Kornimate/medical-research-clean huggingface dataset:
extension study of p1101 after completion of phase 2 study in pv patients or phase 3 study in et patients

Conditions: Polycythemia Vera (PV)

Summary: this is a phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of p1101 patient with pv or et in long-term.

the study is to evaluate the long-term safety and efficacy of p1101 in pv or et patients who participated in study a19-201 or study p1101 et. the subjects who have completed the 52-week p1101 treatment duration in study a19-201 will start treatment with p1101 at the dose at week 50. the subjects who have completed the follow-up/end-of-study visit in study p1101 et will start treatment with p1101 at the dose at week 50. the subjects who were treated with anagrelide will start treatment with p1101 at a dose of 250 μg. the dose of p1101 during this study may be increased or decreased up to 500 μg depending on the condition. evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ecg evaluation, heart echo, lung x-ray, ecog performance status, ocular examination, and aes. efficacy evaluations, safety assessments, and immunogenicity evaluations of p1101 will be performed. evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of calr, jak-2, and mpl, spleen size measurements, bone marrow sampling.

Eligibility criteria:
inclusion criteria: * patients who have completed the 52-week treatment duration in study a19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study * patients who have given written informed consent to participate in this study exclusion criteria: * patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with p1101

Keywords: myeloproliferative neoplasms
cohort study of bowel function following robotic-assisted laparoscopic sacrocolpopexy

Conditions: Pelvic Organ Prolapse; Constipation; Bowel Dysfunction; Irritable Bowel Syndrome

Summary: compare changes in bowel function before, 6 months and one year after robotic-assisted laparoscopic sacral colpopexy. compare objective anatomic outcomes before, 6 months and one year after robotic-assisted laparoscopic sacral colpopexy.


Eligibility criteria:
inclusion criteria: * all patients who underwent robotic assisted laparoscopic sacral colpopexy exclusion criteria: * any other procedure for the treatment of pelvic organ prolapse

Keywords: pelvic organ prolapse constipation bowel dysfunction irritable bowel syndrome (ibs) cradi-8 craiq-7 splinting with defecation excessive straining bowel movements fecal incontinence bowel symptoms
vitamin d and adipose tissue: a complex relationship

Conditions: Hypovitaminosis D

Summary: the goal of this observational study is to verify the role of adipose tissue in determining the vitamin d serum level after monthly oral administration in subjects with vitamin d deficiency. the main questions it aims to answer are: * adipose tissue represents a storage environment for vitamin d or it's an environment where vitamin d is sequestered and no longer released * on the other hands, it's possible to verify whether the adipose tissue carries out a bi-modal activity towards vitamin d * if adipose tissue exerts a bi-modal effect, it is possible to identify a specific threshold between the two effects participants will undergo anthropometric measurements (height, weight, waist/hip ratio waist circumference) at baseline and after 6 months of intake of cholecalciferol 50,000 iu/month

vitamin d deficiency and insufficiency are prevalent worldwide, and various factors contribute to their occurrence, including low sun exposure, poor dietary intake, obesity, and abdominal obesity. abdominal obesity, assessed by waist circumference (wc), is associated with metabolic syndrome and has been linked to low vitamin d levels. this study aimed to investigate the relationship between visceral adipose tissue (vat) and vitamin d levels, particularly examining the potential threshold for vitamin d storage and sequestration by adipose tissue. the study is conducted on patients with hypovitaminosis d in an internal medicine outpatient department. blood samples for the evaluation of calcium and vitamin d levels are collected at baseline and after six months of monthly cholecalciferol supplementation. ultrasonography are used to evaluate adipose tissue measurements, including subcutaneous adipose tissue thickness, vat, preperitoneal adipose tissue (ppat), and prerenal adipose tissue (prat). anthropometric measures such as waist-to-hip ratio and waist-to-height ratio are also assessed.

Eligibility criteria:
inclusion criteria: * vitamin d level \< 20 ng/ml * bmi \> 24 exclusion criteria: * administration of vitamin d metabolites in the last year * previous diagnosis of metabolic bone diseases * previous diagnosis of endocrine diseases * previous diagnosis of cancer

Keywords: vitamin d ultrasound adipose tissue storage
a study in healthy men to test how different doses of bi 1815368 are tolerated and how bi 1815368 is taken up in the body with or without food

Conditions: Healthy

Summary: single-rising dose (srd) part the main objectives of the srd part of this trial are to investigate safety, tolerability and pharmacokinetics (pk) of bi 1815368 in healthy male subjects following oral administration of single rising doses. bioavailability (ba) part the main objective of the ba part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.


Eligibility criteria:
inclusion criteria: * healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp),pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 45 years (inclusive) * body mass index (bmi) of 18.5 to 29.9 kg/m2 (inclusive) * signed and dated written informed consent in accordance with international council for harmonisation- good clinical practice (ich-gcp) and local legislation prior to admission to the trial exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmhg), diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * history of relevant orthostatic hypotension, fainting spells, or blackouts * further exclusion criteria apply
a study of immediate and delayed closure of type ii and iiia open tibia fractures

Conditions: Type II and IIa Open Tibia Fractures

Summary: delayed wound closure is considered by many to be the standard of care for the treatment of an open fracture. this study was conducted to determine the feasibility of a large multi-center prospective randomized clinical trial and collect the pilot data needed to compete for the funding for such a trial. the study was designed to compare immediate and delayed closure of gustilo type ii and iiia tibia diaphyseal fractures. the primary outcomes were the infection rates and fracture related complications in patients treated with immediate or delayed wound closure strategies.


Eligibility criteria:
inclusion criteria: * gustilo type ii-iiia tibia fracture * age greater than 15 years * fractures amenable to intramedullary nailing exclusion criteria: * excessive wound contamination * patient cardio-pulmonary or hemodynamic instability preventing prompt surgical intervention * impaired or absent consciousness * refusal of consent
the 36-month extension to follow up sub study

Conditions: Postphlebitic Syndrome; Post-Thrombotic Syndrome; Deep Vein Thrombosis

Summary: the purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop post-thrombotic syndrome (pts) during the 2 years of follow up in the sox trial.

the post-thrombotic syndrome (pts) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (dvt). affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. at present, there is little to offer for the treatment of this condition. prevention of pts is the key to reducing its burden on patients and society. elastic compression stockings (ecs) for two years following dvt could be helpful in preventing or delaying onset of pts at three years, however data supporting this is limited.

Eligibility criteria:
inclusion criteria: * consecutive patients with a first, symptomatic, objectively confirmed proximal dvt diagnosed within the last 14 days (with or without concurrent distal dvt or pulmonary embolism) * who have no contraindications to standard treatment with heparin and/or warfarin, and * who provide informed consent to participate exclusion criteria: * contraindication to compression stockings * limited lifespan (estimated \< 6 months) * geographic inaccessibility preventing return for follow-up visits * inability to apply stockings daily and unavailability of a caregiver to apply stockings daily * treatment of acute dvt with thrombolytic agents

Keywords: elastic stockings stockings, compression randomized controlled trials quality of life
immune response to respiratory syncytial virus (rsv) in health care workers

Conditions: Healthy

Summary: respiratory syncytial virus (rsv) is a human restricted pathogen and is the single most important cause of severe respiratory illness in infants and young children, a major cause of infantile bronchiolitis and is the most frequent cause of hospitalization of infants and young children in industrialized countries. severe rsv infection early in life is associated with an increased risk of subsequent recurrent wheezing and asthma. there are few population-based estimates of the incidence of rsv disease from developing countries, but the existing data clearly indicates that the virus accounts for a high proportion of acute respiratory infections (ari) in children. studies in brazil, colombia and thailand suggest that rsv causes 20-30% of ari cases in children from 1-4 years of age, a proportion similar to that in industrialized countries, and who has estimated the global rsv disease burden at 64 million cases and 160 000 deaths every year. rsv also causes severe disease in elderly and immune-compromised adults, and the burden of rsv disease in the elderly is comparable to that of seasonal influenza. the economic impact of rsv-related disease in adults estimated to be greater than that of influenza in relation to numbers of days lost from work. the development of a safe and effective vaccine against rsv would benefit greatly from data on the immune responses in healthy adults naturally exposed to the virus. rsv infection has been shown to increase and induce short-lived circulating antibody secreting cells and produce an increase in the rsv specific antibody titres but very limited data is available on the cellular immune responses induced by rsv during natural infection in healthy adults. the existence of cell mediated immune response against rsv in humans has been described but characterization of this response remains poor and simultaneous analysis of several immunological parameters have not been attempted in an rsv exposed population before.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study and comply with study requirements * male or female, aged from 18 to 60 in healthy status. * working on a paediatric ward which admits acute medical paediatric admissions during the rsv season (group 1 only). exclusion criteria: * history of any immunodeficiency or immunological disorder which could affect the acquisition of rsv responses. * use of immunosuppressive medications such as steroids. * working on an nhs ward or in close contact with populations at higher risk of rsv transmission (e.g. nursery workers, care home workers, parents of young children) during the rsv season (group 2 only).

