Kornimate/medical-research-clean huggingface dataset:
speed of processing training to improve cognition in traumatic brain injury and mild cognitive impairment

Conditions: Traumatic Brain Injury; Mild Cognitive Impairment

Summary: the purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a traumatic brain injury (tbi) population. the study is designed to study how well this technique can help people with tbi increase their processing speed and their ability to function better in everyday life.

the current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe tbi with documented impairment in ps. the goals of the trial are to (a) test the efficacy of this treatment protocol within a tbi population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. individuals with moderate to severe tbi, with documented impairment in ps, will be randomly assigned to a treatment group or a control group. both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. this design will allow us to assess the efficacy of spt in persons with tbi and evaluate its impact on everyday life.

Eligibility criteria:
inclusion criteria: * diagnosis of traumatic brain injury or mild cognitive impairment * fluent in english * processing speed impairment exclusion criteria: * prior stroke or neurological disease * currently taking steroids and/or benzodiazepines * history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of major depressive disorder, schizophrenia, epilepsy, bipolar disorder * significant alcohol or drug abuse history

Keywords: processing speed cognition intervention traumatic brain injury mild cognitive impairment
a dose-finding study of mm-120 (lsd d-tartrate) for the treatment of anxiety symptoms

Conditions: Anxiety Generalized

Summary: this is a phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of mm-120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (gad).

the study will enroll approximately 200 male and female subjects 18 years to \< 75 years of age who meet dsm-5 criteria for gad and have a minimum ham-a total score of 20. subjects on contraindicated concomitant medications, supplements or other therapeutics at screening (visit 1) will undergo a medication taper prior to advancing to baseline (visit 2).

Eligibility criteria:
inclusion criteria: * bodyweight of ≥ 50 kg * body mass index \[bmi\] ≥ 18 to ≤ 38 mg/kg2 * diagnosis of dsm-5 generalized anxiety disorder * acceptable overall medical condition to be safely enrolled into and to complete the study * ability to swallow capsules * ability to provide informed consent exclusion criteria: * women of childbearing potential (wocbp) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception for the duration of the study, or men physiologically capable of fathering a child who are sexually active with wocbp but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study * women who are currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the study * men who plan to donate sperm during the study * prior history (lifetime diagnosis) with a lifetime diagnosis of schizophrenia spectrum, or other psychotic disorders or bipolar disorder * has a significant risk of suicide attempt based upon medical history or has active suicidal ideation * unwillingness or inability to discontinue prohibited concomitant medications, supplements or other therapeutics (prescription or over-the-counter)
morphine-sparing effect of intravenous paracetamol for post-operative pain management following laparoscopic gastric banding in morbidly obese patients

Conditions: Obesity

Summary: the investigators predict that giving patients paracetamol in the operative period will reduce their need for opioid pain reducers in the post operative setting.

this study is designed as a population-based prospective, double blind cohort study. a prospective cohort of patients admitted to laparoscopic gastric banding due to morbid obesity study goals * to evaluate the morphine-sparing effect of paracetamol iv in obese patients undergoing bariatric surgery. * to identify potential ability of paracetamol iv to attenuate or relief postoperative pain in obesity patient undergoing bariatric surgery * to determine effectiveness of paracetamol iv to reduce postoperative complication rate.

Eligibility criteria:
inclusion criteria: * age ≥18 years * patients admitted for laparoscopic gastric banding * elective surgery * bmi \> 40 * asa (american society anesthesiologists perioperative risk stratification) class 1-2 exclusion criteria: * patients' refusal to participate in the study * patients unable to give an informed consent * pregnancy * emergent surgery * patient with known allergy to morphine or paracetamol * patient with hepatic failure (based on history or elevated liver enzymes). * asa class \>2.

