Kornimate/medical-research-clean huggingface dataset:
calibration of the average breathing rate measurement of the cloud dx pulsewave health monitor (pad-2a) device (ccv-3)

Conditions: Outpatients

Summary: the purpose of this study is to calibrate the average breathing rate measurement of the pad-2a device to be within ±2 breaths per minute of clinical capnography breathing rate measurements.

the plan for this study is to calibrate the average breathing rate measurement of the pad-2a device with the breathing rate measurement of a standard clinical capnography device. the data will be collected and analyzed in order to calibrate the pad-2a device via the capnography measures by adjusting the device algorithm for the breathing rate measurements to be within ±2 breaths per minute. additionally, the secondary objective of this study is to compare the clinical standard respiratory rate measurement of capnography with the respiratory rate measurements of other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and the respiratory inductance plethysmography (rip) belts of the chest and abdomen).

Eligibility criteria:
inclusion criteria: * adults ≥ 19 years of age (minimum 30% male/female) * wrist circumference between 13.5cm - 23cm (5.3 in. - 9.1in.) * specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a gaussian distribution: lowest octile: ≥ 13.5cm to \< 14.7cm lower quarter: ≥ 13.5cm to \< 15.9cm lower-middle quarter: ≥ 15.9cm to \< 18.3cm upper-middle quarter: ≥ 18.3cm to \< 20.7cm upper quarter: ≥ 20.7cm to ≤ 23.0cm highest octile: ≥ 21.9cm to ≤ 23.0cm • willing to volunteer to participate and to sign the study specific informed consent form exclusion criteria: * wrist circumference less than 13.5cm (5.3 in.) or greater than 23cm (9.1 in) * hand or body tremors * canadian cardiovascular society (ccs) grade iii or iv angina pectoris (chest pain) * unexplained shortness of breath at rest * history of seizures (except childhood febrile seizures) * epilepsy * history of unexplained syncope (fainting) * pregnant * a musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm * unwilling to volunteer to participate and to sign the study specific informed consent form

Keywords: average breathing rate (breath per minute) vital sign monitoring telemedicine non-invasive device
identification of pattern and factors affecting recurrence in head and neck carcinoma

Conditions: Recurrent Head and Neck Squamous Cell Carcinoma

Summary: the study will evaluate the local experiences in treatment of head and neck carcinoma by retrospectively analyzing the incidence and location of recurrence, and also studying factors affecting this recurrence.

the investigators will evaluate the local experience in treatment of head and neck scc by retrospectively analyzing the incidence and location of recurrence, either; local recurrence (lr), regional recurrence (rr), or distant mets in eligible head and neck cancer patients treated with imrt and vmat in the period from 2018 till 2022 to allow a follow-up for at least 1 year.

Eligibility criteria:
inclusion criteria: * adults aged more than 18 years. patients with primary non nasopharyngeal head and neck squamous cell carcinoma. patients who were intended to receive radical treatment delivered by imrt and vmat techniques. exclusion criteria: * adults who had double malignancies. metastatic hnscc cases.
sufentanil pharmacokinetics after intra amniotic injection

Conditions: Prenatal Diagnosis

Summary: the fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure. to date, there is very little data and no consensus on fetal analgesia. the aim of the investigators study is to evaluate the pharmacokinetics of sufentanil after intra amniotic injection.


Eligibility criteria:
inclusion criteria: * termination of pregnancy for fetal malformation * gestational age \> 24 weeks of gestation exclusion criteria: * multiple pregnancy * allergy or contraindication to sufentanil * morphinic addiction * fetal gastroschisis, omphalocele or swallowing disorder * maternal cardiac or respiratory distress

Keywords: fetal pain fetal analgesia
pten hamartoma tumor syndrome pediatric patient registry

Conditions: PTEN Hamartoma Tumor Syndrome; Macrocephaly Autism Syndrome

Summary: ptenturkiye.org' is a national ( turkish), web-based registry for pten hamartoma tumour ( phts) syndrome established in 2022. it is designed to increase awareness, gather scientific knowledge by collaboration and increase data accessibility, collect high-quality data on the epidemiology, genetic background and natural history of phts especially for pediatric patients so that more accurate follow up guidelines can be recommended.

there is a limited understanding of the natural history of childhood-onset pten hamartoma tumour syndrome (phts) as a cancer predisposition syndrome. patient registries are important for longitudinal follow up of these patients. our aim is to create a turkish registry especially for pediatric phts patients, but registry is open to adult phts patients as well. the purpose is to engage families with children with phts in the data-sharing process to accelerate research and drug development and share their experiences with other families as a support if they agree to do so. the registry is open to both adults and children with phts. most pediatric patients with phts have autism spectrum disorders, developmental delays and/or intellectual deficiencies. patient registry will help us see if they are getting appropriate behaviour interventions. there is no consensus on the guidelines for cancer surveillance in children. the investigators will follow these patients according to 'pediatric follow-up protocol for pten (phosphatase and tensin homolog) mutated children' created by ciaccio et al. patient registry will also help if these guidelines are sufficient or need improvements. once the individual or their parent/guardian has consented to participate in the registry, the researchers will collect their past and current medical, familial, and other necessary demographic information from their medical records and face to face interviews. the investigators will follow up patients every 6 months or earlier if needed. the investigators will do thorough physical and dysmorphological exam (using autism research exchange dysmorphology check list). for patients with autism and other behavioral problems, the investigators will refer them to child and adolescent psychiatry clinics for evaluation.

Eligibility criteria:
inclusion criteria: * patients who have clinical findings of phts and have mutation in pten gene ( vus included if show clinical findings) and agree to participate in the study exclusion criteria: * patients who do not have clinical findings of phts and do not have mutation in pten gene and do not agree to participate in the study

Keywords: phosphotase and tension holomog macrocephaly autism pten
the role of follicle stimulating hormone in advanced prostate cancer

Conditions: Prostate Cancer Recurrent

Summary: in order to elucidate if fsh can have testosterone like effects, samples from young, non-smoking healthy volunteers, with normal body mass index, and with pharmacologically induced gonadotropin deficiency will be studied regarding their capacity to induce prostate specific antigen (psa), which normally is regulated by testosterone.

normally, prostate specific antigen (psa), which is a marker for prostate disease and progression, is exclusively produced in response to testosterone. in order to elucidate if follicle stimulating hormone (fsh) can have testosterone like effects, samples from n=30 non-smoking healthy volunteers, 20-30 years of age and with normal body mass index (20-25) with pharmacologically induced gonadotropin deficiency will be studied. the men are currently recruited and during 5 weeks undergoing: 1. pharmacologically induced gonadotropin deficiency w 1-3; 2. fsh-treatment of 50% (group a), w 1-5; 3. testosterone (t) treatment of all (group a and b) w 4-5; 4. end and follow up after 5 weeks. a subcutaneous injection with the gnrh antagonist degarelix (240 mg¸ ferring gmbh wittland, kiel, germany) results in drop of both fsh and lh-induced testosterone. half of the men will get recombinant fsh (300 iu; gonal-f, merck serrono s.a. aubonne, schweiz) back, whereas 50% will not. three weeks thereafter, the full spectrum of fsh dependent changes occur and are reflected in blood. from this occasion testosterone (nebido, ferring gmbh wittland, kiel, germany) will be given to all participants to diminish the side-effects of the castration. blood samples are collected at start, after 3 wks and after 5 wks. at that point also a follow up is undertaken. this experimental design will provide samples from each individual during normal conditions, during castration, and after a standardised dose of fsh.

Eligibility criteria:
inclusion criteria: healthy, non-smoking, body mass index 20-25, exclusion criteria: medication or drug abuse -
a multicenter real-world study of screening of cervical cancer based on photoelectric detection

Conditions: Uterine Cervical Cancer; High Grade Squamous Intraepithelial Lesions; Low Grade Squamous Intraepithelial Lesions

Summary: the main purpose of this study is to explore the accuracy and clinical value of fluorescent photoelectric cervical lesion image detector as a screening and shunt tool for cervical lesions through a multi-center, large-sample real-world study with histopathology as the gold standard. the secondary purpose of the study was to verify the coincidence of the fluorescent photoelectric cervical lesion image detector with traditional colposcopic chemical staining. this study is expected to include 20,000 participants with definite histological results, and compare the specificity and sensitivity, negative predictive value and positive predictive value of three cervical lesion screening methods, such as fluorescent photoelectric cervical lesion image detector, hpv nucleic acid detection and cytology detection. the advantages and disadvantages of fluorescent photoelectric cervical disease image detector, hpv nucleic acid detection and cytology examination were analyzed, and their application scenarios were provided to provide evidence-based medical support for the establishment of comprehensive prevention and treatment system of cervical cancer suitable for china's national conditions.


Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years old, ≤ 65 years old, with a complete cervix without deformity. * 2. have clear cervical cancer screening results, meet hpv16/18 (+) or high-risk hpv (+), and cervical cytology results ≥ asc-us. * 3. fully informed and agreed to participate in the study. * 4. no history of cervical cancer disease and cancer in other parts. exclusion criteria: * 1. cannot meet all inclusion criteria. * 2. there is clear immunosuppression, such as hiv infection or organ transplantation, etc., and the vagina or cervix is in the acute inflammation stage。 * 3. there are serious bleeding diseases or photosensitive diseases such as abnormal coagulation.
open label extension to bridging study ctbm100c2303

Conditions: Pseudomonas Aeruginosa; Cystic Fibrosis

Summary: this was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in ctbm100c2303 (all visits) and who were proven infected with pseudomonas aeruginosa (p. aeruginosa) at enrollment into ctbm100c2303.


Eligibility criteria:
inclusion criteria: * completed all visits in study ctbm100c2303, and visit 4 took place not more than 5 days before enrollment into this study. * confirmed diagnosis of cystic fibrosis participants with p. aeruginosa infection. * forced expiratory volume in one second (fev1) at screening (study ctbm100c2303) must be between 25% and 80% of normal predicted values. exclusion criteria: * any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial ctmb100c2303 and the enrollment into this study. * known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Keywords: tobramycin inhalation powder cystic fibrosis lung diseases anti-bacterial agents
ct-based versus conventional simulation for palliative radiotherapy of non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: radiotherapy (rt) treatment to the chest is a standard way of trying to decrease symptoms like cough or shortness of breath. before any rt can be delivered, it must be planned, either using conventional x-rays ("fluoroscopy") or using computer tomography ("ct") scanning. this study is being done because the investigators do not know which of these two common ways of rt planning is better for balancing both treating the cancer and decreasing side effects.

standard rt planning will be performed under conventional simulation, followed by ct-simulation (for study purposes only). retrospectively, 3d treatment fields will be designed using the ct-simulation data, and compared to the actual treatment fields planned using x-rays. coverage of the tumour volume will be assessed, together with doses, field sizes and beam positions, to determine relative undercoverage of tumour and overcoverage of normal tissue between the two planning methods, if any.

Eligibility criteria:
inclusion criteria: * patients with local symptoms secondary to histologically-confirmed non-small cell lung cancer * patients who will be receiving palliative-intent external beam radiotherapy * patients who are clinically appropriate for conventional radiotherapy planning * patients who can provide written informed consent exclusion criteria: * patients who cannot provide written informed consent

Keywords: palliative radiotherapy treatment planning non-small cell lung cancer
ctdna as a assisted diagnosis, early intervention and prognostic marker for peritoneal metastases from colorectal cancer

Conditions: Colorectal Cancer; Peritoneal Metastases

Summary: this is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctdna mutational profile using ngs, aiming to elucidate the correlation between the postoperative ctdna status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.


Eligibility criteria:
inclusion criteria: * patients must be a man or woman of at 18-75; * patients must have an eastern cooperative oncology group (ecog) performance status of 0-21； * patients with primary colorectal cancer proven by pathology； * patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, pt4, ct4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of pt3, positive surgical margin, and tumor rupture and hemorrhage); * 6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctdna tests within one month; * patients who have finished standard adjuvant therapy after surgery; (choose 5-fu or 5-fu analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)； * patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ; * written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study. exclusion criteria: * patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer; * asa class ⅳ to ⅴ; * patients who have other existence of distant metastasis outside the abdomen; * patients with serious mental illness; * patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases; * patients who cannot be followed up as scheduled; * patients who participated in other clinical studies within 3 months prior to the trial; * pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.

Keywords: ctdna
colostrum supplements effect on the physical performance and cognitive function

Conditions: Diabetes Mellitus, Type 2

Summary: the goal of this interventional randomized clinical is to compare the effect of colostrum pharmaceutical preparation and placebo in a sample of iraqi participants. the main questions to answer are: 1. what are the effects of the tested regimens on the level of il-1 and il-15. 2. what are the effects of the tested regimens on the fasting blood glucose? 3. what are the effects of the tested regimens on the hba1c? 4. what are the effects of the tested regimens on the body mass index? 5. what are the effects of the tested regimens on the lipid profile? 6. what are the effects of the tested regimens on c-reactive protein? 7. what are the effects of the tested regimens on hematological indices? 8. what are the effects of the tested regimens on rate pressure product? participants will be separated into four groups: 1. group 1 (healthy control): 24 patients, will be receiving placebo capsule per oral once daily for 60 days 2. group 2 (healthy control) : 26 patients, will be receiving colostrum capsule 500 mg per oral once daily for 60 days. 3. group 3 (diabetes type 2): 23 patieints, will be receiving placebo capsule per oral once daily for 60 days. 4. group 4 (diabetes type 2) : 27 patients, will be receiving colostrum capsule 500 mg per oral once daily for 60 days. researchers will compare groups 1,2,3, and 4 to observe the effect of the tested treatment regimens on il-1, il-6 ,fasting blood glucose, hba1c, body mass index, lipid profile, rate pressure product, c-reactive protein, and hematological indices. and use these measures in special formulas to determine the effect of the tested regimens on physical performance and cognitive function.


Eligibility criteria:
inclusion criteria: * apparently healthy patients for control * patients diagnosed with t2dm * age between 18-70 exclusion criteria: * patients with t1dm * patients with a drug history of anabolic substances for more than 14 days duration. * patients with co-morbidities (e.g. cvs, renal, hepatic, and endocrine disorders) * pregnancy, lactation, or female patient willing for conception.

Keywords: colostrum diabetes mellitus, type 2 cognition physical functional performance
injection site study in patients with type 2 diabetes mellitus (t2dm) and healthy volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: this study is an open-label study in healthy volunteers and in patients with type 2 diabetes mellitus to assess safety and tolerability parameters, the levels of gsk716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. assessments include ecgs, vital signs, repeat blood sampling and monitoring of any side effects.

an open-label, randomized, multi-site study to assess the pharmacokinetics of single subcutaneous injections of 16mg and 64mg of gsk716155 administered at three different injection sites in adult male and female subjects with type 2 diabetes and of single subcutaneous injections of 16mg and 64mg of gsk716155 administered in the abdomen of healthy, normal volunteers

Eligibility criteria:
inclusion criteria: * they can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. t2dm subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a tzd (thiazolidinedione). * subjects must have a bmi between 25 and 40 kg/m² and weigh at least 50kg. * women must be of non-childbearing potential. exclusion criteria: * bloodwork that meets certain criteria (for example, total cholesterol \> 240 mg/dl) * clinically significant hepatic enzyme elevation * hba1c less than 6.5 or greater than 10 * positive test result for hepatitis b surface antigen, positive hepatitis c or hiv * any major illness other than diabetes * previous use of insulin as treatment for diabetes * significant renal disease as defined by screening lab tests * history of drug or other allergy which in the opinion of the investigator contradicts subject participation * smoking or use of nicotine-containing products within the previous 6 months * history of alcohol or drug abuse * unwilling to abstain from alcohol prior to and during the in-patient clinic stays * unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays * use of st. john's wort during the study * has donated 500 nl or more blood within 56 days of dosing or plans to donate blood in the month following study participation.

Keywords: gsk716155 pharmacodynamics pharmacokinetics injection site
comarum palustre in knee osteoarthritis and diabetes

Conditions: Osteoarthritis; Diabetes Mellitus

Summary: the study evaluates analgesic, antiinflammatory and metabolic effects of comarum palustre in patients with knee osteoarthritis (oa) and diabetes mellitus. patients with osteoarthritis will receive comarum palustre together with conventional treatment of osteoarthritis and diabetes.

comarum palustre have been shown to exert analgesic properties in patients with knee osteoarthritis not responding to diclofenac. in animal models comarum palustre showed anti-inflammatory, immunomodulatory, analgesic, antioxidant, antihistamine, and membrane-stabilizing effects. thus, pleiotropic properties of comarum palustre may provide a rationale for this use in patients having both osteoarthritis and diabetes mellitus. in this group of patients comarum palustre may not only relieve oa-related pain but reduce systemic inflammation, decrease progression of atherosclerosis and diabetes complications.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee fulfilling american college of rheumatology (acr) criteria * diagnosis of type 2 diabetes mellitus exclusion criteria: * use of nsaids one month prior to study entry (paracetamol is allowed) * pregnancy and lactation * increased sensitivity to the study drug * clinically significant renal function impairment * use of antidepressants * diagnosis of bipolar disorder * use of symptomatic slow acting drugs of oa (sysadoa) one month prior to study entry * any condition which may lead to difficulties to participation in the study from the viewpoint of investigator