Kornimate/medical-research-clean huggingface dataset:
effect of intravenous amantadine on gait freezing in parkinson's disease

Conditions: Parkinson's Disease

Summary: a double-blinded randomized placebo-controlled trial of intravenous amantadine on gait freezing refractory to oral anti-parkinsonian medications in patients with parkinson's disease. * administration of iv amantadine or normal saline for 5 days, 2 times a day while keeping current oral anti-parkinsonian medications unchanged * follow-up after administration of iv amantadine for 4 weeks * allocation ratio of amantadine:normal saline is 2:1

intravenous amantadine is known to be effective for parkinsonian motor symptoms abruptly aggravated and for disabling motor symptoms from severe motor fluctuation and dyskinesia in patients with parkinson's disease. the study investigators experienced several open label cases who were benefit from intravenous amantadine in their parkinsonian motor symptoms and freezing of gait as well. in addition, there is a pilot open label trial in parkinsonian patients with refractory freezing of gait which showed marked benefit in patients with parkinson's disease, but not in patients with parkinson-plus syndromes. this study was aimed to evaluate the efficacy of intravenous amantadine in both levodopa-unresponsive freezing of gait and disabling off state freezing of gait in patients with parkinson's disease.

Eligibility criteria:
inclusion criteria: * the diagnosis of parkinson's disease according to the united kingdom parkinson's disease brain bank criteria * presence of freezing of gait and the scores of freezing of gait questionnaire 7 or more * having been treated with oral dopamine replacement therapy for 6 months or more * score of korean version of mini-mental status examination is 20 or more exclusion criteria: * presence of significant cognitive dysfunction, behavioral or psychiatric disorders * presence of severe cardiac disease * presence of renal failure, seizure, peptic ulcer disease, liver disease, pheochromocytoma, chronic exhaustive disease, or malignancy * participation to other clinical trial within 4 weeks * pregnancy or lactating women * hypersensitivity to study drugs * history of intoxication to heavy metals
comparison of multigam iv (5% vs. 10%) in patients with an immunodeficiency secondary to a hematological disorder

Conditions: Hematologic Diseases; Secondary Immune Deficiency

Summary: the purpose of this observational study is to compare the administration of standard of care multigam iv 5% and standard of care multigam iv 10% in order to observe changes in infusion time and infusion related reactions. patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.

given the growing number of patient contacts at our day-care center, there is a continuous search to further improve the flow and to shorten the time spent per patient at the day-care center, without loss of quality in care. in order to achieve this goal, this study wants to compare the administration of multigam iv 5% and multigam iv 10%. multigam 5% and multigam 10% are immunoglobulin solutions that are administered to strengthen the body's natural defense system (immune system). in case of recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder can be treated with immunoglobulin substitution therapy. patients can receive multigam iv 5% and multigam iv 10% in daily clinical practice and will receive both formulations in the same manner and intensity, meaning their use is not limited to this study. for this observational study, patients with an immunodeficiency secondary to a hematologic disorder will be evaluated for inclusion. patient characteristics, infusion time, time spent at the day-care center, adverse events and number of actions taken by the nursing staff will be evaluated for multigam 5% administration. after 3-4 weeks, patients will return for multigam 10% administration and an identical evaluation will take place along with a questionnaire for the patient and nursing staff to assess their satisfaction. the results will be processed to compare and evaluate the administration of both immunoglobulin solutions.

Eligibility criteria:
inclusion criteria: * age =\> 18 years * immunodeficiency secondary to a hematologic disorder * patient has received at least 2 multigam iv 5% administrations * patient may not have had any adverse events (grade 2 or higher according to ctcae v4.03) during the last 2 multigam iv 5% administrations * patient needs at least 2 more immunoglobulin administrations * signed informed consent exclusion criteria: * patient has received less than 2 multigam iv 5% administrations * patient has had an adverse event (grade 2 or higher according to ctcae v4.03) during the last 2 multigam iv 5% administrations * refusal to sign informed consent

Keywords: multigam immunoglobulin secondary immunodeficiency
study of a vestibular biomarker of phase in bipolar disorder

Conditions: Bipolar Disorder; Depression, Bipolar

Summary: bipolar disorder show cyclic changes of mood between depression (depressive phase) and mania (maniac phase). vestibular tests have been shown high sensibility and specificity as a biological marker for major depression. this exploratory investigation will measure and compare the vestibular activity of bipolar disorder patients during different phases ( 6 depressed phase, 6 maniac phase, 6 euthimic and 6 control healthy subjects).


