Kornimate/medical-research-clean huggingface dataset:
a study in adults to learn about inherited alpha-1 antitrypsin deficiency (aatd) and aatd related liver problems

Conditions: Alpha1-Antitrypsin Deficiency

Summary: the main aim of this study is to learn about liver problems caused by the lack of alpha-1 antitrypsin (called alpha-1 antitrypsin deficiency or aatd) in adults when not treated (this is called the natural history of a condition) over 5 years. other aims are to learn what can predict the aatd-liver condition starting and getting better or worse, describe how this condition is currently being diagnosed and watched in normal hospital care, and describe how the aatd also affects and adult's lung function. data in this study will be collected to include medical history of a participant, including the date aatd was first identified and/or the date on which the first aatd-related liver or lung problems were diagnosed. at study start and then every year until study end, participants will be asked to completed questionnaires (called patient-reported outcomes or pro).


Eligibility criteria:
inclusion criteria: participants who meet all the following criteria will be included in the study. cohorts 1 and 2: 1. willing to provide written informed consent or currently enrolled in an ongoing participating aatd patient registry that does not require reconsenting to participate in the study. 2. \>=18 years of age at enrollment in this study. 3. participants with documented diagnosis of aatd, meeting the following criteria: 1. cohort 1 (aatd-pi\*zz genotype/phenotype). • pi\*zz genotype as documented from rapid genetic assay, sequencing, or polymerase chain reaction (pcr), or pi\*zz phenotype as documented from iso-electric focusing (ief) electrophoresis. 2. cohort 2 (aatd-pi\*sz genotype/phenotype with liver disease manifestation). * pi\*sz genotype as documented from rapid genetic assay, sequencing, or pcr, or pi\*sz phenotype as documented from ief electrophoresis, and * moderate-advanced or severe liver disease manifestation as defined by either liver biopsy or surrogate laboratory measures, as determined through: * lab and imaging measures to define liver disease manifestation exclusion criteria: participants who meet any following criteria will be excluded from the study. 1. documented aatd genotype/phenotype other than pi\*zz or pi\*sz. 2. history of liver transplant. 3. no results for either biopsies, magnetic resonance elastography (mre), fibro scan (vibration controlled transient elastography \[vcte\]), or aspartate aminotransferase to platelet ratio index (apri) in the 24 months prior to the study baseline date, and has none of these tests ordered in the current visit that will be available in the next 90 days. 4. participants who had previously been treated or in an active participation in an interventional trial studying liver or lung disease. 5. treatment with liver directed aatd investigational therapy as part of a compassionate use request.

Keywords: drug therapy
antenatal development evaluated prospectively

Conditions: Retardation, Fetal Growth; Macrosomia, Fetal

Summary: fetal growth abnormalities is one of the most common problems faced in modern obstetrics. the association between low birth weight and perinatal death as well as severe morbidity is well known. since fetal weight cannot be measured directly, obstetricians use estimates of fetal weight obtained by utilizing various ultrasonographic measurements to diagnose growth abnormalities. currently in clinical practice, the majority of fetal ultrasound centers employ population-based fetal growth curves that have been previously published and updated to estimate fetal weight percentiles. up to 70% of neonates found to be below the 10% percentile for estimated fetal weight in population-based growth curves are actually constitutionally small; that is a neonate deemed "small" based on standardized growth curves but in reality have reached its appropriate growth potential in relation to its genetic predisposition. an equally difficult clinical scenario is fetal macrosomia. a recent meta-analysis revealed that the sensitivity and specificity of ultrasound detection of fetal macrosomia ranges from 15-79%. when compared with neonates with normal birth weight, the odds ratio of emergency cesarean delivery and shoulder dystocia are increased significantly. various ultrasound parameters have been tested in an effort to detect both fetal compromise prior to the development of permanent damage and allow differentiation between true fetal growth abnormalities and normal growth potential. recent reports have introduced the concept of customized fetal growth curve which uses physiological variables to report an adjusted fetal growth assessment. to date, the use of customized fetal growth curves has not been evaluated prospectively. furthermore, this strategy has not been compared to standard population-based fetal growth curves currently used in clinical practice to determine which would be the most ideal for use in clinical practice. the primary research question is: are customized fetal growth curves more accurate than population-based fetal growth curves at predicting abnormalities in fetal growth, defined as small-for-gestational age or large-for-gestational age at birth in newborns of high-risk pregnancies? randomly, participants will be assigned to either having fetal growth reported by customized or population bases growth curves.


Eligibility criteria:
inclusion criteria: 1. gestational age greater than or equal to 24 weeks gestation. 2. maternal age over 18 years, 3. prior normal fetal anatomy ultrasound done at main ultrasound unit exclusion criteria: 1. pregnancies carrying higher order multiples (triplets, quadruplets, etc).

