Kornimate/medical-research-clean huggingface dataset:
a study of cs1001 in subjects with stage iv non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this is a multi-center, randomized, double-blind, phase iii study to evaluate the efficacy and safety of cs1001 in combination with platinum-containing chemotherapy versus placebo in combination with chemotherapy in first-line treatment-naive subjects with stage iv non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: 1. willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (icf). 2. 18-75 years of age (18 and 75 included) on the day of signing icf. 3. histologically or cytologically confirmed stage iv non-small cell lung cancer (staged according to the 8th international association for the study of lung cancer (iaslc) classification. 4. subjects haven't received systemic treatment for advanced/metastatic nsclc. 5. measurable target lesion evaluated by investigators according to recist v1.1. 6. ecog ps of 0-1. 7. life expectancy ≥ 12 weeks. 8. subject with prior anti-cancer treatment can only be enrolled when all toxicities except for hearing loss, alopecia and fatigue, of prior anti-cancer treatment has recovered to ≤ grade 1 according to national cancer institute \[nci\] common terminology criteria for adverse events (ctcae) v4.03. 9. subjects must have adequate organ function. 10. women of childbearing potential (wobpc, as defined in section 13.5) must have a negative pregnancy test ≤7 days prior to the first dose of investigational product. wobcp or fertile men and their wobcp partners must agree to use an effective method of birth control from providing signed icf and for 6 months after last dose of investigational product. exclusion criteria: 1. histologically confirmed small cell lung cancer or containing small cell component. 2. subjects with current active autoimmune disease or prior history of autoimmune disease. 3. malignancies other than nsclc within 5 years prior to randomization. 4. known history of human immunodefiency virus (hiv) infection and/or acquired immune deficiency syndrome. 5. subject with active hepatitis b or hepatitis c. 6. subjects with known history of alcoholism or drugs abuse. 7. has a known hypersensitivity to any component of study treatment, for example pemetrexed, cisplatin, carboplatin or other platinum compounds. 8. subjects with other conditions that in the investigator's opinion may influence subject's compliance or make subjects not suitable for participating in this trial.
cap assisted balloon enteroscopy versus conventional balloon enteroscopy in the evaluation of obscure gastrointestinal bleeding: a randomized controlled trial

Conditions: Obscure Gastrointestinal Bleeding

Summary: gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. balloon assisted enteroscopy (bae) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. unfortunately, bae is unsuccessful in identifying the cause of bleeding in 40-50% of patients. this may be due to limited visualization of the small bowel lining during conventional endoscopy. one way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel. the investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. the investigators will invite patients referred for bae to participate in the study; the alternative to participating in the study is having standard bae (without a cap). if patients choose to participate in the study they will be randomized to bae with or without a cap on the end of the endoscope. subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.


Eligibility criteria:
inclusion criteria: * adult (≥18 years old) patients undergoing bae for the evaluation of ogib or iron deficiency anemia. exclusion criteria: * unable to provide written informed consent. * pregnancy or lactation. * suspected bowel obstruction or gi perforation. * unable to tolerate sedation or general anesthesia due to medical co-morbidities. * uncorrected coagulopathy (platelet count \ 2, ptt\> 2x upper limit of normal). * patient undergoing retrograde bae.

Keywords: obscure gastrointestinal bleeding overt gastrointestinal bleeding occult gastrointestinal bleeding enteroscopy
inherited myokymia: a clinical and genetic study of a family

Conditions: A Study of Clinical and Genetic Mutations in a Family of Neuromyotonia, so Called Isaac's Syndrome

Summary: neuromyotonia (nmt), so called isaac's syndrome, is a rare disorder in which hyperexcitability of peripheral motor nerves leads to intermittent muscle contractions. it is characterized by muscle twitching at rest (visible myokymia), cramps, hyperhidrosis, paraesthesiae, mild muscle weakness. and impaired muscle relaxation, or pseudomyotonia. electromyographic recording is a key diagnostic tool in detecting myokymia and neuromyotonia. pathophysiology of neuromyotonia is claimed to be related immune disorder, autoimmune anti-voltage-gated potassium-channel antibodies and genetic mutation in potassium channel. kcna1 (kv1.1) mutation was mostly reported in a autosomal dominant trait. in the present study, we report a family affected with myokymia，worsening with elevated body temperature, febrile illness or spicy food. how the change in temperature influence clinical features of channelopathies is an interesting topic. variant clinical severity of family members are recorded. the index patient has possible autoimmune mechanism involvement because of his clinical feature of myasthenia gravis with thymoma and hyperthyroidism. further analyzing the genetic mutation in potassium channelopathy may provide researchers some pathophysiological insight into the isaac's syndrome.


