Kornimate/medical-research-clean huggingface dataset:
treatment with second generation tyrosine kinase inhibitors (2g tki) post imatinib failure survey

Conditions: Leukemia, Myeloid, Chronic-Phase (CML-CP)

Summary: the purpose of this study is to determine predictive value of hammersmith score on complete cytogenetic response (ccyr).

historic cohort prolonged by a 12-month follow-up period. prospective: look forward using periodic observations collected predominantly following subject enrollment: one year of follow up of patients with cp-cml alive at the time of the study. retrospective: look back using observations collected predominantly prior to subject selection and enrollment : historical data of patients with cp-cml initiated with a 2g tkis post-imatinib failure (resistance or intolerance) between 1-jan-2005 and 30-june-2009. the inclusion of a historical cohort will allow a rapid enrollment of a large number of patients of this rare pathology, while the prospective follow up of this cohort would allow long term data to be obtained, including the assessment of the impact on survival and appreciate the patient's quality of life (qol), compliance and satisfaction.

Eligibility criteria:
patients with additional chromosomal anomalies (aca) are accepted to be in cp. patients enrolled in open-label clinical trials or other observational trials are also allowed (unless explicitly prohibited by the trial). this trial does not prohibit participation in other observational trials. inclusion criteria: * patients diagnosed with cp-cml. (aca) are allowed * age \>18 years old * prior treatment with imatinib monotherapy as first line treatment, to which the patient is deemed resistant or intolerant.patients treated by inf and/or arac prior (but not concomitant) to imatinib are eligible. * initiated with a 2g tkis post-imatinib failure (resistance or intolerance) between 1-jan-2005 and 30-jun-2009. exclusion criteria: * patients in (or with history of) accelerated or blastic phase cml * patients treated by allogeneic stem cell transplantation. * any other cml treatment except for inf and/or arac,and a short period of hydroxyurea or anagrelide prior to imatinib. * patients treated with 2g tki for reasons other than imatinib failure. * patients with no historical data (e.g. possibility of sokal score calculation) available. * patients participating in clinical or observational trials which explicitly prohibit enrollment in non interventional studies.
a study of edp-235 in healthy subjects

Conditions: SARS CoV 2 Infection

Summary: this study is a randomized, double-blind, placebo-controlled study. it will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of edp-235 in healthy adult subjects.

the first phase assesses single ascending doses of edp-235 or placebo in healthy subjects. a "fasted" and "fed" two-part cohort will also assess food effect. the second phase assesses multiple ascending doses of edp-235 or placebo for 7-days in healthy subjects. each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive edp-235 or placebo.

Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. exclusion criteria: * clinically relevant evidence or history of illness or disease. * infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) at screening and infection with sars-cov-2 at the day -1 visit * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.

Keywords: first-in-human single ascending dose multiple ascending dose healthy volunteer covid-19
stroke patients receiving chiropractic care post-rehabilitation

Conditions: Stroke

Summary: the life university center for chiropractic research is conducting a research study to better understand how 12-weeks of chiropractic care differentially affects the post-rehabilitation brain electrical patterns and body movement patterns of individuals who have experienced hemorrhagic versus ischemic stroke the study will involve visits to the life university center for chiropractic research (ccr) in midtown atlanta. during the 12 weeks of focused care, chiropractic visits could be several times a week depending on the care plan. in addition to the chiropractic care, individuals will receive a physical examination and three follow-up assessments. the assessments in the ccr will include a non-invasive evaluation of the brain wave patterns using electroencephalography (eeg), completion of a few surveys, a balance assessment and a movement assessment. qualified individuals will receive study treatment and care at no cost.


Eligibility criteria:
inclusion criteria: * post stroke rehabilitation exclusion criteria: * not experienced sub-arachnoid bleeding within the last 4 weeks, fractures or trauma to the skull, pregnancy, or progressive ra.
a random clinical trial (rct) of the impact of electrocoagulation on ovarian reserve

Conditions: Ovarian Cyst

Summary: laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but damage to ovarian reserve caused by electrocoagulation has recently been questioned. the purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). however, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. on the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . there is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Eligibility criteria:
inclusion criteria: * age 18-40 years * ultrasound diagnosis as unilateral ovarian cyst and the average size between 5cm and 10cm * no clinical and sonographic suspicion of ovarian cancer * regular menstrual cycles defined as cycle length between 25 and 35 days in the 6 months before surgery * sonographic normal contralateral ovary * agreement to be enrolled in the study. exclusion criteria: * prior ovarian surgery or known endocrine disease * surgical necessity to perform adnexectomy * intraoperative diagnosis of an abnormal contralateral ovary * post operative pathologic diagnosis was not benign ovarian cyst * oral contraceptive use before surgery.

Keywords: ovarian cysts electrocoagulation ovarian function tests laparoscopy
profiling the rcrsp patient: a pain phenotype classification algorithm

Conditions: Rotator Cuff Syndrome; Rotator Cuff Tears; Rotator Cuff Tendinosis; Rotator Cuff Impingement; Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Summary: the aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with rcrsp and by clustering them to create a phenotype system which may assist the individualisation of their management

this study will be conducted at a hospital environment by recruiting people that will seek help for their shoulder pain by a specialist upper- limb orthopaedic surgeon at the department of hand \& upper limb microsurgery of the 'kat general hospital' in athens, greece. participants that will be diagnosed with rcrsp by the orthopaedic surgeon and fulfil the eligibility criteria will undergo a series of one-off measurements. written consent will have to be obtained before a sum of self-reported outcome measures and objective testing will take place. the main categories for which outcome measures will be used are: pain, function, psychosocial and lifestyle factors.

Eligibility criteria:
inclusion criteria: * age: 18-65 * pain: \>3 months, non-traumatic, unilateral or bilateral of anterolateral location * rom: \>50% all planes, arom painful in forward flexion and/or abduction * provocation testing: hawkins-kennedy, neer, painful arc, resisted er, empty can (3 or more out of the 5 +ve) exclusion criteria: * pain \< 3months * history of neck or shoulder trauma * radicular signs, shoulder pain reproduced with neck movements * gh oa * frozen shoulder * tears \>c3 according to snyder classification * fibromyalgia * neurological, systemic local or autoimmune inflammatory conditions * clinical depression * no injected corticosteroids or physiotherapy the last 3/12

Keywords: rotator cuff related shoulder pain chronic pain
the efficacy of acupressure on sleep quality in menopausal women

Conditions: Poor Quality Sleep

Summary: sleep disorder is a common problem in menopausal women and the decrease in the sleep leads to poor daily activity. traditional chinese acupressure is a noninvasive, effective and safe technique that can be easily taught to menopausal women so that they apply it as a self-care method and a manager of sleep disruption. the purpose of the present study was to evaluate the effectiveness of acupressure on sleep quality of postmenopausal women.this double blind randomized clinical trial was performed on 120 qualified menopausal women at the age of 41-65 years; and sleep quality was measured with pittsburgh sleep quality index (psqi ).participants were randomly assigned to an acupressure group, a sham acupressure group and a control group by two time randomized method (systematic and simple randomized). these interventions were carried out for 4 consecutive weeks. participants in acupressure group and sham acupressure group learned to carry out acupressure technique as a self care at home with the simultaneous massage techniques that were to be performed 2 hours before sleep, whereas only conversation was used in the control group. the statistical software package for social science (spss) version 17 was used for data analysis.


Eligibility criteria:
inclusion criteria: * spending at least 12 months after amenorrhea or follicle stimulating hormone * (fsh) serum level ≥ 40, * healthy of the pressure points, * having a full consciousness * having an acceptable ability of listening * speaking to receive training * doing the self- care techniques at home, * no mental and physical disorders, * getting a score higher than 5 from the pittsburgh sleep quality index (psqi) * able to sit for about 30 minutes. exclusion criteria: * having specific eating diets, * addicted to narcotic drugs, * using the drugs causing sleep disorders, * suffering from special disease, * taking hormonal drugs during 3 last months, * using herbal medicine to improve the menopausal symptoms, * bmi higher than 30, * having the moderate and severe depression based on beck depression inventory, * feeling of severe tiredness/ fatigue and anxiety, * having circular job specially night job * lack of cooperation with researchers.

Keywords: menopause sleep quality acupressure
the sukhshanti study: effect of a sanitation intervention on women's health

Conditions: Stress, Psychological

Summary: the study will measure the impact of sanitation access on women and girl's social and emotional health, behaviors, and quality of life in rural india before and after a sanitation intervention compared to a comparison group that will receive the same intervention at a later date.

this mixed-methods, quasi-experimental study will evaluate the extent to which the global sanitation fund (gsf) sanitation program in bihar, india improves health and well-being among women and girls. our study consists of a controlled before-and-after (cba) study with an embedded ethnography. specific objectives are: * measure the effect of the gsf intervention on sanitation-related psychosocial stress (srps), generalized psychosocial stress (pss), perceived quality of life, hair cortisol, and urogenital health among women between the ages of 14 and 65. * measure changes in sanitation adoption (e.g.: sanitation access and exclusive use) among individuals / households receiving the gsf intervention. * document individual and community experiences with sanitation, intervention participation, and latrine coverage through ethnographic methods.

