Kornimate/medical-research-clean huggingface dataset:
acute intermittent hypoxia to improve airway protection in chronic traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: acute intermittent hypoxia (aih) involves 1-2min of breathing low oxygen air to stimulate neuroplasticity. animal and human studies show that aih improves motor function after neural injury, particularly when paired with task-specific training. using a double blind cross-over study we will test whether aih and task-specific airway protection training improves airway protection more than training alone in individuals with chronic mild-moderate traumatic brain injury (tbi).

recent studies have found that acute intermittent hypoxia (aih)-or repetitive exposure to brief episodes of low inspired oxygen--is a promising new strategy that can help restore motor function by promoting neuroplasticity throughout the central nervous system (cns). both rodent and human studies show that motor function is further enhanced when aih is paired with task-specific training/rehabilitation (tst). therefore, this study will investigate the therapeutic potential of combining aih with a task-specific airway protection training. we propose that the combined use of aih + tst will enhance the magnitude and duration of tst training alone in individuals with chronic traumatic brain injury.

Eligibility criteria:
inclusion criteria: * adults aged 21-80 years * a mild to moderate traumatic brain injury (tbi) confirmed by medical records * a glasgow coma scale score between 9-15 * able to consent independently * women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study exclusion criteria: * other neurological diagnoses or a diagnosis of a severe psychiatric disorder * severe aphasia preventing a participant from understanding the protocol and consent form * pre-existing hypoxic pulmonary disease * history of obstructive lung diseases such as chronic obstructive pulmonary disease (copd) or significant asthma) * severe hypertension (\>160/100) * history of head and neck cancer * allergy to barium sulfate * ischemic cardiac disease

Keywords: acute intermittent hypoxia rehabilitation airway protection dysphagia
japanese safety and efficacy study of enoxaparin in patients with hip fracture surgery

Conditions: Hip Fractures

Summary: the purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.


Eligibility criteria:
inclusion criteria: * femoral neck inside or outside fracture exclusion criteria: * any major surgery on lower limbs within 3 months * clinical signs of deep vein thrombosis * use of non-steroidal anti-inflammatory drugs * severe hepatic disease or renal insufficiency

Keywords: blood thinner enoxaparin hip fracture surgery bleeding thromboembolism
efficacy of traditional persian medicine preparation versus artificial saliva for radiation induced xerostomia

Conditions: Xerostomia; Head and Neck Cancers

Summary: head and neck cancers(hnc) is one of the most common cancers worldwide. xerostomia is one of the most common side effect of radiation therapy among patients with hnc. mouth dryness significantly impairs patients' quality of life (qol). hnc.regarding to traditional use of a. digitata and m. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in qol of hnc patients with radiation induced xerostomia


Eligibility criteria:
inclusion criteria: * patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the common terminology criteria for adverse events (ctcae) version 4.0) and finished radiotherapy at least two months before the study(22). exclusion criteria: * history of connective tissue disorder (e.g., sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to a. digitata and m. sylvestris
study to assess the efficacy and safety of pt003, pt005, and pt001 in subjects with moderate to very severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a chronic dosing (24 weeks) study to assess the efficacy and safety gff mdi; pt003), ff mdi; pt005, and gp mdi; pt001) in subjects with moderate to very severe copd, compared with placebo.

a randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (gff; pt003), formoterol fumarate inhalation aerosol (ff; pt005), and glycopyrronium inhalation aerosol (gp; pt001) in subjects with moderate to very severe copd, compared with placebo.

Eligibility criteria:
inclusion criteria: * non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or child bearing potential, has a negative serum pregnancy test at visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study. * subjects with an established clinical history of copd as defined by the american thoracic society (ats)/european respiratory society (ers). * current or former smokers with a history of at least 10 pack-years of cigarette smoking. * forced expiratory volume in 1 second/forced vital capacity (fev1/fvc) ratio of \<0.70. * fev1 must be \<80% predicted normal value calculated using the third national health and nutrition examination survey (nhanes iii) reference equations. (or reference norms applicable to other regions). exclusion criteria: * significant diseases other than copd, ie, disease or condition which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study. * women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception. * subjects, who in the opinion of the investigator, have a current diagnosis of asthma. * subjects who have been hospitalized due to poorly controlled copd within 3 months prior to visit 1 (screening) or during the screening period (visit 1 to visit 4). * subjects who have poorly controlled copd, defined as acute worsening of copd that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to visit 1 (screening) or during the screening period (visit 1 to visit 4). * subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible. * subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the mdi.

