Kornimate/medical-research-clean huggingface dataset:
physical activity to reduce diabetes risk in serious mental illness

Conditions: Mental Disorders, Severe

Summary: the aim of this project is to trial the protocol of a park-based physical activity (pa) intervention in adults with severe mental illness (smi) in a community mental health center's peer support program.

aim 1: test the feasibility and acceptability of a park-based pa intervention led by certified peer specialists (cps) and adapted for adults with smi. rationale: park-based interventions led by cpss represent a novel approach to increase program satisfaction and adherence to pa behavior change in persons with smi. hypothesis 1a: most (80%) people offered the intervention will participate most of the time (≥2 day/week). hypothesis 1b: cpss and smi patients will express satisfaction with the program (6 on an 8-point scale). aim 2: test the effectiveness of a park-based pa intervention led by cpss on increasing pa and improving fitness in adults with smi. rationale: park-based pa is associated with greater intensity and duration of pa, better fitness, and less obesity and depression, issues that are especially problematic for adults with smi. hypothesis 2a: people enrolled in the intervention will engage in more pa than at baseline (90min moderate to vigorous pa (mvpa)/week). hypothesis 2b: the intervention will result in improved fitness (6 min walk test) relative to baseline.

Eligibility criteria:
inclusion criteria: * authorized for peer group treatment through the serenity behavioral health facility * medically cleared for participation * able to act as their own legal guardian exclusion criteria: * age under 18
sleep loss and energy metabolism in people with family history of type 2 diabetes.

Conditions: Sleep; Sleep Deprivation; Insulin Resistance; Type 2 Diabetes

Summary: the use of energy from food changes when people sleep. however, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities. this study is being done to test the hypothesis that the daily use of energy in people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 16 days in comparison to when they have slept longer hours for 16 days.

study participants will complete two 16-day inpatient stays in the sleep laboratory of the university of chicago clinical resource center that will be scheduled at least 4 weeks apart. bedtime duration will be set at 5.5 hours per night during one of these stays and at 8.5 hours per night during the other. no daytime naps will be allowed. study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. on weekdays all participants will engage in simulated "office work" in the sleep laboratory. during the rest of the time participants will maintain their usual indoor and outdoor activities as much as possible within the limits of the university of chicago campus. at the beginning of each inpatient stay, study participants will drink a glass of water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found in natural water. several urine samples will be collected before and after the participants drink the water and again 14 days later in order to measure the amount of energy that was used by them during this time. at the end of each stay participants will also undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal, and will complete tests to determine how much insulin does their body produce in response to an intravenous glucose infusion and how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Eligibility criteria:
inclusion criteria: * regular sleep habits * bmi 20 to 27 kg/m2 * at least one parent, sibling or grandparent with type 2 diabetes * must exercise regularly exclusion criteria: * active smoker * night or shift work * have highly variable sleep habits * have a hormonal disorder * have a sleep disorder * have an active medical problem * women only: use of birth control pills * women only: irregular menstrual periods or pregnancy * use of medications/compounds that can disrupt sleep

Keywords: short sleep duration energy expenditure insulin secretion insulin action lipid turnover free fatty acids
sjov vs. hfno for hypoxia during procedural sedation at high altitudes

Conditions: Hypoxia; High Altitude

Summary: this study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (sjov) with high-flow nasal oxygen therapy (hfno) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.

the participants will be randomly allocated to either sjov or hfno in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. in the hfno group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (fio2) of 100%. in the sjov group, sjov is conducted using a wei nasal jet tube (wnj, well lead medical co. ltd, guangzhou, china) which is connected to a manual jet ventilator (well lead medical co. ltd, guangzhou, china) via its jet port. the initial settings of sjov were as follows: driving pressure (dp) 15 psi; respiratory rate (rr) 20 bpm; inspiratory-to-expiratory (i/e) ratio 1:2, and gas supply, 100% oxygen.

Eligibility criteria:
inclusion criteria: 1. 18 years or older; 2. underwent routine gastrointestinal endoscopy under procedural sedation; 3. consented to participate in this trial. exclusion criteria: 1. infection of the upper airway; 2. anatomical abnormalities of the face, nose, and upper airway; 3. coagulopathies; 4. anticipated or known difficult airway; 5. known allergy against propofol, soybeans, and egg; 6. absence from the high-altitude environment during the past 3 months.
depression in youth onset type 2 diabetes

Conditions: Type 2 Diabetes; Depression

Summary: the main purpose of this study is to compare a group-based interpersonal psychotherapy (ipt) program and a type 2 diabetes education program to determine if there are differences in depression levels, diabetes distress, and glycemic control in adolescents with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosis ≥ 3 months * age 12-17yr * elevated depression symptoms * hba1c ≥7.0% exclusion criteria: * currently receiving psychotherapy from a licensed counselor * psychotropic meds \<8 weeks
n-acetylcysteine in alcohol dependence

Conditions: Alcoholism

Summary: the present study is designed to find out if n-acetylcysteine works in reducing alcohol drinking and craving.

the 2 groups (placebo and n-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. the total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.

Eligibility criteria:
inclusion criteria: * age 18 - 65 * alcohol dependence by dsm-iv * heavy drinking at least 4 times in the past month * able to provide informed consent exclusion criteria: * current drug abuse or dependence by dsm-iv criteria (except nicotine or cannabis) * current psychotic disorders, bipolar disorders, or cognitive disorders * current suicidal or homicidal ideation * positive illicit drug screen (except cannabis) * clinical institute withdrawal assessment for alcohol, revised \>15 * initiation of individual therapy or counseling in the past 3 months * changes in doses of psychiatric medications in the past 3 months * clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease * current use of naltrexone, disulfiram or acamprosate * pregnant or nursing women, or inadequate birth control methods in women of childbearing potential

Keywords: n-acetylcysteine alcoholism treatment
physical and cognitive performance during the two first years of lemtrada treatment

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic autoimmune neurodegenerative disease of the central nervous system (cns). the symptoms of ms are wide-ranging, but patients perceive loss of physical function (gait) and cognitive function as the most critical consequences of the disease. moreover, recent studies have shown that already at early disease stages functional impairments are present. one of the more recent approved medical treatments for ms patients is alemtuzumab (product name lemtrada), a humanized monoclonal antibody targeting cd52 cells, that depletes and repopulates b lymphocytes and t lymphocytes, causing sustained changes in the adaptive immunity. in 2013 and 2014 alemtuzumab was approved in eu and usa, respectively. with the exception of the ms functional composite z-score, the previous clinical studies investigating the effect of alemtuzumab have exclusively focused on clinical parameters such as mri indications of disease activity (accumulation of lesion, total and regional brain atrophy etc.), relapse-rates, changes in 'expanded disability status scale' (edss) and side-effects/adverse events. however, no previous studies have performed in depth monitoring on how physical or cognitive performance are affected following initiation of treatment with alemtuzumab despite the paramount importance to patients. the primary purpose of this project is to monitor the changes in physical performance during the first two years of treatment with alemtuzumab in a well characterised danish cohort of people with relapsing-remitting ms. a secondary purpose is to monitor the impact of alemtuzumab treatment on cognition during the first two years of treatment.


Eligibility criteria:
inclusion criteria: * clinical definite multiple sclerosis diagnosis according to the mcdonald criteria * about to commence alemtuzumab (lemtrada) treatment * expanded disability status scale (edss) ≤ 5.5 * signed informed consent exclusion criteria: * co-morbidities that prevent participation in the project (dementia, serious cognitive disorders etc.)
mdr - pmcf study for taperloc complete stems

Conditions: Hip Arthritis; Hip Disease; Hip Fractures; Hip Injuries; Hip Pain Chronic

Summary: the objective of this consecutive series pmcf study is to collect data confirming safety, performance, and clinical benefits of the taperloc complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. since taperloc complete was introduced to the eu in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

the objective of this consecutive series pmcf study is to collect data confirming safety, performance, and clinical benefits of the taperloc complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. since taperloc complete was introduced to the eu in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point. the primary objective is to confirm safety of the study products. this will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. relationship of the events to either implant or instrumentation should be specified. the secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (proms). \*the most recent available data will be used. if any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older and skeletally mature * patient must be willing and able to sign irb approved informed consent * patient must have undergone primary or revision hip arthroplasty with the -taperloc complete stem according to a cleared indication, which includes the following: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis * correction of functional deformity * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques exclusion criteria: * off-label use * infection * sepsis * osteomyelitis * uncooperative patient or patient with neurologic disorders who are incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, or neuromuscular disease * patient is known to be pregnant or nursing * patient is a prisoner * patient is a known alcohol or drug abuser * patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
resistive inspiratory manoeuvre as airway clearance technique in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this trial aims to analyze whether the resistive inspiratory manoeuvre (rim) performed previously to autogenic drainage (ad) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable cf patients.

it is a multicenter study. 4 different spain cystic fibrosis foundations are included in the study (madrid, valencia, murcia and aragón). all patients will perform three different arms of treatment in a crossover randomization. each arm of treatment will be apply only in one session. the wash-out period will be one week. before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess. during the study period the patients' pharmacological treatment remained unchanged

Eligibility criteria:
inclusion criteria: * cystic fibrosis (cf) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l) * clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk); * chronic sputum production, at least ≥ 15 ml /24h * familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions) * to be able to provide written, informed consent exclusion criteria: * lung function: forced expiratory volume in 1 second \< 30 % pred . ; forced vital capacity \< 40 % pred. * active haemoptysis during the previous month * supplemental oxygen or non-invasive ventilation (niv)

Keywords: autogenic drainage resistive inspiratory manoeuvre computerized respiratory sounds airway clearance techniques mucus clearances
non-invasive artificial intelligence-based platform monitoring program (nip it!)

Conditions: Breast Cancer; Melanoma; Gastrointestinal Neuroendocrine Tumor

Summary: patients who have undergone curative treatment may be at risk of relapse. this study will collect, annotate, and sequence biospecimens (blood, stool, and tissue) from patients across different tumor types to detect molecular residual disease (mrd) before metastases become radiographically or clinically detectable. this will allow for early cancer interception, and hopefully prolong relapse-free survival across tumor types.

the development of anticancer drugs typically starts with patients with advanced cancers who have exhausted standard treatments. yet even the most active new drugs produce only modest benefits in patients with advanced cancers because of the emergence of resistance, similar to the resistance that bacteria develop when they are repeatedly exposed to antibiotics. in order to achieve larger magnitude gains in survival and make greater impact in the field of cancer, promising drugs must be tested in patients with curable malignancies who have undergone definitive treatment but are at high risk of relapse. interception is the active intervention of cancers at an early stage, offering an opportunity to eliminate molecular residual disease (mrd) before clinical relapse. mrd describes the situation in which cancer-derived biomarkers are detectable, typically using highly sensitive and specific molecular assays in blood or other body substances that are below the threshold of detection by conventional tests such as ct scans or radiological imaging. using innovative technologies to monitor patients at high risk of relapse, and applying them to serial samples of their circulating tumor dna, other body fluids, stool and radiological images, the goal is to develop ai-based models to identify those who are at the highest risk of relapse. this will allow interception studies to be conducted to target microscopic tumor cells in these patients to increase cancer cure rates.

Eligibility criteria:
inclusion criteria: 1. patients with histological confirmation of a solid tumor. 2. patients must have early stage or locally advanced disease that is planned for or have undergone curative treatment. 3. patient must be ≥ 18 years old. 4. all patients must have signed and dated an informed consent form. exclusion criteria: none

Keywords: molecular profiling minimal residual disease liquid biopsy circulating tumor dna
five sessions intervention to facilitate adaptation to breast cancer

Conditions: Breast Cancer

Summary: to test the effects of 2 different 5-wk stress management interventions (cognitive behavioral training or relaxation training) vs. a time-matched 5-wk health education condition on psychosocial adaptation and physiological adaptation in women being treated for breast cancer. participants assigned to either of the stress management conditions will show improved psychosocial adaptation and physiological adaptation compared to those assigned to the health education condition.

this is a randomized controlled trial comparing the effects of 5-wk group-based stress management interventions (cognitive behavioral therapy \[cbt\] or relaxation training \[rt\]) vs a time-matched 5-wk group-based health education (he) condition on psychosocial adaptation (negative and positive mood, social disruption) and physiological adaptation (cortisol and immune function) in women with non-metastatic breast cancer who are undergoing primary treatment. participants are recruited in the weeks after surgery and before the start of adjuvant chemotherapy or radiation, are assessed for baseline psychosocial and physiological adaptation indicators, and are then randomly allocated to either cbt, rt or he. they are re-assessed for psychosocial and physiological adaptation at 6 and 12 month follow-up. primary hypothesis is that women assigned to cbt or rt will show greater reductions in negative affect and social disruption, and greater increases in positive affect over time compared to women assigned to he. secondary hypothesis is that women assigned to cbt or rt will show greater decreases in cortisol and greater increases in immune functioning over time compared to those assigned to he.

Eligibility criteria:
inclusion criteria: * women diagnosed with breast cancer at stage iii or below who had recently undergone lumpectomy or mastectomy exclusion criteria: * prior cancer, prior psychiatric treatment for a serious disorder (e.g., psychosis, suicidality), lack of fluency in english and had begun adjuvant therapy at time of first assessment
botulinum toxin for the treatment of depression

Conditions: Depression

Summary: depression is frequently accompanied by a specific sad facial expression. this expression is in part mediated by the same muscle activity that produces frown lines. based on the assumption that there is a positive feedback between depressed mood and the correspondent facial muscle activity (facial feedback) the investigators will conduct a randomized controlled pilot study in which the investigators will apply a classical cosmetic treatment of frown lines with injections of botulinum toxin to depressed patients who did not sufficiently respond to antidepressant medication. the investigators hypothesize that this treatment will contribute to the amelioration of depressive symptoms in these patients. this hypothesis is supported by a previous open case series in which remission of depression was reported after such treatment (finzi and wasserman, 2006).


Eligibility criteria:
inclusion criteria: * mild to moderate depression (ham-d \>=15) * therapy with one antidepressant for at least four weeks * at least moderate frown line exclusion criteria: * bipolar depression * psychiatric comorbidity * severe somatic comorbidity * pregnancy * peculiarities at the injection site * psychiatric medication other than one antidepressant * specific psychotherapy * previous application of botulinum toxin * medication interfering with botulinum toxin

Keywords: depression depressive botulinum botox
induction chemotherapy for advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: over the last 30 years, induction chemotherapy (ic) has become important for the management of patients with locally advanced hnscc (lahnscc), particularly since the introduction of taxanes. the results reported in the tax 323 and tax 324 trials indicate that the tpf regimen (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with the pf regimen (cisplatin and 5-fluorouracil), and the tpf regimen is globally the most accepted induction regimen for the treatment of lahnscc. however, the tpf regimen has been associated with high toxicity rates, and patients frequently decline cisplatin during concurrent radiotherapy and require the use of infusion pumps and a central venous catheter. extensive efforts are ongoing to identify alternative schemes that are less toxic than the tpf regimen but are as effective for lahnscc and safely allow the use of definitive concurrent treatment based on cisplatin and radiotherapy.

this non-randomized phase ii trial evaluated the safety, feasibility and response rates of concurrent therapy (cisplatin and radiotherapy) after three cycles of an ic regimen based on the combination of cisplatin plus paclitaxel without 5-fluorouracil (5fu) (thereby avoiding infusion pumps and a central venous catheter) in lahnscc patients with a high tumor burden. the patients were stratified by tumor subsite (oropharynx and hypopharynx/larynx) and by tumor resectable status (resectable or irresectable advanced squamous cell).

Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced squamous cell carcinoma of head and neck (stage iii and iv) eligible to chemoradiotherapy. * presence of measurable disease * ≥ 18 year * ecog performance status: 0-2 * adequate bone marrow functions evidenced by: absolute neutrophil count ≥ 1.5 x 109/l; platelet count ≥ 100 x 109/l and hemoglobin ≥ 90 g/l * adequate renal function. * adequate hepatic function. * patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the study. exclusion criteria: * any previous chemotherapy or radiotherapy * patients who have known hypersensitivity to paclitaxel or cisplatin * patients who are receiving concurrent investigational, biological or immune therapies * concomitant administration of high doses of systemic corticosteroids * known hiv or hepatitis b or c (active, previously treated or both; testing is not required) * uncontrolled cns disease (e.g., seizures not controlled with standard medical therapy) * clinically significant cardiovascular disease.

Keywords: head and neck cancer induction chemotherapy