Kornimate/medical-research-clean huggingface dataset:
a multicenter randomized trial comparing im nails and plate fixation in distal femur fractures

Conditions: Femoral Fractures

Summary: this study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" both procedures being studied are standard of care (used routinely) and use fda approved devices. all medical and surgical treatment will be the same for participants as non-participants.

the study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. the first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (nail group). the second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (plate group). the null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. to the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Eligibility criteria:
inclusion criteria: * skeletally mature * fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a tka * fracture requiring operative treatment amenable to either im nail or plate * informed consent obtained * patient is english speaking exclusion criteria: * fracture of the metaphyseal distal femur with intra-articular communition, * fracture with vascular injury (gustillo type iiic injury) requiring repair, * pathological fracture, * known metabolic bone disease, * contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee * retained hardware or existing deformity in the affected limb that would complicate im nailing or plating * symptomatic knee arthritis * soft tissue injuries compromising either treatment method with nail or plate * surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures * immunocompromised * unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired) * current or impending incarceration * unlikely to follow-up in surgeon's estimation

Keywords: distal femur femur fracture
effect of treatment on connective tissue in low back pain

Conditions: Low Back Pain; Connective Tissue Defect (Diagnosis)

Summary: the purpose of the study is to investigate the effects of instrument assisted soft tissue mobilization (iastm) and kinesiology taping (kt) that are additional treatment to the conservative treatment for the lumbar region and hamstrings and connective tissue thickness in patients with chronic non-specific low back pain (cnslbp).


Eligibility criteria:
inclusion criteria: * between the ages of 30 and 50 * who had low back pain for at least 12 weeks, * received no physical therapy in the last 6 months, * received no iastm or chemotherapy, * had normal movement of the hip joint * visual analog scale value above 3 exclusion criteria: * the presence of allergy and skin diseases, * pregnancy, * major structural spinal deformity (scoliosis, kyphosis, stenosis), * inflammatory disease, * presence of extruded and sequestered herniation, -signs of neurological disease, - * presence of orthopedic diseases such as fracture * a history of spinal surgery.
pythagorean self-awareness intervention on psoriasis patients.

Conditions: Psoriasis

Summary: this one-arm, pilot, non-randomized, study was conducted at the specialized psoriasis unit of andreas syggros hospital in athens, greece. all participants were informed about the objectives and procedures of the study, and written informed consent was provided prior to participation. the study protocol was approved by the hospital's scientific and ethics committee (protocol number: 472 /07-12-2023)and was in accordance with the declaration of helsinki.

pythagorean self-awareness intervention (psai) to a sample of psoriasis patients. primary aim was the reduction of perceived stress levels. secondary aims were the enhancement of stress response (hrv), increase cortisol levels, improvement of sleep quality, adoption of healthy behaviors, emotional regulation (e.g., shame and anger), cognitive performance enhancement (e.g., visual-spatial memory, verbal learning, information processing speed), as well as improvements in body composition indices (e.g., weight, body mass index (bmi), intermuscular adipose tissue (imat), fat mass, and free fat mass).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of psoriasis * speaking and writing in greek language exclusion criteria: * use of oral corticosteroids * diagnosis of any serious mental disorder * drug addictions

Keywords: psoriasis pythagorean self-awareness intervention stress management perceived stress sleep quality cognitive function hair cortisol clinical samples
a multicentre real-world study of heptapopal ethanolamine tablets in concurrent/sequential radioimmunoinduced thrombocytopenia

Conditions: Cancer, Therapy-Related

Summary: the objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world. the subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia. this study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. the study included a screening period (no more than one week) and a treatment period (at least two cycles).participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/l during radioimmunotherapy.