Eligibility criteria:
inclusion criteria: * bipolar disorder i or ii * depressive phase of bipolar disorder * maniac phase of bipolar disorder * euthimic phase of bipolar disorder exclusion criteria: * drugs addiction * alcohol addiction * neurologic condition, disorder
civaderm(tm) surface therapy pilot study

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma of the Skin

Summary: this is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.


Eligibility criteria:
inclusion criteria: * subject signed informed consent * confirmed superficial or nodular basal cell or squamous cell carcinoma * biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities) * \>5 mm of residual tumor * tumors \< 3 cm * capable of complying with patient release instructions exclusion criteria: * is unable or unwilling to comply with the protocol requirements * pregnant or breast feeding * metastases

Keywords: radiation brachytherapy skin cancer
mechanical coring to achieve directional skin tightening

Conditions: Skin Tightening; Healthy Volunteers

Summary: the objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. this study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.

the study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.

Eligibility criteria:
inclusion criteria: 1. healthy, male or female subjects between 30 and 70 years of age. 2. able to read, understand, and voluntarily provide written informed consent. 3. able and willing to comply with the treatment/follow-up schedule and requirements. 4. women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative urine pregnancy test at baseline. 5. subjects may have any fitzpatrick skin type, however, no more than 35% of subjects may have fitzpatrick skin type v or vi. exclusion criteria: 1. previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months. 2. fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area. 3. history of keloid formation 4. active smoker or having quit smoking in the last 3 months. 5. active, chronic, or recurrent infection 6. compromised immune and/or healing system (e.g. diabetes) 7. hypersensitivity/allergy to analgesic agents, betadine, tumescent, benzoin tincture, tegaderm or tensioning tape that will be used in the study. 8. co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements. 9. pregnant or breastfeeding 10. any indication that may cause excessive bleeding, e.g., anticoagulants. 11. carcinoma, melanoma, or any other cancerous condition in the last 6 months. 12. allergy to adrenaline, epinephrine, or tranexamic acid (txa). 13. currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device 14. any issue that, at the discretion of the investigator would contra-indicate the subject's participation.

Keywords: rhytides wrinkles loose skin skin laxity mechanical coring robotic coring skin scarring scars stretch marks
a study to evaluate efficacy and safety of the combination of scta01 & scta01c in outpatients with covid-19

Conditions: COVID-19

Summary: the study is comprised of two parts: safety evaluation part (phase i/ii) and the pivotal study (phase iii) to evaluate the efficacy and safety of the combination of scta01 \& scta01c compared to placebo in addition to standard of care (soc).


Eligibility criteria:
inclusion criteria: * male or non-pregnant female adults, ≥18 years old of age at the time of randomization; * participants should have at least one of covid-19 risk factor; * participants should have at least 2 covid-19 related symptoms; * has symptoms consistent with covid-19 as determined by the investigator with onset ≤10 days before randomization; * first positive sars-cov-2 viral infection tested (pcr or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion; exclusion criteria: * participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema; * have spo2 ≤ 93% on room air at sea level or pao2/fio2 \< 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (fda); * require mechanical ventilation or anticipated impending need for mechanical ventilation; * suspected or proven serious bacterial, fungal, viral, or other infection (besides covid-19) that in the opinion of the investigator could constitute a risk when taking part in this study; * have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
effect of ezetimibe on oxidized low-density lipoprotein (ldl) cholesterol

Conditions: Coronary Artery Disease; Diabetes

Summary: randomized study. patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. oxidized ldl cholesterol will be measured at baseline and after 8 weeks of treatment. hypothesis is that ezetimibe will lower oxidized ldl


Eligibility criteria:
inclusion criteria: * cad or cad equivalent exclusion criteria: * prior cabg or pci within 3 months prior use of ezetimibe within 3 months receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin chf nyha stage \>2 creatinin clearance \< 30 ml/min
guideline directed medical therapy (gdmt) optimization and adherence longitudinal study for heart failure.

Conditions: Heart Failure

Summary: a multicenter, non-randomized prospective longitudinal study to evaluate the feasibility of tricog's remote platform for guideline directed medical therapy (gdmt) titration and remote patient monitoring among patients with heart failure.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. recent hospitalization (within 4 weeks of enrollment) for hf with iv diuretic use 3. echocardiographic data with ef measurements available in the last 6 months and after hf diagnosis 4. established outpatient care at the participating sites 5. eligible to receive at least 2 of the 4 gdmt classes (acei/arb/arni, beta-blockers, mra, and sglt2i) for hfref and hfmref and at least one of the three (arb/arni, mra, sglt2i) for hfpef 6. not on target gdmt for all the eligible gdmt classes 7. \>12 months of expected survival 8. comfortable with spoken and written english communication 9. access to apple watch-compatible iphone exclusion criteria: 1. under consideration for or recipient of advanced heart failure therapies (lvad, transplant) 2. current or anticipated use of home intravenous inotrope therapy. 3. unwilling or unable to perform all study related procedures (wear watch, take measurements and maintain daily logs) 4. post-discharge placement in nursing, rehabilitation, or long-term care facility 5. planned (within next 6 months) surgery 6. inability to provide written consent
symptom management in african-american men with localized prostate cancer

Conditions: Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life. purpose: this clinical trial is studying symptom management in african-american men with localized prostate cancer.

objectives: * develop a symptom management intervention for african-american men treated for localized prostate cancer, with a particular emphasis on low health literacy men. outline: participants are interviewed by the principal investigator over the phone or meet the principal investigator at the veterans administration prostate cancer clinic. if the interview is conducted in the clinic, it is held in a private room in the clinic.

Eligibility criteria:
disease characteristics: * biopsy-proven localized prostate cancer * has received treatment for prostate cancer * patient self-identifies as being of african-american descent patient characteristics: * able to speak and read in english * has an address in order to receive study materials by mail (a street address or post office box) * has either a telephone in order to be interviewed or is able to meet the principal investigator at the veterans administration prostate clinic and be interviewed there prior concurrent therapy: * see disease characteristics

Keywords: psychosocial effects of cancer and its treatment stage i prostate cancer stage ii prostate cancer stage iii prostate cancer
dexmeditomedine versus no sedation in management of agitation in copd patients receiving noninvasive ventilation

Conditions: COPD

Summary: the aim is to compare sedation using dexmedetomidine to sedation -free approach in management of agitated copd patients receiving niv

the aim is to compare sedation using dexmedetomidine to sedation -free approach in management of agitated copd patients receiving niv

Eligibility criteria:
inclusion critera * age\>18 * agitation * niv intolerance exclusion criteria * cardiac dysfunction * hepatic dysfunction * haemodynamic instability
our stress/ emotion management for black/african american women with hypertension

Conditions: Stress, Psychological

Summary: covid-19 is an additional stressor black women have to deal with that may interfere with hypertension self-care management. social connectedness is a source of resilience for black women to promote mental and physical health. unfortunately, in the face of the covid-19 pandemic, social distancing is a challenge further isolating black women from their networks. how is social connectedness to manage stress and emotional well-being in a social-distancing society for black women with hypertension? the research team proposed a synchronous web-based version of enhanced co-created health education intervention (eco-chin) that build the success and best practices derived from the original intervention. a covid-19 session will be included as a way of helping black women to maintain resilience and self-care during stressful times. the eco-chin intervention is innovative and timely because the research team are using a synchronous platform preparing black women on how to deal with covid-19 while taking care of self. the primary investigator for this pilot study (dr. wright) is a black early stage investigator and former kl2 (career development) awardee. the interdisciplinary research team has the expertise and resources to deliver this enhanced co-chin intervention.

the rationale for the study is that the adherence to healthy self-care behaviors reduces poor nutrition, altered sleep, sedentary behavior, psychosocial stress, and emotional dysregulation, thereby reducing negative impacts on the brain, since all these factors contribute to neural inflammation and increased bp. health-promoting self-care behaviors have the known short-term effect of enhanced cognitive function (processing speed, attention, and executive function) through the use of the repeatable neuropsychiatric battery (rbans) which is also an innovative component of our project. thirty middle-aged black women (45-65 years old) with a self-reported diagnosis of hypertension will be enrolled. the development of this group-delivered intervention will be an iterative process, and the research team will use this pilot data to submit an r21 for a 12-week intervention through the national institutes on aging.

Eligibility criteria:
inclusion criteria: * english speaking, * self-identification as black/african america * diagnosis of hypertension (treated with medications and or lifestyle management) * female sex * access to a smart phone or a computer capable of connecting to the internet exclusion criteria: * no access to computer with internet smart phone * diagnosis of resistant hypertension defined as blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes, one of which should be a diuretic/water pill.

