Kornimate/medical-research-clean huggingface dataset:
medium term outcome of nonoperative treatment after achilles tendon rupture.

Conditions: Achilles Tendon Rupture

Summary: a total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. this study consists of an additional follow up after 4-5 years depending on original date of injury.

30 patients suffering from acute achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. originally patients was monitored using: atrs questionnaires, atra: achilles tendon resting angle, heel raise work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.

Eligibility criteria:
inclusion criteria: * suffered acute achilles tendon rupture from april 2011 to march 2012, and then referred to copenhagen university hospital hvidovre. * participated and completed the original study. * the patient must be able to speak and understand danish, as well as be capable to give informed consent to participating. exclusion criteria: * terminal disease or serious illnesses with an asa score of 3 or above. * any injury significantly influencing gate and function of the lower extremities other than re-rupture of the achilles tendon.

Keywords: achilles tendon rupture conservative treatment early weight bearing dynamic atrs atra heel raise work
factors affecting newborn body composition and later health in helsinki birth cohort 2018-2022

Conditions: Offspring, Adult; Lifestyle; Obesity, Childhood; Pregnancy Related; Child Development

Summary: in helsinki birth cohort 2018-2022 a large, longitudinal and well-phenotyped birth cohort of infants and their parents will be established. mothers, fathers/spouses and their children in helsinki and uusimaa hospital district are recruited in the study and newborn composition of the children born in helsinki women's hospital will be measured. data on maternal and paternal diet quality, physical activity and depression during and after pregnancy will be collected and data from the hospital and national registers will be collected. health of offspring and parents will be followed during their later life.

helsinki birth cohort 2018-2022 (hebico) study is designed to find evidence between various intrauterine exposures and offspring adiposity and later health. it will be examined how different maternal (e.g. chronic diseases, ethnicity, bmi), and obstetric factors (e.g. gestational weight gain, diagnoses during pregnancy) as well as parental lifestyle and psychological aspects (e.g. diet quality, physical activity, depression and anxiety) are associated with newborn body composition and later health (e.g. obesity and neurocognitive health). in the first phase of the study the participants are recruited on postnatal ward after delivery. the umbilical cord blood sample will be collected of all the neonates. after a consent the participants fill in the digital background, food frequency, depression and physical activity questionnaires. if the parents do not give their consent, the umbilical cord blood sample will be destroyed. body composition of offspring will be assessed within 72 hours after birth. registry data will be collected. the second phase of the hebico study is based on the hus womenshub treatment path and/or apotti platform. the second phase of the hebico constitutes of the mother-child pairs (and fathers/spouses) whose pregnancy can be followed from the early pregnancy to the end of the pregnancy through treatment path. body composition of offspring born in helsinki women's hospital will be assessed within 72 hours after birth. the future studies will include 1) the intervention studies with digital service concept through womenshub platform, and 2) the follow-up studies of offspring and parents in later life (to establish e.g. growth trajectories and later metabolic health of offspring). the first phase of the hebico study was registered 3/2018. the second phase will be registered now.

Eligibility criteria:
inclusion criteria: mothers, fathers/spouses and offspring in helsinki and uusimaa hospital district. exclusion criteria: inability to communicate in finnish language
repetitive transcranial magnetic stimulation and the development of ongoing muscle pain

Conditions: Pain Relief

Summary: the main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rtms) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.

this study aims to investigate whether i) rtms of left dlpfc will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (ngf) injection; ii) the analgesic effects of left dlpfc rtms will be related to an improved cognitive network function as assessed by electroencephalography (eeg).

Eligibility criteria:
inclusion criteria: * healthy men and women * speak and understand english. exclusion criteria: * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses * lack of ability to cooperate * history of chronic pain or current acute pain * previous experience with rtms * contraindications to rtms application (history of epilepsy, metal in the head or jaw etc.). * failure to pass the "tass questionnaire" (tass = transcranial magnetic stimulation adult safety screen)

Keywords: nerve growth factor repetitive transcranial magnetic stimulation dorsolateral prefrontal cortex
biosimilar of adalimumab, an european evaluation

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Crohn Disease; Ulcerative Colitis

Summary: the study objective is aimed to describe all country, site, investigator and patient variables that lead to treatment persistence for at least 12 months among patients with rheumatologic and intestinal chronic inflammatory diseases who were switched to fk adalimumab, in order to develop a model to predict persistence at 12 months.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years, male or female. 2. patients diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (crohn's disease, ulcerative colitis) diseases. 3. patients who have been switched to fk adalimumab from the reference product (humira®) or another adalimumab biosimilar. 4. patients who have been prescribed fk adalimumab according to the smpc prior to the inclusion. 5. patients able to understand and complete the study questionnaires in local language during the study visits. 6. patients willing to sign informed consent to meet data protection requirements exclusion criteria: 1. unwillingness to provide written informed consent. 2. patients participating or expected to participate in any randomised clinical trial during their treatment with fk adalimumab. 3. patients not expected to be available for study visits during 12 months.