Keywords: rsv immune response
changes in the distribution of mitochondria during oocyte maturation

Conditions: Infertility

Summary: cytoplasmatic maturation is an important event in the general maturation of of the oocyte. mitochondria is one of the major organelles involved in the process of cytoplasmatic maturation. the aim of this study is to investigate the presence and distribution of the mitochondria in the cytoplasma of immature oocytes that are retrieved in the routine in-vitro maturation cycle with intracytoplasmatic sperm injection (icsi). these oocytes will not undergo icsi because of their immaturity. usually, they are discarded. in addition to these immature oocytes the investigators shall also investigate the mitochondria in mature oocytes that underwent icsi but did not become fertilized and are discarded.


Eligibility criteria:
inclusion criteria: * infertile patients needing ivf treatment exclusion criteria: * patients not requiring the icsi procedure
acute and chronic pain after one-stage hybrid arrhythmia ablation surgery

Conditions: Arrythmia; Chronic Pain; Acute Pain; Post Operative Pain

Summary: after one-stage hybrid arrhythmia ablation surgery there are possible side effects like acute and chronic pain. there is a lot of research surrounding these pains but not specifically after one-stage hybrid arrhythmia ablation surgery. the investigators want to research factors that may be associated with the absence of chronic pain after hybrid ablation include ketamine, peroperative opioids, loco-regional blocks, neuraxial blocks, wound infiltration, postoperative patient-controlled analgesia. the presence of corticosteroids or nsaids, will also be evaluated. furthermore, non-adaptable factors such as genetics complicate the onset of chronic post-operative pain. taking existing knowledge in this field into account, incidence risk as well as acute pain duration and intensity and their effects on chronic pain will become the primary focus of this study. the investigators will contact all patients who had a one-stage hybrid arrhythmia ablation surgery at uz brussels. participants will be sent a questionnaire with a consent form in and a survey asking about their pain 3 months postop and their current pain management therapy.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * he/she must understand and read the dutch, french or english language * be able to digitally agree to participate in the study * had to have a one stage hybrid procedure at least three months ago * have an asa score of i, ii or iii. exclusion criteria: * patients with previously known chronic pain syndromes, fibromyalgia, complex regional pain syndrome are excluded. * subjects with previous known chronic conditions such as diabetes neuropathy, rheumatoid arthri-tis, ... are also excluded. * subject are excluded if they underwent a surgical treatment within the observed period. * patients are excluded when under treatment with chemotherapy/radiotherapy * pregnant patients are also excluded. * patients with known psychological conditions such as depression are excluded.
a study of an investigational drug sitagliptin for type 2 diabetes mellitus (0431-044)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus exclusion criteria: * patients with type 1 diabetes mellitus
continuous endotracheal cuff pressure control to prevent ventilator associated respiratory infections

Conditions: Mechanical Ventilation Complication; Tracheal Intubation Morbidity; Ventilator-Associated Pneumonia; Hospital Acquired Infection

Summary: the purpose of the study is to determine whether automated cuff pressure control results in a reduction in the proportion of patients developing ventilator associated respiratory infections during their stay in intensive care.

the proposed study is a randomized controlled trial of tracheal cuff pressure control using continuous control via an automated electronic device as compared with intermittent pressure control for the prevention of ventilator associated respiratory infection in icu. the study will be conducted at multiple sites in vietnam. recruitment will be for 18 months at all centers. patients experiencing any hospital acquired infection whilst at risk of ventilator associated respiratory infections will be evaluated in using a standardised investigation protocol to identify cases of vari and other hospital acquired infections (hai)s. assessment of vari will be based on published criteria and carried out by an endpoint review committee independent of patient care and blinded to the allocation of the patient. antibiotic use data and duration of stay will be important secondary outcome measures.

Eligibility criteria:
inclusion criteria: * about to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy) * for active treatment exclusion criteria: * previously enrolled in this study * previously intubated within 14 days * suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury

Keywords: cuff pressure ventilator associated pneumonia respiratory tract infections
evaluation of the effects of different rapid maxillary expansion appliances on obstructive sleep apnea

Conditions: Sleep Apnea Syndrome; Rapid Maxillary Expansion

Summary: rapid maxillary expansion (rme) is a commonly used orthodontic treatment in patients with maxillary constriction to provide skeletal expansion, correct posterior crossbite and resolve naso-respiratory problems by reducing oral respiration.the aim of this randomized controlled trial was to evaluate the effects of tooth-borne, tooth tissue-borne and bone-borne rme appliances on sleep quality with polygraphy. the null hypothesis was that there is no difference for the sleep quality between the appliances.

introduction. the aim of this 3-arm randomized controlled trial (rct) was to evaluate the effects of tooth tissue-borne (kbme), tooth-borne (hyrax), and bone-borne (midme) rapid maxillary expansion (rme) appliances on sleep quality with polygraphy. methods. this study was designed in parallel with an allocation ratio of 1:1:1. 46 patients with narrow maxilla and osas were included in this study and randomly assigned to three groups: tooth tissue-borne, tooth-borne and boneborne expanders. participants were congregated from the department of orthodontics, faculty of dentistry, izmir katip celebi university, turkey. in all groups, the expansion appliance was activated one-quarter turn twice a day until the desired suture opening was achieved. the primary outcome of this study was the correction of posterior crossbite. secondary outcomes included polygraphic assessment of sleep parameters. each subject participated in 1 overnight sleep test with polygraphy before the expansion (t0) and after a 3- month retention phase of treatment (t1). according to the results of polygraphy, 7 parameters; (apnea hypopnea index (ahi), number of apnea and hypopnea, desaturation index, lowest desaturation, average saturation, supin ahi) were examined to evaluate the changes in sleep scores. kruskal-wallis analysis and dunn-bonferroni test were used for inter-group comparisons and wilcoxon analysis was used for intra-group evalaution. p\<0.05 was accepted statistically significant. computer-generated randomization was used with group allocation concealed using opaque, sealed envelopes. the outcome assessor was blinded to group assignment. the outcome assessor was blinded; however, it was not feasible to blind either operator or patients.

Eligibility criteria:
inclusion criteria: 1. no previous tonsillar, nasal or adenoid surgery and orthodontic treatment, 2. bilateral crossbite and need for rme, 3. maxillary and mandibular permanent teeth fully erupted, 4. ahi ≥ 1 exclusion criteria: 1. the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy 2. having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene, 3. history of previous orthodontic treatment.

Keywords: obstructive sleep apnea rapid maxillary expansion polygraphy
vildagliptin versus sitagliptin - differences in fasting plasma glucose lowering efficacy

Conditions: Diabetes Mellitus Type 2

Summary: this study is designed to assess the potential difference in fasting plasma glucose (fpg) lowering efficacy between the two dpp-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.


Eligibility criteria:
inclusion criteria: patients with type 2 diabetes 18 to 85 years metformin monotherapy \> 4 weeks hba1c 6.5 - 9.5% exclusion criteria: fpg \> 270 mg/dl use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (mi, stroke...)

Keywords: diabetes mellitus type two t2dm vildagliptin sitagliptin fpg dpp-4
association between surgical timing and route of total hysterectomy after leep and perioperative risk in patients with cervical hsil

Conditions: High-Grade Squamous Intraepithelial Lesions

Summary: this study aimed to analyze perioperative information in patients with high-grade squamous intraepithelial lesion (hsil) undergoing total hysterectomy (th), offering insights into optimal surgery timing, selecting the operation path, and enhancing surgical operation details.


Eligibility criteria:
inclusion criteria: * patients were confirmed with hsil through pathology at our hospital or another tertiary facility, with additional confirmation via pathological consultation at our facility; * lh or abdominal hysterectomy (ah) +/- bilateral fallopian tube or bilateral adnexectomy was performed after leep; * the patient had no history of systemic malignancies. exclusion criteria: * severe medical and surgical complications; * an extensive or subextensive hysterectomy was performed; * surgical removal scope involving tissues (such as lymph nodes) or organs (such as the appendix) other than the uterus, ovaries, and fallopian tubes; * fever symptoms within the last month; * incidence of pelvic and abdominal infections, vaginitis, or similar conditions within the past month.