Kornimate/medical-research-clean huggingface dataset:
peg-rhg-csf in patients with breast cancer receiving chemotherapy to prevent neutropenia

Conditions: Breast Cancer

Summary: the purpose of this study is to estimate the efficacy and safety of peg-rhg-csf in patients with breast cancer receiving chemotherapy.


Eligibility criteria:
inclusion criteria: * patients with age between 18 and 70 years * diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy * grade iii/iv neutropenia after chemotherapy * kps score≥70 * life expectancy of at least 3 months * written informed consent are acquired exclusion criteria: * have accepted any other drug related clinical trial within 4 weeks before anticipated * uncontrolled infection * pregnancy * other situations that investigators consider as contra-indication for this study

Keywords: peg-rhg-csf neutropenia
comparing cetaphil restoraderm system versus standard skin care in infants

Conditions: Atopic Dermatitis

Summary: the goal of this study is to determine what effect cetaphil® restoraderm® system has on babies' skin versus johnson \& johnson baby lotion and skin cleanser.

subjects will randomly be divided into a group using cetaphil® restoraderm® system or a group using johnson \& johnson baby lotion and skin cleanser . at 3, 6, and 12 months non-invasive measurements of barrier function will be used to test the babies' skin. the procedures are as follows: * transepidermal loss (tewl - measures the water loss from the skin) * skin electrical capacitance (measures how much water stays in the top layer of skin) * skin ph (measures level of ph) * skin microbiome analysis (skin swabs to check genetic code of skin bacteria) * lipidomic and natural moisturizing factor analysis (measures lipids (oils) in the top layer of skin) both groups will be reminded to follow the instructions about general good skin care of infants. subjects will be asked if they agree to provide a saliva sample. if yes, a saliva sample will be collected from the inside of the infant's cheek at the 6 month visit and will be shipped to the laboratory of dr. irwin mclean at the university of dundee, where it will be tested for gene defects in the skin barrier that might trigger the development of eczema. defects in the gene called filaggrin have been shown to increase the risk of developing eczema. the samples will be identified by a code to protect your infant's identity. the saliva samples will be stored only for this study, and then the sample will be destroyed.

Eligibility criteria:
inclusion criteria: * infants up to three weeks of age born to mothers aged 18-45 years will be recruited for this study. * infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health. exclusion criteria: * preterm birth defined as birth prior to 37 weeks gestation * major congenital anomaly * hydrops fetalis * significant dermatitis at birth not including seborrheic dermatitis on the scalp ("cradle cap") * any immunodeficiency disorder * any severe genetic skin disorder * any other serious condition that would make the use of emollients inadvisable * any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess

Keywords: atopic dermatitis skin care
theta burst study ghent

Conditions: Unipolar Major Depression

Summary: 50 right-handed antidepressant-free unipolar depressed patients (age 18-65 years) will be treated with in total 20 theta burst sessions; these will be spread over 4 days. on each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes. patients will be selected using the structured mini-international neuropsychiatric interview (mini). all will be at least stage i treatment resistant. because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. only habitual benzodiazepine agents will be allowed. all patients will be closely matched for gender and age with 50 never-depressed medication-free healthy volunteers. only baseline measurements will be collected: no volunteer will undergo the treatment. we expect that real theta burst treatment and not sham will result in a significant and clinical meaningful response.


Eligibility criteria:
inclusion criteria: * antidepressant-free unipolar depression * age between 18 and 65 years * right handed * at least stage i treatment resistant exclusion criteria: * current or past history of epilepsy, neurosurgical interventions, having a pacemaker or metal or magnetic objects in the brain, alcohol dependence and suicide attempts within 6 months before the start of the study.

Keywords: depression
arthroscopic rotator cuff repair augmented with platelet rich plasma

Conditions: Rotator Cuff Tears

Summary: purpose: to assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by mri) compared to a control group that only underwent the isolated arthroscopic repair. hypothesis: platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.

platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by mri) compared to a control group that only underwent the isolated arthroscopic repair.

Eligibility criteria:
inclusion criteria: * adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (mri). * minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids) exclusion criteria: * refusal to participate or informed consent, * revision surgery, * partial repair, * patients with shoulder osteoarthritis\> 2 * advanced fat infiltration of the rotator cuff muscles (stage 3 or 4) * systemic or rheumatoid arthritis, * uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist) * acute or chronic infections of the shoulder to be operated on * ongoing cancer chemotherapy therapies * sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes; * previous operations on the affected shoulder, * patients with autoimmune diseases; * pregnant
effects of virtual reality glasses, kaleidoscope and distraction cards on pain and anxiety during blood draw in children

Conditions: Acute Pain; Virtual Reality; Kaleidoscope; Distraction Cards; Nursing Caries; Children, Only; Fear; Anxiety

Summary: the study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using virtual reality glasses, kaleidoscope and distraction cards in reducing pain and anxiety during blood draw in children.

n the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. in light of this information, this study aimed to compare the effect of distraction by using virtual reality glasses, kaleidoscope and distraction cards in reducing pain and anxiety during blood draw in children. this study is a prospective, randomized and controlled trial. children aged 7 to 11 years who required blood draw were divided into three groups; virtual reality glasses, kaleidoscope, distraction cards and control. data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. the children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using wong-baker faces. the children's anxiety levels were also assessed using the children's fear scale. the study population consisted of children aged 7 to 11 years who presented to the children's blood draw room of the hospital. sample of the study consisted of a total of 400 children who met the sample selection criteria and were selected via randomization method. children were randomized into three groups: virtual reality glasses group (n= 100), kaleidoscope group (n= 100), distraction cards group (n= 100) and control group (n= 100). data were collected using the interview and observation form, wong-baker faces pain rating scale, children's fear scale.

Eligibility criteria:
inclusion criteria: * children between the ages of 7-11, * volunteering of the child and parent to participate in the study, * blood draw for routine control purposes, * blood draw should be done by the same nurse, * the needle on which blood draw will be performed must be of the same thickness. exclusion criteria: * the child has any acute or chronic disease, * the child has a mental disability, vision, speech or communication problems, * the parent has hearing, vision or verbal communication difficulties, * the child used analgesics in the last 6 hours, * infection, disruption of skin integrity and rash in the area where the application will be made, * exclusion criteria were that the parent or child wanted to leave the study at any point.
virtual trial to compare two digital therapeutics as interventions for physical and mental health in people with cancer

Conditions: Cancer

Summary: this is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. the study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site. the digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). the study will enroll at least 352 stage i-iii cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.


Eligibility criteria:
inclusion criteria: * stage i-iii cancer diagnosis * currently in active systemic treatment of chemotherapy, radiation or immunotherapy, have completed systemic treatment within the past 6 months, or have a treatment plan including planned systemic treatment. * are experiencing at least moderate anxiety * 18 years of age or older * are fluent in english * have access to a smartphone (a mobile phone that performs many of the functions of a computer, typically having a touchscreen interface, internet access, and an operating system capable of running downloaded applications) or tablet that runs ios or android software, with cellular data service or wifi access. * willing to download software onto smartphone or tablet from apple store or android store exclusion criteria: * systemic treatment plan includes only endocrine therapy. * treatment plan includes stem cell/bone marrow transplant. * currently participating in any other investigative cbt trial for treatment of anxiety or depression. * participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study * recently completed use of blue note therapeutics covid cancer care program or other blue note therapeutics device or blue note therapeutics-sponsored study * are experiencing severe levels of depression or indicate suicidal risk (measured by surveys during screening for the study) * are experiencing anxiety below the required level (measured by a survey during screening for the study) * cancer diagnosis is melanoma, multiple myeloma, unstaged cancer.

Keywords: breast cancer colon/rectal cancer endometrial cancer lymphoma leukemia lung cancer ovarian cancer pancreatic cancer prostate cancer thyroid cancer
effectiveness and safety study of lap-band treatment in subjects with bmi >/= 30 kg/m2 and < 40 kg/m2

Conditions: Obesity

Summary: the purpose of this study is to determine whether the lap-band system is safe and effective in subjects with bmi ≥ 30 kg/m2 and \< 40 kg/m2.

lbmi-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the lap-band system is safe and effective in subjects with bmi ≥ 30 kg/m2 and \< 40 kg/m2. primary and secondary outcome measures were analyzed at 1 year post lap-band implantation. subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in post-hoc outcome measures.

Eligibility criteria:
inclusion criteria: * have a bmi ≥ 30 kg/m2 and \< 35 kg/m2 (with or without comorbid conditions) or a bmi ≥ 35 kg/m2 and \< 40 kg/m2 without severe comorbid conditions * have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs exclusion criteria: * subject history of congenital or acquired anomalies of the gastrointestinal tract * severe cardiopulmonary or other serious or uncontrolled organic disease * severe coagulopathy; hepatic insufficiency or cirrhosis * history of bariatric; gastric; or esophageal surgery * history of intestinal obstruction or adhesive peritonitis * history of esophageal dysmotility disorders * type i diabetes
perfusion augmentation through exercise

Conditions: Stroke, Ischemic

Summary: large cerebral vessel occlusion is a common phenomenon in the general population and accounts for 13-35% of ischemic strokes. chronic stenosis in the large cerebral arteries is associated with cerebral hypoperfusion, cognitive decline and an increased risk of stroke or recurrent stroke, respectively. even with upgrowth of surgical or endovascular interventions, mechanical reopening of the occluded vessels is often not possible. alternative treatment opportunities include minimal-to-moderate blood pressure elevation (typically by ceasing antihypertensives) waiting for collateral circulation to develop spontaneously. another conservative approach to increase cerebral perfusion is aerobic exercising. physical activity has shown to lead to cerebral blood flow increase, especially in activated brain areas of healthy human and rat models. however, it is remains unknown, how physiological adaptation to physical activity expresses in persons after stroke due to large vessel occlusion. herein, it is hypothesized that aerobic exercise facilitates the development of an extensive and functional vascular collateral network in persons with ischemic stroke and perfusion compromise.


Eligibility criteria:
inclusion criteria: * male and female patients of 18 years of age or above * subjects after ischemic cerebral stroke (≥ 3 months) due to large vessel occlusion * subjects do not qualify for flow augmentation through ecic bypass or endovascular treatment * persistent deficit in bold-cvr * functional ambulatory categories \>2 * discharged from hospitalization / inpatient rehabilitation * living independent before stroke (mrs ≤3) * written informed consent exclusion criteria: * severe cardiac disease, such as instable angina pectoris, pericarditis, heart failure (new york health association \> ii°), or hemodynamically significant valvular dysfunction * complete arterial stenosis * peripheral artery disease with mild to moderate claudication at \< 200m or 200-1000m of walking * contra-indication, such as a history of a seizure, prior electroconvulsive therapy, deep brain stimulators or other metal in the head, skull defect, pacemaker, neuroleptic medication * inability to follow the procedures of the study, e.g., due to language problems (unable to follow to stage commands), psychological disorders (major depression), and / or a neurodegenerative disease (dementia) * known or suspected non-compliance, documented drug, or alcohol abuse * pregnancy

Keywords: cerebral perfusion aerobic exercise
multi-center clinical study of early antibios of severe acute pancreatitis

Conditions: Pancreatitis,Acute Necrotizing

Summary: strategy of antibiotic therapy in sap,de-escalate (cefoperazone+metronidazole) or escalate (meropenem) therapy,which one is better.

sap is a serious and life-threatening disease and requires intensive and aggressive management of multiple organ failure and severe infectious complications that can develop in these patients. the most common cause of death in patients suffering from severe acute pancreatitis (sap) is the infection of pancreatic necrosis by enteric bacteria with mortality rates of 30% (range 14- 62%),spurring the discussion of whether or not prophylactic antibiotic administration could be a beneficial approach. pancreatic infections are more often monomicrobial, especially e. coli in the two first weeks (100% and 62.5%) of onset, with a shift from gram-negative to gram-positive as the pancreatitis progressed. in order to evaluate the benefit of prophylactic antibiotic application, a number of randomized controlled clinical trials have been published over the past 15 years. since the results were conflicting and most studies were of low methodological quality and/or statistically underpowered, meta-analyses have been performed to assess this important issue. however, their results ranged from absolutely no effect of antibiotic prophylaxis to positive effects regarding mortality, the incidence of infected pancreatic necrosis and the incidence of extra pancreatic infections. in order to provide reliable evidence of the effect of antibiotherapy strategy in sap, we performed a prospective randomized multicenter clinical trial.

Eligibility criteria:
inclusion criteria: * severe acute pancreatitis according to atlanta criteria revisited in 2012 exclusion criteria: * concurrent sepsis or (peri)pancreatic infection caused by a second disease * patients with chronic organ failure (chronic renal failure needs kidney replacement, chronic heart failure, decompensate hepatic cirrhosis, chronic obstructive pulmonary disease) * recurrent or endoscopic retrograde cholangiopancreatography (ercp), or traumatic or operative pancreatitis * pregnancy, malignancy or immunodeficiency * a history of allergy to meropenem, cefoperazone and metronidazole * a history of antibiotic administration within 48 h prior to enrollment * possible death within 48 h after enrollment

Keywords: antibiothearpy strategy cefoperazone metronidazole meropenem
oxygen therapy use in patients with fibrotic interstitial lung disease

Conditions: Lung Diseases, Interstitial

Summary: the purpose of this study is to describe initiation and use of oxygen therapy among patients with fibrotic interstitial lung disease (ild) and to assess the impact of oxygen therapy on clinical outcomes among patients with fibrotic ild.


Eligibility criteria:
inclusion criteria: * ≥2 fibrosing interstitial lung disease (ild) diagnoses in any position on different dates of service, within 365 days of each other, and in the same continuous enrollment period during the patient identification period. the fibrosing ild diagnosis date will be defined as the date of the first fibrosing ild diagnosis. the two fibrosing ild diagnosis codes can be one of the following combinations: * 2 fibrosis codes * 1 fibrosis code \& 1 ild code that requires fibrosis code * ≥18 years of age as of the fibrosing ild diagnosis date * continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ild diagnosis date (pre-ild baseline period) exclusion criteria: * fibrosing ild diagnosis in the 12-month pre-ild baseline period * unknown gender, geographic region, or insurance type
cardiovascular risk predictors in patients with psoriasis

Conditions: Psoriasis; Cardiovascular Diseases

Summary: the investigators are planning to find the right modification of traditionally used risk scores (pasi, dlqi) in patients with psoriasis of different severity to guide the treatment that could potentially extend life, improve cardiovascular outcomes and quality of life in patients with psoriasis and cardiovascular risk factors in a prospective observational study. the traditionally excluded groups of older patients with diabetes mellitus, decreased kidney function and those with potentially worse prognosis are going to be included in the study. as it's known, the number of those patients is on the rise each year and require a close attention of multidisciplinary teams.


Eligibility criteria:
inclusion criteria: * age over 18 years * written informed consent of the patient to participate in the study exclusion criteria: * age under 18 * pregnancy, lactation * very high cardiovascular risk * life-threatening, independently influencing prognosis and disabling diseases, * mental disorders that do not allow to give informed consent or answer questions adequately * refuse of the patient to participate in the study

Keywords: psoriasis cardiovascular risk risk factors
immnc-hf: intramyocardial injection of bone marrow mononuclear cells in heart failure (hf) patients

Conditions: Heart Failure

Summary: this is a prospective, randomised double blind, controlled, parallel-group phase i and ii study. its aim is to assess the evaluation of the intramyocardial injection of autologous bone marrow derived mononuclear stem cells is safe and effective in hear failure patients with reduced left ventricular ejection fraction(\<=30%) when compared to a control group of patients undergoing best medical care.


Eligibility criteria:
inclusion criteria: 1. men and women of any ethnic origin 18 ≤ aged≤ 65 years 2. ef≤40 (by echocardiography) and regional wall motion abnormality 3. not responding to standard therapies 4. the new york heart association (nyha) class ≥ iii 5. myocardial infarction due to coronary artery atherosclerotic disease 6. an area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or mri) 7. normal liver and renal function 8. no or controlled diabetes 9. able to give voluntary written consent and understand the study information provided to him exclusion criteria: 1. participation in another clinical trial within 30 days prior randomisation 2. previously received stem/progenitor cell therapy 3. pregnant women 4. mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol 5. cardiogenic shock requiring mechanical support 6. congenital / valvular heart disease 7. implantable cardioverter defibrillator (icd) transplant 8. platelet count \<100.000/µl, or hemoglobin \<8.5 g/dl 9. impaired renal function, i.e. creatinine \>2.5 mg/dl 10. fever or diarrhea within 4 weeks prior screening 11. history of bleeding disorder within 3 months prior screening 12. uncontrolled hypertension (systolic \>180 mmhg and diastolic \>120 mmhg) or sustained ventricular arrhythmia 13. life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease