Kornimate/medical-research-clean huggingface dataset:
pharmacodynamic and pharmacokinetic dose ranging study of tiotropium bromide administered via inhalation solution in patients with chronic obstructive pulmonary disease (copd)

Conditions: Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)

Summary: pharmacodynamic and pharmacokinetic dose ranging study of tiotropium bromide administered via inhalation solution in patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * male and female subjects ≥40 years and ≤85 years of age at the time of consent. * subject must have a primary diagnosis of mild or moderate copd defined as post-bronchodilator fev1/fvc ratio of \<70% and fev1 of ≥50% of predicted normal value as per the nhanes iii predicted normal values at screening. * willing to stop all other copd medications or other medications which will interfere with the study results for the entire duration of the study, except albuterol/salbutamol as needed. * current or ex-smoker with ≥10 pack-year smoking history. exclusion criteria: * subjects with a chest x-ray/ct scan that suggests a diagnosis other than copd (eg, pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken within 6 months prior to study start. if there is no chest x-ray or ct scan taken within 6 months prior to study start, or if recent results are unavailable for review, a chest x-ray must be performed. * use of oral/parenteral corticosteroids or antibiotics for copd within 6 weeks or depot corticosteroids within 3 months prior to screening or subject has had a change in dose or type of any medications for copd within 14 days before screening. * hospitalization for copd exacerbation or pneumonia within 3 months prior to screening. * subjects with a history of asthma, with the exception of outgrown childhood asthma, defined as transient wheezers outgrown by 5 years of age. * subject has a known history of alpha 1 antitrypsin deficiency-related emphysema. * subject requires nocturnal oxygen or continuous supplemental oxygen therapy. * subject with history of a positive result for hbsag or hcv antibody. * subject is known to be seropositive for human immunodeficiency virus. * female subject is pregnant or lactating. * subject has a history of allergic reaction to the anti-cholinergic or any components of the study medications.
slim sheath 22f holmium laser enucleation of the prostate (holep) vs 26 f sheath holep for bph: rct

Conditions: Benign Prostatic Hyperplasia

Summary: holmium laser enucleation of the prostate (holep) is routinely performed with 24f, 26f, and 28f laser scopes. proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. proponents of a smaller scope diameter suggest that by eliminating the need for pre-holep urethral dilation to accommodate a larger scope. it has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. currently, to our knowledge, there are no level one evaluation examining scope size 22f versus 26f sheath in laser enucleation outcomes. the aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates


Eligibility criteria:
inclusion criteria: 1. males over 50 years of age at the time of enrollment 2. referred to urology for refractory luts secondary to bph 3. failed medical (non-surgical) treatment 4. prostate size on preoperative trus of \> 80 ml 5. ipss \>15, qol score ≥3 and qmax \<15 ml/sec 6. written informed consent to participate in the study 7. ability to comply with the requirements of the study procedures exclusion criteria: 1. previous surgical treatment for bph 2. history of prostate cancer 3. prostate size \< 80 ml 4. history of urethral stenosis or its management 5. known or suspected neurogenic bladder 6. participants with active urinary tract infection until appropriately treated 7. participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
n-acetylcysteine for pediatric trichotillomania

Conditions: Trichotillomania; Hair Pulling

Summary: trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania. research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. by contrast, randomized controlled trials in adults have suggested the efficacy of n-acetylcysteine as well as behavioral treatments such as habit reversal therapy. the goal of this trial is to determine the efficacy of n-acetylcysteine for pediatric trichotillomania. n-acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.


Eligibility criteria:
inclusion criteria: * children aged 8-17 years. * primary dsm-iv diagnosis of trichotillomania or chronic hair pulling. * duration of trichotillomania greater than 6 months. exclusion criteria: * comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (iq\<70). * recent change (less than 4 weeks) in medications that have potential effects on ttm severity (such as ssris, cmi, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). medication change is defined to include either dose changes or medication discontinuation. * asthma requiring medication use within the last 6 months. * known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation * current use (within last week) of psychostimulant medications. * positive pregnancy test or drug screening test

Keywords: trichotillomania hair pulling glutamate n-acetylcysteine children
contribution of cardiac mri in the early diagnosis of myocarditis induced by immunotherapy

Conditions: Myocarditis

Summary: anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. it is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. blocking these checkpoints, such as pd-1, unleashes the action of anti-cancer t cells that can then destroy the tumor. the efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.immune checkpoint inhibitors (icis) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.most side effects of icis occur within the first few months after initiation of treatment. the toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected. cardiac autoimmune involvement in icis can involve the myocardium, pericardium, and/or vascular endothelium. these entities may be interrelated or, on the contrary, isolated. in the last 5 years, the number of described cases of myocarditis associated with icistreatment has increased. their incidence remains low, estimated between 0.5 and 2%. this probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%. in recent years mri has become very important in the noninvasive diagnosis of acute myocarditis. the latest update of the lake louise criteria in 2018 has thus confirmed cardiac mri in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.


Eligibility criteria:
inclusion criteria: * patients undergoing immunotherapy with an indication for cardiac mri for suspected myocarditis or other cardiovascular complications * patient over 18 years of age * patient affiliated to a health insurance plan * patient who has given free, informed and oral consent exclusion criteria: * contraindication to immunotherapy * pregnant or breastfeeding patient (if applicable) * contraindication to cardiac mri

Keywords: anti-cancer immunotherapy cardiac autoimmune diseases myocarditis
staphvax immunogenicity and safety in orthopaedic joint surgery

Conditions: Staphylococcal Infections

Summary: staphylococcus aureus (s. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. staphvax® is a bivalent s. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides that have been implicated as a major factor in the invasiveness of s. aureus. immunoprophylaxis by vaccinating against s. aureus prior to surgery could provide sufficient antibody concentrations during surgery and the wound healing period so as to decrease the risk of s. aureus infection. this study aims to demonstrate the immunogenicity and safety of a single dose of staphvax in patients who are candidates for orthopedic surgery.


Eligibility criteria:
inclusion criteria: * age 18 years or older * candidate for knee or hip replacement * expectation of protocol compliance * negative pregnancy test, where appropriate exclusion criteria: * known s. aureus infection in the prior 3 months * infection in the prior 2 weeks * known hiv infection * immunomodulatory drugs * malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early prostate cancer) * hypersensitivity to components of staphvax

Keywords: knee replacement surgery hip replacement surgery nosocomial infections arthroplasty
microbiota and carcinogenesis of small-intestine neuroendocrine tumors

Conditions: Small-intestine Neuroendocrine Tumors

Summary: the aim of the study is to investigate the impact of the microenvironment on tumorigenesis of small intestinal neuroendocrine tumors often located in the terminal ileum, without identified driver mutations.


Eligibility criteria:
inclusion criteria: * patient with one or more small-intestine neuroendocrine tumor with indication of surgery * patient with consent for the collection, storage and reuse of data associated with his/her disease * age ≥ 18 years at the time of inclusion * non-objection statement obtained for participation in the study exclusion criteria: * patients with poorly differentiated neuroendocrine carcinoma or net (neuroendocrine tumors) of non-intestinal origin or mixed tumors (minen) * pregnant, parturient or breast-feeding women * minors * persons deprived of liberty by judicial or administrative decision * adults under legal protection (guardianship, curatorship)

Keywords: small-intestine neuroendocrine tumor microbiota tumorigenesis
mwm technique in patients with knee oa

Conditions: Mobilization

Summary: the aim of this study is to investigate the effect of the mwm technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (oa).

the aim of this study is to investigate the effect of the mwm technique on pain, normal joint movement, muscle strength, proprioception, mobility, balance, functionality and quality of life in patients with knee oa.

Eligibility criteria:
inclusion criteria: * being diagnosed with knee osteoarthritis, * being diagnosed with knee oa at the earliest 6 months ago exclusion criteria: * participants who were pregnant, * had knee surgery, had an infection, * had a pacemaker, had an infraction, * had cancer, or were receiving corticosteroid treatment were excluded from the study

Keywords: knee osteoarthritis mobilization proprioception pain
smartwatches to manage stress and anxiety in residential settings

Conditions: Baseline; Technology

Summary: the purpose of the study is to conduct a prospective evaluation of a smartwatch technology and an associated application (developed by awake labs) in a clinical cohort from centre for addiction and mental health (camh) adult neurodevelopmental services (ans) and adults with developmental disabilities in the community who have received a watch.

tools that help predict the onset of anxiety and agitation can not only help a person learn to self-monitor their emotions, but can may also help others feel more efficacious in understanding the internal state of the person they are supporting (especially if not able to communicate), and help them respond in a way that keeps the individual and others safe. the purpose of the study is to conduct a prospective evaluation of the smartwatch technology with modifications recommended by the researchers (based on a previous retrospective study) in a clinical cohort at camh adult neurodevelopmental services (ans) and in adults with developmental disabilities in the community. specifically, this study seeks to evaluate the utility and validity of the smartwatch and associated mobile application as a clinical tool by gathering behavioral data when the applications gives a notification. the person wearing the watch or those in their environment will be asked to report the following in the application after the smartwatch gives a notification: 1) the valence of the emotion of the person wearing the smartwatch, 2) what events were occurring prior to notification (e.g., potential triggers for behaviours that challenge), and 3) what happened after the notification (e.g., how the person or others in their environment responded to the notification). results will be used to inform future iterations of the technology and make recommendations for clinical use.

Eligibility criteria:
inclusion criteria: * individuals with an intellectual and/or developmental disability * living in the community or receiving services from camh ans department exclusion criteria: * under 18 years old

Keywords: technology anxiety idd/dd
sentinel lymph node biopsy with indocyanine green in breast cancer after neoadjuvant chemotherapy (shine)

Conditions: Breast Cancer

Summary: this is a prospective, open-label, within-patient clinical trial to determine the accuracy of indocyanine green (icg) guided sentinel lymph node biopsy (slnb) compared to the standard dual-tracer slnb in breast cancer patients who have had chemotherapy as a first treatment using a non-inferiority design. patients with operable breast cancer treated with chemotherapy and eligible for slnb will be included in the study. during surgery, icg will be injected and used to identify fluorescent sentinel nodes using a hand-held imaging camera; radiotracer and blue dye will also be used as per standard protocols. intraoperative and clinicopathologic outcomes such as complications, characteristics of nodes, false negative rates and feasibility will be assessed. patients will be asked to complete standardized patient reported outcome questionnaires (breast-q, fact-b+4, vas) to define the patient experience with this novel technique.


Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 and ≤ 80 2. stage i-iii core biopsy confirmed invasive breast cancer, who have undergone neoadjuvant chemotherapy and are planned to undergo slnb with dual tracer (blue dye+tc-99m) 3. eastern cooperative oncology group (ecog) \< 2 4. no icg/iodine allergy 5. capable of providing informed consent 6. english literacy exclusion criteria: 1. significant medical comorbidities (asa 4) 2. breast cancer stage t4/inflammatory or n2 disease at presentation (slnb is contra-indicated in this setting) 3. clinical node positive after neoadjuvant therapy (slnb is contra-indicated in this setting) 4. previous axillary surgery or breast/axillary radiotherapy to ipsilateral breast 5. active pregnancy or breastfeeding

Keywords: invasive breast cancer indocyanine green sentinel lymph node biopsy neoadjuvant chemotherapy
platelet rich plasma testis treatment for infertile men

Conditions: Male Infertility; Nonobstructive Azoospermia; Azoospermia

Summary: investigate the effect of intratesticular injection of autologous platelet rich plasma (prp) on sperm retrieval rates and ivf outcomes in infertile men who already underwent a negative sperm retrieval. currently, there is no alternative treatment after failed tese. prior series suggest that intratesticular prp injections may improve tese outcomes. we hope to determine whether prp is an effective treatment for this patient population.


