Kornimate/medical-research-clean huggingface dataset:
emd 1201081 + 5-fu + cisplatin + cetuximab in subjects with recurrent / metastatic squamous cell carcinoma of the head and neck

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: the primary purpose of this trial is to assess the safety and tolerability of emd 1201081, a novel immunomodulatory agent that is an agonist of tlr9, in combination with 5-fu/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (mtd) among the dose levels.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (scchn). * recurrent and/or metastatic scchn, not suitable for local therapy. * at least 1 measurable lesion either by computerized tomography (ct) scan or magnetic resonance imaging (mri) (according to recist 1.0). * karnofsky performance status (kps) of ≥ 70 / eastern cooperative oncology group performance status (ecog ps) of 0 or 1 at trial entry. exclusion criteria: * prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry. * nasopharyngeal carcinoma. * medical history of diagnosed interstitial lung disease. * known hypersensitivity against any of the components of the trial treatment. * previous treatment with experimental or non-approved epidermal growth factor receptor (egfr) targeting therapy or experimental or nonapproved egfr signal transduction inhibitors (prior treatment with cetuximab is allowed). * relevant cardiovascular co-morbidities. * concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent. * known human immunodeficiency virus (hiv) positivity, active hepatitis c, or active hepatitis b.

Keywords: safety tolerability maximum tolerated dose of emd 1201081 tlr9 agonists squamous cell carcinoma of the head and neck first line subjects recurrent/metastatic
pilot study describing the early evolution of the sexual function of patients receiving adjuvant hormone therapy for breast cancer

Conditions: Breast Cancer

Summary: the 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life". the impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment. none of these studies specifically assessed the early impact on the quality of sexual life of patients. the purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * female gender * histologically proven non-metastatic breast cancer * indication of adjuvant hormone therapy * patient able to understand a newsletter and to agree to participate exclusion criteria: * age under 18 years * pregnant woman * adjuvant chemotherapy * patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship) * persons protected or deprived of their liberty * male
the capture study: validating a unique copd case finding tool in primary care (aim 1)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: a prospective multi-center study to define the sensitivity and specificity of capture for identifying previously undiagnosed patients with clinically significant copd in a broad range of primary care settings.

the capture tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (pef) measurement, designed to identify clinically significant copd. for aim 1 approximately 5,000 patients will be recruited across 100 participating primary care clinics. eligible participants will undergo a baseline visit during which the capture tool and pef will be obtained, as well as spirometry and other participant characteristics.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 45-80 years exclusion criteria: 1. previous clinician provided diagnosis of copd 2. treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days of baseline 3. participants unable to perform spirometry due to any of the following conditions within the past 30 days of baseline 1. chest surgery 2. abdominal surgery 3. eye surgery 4. heart attack 5. stroke

Keywords: capture, copd
the clinical significance of sentinel lymph node imaging combined with imaging examination in pelvic and peritoneal lymphadenectomy for endometrial carcinoma

Conditions: Endometrial Carcinoma; Lymphadenectomy

Summary: the aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management.

the clinical data including surgical procedure, the situation of sentinel lymph node imaging and pathological results of patients with endometrial carcinoma treated in our hospitals between april 2019 and april 2021 will be analyzed in this study to clarify the homogeneity of imaging evaluation, sentinel lymph node development evaluation and pathological results.

Eligibility criteria:
inclusion criteria: 1. females who are diagnosed with endometrial carcinoma; 2. patients who are willing to receive primary non-reserved fertility function surgery to treat their disease; 3. patients who are agreed to participated in this prospective cohort study. exclusion criteria: 1. patients who still have the will to have pregnancy; 2. patients who have other diseases or heavy injuries that will interfere with the results; 3. simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
lach-trial: laparoscopic correction of hernia

Conditions: Incisional Hernia; Ventral Hernia

Summary: method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain. the study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.

one of the complications in laparoscopic incisional / ventral hernia repair is postoperative pain. method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of this postoperative pain. fixation of the mesh might also influence other outcome parameters such as return to preoperative activities, costs and recurrence rate. the study hypothesis is that there is no difference in postoperative pain when comparing three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia repair.

Eligibility criteria:
inclusion criteria: * non-acute incisional hernia of the abdominal wall or ventral hernia of the abdominal wall * informed consent * elective surgery exclusion criteria: * \ 80 years * prednison \> 15 mg/24hr, started more than 2 weeks prior to surgery * chronical cough (severe copd etc) * ascites * peritoneal dialysis * current abdominal infection * complete loss of abdominal domain due to hernia (diameter more than 10 cm?) * re-laparoscopic correction of ventral hernia

Keywords: laparoscopic correction ventral and incisional hernia mesh fixation postoperative pain
drug-drug interaction study with glpg3667 and midazolam in healthy subjects

Conditions: Healthy

Summary: a study in healthy volunteers to look at the effect of the test medicine, glpg3667, on how midazolam (mdz) is taken up and eliminated by the body.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form. female subjects should be of non-childbearing potential, defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy, i.e. surgical removal of the fallopian tubes, or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause and a follicle-stimulating hormone level in the postmenopausal range. these female subjects must also have a negative pregnancy test. for surgical sterilization, documented confirmation will be requested. * a body mass index between 18.0 and 30.0 kg/m², inclusive. * judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ecg), and fasting clinical laboratory safety tests available at screening and prior to enrolment. neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be within normal ranges. other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator. this list only contains the key inclusion criteria. exclusion criteria: * known hypersensitivity to investigational product (ip) and/or mdz ingredients or history of a significant allergic reaction to ip and/or mdz ingredients as determined by the investigator. * treatment with any medication (including over-the-counter and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy for postmenopausal subjects) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing. this list only contains the key exclusion criteria.
a trial of cognitive training in schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia is associated with a wide range of symptoms impacting a number of different domains, including cognitive impairment. given the array of cognitive deficits associated with schizophrenia and their relationship to daily functioning, numerous research groups have examined the impact of cognitive remediation on many aspects of cognition. however, it is currently unclear as to which domains of cognition should be targeted to produce the most widespread and durable benefits for schizophrenia patients. it may be the case that targeting lower-level cognitive processes that are important for higher-level and more complex aspects of cognition may produce the most widespread benefits in cognition and everyday functioning. relatively few studies have examined the effects of working memory or processing speed training on individuals with schizophrenia, as most studies examine broad-based remediation programs. thus, there is a need for targeted working memory and processing speed training studies to better understand the mechanisms of cognitive enhancement through training in patients. this study will aim to: 1) investigate near-transfer gains associated with working memory and processing speed training in schizophrenia patients, 2) investigate far-transfer gains associated with working memory and processing speed training (i.e., gains in other neurocognitive domains and social cognition), and 3) investigate real-world gains associated with training (i.e., gains in daily functioning). towards this aim, 81 schizophrenia patients will be recruited and randomly assigned to a working memory training group, a processing speed training group, or a no training control group. training will be completed at home for 30 minutes per day, 5 days per week, for a total of 10 weeks. neurocognitive, social cognitive, and daily functioning measures will be administered both pre- and post-training to detect training-related gains.


Eligibility criteria:
inclusion criteria: * male or female * age between 18 and 65 years * a diagnosis of schizophrenia or schizoaffective disorder * minimum iq of 70 * no uncorrected visual impairment, including colour blindness * no uncorrected hearing impairment * able to provide informed consent exclusion criteria: * meeting diagnostic and statistical manual of mental disorders 5th edition (dsm-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode * past 1 month history of electroconvulsive therapy (ect) * past 1 month history of transcranial magnetic stimulation therapy (tms) * past 3 month history of substance abuse * diagnosed with a medical condition known to affect cognition (e.g., endocrine disease) * score less than 70 on the wechsler abbreviated scale of intelligence (wasi)

Keywords: cognitive training working memory processing speed
pet/ct imaging study with simultaneous dual-nuclide imaging technique

Conditions: Prostatic Neoplasms; Glioma; PARKINSON DISEASE (Disorder)

Summary: this is a study using a parallel control approach and is expected to recruit 35 volunteers, including 8 prostate cancer patients, 8 neuroendocrine tumour patients, 8 glioma patients, 8 parkinson's syndrome patients, and 3 normal volunteers, to undergo dual-nuclide pet/ct imaging and to validate the isolation effect and quantitative accuracy of simultaneous dual-nuclide imaging in humans.


Eligibility criteria:
inclusion criteria: * age: 18 \~75 years old (including boundary values); gender: male or female; normal volunteers: males weighing ≥50kg, females weighing ≥45kg, and body mass index \[bmi = weight (kg)/height 2 (m2)\] within the range of 19.0 \~ 26.0kg/m2 (including borderline values); patients with prostate cancer: patients with pathologically-confirmed biochemical relapsed or primary diagnosed prostate cancer with highly suspected systemic metastases on conventional imaging or psa levels; patients with neuroendocrine tumour patients: patients with net (g2-g3) or nec confirmed by pathology and highly suspected of having more than 3 metastases by conventional imaging; patients with glioma: patients with glioma confirmed by pathology or highly suspected by enhanced mri and proposed to undergo surgical resection; patients with parkinson's syndrome: patients with high clinical suspicion of parkinson's syndrome. subjects can fully understand and voluntarily participate in this experiment and sign an informed consent form. exclusion criteria: * those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness); those with alcohol allergy; and those who, in the opinion of the investigator, are unsuitable to undergo or are unable to complete imaging studies such as pet for specific reasons; under 18 years of age or ecog score \> 2; less than 1 month after completion of radiotherapy and less than 2 months after completion of octreotide treatment in patients with neuroendocrine tumours; women during pregnancy and breastfeeding; practitioners requiring prolonged exposure to radioactive conditions; serious diseases of heart, kidney, lung, vascular, nervous and mental systems, immunodeficiency diseases and hepatitis/cirrhosis; participation in other interventional clinical trials within 1 month prior to screening; presence of other conditions that, in the opinion of the investigator, make participation in this study unsuitable.
measurements of displacement amplitude and angular velocities during passive extension of the wrist and hand complex in stroke patients

Conditions: Muscle Spasticity; Stroke

Summary: the main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands. secondary objectives: * to compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers, * to compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger), * to assess pain due to mobilization in stroke patients.

conduct of research: the realization of the measures will take place at the ghrmsa rehabilitation department. after receiving the written consent of the study participant, the physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers. videos of the hand will be made using the darfish system which will allow analysis of the primary endpoint. two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. the order of mobilization will be determined by randomization.

Eligibility criteria:
eligibility criteria of stroke patients with hand spasticity: inclusion criteria: * age ≥ 18 years old * first stroke diagnosed less than 3 months ago * non-functional wrist defined by the fugl-meyer assesment (fma-eu) upper limb motor subscale with a score ≤45 * wrist flexor spasticity defined by the modified tardieu scale (mts) with a rating ≥1 * written informed consent exclusion criteria: - none eligibility criteria of healthy volunteers: inclusion criteria: * age ≥ 18 years old * written informed consent exclusion criteria: - none

Keywords: muscle spasticity mobilization wrist and hand complex
ultrasonography in diagnosis of polyneuropathy

Conditions: Polyneuropathies

Summary: the main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies.


Eligibility criteria:
inclusion criteria: * age 18-80 years * clinical signs of particular polyneuropathy not explained by other causes exclusion criteria: * entrapment or compression neuropathies * nerve trauma * the diagnosis of vasculitic neuropathy, neuralgic amyotrophy, diabetic radiculo-plexo-neuropathy, hereditary neuropathy with liability to pressure palsies and motor neuron disorders including monomelic amyotrophy.
noninterventional observational prospective longitudinal study of the incidence of ulcerative colitis and crohn's disease among the adult population of the republic of kazakhstan

Conditions: Ulcerative Colitis Chronic; Crohn Disease Colon

Summary: the nucacd study aims to develop a reliable registry of patients suffering inflammatory bowel diseases in the republic of kazakhstan.

the nucacd aims to study the prevalence of inflammatory bowel diseases in the republic of kazakhstan and create a reliable database, which will greatly facilitate future planning of the volume of health resources needed to address these diseases management and will help to optimize preventive measures and will support future research to better understand the etiology, new options treatment and factors affecting prognosis, relapses, development of complications and quality of life.

Eligibility criteria:
inclusion criteria: * availability of a signed informed consent form; or the presence of a disinterested witness if the patient is unable to examine and sign the consent form due to illiteracy or disability (for example, in the case of blindness); * the patient has a documented diagnosis of ulcerative colitis or crohn's disease (endoscopy, histology, if indicated by radiation diagnostics); * patients who have applied for treatment or are already taking treatment from a gastroenterologist / coloproctologist, including inpatients; * citizenship of the republic of kazakhstan (or resides). exclusion criteria: * patient takes part in an interventional clinical trial; * patient is unable to follow the schedule of the visits; * any condition that the pi believes would prevent a study participant from participating in the study.

Keywords: nonspecific ulcerative colitis crohn disease patient registry
eggs and age-related macular degeneration (eggsamd) study.

Conditions: Intermediate Age-Related Macular Degeneration

Summary: age-related macular degeneration (amd) is the primary cause of vision loss in people over the age of 55. currently, no cure is available for individuals suffering from amd. the purpose of this pilot study is to evaluate the feasibility of implementing a 5-month egg intervention in adults with intermediate amd. the objective of this research study is to evaluate the feasibility of a whole egg (2 or 4 per day) intervention in older adults with intermediate amd. the secondary objective of this research is to determine descriptive statistics, change over time and estimate effect sizes for retinal sensitivity, and vision, cognition and physical function. by completing these research objectives, the researchers hope to gain preliminary evidence in support of a larger trial that will assess the impact of egg consumption on eye health in adults with amd.


Eligibility criteria:
inclusion criteria: * capable to provide consent * diagnosed with intermediate dry amd as noted in their medical record (defined as having multiple medium drusen, at least one large druse (\>125 μm or the approximate size of a vessel coming off the optic nerve), and/or non-center involving geographic atrophy) who are bcva stable from prior exam within 6 months - defined by change of \< 10 letters on edtrs chart (bcva within 10 letters within past 6 months) * 55 years of age and older * willing to limit consumption of eggs for one month prior to beginning the study intervention * willing to follow diet protocol * body mass index (22.0 - 39.9 kg/m2) * access to refrigeration * access to reliable transportation exclusion criteria: * presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid and other macular pathology other than amd * presence of dense cataracts * presence of glaucoma * previous retinal laser or surgical therapy that has impacted the integrity of the retina * any other ocular condition requiring long-term therapy or surgery during the study period * participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing * diagnosis of nystagmus that will interfere with testing * egg allergy * uncontrolled hyperlipidemia (cholesterol \>240 mg/dl in the last 12 months, unless under active medication management to achieve \<240 mg/dl)

Keywords: intermediate age-related macular degeneration older adults eggs vision