Keywords: adalimumab biosimilar
a study of blue light flexible cystoscopy with cysview in the detection of bladder cancer in the surveillance setting

Conditions: Bladder Cancer

Summary: the purpose of this study is to investigate if blue light cystoscopy with cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the karl storz d-light c pdd flexible videoscope system. another purpose is to investigate if cysview and blue light is safe and effective when used repeatedly.


Eligibility criteria:
1. patients with bladder cancer in follow-up for tumor recurrence (note: patients must be included only at the first surveillance cystoscopy after a histologically confirmed tumor. the histologically confirmed tumor could either be from a turb or from a surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by histology) 2. history of one or more of the following: * multiple tumors * recurrent tumors * high grade tumor(s) exclusion criteria: 1. gross haematuria. (note: gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy) 2. patients who cannot undergo in-office or operating room cystoscopy (note: training patients are eligible even if they cannot undergo operating room cystoscopy) 3. patients who have received bacillus calmette-guérin (bcg) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure 4. porphyria 5. known allergy to hexaminolevulinate hydrochloride or a similar compound 6. pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study 7. participation in other clinical studies with investigational drugs either concurrently or within the last 30 days 8. patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 9. patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study

Keywords: non-muscle invasive bladder cancer nmibc cysview
research evaluating a pde5 inhibitor for erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction


Eligibility criteria:
inclusion criteria: * males ≥ 18 years of age; * minimum 6 months of erectile dysfunction; * in a monogamous, heterosexual relationship for at least 3 months; * agree to make at least 4 attempts at intercourse per month; * provide written informed consent; * agree not to use any other ed treatments for erectile dysfunction; * willing and able to comply with all study requirements. exclusion criteria: * allergy or hypersensitivity to pde5 inhibitors; * history of dose-limiting aes with a pde5 inhibitor or discontinued use of a pde5 inhibitor; * concomitant use of one or more of the following medications: * other prescription or otc drugs known to interfere with metabolism by the cyp 3a4 enzyme; * dose of an alpha blocker that has not been stable for at least 14 days; * any nitrate; * ed as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy; * myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months; * unstable angina, angina with sexual intercourse, or congestive heart failure \> nyha class ii; * poorly controlled type 1 or type 2 diabetes; * evidence of prostate cancer or previous radical prostatectomy; * untreated hypogonadism or total testosterone levels outside normal reference range; * abnormal laboratory value(s) judged to be clinically significant by the investigator; * positive urine drug screen; * history of retinitis pigmentosa, nonarteritic anterior ischemic optic neuropathy or glaucoma; * previous participation in any other study with avanafil; * use of any other investigational medication or device for any indication within 30 days prior to enrollment or at any time during this study; * evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, contraindicate sexual activity or confound the interpretation of study results.

Keywords: ed
a study to investigate the safety and tolerability of ziftomenib in combination with venetoclax/azacitidine, venetoclax, or 7+3 in patients with aml

Conditions: Acute Myeloid Leukemia; Mixed Lineage Acute Leukemia; Mixed Lineage Leukemia Gene Mutation; Mixed Phenotype Acute Leukemia; Refractory AML; AML With Mutated NPM1; Acute Myeloid Leukemia Recurrent; Acute Myeloid Leukemia, in Relapse; NPM1 Mutation; KMT2Ar; Myeloid Sarcoma

Summary: this phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, npm1-m and kmt2a-r.


Eligibility criteria:
key inclusion criteria: * patients must have a documented npm1 mutation or kmt2a rearrangement and have either newly diagnosed or relapsed/refractory aml * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * adequate liver, renal, and cardiac function according to protocol defined criteria * a female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. a male of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention key exclusion criteria: * diagnosis of either acute promyelocytic leukemia or blast chronic myelomonocytic leukemia * known history of bcr-abl alteration * advanced malignant hepatic tumor \[for patients receiving ven/aza combination\] * administration of live attenuated vaccines within 14 days prior to, during, or after treatment until b-cell recovery * active central nervous system (cns) involvement by aml. * clinical signs/symptoms of leukostasis or wbc \> 25,000 / microliter. hydroxyurea and/or leukapheresis are permitted to meet this criterion * not recovered to grade ≤1 (nci-ctcae v5.0) from all nonhematological toxicities except for alopecia * known clinically active human immunodeficiency virus, active hepatitis b or active hepatitis c infection * for newly diagnosed cohorts: received prior chemotherapy for leukemia, except hydroxyurea and/or leukapheresis to control leukocytosis, prior treatment with all-transretinoic acid for initially suspected acute promyelocytic leukemia, or non-hma therapy for prior myelodysplastic syndrome * for relapsed/refractory cohorts: received chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational \< 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug * uncontrolled intercurrent illness including, but not limited to, cardiac illness as defined in the protocol * mean corrected qt interval corrected for heart rate by fredericia's formula (qtcf) \>480 ms on triplicate ecgs * uncontrolled infection * women who are pregnant or lactating * an active malignancy and currently receiving chemotherapy for that malignancy or disease that is uncontrolled/progressing
seizure treatment in glioma

Conditions: Glioma

Summary: currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. the overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.

currently, treatment of glioma patients with a specific anti-epileptic drug (aed) mainly depends on the physicians' preference, as there is no robust evidence from randomized controlled trials supporting the use of one specific anticonvulsant above the other in glioma patients. levetiracetam and valproic acid are the most commonly used aeds in glioma patients. both drugs are used for the treatment of seizures, have similar toxicity profiles and are non-enzyme inducing aeds, therefore not interfering with chemotherapeutic drugs. however, it is not known whether one drug is more effective than the other in reducing seizures.