Keywords: fetal growth restriction macrosomia
open-label ziprasidone study for psychosis treatment in adolescents

Conditions: Schizophreniform Disorder; Schizoaffective Disorder; Psychosis; Depressive Disorder, Major; Bipolar Disorder

Summary: this open-label study will assess the medication geodon® (ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. eligible adolescents will receive geodon® for 7 weeks and stay at the nyspi children's day unit (cdu) during the day. if clinically appropriate, they may also stay at the new york state psychiatric institute (nyspi) schizophrenia research unit (sru) inpatient facility.

this study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified \[nos\], major depressive disorder with psychotic features, and bipolar disorder with psychotic features) in an inpatient and day hospital setting with ziprasidone (geodon). ziprasidone is a second-generation antipsychotic (sga) that is fda-approved for the treatment of schizophrenia and for the treatment of the manic phase of bipolar disorder in adults. it is also used clinically in the treatment of psychotic disorders in children, adolescents and adults. this protocol will help to elucidate the feasibility of studying the treatment of psychotic disorders with ziprasidone in adolescents 13-17 years and help facilitate the further study of the treatment of psychosis with novel agents that have a favorable side effect and weight gain profile. the duration of the study can be up to 7 weeks. depending on the level of symptom severity patients will be managed on either the schizophrenia research unit (sru) (gas\ 5), or the children's day unit (cdu) of the nyspi. the seven weeks would encompass a 3 day period at the beginning of the study including time for screening and reviewing lab results. over a period of one to two weeks patients will be titrated up to 120 mg/day (80 mg for patients under 45kg), and, if necessary, cross tapered off of another sga that had not been working successfully. subjects who do not respond to the medication after 1 week at the target dose will be discontinued from the study.

Eligibility criteria:
inclusion criteria: 1. children who meet dsm-iv criteria for the following psychotic disorders: schizophreniform disorder, schizoaffective disorder, psychosis nos, major depressive disorder with psychotic features, and bipolar disorder with psychotic features. 2. children with an iq of at least 70. 3. children who are in good physical health. 4. the parent/guardian of the child must be willing to attend all study visits. exclusion criteria: 1. children who are currently receiving an effective treatment without detrimental side effects. 2. children who are allergic to geodon®. 3. children who have previously failed to respond to an adequate trial of geodon®. 4. females who are pregnant or breast-feeding.

Keywords: psychosis nos mdd w/ psychotic features bipolar disorder w. psychotic features
perfusion enhancement with respiratory impedance in stroke (peri-stroke)

Conditions: Stroke

Summary: this is a non-randomized phase 2 study designed to asses the mean flow velocity (mfv) and cerebral blood flow (cbf) response to non-invasive respiratory impedance.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. ability and willingness to sign informed consent by patient or legally acceptable surrogate decision maker 3. acute ischemic stroke within 72 hours of study enrollment 4. imaging or examination confirming unilateral frontal lobe involvement in the stroke exclusion criteria: 1. hemorrhagic conversion of ischemic infarct 2. history or presence of congestive heart failure, as defined by any of the following: 1. any preceding diagnosis of congestive heart failure as per patient report or medical record 2. report of moderate or severe systolic or diastolic dysfunction on prior 3. reduced ejection fraction, \<50%, on prior echocardiogram 4. jugular venous pulsations \>10 cm 5. pulmonary edema on chest radiography of note, an echocardiogram is not required prior to study enrollment. 3. history or presence of cardiomyopathy, as per medical record, patient report, or prior echocardiogram 4. history or presence of pneumothorax or hemothorax 5. history or presence of copd 6. history of current use of home oxygen 7. presence of pneumonia, as clinically determined by the primary medical team after admission chest radiography 8. age \< 18 years 9. skull defect that would interfere with cbf monitoring 10. pregnancy (urine or serum testing will required prior to enrollment of any pre-menopausal women) 11. structural brain lesion, including known primary tumor, metastatic tumor, or vascular malformation 12. prior neurosurgical procedure 13. any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
angina prevalence and provider evaluation of angina relief

Conditions: Stable Coronary Artery Disease CAD

Summary: the purpose of this study is describe the frequency of chest pain and how chest pain impacts patients' quality of life in the outpatients with chronic coronary artery disease in contemporary cardiology practice settings.

the primary goals in the management of stable coronary artery disease (cad) are to reduce risk factors for heart attack and to control the symptoms of angina (chest pain). ideally angina is well controlled with medications alone, but invasive procedures are a valuable option for patients with persistent angina. the amount of angina among patients with stable cad in the outpatient setting, however, is unknown. an australian study reported that almost 1 in 3 patients with stable angina being treated by primary care doctors had angina at least once a week, which was associated with worse quality of life. we propose to examine the burden of angina in outpatients with stable cad who are being medically managed by cardiologists in the united states through administration of a one-time survey. the information from this study could ultimately help improve management of stable cad and angina and illuminate potential underuse of revascularization. while cardiologists are generally expected to provide better angina control than primary care doctors, establishing the prevalence of angina among the best providers will help with a framework for interpreting symptom control among other practitioners.

