Kornimate/medical-research-clean huggingface dataset:
clinical effect of dtms in major depressive disorder

Conditions: MAjor Depressive Disorder

Summary: aim: to test if there is a relation between deep transcranial magnetic stimulation (dtms) dose and clinical effect on major depressive disorder (mdd) method: 30 patients with moderate to severe mdd without concurrent medication will be randomised to three different treatment protocols of dtms. symptom severity of mdd will be quantified before, during and after dtms.

population: inclusion criteria: 1. ongoing episode of mdd (icd10 f32.x) according to mini/scid1. 2. montgomery asberg depression rating scale (madrs) score 20-60 3. tms safe exclusion criteria: 1. bipolar disorder 2. substance abuse 3. fluoxetine treatment last three weeks 4. other major central nervous system (cns) disorder 5. acute medical disorders 6. previous tms or electro convulsive treatment (ect) \<2 months before inclusion ratings: madrs at inclusion, baseline, weekly, at last visit clinical global impression severity (cgi-s) score at baseline, at last visit global self-evaluation-memory (gse-my) at last visit alcohol use disorder identification test (audit-c) at inclusion euroqual 5 dimension (eq5d) at baseline, at last visit quick inventory of depressive symptomatology self rating (qids-sr) baseline, weekly, last visit condition: each subject is randomised to condition a, b or c of dtms (brainsway): half the standard protocol (10 min; a), standard protocol (20 min; b) or double standard protocol (40 min, c). 20 treatment sessions/subject. 10 subjects in each group. primary endpoint: madrs at baseline - madrs at last visit (intention to treat (itt), last observation carried forward (locf))

Eligibility criteria:
inclusion criteria: * see above exclusion criteria: * see above

Keywords: transcranial magnetic stimulation
emotional and cognitive self-regulation, an eeg study

Conditions: Complex Posttraumatic Stress Disorder (cPTSD); Dissociative Disorder Not Otherwise Specified (DDNOS); Dissociative Identity Disorder (DID)

Summary: the main goal of the proposed project is to assess treatment-induced changes of electrophysiological and psychophysiological correlates of the capacity to regulate emotion, executive functions, and clinical measures in individuals with complex posttraumatic stress disorder and dissociative disorders in a naturalistic inpatient setting.


Eligibility criteria:
inclusion criteria: -ability to undergo eeg measurement/psychophysiological measurement exclusion criteria: * regular substance use * acute suicidality * comorbid psychosis
study to evaluate the efficacy of asystems' complete calm supplementation on sleep quality and duration, anxiety, and stress

Conditions: Sleep; Stress; Anxiety

Summary: this is an open-label observational single-arm clinical trial to study the efficacy of a commercial dietary supplement and its effect on sleep quality, sleep duration, anxiety, mood, and stress.

it is hypothesized that the dietary supplement marketed as "asystems complete calm" (consisting of de-stress gummies and sleep gummies) will improve subjective wellbeing in trial participants, through promoting restful sleep (looking at sleep quality and duration), and reducing stress and anxiety, while lifting up the participants' mood. a total of 35 participants will be recruited for the trial following the screening. the trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants, and all participants will take the complete calm product, consisting of the de-stress gummies (day) and sleep gummies (night) for four weeks.

Eligibility criteria:
inclusion criteria: * male \& female between 24-45 years old * self-reported (undiagnosed) mild to moderate sleep issues * self-reported (undiagnosed) mild to moderate anxiety * self-reported stressful lifestyle * must be in good health (don't report any medical conditions asked in the screening questionnaire) * following a stable, consistent diet regimen * willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes exclusion criteria: * currently taking any prescription anti-depressants * currently receiving other psychotherapeutic treatment for anxiety or depression * severe chronic conditions including oncological conditions, psychiatric disease, or other * diagnosed insomnia * diagnosed anxiety or depression * food intolerances/allergies that require an epipen * females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
bone strength and physical activity in patients with a recent clinical fracture

Conditions: Fractures, Bone; Patient Fall; Osteoporosis; Physical Activity

Summary: the risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. the risk for a subsequent fracture is not dependent of bmd as measured by conventional dxa. in recent studies, it has been shown that hrpqct measurements provide information about bone structure, bone quality and bone strength in addition to bmd measurements. diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.