Eligibility criteria:
inclusion criteria: * histologically proven or suspected diffuse astrocytoma (isocytrate dehydrogenase-1 (idh-1) wildtype or idh-1 mutated), diffuse oligodendroglioma (idh-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (idh-1 wildtype or idh-1 mutated), anaplastic oligodendroglioma (idh-1 mutated and 1p/19q co-deleted), glioblastoma (idh-1 wild-type or idh-1 mutated), or diffuse astrocytoma not otherwise specified (nos), anaplastic astrocytoma nos, oligodendroglioma nos, oligoastrocytoma nos, anaplastic oligoastrocytoma nos, anaplastic oligodendroglioma nos or glioblastoma nos. * adult patients: ≥18 years of age * first epileptic seizure, no longer than 2 weeks ago * monotherapy with antiepileptic drugs is considered most appropriate at the time of randomization * willing to provide written informed consent exclusion criteria: * previously treated with antiepileptic drugs, except emergency treatment in the past 2 weeks * history of non-brain tumor related epilepsy * pregnancy * presence of contra-indications for use of levetiracetam or valproic acid
quality of life in patients with inoperable malignant bowel obstruction

Conditions: Intestinal Obstruction

Summary: the primary objective of the study is to evaluate the impact on quality of life of lanreotide autogel 120 mg in combination with standard care, in comparison to the standard care alone, in subjects affected by inoperable malignant bowel obstruction.


Eligibility criteria:
inclusion criteria: * subjects must demonstrate willingness to participate in the study and to be compliant with any protocol procedure. * provision of written informed consent prior to any study related procedure. * diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report. * in case of peritoneal carcinomatosis, diagnostic confirmation by ct or mri scan. * confirmed as inoperable after medical advice. * patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours. * patient life expectancy must be more than 14 days. exclusion criteria: * has operable obstruction or any sub-obstruction. * has bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc). * has signs of bowel perforation. * has prior treatment with somatostatin or any analogue within the previous 60 days. * has a known hypersensitivity to any of the study treatments or related compounds. * is likely to require treatment during the study with somatostatin or any analogue other than the study treatment. * is at risk of pregnancy or lactation, or is likely to father a child during the study. females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral or double barrier contraception. non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study. * has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. * has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
effect of tadalafil on insulin secretion and insulin sensitivity in obese men.

Conditions: Obesity

Summary: obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors. tadalafil is is a drug inhibiting the enzyme phosphodiesterase-5 (pde-5), responsible for inactivating the vasodilator nitric oxide. using paragraph was mainly treat erectile dysfunction, and recently approved for the treatment of pulmonary hypertension , it is innovative because of its longer life means, provides efficacy after 36 hours and the highest selectivity. the aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and insulin secretion in obese men. the investigators hypothesis is that the administration of tadalafil improve the insulin sensitivity and insulin secretion in obese men.

a randomized, double-blind, placebo-controlled clinical trial in 18 men aged between 30 and 50 years with obesity (bmi 30-39.9) according to the world health organization (who) criteria without treatment. they will be assigned randomly in two groups of 9 patients, each to receive 5 mg of tadalafil or placebo every day at night during 28 days. there will be evaluated insulin secretion, both first phase of insulin secretion by stumvoll inex as well as total insulin secretion by area under the curve of glucose and insulin and insulinogenic index, and insulin sensitivity by matsuda index. waist circumference, glucose and insulin levels, lipid profile and blood pressure are going to be load will be evaluated before and after intervention in both groups. statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. qualitative variables will be analyzed by x2, will be used for differences inter-group mann-whitney u test and wilcoxon test for the within-groups differences. will be considered statistical significance p ≤0.05. this protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Eligibility criteria:
inclusion criteria: * men * age: 30-50 years * bmi: 30 to 39.9 kg/m² * no pharmacotherapy during the last 3 months * signature consent under information exclusion criteria: * cholesterol: ≥ 240 mg / dl * triglycerides: ≥ 400 mg / dl * fasting glucose: ≥ 126 mg / dl * diabetes mellitus. * hypertension * patients with renal, liver and / or thyroid disease * consumption of drugs with known effects on glucose or insulin metabolism. * use of cigar and / or drugs * hypersensitivity to tadalafil

Keywords: obesity tadalfil insulin secretion insulin sensitivity