Keywords: morphine-sparing paracetamol obesity gastric banding
microporous polysaccharide hemospheres epistaxis

Conditions: Epistaxis

Summary: the purpose of this study is to compare a new treatment for nosebleeds to the treatment that has been used for many years.

nosebleeds are a common condition which affect many americans every day.the standard treatment in this hospital for nosebleeds that do not resolve with squeezing the nose or nasal spray is to place a nasal packing (aka nasal tampon) into the nose. this is an effective treatment in most cases, but patients may find it to be uncomfortable. the investigators will be comparing the standard nasal packing with a new type of powder which may also stop nosebleeds.

Eligibility criteria:
inclusion criteria: * acute epistaxis who have failed conservative measures (including application of pressure and application of oxymetazoline spray) and for which the otolaryngology service has been consulted * must be alert and oriented * hemodynamically stable with a hemoglobin greater than 9 g/dl * cooperative exclusion criteria: * unable to consent or cooperate * history of hereditary hemorrhagic telengectasias * hemophilia * clotting factor deficiencies * history of prior surgery for epistaxis control * nasal trauma * recent sinonasal surgery * hemodynamic instability * posterior bleed (as determined by ear, nose, throat physician) * visibly bleeding vessel * allergy to product * current diabetic ketoacidosis
efficacy and safety study of intravenous progesterone in patients with severe traumatic brain injury

Conditions: Brain Injuries

Summary: the synapse trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.


Eligibility criteria:
inclusion criteria: 1. male or female patients between the age of 16 and 70 years, inclusive 2. weight from 45 to 135 kg, inclusive 3. sustained a closed head trauma no more than 8 hours before start of study drug infusion 4. tbi diagnosed by history and clinical examination 5. post-resuscitation glasgow coma scale (gcs) score between 3 to 8, inclusive 6. at least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive) 7. evidence of tbi confirmed by abnormalities consistent with trauma on ct scan upon admission (diffuse injury ii-iv, evacuated and non-evacuated mass lesion, marshall's ct classification) 8. indication for icp monitoring exclusion criteria: 1. life expectancy of less than 24 hours as determined by the investigator 2. prolonged and/or uncorrectable hypoxia (pa02\< 60 mmhg) or hypotension (systolic blood pressure \< 90 mmhg) at the time of randomization 3. any spinal cord injury 4. pregnancy 5. penetrating head injury 6. bilaterally fixed dilated pupils at the time of randomization 7. coma suspected to be primarily due to other causes (e.g. alcohol) 8. pure epidural hematoma 9. preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome 10. severe cardiac or hemodynamic instability prior to randomization 11. known treatment with another investigational drug therapy or procedure within 30 days of injury 12. a history of allergic reaction to progesterone and related drugs or any of the components of the infusion 13. any disease, in the opinion of the investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. 14. patients who, in the opinion of the investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)

Keywords: brain injury trauma
using d-galactose as a food supplement in congenital disorders of glycosylation

Conditions: Congenital Disorders of Glycosylation

Summary: the goal of this study is to better characterize the metabolic alterations and sugar structure alterations (glycosylation abnormalities) in patients diagnosed with congenital disorders of glycosylation. the investigators aim to assess the safety and tolerability of oral galactose treatment in a small pilot group of congenital disorders of glycosylation patients. the investigators will also determine the relationship between simple milk sugar intake (galactose dose) in the diet and the blood and urine markers of protein glycosylation abnormalities.

the primary hypothesis in this study is that adding simple milk sugar (galactose) to the diet of congenital disorders of glycosylation patients will normalize the metabolic abnormalities. the secondary hypothesis posits that galactose intervention in congenital disorders of glycosylation patients will normalize specific physiological biomarkers of protein glycosylation that can be utilized for future phase ii/iii trial development. the knowledge gained from the investigation of these two aims will help the investigators learn more about the disrupted metabolic mechanism of this disease and should lead to the identification of new disease biomarkers that can be used to evaluate clinical efficacy in future therapeutic trials. over a two-year period, the investigators will enroll patients diagnosed with congenital disorders of glycosylation. the investigators propose to administer oral galactose supplementation for a period of 18 weeks in increasing dose to assess its effectiveness at normalizing glycosylation. galactose will be given in a series of doses within the range of normal dietary intake of galactose over fixed time points. to assess the effects of oral galactose supplementation for each participant, changes in participant growth, as well as blood sugar levels, coagulation parameters and liver function (the primary clinical features of congenital disorders of glycosylation) will be correlated with biomarkers derived from participant blood and urine samples obtained at key time points and then compared to standard normative ranges of data for each measure.

Eligibility criteria:
inclusion criteria: * biochemically and genetically proven congenital disorders of glycosylation. exclusion criteria: * any of the following conditions: * aldolase b deficiency * galactosemia (unable to process galactose) * hemolytic uremic syndrome * severe anemia * diagnosis of intellectual disability or developmental delay * galactose intolerance * has previously experienced any of the following severe side effects from oral galactose: * diarrhea * vomiting * constipation * galactosuria (galactose in the urine) * increased liver glycogen storage.

Keywords: glycosylation glucose metabolic disorder galactose
assessment of safety and feasibility of exablate blood-brain barrier (bbb) disruption in gbm patients

Conditions: Glioma, Malignant; Glioblastoma

Summary: the purpose of this study is to evaluate the safety of the exablate model 4000 type 2.0 used as a tool to disrupt the bbb in patients with high grade glioma undergoing standard of care therapy.

the primary objective is to evaluate the safety and feasibility of bbb disruption using the exablate type 2.0 system in adult patients with glioblastoma (gbm) undergoing adjuvant tmz chemotherapy, which occurs following maximal safe surgical resection and completion of the initial concurrent radiation-chemotherapy in accordance with the current standard of care

Eligibility criteria:
inclusion criteria: 1. patient is eligible for adjuvant tmz treatment. 2. men or women age between 18 and 80 years, inclusive. 3. able and willing to give informed consent. 4. grade iv glioma (gbm) confirmed subjects 5. karnofsky rating 70-100. 6. able to communicate during the exablate bbbd procedure. 7. life expectancy of at least 3 months. exclusion criteria: 1. evidence of acute intracranial hemorrhage. 2. the subject presents with severe symptoms and signs of increased intracranial pressure 3. patients with cerebellar or brainstem tumors. 4. patients with positive hiv status 5. patients with brain tumors containing 1p/19q chromosomal co-deletion 6. patient receiving bevacizumab (avastin) therapy 7. patients undergoing other concurrent therapies 8. cardiac disease or unstable hemodynamics 9. severe hypertension 10. anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment 11. history of a bleeding disorder and/or coagulopathy 12. known sensitivity to gadolinium-based contrast agents 13. known sensitivity to ultrasound contrast agent 14. severely impaired renal function 15. subjects with significant liver dysfunction

Keywords: glioma, mrgfus, exablate, tmz
attain success clinical trial

Conditions: Heart Failure

Summary: the purpose of the study is to assess lead implant success and complication rate using the medtronic attain family of left-heart leads and delivery catheters.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age or older * subject will be implanted with medtronic cardiac resynchronization therapy (crt) device and medtronic left heart lead utilizing (or attempting to utilize) attain family of delivery catheters. the implant procedure may include upgrades to crt from implantable pulse generator (ipg) or implantable cardioverter-defibrillator (icd). exclusion criteria: * subject is enrolled in a concurrent study with the exception of a study approved by the medtronic clinical trial leader prior to enrollment * subject has existing crt system implanted or was previously implanted with a crt system.
heavy metals' influence on early pregnancy through oxidative stress

Conditions: Spontaneous Abortion; Oxidative Stress

Summary: patients with diagnosis of spontaneous abortion are enrolled in the cohort, in the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken for heavy metal level examnation. part of the villi tissue was sent for genetic testing, and the results were traced. in addition, about 10g of villi tissue was frozen for testing. patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.

from may 1, 2019, patients with diagnosis of spontaneous abortion are enrolled in the cohort, exclusion criteria were: not long-term residents in peking; inconvenient for following up; long-term of drug use; cesarean section scar pregnancy and other high-risk pregnancy; diagnosis of pregnancy beyond 12 weeks. in the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken on the day of admission for curettage and suction, and the levels of heavy metals were tested. part of the villi tissue was sent for genetic testing, and the results were traced. in addition, about 10g of villi tissue was frozen for testing. patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.

