Kornimate/medical-research-clean huggingface dataset:
gene transfer for cancer pain

Conditions: Cancer Pain

Summary: the primary purpose of this study is to examine the safety of np2 (a nonreplicating hsv-based vector expressing enkephalin) in patients with cancer pain. the secondary purpose is to evaluate efficacy.

therapeutic hsv-based vectors deliver genes from skin inoculation to sensory neurons to interrupt pain signaling at the spinal level. side effects may be limited by the focal distribution of vector delivery and preproenkephalin expression. preproenkephalin is a natural human gene that produces peptides that bind to opioid receptors in the body. the therapeutic being evaluated, np2, is a replication defective herpes simplex type 1 virus (hsv-1) modified to express the human preproenkephalin gene that has demonstrated efficacy in numerous model of pain, including pain caused by cancer.

Eligibility criteria:
inclusion criteria: 1. patients with intractable pain from malignant disease with a 5 year projected survival of less than 25%. 2. female patients of childbearing potential who have a negative pregnancy test and using birth control. 3. patients who have not received recent treatment with a radiation, chemotherapeutic or immunotherapeutic agent and are not expected to undergo such treatment 28 days after injection of np2. 4. patients who have not had surgical stabilization/resection within 4 weeks of screening and have no plans for additional surgical procedures. 5. patients with adequate bone marrow function, igg levels greater than 565 mg% and cd4 count greater than 500. . exclusion criteria: 1. patients with serious uncontrolled medical conditions other than malignancy. 2. patients with severe liver or renal impairment 3. patients currently or previously with positive serology for hiv, hepatitis b or hepatitis c. 4. patients with a hemoglobin \<9 gm% or uncontrolled coagulopathy or bleeding diathesis. 5. patients with a clinical diagnosis of any active herpes infection within the past 6 months. 6. patients who have been vaccinated to prevent hsv infection or a history of shingles or the presence of active shingles.

Keywords: gene therapy replication defective hsv vector pain enkephalin intradermal
the effects of telerehabilitation in patients with copd

Conditions: COPD

Summary: chronic obstructive pulmonary disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. nowadays, copd patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. pulmonary rehabilitation has proven to be the best supportive treatment for individuals with copd. however, there are difficulties in rehabilitation practices in terms of the fragility of patients, transportation and access problems. telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. there are different studies demonstrating the effect of telerehabilitation in copd patients and confirming that it is safe, but it is a developing area and has a limited area of use. in this randomized controlled study, it is aimed to examine the effect of telerehabilitation training on respiratory functions, exercise capacity, quality of life, fatigue and psychosocial factors in individuals with copd via video conferencing including respiratory exercises and postural exercises.


Eligibility criteria:
inclusion criteria: * having been diagnosed with chronic obstructive pulmonary disease according to the global initiative for chronic obstructive lung disease (gold) criteria * not having an attack in the last 2 months * volunteering to participate in the study * being between the ages of 40-80 * to have a device that can be used in telerehabilitation application and an active internet connection. exclusion criteria: * unstable angina, previous myocardial infarction, severe congestive heart failure resistant to medical therapy, uncontrolled hypertension, cancer, neurological or musculoskeletal disorders with functional limitations * currently addicted to alcohol or drugs * having an injury to the lower extremity such as sprains, sprains or fractures in the last 6 months, not being able to perform independent ambulation * having serious vision and hearing problems * having severe cognitive impairment

Keywords: telerehabilitation
onabotulinum dose comparison in chronic migraine superior to 100 units?

Conditions: Chronic Migraine, Headache

Summary: the study will enroll patients through the neurology department at naval medical center san diego (nmcsd). eligible participants will meet criteria for chronic migraine, but will not be excluded based on the presence of significant comorbidities. participants with comorbidities and medication regimens commonly exhibited within real-world dod medical settings will not be excluded, such as pain disorders, psychiatric illness, medication overuse, and those who have used prophylactic medication during the baseline period. this will comprise "group a". a carefully screened group will comprise "group b" and meet exclusion criteria designed to approximate that of the preempt2 trial. within each group, half of the patients (155u arm) will be randomly selected to receive the standard 155u over 31 fixed sites every 12 weeks while the other half (100u arm) will receive 100u over 19 fixed sites every 12 weeks. minimum sample size for the entire cohort is 132 participants (maximum n = 180), with a minimum of 66 participants per comparison.