Eligibility criteria:
inclusion criteria: * understand the research procedure and voluntarily sign the informed consent to participate in the study * subjects ≥18 years of age receiving synchronous/sequential chemotherapeutic therapy * patients with platelet count ≤100×109/l or platelet count decrease ≥ 50×109/l or platelet count \> 100×109/l but need to be prophylaxis with hexapopethanolamine tablets * researchers believe that subjects need to be treated with hexapopal. exclusion criteria: * the subjects are conducting clinical intervention studies * patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar * pregnant or lactating women * other conditions deemed unsuitable for inclusion in the study by the researcher.
comparison effects of different exercise approaches on type 2 dm women

Conditions: Type 2 Diabetes

Summary: type 2 diabetes mellitus (t2dm) is one of the most common metabolic diseases with a complex, multifactorial etiology, and is a chronic disease with various clinical and biochemical manifestations. it has been known for a long time that t2dm treatments include medication, diet, and exercise. exercise can improve blood glucose control, increase insulin sensitivity, respiratory capacity, well-being and cognitive functions, regulate lipid profile, blood pressure, reduce cardiovascular disease risk, abdominal obesity, weight. although there are many studies in the literature on the effects of exercise in t2dm, there is no consensus on which exercise protocol is more effective. in the studies, the obstacles in front of the diabetic patients' adaptation to exercise; laziness, lack of motivation and energy, embarrassment from family and social environment, lack of support, time constraints, financial problems, lack of space to exercise, fear of hypoglycaemia, pain, stiffness, fatigue, shortness of breath, presence of additional diseases, fear of injury. blue prescription (bp) is a model developed to facilitate the participation in physical activity. in traditional home programs, patients are told what to do. the bp approach, on the other hand, involves providing the person with options for physical activity, removing the barriers to activity instead of the classical home exercise program or physical activity counselling, and being in communicate according to the person's preferences during this process. this approach has been developed to facilitate participation in physical activity and to ensure the sustainability of physical activity in individuals with chronic diseases. philosophy of the approach aims to increase the activity level gradually, improve the quality of life and participation in the activity with motivational interview, continuous support, communication and activity diary, instead of recommending physical activity with classical methods due to the different needs, desires and preferences of people. studies using the bp in the literature have focused on multiple sclerosis and stroke, and no publications on other chronic diseases have been found. the aim of this study is to examine the effects of bp, video-based home exercise and supervised group exercises on hba1c, physical activity level, functional capacity and other metabolic control variables in primary care women with t2dm.


Eligibility criteria:
inclusion criteria: 1. between 25-65 years of age 2. having type 2 dm for at least 5 years 3. hba1c value\> 6.5% / fasting blood glucose\> 126 mg / dl 4. ability to walk independently 5. volunteering to participate in research exclusion criteria: 1. type 1 dm 2. using insulin 3. orthopedic and neurological diseases that prevent exercise 4. having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.
fast and simple covid-19 causing virus sars-cov-2 detection

Conditions: COVID-19

Summary: observational study using biological material. the group of subjects in the study is represented by 100 male and female patients hospitalized with covid-19 symptomatology and 100 non-hospitalized subjects with suspected covid-19 diagnosis for a total of 200 patients. the expected recruitment time is about 6 months.

clinical study using biological material. the group of subjects in the study is represented by 100 male and female patients hospitalized with covid-19 symptomatology and 100 non-hospitalized subjects with suspected covid-19 diagnosis for a total of 200 patients. the expected recruitment time is about 6 months. each patient will be carried out a nasopharyngeal swab in utm medium™ which will be tested according to the diagnostic procedure in use, a second nasopharyngeal swab resuspended in mswab™ and a third oral dry swab that will be transported to the laboratory of clinical microbiology and virology of unimib and resuspersed in the mswab™ transport medium. the samples will then be treated according to the new workflow defined by the pilot study, i.e. optimization of alternative sample transport systems, in combination with a rapid method of viral rna extraction, and evaluation of viral inactivation at the end of the extraction phase, by viral culture at the bsl3 laboratory of the virology laboratory of the university of milan. the samples collected and transported on utm™ medium will be sent to the microbiology laboratory of the asst of monza and analyzed through the nimbus-seegene platform as per diagnostic routine. the residual volume of the utm™ medium sample and all remaining samples taken by each patient will be sent to the laboratory of microbiology and clinical virology of the university of milano-bicocca to be processed through the new preanalytic method in combination with different analytical kits. a percentage of each sample will be sent to the virology laboratory of the university of milan for testing using the analytical protocol suggested by the cdc. the study samples will also be used for the validation of a new innovative analytical test for sars-cov-2, in real-time multiplex one- step pcr, developed to be combined with the preanalytic process with thermal extraction, fast and low cost, with high-throughput automation. all residual volumes of the samples in the study, and related nucleic acids, will be rated and stored in bio-bank according to international "standard operating procedures" the validation of further and/or new diagnostic tests for the search for for sars-cov-2 (asst pg23 in collaboration with bbmri.it).