Keywords: copd
a study to learn about the dangers linked to myelosuppression (decreased bone marrow function) in breast cancer patients treated with the study medicine palbociclib (pal bow sai klib)

Conditions: Breast Cancer

Summary: the purpose of this study is to explore risk factors for grade 4 neutropenia in users of the study medicine palbociclib for the potential treatment of palbociclib. this study is seeking participants: * treated with the study medicine palbociclib * having any breast cancer records in same month as the initiation date * having prescription records of palbociclib from 15 december 2017 to 29 february 2024 the study design is a nested case control study. this study design uses de-identified patient data from a hospital based electronic medical record and claim database in japan. this design was selected since the primary objective is to explore risk factors of grade 4 neutropenia in users of the study medicine palbociclib. one of the important side effects of taking palbociclib is neutropenia (decreased count of neutrophils - a type of white blood cell). in this study the effect of palbociclib in decreasing the neutrophil count was studied after it was released to the market. to do that, the study gathered details of breast cancer patients newly treated with palbociclib from 23 hospitals and 10 medical institutes across japan. the below patient details were collected: * dose of palbociclib * other medicines prescribed for cancer * age * gender * past information on cancer treatments * laboratory findings at baseline the result was based on the neutrophil count collected from the laboratory data. around 1300 patients newly treated with palbociclib for breast cancer was calculated by the medical information database network (mid-net) in 6 years from 15 december 2017. patients who develop grade 4 neutropenia after palbociclib initiation will be matched to controls who do not develop grade 4 neutropenia. a statistical model will be used to explore risk factors of grade 4 neutropenia adjusted for important potential confounding factors.


Eligibility criteria:
inclusion criteria: * having prescription records of palbociclib from 15 december 2017 to 29 february 2024. * having any breast cancer records in same month as the first prescription date. exclusion criteria: * having an anc less than the threshold value for grade 4 neutropenia within 30 days of the first prescription of palbociclib * having any records of anti-her2 medication

Keywords: safety data base study in japan ibrance palbociclib hormone receptor-positive (hr+)/human epidermal growth factor receptor 2-negative (her2-) inoperable or recurrent breast cancer
hybrid mathieu urethroplasty

Conditions: Distal Penile Hypospadias (Disorder)

Summary: the aim is to study the results of simple modification of classic mathieu urethroplasty to increase the scope of cases candidates for that procedure.

background: distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. successful hypospadias repair should provide a functional penis and good cosmesis. mathieu urethroplasty is one of the most popular techniques used. authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic mathieu urethroplasty. methods: forty-three patients with distal hypospadias were operated by hybrid mathieu urethroplasty (hmu) during the period from march 2012 to december 2020. creation of the peri meatal based flap was performed as mathieu disrobed. this was followed by developing of glanular wings. the additional step was deep incision of the urethral plate. then, urethroplasty was performed. the catheter was left in place for one to three days.

Eligibility criteria:
inclusion criteria: * distal penile hypospadias exclusion criteria: * sever hypospadias * cases need redo

Keywords: distal hypospadias mathieu urethroplasty modified urethral plate
methylprednisolone adjunctive to endovascular treatment for stroke

Conditions: Acute Ischemic Stroke

Summary: the efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (aspects score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. this is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * the time from onset to randomization was within 12 hours. * anterior circulation ischemic stroke was determined according to clinical symptoms and imaging examination. * occlusion of the intracranial internal carotid artery, the m1- or m2-segment of the middle cerebral artery confirmed by ct angiography (cta), mr angiography (mra), or digital subtraction angiography (dsa). * baseline national institutes of health stroke scale (nihss)≥6. * baseline alberta stroke program early ct score (aspects)\<6. * planned treatment with endovascular therapy (evt). * informed consent obtained from patients or their legal representatives. exclusion criteria: * intracranial hemorrhage confirmed by cranial computed tomography (ct) or magnetic resonance imaging (mri). * mrs score ≥ 2 before onset. * pregnant or lactating women. * allergic to contrast agents or glucocorticoids. * participating in other clinical trials. * systolic blood pressure \>185 mmhg or diastolic pressure \>110 mmhg, and oral antihypertensive drugs cannot control. * genetic or acquired bleeding constitution, lack of anticoagulant factors, or oral anticoagulants and inr \> 1.7. * blood sugar \ 22.2 mmol/l (400 mg/dl), platelet \< 90 x 10\^9/l. * the artery is tortuous so that the thrombectomy device cannot reach the target vessel. * bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month. * chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \ 220 umol/l \[2.5 mg/ dl\]). * life expectancy due to any advanced disease \< 6 months. * follow-up is not expected to be completed. * intracranial aneurysm and arteriovenous malformation. * brain tumors with imaging mass effect. * systemic infectious disease.
study of darbepoetin alfa for the treatment of anemia of cancer

