Kornimate/medical-research-clean huggingface dataset:
a phase 1 study to estimate the effects of pd 0332334 on lithium pharmacokinetics in healthy subjects

Conditions: Generalized Anxiety Disease

Summary: the purpose of this study is to investigate if pd 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.

additional study purpose details: to investigate potential drug-drug interaction between pd 0332334 and lithium

Eligibility criteria:
inclusion criteria: * healthy males and/or females * age from 21 to 55 (inclusive) * bmi ranges from 18 to 30 kg/m2 exclusion criteria: * previous participation in a pd 332334 study * pregnant or nursing females * hypersensitivity (allergic) to lithium, neurontin (gabapentin), or lyrica (pregabalin)

Keywords: drug-drug interaction, lithium, pd 0332334, pharmacokinetics
user performance evaluation of contour plus, accu-chek active, accu-chek performa and onetouch select simple blood glucose monitoring systems following iso 15197:2013

Conditions: Diabetes

Summary: the user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. in this study, user performance evaluation will be performed for contour plus (bayer healthcare diabetes care), accu-chek active (roche diagnostics), accu-chek performa (roche diagnostics) and onetouch select simple (lifescan) following iso 15197:2013, clause 8. the study will be performed in 2 parts. each part will comprise testing of 2 bgms. for each bgms, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects. the same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).


Eligibility criteria:
inclusion criteria: * male or female, with type 1 diabetes, type 2 diabetes or no diabetes * for provoked blood glucose excursions due to insulin dose adjustment: male or female with type 1 diabetes or type 2 diabetes and intensified insulin therapy or insulin pump therapy. * minimum age of 18 years * signed informed consent form * legally competent and capable to understand character, meaning and consequences of the study exclusion criteria: * pregnancy or lactation period * severe acute disease (at the study physician's discretion) * severe chronic disease with potential risk during the test procedures (at the study physician's discretion) * physical or mental constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) * incapability of giving informed consent * \< 18 years * legally incompetent * accommodated in an institution (e.g. psychiatric clinic) * language barriers potentially compromising an adequate compliance with study procedures * dependent from investigator or sponsor * for provoked blood glucose excursions 50 - 80 mg/dl: * coronary heart disease * condition after myocardial infarction * cerebral incidence * peripheral arterial occlusive disease * hypoglycemia unawareness
homeopathic remedy for the third stage of delivery

Conditions: Third Stage of Labor

Summary: the homeopathic remedy consisting of arnica and bellis perennis have been shown in a previous pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared with placebo treatment. the purpose of this study is to repeat the previous methodology, this time on a larger population. 210 parturients will be randomized to one of three groups: arnica montana c6 and bellis perennis c6 (n=70), arnica montana c30 and bellis perennis c30 (n=70), or double placebo (n=70).


Eligibility criteria:
inclusion criteria: * healthy women in 3rd stage of labor * age 20-35 * second to fifth gestation * spontaneous pv delivery * term delivery (37-42nd weeks) exclusion criteria: * scarred uterus * multifetal pregnancy * history of bleeding problems * caesarian section delivery * chorioamnionitis * pregnancy-induced hypertension * gestational diabetes mellitus * polyhydramnios, premature rupture of membrane * suspected macrosomy/sga

Keywords: third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis
predictors of postoperative pain

Conditions: Postoperative Pain

Summary: this is a retrospective chart review using trihealth electronic privacy identification center (epic) and previously developed databases for trihealth institutional review board (irb) approved research studies within the division of urogynecology and reconstructive pelvic surgery to determine the predictors of postoperative pain specific to the urogynecologic patient population.

postoperative pain remains the most important consideration for both patients and surgeons. therefore, there has been much attention brought toward investigating predictive factors of postoperative pain. a systematic review of 48 eligible studies with 23,037 patients showed preexisting pain, anxiety, age, and type of surgery are the four most significant predictive factors for the intensity of postoperative pain. however, this paper evaluated all types of surgical approaches. more recently, a prospective observational study showed that preoperative state trait anxiety inventory (stai) and numerical rating scales (nrs) for anxiety and pain expectations are independent predictors of pain and morphine consumption following abdominal hysterectomy. to date, little is known about the predictive factors of postoperative pain in the urogynecologic patient population. the purpose of this study is to determine the predictors of postoperative pain specific to the urogynecologic patient population. we aim to investigate the relationship between perioperative factors (such as demographics and medical history) and postoperative pain scores on postoperative day 1 with patients who have undergone urogynecologic surgery, specifically vaginal reconstruction for pelvic organ prolapse. this information would not only fill a gap in knowledge, but would also allow us to counsel our patients more accurately in regards to postoperative expectations. furthermore, if we find any positive correlation between modifiable perioperative factors and postoperative pain scores, we may be able to minimize these effects in future surgical cases.