Eligibility criteria:
inclusion criteria: * coronary artery disease patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey. exclusion criteria: * too ill to take survey * previously completed this survey * refused to participate

Keywords: angina stable ischemic heart disease quality of life seattle angina questionnaire (saq)
home oscillatory positive expiratory pressure - aerobic exercise rehabilitation study

Conditions: COPD; AECOPD

Summary: the goal of this clinical trial is to evaluate the feasibility and effectiveness of home opep therapy and aerobic exercise training in patients with moderate to severe chronic obstructive pulmonary disease (copd) who are at high risk of acute exacerbations, aged 40-80 years. the main questions it aims to answer are: does home opep therapy, aerobic exercise training, or the combination of both reduce the incidence and hospitalization rate of acute exacerbations of copd compared to conventional treatment? what are the effects of these interventions on 6-minute walk distance, all-cause mortality, lung function, quality of life, and treatment adherence? researchers will compare a) conventional treatment, b) opep therapy, c) aerobic exercise training, and d) opep therapy combined with aerobic exercise training to see if opep therapy and/or aerobic exercise training improve pulmonary rehabilitation outcomes. participants will: receive assigned intervention based on the study arm (conventional treatment, opep therapy, aerobic exercise, or combined therapy). use respiratory training devices and/or wearable monitoring devices as required by their assigned group. follow training plans and therapy schedules. attend follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months. complete questionnaires and undergo assessments (e.g., lung function tests, 6-minute walk tests) at baseline and follow-up visits.


Eligibility criteria:
inclusion criteria: * age 40-80 years. * diagnosis of aecopd according to 2025 gold criteria, gold stage 2-4. * patients seeking treatment for acute exacerbation of copd (aecopd) as outpatients or inpatients. * residing in the study center area with no plans to relocate during the study. * voluntary participation with signed informed consent. exclusion criteria: * inability to walk or tolerate the 6-minute walk test. * inability to cooperate with lung function tests. * life expectancy \<6 months (e.g., uncontrolled advanced malignancy, recent mi, unstable angina, acute stroke, acute heart failure). * active pulmonary tuberculosis or history of lung resection. * pregnancy or lactation. * liver or kidney failure requiring dialysis. * participation in other drug clinical trials or interventional studies. * vulnerable populations (e.g., mental illness, cognitive impairment, critically ill, illiterate). * other reasons deemed unsuitable by the researcher.

Keywords: oscillating positive expiratory pressure opep copd aecopd chronic obstructive pulmonary disease acute exacerbation of chronic obstructive pulmonary disease airway clearance global initiative for chronic obstructive lung disease gold aerobic exercise cardio copd management internet of things iot
does a low volume ultrasound-guided technique reduce common complications of interscalene brachial plexus block?

Conditions: Pain After Shoulder Surgery

Summary: peripheral nerve blocks provide many advantages for patients (excellent pain control and reduction in nausea) undergoing upper and lower limb surgery however several commonly occurring complications can produce annoying but sometimes serious adverse effects. the interscalene brachial plexus block (isbpb) is one such technique, commonly performed for shoulder surgery, but also produces paralysis of the diaphragm, horner's syndrome and sometimes vocal cord paralysis with standard volumes of local anesthetic. this threat of these side effects limits the use of isbpb in many patients who would particularly benefit e.g. patients with lung disease. recently the use of ultrasound guidance is allowing practitioners to place smaller volumes of local anesthetic with much greater accuracy. this can potentially avoid anesthetizing important adjacent nerves to the target structure. if ultrasound-guided techniques with smaller volumes of local anesthetic could be demonstrated to reduce the incidence of complications without reducing effectiveness this would be very beneficial for patients.this will be the first randomized, double blind study to evaluate if an ultrasound-guided isbpb with low volumes of local anesthetic can reduce complications for patients whilst maintaining quality of anesthesia and pain relief in the intra-operative and postoperative period.


Eligibility criteria:
inclusion criteria: * patients undergoing elective shoulder surgery. * patients aged \>=18 and \<=70 years * asa i-iii * bmi\<35 exclusion criteria: * preexisting copd * unstable asthma * psychiatric history * allergy to ropivacaine. * opioid tolerance (\>30mg oral morphine or equivalent/day)

Keywords: ultrasound, complications, regional anesthesia
continuous 7-day detection of arrhythmias in dialysis population

Conditions: Arrythmia; Dialysis; Complications

Summary: the carnation ambulatory monitor (cam) is an innovative diagnostic patch device that allows to differentiate the different kinds of arrhythmias more precisely than any other ecg-monitoring device. it attaches on the sternum and can be carried for a week without any breaks. this allows a continuous rhythm monitoring without any gap for 7 days. this device will be used in dialysis patients to monitor arrhythmias during changes in volume and/or electrolyte balance due to dialysis, in the phases after dialysis as well as before dialysis in the short or long intervals between dialysis sessions.