Eligibility criteria:
inclusion criteria: * patients admitted to the u.o. of infectious diseases of the san gerardo hospital in monza with documented covid-19 symptomatology; * covid-19 asymptomatic or post-hospital discharge; * people of legal age; * patients who agree to participate have given their consent by signing a specially prepared form. exclusion criteria: * none

Keywords: covid-19 sars-cov-2 molecular diagnostic test
the impact of cbt-i on cpap therapy use and drop outs in osas patients with insomnia.

Conditions: Insomnia; Obstructive Sleep Apnea; Cognitive Behavioral Therapy; Continuous Positive Airway Pressure

Summary: patients follow the fully standard sleep test according to the normal procedure. this means that they undergo a polysomnography and fill in a questionnaire. if according to the questionnaire, there is insomnia, the patient also receives an intake interview to check whether this is indeed the case. if the patient has both disorders and meets the inclusion and exclusion criteria, they will be asked to sign the informed consent. if the patient agrees, the cpap-therapy will be started as usual, simultaneously with cgt-i. the latter will last 7 weeks and will cover the following points: psycho-education, sleep restriction and sleep hygiene, cognition, relaxation and relapse prevention. because of the design of this study (starting cgt-i as soon as possible after the diagnosis of osas) and the groups already planned for cbt-i, it is not possible for all participants to participate in group cognitive behavioral therapy, therefore individual sessions were provided for these participants. the patient comes for monitoring at set times.


Eligibility criteria:
inclusion criteria: * all patients, male and female, with an osas diagnosed by full polysomnography and insomnia diagnosed by questionnaires. * age between 18 and 75 years * dutch as native language exclusion criteria: * patients younger than 18 years and older than 75 years * patients with a burn-out * patients with restless legs * pregnant woman * patients who work as shift workers * patients with severe psychiatric disorder * patients who take sleep medication, unless it can be reduced and stopped during cognitive behavior therapy * patients with daily alcohol abuse (men \> 3 drinks on any day or 14 per week, women \> 2 drinks on any day or 7 per week)
chest physiotherapy in tracheotomized patients

Conditions: Acute Respiratory Distress Syndrome

Summary: positive expiratory pressure (pep) breathing is common for treatment of different lung diseases and can increase lung volume and increase elimination of secretion from the airways. today there is no evidence whether the treatment is effective or not for patients in the intensive care unit. the purpose of this study is to evaluate if pep breathing can increase oxygenation for patients in the intensive care unit during weaning from the ventilator after acute respiratory distress syndrome. pep breathing will be applied on the tracheal cannula for 15 minutes. measure of the pep effect will be done before, during and for 20 minutes after pep breathing.

procedure: to achieve steady state, all subjects are positioned in a semi-recumbent position (30°) for 60 minutes before the start of the intervention and remain in that position during the entire investigation. subjects are instructed to avoid talking and movements during both steady state and measurements. airway suctioning (up to 20 kpa) through the tracheal cannula is performed only if there is risk for tube obstruction or if spo2 decreases below 90%. frequency of airway suctioning, and number of coughs during the study time are registered. an extra pre-intervention measurement is performed 15 minutes after the first to increase the validity of baseline measurements and control for changes in measured variables due to spontaneous variations. a pep device consisting of a one-way valve and exchangeable resistance nipples is used during the pep breathing treatment. the resistance nipple is chosen at the start of the intervention aiming at an airway pressure of 10-15 cmh2o during tidal breathing (measured with a calibrated manometer). the duration of the pep treatment is 15 minutes. complementary oxygen is delivered at the same amount as before the intervention. measurements: the primary outcome is pao2. five separate arterial blood samples of 0.7-1.5 ml each (altogether 3.5-7.5 ml for each subject) are drawn from an existing arterial catheter in the radial artery in the left or the right arm by nurses at the ward, and directly analysed. subject characteristics are registered from the clinical records, including gender, age, body mass index (bmi), smoking history, duration of invasive ventilation, and length of icu stay.

