Kornimate/medical-research-clean huggingface dataset:
incidence of neo-aortic insufficiency

Conditions: Congenital Disorders

Summary: the records of all the patients that underwent the norwood-sano operation at children's healthcare of atlanta, emory university between january 1, 2002 and december 31, 2004 will be investigated. these patients will be compared with an equal number of consecutive cases treated by classic norwood stage i operation in order to determine the incidence of neo-aortic valve insufficiency and the clinical outcome of these patients.

neoaortic valve insufficiency after norwood type palliation of single ventricle patients has not been well studied. patients with mild insufficiency tolerate it well; moderate to severe insufficiency however is poorly tolerated and can result in the death of the patient or at least require re-operation. re-operation for neo-aortic insufficiency in this small size child is a difficult operation and the operative options are very limited. the introduction of the sano modification of the norwood procedure introduced a new set of variables due to the presence of a ventricular incision and possible distortion of the neo-aortic valve. it is therefore critical to determine the incidence of neo-aortic insufficiency and compare it to the standard norwood operation, as well as to determine the clinical consequences of the presence of this phenomenon immediately postoperatively as well as long-term, up to completion of the stage ii of the norwood procedure (glenn stage).

Eligibility criteria:
inclusion criteria: * patients undergone norwood-sano at children's healthcare of atlanta between 9.2.2002 and 12.31.2004 * equal number of consecutive patients undergone norwood classic stage i at children's healthcare of atlanta between 9.2.2002 and 12.31.2004 exclusion criteria: * those who do not meet the inclusion criteria

Keywords: pediatric cardiac neo-aortic insufficience norwood standard stage i procedure norwood sano procedure
memory study of youngest women enrolled in the women's health initiative hormone therapy (ht) arm

Conditions: Dementia

Summary: whims-y provides valuable information on the long-term effects on risk of cognitive impairment of hormone therapy in a subset of whi participants in the whi hormone trials. following cessation of study-prescribed ht cognitive function and impairment were assessed.

the women's health initiative memory study of younger women (whims-y) is proposed to assess the long-term impact of random assignment to postmenopausal hormone therapy (equine estrogen alone or in combination with medroxyprogesterone versus placebo) among women who were aged 50-54 at the time of randomization into the whi hormone trials. secondary objectives relate to the consistency of any treatment effects across unopposed or opposed therapy and whether there exists evidence of graded relationships between cognitive effects and age of administration, years from menopause, and baseline risk factors for cognitive impairment.

Eligibility criteria:
inclusion criteria: * must be enrolled in the women's health initiative extension exclusion criteria: * not enrolled in the women's health initiative extension

Keywords: cognition memory hormone therapy
primary preventive ventricular tachycardia ablation in high-risk patients who receive a prophylactic implantable cardioverter defibrillator

Conditions: Heart Failure

Summary: this prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (icm) patients referred for primary icd implantation. participants will be randomized to receive either prophylactic vt ablation within three months of icd implantation or continued medical management. the primary objective is to assess the efficacy of preventive vt ablation versus medical management in reducing vt arrhythmia burden.

this study aims to assess the impact of prophylactic catheter-based ventricular tachycardia (vt) ablation compared to medical management in high-risk patients with ischemic cardiomyopathy (icm) undergoing primary implantable cardioverter defibrillator (icd) implantation. the primary outcome measure is the burden of vt arrhythmias (vta), defined as the total number of vt events, one year post-icd implantation. the hypothesis suggests that employing vt ablation with high-density electroanatomic mapping (ensitetm) will significantly reduce both treated and monitored vt episodes. the study will randomize 62 participants in a 1:1 ratio across 20 experienced sites in europe.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years (no upper age limit) * willing and able to provide informed consent * candidate for a primary prevention icd/crt-d per esc guidelines17 * ischemic cardiomyopathy (icm) with left ventricular ejection fraction (lvef) ≤ 35% * willing and able to receive an icd * willing and able to undergo catheter-based vt ablation one or more of the following: * madit-icd benefit score \>75 * history of nonsustained ventricular tachycardia (nsvt) * multiple premature ventricular complexes (pvcs ≥10%) exclusion criteria: * existing icd or crt-d * history of sustained vt or vf * chronic renal failure requiring hemodialysis * coronary revascularization within the past 3 months * st-elevation mi within the past 3 months * participation in concurrent clinical trials without approval from the coordination center (observational registries are allowed with approval) * currently pregnant or planning to become pregnant in the near future * inability or unwillingness to adhere to the study protocol * inability or unwillingness to provide informed consent for participation * life expectancy \< 1 year
study of the cat rx aspiration catheter when used in patients with large occlusive thrombus in coronary arteries

Conditions: Coronary Vessel Occlusion

Summary: the objective of this study is to demonstrate the safety and performance of the indigo aspiration system using the cat rx aspiration catheter in a population presenting with acute high thrombus burden coronary vessel occlusion who are referred for percutaneous coronary intervention (pci).