Conditions: Anemia; Cancer

Summary: the purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.


Eligibility criteria:
inclusion criteria: * subjects with non-myeloid malignancies * anemia due to cancer * ecog status 0 to 2 * greater than or equal to 4-month expectancy * greater than or equal to 18 years and of legal age for informed consent * screening hemoglobin concentration less than or equal to 11.0g/dl * adequate serum folate and vitamin b12 * adequate renal and liver function * written informed consent exclusion criteria: * subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization * in complete remission, as determined by the investigator * subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc) * documented history of pure red cell aplasia * known history of seizure disorder * cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia * uncontrolled hypertension * clinically significant systemic infection or chronic inflammatory disease present at the time of randomization * iron deficiency * known positive test for hiv infection * previously suspected of or confirmed to have neutralizing antibodies to rhuepo or darbepoetin alfa * received rhuepo or darbepoetin alfa therapy within 4 weeks of randomization * less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority * pregnant or breast feeding * subject of reproductive potential who is not using adequate contraceptive precautions * known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product * previously randomized into this study * concerns for subject's compliance with the protocol procedures

Keywords: cancer-related anemia
optimal patient positioning for erector spinae plane block in laparoscopic cholecystectomy:

Conditions: Postoperative Pain; Laparoscopic Cholecystectomy; Anesthesia, Regional; Pain Management

Summary: this randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (esp) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. the study also evaluates the variation in skin-to-block site distance depending on patient positioning.

erector spinae plane (esp) block is a relatively recent regional anesthesia technique performed under ultrasound guidance, widely used for managing acute postoperative pain. while the esp block is known for its safety, simplicity, and versatility, there is limited evidence regarding the influence of patient positioning on its clinical effectiveness and technical performance. this prospective, randomized, single-blind study investigates the impact of administering bilateral esp block at the t7 vertebral level in three different patient positions: lateral decubitus, prone, and sitting. the study includes adult patients (aged 18-65, asa i-ii) undergoing elective laparoscopic cholecystectomy under general anesthesia. primary outcomes include postoperative pain scores (vas and nrs). secondary outcomes include total rescue analgesic consumption (tramadol), time to first analgesic requirement, patient satisfaction scores (likert scale), and measurement of the skin-to-block site distance across different positions. data will be collected at defined intervals up to 24 hours postoperatively. the findings are expected to inform clinicians on the optimal patient positioning for esp block to enhance block efficacy and patient comfort during laparoscopic abdominal surgery.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * scheduled for elective laparoscopic cholecystectomy * asa physical status i-ii * ability to understand and provide written informed consent exclusion criteria: * allergy to local anesthetics * history of chronic opioid use or substance abuse * coagulopathy or current anticoagulant therapy * local infection at the block site * severe spinal deformities or scoliosis * bmi \> 35 kg/m² * pregnancy or breastfeeding * refusal to participate in the study

Keywords: erector spinae plane block patient positioning ultrasound-guided regional anesthesia
a study to evaluate the tolerability, safety, pharmacokinetics of hec89736 in patients with relapsed or refractory b-cell hematologic malignancies

Conditions: Relapsed or Refractory B-cell Hematologic Malignancies

Summary: evaluate the safety, pharmacokinetics and efficacy of hec89736 in patients with relapsed or refractory b-cell hematologic malignancies


