa severity and craniofacial phenotypes / aortic diameter in eds patients.

Eligibility criteria:
inclusion criteria: * informed consent * diagnosis of ehlers-danlos syndrome (not for control group) exclusion criteria: * moribund or severe disease prohibiting protocol adherence * continuous positive airway pressure treatment for osa during sleep study * physical or intellectual impairment precluding informed consent or protocol adherence * pregnant patients

Keywords: ehlers-danlos syndrome obstructive sleep apnea prevalence aortic aneurysm
randomized controlled trial of open stabilisation versus tps

Conditions: Metastatic Spinal Disease

Summary: spread of cancer to the spinal column is a growing problem in patients with cancer. it can cause a number of problems including pain, instability and neurologic problems. if left untreated, progressive weakness, numbness and bladder/bowel disturbance occurs. the aim of treatment is to help with pain and to reduce the risk of these neurological problems. this treatment has traditionally been radiotherapy to the spine. surgery has always meant large open operations with a long recovery time and significant risk of complications. there has been new technology that has allowed less invasive operations to take place to stabilise the spine. the aim is to relieve the pressure on the spinal cord in addition to stabilising the spinal cord. these techniques are called 'minimally invasive' and include surgical techniques such as cement augmentation and percutaneous instrumentation. the aim of this study is to compare traditional open operations with these new minimally invasive techniques to see if they do result in reduced complications and quicker recovery in addition to achieving the goals of surgery.


Eligibility criteria:
inclusion criteria: * has an age ≥ 18 years * is suitable for radiotherapy * has been assessed by the oncologist * has symptoms of pain * is diagnosed with metastatic spinal pain from mri findings with or without biopsy * technically possible to perform the surgery * is willing and able to comply with required followup questionnaires * is able to understand the risks and benefits of participating in the study * understands and has signed the informed consent form. * life expectancy of \> 3 months exclusion criteria: * active systemic infection or infection localized to the site of implantation * allergy or sensitivity to polyether ether ketone (peek), titanium or tantalum * a bleeding disorder precluding from invasive surgery * rapid neurological deterioration requiring urgent surgery which would be delayed to the detriment of the patient by including in this study
prevention of persistence of bacterial vaginosis

Conditions: Bacterial Vaginosis

Summary: this purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent bacterial vaginosis.


Eligibility criteria:
inclusion criteria: * women 18-40 yrs old * abnormal vaginal discharge or malodor * positive quickvue test * positive koh whiff test * positive finding of clue cells greater than or equal to 20% on wet mount * able to give informed consent * willing to abstain from alcohol during the 5 day therapy and 1 day following exclusion criteria: * immunocompromised women * symptomatic vvc * pregnancy or positive pregnancy test * menstruating or breastfeeding women * other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks * women with mpc, pid