Eligibility criteria:
inclusion criteria: 1) the length of fetal bud is equal to or greater than 7 mm and there is no cardiac activity; 2) the maximum zh diameter of the pregnancy sac is equal to or greater than 25mm, and there is no fetal heart beat; 3) an embryo with no heartbeat at 2 weeks or more after ultrasound examination showing a pregnancy sac without yolk sac; 4) embryos without heartbeat for 11 days or longer after ultrasonography showed the yolk sac as a type pregnancy sac.
safety and efficacy of lorbrena

Conditions: Non-small Cell Lung Cancer

Summary: to investigate the following matters under post-marketing use of lorbrena in patients who received this drug 1. factors affecting the onset of central nervous system disorder 2. effect of lorbrena in combination with cyp3a inducers on the onset of hepatic dysfunction


Eligibility criteria:
inclusion criteria: * all administered patients exclusion criteria: * nothing
compression bandages in upper limb lymphedema

Conditions: Lymphedema

Summary: despite different types of bandages are using in the lymphedema treatment, numerous of them have not been directly compared. the aim of this study is to compare the efficacy of five different kinds of bandages on limb volume and lymphedema-related symptoms. it was also measured as secondary variables the comfort of the bandage related by the participants and the directly cost of each kind of bandage during the treatment.


Eligibility criteria:
inclusion criteria: * women after breast cancer surgery undergoing upper limb lymphedema not previously treated * having more than two centimeters between two adjacent measurements between the lymphedematous and the contralateral upper limb * the presence of heaviness, tension or fovea in the affected limb * more than six months post-surgery or radiation to eliminate the possibility of being a post-chirurgical oedema exclusion criteria will be: * bilateral breast cancer surgery * only hand lymphedema * active cutaneous infection * a loco-regional cancer recurrence * the impossibility of complete all the physical therapy sessions * a primary lymphedema * women with lymphedema symptoms like thickness and heaviness in the upper limb but without a difference of two centimeters in two adjacent points * any contraindication to physiotherapy
a single dose, open-label, dose-escalation study of the safety and imaging characteristics of ls301-it for intraoperative imaging of lung cancer

Conditions: Lung Cancers

Summary: the aim of this phase 1b study is to investigate the safety and fluorescence signal of a single dose of ls301-it, a novel fluorescence imaging agent developed by integro theranostics (it), administered by slow intravenous (iv) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.

this is a phase 1b, open-label study to investigate the use of ls301-it (investigational medicinal product \[imp\]), a fluorescence imaging agent used for visualization of tumor margins and other suspicious nodules in patients with primary diagnosis, or a high clinical suspicion, for cancer in the lung based on ct, biopsy, or other imaging. up to 24 patients (4 dose cohorts, up to 6 patients each) for phase 1b study (total of 24 patients maximum). there will be no stratification by dosing interval or lung cancer type (e.g., lung adenocarcinoma, lung squamous cell carcinoma). as safety is the primary objective of this study, the safety of each dose level will be assessed by the safety review committee (src). based upon the safety results of the first cohort, the src will recommend to the sponsor which dose levels of ls301-it may be administered in subsequent cohorts.

Eligibility criteria:
inclusion criteria: * ecog performance status of 0 to 2 * have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on ct, biopsy, or other imaging. * are scheduled to undergo surgical thoracoscopy and resection of the lung. exclusion criteria: * contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject * no planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery history of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (icg) or other agents used in the study, or known shellfish allergies. known sensitivity to near infrared light patients with impaired renal function as defined by a creatinine clearance (crcl) \<60 ml/min at screening, according to the cockcroft-gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female) history, or presence in the ecg at screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as fridericia's corrected qtc interval (qtcf) \> 470 ms

Keywords: lung cancer imaging lung cancer surgery