Kornimate/medical-research-clean huggingface dataset:
management of proximal humerus fractures in adults: a clinical trial

Conditions: Shoulder Fractures

Summary: prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment.

the present study shall be conducted in accordance with the spirit 2013 statement: defining standard protocol items for clinical trials. all patients who sustained a phf and presented at the department of orthopedics at the academic hospital of bolzano (italy) will be prospectively incited to participate in the present clinical trial. patient recruitment will begin in april 2024, and end in april 2026. the follow-up period will start in october 2024, and end in april 2028. data analysis will commence in october 2024 and end in april 2028. the present study shall be conducted according to the principles of the declaration of helsinki. the authors receive no financial support for the research, authorship, and/or publication of this article. the protocol of the study has been prospectively registered and approved by the german registry of clinical trials (id drks00030614). ethics approval has been received from the ethic committee of the south tyrolean health authority, bolzano, italy (id 2022374 of june 22, 2023). all surgical and conservative procedures under analysis are already routinely carried out at the department of orthopaedics and trauma surgery of the academic hospital of bolzano, italy. patients who meet the inclusion criteria and agree to participate in the study by signing the consent form and the personal data processing form will be included in the study. data curation personal data, including sensitive data, will be pseudonymised and associated with a code from which it will be impossible to trace the patient's identity. only the principal investigator and sub-investigators of the study will be able to link the code to the name. the pseudonymised data will be collected in a table of microsoft office excel version 16 (microsoft corporation, redmond, us). statistical analyses assuming an actual difference in means between the test and reference group of 3 units and a pooled standard deviation of 5 units, the study would require a sample size of 117 patients for each group (i.e. a total sample size of 351, assuming equal group size), to obtain a power of 80% and a significance level of 5%, to declare the superiority of a technique with a margin of prominence of 5 units, assuming a minimum clinically important difference oss of 2.7/100 .

Eligibility criteria:
inclusion criteria: 1. adults who sustained a proximal humerus fracture within the last week 2. type of proximal humerus fracture ao 11-(a2, a3), 11- (b1, b2, b3) 3. bmi lower than 40 kg/m2 exclusion criteria: 1. stress fractures 2. revision setting 3. open fractures 4. fractures associated with a neurologic lesion; previous fractures or bony procedure at the homolateral side 5. patients unable to understand the procedure or instructions for rehabilitation 6. terminal patients 7. patients presenting multiple injuries
metformin as added on therapy in patients with ulcerative colitis

Conditions: Inflammatory Bowel Diseases

Summary: ulcerative colitis (uc) is a chronic inflammatory bowel disease that is marked by increased intestinal motility and bloody diarrhea. the clinical value of existing therapeutic strategies of uc, including glucocorticoids, anti-tumor necrosis factor α (tnf-α), mesalamine, and thiopurines is still limited. therefore, the discovery of new therapeutic approaches is essential to improve the effectiveness of the treatment.adenosine monophosphate (amp)-activated protein kinase (ampk) is a conserved fuel-sensing enzyme that plays an important role in the regulation of cellular metabolism where it increases glucose and fatty acids uptake and activates the oxidation process to improve the cellular energy utilization


Eligibility criteria:
inclusion criteria: - age ≥ 18 years both males and females will be included negative pregnancy test and effective contraception mild and moderate uc patients diagnosed and confirmed by the endoscope exclusion criteria: - breastfeeding significant liver and kidney function abnormalities diabetic patients colorectal cancer patients patients with severe uc patients taking rectal or systemic steroids
evaluation of hiv-1 recent infection testing in rwanda

Conditions: HIV Infections

Summary: the study is a longitudinal, observational cohort study of people who are newly-diagnosed with hiv who consent to recency testing and participate in index testing services, and their disclosed contacts. the study will evaluate the impact of recency testing on hiv positive yield of index testing among the contacts of newly diagnosed people living with hiv and the incidence of adverse events or social harm as a result of returning recency results among newly diagnosed people living with hiv.

the rapid test for recent hiv infection (rtri) assay can distinguish between people who are recently-infected and those who are long-term hiv cases. this may help guide efforts to identify ongoing hiv transmission and direct prevention or treatment efforts. but, more research is needed on the impact of rtri on the number of hiv+ individuals that can be identified through testing. furthermore, not much is known about the impact that returning rtri results may have on the occurrence of intimate partner violence. a primary objective of this study is to compare the hiv testing yield among contacts of people newly diagnosed with hiv by recency testing result. the investigators will abstract routinely collected data from participant medical records and registers. in addition, a second primary objective of this study is to assess the incidence of intimate partner violence associated with the return of recency testing results among those classified as testing recent versus long-term. index study participants newly diagnosed with hiv will be interviewed at the initial enrollment visit following hiv diagnosis and during follow-up visits at 1, 2, and 6-months using a health-related quality of life instrument and intimate partner violence questionnaire. participants will be recruited from 60 high-volume facilities across all provinces in rwanda during the evaluation period.

Eligibility criteria:
inclusion criteria: * aged ≥15 years * be newly diagnosed with hiv * ability to speak and understand english or kinyarwanda * consented to be part of both case-based surveillance (cbs) (which includes pns) and recency surveillance under the separate, approved cbs protocol. * give voluntary written informed consent for data collection via semi-structured interview and survey instruments * give voluntary written informed consent for use of routinely collected data * be female if they are received at the facility at the same time as their partner (for intimate partner violence objective only). exclusion criteria: * opt out or do not consent, or are unable to consent to participate in semi-structured interviews and completion of survey instruments * have a history of testing hiv positive (i.e., not newly diagnosed with hiv) * report antiretroviral drug (arv) use for hiv management at any point during the hiv testing service (hts) visit

Keywords: hiv infections hiv-1 rapid test for recent infection rtri recent infection newly diagnosed people living with hiv
antipsychotic discontinuation in high-risk subjects

Conditions: Schizophrenia

Summary: * would be there any difference in dopamine synthesis between remitted clinical high risk subjects for psychosis and healthy control? * what would happen to dopamine synthesis after antipsychotic discontinuation in clinical high risk subjects for psychosis? * what about the dopamine synthesis in recurred clinical high risk subjects for psychosis after the discontinuation?

after the antipsychotic medication discontinuation, we are going to assess the changes of the biological markers

Eligibility criteria:
inclusion criteria: * diagnosed as a clinical high risk * treated with antipsychotic drugs * psp1-5 (from sips criteria) \<3 (severity index)for more than 6 months * had not experienced a symptomatic relapse in the 6 months exclusion criteria: * significant abnormality in laboratory tests * history of head trauma
xspect-based myocardial perfusion scintigraphy: consistency of functional values and feasibility of myocardial uptake quantitation in patients with suspected coronary artery disease

Conditions: Coronary Artery Disease

Summary: this study is to evaluate the feasibility of myocardial standardized uptake volume (suv) assessment by means of x- (single photon emission tomography) spect/computed tomography (ct), to assess normal reference value under rest and stress in a homogeneous population without coronary artery disease (cad) and to assess the variation of absolute quantitative suv measurements under rest and stress. the values will be evaluated in comparison with perfusion positron emission tomography (pet)/ct (using 82rb as perfusion tracer) and ct coronary angiography (ctca) with contrast medium.).


Eligibility criteria:
inclusion criteria: * referral to non-invasive nuclear ischemia test as part of clinical care * suspected coronary artery disease based on clinical symptoms * informed consent as documented by signature exclusion criteria: * pregnancy * allergy against adenosine * allergy against iodinated contrast medium * recent myocardial infarction (\<1 month) * previous history of coronary revascularization * severe asthma * thyroid hyperfunction * atrioventricular block (av) block \> i grade * arrhythmic cardiopathy * weight \>101 kg. * acute or chronic renal impairment defined as serum-creatinine: above 1.5x upper limit of normal (uln) and/or glomerular filtration rate (gfr) \< 30 ml/min * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * participation in another study with investigational drug within the 30 days preceding and during the present study, * enrolment of the investigator, his/her family members, employees and other dependent persons, * claustrophobia * intake of caffeine \<24 hours before the first day of examination * enrolment into another study using ionizing radiation within the previous 12 months.

Keywords: 82rb-chloride myocardial perfusion pet with ctca 99mtc-sestamibi myocardial perfusion spect myocardial perfusion spect absolute myocardial blood flow (mbf) myocardial standardized uptake value (suv) ct coronary angiography (ctca)
implementation of covid-19 testing strategies in community health centers

Conditions: Covid19

Summary: this project is part of a competitive revision to accelerate covid-19 testing in underserved populations. the overall aim is to implement strategies to expand covid testing in hotspot communities in ma, through 6 community health center (chc)-community partnerships. a base strategy will be implemented at all sites. a tailored strategy unique to local populations will be added and tested in a stepped wedge design.


Eligibility criteria:
inclusion criteria: * participants are patients at the intervention or control chcs or members of the local community. the participating sites constitute one group; a set of matched control chcs that will conduct testing as usual constitute the second group. exclusion criteria: * none

Keywords: implementation science community health center
efficacy of audio recorded guided imagery vs deep breathing exercises on functional gastrointestinal pain disorders

Conditions: Abdominal Pain; Functional Gastrointestinal Disorders

Summary: the purpose of this study is to: 1. determine if audio recorded guided imagery vs deep breathing exercises delivered via a digital media player improves abdominal pain symptoms in children with functional gastrointestinal pain disorders managed in the primary care setting. 2. determine if audio recorded guided imagery and deep breathing exercises delivered via a digital media player improves psychosocial distress in children affected by functional gastrointestinal pain disorders managed in the primary care setting. the possibility of treating functional gastrointestinal pain disorders using remotely delivered psychosocial therapies has the potential to treat many children affected by functional gastrointestinal pain disorders in a cost-effective manner. this study will provide insight into how well these patients in the primary care could benefit from such interventions.

children managed in primary care with a functional gastrointestinal pain disorder will be recruited and studied for this trial. after participants are deemed eligible, they will complete multiple questionnaires and then be randomly assigned (like a flip of a coin) to either guided imagery or deep breathing exercises delivered via a digital media player. participants will be instructed to listen to the tracks at least 5 days per week for an 8 week intervention period. at week 3 of the intervention period, the participant will complete another 2 week pain and stool diary. at week 7 of the intervention period, the participant will complete another 2 week pain and stool dairy. after this diary is completed, the participant will again complete multiple questionnaires for their final visit.

Eligibility criteria:
inclusion criteria: 1. children who meet criteria for a functional gastrointestinal pain disorder. 2. children who manage their abdominal pain in the primary care setting. exclusion criteria: 1. children who have other comorbidities that are associated with chronic abdominal pain including abdominal surgery and other medical diagnoses that can cause chronic abdominal pain. 2. children with an intellectual disability which would hamper their ability to communicate with study staff about their pain and complete study questionnaires. 3. children who have presented to a gastroenterologist for abdominal pain management 4. children who have previously used deep breathing exercises or guided imagery to manage their abdominal pain.
real-world study of taletrectinib for advanced ros1+ nsclc with brain metastases

Conditions: Non-Small Cell Lung Cancer

Summary: this is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of taletrectinib in ros1-positive non-small cell lung cancer (nsclc) with brain metastases. patients deemed eligible for taletrectinib by their physicians were enrolled after providing informed consent. taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.


Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria to be eligible for enrollment into the study: 1. age ≥ 18 years. 2. histologically or cytologically metastatic nsclc (uicc/ajcc tnm staging system, 9th edition, stage ⅳ). 3. at least one measurable target tumor lesion as accessed by recist v1.1 criteria. 4. radiographically confirmed brain metastasis(es) , with stable cns symptoms within 2 weeks prior to enrollment. 5. documented ros1 gene fusion identified by an approved molecular testing method (fish, rt-pcr, or ngs). 6. considered by the investigator to be candidates for taletrectinib treatment ; or patients with ≤6 months of prior taletrectinib exposure enrolled retrospectively. (note: for retrospective patients deceased before enrollment, waiver of informed consent is required. patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible). 7. signed informed consent. exclusion criteria: patient presenting with any of the following criteria will not be included in the study： 1. patients with driver gene mutations/alterations that have approved targeted therapies , including but not limited to egfr, alk, ret, etc. 2. currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment . 3. pregnancy or breastfeeding. 4. patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy. 5. other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.
ayurvedic versus conventional counseling in mothers with burnout-syndrome

Conditions: Burnout-Syndrome

Summary: aim of this study is to evaluate the effectiveness of ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

ayurveda is a traditional indian medicine: as a whole medical system it consists of diagnostic procedures and complex treatments. ayurveda-treatment is based on ayurvedic diagnosis and has a special focus on lifestyle and nutritional counseling, based on the individual constitution of the patient. ayurvedic counseling can easily be followed by the patients in their day-to-day life and is an inexpensive way of self-care. in ayurveda it is often used for the treatment of burnout-syndrome. however, no systematic data is available on its effectiveness in comparison to conventional standard diet and lifestyle counseling. the aim of this study is to evaluate the effectiveness of ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

Eligibility criteria:
inclusion criteria: * signed informed consent * age between 18 and 50 * mother of ≥ 1 child ≤ 12 years of age * job, education or studies ≥ 20 hours per week * subjective feeling of physical and mental exhaustion since ≥ 3 month * ≥ 18 points in the mbi subscale "emotional exhaustion" at screening exclusion criteria: * change of psychotropic drug medication ≤ 6 weeks before inclusion * pregnancy or breastfeeding * pre-diagnosed major depression * serious chronic co-morbidity (e.g. chf nyha iv) * serious acute somatic health conditions * intake of opiods * simultaneous participation in other trials * praticipation in other trials during ≤ 6 month before inclusion

Keywords: burnout-syndrome ayurveda ayurvedic traditional indian medicine cam whole medical system diet and lifestyle counseling
study of long-term antibiotic treatment in reactive arthritis

Conditions: Reactive Arthritis

Summary: this is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. patients are followed-up at regular intervals until 6 months. the main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, ritchie index, joint pain, serum c-reactive protein level and blood erythrocyte sedimentation rate. the study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.


Eligibility criteria:
inclusion criteria: 1. diagnosis of acute reactive arthritis 2. preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months 3. age 18 or older exclusion criteria: 1. allergy to quinolones or macrolides 2. treatment with systemic corticosteroids within 2 weeks 3. serum creatinine level elevated over the reference limit 4. alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit 5. current or planned pregnancy, or lack of contraception 6. known hiv positivity 7. blood leukocyte count less than 4.0x109/l 8. blood platelet count less than 100x109/l 9. lack of co-operation.

Keywords: reactive arthritis antibiotics
contribution of nasal high flow in pneumology assessed in acid-free hypercapnic acute respiratory failure

Conditions: Respiratory Insufficiency

Summary: the hypothesis is that nasal high flow therapy for patients with hypercapnic acute respiratory failure without acidosis, in addition to standard treatment would improve the care.

the aim of the pirahna study is to compare patients treated with nasal high flow in association with conventional standard treatment versus patients treated only with conventional standard treatment. primary objective : to demonstrate the therapeutic superiority of nasal high flow in hypercapnic acute respiratory failure without acidosis, in combination with conventional standard treatment secondary objectives : 1. identify the characteristics (etiologies) of responder patients (defined by a decrease in capnia and a failure to develop acidosis within two weeks of hospitalization) 2. identify the etiology (trigger) of the acute respiratory failure of responder patients 3. compare the evolution of respiratory rate between the two treatment groups 4. compare the evolution of dyspnea between the two treatment groups 5. compare the evolution of gas exchanges between the two treatment groups 6. compare the length of stay between the two groups 7. compare the evolution of patients comfort state in the two treatment groups

Eligibility criteria:
inclusion criteria: * major patient ≥ 18 years old * medical diagnosis of acute respiratory failure less than 48 hours * with partial pressure of carbon dioxide (paco2) \> 45 and ph \> 7.35 for less than 48 hours, with no indication of non-invasive ventilation (niv) placement * underlying terrain of known or unknown chronic respiratory pathology (may be unknown at time of diagnosis) examples : copd, bronchiectasis, pulmonary fibrosis, asthma, sequelae pathologies ... * all etiologies (infectious, cardiac decompensation, trauma, etc.) * having given informed consent * patient under a social security scheme * possibility to include a patient having already been included in the study but suffering from a new episode of hypercapnic non acidic acute respiratory failure exclusion criteria: * restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies * drug-induced acute respiratory failure * pneumothorax (x-ray pulmonary detachment) * oxygen poisoning * severe acute respiratory syndrome (sars) coronavirus 2 (covii) pneumonia * tracheostomy * prior treatment with chronic or initiated niv just prior to treatment (e.g. intensive care unit) * respiratory severity criteria for resuscitation management * agitation or non-cooperation * pregnancy or breastfeeding * person participating in other biomedical research * any other reason that the investigator believes may interfere with the evaluation of the study objectives * person under judicial protection (guardianship, curatorship) * person deprived of liberty by a judicial or administrative decision

Keywords: nasal high flow acute respiratory failure respiratory non-acidosis pneumology hypercapnia