Eligibility criteria:
inclusion criteria: * patient age ≥ 18 years * patient presents to treating facility within 12 hours of symptom onset * high thrombus burden at coronary angiography, defined as timi thrombus grade 4 or 5 by physician visual estimate after the guidewire crosses the target lesion * frontline treatment with the indigo® aspiration system using the cat rx aspiration catheter, prior to standard of care pci * target lesion is located in a native coronary artery * informed consent is obtained from either patient or legally authorized representative (lar) exclusion criteria: * new onset of stroke symptoms and nihss \> 2, prior to index procedure * treatment with fibrinolytic therapy for index coronary vessel occlusion * life expectancy less than 6 months due to any comorbidities * patient is unwilling or unable to comply with protocol follow up schedule and/or based on the investigator's judgment the patient is not a good study candidate * participation in another investigational drug or device study that may confound the results of this study. studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies. * patient is pregnant
comfort and tolerance of surface neuro muscular electrical stimulation in parkinson's disease.

Conditions: Parkinson's Disease

Summary: the purpose of this study is to investigate issues relating to comfort and tolerance to surface neuro muscular electrical stimulation in a parkinson disease population.

the comfort and tolerance of parkinson disease (pd) patients to surface neuro muscular electrical stimulation (nmes) will be investigated. six muscle sites will be tested sensory, motor and pain thresholds recorded. furthermore pain tolerance will be recorded as the level at which the stimulus is unbearable.

Eligibility criteria:
inclusion criteria: * a diagnosis of idiopathic pd (uk, pd brain bank criteria) * a hoehn and yahr stage of 2 - 4 * exhibiting freezing of gait or another gait abnormalityin the on or off state. * an ability to mobilise independently for the purpose of research when in the 'off' state * an ability to walk unaided for 10 meters. exclusion criteria: * a serious cognitive impairment (mmse\<24) * pregnant or currently involved in another clinical trial. * uncontrolled heart problems * pacemakers * on opioid or neuropathic pain medication

Keywords: parkinson's disease freezing of gait neuromuscular electrical stimulation comfort pain tolerance pain sensory threshold motor threshold pain threshold
a prospective longitudinal study in adults with multifocal motor neuropathy

Conditions: Multifocal Motor Neuropathy

Summary: this prospective longitudinal study will follow participants with multifocal motor neuropathy over time and collect data on their clinical outcomes, quality of life, and use of health care resources. participants will follow their regular visit schedule with their treating physician, except for an optional second visit occurring 7 to 14 days after the start of the study to collect biomarker data. no imp will be administered.


Eligibility criteria:
inclusion criteria: * is at least the local legal age of consent for clinical studies when signing the icf * is capable of providing signed informed consent and complying with protocol requirements * has an existing or new diagnosis of mmn made by a neuromuscular specialist or neurologist exclusion criteria: * is currently participating in any clinical study with an imp * has other medical conditions that could affect the assessment of mmn
a clinical study to evaluate the safety of cs-1103 in healthy participants

Conditions: Substance Use Disorders; Methamphetamine Abuse; Methamphetamine Intoxication

Summary: the purpose of this phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (pk) of single, ascending doses of cs-1103, administered by intravenous (iv) infusion in healthy participants.


Eligibility criteria:
major inclusion criteria: 1. healthy male and/or female participants aged 18 to 55 years, inclusive. 2. a body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 50 kg. 3. females must be of nonchildbearing potential. major exclusion criteria: 1. estimated glomerular filtration rate \<90 ml/min/1.73 m2 2. any clinically significant abnormalities in rhythm, conduction or morphology of the resting ecg, and any clinically important abnormalities in the 12-lead ecg 3. current smokers, or those who have smoked or used nicotine products (including nicotine patches) within 1 month prior to dose administration. 4. history of alcohol abuse or excessive intake of alcohol
effects of ketone supplementation on acute alcohol withdrawal

Conditions: Alcohol Use Disorder; Alcohol Withdrawal; Alcohol Dependence; Ketosis

Summary: the goal of this study is to study the effects of the ketone supplement kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the caron treatment center.