Eligibility criteria:
inclusion criteria: * age is over 18 years old * histologically or cytologically diagnosed patients with recurrent or refractory b-cell malignancies * ecog performance status (ps) 0 \~ 1 * expected survival of \> or = 3 months exclusion criteria: * the use of pi3ks as the target of anti-tumor drugs progress (due to intolerance group) * received any other anti-cancer treatment within 4 weeks * unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption * allergy, or known to have a history of allergy to the drug components
oocyte retrieval and virtual reality (revpo)

Conditions: Oocyte Retrieval; Pain; Fertilization in Vitro

Summary: the aim of the study is to ass wether or not the use of virtual reality during oocyte retrieval provides a better pain relief for patients, compared to a standard analgesic procedure.

patients will be included during the consultation with the gynaecologist, whom will explain the protocol to the patient and give her the consent to sign. the patient will be then randomized by a computer (using the software redcap) into either the experimental group or the standard group. in the experimental group, a virtual reality device will be installed on the patient as soon as she arrives in the operating room, and the intervention will start after 3-5 minutes. in both group, the patient will benefit of a local anesthesia in the vagina, and if they want it of an oral analgesic before the intervention. just at the end of the intervention, the pain will be evaluated orally by the nurse, using a numeric rating scale. this consist of the primary outcome. after the intervention, the gynaecologist will fill a form assessing his satisfaction concerning the use of virtual reality during the intervention (efficacy, security...) one hour after the intervention, the patient will fill a form about her self-estimation of the post-procedural pain and her satisfaction concerning the use of virtual reality. the number of oocytes collected and the number of oocytes expected on the ultrasound monitoring will be gathered and a ratio will be calculated, in order to estimate the efficacy of the retrieval. five days after the intervention, the patient will have to fill a form evaluating her consumption of painkillers during the 48hours following the intervention.

Eligibility criteria:
inclusion criteria: * aged between 18 and 43 years * first attempt of oocyte retrieval under local anesthesia in the context of a protocol for medically assisted procreation exclusion criteria: * former attempt of oocyte retrieval * poor oocyte stock : \> 40 years and low markers (amh \< 0.5-1.1 ng/ml or afc \< 5-7) * unsteady epilepsia

Keywords: reproductive techniques, assisted oocyte retrieval virtual reality medically assisted procreation pain analgesia
minimal hepatic encephalopathy among cirrhotics. a cross sectional, clinico-epidemiological, multi-centre, study in patients of pakistan

Conditions: Hepatic Encephalopathy

Summary: the preempt study is likely to help determine the frequency of patients suffering from minimal hepatic encephalopathy (mhe) and are cirrhotics. it will also enable us to know about the quality of life of these patients.


Eligibility criteria:
inclusion criteria: * patients of either sex, 18-65 years of age, who have attended school at least till the 5th class/standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with grade 0 of west haven criteria. * patients willing to undergo the neuropsychological (np) tests and to complete the sf-36 questionnaire for the estimation of health related quality of life (hrqol). * patients willing to provide written authorization to provide data for the study. exclusion criteria: * patients with inability to perform neuropsychometric tests and to complete the sf-36 questionnaire as decided by the physician.
electrocardiographic diagnostic performance of the apple watch augmented with an artificial intelligence algorithm

Conditions: Atrial Fibrillation; Tachycardia; Bradycardia; Premature Supraventricular Beat; Premature Ventricular Contraction

Summary: the swaf study will compare the performance of a smartwatch combined with cardiologs platform algorithm in the detection of atrial fibrillation and other arrhythmias with that measured on a manually read 12-lead ecg in subjects hospitalized for cardioversion or af ablation.

the swaf study is a prospective, non-significant risk, non-randomized, multicentric, open, comparative, confirmatory study. under subject consent, subjects hospitalized for cardioversion or af ablation will have a smartwatch ecg recording done simultaneously with 12-lead ecg measurement right before the intervention. if a subject is found in normal sinus rhythm he/she will be discharged otherwise the patient will undergo cardioversion and will have simultaneous recordings done a second time after the intervention. all the measurements will be done in accordance with the existing subject monitoring protocol.

Eligibility criteria:
inclusion criteria: * subjects over 18, able and willing to participate in the study * subjects who are admitted to the hospital for a cardioversion or af ablation procedure. * subjects having read the patient information letter and provided his/her consent to participate in writing, by dating and signing the informed consent prior to any trial-related procedure being conducted exclusion criteria: * subjects with paced rhythm or implanted electronic devices * pregnant or breast-feeding subjects