Eligibility criteria:
inclusion criteria: * between 14 years to 65 years old * live in geographic area receiving gsf sanitation intervention in 2016 * live in geographic areas matched to intervention communities exclusion criteria: * less than 25 years old and not reached menarche * greater than 25 years old and never married * refusal to participate
time to lose the weight? comparison of weight-based and non-weight-based vasopressors for septic shock

Conditions: Septic Shock; Weight, Body

Summary: at present, there is conflicting evidence regarding outcomes in patients with septic shock receiving weight-based vasopressor (wbvp) versus non-weight-based vasopressor (nwbvp) dosing strategies. at mcmc, a weight-based strategy is in place whereas mdmc, mmmc and mrmc currently utilize a non-weight-based dosing strategy. obese patients (bmi \> 30) receiving either strategy may potentially be receiving substantially more or less vasopressor exposure compared to their non-obese (bmi \< 30) counterparts. determining total vasopressor exposure and assessing clinical outcomes would benefit our institution and others by providing optimal vasopressor dosing strategies in obese and non-obese patients. there is a difference in clinical outcomes between patients receiving weight-based and non-weight-based vasopressor dosing strategies. there is a difference in total vasopressor exposure between obese and non-obese patients utilizing wbvp and nwbvp strategies.

vasopressors are a mainstay of therapy for patients with septic shock to achieve and maintain hemodynamic stability.1 both weight-based and non-weight-based dosing recommendations exist with no clear evidence that one is better than the other.3-10 however, in light of the obesity epidemic and emerging evidence regarding the dangers of excessive catecholamine exposure, an evaluation of dosing practices is warranted. the aim of this study is to determine whether clinical outcomes differ between patients receiving weight-based and non-weight-based vasopressor dosing strategies for septic shock. this is a multicenter, retrospective chart review. patients admitted to mdmc and mcmc from 4/1/2017-8/31/2019 will be identified through the electronic medical record utilizing icd codes for sepsis and septic shock. patients meeting study inclusion criteria will be analyzed as described below. outcomes will be assessed between patients receiving wbvp and nwbvp with planned subgroup analysis in each group between patients with bmi \ 50.

Eligibility criteria:
inclusion criteria: * icu admission * medical admission type * received ne, epinephrine (epi), phenylephrine (pe), or dopamine (da) for septic shock * received ne/epi/pe/da for \> 24 hours * age ≥ 18 years exclusion criteria: * non-sepsis indication for vasopressors * surgical or trauma admission type * icu length of stay \< 24 hours * pregnant
evaluation of interest of lumeen virtual reality headset to reduce preoperative anxiety in ambulatory surgery

Conditions: Anxiety

Summary: this study evaluate the interest of virtual reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. half of the patients will received the virtual reality program, and the other half will received de common treatment.


Eligibility criteria:
inclusion criteria: * asa i-ii (classification of the american society of anesthesiologists). * ambulatory surgery scheduled * score stai ya \> 45 * affiliated to a social security * understanding the study and signing the informed consent exclusion criteria: * contraindications for midazolam * patients with disorders not compatible with virtual reality: severe cognitive or psychiatric disorders, blindness, claustrophobia, epilepsy * patient with a pacemaker of others implantable medical devices * patient with burns or wounds on the upper face or scalp * visual hallucinations * contagious disease by air or indirect contact * person unable to express their consent * minor patient or patient under curatorship or guardianship * patient participating in another interventional clinical trial

Keywords: virtual reality preoperative anxiety anxiety
pediatric diabetics type 1 using insupatch

Conditions: Type 1 Diabetes Mellitus

Summary: this study is a prospective, single-center, open label, randomized; two-arms cross over study. this is the test protocol for the insupatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

twenty(20) type 1 children with type 1 diabetics mellitus (tidm) who are meeting the inclusion/exclusion criteria as outlined below and who provide written informed consent will be enrolled in the study. the study will consist of an outpatient enrollment visit and two admissions(one clamps with the insupatch and one clamp without the insupatch) . each subject will thus serve as his/her own control.

Eligibility criteria:
inclusion criteria: 1. age 12-17 (inclusive) 2. clinical diagnosis of t1dm at least one year's duration 3. on csii therapy for at least three months 4. hemoglobin a1c(hba1c) values below 10% and above 6.5% 5. minimum weight requirements of at least 37.9 kg. 6. ability to comprehend written and spoken english 7. body mass index z-score below 90% exclusion criteria: 1. celiac disease, gastroparesis, or other gastrointestinal disorder associated with alerted carbohydrate absorption or intestinal motility. 2. medication besides insulin known to alter blood glucose, gastric motility, or intestinal carbohydrate absorption 3. female subjects of reproductive potential who are pregnant or breast feeding 4. inability to comprehend written and spoken english 5. any other condition, which in the judgment of the investigators, would interfere with the subject's or parents' ability to provide informed consent or the investigator's ability to perform the study. 6. hematocrit below 35 or serum potassium below 3.4 (confirmed by two samples)

Keywords: tidm
nausea induced by radiation of the dorsal vagal complex for benign brain tumors (nausicaa)

Conditions: Benign Brain Tumor

Summary: patients irradiated to the brain frequently experience nausea. the dorsal vagal complex (dvc) area is a specific brainstem zone and has been identified as likely responsible for nausea. existing clinical studies show correlation between dose to the dvc and nausea, but they concern tumors of the airways and upper digestive tract, where there are many confounding factors. the aim of this study is to establish a ling between radiation dose to the dvc and nausea. defining a dose threshold to the dvc will allow radiation oncologists to optimize radiation dose distribution and reduce nausea in patients.

patients irradiated to the brain frequently experience nausea. the dorsal vagal complex (dvc) area is a specific brainstem zone and has been identified as likely responsible for nausea. existing clinical studies show correlation between dose to the dvc and nausea, but they concern tumors of the airways and upper digestive tract, where there are many confounding factors. a retrospective study was carried out a in the radiotherapy oncology department of bordeaux university hospital on 102 patients irradiated for a benign brain tumor. this study showed that dvc irradiation was significantly associated with the onset of nausea. however, this symptom alters the quality of life on a daily basis. the objective of this prospective, multicenter, non-interventional study is to evaluate, using nausea validated questionnaires : functional living index-emesis (flie score), the correlation between dvc irradiation and nausea in benign brain tumors, at the end of radiotherapy, 1 month later and 3 months later. fatigue associated with brain irradiation will also be studied with bfi (brief fatigue inventory). if there is an established link, a secondary dose constraint on this structure will be able to be proposed to reduce nausea in these radiotherapy indications.

Eligibility criteria:
inclusion criteria: * more than 18 years old * with benign brain tumor * irradiated with conventional fractionation (1,8-2gy/fraction) exclusion criteria: * history of brain radiation * history of head and neck radiation * demencia * concurrent chemotherapy * nausea at the time of inclusion * anti-nausea treatment : corticosteroids, metoclopramide, setrons, other

Keywords: radiation induced nausea dorsal vagal complex brain tumors brainstem dosimetric constraint
hyperinsulinemic therapy in sepsis

Conditions: Sepsis

Summary: insulin regulates blood sugar and acts to suppress inflammation. hyperinsulinemic therapy is a protocol for insulin administration that involves the administration of a calculated higher dose of insulin into the blood stream. this therapy is called dextrose/insulin clamp. it has been shown to be safe and successful in maintaining normal glucose levels. the objective of the study is to assess if the clamp can achieve a steady and normal blood glucose level in patients admitted to the intensive care unit with sepsis. furthermore, if the higher insulin dose would lead to a drop in the inflammatory response seen in septic patients.


Eligibility criteria:
inclusion criteria: * admission to the icu with a diagnosis of septic shock or severe sepsis. exclusion criteria: * age less than 18 years old. * pregnancy. * patients who cannot provide informed consent and there is no surrogate decision maker. * a delay of more than 24 hours between eligibility and randomization. * patients admitted to the intensive care unit for treatment of diabetic ketoacidosis or hyperosmolar state. * imminent death. * patients who the treating clinicians are not committed to full supportive care. this is confirmed by a documented treatment-limitation order that exceeds a "do-not-resuscitation" order.

Keywords: sepsis insulin
anticardiolipin autoantibodies and mortality in septic patients

Conditions: Morality

Summary: the detection of antiphospholipid antibodies (apl) is of interest because of their importance in the pathogenesis of arterial or venous thrombosis and their responsibility for a wide spectrum of clinical manifestations such as infection. the aim of the study was to assess the performance of antiphospholipid antibodies biomarker to predict in- hospital mortality in intensive care unit (icu) septic patient's.

the investigators conducted a prospective single-center observational study including consecutive critically ill septic adults admitted to the intensive care unit. clinical and laboratory data including chemiluminescence immunoassay for antiphospholipid antibodies \[anticardiolipin (acl), antiphosphatidylserine (aps)\] were obtained. blood samples were collected on days 1, 3, 5, 8 and 10 of hospitalization. the primary study endpoint was icu mortality defined as death before icu discharge. secondary end points included correlation between sofa score and biological parameters.

Eligibility criteria:
inclusion criteria: * patients, admitted to the icu for sepsis and older than 18 years exclusion criteria: * pregnancy * clinical history of antiphospholipid syndrome * auto-immune diseases * immunosuppressive treatment

Keywords: anti-phospholipid sepsis intensive care unit