Kornimate/medical-research-clean huggingface dataset:
a new approach of neostigmine in unavoidable post operative ileus

Conditions: Ileus

Summary: postoperative ileus (poi) in the absence of any mechanical obstruction remains a commonly encountered clinical problem.so, this study aimed to show the effective way to decrease the rate of postoperative ileus (poi).

we honestly declare that, the use of parasympathomimetic agents such as neostigmine is not without risk. patients with underlying bradyarrhythmias or those receiving β-adrenergic antagonists may be more susceptible to neostigmine-induced bradycardia. similarly, neostigmine increases airway secretions and bronchial reactivity, which may exacerbate active bronchospasm. recently, a new class of drugs-peripherally acting mu-opioid receptor antagonists-may help enhance multimodal management of poi. although, the cost benefit of the new class of drugs is debated. it has been suggested that the individual components of multimodal protocols-for example, laparoscopy-may reduce certain post surgical morbidities (including poi) but do not by them prevent poi. therefore, combinations of strategies with demonstrated effectiveness-early feeding , epidural analgesia, laparoscopic surgery, and use of peripherally acting mu-opioid-receptor antagonists-may help transform the reactive approach to poi into a proactive multimodal paradigm that effectively targets the diverse etiologic factors leading to this common clinical problem.

Eligibility criteria:
inclusion criteria: * patients with acute colonic pseudo-obstruction who were 18 years of age or older * patients had to have a cecal diameter of at least 10 cm on plain radiographs * mechanical obstruction was ruled out by the finding of air throughout all colonic segments including the rectosigmoid on plain abdominal radiographs exclusion criteria: * exclusion criteria included a base-line heart rate of less than 60 beats per minute or systolic blood pressure of less than 90 mm hg; signs of bowel perforation * with peritoneal signs on physical examination or free air on radiographs; active bronchospasm requiring medication * treatment with prokinetic drugs such as cisapride or metoclopramide in the 24 hours before evaluation * a history of colon cancer or partial colonic resection * active gastrointestinal bleeding * pregnancy * positive history of myocardial infarction, intestinal resection or a serum creatinine concentration of more than 3 mg per deciliter (265 µmol per liter)

Keywords: neostigmine, post operative, ileus
focus on the humeral component following reverse shoulder arthroplasty

Conditions: Rotator Cuff Arthropathy

Summary: reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. the goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to functional failure. fixation of the humeral component has evolved from cemented to mostly uncemented with diaphyseal of metaphyseal press-fit stems. bony changes around the stem reflect the bone-implant interface; research to evaluate and interpret these changes is insufficient at this moment. since several patients have shown cortical thinning of the proximal lateral humeral cortex during follow-up, further research is recommended to evaluate the cause and clinical impact of these radiographic changes. the goal of this study is to collect long-term radiographic and clinical data in order to facilitate the identification of risk factors.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years old * total shoulder replacement using a reverse type implant (delta xtend or zimmer tm) between 2007 and 2017 in uz leuven * primary indication for surgery is rotator cuff arthropathy * informed consent obtained exclusion criteria: * total shoulder replacement in post septic arthritis. * total shoulder replacement in post-instability arthritis. * revision total shoulder arthroplasty. * posttraumatic total shoulder arthroplasty (after failed index operation)

Keywords: reverse total shoulder arthroplasty
a comparison between the effects of conventional diets vs intermittent fasting diabetic and pre-diabetic patients

Conditions: Diabetes Mellitus, Type 2; PreDiabetes

Summary: this research aims to find an effective dietary intervention among the pakistani population. according to who, diabetes is on the rise in developing countries; the current prevalence among the pakistani population is 11.2% which is expected to increase in the coming years which is in line with the similar documented trend in neighboring south asian countries.3,11 since, ethnic south asians carry a greater risk for developing t2d at a younger age and along with the complications associated with diabetes due to its chronicity, this poses a significant threat and an increased disease burden on the health care system.11 this will be the first trial conducted on determining the efficacy of caloric restriction in a subset of pakistani population. there is limited inconsistent data on the efficacy of time-restricted feeding, however, this will help elucidate if it does lead to positive effects on the bio-health markers. one of the major hurdles in caloric restriction is patient compliance, therefore, one of the intervention group will be used to determine if trf with caloric restriction helps improve the patient's compliance and produces significant results. if such an intervention is effective in inducing weight loss it can also be applied for other overweight patients. eventually, it will help in countering the rising obesity in the region. the ultimate purpose of the knowledge obtained is to find a patient friendly, novel and therapeutic dietary intervention which will help in limiting the rise in t2d patients. it'll help in introducing an effective lifestyle intervention to promote health, which will reduce the dependence on pharmacological therapies, as well as, in the long-term reduce burden on the health care system. the information obtained can provide framework for new guidelines in helping the patients to lose weight, which can be utilized by the government to increase general awareness which will help prevent diseases linked to obesity. in light of the randomized controlled trial, the primary health physicians can educate and increase awareness regarding the different dietary interventions the patients can utilize which will help increase the number of options for the patients. social media platforms can be utilized due to their extended outreach for the transmission of accurate information to the general population.


Eligibility criteria:
inclusion criteria: * glycemic values belonging to diabetes or prediabetes category. * weight stable for at least 6 months prior to start of study. * ability to understand english and use english language mobile applications. exclusion criteria: * pregnant or breastfeeding women. * diabetics taking insulin or sulfonylureas. * smokers. * history of cardiovascular disease. * history of psychiatric or eating disorders. * history of hypoglycemic episodes.
a research study to look at how cagrisema influences food intake, appetite and emptying of the stomach in people with excess body weight

Conditions: Obesity

Summary: this research study tests if cagrisema influences food intake, appetite and emptying of the stomach in people with excess body weight. participant will either get cagrisema (active medicine) or placebo (a dummy medicine), which has no effect on the body. the treatment participants get is decided by chance. the study will last for about 32 weeks.


Eligibility criteria:
inclusion criteria: * male or female. * aged 18-65 years (both inclusive) at the time of signing informed consent. * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. * body mass index (bmi) equal to or above 27.0 kilograms per meter square (kg/m\^2) at screening. overweight should be due to excess adipose tissue, as judged by the investigator. exclusion criteria: * glycated haemoglobin (hba1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole \[mmol/mol\]) at screening. * history of type 1 or type 2 diabetes mellitus. * any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening. * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
a trial to test the safety and efficacy of tev-53408 in treating vitiligo

Conditions: Vitiligo

Summary: the primary objective of the trial is to evaluate the safety of tev-53408 administered subcutaneously for the treatment of adults with vitiligo. a secondary objective is to further evaluate the safety of tev-53408. the planned study period per participant is 84 weeks including a screening period (up to 4 weeks), a 24-week open-label treatment period, a 16-week washout period, and a 40-week follow-up period.


Eligibility criteria:
inclusion criteria: * the participant has a diagnosis of active or stable vitiligo for at least 3 months. * the participant has a body mass index (bmi) within the range of 18.5 to 40.0 kg/m2 * a female participant is eligible if she is not pregnant or breastfeeding and is a woman of nonchildbearing potential or is a women of childbearing potential using a contraceptive method that is highly effective and agrees not to donate eggs for the purpose of reproduction for the required period * a male participant is eligible if he agrees to refrain from donating sperm plus remain abstinent from heterosexual intercourse or use a male condom with a female partner for the required period * the participant is capable of giving signed, informed consent * the participant agrees to discontinue all agents and procedures used to treat vitiligo during the treatment period in the trial * if receiving permitted concomitant medications for any reason other than vitiligo, the participant must be on a stable regimen, * the participant must agree to avoid prolonged exposure to the sun, must use sunscreen, and must not use tanning booths, sun lamps, or other ultraviolet light sources note - additional criteria apply, please contact the investigator for more information exclusion criteria: * the participant suffers from vitiligo induced by exposure to chemicals or immunotherapy known to induce vitiligo * the participant has other autoimmune diseases for which systemic immunotherapy is or may be warranted * the participant has current or history of malignancy or treatment of malignancy in the last 5 years, excluding fully-treated basal cell carcinoma * infectious disease * the participant has used skin bleaching treatments for past treatment of vitiligo or other pigmented areas * the participant has a history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. after 2 or more years since last melanocyte-keratinocyte transplantation procedure, the participants may be included in the trial. * the participant has donated or received any blood or blood products (white blood cells, platelets, etc) within the 60 days prior to screening or has donated blood or blood products on 2 or more occasions within the 6 months prior to imp administration, or has donated plasma within 7 days before the screening visit, or has planned donations during the trial * the participant has current or history of alcohol or other substance abuse note- additional criteria apply, please contact the investigator for more information
evaluation of long-term immunogenicity and safety of a human papillomavirus (hpv) vaccine in healthy female subjects.

Conditions: Infections, Papillomavirus; Papillomavirus Vaccines

Summary: infection with human papillomavirus (hpv) has been clearly established as the necessary cause of cervical cancer. this study is designed to evaluate the long-term immunogenicity and safety of the 580299 hpv vaccine up to 10 years after administration of the first dose of hpv vaccine (month 0) administered in the primary study 580299/013. this protocol posting deals with objectives \& outcome measures of the extension phase from month 60 to month 120. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct00196924). the objectives \& outcome measures of the extension phase up to month 48 are presented in a separate protocol posting (nct00316706).

subjects were aged 10-14 years at the time of entry into the primary study. no vaccine will be administered in this extension study. results on outcome measures describing analyses on other studies are not reported in this record. please refer to the records mentioned in the respective outcome measure titles.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they and/or their parents or legally acceptable representative (lar) can and will comply with the requirements of the protocol should be enrolled in the study. * a female enrolled in the immunogenicity subset of study 580299-013, who received three doses of hpv vaccine and participated in the extension study of 580299-013. * written informed assent obtained from the subject. for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative of the subject. exclusion criteria: * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. * administration or planned administration of any hpv vaccine, other than the vaccine administered in study 580299-013. * chronic administration of immunosuppressants or other immune-modifying drugs occurring within the three months preceding study entry. * administration of immunoglobulins and/or any blood products occurring within the three months preceding study entry.

Keywords: hpv vaccine cervical cancer
antiproteinuric agents and fabry disease

Conditions: Fabry Disease; Proteinuria

Summary: fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. proteinuria is recognized as an important risk factor for progression of chronic kidney disease. our hypothesis is that using drugs that reduce urine protein excretion (ace inhibitors and arbs) will have a beneficial effect on patients with fabry disease who already are receiving enzyme replacement therapy. a longitudinal, observational study is being undertaken to determine the utility of these agents in fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with fabry disease have relatively low blood pressures at baseline.

fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. proteinuria is recognized as an important risk factor for progression of chronic kidney disease. our hypothesis is that using drugs that reduce urine protein excretion (ace inhibitors and arbs) will have a beneficial effect on patients with fabry disease who already are receiving enzyme replacement therapy. a longitudinal, observational study is being undertaken to determine the utility of these agents in fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with fabry disease have relatively low blood pressures at baseline.

Eligibility criteria:
inclusion criteria: * genetically confirmed fabry disease * institution of commercially available agalsidase-beta exclusion criteria: * s/p kidney transplant

Keywords: proteinuria arbs agalsidase-beta mdrd estimated gfr chronic kidney disease
ivosidenib (ivo) monotherapy and azacitidine (aza) monotherapy in patients with hypomethylating agent (hma) naive myelodysplastic syndromes (mds) with an idh1 mutation

Conditions: Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS); Myelodysplastic Syndromes (MDS)

Summary: this study will enroll participants with myelodysplastic syndromes (mds) with an isocitrate dehydrogenase protein, 1 (idh1) mutation, who have not received treatment with a hypomethylating agent previously. participants will be randomized to receive either ivosidenib (ivo) alone or azacitidine (aza) alone. ivo will be administered daily throughout the 28-day treatment cycle and aza will be administered for the first 7 days of each 28-day cycle. study visits will be conducted every week during cycle 1 (days 1, 8, 15, and 22), and day 1 of each cycle thereafter. after the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. study visits may include a bone marrow aspirate, physical exam, echocardiogram (echo), electrocardiogram (ecg), blood and urine analysis, and questionnaires.


Eligibility criteria:
inclusion criteria: * diagnosis of hma naive idh1 r132 mutated mds defined according to who criteria (5th edition): * moderate high, high and very high-risk mds per ipss-m score will be eligible regardless of blood counts and with blast counts 0-19%. * low and moderate low-risk mds per ipss-m score must: * have cytopenias related to mds, defined as: \<100 platelets/microliter, or absolute neutrophil count (anc) \<1000/mm3, or hemoglobin \<10g/dl and * have a blast count between 5-19% and * be eligible for hma therapy (very low risk participants are to be excluded) * locally or centrally confirmed idh1 r132 c/g/h/l/s mutation exclusion criteria: * received prior anticancer/disease modifying treatment for mds (including hma's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (hsct), idh1 inhibitors). for lr-mds patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed. * \>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate/biopsy
top-mums, for a healthy start

Conditions: Overweight; Obesity; Pregnancy Complications

Summary: this study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. half of the patients will receive the lifestyle intervention while the other half will receive usual care. it is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.


Eligibility criteria:
inclusion criteria: * women with a pregnancy wish within 1 year; * aged 18-40 years; * overweight/obesity (bmi ≥ 25 kg/m2). exclusion criteria: * haemodynamically significant heart disease; * restrictive lung disease; * congenital metabolic disease; * mentally retarded; * bariatric surgery; * diabetes type ii, dependent on medicine.
a field study evaluating clinical benefit and safety of aigiv (anthrasil®) in inhalational anthrax patients

Conditions: Inhalational Anthrax

Summary: this study will evaluate safety and clinical benefit of aigiv used for treatment of patients with inhalational anthrax. this study will be implemented only in the event of a major anthrax exposure event. the study is designed to collect information on safety, clinical benefit (such as extent of anthrax illness and survival) and serum concentrations of aigiv (for aigiv pharmacokinetics) and anthrax toxins from inhalational anthrax patients treated with aigiv.

this study is a post-marketing requirement from the fda to evaluate safety and clinical benefit of aigiv administered to patients as part of their medical care after inhalational exposure to bacillus anthracis. study information (i.e. data on safety and clinical benefit evaluation of aigiv up to day 30 following administration) and patient samples (for assessment of aigiv pharmacokinetics and anthrax toxin levels) will be collected (up to day 7 following aigiv administration) prospectively to the extent possible; however, due to logistical complexities that will likely occur during a mass anthrax exposure event, most data for this study will be collected retrospectively (including scavenged patient samples for assessment of serum aigiv concentration and anthrax toxin levels). therefore, both prospective and retrospective data collection are allowed in this study to maximize the amount of information obtained from inhalational anthrax patients who have been administered aigiv.

Eligibility criteria:
inclusion criteria: * confirmed or suspected inhalational anthrax linked to an identified broad exposure scenario. * treatment with aigiv. * informed consent/assent (as applicable). exclusion criteria: * there are no exclusion criteria for subjects enrolling in this study.

Keywords: anthrax bacillus anthracis inhalational anthrax bacterial infection aigiv anthrasil anthrax immune globulin anti toxin polyclonal antibodies