Eligibility criteria:
inclusion criteria: chronic migraine headache - diagnostic criteria: a. headache (tension-type-like and/or migraine-like) on 15 days per month for \>3 months2 and fulfilling criteria b and c b. occurring in a patient who has had at least five attacks fulfilling criteria b-d for 1.1 migraine without aura and/or criteria b and c for 1.2 migraine with aura c. on 8 days per month for \>3 months, fulfilling any of the following 3 : 1. criteria c and d for 1.1 migraine without aura 2. criteria b and c for 1.2 migraine with aura 3. believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative d. not better accounted for by another ichd-3 diagnosis. - exclusion criteria: previous exposure at any time to any botulinum toxin serotype pregnancy, breastfeeding or plans to become pregnant within 6 months age \<18 years failure to complete at least 20 days of headache diary in the 28 day baseline period
application of moses technology in bph

Conditions: Benign Prostatic Hyperplasia (BPH); Lower Urinary Tract Symptoms

Summary: in this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the holmium laser in prostate enucleation.

in this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the holmium laser in prostate enucleation using moses technology.

Eligibility criteria:
inclusion criteria: * prostatic volume between 70-200cc * acceptance to participate in the study. exclusion criteria: * previous urethra stricture * previous prostate surgery * neurogenic bladder * bladder tumor * neurological disease with repercussion in the lower urinary tract. * severe psychiatric illness * inability of the patient to consent

Keywords: laser holmium holep moses
the effect of smart ring assisted physiotherapeutic intervention after tkr

Conditions: Osteo Arthritis Knee

Summary: the goal of this randomized controlled trial is to learn about the effect of a wearable activity tracker assisted physiotherapeutic intervention on the risk of poor patient reported outcome after a primary total knee replacement. the main question it aims to answer is whether a wearable activity tracker assisted physiotherapeutic intervention and remote monitoring may help to decrease the number of the poor patient reported post-operative outcome 12 months after a primary total knee replacement. participants will receive standard postoperative care which includes physiotherapy appointments 4 weeks and 3 months after the surgery and they will use smart rings (oura ring) 3 months postoperatively. patients will be remotely monitored to follow their recovery from total knee replacement surgery: the study group physiotherapists will follow the patients' activity and sleep and if necessary, make a contact with patient if there seems to low activity indicating difficulties with recovering from the surgery. researchers will compare the intervention group to a group of participants who will receive only standard postoperative care with physiotherapy appointments 4 weeks and 3 months, to see if the use of the oura ring may decrease the number of participants with poor patient reported post-operative outcome after total knee replacement.


Eligibility criteria:
inclusion criteria: * patients undergoing primary tka for primary osteoarthritis. * patients able to consent and willing to comply with the study protocol. * patients aged 18 to 70 years * patients is able to use a smartphone and a smart ring. exclusion criteria: * patients unwilling to provide informed consent * \>15 degrees varus or valgus, or \> 15 degrees fixed flexion deformity * physical, emotional, or neurological conditions that would compromise the patient, e.g., poor compliance with postoperative rehabilitation and follow-up (e.g., drug or alcohol abuse, serious mental illness, general neurological conditions, such as parkinson, ms, etc.) * patients unable to attend the study physiotherapy appointments at the outpatient clinic. * patients unable to wear oura ring (example in case of oa or rheumatoid arthritis in the finger joints). * patients with cardiac arrhythmia.

Keywords: total knee replacement wearable activity tracker smart ring physiotherapy
the effectiveness of blastocentesis versus trophectoderm biopsy

Conditions: Abnormal Karyotype

Summary: for the purpose of this study, the investigators will perform the removal of trophectoderm (te) the cells as required for the purpose of pre-implantation genetic screening, in order to perform the genetic analysis. additionally, the investigators will remove the blastocoelic fluid (bf) and perform additional genetic analysis on the embryo in order to determine the agreement of the genetics results between te cells and bf.