this is a 5 day double-blinded, placebo-controlled intervention study of 50 treatment-seeking individuals with aud, who are receiving detoxification treatment at caron treatment center. participants will be recruited for participation within 48 hours of admission to the inpatient unit. participants will be consented and randomized to receive 10 g of ketone supplement three times daily (n=30; 1,3-butanediol and d-hydroxybutyric acid from kenetik, vitanav inc., washington d.c.) for 5 days or a placebo beverage (n=20). benzodiazepines and other "comfort" medications will be administered daily following the caron withdrawal management protocol, with additional benzodiazepines administered based on withdrawal symptoms, monitored with the revised clinical institute withdrawal assessment for alcohol (ciwa-ar). the ciwa-ar is given three or more times per day clinically to determine patient withdrawal levels and adjust medication dosages. total daily maximum ciwa-ar scores, benzodiazepine dosage and other "comfort" medications will be analyzed with a repeated measures design, with a binary factor for intervention, factor of time, and intervention by time interaction. daily mood and alcohol craving questions will assess differences between treatment groups.

Eligibility criteria:
inclusion criteria: 1. meets current dsm-5 criteria for aud and admitted for alcohol withdrawal management treatment at caron treatment center 2. willingness to provide signed, informed consent and commit to completing the procedures in the study exclusion criteria: 1. current, gastrointestinal (gi), liver or other clinically significant physical disease that may interfere with the intake of the ketone supplement based on medical history, and evaluation of the study physician. 2. currently pregnant or lactating, based on urine pregnancy test and clinical exam. 3. current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan. 4. judged by the principal investigator, study physician, or their designee to be an unsuitable candidate for the study.

Keywords: alcohol use disorder alcohol withdrawal alcohol dependence ketone supplement ketosis
abbott ventricular tachycardia pas

Conditions: Ventricular Tachycardia

Summary: this post-approval study (pas) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the flexabilitytm ablation catheter, sensor enabledtm (flexability se) for the treatment of ventricular tachycardia in a post-market environment. this is a prospective, single arm, open-label, multi-center, observational study.


Eligibility criteria:
inclusion criteria: 1. patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure 2. subjects who have recurrent, drug-refractory, sustained mmvt with non-ischemic structural heart disease and a clinical decision has been made to use flexability se for an ablation procedure prior to enrollment in the research study 3. refractory (i.e. not effective, not tolerated or not desired) to at least one class i/iii anti-arrhythmic medication for treatment of mmvt 4. implanted with a market released icd or crt-d prior to the index ablation procedure 5. able and willing to comply with all study requirements exclusion criteria: 1. documented or known intracardiac thrombus or myxoma 2. active systemic infection 3. history of atriotomy or ventriculotomy within 4 weeks prior to the index ablation procedure 4. patients with prosthetic valves as the catheter may damage the prosthesis 5. unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
elderberry consumption and human health

Conditions: Obesity, Unspecified

Summary: the objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. to accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.


Eligibility criteria:
inclusion criteria: * women and men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above exclusion criteria: * pregnant or trying to become pregnant * have a body mass index less than 25 kg/m2 * are younger than 22 years of age, or older than 75 years of age * known allergy or intolerance to elderberries * history of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study * adherence to restrictive (vegetarian or vegan) or extreme (fad \[ex. ketogenic or atkins\] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight * habitual use of tobacco (including vaping) products in the last 6 months * diagnosis or treatment of cancer in the past 3 years * crohn's disease or diverticulitis * suspected or known strictures, fistulas or physiological/mechanical gi obstruction * use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications * type 2 diabetes requiring the use of medication * fasting blood glucose \&gt; 125 mg/dl * unable or unwilling to give informed consent or communicate with study staff * self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in alcoholics anonymous is not an exclusion) * other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol

Keywords: obesity elderberry
pge1 as additive anticoagulant in ecmo-therapy

Conditions: Respiratory Distress Syndrome, Adult; Extracorporeal Membrane Oxygenation

Summary: bleeding complications and thromboembolic complications are frequent during extracorporeal membrane oxygenation (ecmo). retrospective data suggest that platelet inhibition using prostaglandins, in this case pge1, may reduce thromboembolic complications without increasing the bleeding risk. this randomized, double-blind trial aims to investigate the effects of pge1 on bleeding risk, thromboembolic complications and the function of the ecmo.

prostaglandins may inhibit platelet activation via the p2y1 adp receptor. platelets may contribute to thromboembolic complications and coagulation activation during ecmo therapy. retrospective data suggest that treatment with pge1 may serve beneficial by reducing the amount of heparin needed for inhibition of coagulation activation, and by reducing the thromboembolic risk without increasing the risk of bleeding. inhibition of platelets via pge1 (alprostadil) may be interesting in this setting, because, in contrast to other platelet inhibitors, it has a very short half-life and platelets remain susceptible for activation by more potent agonists (i.e. thrombin, adp). thus, although reducing the contribution of platelets to coagulation activation, it may not affect safety of participating subjects. this randomized, double-blind, placebo controlled trial will investigate whether treatment of patients with ecmo therapy proves beneficial.

