Kornimate/medical-research-clean huggingface dataset:
a study of rslv-132 in females with sjögren's syndrome

Conditions: Primary Sjögren Syndrome

Summary: the goal of this clinical study is to learn if rslv-132 improves the symptoms of ss in adults. it will also learn about the safety of rslv-132. the main questions it aims to answer are: * does rslv-132 improve the cardinal symptoms of sjogren's including fatigue, dryness and pain? * does rslv-132 improve the tiredness/fatigue caused by sjogren's? * what are the blood levels of rslv-132 over time? * what is the immune (antibody) response in the body to rslv-132? * what is the safety profile of rslv-132? researchers will compare rslv-132 to a placebo (a look-alike substance that contains no drug) to see if rslv-132 improves the symptoms of pss. participants will: take rslv-132 or a placebo 13 times over 22 weeks visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (day 211) for check-ups, tests and to answer questionnaires about their symptoms record their symptoms every day on an electronic device


Eligibility criteria:
inclusion criteria: * providing written informed consent * weight at least 45 kg * meet the 2016 american college of rheumatology (acr)/european league against rheumatism (eular) classification criteria for pss * diagnosis in the last 10 years * positive anti-ro/ssa antibody test * score of 5 or higher on the eular sjögren's syndrome patient reported index (esspri) scale and the esspri fatigue scale * of non childbearing potential or of childbearing potential and using highly effective contraceptive measures exclusion criteria: * diagnosis of any active autoimmune disease other than pss that could affect the efficacy assessments * uncontrolled hypothyroidism or severe fibromyalgia * new medications or change in medications in the last 4 weeks for pss symptoms * receipt of other prohibited medications * apheresis or blood donation * allergic reaction to rslv-132 or biologic therapy * clinically significant infection in last 30 days * participation in another clinical study * malignancy in last 5 years * positive test for hiv or hepatitis * major surgery in last 30 days or anticipated surgery during the study * pregnancy or breast feeding * laboratory blood tests outside of specified ranges * other medical conditions or medications that would make the participant unsuitable
comparing anastrozole-placebo to the combination anastrozole-zd1839 in postmenopausal patients with estrogen receptor and/or progesterone receptor metastatic breast cancer

Conditions: Breast Cancer

Summary: this study is being carried out to see if treatment with zd1839 (gefitinib) combined with arimidex (anastrozole) has improved efficacy over arimidex alone in preventing progression of metastatic breast cancer.

this is a phase ii, multicenter, double-blind, randomized, placebo-controlled trial. patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day zd1839 or matched placebo in combination with 1 mg/day anastrozole. the dose of zd1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. the 1 mg dose of anastrozole is the standard approved dose.

Eligibility criteria:
inclusion criteria: * female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer. * patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial. * a paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required. exclusion criteria: * patients cannot be on hormone replacement therapy while on study. * prior chemotherapy received for metastatic disease is not allowed. * previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed. * patients who have evidence of an active interstitial lung disease are not eligible.

Keywords: metastatic breast cancer
hypercapnia: cognitive effects and monitoring

Conditions: Hypercapnia; Exercise; Nitrogen Narcosis; Diving; Immersion

Summary: the investigators will simulate the conditions of a working, helmeted diver by using exercising, "head out" immersed subjects to test the following hypotheses: 1. an algorithm can be developed which predicts cognitive performance in immersed exercising divers, based on the exhaled carbon dioxide (petco2) and the diver's inspired partial pressures of oxygen and nitrogen (pio2 and pin2). 2. petco2 using mass spectrometry is an accurate estimate of arterial carbon dioxide (paco2) at rest and during immersed exercise and can be used as a paco2 surrogate at levels exceeding 50 mmhg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165 fsw density of 6.8 g/l).


Eligibility criteria:
inclusion criteria: * healthy, * male, * age greater than 18, * age less than 50 exclusion criteria: * smoker, * asthma, * cardiac disease, * inability to pedal a bicycle ergometer, * inability to perform vigorous exercise

Keywords: diving cognitive impairment nitrogen narcosis narcosis end tidal carbon dioxide arterial carbon dioxide immersion
sportspro: post-market clinical follow up study

Conditions: Shoulder Injuries; Knee Injuries; Hip Injuries

Summary: retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)

the purpose of this study is to leverage standard of care data to provide further characterization of clinical outcomes following shoulder, hip and knee joint surgeries. * primary objective: to describe clinical outcomes of the stryker device in the shoulder, hip, and knee joints 6 months after surgical intervention. * secondary objective: to describe clinical outcomes of the stryker device in the shoulder, hip, and knee joints 3 months after surgical intervention. * safety objective: to describe safety of the stryker implants in the shoulder, hip, and knee joints 6 months after intervention.

Eligibility criteria:
inclusion criteria: 1. subject was ≥ 18 years of age at the time of the surgery 2. subject has undergone joint space repair using one of the study devices exclusion criteria: 1. subjects who are less than 6 months post-intervention 2. concurrent participation in an investigational clinical study during the study period
do patients with chronic daily headache have continuous headache or moments of headache relief?

Conditions: Chronic Daily Headache

Summary: the objective of this study is to determine if patients with chronic daily headache have continuous headache or moments of headache relief. the secondary objective of this study is to determine the period of time patients who have chronic daily headache that is not continuous are headache free.

this study is a retrospective chart review of all patients over the age of 18 who are seen by the co-investigator during one initial, or routine follow up visit, with the diagnosis of chronic migraine, chronic tension type headache, new daily persistent headache, or chronic post traumatic headache(per international headache classification ii guidelines6). patients with the above diagnosis during their routine care are asked five standard questions about their headaches by the co-investigator, and the responses are recorded in the patient's medical record (see question sheet attached). these questions pertain to the patients' health care, and are asked of most patients at the jefferson headache center with chronic headache routinely during office visits.

Eligibility criteria:
inclusion criteria: * patients with chronic migraine, new daily persistent headache, chronic tension type headache, or chronic post traumatic headache seen at the jefferson headache center. exclusion criteria: * subjects under age 18.
registry of cardiovascular disease patients

Conditions: Ischemic Heart Disease; Congestive Heart Failure; Peripheral Vascular Disease; Cerebrovascular Disease; Atrial Fibrillation; Cerebrovascular Atherosclerosis

Summary: a computerized registry of cardiovascular disease patients in a large health maintenance organization in israel. the registry is aimed to be used by health professionals to identify cardiovascular disease patients and to follow the courses of their illnesses and risk factors.

the registry was initiated in 1998 by maccabi healthcare services, which is the second largest publicly funded hmo in israel,serving 24% of the total population with a nationwide distribution. the registry uses advanced information technology that integrates personal computerized community and hospital records, data from laboratory tests, dispensed medications, physiological signals, radiological images, and reports from investigations and procedures.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of the following: ischemic heart disease,mi,non-mi,congestive heart failure,peripheral vascular disease, cerebrovascular disease cva,tia,patients with first ami diagnosis from community physicians if they were hospitalized for lasting at least 3 days during a 30-day period prior to diagnosis. * patients with prior coronary artery bypass grafting(cabg) or percutaneous coronary intervention (pci), using relevant current procedural terminology (cpt) codes exclusion criteria: * patients who were diagnosed as suffering from chd by primary physician or general hospitals prior to 2000 with no further indication * patients whose primary physician reported that the patient is chd-free providing adequate medical records

Keywords: registry, cardiovascular, cvd, health maintenance organization
alpha-1-acid glycoprotein as a biomarker of developmental diagnosing and monitoring effectiveness in sepsis

Conditions: Systemic Inflammatory Response Syndrome; Sepsis

Summary: to assess the potential value of alpha-1-acid glycoprotein (agp) for early diagnosis and prognosis of patients with sepsis, and then compared with c-reactive protein (crp), procalcitonin (pct), white blood cell (wbc) counts, acute physiology and chronic health evaluation (apache) ii score and sequential organ failure assessment (sofa) score. 164 patients were enrolled in the study, including 25 cases with systemic inflammatory response syndrome (sirs) and 139 cases with different levels of sepsis (46 moderate sepsis, 52 severe sepsis and 41 septic shock ). serum levels of alpha-1-acid glycoprotein (agp), c-reactive protein (crp), and procalcitonin (pct), and white blood cell (wbc) counts were measured on the day of admission to intensive care unit (icu).


Eligibility criteria:
inclusion criteria: 1. male and female aged 18 years old and over; 2. clinically suspected infection; 3. fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °c or lower than 36 °c (b)respiratory rate above 20/min, or pco2 below 32 mmhg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands; exclusion criteria: 1. less than 18 years old; 2. immunosuppression; 3. agranulocytosis (granulocyte counts \<0.5× 109/l); 4. chronic myeloid leukemia (cml); 5. malignancy; 6. less than 24 hours of the length of icu stay; 7. reluctant to participate in the study.