Eligibility criteria:
inclusion criteria: * age 18 years. * written informed consent exclusion criteria: * participation in another study within 4 weeks before study begin * pacemaker * icd
hydroxychloroquine in outpatient adults with covid-19

Conditions: Coronavirus Infection

Summary: primary objective: to assess the effect of hydroxychloroquine versus placebo on nasopharyngeal sars-cov-2 viral load in outpatient adults with covid-19 secondary objectives: * to assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with covid-19 * to assess the safety and tolerability of hydroxychloroquine in outpatient adults with covid-19

the duration of the study per participant will be around 18 days (1 or 2 days of screening followed by a 10-day treatment period and a 4 to 6 days follow-up period)

Eligibility criteria:
inclusion criteria : * participants with diagnosis of covid-19 via an approved or authorized molecular test * presence of symptoms compatible with covid-19 at the time of screening * time between onset of symptoms and first dose of hydroxychloroquine or placebo is 96 hours or less * female participants must use an acceptable birth control method, as specified by each site and country exclusion criteria: * covid-19 disease requiring the use of supplemental oxygen * electrocardiogram (ecg) tracing with qtc interval \> 450 ms for men, \> 470 ms for women (fridericia algorithm recommended) * bradycardia (\< 50 beats/min) * history of cardiac disease (eg. congestive heart failure, myocardial infarction) * history of glucose-6-phosphate dehydrogenase (g6pd) deficiency * women who are pregnant or breastfeeding * concurrent antimicrobial therapy * known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds * hydroxychloroquine use within 2 months before enrollment * history of severe skin reactions such as sevens-johnson syndrome and toxic epidermal necrolysis * history of retinopathy * history of arrythmia, concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death * history of severe renal disease (treatment with dialysis or phosphate binders) or hepatic impairment the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a randomized phase ii study of oral sapacitabine in patients with advanced cutaneous t-cell lymphoma

Conditions: Cutaneous T-cell Lymphoma (CTCL)

Summary: this is an open label, randomized phase ii study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous t-cell lymphoma (ctcl).

this is an open label, randomized phase ii study designed to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with advanced cutaneous t-cell lymphoma (ctcl) who have had progressive, recurrent, or persistent disease on or following 2 systemic therapies.

Eligibility criteria:
inclusion criteria: * adult patients with advanced ctcl * have had at least 2 systemic therapies * must have evaluable disease * eastern cooperative oncology group performance status 0-2 * adequate bone marrow, hepatic and renal function * at least 3 weeks from prior therapies * not receiving topical steroids or have been on a stable dose of topical steroids for at least 2 weeks * able to swallow capsules * at least 3 weeks from major surgery * agree to practice effective contraception * able to understand and willing to sign the informed consent form exclusion criteria: * receiving systemic steroids * receiving topical or systemic retinoids or vitamin a * receiving radiotherapy, biological therapy,or any other investigational agents * uncontrolled intercurrent illness * pregnant or lactating women * known to be hiv-positive * active hepatitis b and/or hepatitis c infection

Keywords: ctcl
study of platelet activation in septic shock patients

Conditions: Septic Shock

Summary: some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. investigators can hypothesize an increase in platelet activation and in leukocyte-platelet aggregates in septic shock.


Eligibility criteria:
inclusion criteria: experimental group * patient who possibly gave an oral agreement to inclusion and may sign a consent once out of intensive care * patients hospitalized in general intensive care * patient hospitalized for less than 72 hours * patient suffering from severe sepsis, whatever their origin, with hypotension (pas \<90mmhg) despite adequate fluid resuscitation and vasoactive requiring the use of amines, with hypoperfusion and / or at least one organ dysfunction ( septic shock) * patient with a sequential organ failure assessment (sofa) score\> 8 (or\> 2 in an organ) in the first 24 hours * patient enjoying a social security scheme or equivalent control group * signed informed consent * patient seen anesthesia consultation for orthopedic knee prosthesis of laying or hip with a negative balance infectious * patient enjoying a social security scheme or equivalent exclusion criteria: experimental group * patient on safeguarding justice, guardianship * patient suffering from a haematological malignancy (leukemia, lymphoma ...) * patient suffering from thrombocytopenia or constitutional thrombopathy * pregnant control group * patient on safeguarding justice, guardianship * patient with infectious positive balance (dental, urinary tract) prior to surgery * patient suffering from a haematological malignancy (leukemia, lymphoma ...) * patient suffering from thrombocytopenia or constitutional thrombopathy * pregnant

Keywords: leukocyte and platelet aggregates platelet activation