Eligibility criteria:
inclusion criteria: * men over the age of 18 diagnosed with noa and at least one failed tese, negative mapping or negative biopsy exclusion criteria: -
the effect of rocking bed on preterm newborns

Conditions: Preterm; Preterm Birth; Nurse's Role

Summary: the study was planned to determine the effect of rocking bed applied to preterm newborns on comfort, physiological parameters and cerebral oxygenase level (rso2).

in most cultures, providing a newborn baby on the lap or in a rocking bed is mostly used to calm the baby. however, preterm babies who leave the uterus, which is their accustomed environment, in the early period, are positioned on a fixed bed such as an incubator or jeans in the nicu. these beds may reduce the infant's vestibular knowledge and the nicu environment may deprive infants of sensory stimuli. it has been suggested that because the vestibular system is one of the first systems to become functional, preterm infants may be more sensitive to stimulation of the vestibular system than other systems. when the studies were examined, it was seen that limited studies were conducted in the sample of preterm infants and the studies were not recent. considering that babies are rocked in most cultures, it is thought that the evidence for the effects of the intervention on the baby is insufficient.

Eligibility criteria:
inclusion criteria: * born at 32-37 weeks of postmenstruel age * not receiving mechanical ventilation support, * not receiving analgesia or sedative drug therapy, * congenital anomaly, intraventricular hemorrhage, meningitis, chromosomal anomalies, cyanotic congenital heart diseases, neonatal seizures and preterm infants without a diagnosis of sepsis exclusion criteria: • infants with diseases that may decrease cerebral oxygenation such as cerebral edema, intraventricular hemorrhage, cerebral hypoxia will be excluded from the study.
effect of fecal microbiota transplantation (fmt) in pediatric functional gastrointestinal disorders

Conditions: Functional Gastrointestinal Disorders

Summary: safety and efficacy of fmt in pediatric functional gastrointestinal disorders

the gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. functional gastrointestinal disorders (fgids), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. fecal microbiota transplantation (fmt) is a process in which a presumed healthy and diverse microbiome is transplanted to a patient using a nasogastric tube, colonoscopy, or enema, or fecal capsule to remodel the intestinal flora balance. at present, there are few clinical studies on the treatment of fgid in children with fmt. the investigators prospectively enrolled functional children who met the rome iv standard, and divided them into conventional treatment group or fmt group with open choice. the efficacy of the two groups was collected and compared at different time points, and the flora of children in the fmt group before and after treatment was collected to monitor fmt-related adverse reactions

Eligibility criteria:
inclusion criteria: * the diagnosis and classification of patients with fgids were in accordance with the rome iv criteria for children exclusion criteria: * organic gastrointestinal disease (as established by medical history, blood routine, biochemistry, c-reaction protein, erythrocyte sedimentation rate, and fecal routine examinations.) * other chronic disease * growth failure

Keywords: functional gastrointestinal disorders; fmt; safety; efficacy efficacy
investigation of the optimal duration of neoadjuvant therapy for resectable pancreatic cancer

Conditions: Pancreatic Cancer Resectable

Summary: investigating the optimal duration of neoadjuvant chemotherapy for resectable pancreatic cancer to determine the true surgical indication.


Eligibility criteria:
inclusion criteria: * radiologically resectable pancreatic cancer patients exclusion criteria: * a body weight loss of greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal, or heart disease
comparison of femoral tunnel and clinical outcome using two anterior cruciate ligament reconstruction techniques

Conditions: Rupture of Anterior Cruciate Ligament

Summary: 1. purpose :to compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation. 2. subjects: anterior cruciate ligament (acl) injury 66 patients * double bundle transportal technique with flexible reamer: 33 * single bundle outside in technique with remnant preservation: 33

anterior cruciate ligament (acl) injury patients : total 66 1. double bundle transportal technique with flexible reamer: 33 * advantage: more normal acl reconstruction than single bundle technique * disadvantage: to make the two bone tunnel must remove all the residual tissue. 2. single bundle outside in technique with remnant preservation: 33 * advantage: good for being synovium and revascularization. remained proprioception function helps to functional recovery. * disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.

Eligibility criteria:
inclusion criteria: 1. lachman test grade ii,iii and pivot shift test grade ii,iii in physical examination 2. acl rupture in mri 3. age 20\~60 4. within 6 months after trauma exclusion criteria: 1. osteoarthritis (oa) change in x-ray 2. history of other ligament injury or acl reconstruction in uninjured knee. 3. operation history of either ipsilateral or contralateral knee(fracture, etc)