Kornimate/medical-research-clean huggingface dataset:
intervention social anxiety: combining parent-child treatment

Conditions: Social Anxiety Disorder of Childhood

Summary: the aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. the added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously.

after a diagnostic trajectory and a 2-week reflection period, children and their parents are invited to come into the lab for baseline 1. during baseline 1, children and their parents will be interviewed and they will fill in some questionnaires. they will then be randomly assigned to a 2-, 4-, or 6-week waiting period. during this waiting period they will fill in experience sampling method (esms) daily, every other week. one week before the end of the waiting period, baseline 2 will take place. after the waiting period children and their parents will start their separate treatments in parallel. children will get an individually tailored cognitive behavioural therapy (cbt)-protocol for social anxiety and parents will get space. in the treatment period, they will fill in esms daily. there is another assessment with interviews and questionnaires at mid-treatment (after 6 sessions) and post-treatment (after 12 sessions), as well as 1- and 2-months after treatment has ended. after the treatment period, the frequency of the esms will go back to daily every other week.

Eligibility criteria:
inclusion criteria: * diagnosis social anxiety * at least 1 parent is willing to participate exclusion criteria: * currently under treatment for anxiety * other complaints that need attention first * not understanding instructions/treatment
ozone therapy in patients with diabetic neuropathy

Conditions: Pain, Chronic

Summary: diabetic neuropathies are the most prevalent chronic complications of diabetes mellitus. the early recognition and appropriate management of neuropathy in the patient with diabetes is important for patient's quality of life and life expectancy. ozone is well known to have anti-inflammatory and analgesic effects through the inhibition of pro-inflammatory mediators; as well as. stimulation of anti-inflammatory mediators' release

introduction: diabetic neuropathies are the most prevalent chronic complications of diabetes mellitus. the early recognition and appropriate management of neuropathy in the patient with diabetes is important for patient's quality of life and life expectancy. the clinical symptoms of dpn range from pain and burning sensations (at rest or at night) to hypoesthesia, paresthesia, and/or numbness . diabetic neuropathy can be axonal or demyelinating and can affect large or small neurons. schwann cells, which are the most abundant glial cells, act as nerve axon insulators and modulators of neurobiology through their role in metabolic support and injury protection. in diabetic patients, church cells' function is disturbed, leading to loss of glial-axon communication and nerve homeostasis, which leads to fiber loss, neurodegeneration, and pain. nerve conduction studies can detect these changes; however, there has been no effective therapy for the treatment of dpn until now. ozone is well known to have anti-inflammatory and analgesic effects through the inhibition of pro-inflammatory mediators; as well as. stimulation of anti-inflammatory mediators' release . previous studies showed that ozone promotes peripheral vascular integrity via induction of vascular endothelial growth factor (vegf), transforming growth factor beta (tgf-β1) an platelet-derived growth factor (pdgf), according with the studies of professor bocci that demonstrated significantly increase and release of pdgf, tgf- β1 and vegf in presence of ozone .

Eligibility criteria:
inclusion criteria: * sixty adult diabetic patients (type ii dm) * clinically symptomatized painful neuropathy for six or more months. exclusion criteria: * patients with other causes of neuropathy (e.g., vitamin b12 deficiency), hereditary neuropathies and entrapment neuropathies, overt neuropathy with foot ulcers and/or amputation, peripheral vascular diseases, vertebral pathologies (e.g., previous surgery, foraminal stenosis, spinal canal stenosis, and/or vertebral disc herniation) * patients with other medical conditions such as connective tissue diseases, thyroid disorders, significant renal or hepatic dysfunction, platelet dysfunction syndrome, critical thrombocytopenia, hemodynamic instability and septicemia * local infection at the site of the procedure * consistent use of nonsteroidal anti-inflammatory drugs within the last two weeks * systemic corticosteroid administration or local injection at the suspected treatment site within the last month * recent fever or illness, hemoglobin level \<10 g/dl, platelet count \<105 _ 109/l, and/or tobacco use.
the colorectal breath analysis (cobra) study