Keywords: sepsis alpha-1-acid glycoprotein (agp) diagnosis prognosis sirs
the effect of topical vibration on injection pain in scalp block

Conditions: Analgesia

Summary: in this study; it's aimed to reduce injection pain during the practice of scalp block, which is used as a method of anesthesia in patients who underwent awake craniotomy surgery. for this purpose, the investigators used topical vibration stimulation, which is non-invasive procedure.

scalp block is an analgesia technique frequently used in neurosurgical procedures. in this block, while providing adequate anesthesia for surgery, it also helps to preserve hemodynamics by inhibiting pain sensation. in this block, there is a certain degree of pain due to multiple injections. the transmission of pain sensation to the cortex is reduced by costimulating the receptors that transmit the pain sensation with vibration stimulus. in this study; it was aimed to investigate the effect of topical vibration on injection pain in participants who received sedoanalgesia with dexmedetomidine in bilateral scalp block practice. in routine clinical practice, bilateral scalp block (local anesthetic injection into greater occipital, lesser occipital, supratrochlear, supraorbital, auriculotemporal, zygomaticotemporal nerves) is performed in participants who is sedated. while local anesthetic is injecting, vibration device (aprilla brand, giving 6000 vibrations per minute) will be vibrated for 10 seconds and then local anesthetic will be injected. meanwhile, participants' numerical pain scores (nrs) and hemodynamic parameters will be monitored. in this study, the nrs scores and hemodynamic variables of the participants will be compared during the local anesthetic application of each 6 nerves bilaterally and during the injections of the nerves with and without the use of vibration.

Eligibility criteria:
inclusion criteria: * between the ages of 18-75 * asa (american society of anesthesiologists) scoring i-iii * cases in which scalp block will be applied exclusion criteria: * asa score iv * uncooperative * known allergy to any of the study drugs

Keywords: scalp clock awake craniotomy vibration
phase 1 pk study of cediranib in single and multiple doses in hepatically impaired patients with solid tumours

Conditions: Advanced Cancer; Hepatic Impairment

Summary: to determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise cediranib.


Eligibility criteria:
inclusion criteria: * written informed consent * advanced solid tumour (not prostate cancer) for which no standard therapy exists * who performance status 0-2 * bilirubin levels within the target range exclusion criteria: * unstable brain/meningeal metastases * inadequate bone marrow reserve * biochemistry/haematology results outside of required ranges * history of significant gi impairment

Keywords: advanced cancer metastatic hepatic impairment
stimulate one hand to improve tactile perception on the other

Conditions: Post-stroke Sensory Deficits at the Hand

Summary: the study is a comparative study, to show that the administration of rss stimulation on one hand compared to the administration of strategy sham stimulation, results in an temporary improvement in the tactile acuity of the other hand in patients with tactile acuity impairment of the hand due to stroke.


Eligibility criteria:
* inclusion criteria: * age: 30-80 years old * patients with diagnosis of unilateral (both right and left) ischemic or hemorrhagic stroke * stroke event dates at least 3 months before the date of inclusion to the study * severe-to-mild sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand) * capacity to provide written consent * affiliation to a social security scheme * non inclusion criteria \* : * sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy * severe speech disorder, global aphasia and/or cognitive impairment * multiple stroke events * bilateral stroke event * history of neurological or psychiatric illness * other experimental procedure is forbidden during the weeks where the study is performed * pregnant, parturient and lactating women * persons deprived of their liberty * adult persons subject to a legal protection measure: guardianship, curatorship * persons in psychiatric care * congenital or acquired malformation/injury of the test fingers * impossibility to maintain hand position necessary for the tests due to severe spasticity exclusion criteria: • severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the rss

Keywords: stroke sensory deficits rss
clinical outcomes for deep brain stimulation

Conditions: Parkinson Disease; Essential Tremor; Dystonia

Summary: the object of this study is to longitudinally collect clinical outcomes of patients receiving deep brain stimulation for movement disorders with the objective of making retrospective comparisons and tracking of risks, benefits, and complications.


Eligibility criteria:
inclusion criteria: * levodopa responsive parkinson disease or * medically refractory essential tremor or * medically refractory dystonia exclusion criteria: * dementia (mattis dementia rating scale \<130) * structural abnormalities precluding intracranial surgery

Keywords: deep brain stimulation
natural history study of patients with hypophosphatasia (hpp)

Conditions: Hypophosphatasia

Summary: hypophosphatasia (hpp) is a rare inherited metabolic disorder characterized by defective bone and teeth mineralization caused by mutations of the alpl gene, which encodes for the tissue-nonspecific alkaline phosphatase (tnsalp) isozyme, resulting in decreased serum and bone alkaline phosphatase levels. to date, over 250 different mutations in the gene encoding tnsalp have been associated with hpp. clinically, the loss of tnsalp function results in progressive skeletal impact as well as progressive impact on all other major organ systems. it clinically manifests as rickets in infants and children and osteomalacia at all ages. the severe form of the disease has been estimated to have a prevalence of about 1 in every 100,000 live births.