Eligibility criteria:
inclusion criteria: * minimum age 18 years * veno-venous- ecmo * minimum of 24h planned ecmo- therapy exclusion criteria: * • long- term therapy with other antiplatelet drugs including acetyl salicylic acid * known heparin induced thrombocytopenia * bleeding diathesis = contraindication for heparin (e.g. gi-bleeding, intracerebral bleeding) * platelets \< 50 g/l * thromboplastin time \< 50% * pregnancy * patient \< 18 years * prothrombin time \<50% drop out criteria: * major bleeding (from type 3 bleeding; see "primary objective") * occurrence of hit (4 t- score: number of platelets, development over time, manifestation of thrombosis, other reasons for thrombocytopenia \[10\]) * plt \< 50 g/l

Keywords: platelet inhibition alprostadil extracorporeal membrane oxygenation bleeding thromboembolic
toripalimab combined with neoadjuvant chemoradiotherapy as first-line treatment for locally advanced，high-risk，mss rectal cancer

Conditions: Locally Advanced; High-Risk; Rectal Cancer; MSS

Summary: this is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (pd-1 antibody) for locally advanced rectal cancer (larc) patients with high risk factors. a total of 53patients will be enrolled in this trial to receive 5\*5gy short-course radiotherapy, followed by 4 cycles of capox chemotherapy and pd-1 antibody. then they will receive the tme surgery and another 2 cycles of capox chemotherapy. the primary end point is the rate of pathological complete response (pcr). the long-term prognosis and adverse effects will also be evaluated and analyzed.


Eligibility criteria:
inclusion criteria: * age 18-75 years old, female and male; * pathological confirmed mss or pmmr rectal adenocarcinoma; * clinical stage t3-4 (ajcc 8th) and at least with one high risk factor（crm+ or emvi+ or lateral lymph nodes+）; * no previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment; * adequate organ function defined at baseline as: anc ≥1.5××109/l，plt ≥100×109 /l，hb ≥90 g/l，15×109 /l≥wbc≥4×109 /l; tbil ≤1.5×uln, alt ≤1.5uln, ast ≤1.5uln, bun and cr ≤1.5×uln or ccr * 60ml/min (cockcroft-gault formula);inr ≤1.5×uln or pt ≤1.5×uln (when patient didn't accept anticoagulant therapy); * women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative; exclusion criteria: * pathological confirmed rectal squamous cell carcinoma; * history of other uncured malignancies within 5 years; * allergic to any component of chemotherapy or immunotherapy; * history of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, wegener granulation swollen disease, sjogren's syndrome, guillain-barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. * with congenital or acquired immunodeficiency (such as those with hiv infection), active hepatitis b or hepatitis c;
covid-19 and pregnancy outcomes

Conditions: Coronavirus Infection; Pregnancy Complications; Vertical Transmission of Infectious Disease; Breastfeeding; Neonatal Infection

Summary: this is a multicenter prospective study that aims to investigate the clinical impact of sars-cov-2 infection in pregnant women, pregnancy outcomes and perinatal transmission.

this is a cohort study of pregnant women confirmed positive for sars-cov-2 infection. data will be collected in portuguese maternities that agreed to collaborate in this study. pregnant women are tested during hospital admission by using nasopharyngeal/oral swabs for sars-cov-2 rt pcr as part of a universal testing policy. maternal demographic data (age, comorbidities, parity, smoking habits), covid-19 related data (symptoms, diagnostic tests, therapy used and icu admission), gestational age at sars-cov-2 confirmed infection, pregnancy outcomes (gestational complications, gestational age at birth, mode of delivery) and neonatal outcome (birthweight and apgar score, rt pcr neonate results) and breastfeeding strategies will be evaluated.

Eligibility criteria:
inclusion criteria: pregnant women infected with sars-cov-2. delivery at portuguese maternities. exclusion criteria: rt pcr sars-cov-2 negative. -
expanded access to telisotuzumab adizutecan

Conditions: Non-Small Cell Lung Cancer

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to telisotuzumab adizutecan prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: - the participant must not be eligible for an telisotuzumab adizutecan clinical trial.

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme