Kornimate/medical-research-clean huggingface dataset:
study to assess efficacy and safety of ns-018 compared to bat in patients with myelofibrosis

Conditions: Primary Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Post-polycythemia Vera Myelofibrosis

Summary: this study will enroll male and female subjects who are 18 years of age or older with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis with severe thrombocytopenia (platelet count \<50,000/µl) including subjects with intermediate-2 or high-risk mf according to the dynamic international prognostic scoring system (dipss).

ns-018 will be self-administered orally at a dose of 300 mg bid. the bat will be administered according to manufacturer's instructions and investigator discretion. subjects will complete study visits at screening, day 1 and day 15 of cycle 1, 2, 3, 4, 5, 6 and day 1 of every cycle thereafter. at these visits, blood/urine sampling, spleen measurements, bone marrow assessments, patient-reported outcome (pro) assessments, and safety assessments may be performed.

Eligibility criteria:
inclusion criteria: * primary mf, post-pvmf or post-etmf according to the dipss risk categories of intermediate-2 or high-risk mf * average platelet count of \<50,000/µl at screening based on 2 measurements taken on different days; both measurements must be \<50,000/µl. * ecog performance status ≤2. * life expectancy \>6 months. * spleen volume of at least 450 cm3 measured by mri (or by ct for applicable subjects). * total symptom score (tss) ≥10 on the myelofibrosis symptom assessment form (mfsaf) version 4.0. * peripheral blast count \<10%. * no mf-directed treatment for at least 2 weeks prior to initiation of ns-018, including jak inhibitor, erythropoietic, thrombopoietic agent, or any use of corticosteroids for mf symptom or blood count management. low dose corticosteroids \<10 mg/day prednisone or equivalent is allowed for non-mf purposes. exclusion criteria: * active, uncontrolled systemic infection. * any prior treatment with more than two jak inhibitors. * previous treatment with ns-018. * subjects actively receiving a concurrent investigational agent. * subjects with any unresolved ae greater than grade 1 other than hematological aes from previous anticancer therapy. * currently taking medication that is substantially metabolized by cytochrome p450 (cyp) 1a2 or cyp3a4 (see appendix 5) or taking medication known to be strong inhibitors or inducers of cyp3a4 (see appendix 5). * radiation therapy for splenomegaly within 6 months prior to study entry (screening). * history of splenectomy or planning to undergo splenectomy. * subjects with a serious cardiac condition within the past 6 months such as uncontrolled arrhythmias, myocardial infarction, angina or heart disease * subjects diagnosed with another malignancy within 2 years prior to an enrollment. * subjects who have had surgery (other than placement of vascular access and bone marrow biopsy) within 4 weeks of study entry (screening), or subjects with incomplete recovery from any prior surgical procedures.
screening for atherotic plaques by ultrasound for assessing cardiovascular risk

Conditions: Atherosclerosis of Artery

Summary: cardiovascular disease is a common diagnosed and treated condition in private practices of primary health care. there is growing evidence that atherosclerotic plaques as predictors for stroke and heart attack are more prevalent than expected based on the clinical score in people with low risk for stroke and heart attack . diagnosing atherosclerotic plaques can help to decide if a lipid lowering therapy should be prescribed even if the clinical risk score is low or on the other hand if they can be observed even in high lipid levels.

both common and proximal internal carotid arteries and both common femoral arteries (including bifurcations) were screened by ultrasound in patients who came for a check-up to a primary care practice with no known cardiovascular disease and low risk for stroke and heart attack according to the agla/gsla risk score which is mostly used in switzerland. all patients agreed and gave written informed consent to be included in this study. presence of plaques was defined as a focal carotid intima-media thickness \>0.5 cm on ultrasound. screening was performed by a medical doctor (dp) certified for the procedure using the following ultrasound system: toshiba nemio xg, probe 7.5 mhz.

Eligibility criteria:
inclusion criteria: * low cardiovascular risk assessed by the agla/gsla-score exclusion criteria: * cardiovascular disease

Keywords: plaques detection by ultrasound
evaluation of amino acid metabolism changes in ovarian cancer

Conditions: Ovarian Cancer

Summary: ovarian cancer is associated with undernutrition in more than half of all cases. the current management of undernutrition-cachexia in cancer is not specific. it is well recognized that the nutritional support currently offered to cancer patients is not effective in combating cachexia, which progresses inexorably, leading to the patient's death. it is therefore necessary to offer specific and adapted care, in particular by optimizing the quality of nitrogen intake. to achieve this, the investigators first need to define the specific amino acid requirements of cancer patients.


Eligibility criteria:
inclusion criteria: * histological diagnosis of high-grade serous ovarian cancer not immediately resectable (stage iii or iva) managed at grenoble alpes university hospital. * affiliation to the french social security system. * able to understand and follow the instructions necessary for the conduct of the trial, and having given written consent for the study. exclusion criteria: * significant active comorbidity requiring long-term drug treatment (e.g. organ failure, diabetes) or history of pathology likely to impact amino acid metabolism (e.g. urea or homocysteine cycle abnormalities, tyrosinemia, alkaptonuria, hyperprolinemia, organic aciduria). * vegetarian or vegan diet * difficult venous access * persons covered by articles l1121-5 to l1121-8 of the csp (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure). * subject receiving more than 4,500 euros in compensation for participation in other research involving the human body in the 12 months preceding this study. * significant biological abnormalities (not explained by the underlying pathology for women with ovarian cancer) * liver metastases
intravenous dexamethasone on postoperative pain and complications in jaw surgery

Conditions: Tooth Extraction Status Nos; Cysts Dental; General Anesthesia

Summary: this study aims to evaluate the effect of single-dose intravenous dexamethasone on postoperative pain and other complications in compacted tooth and cyst enucleation procedures performed under general anesthesia.

during surgery, patients were carefully monitored with standard equipment to track oxygen levels (spo2), heart activity (ecg), blood pressure, and carbon dioxide levels. general anesthesia was started with medications like thiopental, rocuronium, and fentanyl, and maintained with a mix of oxygen, air, sevoflurane, and remifentanil. patients were intubated with appropriate tubes, and the surgical team applied a local anesthetic (articaine with epinephrine) to the area before starting the procedure. after the surgery, patients were given dexamethasone (dxm) and pantoprazole intravenously, then safely extubated and sent to recovery. all patients were discharged on the same day. postoperative recovery was assessed using pain scores (vas) and physical evaluations. pain levels were categorized as mild, moderate, or severe, and an analgesic was provided if the score exceeded 3. facial swelling was measured by comparing pre- and post-surgery facial landmarks, with swelling classified into grades based on the percentage of change. mouth opening was evaluated with a caliper to check for trismus (jaw stiffness), with results grouped into normal, mild, moderate, or severe grades depending on the degree of restriction. follow-ups were conducted by an independent clinician on postoperative days 1, 2, and 7.

Eligibility criteria:
inclusion criteria: * asa physical status i-ii * underwent split-mouth surgery exclusion criteria: * patients undergoing corticosteroid therapy

Keywords: dexamethasone postoperative pain maxillofascial surgery
point-of-care test for diagnosis of peritonitis in peritoneal dialysis patients

Conditions: Peritonitis

Summary: peritoneal dialysis (pd) is a home-based dialysis therapy and peritonitis is a serious complication in pd. a reliable point-of-care test to detect peritonitis is important for patients to self-detect peritonitis at home as delayed diagnosis and treatment of peritonitis will translate to poor outcomes in pd patients. the study aims to examine the effectiveness of periplex®, point-of-care test, in the diagnosis of peritonitis in pd patients.

a reliable point-of-care test to detect peritonitis is indeed needed for early diagnosis of peritonitis at home and seeking medical help early. we hypothesize that periplex® is not inferior to routine leukocyte testing of pd fluid effluent in the diagnosis of peritonitis. the test strip is designed to detect the inflammatory markers (il6 and mmp-8) which are usually released during peritonitis. the strip is intended to be used in the pd patients who suspected to have symptoms of peritonitis. the target population is all adult pd patients who are followed up in singapore general hospital and have signs and symptoms suspected of peritonitis during the study period. the test is considered positive for peritonitis if one or both test lines appear in the window of the test strip. the test will be performed at 2-time points, one at the presentation of peritonitis and one at the completion of antibiotics for the current episode of peritonitis, to document resolution of peritonitis. the results of the tests will be compared with the leukocyte testing of pd effluent.

Eligibility criteria:
inclusion criteria: * adult pd patients who are followed up in singapore general hospital and presented with signs and symptoms suspected of peritonitis including fever, abdominal pain or cloudy effluent will be recruited for the study. exclusion criteria: * 1. pd patients who are not followed up in sgh 2. patients with mentally challenging conditions and who are unable to provide a valid consent 3. non-pd patients 4. pd patients who do not have signs or symptoms suspected of peritonitis

Keywords: peritonitis point-of-care test peritoneal dialysis
tazarotene 0.1% cream for the treatment of cutaneous t-cell lymphoma: a prospective study

Conditions: Cutaneous T-Cell Lymphoma

Summary: this is an open label, prospective study to evaluate therapeutic potential of tazarotene 0.1% cream for the treatment of stage i-iia ctcl. patients with stage i-iia disease are enrolled into the study. tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.


Eligibility criteria:
inclusion criteria: * patients with stage i-iia ctcl must be at least 18 years of age with a skin biopsy prior to enrolment confirming the diagnosis of mycosis fungoides. exclusion criteria: * patients with stage \>iia ctcl at the time of enrolment * women who are pregnant or planning to get pregnant, or unable/unwilling to use adequate contraception * patients who were treated with topical retinoid therapy in the past 3 months * patients who received any systemic ctcl therapy or systemic corticosteroid therapy within 30 days of the study start date * patients who were treated with systemic isotretinoin or bexarotene within 3 months prior to the study start date, systemic acitretin within 2 years prior to study start date

Keywords: to evaluate therapeutic potential of tazarotene 0.1% cream for the treatment of stage i-iia ctcl. patients with stage i-iia disease are enrolled into the study stage i-iia disease ctcl
neuroimaging predictors of relapse during treatment for opiate dependence

Conditions: Opioid Addiction

Summary: this study proposes to use functional magnetic resonance imaging (fmri) to observe brain activity and behavior associated with decision-making about rewards (dd task), working memory and working memory cognitive persistence (wm task), and craving (cr task) in 72 opiate dependent participants initiating buprenorphine. while stably using opiates (initial study appointment) and again during withdrawal (approximately 3 days later), participants will receive an fmri scan with behavioral challenges; immediately after the second fmri, they will receive their first dose of buprenorphine. buprenorphine treatment will continue for twelve weeks, followed by a four week taper. urine toxicological analysis will be performed prior to the first scanning session, weekly for two weeks and biweekly thereafter. participation for all individuals will last 4 months. assessments will occur at baseline, and weeks 1, 2, 4, 8, and 12. buprenorphine induction will begin at the completion of the second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12. all participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will include a taper).


Eligibility criteria:
inclusion criteria: * opiate dependent persons * 21-50 years old * interested in initiating outpatient buprenorphine treatment exclusion criteria: * current methadone maintenance treatment program participation * medically necessary prescription opiate treatment (e.g., for chronic pain) * current criteria for a dsm-v diagnosis of substance dependence for sedative or hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens * diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform or paranoid disorder * current suicidality on the modified scale for suicidal ideation * evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the folstein mini-mental status examination• * anticipated major painful event (significant surgical procedure) in the coming 4 months * probation or parole requirements or an upcoming move that might interfere with protocol participation * history of allergic reaction to buprenorphine or naloxone * currently pregnant or planning to become pregnant in the next 4 months * history of neurological disorder (e.g., epilepsy, stroke, brain injury) * impaired uncorrected vision * fmri contraindications (e.g., claustrophobia, specific metallic implants and injuries)
hyperosmolality and acute kidney injury after cardiac surgery

Conditions: Acute Kidney Injury; Osmolality Disturbance; Cardiopulmonary Bypass

Summary: the goal of this randomized controlled trial is to test if a hyperosmolar prime solution used for cardiopulmonary bypass increases the risk for acute postoperative kidney injury.

two-hundred cardiac surgical patients were randomised into two groups based on the osmolality level of the prime solution used for cardiopulmonary bypass. the high osmolality group (966 mosm) received a prime solution containing ringer-acetate 1000 ml + mannitol 400 ml (60 g) + sodium-chloride 40 ml (160 mmol) and heparin 2 ml (10 000 iu), while the reference group with normal osmolality (388 mosm) received a prime solution containing ringer-acetate 1400 ml and heparin 2 ml (10 000 iu).

Eligibility criteria:
inclusion criteria: * patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass. exclusion criteria: * patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.

Keywords: cardiopulmonary bypass priming solution plasma osmolality acute kidney injury
swallowing and breathing exercises for dysphagia in parkinson disease

Conditions: Parkinson Disease; Dysphagia

Summary: parkinson's disease (pd) is a chronic, degenerative disease described by motors and non-motors symptoms. changes in swallowing and respiratory dynamics increase risk of tracheal aspiration largely responsible for increased morbidity and mortality in this population. thus, interdisciplinary rehabilitation strategies can reduce the complications of dysphagia, with consequent improvement of the prognosis of individuals with pd. objective: to determine the impact of combined oral motor exercises and breathing exercises on swallowing disorders in individuals with pd. method: clinical trial, randomized and blinded for the examinator. for all subjects will be given the stage of pd and applied quality of life questionnaire. the swallowing complaints will be investigated through structured questionnaire and functional aspects of swallowing with videofluoroscopy. the manovacuometry spirometry will determine measures of respiratory function. the assessment of vocal and speech disorders will be done with perceptive, acoustic, aerodynamic and electroglottographic measures as well as analysis of intelligibility. three groups of intervention will be defined: one of them doing oral motor exercises for swallowing, one doing breathing exercises and another must do this two interventions combined. effect of intervention will be assessed through measures of swallowing, breathing, voice and speech. the groups will be compared, according to the principle of "intention to treat" by appropriate statistical tests, according to the distribution of the dependent variables.