Eligibility criteria:
inclusion criteria: * patients aged 50 years and older with a recent fracture that is being evaluated at the fls at viecuri mc. * patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical study procedures * patients who signed the ethics committee approved specific informed consent form prior to inclusion. exclusion criteria: * patients with malignancy metastatic to the bone. * patients with osteomyelitis. * patients with fractures due to failure of a prosthesis. * patients, who as judged by the principal investigator, are mentally incompetent. patients who are compos mentis and understand the patient information, will not be considered mentally incompetent
evaluation of thoracolumbar fascia and relationship with low back pain in individuals with idiopathic scoliosis

Conditions: Idiopathic Scoliosis; Pain

Summary: this observational study seeks to explore the potential association between thoracolumbar fascia characteristics and low back pain in individuals diagnosed with idiopathic scoliosis.

this observational study aims to investigate the potential link between thoracolumbar fascia characteristics and low back pain in individuals with idiopathic scoliosis. the hypothesis underlying this study posits that alterations in thoracolumbar fascia thickness and properties contribute to changes in trunk flexibility and subsequently influence the occurrence and intensity of low back pain in patients with idiopathic scoliosis. the researchers believe that an increase in thoracolumbar fascia thickness may lead to reduced trunk flexibility, restricting the normal range of motion and potentially causing or exacerbating low back pain. to explore this hypothesis, the study will include participants diagnosed with idiopathic scoliosis. the researchers will measure thoracolumbar fascia thickness using ultrasound and assess trunk flexibility through various range of motion tests, including trunk flexion, extension, and lateral flexion using a goniometer, as well as the sit-and-reach test. to quantify the severity of the spinal curvature, the cobb angle will be measured on anteroposterior standing radiographs. participants will also be asked to report their pain levels using the visual analog scale, a simple tool where individuals rate their pain on a scale from 0 to 10. by analyzing the collected data, the researchers aim to establish potential correlations between thoracolumbar fascia thickness, trunk flexibility, and low back pain in individuals with idiopathic scoliosis.

Eligibility criteria:
inclusion criteria (with scoliosis): 1. being 10 years of age or older 2. having a diagnosis of idiopathic scoliosis 3. having a cobb angle measurement above 15 degrees inclusion criteria (for healthy individuals): 1. being 10 years of age or older 2. have no pathological spinal curvature. 3. have no history of low back pain in the last 3 months (visual analog scale score \<3/10). exclusion criteria: 1. having any neurological, psychological, congenital, or rheumatological condition 2. having a history of surgery or trauma involving the lower extremities or spinal region within the last 1 year 3. having received any previous treatment related to scoliosis

Keywords: fascia scoliosis pain
prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis

Conditions: Dry Eye Syndromes; Rheumatoid Arthritis

Summary: this study will evaluate the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis. no treatment is administered in this study.

we investigated the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis by information sheets and direct recruitment of patients of potential study participants diagnosed with rheumatoid arthritis. subjective assessment for dry eye disease was performed using ocular surface disease index (osdi) questionnaire. the following objective tests of dry eye disease were employed: tear osmolarity (to), tear break-up time (tbut), corneal fluorescein staining score and conjunctival lissamine green staining scores using the national eye institute-recommended grading system, and schirmer without anesthetic. the dry eye severity grading scheme highlighted by the dry eye workshop was adapted to quantify dry eye disease severity level.

Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis * 18 years old or older * speaks and understands english and/or spanish exclusion criteria: * unable to provide consent

Keywords: dry eye disease rheumatoid arthritis
prediction and detection of occult atrial fibrillation in patients after acute cryptogenic stroke and tia

Conditions: Cerebrovascular Stroke; Atrial Fibrillation

Summary: proactia is a prospective, event-driven observational study. it aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (paf) in patients after acute cryptogenic stroke and transient ischemic attack (tia).

it will be enrolled 250 participants of both sexes within two weeks after diagnosed cryptogenic stroke and/or tia at akershus university hospital, oslo area, norway. evaluation of participants' comorbidity with chads2-vasc score, ecg, holter ecg, echocardiography, detection of biochemical cardiac markers and screening for obstructive sleep apnea syndrome will be performed. all participants will be monitored with a continuous cardiac rhythm during one year by implantation of implantable cardiac rhythm monitors (icrm). all patients without high bleeding risk will get prescribed oral anticoagulants (oac) after detection of paf. a biobank will be established in order to store the sampled biological material.

Eligibility criteria:
inclusion criteria: - patients diagnosed with cryptogenic stroke and/or tia, in accordance to the toast (trial of org 10172 in acute stroke treatment) classification. exclusion criteria: * patients with known or newly detected af on initial examination including 24 h holter ecg. * patients on oral anticoagulants (oac) for non-af indications. * patients with strong contraindications for oac, even if the presence of underlying af is detected. * patients with atrial- or ventricular thrombi, or atheromas of the aortic arch greater than 4 mm, detected by transesophageal echocardiography. * patients unable to sign the informed consent or with a life expectancy due to comorbidities of less than two years.

Keywords: cryptogenic stroke occult paroxysmal atrial fibrillation
glutamine for the treatment of patients with irritable bowel syndrome

Conditions: Diarrhea-Predominant Irritable Bowel Syndrome

Summary: new and effective treatments are needed for patients with post-infectious irritable bowel syndrome (pi-ibs). we conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.

in a double-blind trial, eligible adults with post-infectious ibs with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. the primary end point was the proportion of patients who had a reduction of ≥50 on the irritable bowel severity scoring system (ibs-ss).

Eligibility criteria:
inclusion criteria: * men and women age 18-72 years old who developed post-infectious diarrhea-predominant ibs (d-ibs) * increased intestinal permeability on lactulose/mannitol permeability test * able and willing to cooperate with the study * \*absence of alcohol or nsaids ingestion for 2 weeks prior to inclusion into study and throughout the study duration exclusion criteria: * current participation in another research protocol or unable to give informed consent * women with a positive urine pregnancy test or breastfeeding * history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue * + hydrogen breath test for bacterial overgrowth * + antiendomysial antibody titer * use of nonsteroidal antinflammatory drug(nsaids) 2 weeks before or during the study * known allergy to glutamine * abdominal surgery except for removal of gallbladder, uterus, or appendix * abnormal blood urea nitrogen(bun) and/or creatinine

Keywords: irritable bowel syndrome glutamine intestinal permeability
treatment of adenovirus disseminated infections in hematopoietic stem cell transplant patients with adenovirus digestive replication

Conditions: Patients Who Underwent Allograft

Summary: disseminated adv infections are associated with high morbidity and mortality in hsct pediatric patients. the most common source of adv infection after pediatric hsct is the host digestive tract where latent adv are reactivated after engraftment. we have shown in a monocentric study that adv viral load in stools is a predictive factor of blood infection in children with digestive adv infections. we assume that an early treatment, with antiviral drugs, such as cidofovir and brincidofovir, may avoid severe adv infections and diseases and thus that molecular surveillance in stool is a critical factor for the control of adv reactivations. the study has two main objectives: (i) confirming the impact of adv viral load in stools on the occurrence of blood infection based on a multicentric prospective cohort study design; and (ii) determining the prognostic and predictive factors for efficacy and toxicity of antiviral drugs, such as brincidofovir and cidofovir.


Eligibility criteria:
inclusion criteria: * allogeneic hematopoietic stem cell transplantation from any donor other than full-matched related donor * age above 2 months and under 20 years * provide written informed consent from the parents (if \<18) and child * free, informed and written consent, signed by the patient and investigator before any study examination. if the patient is a minor by child (if possible) and both parents or child and the legal representative in case only one parent is alive exclusion criteria: * hematopoietic stem cell transplantation from full-matched related donor * females who are pregnant or currently nursing * any patient receiving cidofovir, ribavirin or any other anti-viral drug under development given in order to treat or prevent * current disease attributed to adenovirus infection * lack of affiliation to a social security scheme (as a beneficiary or assignee).current disease attributed to adenovirus infection
effect of imo on intestinal microbiota translocation in cirrhosis

Conditions: Decompensated Cirrhosis

Summary: the goal of this intervention clinical trial is to learn about the protection of isomaltooligosaccharides (imo) on intestinal bacterial translocation in patients with liver cirrhosis. the main question is to answer the changes of lps after adminstration of imo.


Eligibility criteria:
inclusion criteria: * age from 18-75. * cirrhotic patients. * decompensation event: ascites. * lps\>0.45eu/ml. exclusion criteria: * pregnant or breast-feeding. * active bacterial or fungal infection. * other decompensations: hepatic encephalopathy, gastroesophageal varices and hemorrhage. * diagnosis of easl-aclf. * diarrhea. * malignancy. * anticipated short survival time. * adverse reactions or allergies to oral carbohydrate preparations. * substance abuse or addiction. * severe extrahepatic diseases (e.g. patients with ckd-5 stage, severe cardiopulmonary dysfunction, and psychiatric disorders). * be immunosuppressed or immunodeficient states and the use of immunoglobulins or other immune-boosting conditions. * be unsuitable for participating in this trial. * participated in any drug trial within the past month * history of antibacterial or fungal use within 1 week prior to screening
disparities in myocardial infarction remodeling according to gender

Conditions: Myocardial Infarction; Ventricular Remodeling

Summary: following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. a primary hypothesis suggests unfavorable cardiac remodeling in women. this remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study.


Eligibility criteria:
inclusion criteria: * age \> 18 years * first myocardial infarction with st-segment elevation during the hospital phase * coronary angiography performed within 72 hours of the infarction * inclusion in the rima registry * patient affiliated or beneficiary of a social security scheme; signature of informed consent exclusion criteria: * patients already enrolled in the study * poor understanding of the french language * pregnant, breastfeeding, or postpartum women * individuals deprived of liberty by judicial or administrative decision; individuals receiving psychiatric care under coercion * individuals subject to a legal protection measure; individuals incapable of giving consent

Keywords: non-interventional registry biorepository establishment
treatment of erectile dysfunction i

Conditions: Erectile Dysfunction

Summary: randomized, placebo-controlled, double-blind, parallel design, phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of pde-5 versus placebo for the treatment of subjects with erectile dysfunction (ed).


Eligibility criteria:
inclusion criteria: * male, at least 19 years of age * stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity * history of ed (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration * partner is not pregnant or lactating exclusion criteria: * history of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months * cardiac arrhythmias requiring antiarrhythmic treatment * symptomatic congestive heart failure * taking nitrate medication in any form * uncontrolled diabetes (hba1c ≥ 13%) * hypersensitivity to phosphodiesterase type 5 (pde-5) inhibitors such as viagra®, cialis® or levitra® * previously failed to respond to pde-5 inhibitors such as viagra®, cialis® or levitra®
study to determine the safety and effectiveness of antiviral combination therapy to treat hepatitis c virus (hcv) in patients who have previously not received the standard of care

Conditions: Chronic Hepatitis C

Summary: the purpose of the study is to determine whether therapy with the combination of psi-7977 and daclatasvir (bms-790052) with or without ribavirin is effective in treating hepatitis c virus (hcv) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable hcv rna 12 weeks post treatment


Eligibility criteria:
inclusion criteria: * men and women, ages 18 to 70 years. * participants infected with hepatitis c virus (hcv) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other hcv-specific direct-acting antiviral (including daclatasvir and psi-7977). * patients should have chronic hepatitis c genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-hcv antibody; hcv rna; or a hcv genotype at least 6 months prior to screening, and hcv rna and anti-hcv antibody at the time of screening. exclusion criteria: * evidence of a medical condition associate with chronic liver disease other than hcv. * history of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis. * history of hemophilia. * history of torsade de pointes. * current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment. * history of gastrointestinal disease or surgical procedure (except cholecystectomy). * history of clinically significant cardiac disease. * blood transfusion within 4 weeks prior to study drug administration. * poor venous access. * any other medical, psychiatric, and/or social reason which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
ciprofloxacin on burned patients

Conditions: Burns; Bacterial Infections

Summary: this was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. the aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.


Eligibility criteria:
inclusion criteria: * moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, ii deep degree and iii degree according to full-thickness burn model, * hospitalization for burning injury since at least 72h during hyper metabolic phase * active infections microbiological confirmed * signed informed consent exclusion criteria: * pregnant or lactating female patients * previous history of tendinopathy * knowing syndrome of qtc prolongation * impairment renal function * hepatic insufficiency * convulsion * limited life expectancy

Keywords: ciprofloxacin regimen in compromised patients ciprofloxacin burned patients