Kornimate/medical-research-clean huggingface dataset:
treatment of adults with generalized anxiety disorder using glutamine

Conditions: Generalized Anxiety Disorder

Summary: the objective of this randomized clinical trial is to examine the efficacy of l-glutamine for the treatment of generalized anxiety disorder compared versus placebo.


Eligibility criteria:
inclusion criteria: * outpatients with generalized anxiety disorder defined by the criteria of the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) * generalized anxiety disorder is the primary psychiatric disorder. * untreated patients or; patients treated with paroxetine, sertraline, citalopram, escitalopram, venlafaxine or duloxetine at least for 6 weeks on a stable dose; or patients treated with any benzodiazepine at least for 4 weeks on a stable dose. * hamilton anxiety rating scale score major or equal to 20 and a score major or equal to 2 on items 1 and 2 of the same scale at both screening and baseline. * clinical global impression-severity major or equal to 4 at both screening and baseline. exclusion criteria: * unable to give informed consent. * currently participating in another clinical research. * any other psychiatric disorder not included in the anxiety disorders section of the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v). secondary diagnosis of other anxiety disorders are allowed provided the diagnosis is not more prominent than generalized anxiety disorder symptoms. * suicide risk as assessed by the researcher at screening or baseline. * history of substance abuse in the previous six months before the screening visit. * suffering a medically relevant or instable disease. * if woman, being pregnant at screening visit. * if woman, being breastfeeding. * a score major or equal to 20 on the montgomery-asberg depression rating scale at screening or baseline. * as judged by a researcher, the patient might not adhere to the intervention or complete follow-up. * history of use of a banned drug in the past two weeks prior the baseline visit; three weeks in the case of monoamine oxidase inhibitors; one week in the case of fluvoxamine or a tricyclic antidepressant; two weeks for any antipsychotic and; six weeks por long-acting injectable antipsychotics. * history of use of l-glutamine the most part of the days of the previous month before the baseline visit. * history of psychotherapy treatment in the past month before the baseline visit.

Keywords: generalized anxiety disorder randomized controlled trial psychopharmacology drug therapy glutamine
acute appendicitis: active observation with and without antibiotics

Conditions: Appendicitis

Summary: this study evaluates if early provision of antibiotics is a superior treatment compared to "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated appendicitis.

recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence. however, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. a well- recognized approach in sweden is watchful waiting at in-hospital conditions. a certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective. the hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.

Eligibility criteria:
inclusion criteria: * subjects with suspected appendicitis. * age\<60 years. * c-reactive protein \< 60 mg/l. * white blod cell count (leucocytes) \< 13 e9 /l. exclusion criteria: * pregnant
a registered cohort study on cerebellar ataxia in the organization in south-east china for cerebellar ataxia research (osccar)

Conditions: Cerebellar Ataxia

Summary: cerebellar ataxia is a form of ataxia originating in the cerebellum. cerebellar ataxia can occur as a result of many diseases and may present with symptoms of an inability to coordinate balance, gait, extremity and eye movements. to understand the clinical and genetic characteristics of cerebellar ataxia, we establish a registered cohort to follow up chinese patients with cerebellar ataxia.


Eligibility criteria:
inclusion criteria: * patients with cerebellar ataxia based on the diagnoses of tow neurologists * relatives of patients with cerebellar ataxia * unrelated healthy controls * participants or legal guardian(s) willing and able to complete the informed consent process exclusion criteria: * participants are unable to comply with trial procedures and visit schedule
role of gut microbiome in cancer therapy

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study examines how gut microbiome can affect cancer therapy in cancer patients undergoing cancer therapy or stem cell transplant. the human microbiome affects the way some cancer drugs are metabolized in the human body. information from this study may help doctors improve the way cancer treatment is delivered, and increase its effectiveness and success.

primary objective: i. to correlate gut microbiome with specific cancer diagnoses and the clinical response (efficacy), and adverse effects of cancer therapy (single or multiple) and stem cell transplant. outline: patients undergo collection of blood and stool samples and have their medical records reviewed.

