Kornimate/medical-research-clean huggingface dataset:
alice pdx user/validation extended trial

Conditions: Sleep Apnea; Sleep-Disordered Breathing

Summary: the objective of this study is to test the usability of the alice pdx device by both the end user (patient/participant) and the sleep technician. data will be collected via questionnaires regarding the participant's ability to understand the participant user manual under home conditions and the technician's ability to set up the alice pdx according to the health care provider manual. this study will also compare the physiological data recorded by the alice pdx to the physiological data recorded by its predicate device the alice 5 system and validate its equivalence. this will be evaluated by comparing the manual study scores for detected apnea and hypopnea events and on an event by event basis during a standard polysomnography (psg)/ sleep study. the study will test the ability of the alice pdx to record good quality data as determined by the good study indicator (gsi) function of the alice pdx firmware. the primary hypothesis is that the participant will be able to successfully apply the alice pdx basic leads following the participant user manual instructions and the sleep technician will be able to successfully apply the advanced leads in preparation for the sleep study. in addition, it will be demonstrated that the alice pdx is equivalent to the alice 5 system in its intent to record, display and print physiological data to the clinician/physician in order to aid in the screening/follow-up diagnosis of respiratory sleep disorders.

alice pdx is a portable, diagnostic recording device. it may be used for obstructive sleep screening as well as follow-up and diagnostic assessment. the device may be used in a sleep lab or clinical setting by trained professionals and it may be used at home by patients as directed by their health care provider. the alice pdx device is not currently approved by the food and drug administration (fda). the alice pdx device is capable of recording various physiological inputs and storing the data locally on a removable storage card. the device may also be connected directly to a pc (personal computer) running the alice sleepware software application. sleepware can display live or pre-recorded data in a resolution consistent with the computer hardware specifications.

Eligibility criteria:
inclusion criteria: * patients must call into a sleep lab or be referred to a sleep lab for a diagnostic polysomnogram * able to follow directions * able to provide informed consent exclusion criteria: * participants requiring supplemental oxygen therapy * history of having a previous sleep study/polysomnogram performed * current positive airway pressure (pap) users * unable or unwilling to perform a polysomnogram
diagnostic study of acl rupture with anterior drawer test at 90° of hip flexion

Conditions: Anterior Cruciate Ligament Rupture

Summary: for patients with anterior cruciate ligament rupture, the existing physical examinations have certain limitations. the researchers improved the traditional anterior drawer test in clinical work, maintained the flexion of the knee and flexion of the hip, and observed the displacement of the tibia. good diagnostic effect, but no research statistics. the purpose of this study is to explore the effectiveness of the 90° of hip flextion anterior drawer test in the diagnosis of anterior cruciate ligament rupture.

a total of 300 hospitalized patients who were diagnosed with anterior cruciate ligament rupture by mr and prepared for anterior cruciate ligament reconstruction were included, of which 150 cases were injured in the acute phase (within 2 months after the injury) and the chronic phase (more than 2 months after the injury). after the patient was admitted to the hospital, the patients were sequentially subjected to the 90° anterior drawer test, lachman test, pivot-shift test, and anterior drawer test. the examination results were recorded. compare the effectiveness of different physical examinations in diagnosing the anterior cruciate ligament. the patient's age, gender, injury time, bmi, the type of acl rupture in the surgical records, and whether meniscus or cartilage damage were combined were counted. regression analysis was used to evaluate the influencing factors of the modified anterior drawer test to correctly diagnose the rupture of the acl.

Eligibility criteria:
inclusion criteria: * （1）ages between 18 and 60 years old. (2) inpatients diagnosed with unique anterior cruciate ligament rupture and ready for anterior cruciate ligament reconstruction. (3) no combined injuries. exclusion criteria: * (1) the patient is younger than 18 years old or older than 60 years old, (2) multiple ligament injuries of the knee joint are suspected, and (3) combined fractures are suspected.
sublingual tonometry to assess tissue perfusion in patients with chronic obstructive pulmonary disease (copd)

Conditions: COPD; Healthy Subjects

Summary: sublingual positioning of a silicon capillary system is applied. after 15 min, while the individual is in resting position with closed mouth and normal tidal breathing through the nose is performed, the silicon capillary system is connected to a capnometer and co2 tension is measured. the investigators hypothesis is that this setup offers a non-invasive assessment of ventilatory efficiency with similar accuracy as arterial pco2.

we have developed a new silicon capillary system for sublingual monitoring of co2 tension in order to assess tissue perfusion. this set up is non-invasive, cheaper than previous tonometry devices and easier to apply in clinical routine. we have recruited patients with stable copd and healthy individuals. sublingual tonometry results were evaluated after 15 min of tidal breathing with a capnometer for co2 tension. corresponding end tidal co2 (petco2)and arterial blood gas values (ph, paco2, paco2) were also investigated.

Eligibility criteria:
inclusion criteria: * copd patients with stable disease exclusion criteria: * acute exacerbation of copd

Keywords: blood gas analysis ventilatory insufficiency
systemic neoadjuvant and adjuvant control by precision medicine in rectal cancer

Conditions: Colorectal Cancer

Summary: rectal cancer represents the most complex area of multidisciplinary treatment in bowel surgery. in 2017, there were 1221 new rectal cancers in finland. the prognosis of colorectal cancer (crc) patients these days is almost exclusively driven by the occurrence of the metastatic form of the disease. the treatment of rectal cancer often includes a long delay between diagnosis and the initiation of systemic chemotherapy, increasing risk for systemic metastases for those at high risk. on the other hand, the waiting time during pretreatment before surgery enables comprehensive systematic characterization of the primary tumor status before the decisions on adjuvant chemotherapy, opening a window to the use of precision in decision-making. in this randomized controlled treatment trial, outcomes of novel precision methods to select right rectal cancer patients for treatment that they need will be compared to conventional treatment. the study aims to reduce over-treatment of those that most likely do not benefit from additional treatments. with the overall aim to reduce metastatic form of the disease, patients with high-risk features will be randomized to a treatment strategy with early systemic control by chemotherapy followed by circulating tumor dna (ctdna) and organoid-guided adjuvant therapy, or to conventional treatment strategy. both state-of-the-art laboratory practice and routine diagnostic clinical pipelines are introduced to bring future diagnostic models of minimal residual disease and chemoresistance closer to current practice. the outcomes will reveal the clinical benefit of such strategy by recurrence-free survival at highest level of evidence, and produce important clinical outcome data on the application of ctdna in everyday cancer treatment practice. the translational data on the use of ctdna organoids to inform treatment decision and regimen selection will build knowledge of the use of such biomarkers as tools for clinical practice and clinical research. the results will be scalable worldwide in the practice of rectal cancer treatment.


Eligibility criteria:
inclusion criteria: 1. rectal adenocarcinoma, 2. world health organization (who) performance status 0-1, assessed by the mdt to be able to undergo capecitabine and oxaliplatin (capox) treatment, 3) extramural vein invasion by magnetic resonance imaging (mremvi+) and 4) assessed by the multi-disciplinary team (mdt) to require either radiotherapy (rt) or long chemoradiotherapy (crt) by the current standards. exclusion criteria: 1. deficient mismatch repair (mmr) status, 2. non-dihydropyrimidine dehydrogenase (dpyd) genotype, 3. a contraindication to capecitabine, oxaliplatin or rt, or 4. failing in blood tests that describe the adequate circulatory, liver and kidney function for chemotherapy.
repetitive transcranial magnetic stimulation for apathy treatment in alzheimer's disease

Conditions: Alzheimer's Disease; Apathy

Summary: we aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rtms) for apathy treatment in patients with alzheimer's disease (ad). we hypothesize that rtms will be superior to placebo to reduce apathy symptoms and severity in patients with ad.

this study aims to enroll 40 patients with mild and moderate alzheimer's disease with apathy symptoms that will be randomized to receive rtms or sham procedure. subjects will be randomized in two arms (rtms or sham procedure) in 1:1 proportion. eligibility criteria: * diagnosis of alzheimer's disease, mild and moderate stage (mmse range from 10 to 20); * diagnosis of apathy; * age between 60 and 85 years-old; * on stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment; the primary outcome measures is the apathy inventoire. secondary outcome measures are the npi score, adas-cog scores and the zarit burden scale scores.

Eligibility criteria:
inclusion criteria: * age between 60 to 85 years-old * mild or moderate alzheimer's disease (mmse scores between 10 and 20) * apathy diagnosis * on stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment exclusion criteria: * history of epilepsy or convulsions * history of migraine or headaches episodes twice per week or more * history of neurodegenerative diseases other than alzheimer's disease * current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants * history of cerebral ischemic episode

Keywords: apathy; alzheimer's disease; cognition; burden of care
tyk2 inhibition in paradoxical psoriasis

Conditions: Psoriasis

Summary: paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-tnf) that is used to treat diseases of the skin, the intestine or the joints. if paradoxical psoriasis occurs, the anti-tnf-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists. this research project aims to study whether the efficacy of the drug 'deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical psoriasis.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of paradoxical psoriasis caused by anti-tnf treatment, with with investigator global assessment ≥ 2 and body surface area ≥ 2% 2. females who are of child-bearing potential should be practicing highly-effective contraception methods throughout the study and for 28 days after the last dose of study drug; 3. male subjects with a mechanical contraceptive method; 4. be in good health 5. be willing to have skin biopsies taken exclusion criteria: 1. use of any other anti-psoriatic therapy. certain washout periods of treatments needs to be respected 2. infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the baseline visit; 3. a positive serology test for hepatitis b, hepatitis c, hiv; 4. history of lymphoproliferative disease or of malignancy within the past 5 years. 5. chronic recurring bacterial infections or active tuberculosis; 6. positive pregnancy test at screening and at the baseline visit; 7. female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study; 8. history of clinically significant alcohol or drug abuse in the last 12 months 9. known hypersensitivity to deucravacitinib or any of its excipients 10. current severe progressive or uncontrolled disease 11. live vaccine within 12 weeks before baseline visit.

Keywords: drug-induced psoriasis anti-tnf treatment psoriasis tumor necrosis factor inhibitors paradoxical psoriasis
a study of a human anti-intercellular adhesion molecule-1 monoclonal antibody, in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a first in human study which will assess the safety and tolerability of a monoclonal antibody against icam-1 in patients with multiple myeloma. the tumour response rate will also be measured.


Eligibility criteria:
inclusion criteria: * advanced myeloma with measurable disease after at least 2 previous regimens. * life expectancy \> 3 months. * performance status ecog \< 2. exclusion criteria: * prior antineoplastic therapy within 4 weeks prior to inclusion. * no high dose steroids within 7 days prior to screening. * severe other conditions.

Keywords: multiple myeloma monoclonal antibody safety pharmacokinetic
bacillus clausii in liver transplantation

Conditions: Transplantation Infection; Liver Grafting; Hepatic Transplantation

Summary: a prospective, randomized, controlled study of the safety and efficacy of using bacillus clausii probiotic oral preparation to decrease the incidence of infection during the first 30 days after living donor liver transplantation surgery.

patients planned for living donor liver transplantation would be randomized to either intervention or control group 2 weeks before surgery. intervention group shall receive bacillus clausii probiotics for 2 weeks. patients in both groups would be followed-up for adverse events and signs and symptoms of infection up to 30 days postoperatively.

Eligibility criteria:
inclusion criteria: * adults aged 18 - 65 years. * patients suffering from end stage liver disease (esld) with any etiology listed on waiting list and accepting to volunteer in the study with the informed consent. * patients not suffering from any active infection at the start of the study. exclusion criteria: * patients with poorly controlled autoimmune disease on immunosuppression before transplantation. * patients who undergo combined kidney-liver transplantation. * patients with severe renal insufficiency (creatinine clearance \<50 ml/min). * patients with intestinal obstruction (ileus). * patients with cerebral disorders with danger of aspiration. * patients with roux en y-anastomosis. * patients with cystic fibrosis. * retransplantation.

Keywords: liver transplantation infection probiotics bacillus clausii
ungf assessment in patients with detrusor overactivity undergoing sacral neuromodulation

Conditions: Detrusor Overactivity

Summary: the purpose of this study is to find a noninvasive test to help physicians diagnose detrusor overactivity (do), to use this urine test to help diagnose bladder problems, determine if treatments are working, and determine if patients are good candidates for interventions like sacral neuromodulation/interstim therapy.


Eligibility criteria:
inclusion criteria: * for controls: age greater than or equal to 18; female gender, ability to provide informed consent and complete study requirements; subject has to be without urinary symptoms * for cases: age greater than or equal to 18; female gender; ability to provide informed consent and complete study requirements; the subject should have symptoms of detrusor overactivity, including urinary frequency, urgency, or urge incontinence, for greater than or equal to 3 months; urodynamic diagnosis of detrusor overactivity; failed treatment with behavioral modification and anticholinergic medication exclusion criteria: * active urinary tract infection; currently undergoing hemodialysis or has severe renal impairment; bladder tumors; uncontrolled diabetes mellitus; post void residual greater than 100ml; history of use of anticholinergic treatment within past 21 days; history of urinary tract operation within 6 months prior to screening; heart failure; uncontrolled hypertension; severe neurological disease; history of botox usage within 1 year

Keywords: ungf urinary nerve growth factor detrusor overactivity interstim sacral neuromodulation sacral nerve stimulation quality of life questionnaire urodynamic detrusor overactivity overactive bladder
multidimensional assessment of dyspnea in asthma

Conditions: Asthma

Summary: breathlessness is a symptom of asthma that occurs in relation with lower airway obstruction. however, this sensation is not specific of asthma and may be the expression of other disorders. in particular, it can testify to anxiety or hyperventilation, two disorders frequently associated with asthma. the systematic interpretation of dyspnea as a manifestation of asthma in asthmatic patients may lead to an inappropriate increase in asthma controllers. identifying the cause of dyspnea in asthmatic patients (airway obstruction, anxiety or hyperventilation) is therefore crucial for the clinician. this could be facilitated by a multidimensional assessment of dyspnea, evaluating the kind of sensation felt by the patient (for example chest tightness, air hunger etc.) and emotions associated to respiratory sensations (for example anxiety, fear etc.). the objectives of this project are to assess: (1) the sensory and affective dimensions of dyspnea in asthma and, (2) their connection to asthma control, anxiety and depression.


Eligibility criteria:
inclusion criteria: 1. diagnosis of asthma confirmed by: * a history of symptoms compatible with asthma * and a history of airway obstruction, according to the gina definition (2017): fev1/fvc ratio lower than the lower limit of the predicted value at baseline or after a bronchial provocation test * and a variability of airway obstruction defined by at least one of the following criteria: oreversibility of airway obstruction after bronchodilators (400 µg of salbutamol): fev 1 increases by\> 200 ml and\> 12% compared to baseline * or delta peak-flow over the day / average peak-flow averaged over 2 weeks\> 10% * or variability in fev1 between two visits\> 200 ml and\> 12% * or an increase in fev1 of\> 200 ml and\> 12% compared to the baseline after 4 weeks of treatment with oral corticosteroids * or a positive methacholine challenge: decrease in fev1 by more than 20% for a dose \<1600 µg 2. experience of dyspnea in the past 7 days 3. age\> 18 years old 4. social protection affiliation 5. written informed consent exclusion criteria: 1. age \<18 years old 2. active smoker or quitting smoking for less than a year 3. severe exacerbation or respiratory infection within 4 weeks before inclusion (severe exacerbation is defined by an increase in systemic corticosteroid therapy for at least 3 days or injection of a single dose of delayed corticosteroid, emergency room visit due to asthma (with systemic corticosteroid therapy), or hospitalization due to asthma). 4. inability to respond to questionnaires for any reason 5. presence of any pathology other than asthma which may be responsible for dyspnea, in particular cardiovascular or respiratory (ischemic heart disease, heart failure, chronic obstructive pulmonary disease, diffuse interstitial pneumonitis, lung cancer, non-exhaustive list) with the exception of anxiety and hyperventilation syndrome 6. pregnancy 7. persons under guardianship 8. refusal to sign consent or participate in the study 9. no social protection affiliation

Keywords: asthma breathlessness
integrated vs sequential treatment for ptsd and addiction

Conditions: PTSD; Substance Addiction

Summary: the investigators are examining different treatment strategies of helping patients with ptsd and addiction.

the investigators hypothesize that veterans in the integrated conditions will show greater reductions in substance abuse and ptsd symptom severity at the end of treatment and at 6 and 9 month follow-ups. the investigators further hypothesize that offering veterans prolonged exposure (pe) at the onset of treatment in the integrated condition will leader to greater retention and satisfaction than in the sequential treatment design.

Eligibility criteria:
inclusion criteria: * male or female persian gulf era veterans between 18-65 years old. older individuals are unlikely to have served in iraq or afghanistan. * current diagnosis of ptsd (symptom duration \> 3 months) with clinically significant trauma-related symptoms, as indicated by a score of at least 50 on the pcl * current abuse or dependence on alcohol, stimulants such as cocaine, opioids, including prescription opioids or benzodiazepines. subjects must report using on average at least 10 out of 30 days prior to signing consent. of note: subjects can be abusing or dependent upon nicotine or marijuana but these will not be considered sufficient for inclusion * provides informed consent * speaks and reads english exclusion criteria: * current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment * meets current dsm-iv criteria for bipolar affective disorder, schizophrenia or any psychotic disorder * has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease * history of moderate or severe traumatic brain injury (tbi) * participation in prolonged exposure therapy in the last 6 months. * initiation of a new psychotherapy program in the last 2 months. * active participation in a formal addiction treatment program. actively engaged is defined as any visit in the program in the prior month and pending future appointments for the treatment of addictions * change in psychotropic medication in the 1 month prior to treatment except for the use of oxazepam for alcohol detoxification or a taper of a previously used benzodiazepine. * therapeutic use of a benzodiazepine greater than the equivalent of more than 40 mg of diazepam (see chart) at the time of randomization.

Keywords: treatment ptsd addiction