the human embryo (fertilised egg) develops from a single cell and goes through several developmental stages in order to prepare for implantation inside the womb. during the fifth and sixth day post fertilisation, the embryo becomes a blastocyst. it consists of 100-150 cells and has two cell types. the inner cell mass (icm) will give rise to the baby and the trophectoderm cells will become the placenta. the trophectoderm (te) cells surround the icm. following the formation of the two cell types, the te cells start producing fluid. the progressive accumulation of fluid leads to the formation of a cavity that expands to form the blastocele cavity. this cavity contains fluid is known as blastocoelic fluid (bf). the fluid can contain proteins, cells and genetic material. traditionally to make a genetic diagnosis or when to screen embryos for abnormal chromosome number, cells are removed (biopsy) from the trophectoderm. in experienced hands, this is a very safe procedure and causes minimal damage to the embryo. however, recent studies have shown that blastocoele fluid may contain genetic material which can be aspirated (drawn out) from the blastocole cavity (blastocentesis) and used for genetic analysis of an embryo. this is potentially less invasive and harmful to the embryo. the aim of this study is to compare genetic analysis obtained following blastocentesis versus trophectoderm cell biopsy.

Eligibility criteria:
inclusion criteria: * couples undergoing assisted reproduction for pre-implantation genetic diagnosis exclusion criteria: * any other couples undergoing assisted reproduction

Keywords: blastocyst human dna blastocentesis
herniorrhaphy study for opioid elimination

Conditions: Analgesia

Summary: this is a phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of htx-011 and a postoperative non-opioid multimodal analgesic (mma) regimen. the study will be conducted in 2 sequential parts: part 1 is randomized and part 2 is investigator's preference for mma regimen.


Eligibility criteria:
inclusion criteria: * is scheduled and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural). * has an american society of anesthesiologists (asa) physical status of i, ii, or iii. * female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. exclusion criteria: * has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy). * has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * part 1 only: has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. part 2 only: has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months. * has taken any opioids within 24 hours prior to the scheduled surgery. * has a medical condition such that, in the opinion of the investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * has uncontrolled anxiety, psychiatric, or neurological disorder. * has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse.

Keywords: inguinal hernia hernia hernia surgery postoperative pain herniorrhaphy multimodal analgesia
voyager i: patient discharge using the ab5000 portable driver system

Conditions: Acute Cardiac Dysfunction

Summary: the ab portable driver system will allow patients supported with the circulatory support system to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of the ab 5000 ventricle for their heart recovery.


Eligibility criteria:
inclusion criteria: * the subject is an ab5000 circulatory support system patient (in accordance fda-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable; * the subject is male or female, age 18 years or older; * the subject is able to ambulate unassisted; * the subject is on stable oral anticoagulation over 7 days (inr 2-4) with no active bleeding; * the subject is willing and able to read, understand and sign the study specific informed consent form; * the subject agrees to comply with study protocol requirements, including all follow-up visits and completion of qol and nih stroke scale assessments. exclusion criteria: * the subject, pre-device implant, is qualified as a transplant candidate. * there is an absence of a trained companion. * there is an absence of a psycho-social support. * the subject has an inadequate home environment, such as poor access which may hinder movements. * the subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures \< 90 mmhg. * the subject requires respiratory assistance. * the subject has an active infection (positive blood culture and/or body t ≥ 38 degrees c, and/or wbc ≥ 12k/µl). * the subject requires tube feeding. * the subject has any other medical condition requiring hospitalization.

Keywords: patient receiving ab5000 ventricle potentially recoverable
evaluation of protein intake and micronutrient supplementation after bariatric surgery

Conditions: Protein Malnutrition; Vitamin Deficiency; Mineral Deficiency; Trace Element Deficiency; Obesity; Obesity, Morbid

Summary: obesity is a chronic disease in which accumulation of excess body fat can result in impaired health. in cases of severe obesity, weight loss surgery can be necessary as a treatment. there are different forms of surgery but the common basic principle is to restrict food intake and decrease the absorption of food in the stomach and intestines. as a consequence, there is a higher risk of developing nutrient deficiency after surgery and supplementation of protein, vitamins, and minerals can be necessary. this study evaluates intakes of protein, vitamins, and minerals in patients with weight loss surgery and compares them to recommended intakes. further, this study looks at the role of age, sex, and socioeconomic status in this context.