inheritance can be autosomal recessive or dominant, and penetrance is variable resulting in a wide range of clinical expressivity, with a spectrum ranging from stillbirth without mineralized bone to early loss of teeth without bone symptoms. depending on the age at diagnosis six clinical forms are currently recognized: perinatal (lethal), perinatal benign, infantile, childhood, adult and odontohypophosphatasia. severe forms of hpp (perinatal and infantile) are inherited as an autosomal recessive trait and in milder forms (adult and odontohypophosphatasia) autosomal recessive and autosomal dominant inheritance coexist. because of the rarity of hpp as well as the side spectrum of both clinical presentation and inheritance patterns of the hpp trait, a natural history study cataloging specific clinical data with hpp would prove invaluable for future research into this disease. specifically, it is our goal to create a comprehensive multi-discipline modality for care for hypophosphatasia patients, researching clinical manifestations of the disease such as extent of bone disease, ophthalmologic manifestations, orthopedic issues, renal issues, musculoskeletal manifestations as well as other more anecdotal findings such as those seen with cochlear implant failures and/or early menopause.

Eligibility criteria:
inclusion criteria: * patients or their legal representative must provide written informed consent or, if applicable, qualify for waiver of consent. * patients must have a pre-established clinical diagnosis of hpp, as indicated by one or more of the following: * serum alkaline phosphatase (alp) below the age-adjusted normal range * plasma plp at least twice the upper limit of normal (no vitamin b6 administered for at least 1 week prior to determination) * evidence of osteopenia or osteomalacia on skeletal radiographs * genetic analysis fof the alpl gene * must be current patient in the duke university system. exclusion criteria: * any patient without confirmation of clinical diagnosis of hpp.

Keywords: hypophosphatasia hpp
topical application of bmx-010 in subjects with atopic dermatitis and plaque psoriasis

Conditions: Psoriasis; Atopic Dermatitis

Summary: this is a randomized, placebo-controlled phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. in this trial bmx-010 will be topically applied twice daily for up to 28 days.

this is a phase 2, randomized, multicenter, placebo-controlled study sponsored by biomimetix jv, llc (bmx). it is a double-blind parallel cohort study designed to determine the safety and efficacy of bmx-010 (0.03%) relative to placebo in subjects with atopic dermatitis and psoriasis. subjects will be queried regarding adverse events (aes) and concomitant medication usage.

Eligibility criteria:
inclusion criteria: * diagnosis of either atopic dermatitis or psoriasis with mild to moderate lesions involving 1% - 25% of total body surface area * candidate for topical treatment of atopic dermatitis or psoriasis * negative pregnancy test for females of childbearing potential exclusion criteria: * systemic pharmacotherapy or phototherapy for treatment of atopic dermatitis or psoriasis * erythrodermic, guttate or generalized pustular psoriasis * treatment of systemic retinoids, corticosteroids or immunosuppressive agents within 4 weeks of baseline visit * treatment with high potency topical steroids, vitamin d analogs, keratolytics, coal tar, phototherapy, calcineurin inhibitors, or antihistamines within 2 weeks of baseline visit * uv or dead sea therapy within 4 weeks of baseline visit * treatment with a biologic agent (monoclonal antibody) within 30 days or 5 times its circulating half-life (whichever is longer) prior to baseline visit * atopic dermatitis triggered by environmental allergen or irritant * contact dermatitis or drug-induced skin reactions * systemic or skin infection requiring antimicrobial therapy * systemic chemotherapy or radiotherapy within 4 weeks of baseline visit * immunocompromise of any cause * pregnancy, lactation or inadequate contraception * active drug or alcohol dependence * significant acute or chronic medical, neurological or psychiatric illness that would compromise subject's safety
efficacy of n-acetylcysteine (nac) in preventing covid-19 from progressing to severe disease

Conditions: COVID; Sars-CoV2; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Oxidative Stress

Summary: the purpose of this study is to assess the efficacy of n-acetylcysteine (nac) in preventing those with mild or moderate covid-19 from progressing to severe disease

after being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral n-acetylcysteine (nac) as follows: inpatients: * n-acetylcystine (nac) 25 mg/kg po (rounded up to the nearest 600 mg) q4hrs until discharge * n-acetylcysteine (nac) 1200 mg po bid x 1 week post-discharge outpatients: - n-acetylcysteine (nac) 2400 mg po x 1 then 1200 mg po bid x 2 weeks

Eligibility criteria:
inclusion criteria: * known or suspect covid-19 disease and one or more of the following influenza-like symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of breath chest pain exclusion criteria: * minors, pregnant women and people unable to provide informed consent are excluded from this study

Keywords: glutathione acetylcysteine oxidative stress nac covid covid-19 sars-cov2