Eligibility criteria:
inclusion criteria: * age 18-99 * diagnosis of cancer and undergoing cancer therapy or scheduled to start cancer therapy or undergoing stem cell transplant for any hematological condition exclusion criteria: * unable to provide informed consent * vulnerable adults
adaptive optics scanninglaser ophthalmoscope safety and efficacy clinical trial

Conditions: Retinal Disease; Healthy

Summary: this prospective, multicenter, single-group, target-value clinical trial was designed to evaluate the efficacy and safety of an adaptive optics scanninglaser ophthalmoscope(aoslo) for ophthalmic examination.

objective: this study aims to collect aoslo retinal images from human population to assess the imaging quality and quantitative measurement consistency of aoslo devices manufactured by robotrak and also monitor any possible side effects. study population: randomly invited 194 volunteers who meets inclusion criteria design: the study is an observational protocol that participants will be imaged with robotrak aoslo systems to get cellular level images of photoreceptors and blood vessels in foveal area. automatics analysis of cell/blood vessel morphology parameters will be calculated for consistency evaluation. in general, participants will undergo a complete ophthalmic examination including assessments of visual acuity, intraocular pressure, slit lamp examination, ocular biometry, oct, fundus imaging, multi-focal erg and oct scan to assess potential side effects of aoslo imaging. outcome measures: the primary efficacy outcome measure of this study are multi expert grading of the image quality collected. the secondary efficacy outcome measure are quantitative assessment of the morphological parameters generated from the captured images and device operator ratings. the safety measures are side effect signs from ophthalmic examinations before\&after aoslo imaging

Eligibility criteria:
inclusion criteria： 1. age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender; 2. can fully cooperate with instructions to complete the inspection 3. the subject (or their designated agent) voluntarily participates and signs an informed consent form. note: at least 63 subjects with no obvious eye abnormalities were enrolled (determined by the researcher through ophthalmic examination) exclusion criteria： 1. patients with high intraocular pressure (\>21mmhg) or other reasons who cannot undergo mydriasis; 2. for those with a spherical lens degree exceeding 5d or a cylindrical lens degree exceeding ± 2d, 3. those with ptosis or other conditions that cannot fully expose the pupil area 4. aphthalmic or intraocular lens eyes 5. those who have received photodynamic therapy within 48 hours; 6. individuals with a history of photosensitivity or taking medication that may cause photosensitive side effects 7）those who have obvious skin lesions on the lower jaw or forehead and are unable to contact the lower jaw or forehead support 8) individuals with epidemic keratoconjunctivitis or in the active phase of other infectious diseases 9) those whose refractive medium is turbid and unable to obtain satisfactory images; 10) poor fixation or inability to cooperate with the examination due to other reasons; 11) pregnant or lactating women;

Keywords: healthy patients eye disease
prediction of successful weaning from continuous renal replacement theraphy: the possible role of delta c-cistatin

Conditions: Acute Kidney Injury

Summary: the goal of this observational study is to know if, in patients with acute kidney injury, naive for renal injurie, admitted to different icus, the change in plasma concentration of c-cistatin, between initiation and discontinuation of crrt, is a predictive finding to optimize the withdrawal time of renal support


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * diagnosis of acute kidney injury (defined according to kdigo 2012 criteria) * need for support with crrt according to the indications of the nephrologist consultants and clinical practice * obtaining informed consent exclusion criteria: * crrt already ongoing (in another department not participating in the study) at the time of transfer/admission to intensive care; * need for rrt (any type and modality) in the 14 days prior to enrolment; * diagnosis of akd/ckd/esrf on admission; * discontinuation of crrt under conditions that do not comply with the criteria established by the study; * need for crrt not associated with aki condition (e.g. elimination of toxicants); * pregnant women; * presence of known thyreopathy * continuous use of corticosteroids * patient with known neoplastic disease.

Keywords: c cistatin acute kidney injury crrt weaning
the european bifurcation club left main study

Conditions: Percutaneous Transluminal Coronary Angioplasty; Coronary Artery Disease

Summary: the objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.


Eligibility criteria:
inclusion criteria: patients must meet all of the inclusion criteria: * bifurcation distal left main stem stenosis \>50% and * ischaemic symptoms, or * positive non-invasive imaging for ischaemia, or * positive ffr, or * lms ivus mla \<6mm2 * left main diameter ≤5.75mm * true bifurcation lesion type 1,1,1 or 0,1,1 * lad and cx diameter both \>2.75mm * unprotected left main * patient ≥18 years old exclusion criteria: * stemi \<72 hours preceding * cardiogenic shock * chronic total occlusion of either vessel * \>2 other coronary lesions planned for treatment * syntax score for planned lesions to be treated \>32 * lms trifurcation if all vessels are ≥2.75mm diameter * either bifurcation vessel not suitable for stenting * platelet count ≤50 x 10\^9/mm3 * left ventricular ejection fraction ≤20% * patient life expectancy less than 12 months * participation in another investigational drug or device study * patient unable to give informed consent * women of child-bearing potential or lactating
efficacy of type-5 phosphodiesterase inhibitors in primary and secondary pulmonary hypertension

Conditions: Primary and Secondary Pulmonary Hypertension

Summary: the aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension

patients with primary and secondary pulmonary hypertension will be recruited and admitted to the icus of the national taiwan university hospital. each patient will undergo swan-ganz catheterization and hemodynamic monitoring during administration of sildenafil. efficacy of inhaled no and iloprost will also be compared.

Eligibility criteria:
inclusion criteria:patients with primary and secondary pulmonary arterial hypertension - exclusion criteria:unstable patients or patients with allergy to sildenafil

Keywords: pulmonary arterial hypertension type-5 phosphodiesterase inhibitors sildenafil
retrospective-prospective study to evaluate treatment management and outcomes of patients with waldenström's macroglobulinemia (wm) treated in italy according to the zanubrutinib (brukinsa®) compassionate use program (cup) and in common practice following commercial approval.

Conditions: Waldenström's Macroglobulinemia (WM)

Summary: this is a non-interventional, observational, retrospective and prospective multicenter italian study, to describe treatment management and outcomes of waldenström's macroglobulinemia (wm) patients treated according to the italian compassionate use program (cup) and receiving zanubrutinib following its commercial approval.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form * waldenström's macroglobulinemia diagnosis in need of treatment according to esmo (european society for medical oncology) guideline 2018 * patients who received zanubrutinib according to the italian cup or in common practice following zanubrutinib commercial approval * treatment with zanubrutinib according to current smpc (summary of product characteristics) * treatment decision before inclusion into this non-interventional study * age ≥18 years exclusion criteria: * contraindications according to smpc for patients with wm * participation in an interventional clinical trial during zanubrutinib treatment * patients with disease progression during a btki treatment (if pre-treated with btk, only those intolerants are considered eligible)
a clinical trial of acyw135 group meningococcal polysaccharide conjugate vaccine (crm197 vector) in 18-59 year olds

Conditions: Meningococcal Meningitis

Summary: this is a randomized, observer-blind, peer-controlled study. there will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control groups.


Eligibility criteria:
inclusion criteria: * 18\~59 years old at the time of screening. * should not have received any meningococcal vaccine in the last 3 years. * volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit. * volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit. * willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial. exclusion criteria: * fever before vaccination, axillary temperature \>37.0°c. * history of epilepsy, convulsions or seizures or history or family history of psychiatric disorders. * volunteers with current meningitis or a history of meningitis. * blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner. * hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group a meningococcal podophyllotoxin, group c meningococcal podophyllotoxin, group y meningococcal podophyllotoxin, group w135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate). * severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmhg, diastolic blood pressure ≥ 100 mmhg). * previous vaccination-related hospitalizations or emergencies. * bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection. * other vaccinations within 14 days. * participation in other studies involving interventional studies within 28 days prior to study entry (\<28 days) and/or during study participation. * other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.

Keywords: vaccine peer controlled immunogenicity safety 18-59 years
angiolite pmcf study ( repic04f )

Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease

Summary: multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of angiolite sirolimus eluting stent to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with angiolite sirolimus eluting stent.

the objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the angiolite sirolimus eluting stent in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: * patients treated with angiolite according to routine hospital practice and following instructions for use * informed consent signed exclusion criteria: • not meet inclusion criteria

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) drug eluting stent
feeding pattern and hypoalbuminemia in pediatrics with chronic kidney disease.

