Kornimate/medical-research-clean huggingface dataset:
iknow: a prospective study to evaluate the use of multi-omics in multi-system, early onset disorders

Conditions: Genetic Disease

Summary: prospective observational study to further understand the value that a multi-omic approach has in individuals with a multi system, early onset disorder that does not have a molecular diagnosis by whole genome sequencing.

understand the value and utilization of integrated multi-omics, in multi-system early onset disorders that have failed to yield findings by whole genome sequencing

Eligibility criteria:
inclusion criteria: * undiagnosed probands must meet all of the following: 1. must be able to understand and sign an informed consent and speak, read, and write in their native language (if the subject is a minor, their parent must have these abilities) 2. proband between the ages of 12 months and 65 years 3. study consent and participation of at least two unaffected family members (biological parents preferred. one biological parent and unaffected sibling allowed) 4. if applicable, unaffected sibling must be between the ages of 12 months and 65 years 5. a high prior probability of a multi-system early onset undiagnosed genetic disorder based on an expert medical assessment 6. clinical wgs that did not yield a definitive diagnosis 7. it is preferred but not required that ancestry is from an under-represented population in current clinical genetic and translational research data repositories, especially african american, asian american and native american 8. must be willing to have blood, urine and fecal samples taken to include participating family members diagnosed probands must meet all of the following: 1. must be able to understand and sign an informed consent and speak, read, and write in their native language (if the subject is a minor, its parent or legally authorized representative must have these abilities). 2. proband between the ages of 12 months and 65 years 3. study consent and participation of at least two unaffected family members (biological parents preferred. one biological parent and unaffected sibling allowed) 4. if applicable, unaffected sibling must be between the ages of 12 months and 65 years 5. known genetic cause(s) of disease, disorder, or phenotypic defect through prior clinical whole genome sequencing 6. it is preferred but not required that ancestry is from an under-represented population in current clinical genetic and translational research data repositories, especially african american, asian american and native american 7. must be willing to have blood, urine and fecal samples taken to include participating family members exclusion criteria: * undiagnosed probands must not meet any: 1. known non-genetic cause(s) of disease, disorder, or phenotypic defect 2. principal investigator decides that the study is not in the best interest of the proband diagnosed probands must not meet any: 1. principal investigator decides that the study is not in the best interest of the proband
exploratory trial to assess the functionality of an integrated call center for the digital medicine system

Conditions: Schizophrenia; Major Depressive Disorder; Bipolar I Disorder

Summary: this study will assess the helpfulness of the integrated call center in optimizing use of the digital medicine system in adult subjects with schizophrenia, major depressive disorder, or bipolar disorder taking oral aripiprazole.

the digital medicine system includes a drug-device combination of aripiprazole + an ingestible event marker (iem), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion. physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. the sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.

Eligibility criteria:
inclusion criteria: * primary diagnosis of schizophrenia (sch), major depressive disorder (mdd), or bipolar 1 disorder (bp1), per the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) * must be able to swallow tablets * currently taking a stable daily dose of oral aripiprazole * must have capacity to utilize the technology * skin in area of patch application must be free of any skin disorders or dermatological problems exclusion criteria: * subjects using long acting injectable antipsychotic medications * subjects likely to be incapable of using the digital medicine system even with assistance * subjects who present serious risk of suicide * history of epilepsy or seizures * history of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker * current history of substance use disorder meeting dsm-5 criteria * subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization
gender-based impact on safety and efficacy of lenvatinib in patients with differentiated thyroid cancer

Conditions: Differentiated Thyroid Cancer; Gender

Summary: lenvatinib is approved for the treatment of radioiodine refractory differentiated thyroid cancer. despite gender can play a crucial role un in safety and efficacy of oncological product, little is know on gender difference in lenvatinb effacacy and safety in the context of radioiodine refractory differentiated thyroid cancer. the primary objective of the study is to assess safety and toxicity profile in male and female patients in terms of dose reduction. the secondary objectives are to assess sex and gender difference in: the number and the incidence of adverse events; response rate according to recist criteria 1.1; progression free survival, overall survival and duration of response.

lenvatinib is an orally available potent inhibitor of the split-kinase family of transmembrane growth factor receptors including flt-1/vegfr-1 and kdr/vegfr. lenvatinib has been investigated in hepatocellular carcinoma and in rai-resistant thyroid cancer (phase iii trials) and in other malignancies, showing high rates of activity. in rai-resistant thyroid cancer, lenvatinib showed a remarkable response rate over placebo (65% vs 2), combined with a prolonged progression free survival (18.3 vs 3.6 months). it has been approved for the treatment of locally recurrent or metastatic, progressive rai resistance-dtc in the united states, europe, and japan, based on the results from select trial. moreover, lenvatinib demonstrated a meaningful clinical activity (response rate 64.8% in treatment arm vs 1.5% in placebo arm, p\<0.001;) significantly reducing the tumour burden, with a median maximum percentage change in tumour size of -42.9%. response was mostly pronounced at the first assessment (median -24.7% at 8 weeks after randomization) but it has been observed even in the following months (-1.3% per month). recently, the efficacy of lenvatinib was confirmed in specific patient population, such as elderly. although the efficacy is remarkable toxic effects are considerable and not all patients have the same risk to benefit ratio from lenvatinib treatment. results derived from controlled clinical trials are rarely replicable in the real-life because these trials are usually conducted in selected populations, in a highly controlled setting, optimized to show the effect of the drug. in this context growing evidences are showing gender associated functions playing a role in cancer incidence, progression and response to therapy; gender disparities in toxicities and effectiveness of certain drugs used in the treatment of the most common cancer is already well known.the aim of the present study is to evaluate the safety and efficacy profile of lenvatinib based on gender in patients with refractory iodine dtc.

Eligibility criteria:
inclusion criteria: * patients with refractory iodine dtc treated with lenvatinib * signed written informed consent exclusion criteria: - age \< 18 years
the role of diet education and nutritional counselling in the ongoing care of people living with hiv in thailand

Conditions: HIV Infections

Summary: to evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with hiv/aids (plwha) attending an hiv treatment facility in bangkok thailand.

to evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with hiv/aids (plwha) attending an hiv treatment facility in bangkok thailand. this will be achieved by determining if dietary counselling and nutrition education has an effect on nutritional status (weight, lean body mass and fat mass), dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, ldl/ hdl cholesterol and triglyceride), experience of symptoms and patient satisfaction

Eligibility criteria:
inclusion criteria: * hiv positive * 18 years of age or older * receiving ongoing care as part of the trcarc family clinic (trcarc wellness plus clinic) * either art naive or have been on stable art for more than 6 months exclusion criteria: * hiv negative * unintentional weight loss of more than 10% usual body weight, or bmi\<17 * bmi\>30 * suspected or documented hiv related opportunistic infection * pregnant women * women less than 3 months post-partum

Keywords: nutritional status nutrition counselling nutrition assessment hiv alternative medicine complementary medicine
neuropathic pain in patients with degenerative lumbar stenosis

Conditions: Lumbar Spinal Stenosis; Neuropathic Pain; Spinal Disease

Summary: pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the patient's recovery and cast doubt on the fullness of the performed decompression. neural compression in the spinal canal and back pain may be the cause of the patient's antalgic posture and sagittal imbalance as seen on x-ray, to need for corrective interventions surgical procedure. thus, it is necessary to clarify the role and the influence of the pain and its type on the perioperative period in patients with degenerative lumbar spinal stenosis.

the current study is prospective observational study to evaluate the role of pain syndrome including neuropathic pain in surgical outcomes in patients with degenerative lumbar spinal stenosis. this study will be conducted at priorov central institute for trauma and orthopedics, moscow, russia. the study is expected to enroll at least 120 adult patients with degenerative lumbar stenosis. the neuropathy will be assessed preoperatively, and then the patient will undergo decompressive lumbar surgery without fusion. the neuropathic pain will be evaluated according to dn4 preoperatively, each patient will be assigned to one of two groups depending on the total value of dn4 - with the presence of neuropathy (dn4\>= 4) and without neuropathy (dn4 \<4). postoperative evaluation will include 2 visits during one year to evaluate clinical and radiological outcomes.

Eligibility criteria:
inclusion criteria: 1. age 18-85 years; 2. radicular leg pain with or without neurogenic claudication with or without back pain; 3. planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis; 4. symptoms persisting for at least 3 months prior to surgery; 5. given written informed consent; 6. able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements exclusion criteria: 1. prior lumbar fusion at any level; 2. any contraindication or inability to undergo baseline and/or follow up mri or x-ray as required per protocol; 3. back or non-radicular pain of unknown etiology; 4. history or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis); 5. any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study; 6. previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
neurobehavioral therapy for epilepsy and major depressive disorder

Conditions: Major Depressive Disorder; Epilepsy

Summary: the purpose of this study is to examine the feasibility and acceptability of an online group neuro-behavioral therapy (nbt) with text messaging intervention for veterans with epilepsy and major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * english speaking veterans * has home internet access * has access to and familiarity in using a computer or tablet at least weekly * asymptomatic patients with chronic conditions * has access to a mobile device with short message service (sms) text and picture capability * has an active clinical diagnosis of major depressive disorder based on the international classification of diseases, 10th version (icd-10) * has an icd-10 diagnosis of epilepsy with at least one seizure documented within the last five years exclusion criteria: * pregnancy * veterans that have current suicidal ideation * have active psychosis; and have an icd-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.

Keywords: veterans
epidemiological study on haemophilia care and orthopaedic status in developing countries

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia A With Inhibitors; Haemophilia B; Haemophilia B With Inhibitors

Summary: this study is conducted in africa and asia. the aim of this study is to evaluate in the participating countries the orthopaedic status and the degree of arthropathy of severe haemophilia patients in general.


Eligibility criteria:
inclusion criteria: * patient (and/or parents or the patient's legally acceptable representative, if applicable) must give signed and dated informed consent before enrolment in the study * male patients at least 6 years old with diagnosis of severe congenital haemophilia a or b with or without inhibitors * patients receiving on demand replacement factors/bypassing agents therapy exclusion criteria: * clinically relevant coagulation disorders other than congenital haemophilia a or b * patients on currently active treatment for hcv (hepatitis c virus) or hiv (human immune deficiency virus) infections
analgesia of erector spinae plane block versus quadratus lumborum block

Conditions: Colorectal Cancer

Summary: colorectal cancer is the third most common cancer worldwide. these patients usually undergo open surgical resection of cancer under general anaesthesia. the aim of this study is to detect whether the erector spinae plan block or quadratus lumborum block will provide the most ideal analgesia for these patients. erector spinae plan block is a novel analgesic technique that provides both visceral and somatic analgesia due to its communication with the paravertebral space. quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. ultrasound guidance increases the accuracy and safety of both techniques. a local anaesthetic mixture of bupivacaine 0.25% and dexamethasone will be used for both techniques.

erector spinae plane block and quadratus lumborum block are analgesic techniques suitable for open colorectal cancer surgeries. postoperative pain score, serum levels of biomarkers of stress (cortisol and crp), primary hemodynamics, time to first rescue analgesic request, the total amount of rescue analgesic consumption and postoperative nausea and vomiting are the parameters of comparison between both techniques.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i or ii * body mass index from 18.5 to 35 kg/m2 exclusion criteria: * body mass index more than 35 kg/m2. * severe or uncompensated cardiovascular disease. * severe renal disease. * severe hepatic disease. * severe endocrinal disease. * pregnancy. * postpartum. * lactating females * allergy to one of the agents used. * refusal to participate in the study.
the efficacy of conventional screening versus mhealth screening in early detection of oral potentially malignant disorders and oral cancer amongst the rural population of varanasi: a prospective and blinded study

Conditions: Smoking; Smoking, Cigarette; Smoking, Tobacco; Betel Chewer's Mucosa; Tobacco Use; Tobacco Smoking; Alcohol Drinking; Smokeless Tobacco Hyperkeratosis

Summary: mobile health (mhealth) will be used for early detection of oral cancer and pre-cancer lesions, and to improve awareness of oral cancer among the population and knowledge of oral cancer diagnosis among frontline health providers. this program is inclusive of long term surveillance to downstage oral cancer in india


Eligibility criteria:
inclusion criteria: positive for any one or more of the following: * all individuals aged above 18 years positive for habits (smoking and smokeless tobacco, chewing betel leaf, areca nut, paan masala, and/or regular use of alcohol) * clinical signs/symptoms (non-healing ulcers, white/ red/red \& white patches in the mouth, restriction of mouth opening and swelling of the neck) * all individuals aged above 40 irrespective of habit/oral lesions exclusion criteria: * individuals already diagnosed with oral cancer and undergoing treatment for oral cancer * under treatment for tuberculosis or suffering from any acute illness/ debilitating systemic disorders

Keywords: smoking smoking, cigarette smoking, tobacco smokeless tobacco betel leaf areca nut paan masala alcohol use memorial sloan kettering cancer center 24-148
balance and falls in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study hypothesis is that for people with moderate to severe multiple sclerosis postural balance and walking improve and the risk of accidental falls are reduced after participating in a specific training intervention of 7 weeks. the hypothesis is also the the effect remain a further 7 weeks post training. multiple sclerosis (ms) is disease affecting the central nervous system. walking and postural balance are often affected early in the course of the disease. the risk of falls is large. many persons with ms have decreased trunk stability compared to healthy persons . in an earlier study including people with mild to moderate ms we found that a period of core stability exercises reduced the risk of falls. in this study the training concept will be applied for persons with more severe walking limitations.


Eligibility criteria:
inclusion criteria: * diagnosed multiple sclerosis * expanded disability scale score of 5-6.5 * walking speed of less than 0.8 m/s as tested on a 10 meter walking test exclusion criteria: * ongoing relapse * cognitive or language difficulties that prohibit participating in the intervention or performing the outcome measures * change in specific ms medication during the last 30 days

Keywords: walking postural balance falls
effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia

Conditions: Temperature Change, Body

Summary: this study aims to evaluate the effect of dexmedetomidine and remimazolam on body temperature in patients undergoing spinal anesthesia.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective surgery under spinal anesthesia exclusion criteria: * severe vascular disease * thyroid dysfunction
korea study (korea osimertinib real world evidence study to assess safety and efficacy)

Conditions: Non-Small Cell Lung Cancer

Summary: the objectives of this study are to assess the safety and efficacy of single agent tagrisso (osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (egfr) t790m mutation-positive non-small cell lung cancer (nsclc), who have progressed on or after egfr tyrosine kinase receptor (tki) therapy.


Eligibility criteria:
inclusion criteria: * 1. eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, egfr t790m mutation-positive nsclc, who have progressed on or after egfr tyrosine kinase receptor (tki) therapy * 2. provision of signed and dated written informed consent by the patient or legally acceptable representative exclusion criteria: * 1. history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug * 2. pregnancy and/or breast feeding * 3. current participation in any interventional trial
left ventricular diastolic dysfunction in kidney recipients

Conditions: Kidney Transplantation

Summary: the purpose of this study is to examine the relationship between pre-operative lv diastolic function and post-operative complications and kidney function in living-donor kidney transplantation patients.


Eligibility criteria:
inclusion criteria: * elective kidney transplantation patients exclusion criteria: * no data of preoperative echocardiography
using diode laser in 2nd stage of implant.

Conditions: Dental Implant Exposure Using Diode Laser

Summary: dental implants that are teeth replacements usually place with two stages. in the second stage the implant fixture, (which is the body that inserted in the bone is exposed to place the artificial tooth), is exposed using surgical blade, however; an alternative method using diode laser may be used. this study aimed to compare the two methods in relation to pain anticipated by the patients and the need for local anesthesia usage.

second-stage implant exposure involves removing soft tissue above the dental implant, as a part of the implant procedures to replace the missing teeth which can be done either by using diode laser or traditional method this study included fifteen patients, aged between 18 and 70 years old. implant exposure was performed on 15 patients has at least two implants in two groups: group 1 with a diode laser at 940nm and group 2 with the traditional method performed either using a puncture, flap, or incision in 5 private clinics and one governmental run hospital in city of baghdad/ iraq.

Eligibility criteria:
inclusion criteria: - 1. describe the target population and the criteria for their inclusion. patients indicated for fixed implant treatment with conventional implant procedure with implant insertd before (3-6) months by using two stage dental implant. 2. treatment with two or more implant in same patient. 3. patients aged from 18 to 70 years of both the gender with the presence of adequate osseointegration and healthy keratinized tissue surrounding the implant site. exclusion criteria: * 1. patient have single implant. 2. expose dental implant or already have gingival former. 3. poor oral hygiene. 4. failure implant osseointegration to bone.

Keywords: diode laser dental implant local anasthesia