obesity is defined by the world health organization as abnormal or excessive fat accumulation that may impair health. these days, bariatric surgery is considered the most effective treatment of morbid obesity. in the last decade, the number of bariatric surgeries performed worldwide constantly increased. common bariatric surgery procedures include gastric bypass, sleeve gastrectomy, adjustable gastric band, and biliopancreatic diversion with duodenal switch. after surgery, weight loss is induced by a reduced food volume the stomach can hold, malabsorption of nutrients, or by a combination of both mechanisms. in consequence, patients with bariatric surgery have an increased risk of developing nutrient deficiency. therefore, guidelines recommend supplementation of critical nutrients, i.e. protein, vitamins, and minerals, after bariatric surgery. this study assesses intake of these nutrients in patients with bariatric surgery based on the recommendations provided by the german s3 guideline group on the surgical treatment of obesity and metabolic diseases. in particular, this study assesses the association of therapy adherence with age, sex, and socioeconomic status.

Eligibility criteria:
inclusion criteria: * sleeve gastrectomy (postoperative) * roux-en-y gastric bypass (postoperative) * postoperative period \> 6 month exclusion criteria: * missing consent * pregnancy * malignant tumor * implanted pacemaker * any other serious primary disease

Keywords: gastric bypass gastric sleeve
effect of remimazolam on postoperative delirium

Conditions: General Anesthetic Drug Adverse Reaction

Summary: remimazolam is a novel benzodiazepine with ultra-short onset and offset of its effect. it can be used for general anesthesia. however, classical benzodiazepine such as midazolam was reported to increase the risk of postoperative delirium. thus, the investigators aim to investigate the effect of remimazolam general anesthesia on postoperative delirium in elderly patients.


Eligibility criteria:
inclusion criteria: * age ≥65 years * patients scheduled for elective surgery under general anesthesia exclusion criteria: * american society of anesthesiologists status ≥ⅳ * history of neurologic or psychiatric diseases * difficulty in communication * abuse of drug or alcohol * suspected allergy to propofol or benzodiazepines

Keywords: general anesthesia elderly patients remimazolam propofol
the effects of almond on facial skin collagen and wrinkles

Conditions: Collagen Degeneration; Wrinkle; Pigmentation; Elastic Skin

Summary: investigate the effects of almond consumption on collagen production, elastin levels, wrinkles, and pigmentation among premenopausal women and postmenopausal women belonging to all fitzpatrick skin types.

almonds are energy-dense and rich in beneficial nutrients including b vitamins, vitamin e, mono- and polyunsaturated fatty acids, protein, fiber, minerals and polyphenols. polyphenols and vitamin e in almonds provide protection to the body in part, through their ability to combat oxidative stress. clinical studies have demonstrated beneficial effects of almond consumption on diseases such as diabetes and cardiovascular disease. almond consumption has been shown to significantly decrease wrinkle severity in two clinical studies conducted with postmenopausal women with fitzpatrick skin type i and ii. almond intake has also been shown to increase resistance to erythema induced by ultraviolet exposure. the extracellular matrix contains proteins including collagen and elastin, which contributes to the integrity of the skin. enzymatic and ultraviolet radiation induced degradation and a reduction in synthesis of collagen and elastin contribute to wrinkle formation. furthermore, the process of menopause decreases the level of estrogen which affects the skin in several ways, including a decrease in skin collagen and hydration, and an increase in wrinkling.

Eligibility criteria:
inclusion criteria: * subjects 35 to 70 years of age of all skin types * 50% of the subjects will be postmenopausal women determined as \>1-year loss of menstrual period * 50% of the subjects will be premenopausal women * bmi 18.5 - 35 kg/m2 * individuals with a habitual diet that has been maintained for at least 6 months and to be maintained for the duration of the study * individuals must maintain their usual skincare products, defined as products that has been used for at least 1 month, for the duration of the study exclusion criteria: * those with a nut allergy * those who are unwilling to discontinue oral collagen supplementation 1 month prior to the start of the study * individuals who are unwilling to discontinue vitamin e or nut containing supplements 2 weeks prior to and during the intervention. * individuals who are pregnant or breastfeeding * change in skincare products during the study * had a medical or cosmetic procedure such as laser resurfacing or plastic surgery to the face within the last 6 months (include botulinum toxin, dermal fillers, collagen, or other similar cosmetic procedure) * has an autoimmune photosensitive condition or known genetic condition with a deficiency in collagen production (such as ehler-danlos) * those with a skin disease on their face that would affect the assessment of their skin based on the assessment of the investigator. * current tobacco smoker or a tobacco smoking history of greater than 10 pack-years