Conditions: Chronic Kidney Diseases

Summary: to determine the impact of feeding pattern on the development of hypoalbuminemia and out come of pediatric patients with chronic kidney disease.

chronic kidney disease (ckd) is characterized by an irreversible deterioration of renal function that gradually progresses to end-stage renal disease. during the past 2 decades, the incidence of ckd in children has steadily increased.children, adolescents, and young adults constitute less than 5% of the end-s population, and their 10-year survival ranges from 70% to 85%.although children represent only a small proportion of all patients with ckd, affected children pose unique challenges to the health care system and to their providers, who must address not only the primary renal disorder, but the many extrarenal manifestations of ckd that complicate management.serum albumin is a strong predictor for adverse outcomes in adults with chronic kidney disease (ckd). because these conditions are amenable to treatments, recognition of hypoalbuminemia and underlying status may improve patient management, potentially leading to better clinical outcomes.hypoalbuminemia is known to be an independent predictor of survival and hospitalization in adult patients with end-stage renal disease (esrd) on dialysis.in children with esrd, a few studies have focused on mortality or hospitalization as outcomes, showing the association of hypoalbuminemia with high mortality in incident dialysis patients and high hospitalization frequency in prevalent dialysis patients.further, patients with chronic diseases and hypoalbuminemia lose fat-free mass, considered to be an essential indicator of the undernourished state, despite adequate food intake.protein energy wasting (pew) is common in patients with ckd and associated with adverse clinical outcomes .(pew) is closely associated with malnutrition and inflammation, where serum albumin is an established surrogate biomarker. children with ckd are also at high risk of poor nutrition and chronic inflammation .malnutrition and inflammation are associated with adverse outcomes such as death or hospitalization.furthermore, among children with ckd, inadequate nutrition is one of the most common causes of growth failure, resulting in short stature or low body mass index (bmi)which is also associated with death or hospitalization.

Eligibility criteria:
inclusion criteria: the study will include patient on maintenance hemodialysis with hypoalbuminemia according to\] mites sedbuffone gjed pediatric clinical chemistry. 3rd ed., press(1989)\[ (hypoalbuminemia was defined as an albumin level of less than 3.4 g/dl for patients 7 months or older and less than 2.5 g/dl for patients younger than 7 months. ) who fulfilled the following criteria will be included in the study: 1. age range from 2-16 years old. 2. both sexes. 3. on maintenance hemodialysis with hypoalbuminemia exclusion criteria: 1. other causes of hypoalbuminemia such as heart disease, diabetes mellitus , hepatic failure . 2. chronic kidney disease without hypoalbuminemia.
profiling program of advanced/metastatic pancreatic cancer patients

Conditions: Metastatic Pancreatic Cancer; Advanced Pancreatic Cancer

Summary: the proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.


Eligibility criteria:
inclusion criteria: * male or female patient \> 18 years * metastatic or advanced pdac * patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy). * availability of an archival representative ffpe tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block. * life expectancy \> 3 months * ps score 0 or 1. exclusion criteria: * curative therapy available * any condition contraindicated with blood sampling procedures required by the protocol. * known additional malignancy that is progressing or requires active treatment. exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer. * any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.

Keywords: molecular screening genomic profiles transcriptomic profiles
a new supplement for the "metabolic syndrome"

Conditions: Metabolic Syndrome

Summary: this study evaluates the effect of a combination of glycirrhizic acid, cinnamomun zeylanicum and corosolic acid for the treatment of metabolic syndrome. participants receive the supplement or a placebo.

the supplement is composed by of a combination of glycirrhizic acid, cinnamomun zeylanicum and corosolic acid. they act in different way reducing insulin resistance, which is the main cause of metabolic syndrome. it was a randomized, controlled study involving 60 women with the metabolic syndrome following the criteria proposed by atp iii in 2015. main outcomes were the improvement of the parameters that characterizes the metabolic syndrome, such as glucose and insulin levels, triglycerides, hdl-cholesterol and blood pressure.

Eligibility criteria:
inclusion criteria: postmenopausal women affected by metabolic syndrome, diagnosed by atp 2015 criteria. - exclusion criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs -

Keywords: insulin resistance, blood pressure,