Eligibility criteria:
inclusion criteria: * participant in one of six research studies previously performed by the division of urogynecology and pelvic reconstructive surgery (#13090, #13072, #12136, #12132, #10072, or #09001) * postoperative pain scoring data complete and available * vaginal reconstructive surgery as primary treatment * general anesthesia exclusion criteria: * incomplete or unavailable postoperative pain scoring * robotic sacrocolpopexy patients will be excluded
a retrospective study on personalized dosing strategy of patients treated by carbapenems: 2018-2021

Conditions: Bacterial Infections

Summary: patients may benefit from the personalized carbapenem dosing strategy based on pharmacokinetics. the objective of this study is to retrospectively review and analyze the clinical outcomes of patients with different dosing strategy.

rational use of carbapenem is closely associated with the clinical outcome of patients with infections. serum concentration of carbapenem varies from different populations. the objective of this study is to describe the clinical outcome of patients with infection treated by carbapenem in china, regarding diagnosis, treatment and follow-up. it is a single-center, retrospective, descriptive study. inclusion criteria are an age ≥ 18, diagnosed as bacteria infection and serum concentration must be determined during therapy. data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. a descriptive analysis will be performed.

Eligibility criteria:
inclusion criteria: age over 18 years chinese patient: male or female diagnosed as bacterial infection treated by carbapenem serum concentration determined during therapy exclusion criteria: duration of carbapenem treatment less than 48 hours patients renal or liver function not tested before treatment started using more than two kinds of carbapenem

Keywords: carbapenem bacterial infections
prevalence of impaired glucose tolerance (igt) in patients with frozen shoulder

Conditions: Frozen Shoulder; Impairment Glucose Tolerance

Summary: idiopathic adhesive capsulitis, frozen shoulder is a condition in which there is a limitation and significant pain at the shoulder and it is increases with shoulder movements. the causes are not clear. the prevalence of this condition is four times higher in diabetic patient compare to the general population. the relation between frozen shoulder and impaired glucose tolerance remain unclear. our hypothesis is that patients with no diabetes and that suffer from frozen shoulder have a higher prevalence of impaired glucose tolerance than the general population age matched.


Eligibility criteria:
inclusion criteria: 1. age 30-60. 2. previous xray that eliminates other disease of the shoulder. 3. previous us that eliminates tendon shoulder rupture 4. shoulder movement in all directions, with limitation in the external rotation (at least 50%) exclusion criteria: 1. diagnosed diabetes (pregnancy diabetes includes) 2. taking hyperglycemic medications (like steroids) 3. fracture or operation in the shoulder before the diagnosis of frozen shoulder.
therapeutic plasmaexchange in early septic shock

Conditions: Septic Shock

Summary: sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (\> 60%). death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vwf cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (tpe) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. this therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. the investigators designed the exchange trial to analyze in a randomized fashion the benefit of tpe as an add-on treatment to state of the art standard sepsis care. only patients with early septic shock (\ 0.4 ug/kg body weight/min) will be included. those in the treatment group will receive 1 tpe within 2 hours following randomization. the primary outcome is norepinephrine dose 6 hrs after randomization. the recruitment period is 2 years and will be performed at the hannover medical school university hospital in germany. secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after tpe. the investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock.


Eligibility criteria:
inclusion criteria: * onset of septic shock within less than 24 hrs * norepinephrine dose of ≥ 0.4 ug/kg/min bodyweight (target mean arterial pressure ≥ 65 mmhg) ≥ 30 min exclusion criteria: * age\ 80 years * pregnancy * known history of transfusion reactions

Keywords: septic shock therapeutic plasma exchange sepsis
study of kp-1461 for the treatment of hiv positive patients who have failed multiple haart regimens

Conditions: HIV Infections

Summary: the primary purpose of the study is to assess the safety and pharmacokinetics of kp-1461 given every 12 hours for 14 days when administered to hiv+ patients who have failed multiple highly active antiretroviral therapy (haart) regimens. patients currently on haart will be required to discontinue all haart medications for up to 6 weeks after screening eligibility has been determined.

kp-1461 is a carbamate prodrug of the active nucleoside, kp-1212. kp-1212 is incorporated into the proviral dna. after multiple rounds of replication, kp-1212 increases the high inherent mutation rate of hiv beyond the threshold of viability, a process called "viral decay acceleration". kp-1212 is unique from conventional nucleoside reverse transcriptase inhibitors in that it inserts mutations randomly across the entire 10,000 nucleotide hiv genome and does not exert selective pressure by targeting a specific viral or cellular process, thus potentially avoiding drug resistance.

Eligibility criteria:
inclusion criteria: * cd4 \> 100 cells/mm3 * viral load 2,500 - 200,000 copies/ml * exposure to at least 2 different haart regimens containing nrti(s), nnrti(s), and 2 pi(s), excluding ritonavir, for a minimum of 4 months or documented resistance to at least 3 of the 4 classes of approved antiretroviral drugs. * few, if any, effective treatment options available exclusion criteria: * hbsab (hepatitis b) positive serology

Keywords: hiv treatment experienced
muscle capillarization and sarcopenia

Conditions: Sarcopenia

Summary: aging is associated with a loss of muscle mass, termed sarcopenia, that reduces mobility, decreases physical function and accelerates progression of other age-related disorders. this study is designed to determine whether increasing skeletal muscle capillarization through aerobic exercise will enhance muscular adaptations to strength training in older adults with sarcopenia.

sarcopenia, or the aging-related loss of muscle mass, affects a large number of older adults. the presence of sarcopenia is associated with physical disability, poor quality of life, and all-cause mortality, in part because sarcopenic adults have low muscle skeletal muscle capillarization and may lack the adequate perfusion needed to maintain muscle mass and function. this study will test the effects of increasing skeletal muscle capillarization through aerobic exercise training on responses to resistance training in older adults. eligible participants will be randomized to one of two groups, resistance training preceded by aerobic exercise training (aex-rt), or resistance training followed by aerobic exercise training (rt-aex). participants in the aex-rt group will undergo 3 months of aerobic exercise training to increase skeletal muscle capillarization, followed by 3 months of resistance training. participants in the rt-aex group will undergo 3 months of resistance training, followed by 3 months of aerobic exercise training. before and after the interventions, participants will undergo assessments of muscle size, strength, and capillarization, as well as assessments of physical function.

Eligibility criteria:
inclusion criteria: * body mass index = 18-32.5 kg/m2 * non-smoker * presence of at least moderate sarcopenia (low muscle mass per unit body height) exclusion criteria: * diagnosis of diabetes, cancer, pulmonary or renal disease * physical impairment preventing exercise * recent history of exercise training

Keywords: muscle capillary exercise
impact of confirmed autoimmune encephalitis on brain glucose metabolism

Conditions: Autoimmune Encephalitis

Summary: prospective cohort study evaluating fdg pet in 56 patients with confirmed autoimmune encephalitis - based on 2016 graus criteria, and 2021 paraneoplastic neurological syndromes criteria - at the acute phase, before immunomodulating treatment, or within 10 days of treatment initiation.

autoimmune encephalitis is a diagnostic challenge, and requires early diagnosis for improved neurological outcomes. fdg pet has shown very high sensitivity, suggesting better performances than mri, but almost exclusively in small sized retrospective studies. brain fdg pet is therefore not included in current diagnostic criteria, conversely to brain mri. this study will include 56 patients with confirmed - seropositive or seronegative - autoimmune encephalitis, based on 2016 graus criteria for autoimmune encephalitis and 2021 criteria for paraneoplastic neurological syndromes. the main objective is to conduct a prospective evaluation of the diagnostic value of fdg pet performed in the acute phase before treatment initiation, or within 10 days of treatment initiation. a follow-up pet performed 3 months after treatment initiation will also be performed and analysed for all patients as part of secondary objective analyses.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * newly diagnosed autoimmune encephalitis based on at least 1 of the 3 following criteria : 1. " definite limbic autoimmune encephalitis " according to 2016 graus et al. criteria 2. " possible autoimmune encephalitis " according to 2016 graus et al. criteria and typical autoantibody detected in serum or csf 3. " probable or certain paraneoplastic neurological syndrome " according to graus et al. 2021 criteria (excluding peripheral neurological syndromes) * less than 6 months since first neurological symptoms imputable to autoimmune encephalitis * affiliated or entitled to a social security system (except ame) * obtaining free, written and informed consent (patient or legal representative or the close relative) exclusion criteria * history of brain tumor, head trauma, infarction or cerebral hematoma likely to result in altered cerebral carbohydrate metabolism on pet * patients who hae been on immunotherapy (corticosteroid bolus, ivig, plasma exchange, endoxan, rituximab or other immunotherapy) fr more than 10 days * pregnant or breast-feeding woman * ventilated intubated patient * absolute contraindication to mri (pacemaker, cochlear implant, etc.) * presence of cognitive disorders incompatible with goog cooperation with the pet scan * algic or agitated patient unable to remain immobile in supine position for 30 minutes * deprived of liberty or under a protective measure (guardianship or curatorship) * patient taking part in other interventional research involving radiopharmaceutical injections

Keywords: autoimmune encephalitis pet fdg nmdar lgi1 caspr2 gad
interfant-21 treatment protocol for infants under 1 year with kmt2a-rearranged all or mixed phenotype acute leukemia

Conditions: Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia

Summary: this study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. the purpose of the study is to improve the outcome of this disease in infants.

all infants that are eligible for this study and for whom the parents/legal representatives give informed consent will be enrolled in this study. all patients will receive one cycle of blinatumomab on top of the standard treatment backbone after induction therapy. medium risk patients, that respond well to the 1st cycle will be treated with a 2nd cycle of blinatumomab replacing one chemo course after consolidation therapy. if they do not respond well enough they will be treated according to the current treatment standard. minimal residual disease will be used to determine the response to blinatumomab. high risk patients will be eligible for allogeneic stem cell transplantation after the first blinatumomab cycle if they are minimal residual disease (mrd) negative (defined as \< 0.01%). also medium risk patients with insufficient mrd response after induction or after the 1st cycle of blinatumomab will be allocated to high risk treatment and will be eligible for allogeneic stem cell transplantation.

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed b- precursor acute lymphoblastic leukemia (all) or b- cell mixed phenotype acute leukemia (mpal) according to the world health organization (who) classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with kmt2a-rearrangement. 2. ≤365 days of age at time of diagnosis of all 3. written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations. exclusion criteria: 1. kmt2a-germline patients 2. t-all 3. age \> 365 days at the time of diagnosis 4. relapsed all 5. treatment with systemic corticosteroids (equivalent prednisone \>10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. patients who received corticosteroids by aerosol are eligible for the study. additional exclusion criteria for blinatumomab: 1. cd19 negative b-precursor all at diagnosis 2. cns involvement (cns2/cns3 status) at the eoi. patients with cns disease at the time of diagnosis are eligible if cns1 status is achieved prior to the start of the first blinatumomab cycle (lumbar puncture at \~day 33 of induction). 3. proven hypersensitivity to the active substance or any of the excipients in blinatumomab. 4. patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to b-cell recovery after the last dose of blinatumomab. if exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.

Keywords: infant under one year kmt2a-rearranged
colorectal cancer in crohn's disease

Conditions: Crohn Disease; Colorectal Cancer; Inflammatory Bowel Diseases

Summary: retrospective multicentre study. all patients with a diagnosis of crohn's disease (cd) and operated for colorectal cancer (crc) between 01/01/2010 and 01/01/2020 will be included in the dataset. data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible. the study will focus on a comparison between patients treated with total proctocolectomy (tpc) and patients treated with subtotal colectomy (stc) or segmental resection (sr). primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. secondary endpoints include quality of life (qol).


Eligibility criteria:
inclusion criteria: * all patients with a diagnosis of crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020 exclusion criteria: * patients who underwent non-oncologic segmental resection will be excluded from outcome analysis. * patients with known genetic colorectal cancer syndromes (eg. familial adenomatous polyposis, hereditary non-polyposis colorectal cancer syndrome)

Keywords: colorectal surgery