Keywords: hypertension covid-19 black and african american women mindfulness diet
the caliber study randomized controlled trial of linx versus double-dose proton pump inhibitor therapy for reflux disease

Conditions: GERD Gastroesophageal Reflux Disease

Summary: this study compares mechanical sphincter augmentation (linx reflux management system) to double-dose proton pump inhibitors (ppis) for the management of reflux symptoms related to gastroesophageal reflux disease (gerd).

prospective, multicenter, 2:1 randomized, cross-over, two arms * control arm: double-dose ppi \[omeprazole 20 mg bid (twice a day)\] * treatment arm: linx reflux management system up to 20 study centers throughout the u.s. will participate. approximately150 patients will be enrolled into the study. subjects will be randomized 2:1 into the double-dose ppis arm (100 subjects) and the linx arm (50 subjects).

Eligibility criteria:
key inclusion criteria: 1. patient seeks consultation for lack of satisfactory symptom response to once daily ppis. 2. age≥ 21 years old. 3. abnormal distal esophageal ph determined by total % time ph \<4 or demeester score. testing to be completed off gerd medications for at least 7 days, with the exception of antacids, which may be taken up until the morning of assessment. 4. suitable surgical candidate (i.e. is able to undergo general anesthesia and laparoscopic surgery). 5. patient has provided written informed consent for participation in the randomized study. key exclusion criteria: 1. currently taking double-dose ppis (twice daily dosing). 2. hiatal hernia \>3cm as determined by endoscopy. 3. distal esophageal motility (average of sensors 3 and 4) is less than 35 mmhg peristaltic amplitude on wet swallows or \<70% (propulsive) peristaltic sequences. 4. esophagitis grade c or d (los angeles classification). 5. body mass index \>35. 6. diagnosed with an esophageal motility disorder les. 7. esophageal stricture or gross esophageal anatomic abnormalities 8. history of/or known barrett's esophagus. 9. suspected or known allergies to titanium, stainless steel, nickel or ferrous materials.

Keywords: esophageal reflux gastric acid reflux disease heartburn
genetics of periodontal diseases in chinese

Conditions: Periodontitis

Summary: (a retrospective case control study to validate the association between interleukin-1 gene variations and adult chronic periodontal disease in chinese (shanghai))


Eligibility criteria:
inclusion criteria: - to be included in this study, an individual needs to be han chinese of 35 years of age or older at time of enrollment. exclusion criteria: - 1) age younger than 35 years old. 2) patients with diagnosis of rheumatoid arthritis, psoriasis, inflammatory bowel disease, glomerulonephritis/kidney disease, cancer, or sjogren's syndrome. 3) organ transplant recipients.
intracoronary stem cells in large myocardial infarction

Conditions: Myocardial Infarction

Summary: despite the widespread use of effective reperfusion therapies, the patients presenting late with large myocardial infarction have poor outcomes. the aim of the study was to investigate the safety and efficacy of intracoronary injection of autologous bone marrow-derived mononuclear cells (bmncs) in patients with large myocardial infarction

in the current era, up to 30% of patients with st-segment elevation myocardial infarction, usually those presenting late, show ongoing left ventricular (lv) remodeling and poor clinical outcome despite primary percutaneous coronary intervention (pci). cardiac transfer of bone marrow-derived stem and progenitor cells has been investigated as an adjunctive therapy to promote regeneration of infarcted myocardium. therefore, we designed a multicenter, randomized study to test the safety and efficacy of intracoronary injection of autologous bmncs in patients with large acute anterior myocardial infarction and late presentation, who were treated with successful primary pci.

Eligibility criteria:
inclusion criteria: * patients with the first st-segment elevation acute anterior myocardial infarction due to occlusion of the proximal left anterior ascending coronary artery (lad), who will underwent successful primary stented pci. patients are eligible if they have primary pci from 4 to 12 hours after symptoms onset and show reduced lv ejection fraction ≤ 45% with at least 3 akinetic segments in the lad perfusion territory at echocardiogram performed 24 hours after pci. exclusion criteria: * exclusion criteria are age ≥ 80 years, cardiogenic shock (killip iv), multivessel coronary artery disease, serious renal or hepatic disease, blood cells disorders, documented cancer or terminal illness.