Eligibility criteria:
inclusion criteria: * the disease was initially diagnosed of isaacs syndrome by two neurologist(dr tsai and dr yang). we will recruit family members of diseased patient and normal subjects for clinical, electromyographic and genetic studies. exclusion criteria: * none

Keywords: neuromyotonia, isaac's syndrome; peripheral nerve hyperexcitability; myokymia; potassium channelopathy
dysport® adult lower limb spasticity study

Conditions: Leg Spasticity

Summary: the purpose of this research study is to assess the efficacy of dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.


Eligibility criteria:
inclusion criteria: * subjects aged 18 to 80 years of age * post stroke or brain injury * intensity of muscle tone greater than or equal to 2, as measured on the modified ashworth scale * ambulatory patients exclusion criteria: * fixed contractures * physiotherapy initiated less than 4 weeks before entry * previous surgery or previous treatment with phenol and/or alcohol in lower limb * neurological/neuromuscular disorders which may interfere with protocol evaluations
feasibility study for instant cardiac diagnostic and post-operative risk assessment with the lynxpatch device

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: in this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the lynxpatch.

the lynxpatch is a non-invasive, wireless device for cardiac diagnosis. the aim of this study is to compare the lynxpatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. the study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. the lynxpatch measurement procedure has a duration of about 30 minutes.

Eligibility criteria:
inclusion criteria: * provision of informed consent, i.e., the subject must be able to understand and sign the patient information and consent form. * group 1: patients that have an indication for an echocardiographic assessment. * group 2: patients that are scheduled for a non-cardiac surgery exclusion criteria: * subjects has implanted cardioverter defibrillator * subject is pregnant * subject is breastfeeding * subject has compromised skin in the location where the lynxpatch is intended to be positioned

Keywords: cardiac diagnosis
thrive study: positive affect training for endocrine therapy medication adherence

Conditions: Breast Cancer; DCIS

Summary: the purpose of this study is to pilot and refine an online behavioral intervention based on positive affect training (pat) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (et, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed et to prevent recurrence of breast cancer.


Eligibility criteria:
inclusion criteria: * hormone receptor-positive breast cancer stages 0-3 * have finished primary treatment (chemotherapy/radiation/surgery) * are prescribed endocrine therapy (et) currently or within the last two years * score above specified cut off (range, 0-10) on any of three questions: 1. how upset are you by having to take anti-hormonal therapy 2. how bothered are you by the side effects? 3. how difficult is it for you to take your anti-hormonal medication every day? * have internet access to complete online assessments and intervention components or agree to use and return a study wifi-activated ipad. exclusion criteria: * metastatic disease * individuals who are unable to interact with the intervention as needed. this includes those who are extremely visually impaired to the degree that they cannot see the screen and interact as required and individuals who cannot read and/or write in english. this is due to the nature of the intervention itself. if a participant is unable to interact with thrive as required, they are unlikely to benefit from the intervention or offer insightful feedback that can be used in refining the program.
the influence of baseline sensitivity and expectation on exercise-induced hypoalgesia in young healthy adults

Conditions: Healthy Subjects

Summary: the purpose of this study is to investigate the influence of baseline experimental pain sensitivity and expectation on the pain response following a single exercise session. pain assessment will be done with different intensities of noxious stimuli. in addition, the expectation of how exercise impacts pain will be studied.

the relation between baseline pain sensitivity and the pain response following exercise is not clear. the aims of this study are to investigate the influence of baseline experimental pain sensitivity on the pain response following submaximal isometric exercise, and whether expectations would influence outcomes with subsequent exposure to exercise.

Eligibility criteria:
inclusion criteria: * healthy adults * english proficiency exclusion criteria: * acute pain condition * chronic pain condition * mental health disorder * cardiovascular disease * any chronic illness * difficulty with physical exercise * recent surgery * pulmonary disease * diabetes * smoking * raynaud disease * claustrophobia

Keywords: exercise hypoalgesia pain expectation
importance of forces and safety features in car crash multitrauma

Conditions: Multiple Trauma

Summary: the pupose of the study is a prospective evaluation of external and internal factors/causes of importance for the trauma and final outcome experienced by persons inside motor vehicles in serious car accidents. we hypothesise that there is an association between the use and function of safety features and the results for the patient and an association between material damage and the severity of injury.

we plan to study approximately 200 road accidents with multitraumatised patients and accidents with modern cars and severe material damage with little or moderate damage to persons inside the vehicle. a researcher will be alerted by the call centre (norwegian 911-equivalent), move to the place of accident and take a pure observers role (unless ethically unacceptable due to lack of other health personnel). he will document the accident including use and condition of safety features, conditions inside the coupe, weather conditions, etc. other available information on the vehicles, crashtests etc will be gathered from the manufacturer. all medical information will be gathered from the ambulance service, hospitals, pathology and forensic departments. information from police and fire department will also be gathered. patient, next-of-kin, others invloved will be interviewed as appropriate in follow-up. four accident groups: front-to-front or -object \> 60 km/hour, same \< 60 km/hour, car rolled over on road, car rolled over out-of-road. factors: age of vehicle, damage to coupe, cause of accident, on-scene time, initial evaluation by health personnel, injury severity scoring in hospital.

Eligibility criteria:
inclusion criteria: * patients with multiple trauma from severe motor vehicle accidents in eastern norway patients from motor vehicle accidents in eastern norway with severe material damage

Keywords: multiple trauma traffic accident outcome safety injury severity
dorsal root ganglion stimulation for the management of painful intractable small fibre neuropathy:

Conditions: Neuropathy Small Fibre

Summary: a prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of dorsal root ganglion stimulation (drgs) in alleviating the painful symptoms in patients with small fiber neuropathy (sfn).

this study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with sfn. all enrolled patients will receive a trial neurostimulation (tns) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (ins) phase. the target number of patients eligible for ins is 10 and this population will be assessed for impact of drgs on the neuropathic pain caused by sfn. the expected duration of patients participation will be 14 months. the rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).

Eligibility criteria:
inclusion criteria: * 18 years or older at inclusion * chronic, intractable painful sfn in the peripheral limbs during at least 12 months and a biopsy positive for sfn, with a chronic pain intensity of ≥ 6 on a numeric rating scale (ranging from 0 to 10), for which previous drug therapy was unsuccessful * stable medication dosage in the 30 days prior to inclusion * stable pattern of neurological symptoms exclusion criteria: * known or suspected non-compliance * drug or alcohol abuse * pain predominantly in upper limbs * neuropathy or chronic pain in limbs of other origin than sfn * peripheral vascular disease * severe foraminal stenosis at the expected target level * coagulation disorders * known immune-deficiency * other significant concomitant diseases and any concomitant malignancies * presence of other indwelling devices
feasibility study of laparoscopy-assisted d2 distal gastrectomy to treat advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with d2 lymph node dissection for advanced gastric cancer.

to test oncological feasibility, compliance of nodal dissection was selected as a primary end point. when there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. other secondary outcomes will be supplementary to evaluate feasibility of d2 dissection.

Eligibility criteria:
inclusion criteria: * histologically proven primary gastric adenocarcinoma * t2 or t3 or t4a, n0 or n1 or n2 or n3a (ajcc 7th), which is assessed by computed tomography (ct) scan - mid 1/3 or low 1/3 location * no evidence of other distant metastasis * not stump carcinoma,(vi) aged 20-80 year old * performance status (ps) of 0 or 1 on eastern cooperative oncology group (ecog) scale * no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection * adequate organ functions defined as indicated below: * wbc 3000/mm3, wbc 12 000/mm3 * hb 8.0 g/dl without any transfusion 2 weeks before enrollment * plt 100 000/mm3 * ast 100 iu/l * alt 100 iu/l * t.bil 2.0 mg/dl * written informed consent exclusion criteria: * active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) * pregnant or breast-feeding women * severe mental disorder * systemic administration of corticosteroids * unstable angina or myocardial infarction within 6 months of the trial * unstable hypertension * severe respiratory disease requiring continuous oxygen therapy * previous upper abdominal surgery except laparoscopic cholecystectomy
asthma in the delta region of arkansas: characterization of disease and impact of environmental factors

Conditions: Asthma

Summary: the purpose of the study is to evaluate asthma and examine the homes of children with asthma living in rural areas of the state. this study is being done to give investigators more information about the presence of allergens and endotoxin in the homes of children with asthma living in the delta region of arkansas.

asthma is the most common chronic disease of children and disproportionately affects minority and low-income children. current pediatric asthma research in this high-risk group focuses on children living in inner-city environments. low-income, minority children with asthma from non-urban locales have not been studied extensively. the specific aims of the study will examine the impact of home environmental exposure to endotoxin on asthma severity and atopy status in the rural setting among predominately african american, low-income asthmatics. this study will answer several research questions. the first question involves the relationship between asthma severity and exposure to endotoxin among rural children at high risk for increased morbidity and mortality. second, the relationship between atopy and endotoxin exposure has been the subject of recent debates among asthma researchers. the hygiene hypothesis suggest that the recent rise in atopic disease in westernized societies is due to decreased microbial burden. last data on atopy and aeroallergen exposure among high-risk rural asthmatics will be critical in the design and implementation of future intervention programs.

Eligibility criteria:
inclusion criteria: * english speaking participants aged 4-17 years from four rural schools with physician diagnosed asthma or symptoms of asthma in the previous 12 months (coughing, wheezing, chest tightness, shortness of breath) (per parental or legal guardian report) and current taking prescribed medications for asthma such as inhalers, syrup or breathing machine. exclusion criteria: * children with significant underlying respiratory disease other than asthma (such as cystic fibrosis) or significant co-morbid conditions such as severe developmental delay or cerebral palsy will be excluded from the study.

Keywords: asthma, children, rural population, morbidity, endotoxin
the effect of simple gymnastics training for parkinson's patients in the community

Conditions: Parkinson Disease

Summary: the goal of this clinical trial is to explore the impact of simple gymnastics training on limb motor function and mental health in parkinson's patients in the community (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of parkinson's diseases among community-dwelling elderly individuals, and 2) the effects of simple gymnastics training on limb motor function and mental health in community-dwelling parkinson's patients. all patients are required to undergo a continuous three-week (21 days) simple gymnastics training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 30 minutes each.

in the early stages of parkinson's disease, many patients do not seek medical attention. the goal of this clinical trial is to explore the impact of simple gymnastics training on limb motor function and mental health in parkinson's patients in the community (≥60 year old) with swallowing disorders. it primarily aims to address two key aspects: 1) the prevalence of parkinson's diseases among community-dwelling elderly individuals, and 2) the effects of simple gymnastics training on limb motor function and mental health in community-dwelling parkinson's patients. all patients are required to undergo a continuous three-week (21 days) simple gymnastics training, with weekends off and training conducted only on weekdays. the training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility criteria:
inclusion criteria: * age \>60 years. * meeting the diagnostic criteria for parkinson's disease developed by the neurology branch of the chinese medical association in 2006. exclusion criteria: * complicated with cognitive impairment or consciousness dysfunction. * simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. * complicated with severe liver and kidney failure, tumors, or hematological disorders.
effects of pelvic floor muscle training and diaphragmatic breathing exercise on body posture

Conditions: Telerehabilitation; Body Posture; Pelvic Floor Muscle Training; Diaphragmatic Breathing; Quality of Life

Summary: this study; it will be done in order to show evidence of the effects of pelvic floor muscle training and diaphragmatic breathing exercise via telerehabilitation on body posture and quality of life in healthy individuals. international physical activity quastionnaire short form (ipaq), pelvic floor impact quastionnaire short form (pfiq-7), 36-item short form survey(sf-36) and new york posture rating chart will be applied.


Eligibility criteria:
inclusion criteria: * body mass index between 18-25 * being a woman over the age of 18 exclusion criteria: * obstructive or restrictive lung disease * diagnosed with urinary incontinence or pelvic organ prolapse * pelvic pain * history of pelvic surgery * any history of spinal, thoracic or abdominal surgery * to smoke * cardiac, neurological and rheumatological disease * congenital deformity or previous history of surgery in the spine and thorax * endocrine and metabolic disease * psychiatric disorders * cardiological disorders * malignancy * doing regular physical activity or sports for the last 3 months