Eligibility criteria:
inclusion criteria: * parkinson's disease diagnosed following ukpds criteria * complaints and symptoms of dysphagia * dopaminergic treatment exclusion criteria: * cranial trauma * severe heart disease * others neurologic disease * psychiatric diseases * therapy for swallowing or breathing in the last 3 months

Keywords: parkinson's disease dysphagia swallowing treatment
the effects of anesthetics on persistent pain following breast cancer surgery

Conditions: Breast Cancer; Chronic Post-Procedural Pain

Summary: persistent postoperative pain occurs up to 25 to 60 % after mastectomy. this occurs at a higher frequency than the rate of invasive surgery.therefore, many ways have been tried to study risk factors. a study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). as a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain. this study try to find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.

persistent postoperative pain occurs up to 25 to 60 % after mastectomy. this occurs at a higher frequency than the rate of invasive surgery.therefore, many ways have been tried to study risk factors. a study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). as a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain. there were reports of no association with anesthesia in the area of anesthesia to the high pain control requirement in the postoperative recovery room, 24 hours of high pain medication, use of inhalation agent, and a high dosage of remifentanil. however, an anesthesia-related study was either a retrospective study or anesthetic was injected with more than a clinical dose in order to make the difference following methods. in this study, bispectral index is used to maintain anesthesia depth. in addition, the commercially available noninvasive pain depth equipment (surgical pleth index) is used to assess the nociception-antinociception balance. displays the automatically calculated values of spi=100-(0.3\*heartbeat interval + 0.7\*photoplethysmographic pulse wave ampule) using a waveform with peripheral oxygen saturation. through this process, patients want to objectify the amount of anesthetic agent used during surgery. and all patients are inserted the laryngeal mask airway. this study would try find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges. the investigators hypothesize that patients who suffered severe acute postoperative pain, regardless of their anesthesia method, have a higher incidence of persistent post-mastectomy pain.

Eligibility criteria:
inclusion criteria: -undergoing breast conserving surgery + sentinel lymph node dissection exclusion criteria: * cardiac arrythmia * allergic history for drugs * renal failure (cr\> 1.5 mg/dl) * performing axillary lymph node dissection or total mastectomy * difficult airway and failed to place laryngeal mask airway properly
high-dose isoniazid adjuvant therapy for multidrug resistant tuberculosis

Conditions: Tuberculosis, Multidrug-Resistant

Summary: the need for a standardized treatment protocol for multidrug resistant tuberculosis (mdr-tb) in resource-limited countries is being increasingly recognized. this single center, double blind, randomized controlled trial was designed to compare the time required for sputum culture conversion and extent of radiological improvement in cases of mdr pulmonary tuberculosis when isoniazid was included (both at a regular dose and at a high dose) as an adjuvant to the standardized second line of treatment. the study was designed to test the hypothesis that inclusion of high-dose isoniazid will enhance the effectiveness of the second line of treatment in cases of mdr-tb without significantly increasing the toxicity.

tuberculosis was declared a global emergency by the world health organization (who) in 1993. the global problem of tuberculosis is further complicated by a substantial increase in drug resistant tuberculosis. available data suggest that drug resistant tb especially multi drug resistant may represent a public health threat in areas with a high prevalence of tuberculosis, suboptimal tb control programmes and/ or hiv. the cure rate of these cases has been reported to be lower than for non-drug resistant tb with a failure rate of 44%. new therapies for mdr-tb have not been introduced since the fluoroquinolones in the 1970s. strains of mycobacterium tuberculosis (m. tub.) in h resistant cases often contain mixture of susceptible \& resistant organisms. use of high dose h (16- 20 mg/kg) can eliminate susceptible \& those with low level resistance4. this study was done to evaluate the role of isoniazid (inh) at high \& normal dosages as an adjuvant therapy in treatment of patients with persistent culture positive pulmonary tuberculosis despite 6 months of continuous first line antitubercular treatment and on culture at least resistant to isoniazid and rifampicin.

Eligibility criteria:
inclusion criteria: * consecutive patients reporting to the study center * sputum-positive for acid-fast bacilli * hiv-uninfected * mdr-tb defined as resistance to at least the following two drugs: isoniazid and rifampicin. exclusion criteria: * unwilling to give consent * abnormal renal or hepatic profile * history suggestive of isoniazid hypersensitivity * pregnancy * lactating mother * previous history of taking any of the following: kanamycin, prothionamide, levofloxacin, cycloserine and p-aminosalicylic acid

Keywords: randomized control trial multidrug resistant tuberculosis isoniazid standardized regimen adjuvant therapy