Conditions: Colorectal Cancer; Colorectal Polyps; Colorectal Adenocarcinoma

Summary: this study aims to determine whether a breath test could be used for early detection of colorectal cancer and colorectal polyps. patients who are attending for a planned colonoscopy or who are scheduled to undergo elective resection of histologically confirmed colorectal cancer (adenocarcinoma) will be approached to provide a breath sample. multi platform mass spectrometry analysis will be performed to establish volatile biomarkers that can discriminate between colorectal cancer, benign colorectal disease (e.g. polyps) and healthy controls.

colorectal cancer is the 2nd most common cause of cancer death in the uk where survival rates are among the lowest in europe. if diagnosed early survival may exceed 90%. the proposed breath test is a non-invasive investigation that can detect the presence of volatile organic compounds (vocs) in breath and their relative abundance in disease states including colorectal cancer. this test has potential to be used in a primary care setting to identify patients at high risk of colorectal cancer, supporting earlier referral for definitive investigation. a negative test may provide reassurance to patients and prevent unnecessary tests in this group. the test could also have an application for colorectal cancer screening. in this study the investigators will determine the diagnostic accuracy of an exhaled breath test for the detection of colorectal adenocarcinoma and colonic polyps. to determine the accuracy of the breath test a multicentre cross-sectional study will be conducted to analyse single breath samples from patients attending hospital for planned colonoscopy or elective resection of histologically confirmed colorectal cancer. the target for the study is 1463 patients. breath collection will be conducted using a previously validated method. samples of breath (500ml) collected using a ce-marked handheld reciva sampling device (owlstone medical ltd., cambridge, uk) during a period of tidal breathing (approximately 5minutes) will be absorbed onto thermal desorption tubes (markes international, llantrisant, uk). all patients will have received bowel preparation and will be fasted for a minimum of 6 hours prior to the breath sample. breath samples collected within thermal desorption tubes will be transferred to a central laboratory for analysis by gas chromatography mass spectrometry (gc-ms) and proton transfer reaction time of flight mass spectrometry (ptr-tof-ms). raw data files will be extracted and analysed in accordance with established protocols. quality assurance measures will be formally assessed at each stage of sample handling.

Eligibility criteria:
inclusion criteria: * ≥18 years and ≤90 years of age * undergoing planned colonoscopy or elective resection of histologically confirmed colorectal adenocarcinoma * fasted \>6 hours * able to provide informed written consent exclusion criteria: * any patient \ 90 years of age. * lacks capacity or is unable to provide informed written consent.

Keywords: volatile organic compounds mass spectrometry early detection
peanut protein supplementation to prevent muscle atrophy and improve recovery following total knee arthroplasty

Conditions: Surgery

Summary: this randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty.

total knee arthroplasty (tka) is an effective treatment for patients with knee osteoarthritis (oa) accompanied by severe pain and functional limitations. with the success of this treatment and increasing incidence of oa, it has been projected that \~3.5 million older adults will undergo tka annually by the year 2030. while tka is effective for reducing pain and improving health-related quality of life, tka patients experience significant skeletal muscle atrophy and weakness in the surgical leg following surgery which, long-term, can compromise balance, functional mobility and increase fall risk. thus, interventions to mitigate muscle atrophy and weakness post-surgery are essential to improving long-term outcomes in patients undergoing tka. this randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty. patients (n=30) between the ages of 60-75 years scheduled to undergo total knee arthroplasty at the jack hughston clinic/hospital will be recruited to participate. participants will be stratified by gender and randomized to a peanut protein (pp) supplementation (72g daily, n=15) or waitlist control (standard care with no pp, n=15) group who will be provided with pp following the intervention. participants in the pp group will consume pp daily starting 7 days prior to surgery and for 6 weeks post-surgery. participants will be monitored for changes in muscle size and quality (peripheral quantitative computed tomography), upper-leg strength (isokinetic dynamometry), knee range of motion (rom; goniometry), pain (questionnaire and pressure algometry), and functional mobility outcomes (questionnaire, timed up and go, 2-min walk test) prior to surgery and at 6 and 12-weeks post-surgery.

Eligibility criteria:
inclusion criteria: * total knee arthroplasty scheduled within two weeks under the care of surgeons at the jack hughston clinic exclusion criteria: * history of invasive lower extremity surgery within the last 5 years * allergy to peanuts or peanut products * body mass index \ 35 kg/m2 * currently adhering to a restrictive weight loss diet * current or recent (within the last 2 months) steroid use * any physical condition that interferes with performing post-surgery rehabilitation * known peripheral vascular disease, kidney disease, liver disease, or uncontrolled endocrine disorder * known overt cardiovascular or metabolic such as heart disease/failure or diabetes * radiation exposure within the last 6 months other than dental x-rays or associated with current knee treatment/diagnosis

Keywords: total knee arthroplasty physical rehabilitation protein supplementation muscular atrophy inflammatory cytokines
the effect of split-belt treadmill training on gait in parkinson's disease

Conditions: Parkinson Disease; Freezing of Gait

Summary: people with parkinson's disease (pd) often show gait impairments such as, shuffling gait, short steps and gait asymmetry and irregularity. these gait problems are already apparent in the early disease stages, having an immense effect on daily life functioning. especially freezing of gait (fog), where the patients are not able to initiate or continue their movement despite their intention to do so, is a debilitating problem. it is thought that lack of gait adaptability could be an underlying cause of fog. with a split-belt treadmill the speed of both legs can be controlled independently, which forces participants to actively adapt their gait to the new situation. in a previous study performed at our lab, it was shown that only one session of split-belt training (sbt), in which the speed of one leg was reduced, improved gait adaptability and other gait features compared to tied-belt training (tbt). furthermore, overground turning speed improved after only one single training session and this was even retained 24 hours later, indicating training induced long-term potentiation. since the short-term effects of sbt are promising, the objective of this study is to investigate if 4 weeks of sbt, 3 times a week, has an effect on gait deficits found in individuals with pd, compared to 4-weeks, 3 times a week, of tbt.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of pd according to the recent criteria of the movement disorders society made by a neurologist 2. participants should be able to walk 5 minutes at a stretch without a walking aid 3. hoehn \& yahr stage ii or iii in the on state of medication 4. mini mental state examination score of 24 or above 5. participants should have a steady medication schedule at the start of the study (no change in the past month). 6. to be included as a freezer participant a score of at least 1 or higher should be recorded with the new freezing of gait questionnaire. exclusion criteria: 1. current enrollment in another clinical study which may interfere with the conduction of this study. 2. orthopedic injuries or other musculoskeletal problems, which could possibly effect balance and/or gait. 3. unable or unwilling to commit to 4 weeks of training, 3 times a week 4. participation in walking training in the month prior to the start of the study 5. other neurological impairments (except pd) 6. cardiovascular exercise risk factors diagnosed by a doctor

Keywords: parkinson disease freezing of gait rehabilitation gait adaptation split-belt treadmill training
safety surveillance of targeted drugs for pulmonary hypertension using a computerized follow-up system: a nationwide cohort study

Conditions: Pulmonary Hypertension

Summary: recruit at least 700 ph patients, follow up every 6 months based on a computerized follow-up system. primary outcomes are adverse drug events and all-cause death.


Eligibility criteria:
inclusion criteria: * age from 3 months to 85 years, no sex preference; * right heart catheter meet the following conditions simultaneously: mpap≥25mmhg, and pvr \> 3 wood units(in children pvri \> 3 wu x m2), and pawp≤15 mmhg at rest; * patients diagnosed with group 1,2,4,5 ph according to the who classification, detailed description is as follows: pulmonary arterial hypertension, lung disease / chronic hypoxia associated pulmonary hypertension, pulmonary hypertension associated with pulmonary artery stenosis / obstruction and pulmonary hypertension caused by other multiple factors * take at least one pulmonary hypertension targeted drug or calcium antagonist; * signed written informed consent. exclusion criteria: * patients diagnosed with pulmonary hypertension related to left heart disease;
serial platelet-rich plasma injections for vocal fold atrophy, scar, and/or sulcus vocalis

Conditions: Presbylarynx; Atrophy; Larynx; Dysphonia; Vocal Cord Atrophy; Presbylarynges; Vocal Fold Scar; Sulcus Vocalis of Vocal Cord

Summary: this study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency

vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging americans, up to 35% of those 65 or older. currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. these modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. the investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (prp) injection for vocal fold atrophy, sulcus vocalis and scar. prp is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. patients with vocal fold atrophy, sulcus vocalis, and scar identified in the usc voice center will be offered participation in a study to receive serial prp injections in one vocal fold. outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. the investigators hypothesize that serial prp injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.

Eligibility criteria:
inclusion criteria: * vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist * patients with a pre-injection vhi-10 score of ≥ 10 * willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure * ability to give informed consent exclusion criteria: * other co-existing laryngeal pathology that would affect either the safety or potential benefit from prp injection * current smoker * underlying coagulopathy, thrombocytopenia, or platelet dysfunction

Keywords: presbyphonia presbylarynx vocal fold atrophy dysphonia platelet rich plasma prp vocal fold scar
tranexamic acid dosing in adult spinal deformity surgery

Conditions: Adult Spinal Deformity

Summary: the purpose of this study is to evaluate two dosing protocols for tranexamic acid (txa), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.

after consent is obtained and the patient is enrolled in the trial, patients will be assigned de-identified, unique identification (id) numbers. randomization of these ids to either low or high dose txa will occur via a computer generated random assignment. given the variations that may exist in surgical technique (e.g. performance of osteotomies), stratified randomization will be performed by attending surgeon. based upon the randomization, the pharmacy will prepare txa for one of two intravenous dosing protocols: 1. low dose (standard of care/control): loading dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion 2. high dose (study group): loading dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. the surgeon, anesthesia team, and operating room staff will be blind to the concentration of txa in the medications received. treatments may be "unblinded" at the discretion of the surgeon and anesthesiologist, in cases of extreme blood loss. if additional anti-fibrinolytics are given, the change in dose will be recorded. post-operative care will be the same as any other patient and data collection will be information contained in the patient's medical record that is part of routine, standard of care.

Eligibility criteria:
inclusion criteria: * adult patients (ages 18-75) scheduled to undergo long segment (greater than 8 motion segments) posterior spinal fusion with instrumentation (psf) for adult scoliosis exclusion criteria: * patients with acquired defective color vision * subarachnoid hemorrhage * active intravascular clotting * hypersensitivity to tranexamic acid or any of the ingredients * patients who pre-donate autologous blood for intra- or post-operative use (directed donor units are acceptable) * history of suspected blood disorders or abnormal coagulation laboratory results * current anticoagulation therapy that cannot be interrupted * history of deep vein thrombosis (dvt) * impaired renal function or creatinine clearance \<60 ml/min * pregnancy or women who are lactating/breastfeeding * women on hormonal contraceptives

Keywords: tranexamic acid, reconstructive spine surgery
femoral triangle + ipack blocks for acl reconstruction analgesia

Conditions: Anterior Cruciate Ligament Rupture; Acute Pain; Pain, Postoperative; Knee Injuries

Summary: an adequate balance between analgesia and motor function is an essential requirement to facilitate functional recovery and early discharge after anterior cruciate ligament (acl) reconstruction surgery. proximal nerve blocks (i.e. femoral and sciatic nerve blocks) are associated with optimal analgesia, but they can cause muscle weakness, interfering with rehabilitation and increasing the risk of falls . a recent randomized controlled trial concluded that, compared to mid-and distal acb, a distal femoral triangle block (ftb) is associated with lower opioid consumption and improved postoperative analgesia for ambulatory acl reconstruction. in acl reconstruction surgery there are other potential sources of pain not covered by a ftb, such as intra-articular structures (menisci, cruciate ligaments), posterior knee capsule and the graft donor site. evidence supporting the addition of an ipack block to a ftb has been studied for patients undergoing total knee replacement, nonetheless, there is no trial analyzing the analgesic contribution of ipack to a ftb in the context of acl reconstruction surgery. in this multicentric trial, the investigators set out to analyze the analgesic benefit of adding an ipack block to a ftb.


Eligibility criteria:
inclusion criteria: * patient scheduled to undergo anterior cruciate ligament reconstruction under general anesthesia with ipsilateral autologous graft. * age between 18 and 65 years * american society of anesthesiologists classification 1-3 * body mass index between 19 and 35 (kg/m2) exclusion criteria: * adults who are unable to give their own consent * pre-existing neuropathy (assessed by history and physical examination) * coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50) * renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) * hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) * allergy to local anesthetics (las), morphine or tramadol * pregnancy * acl revision surgery * contralateral graft or any type of allograft * chronic pain syndromes requiring opioid intake at home

Keywords: nerve block ipack femoral triangle