Eligibility criteria:
inclusion criteria: * tracheostomized participants * ≥18 years old * moderate or severe ards during the icu period, according to the berlin definition. * ability to maintain pao2 ≥ 67.5mmhg, with supplementary oxygen if needed, during spontaneous breathing for at least three consecutive hours. * normal curvature of the spine. exclusion criteria: * lack of informed consent

Keywords: breathing exercises intensive care physical therapy modalities physiotherapy respiratory distress syndrome, adult ventilator weaning
catheter associated asymptomatic thrombosis in intensive care unit

Conditions: Central Venous Catheters; Central Venous Catheter Thrombosis; Thrombosis, Venous; Intensive Care Unit

Summary: this study aims to describe the incidence of catheter-related and non-catheter-related thrombosis in a population of adults in icu and to assess its correlation with alteration of coagulation parameters.

central venous catheter (cvc) is now indispensable in the monitoring and care of patients in intensive care (icu). unfortunately, one of the complications of its positioning is catheter-related thrombosis (crt) and its consequences. despite the widespread use of cvc and the extensive literature describing its complications, areas of uncertainty regarding the onset, treatment and prevention of crt persist, especially with regard to asymptomatic thrombosis. this study aims to describe the incidence of catheter-related and non-catheter-related thrombosis in a population of adults in icu and to assess its correlation with alteration of coagulation parameters. the main objective of this study is to assess the proportion of patients developing crt (proportion) and the incidence of crt (rate expressed in catheter events/days) in patients in icu.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 * admitted to intensive care who have for clinical reasons need to place a central venous catheter * signing of informed consent exclusion criteria: * patients under 18 years of age * known cancer status * congenital thrombophilia
investigation of a physiotherapist and nurse practitioner intervention for chronic low back disorders delivered through telehealth

Conditions: Chronic Low Back Pain

Summary: the purpose of this project is to compare "usual care" for chronic low back disorders in a rural setting (nurse practitioner/np) to two different means of integrating physical therapy (pt) into a rural health care team: 1. in-person pt assessment, where the pt travels from an urban center 2. interprofessional telehealth assessment where the local np is joined by a pt via telehealth. the project will evaluate health, systems and process outcomes, comparative effectiveness and costs of the three methods of assessment. the hypothesis is that an interprofessional telehealth assessment with be as effective as an in-person pt assessment, but more effective than usual care.

the study design will include two intervention groups and a control group with 20 participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person pt and, 3. "usual-care" provided by a np. due to the interprofessional nature of the intervention, the np involved in the telehealth-based intervention group may alter their "usual care" practice; therefore, the control group participants will be drawn from the practices of 2 nps not involved in the telehealth intervention providing services out of a different clinic. each pt and the np alone will complete a standardized online diagnostic classification tool.participants will be randomly assigned to one of the three groups.

Eligibility criteria:
inclusion criteria: * adult 18-80 * low back pain and/or related leg pain affecting function, \>3 months duration exclusion criteria: * clients within a third party payer insurance coverage system * clients with primarily neck or thoracic pain * clients with language or comprehension difficulties that would limit completion of paperwork

Keywords: low back pain telehealth videoconferencing access to physical therapy interprofessional care rural health
effect of intrathecal clonidine in hypertensive subjects with poorly controlled blood pressure

Conditions: Hypertension

Summary: the purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.

hypertension occurs commonly, is associated with major morbidity and mortality, and responds poorly to current therapies in a small minority of compliant patients. the goal of this investigator-initiated study is to determine whether intrathecal administration of clonidine reduces blood pressure in hypertensive patients, focusing on a group who often achieve inadequate blood pressure control with multiple drug therapy. after consent, pts will be screened and if qualified brought into center and intrathecal injection of clonidine given. patients will be closely monitored for 4 hours, while data is collected.

Eligibility criteria:
inclusion criteria: * diagnosis of hypertension * stable systolic blood pressure \>140 mmhg and \< 190 mmhg * on 3 or more antihypertensive medications * on a diuretic * patients must be able to understand the risks exclusion criteria: * allergy to clonidine * presently on clonidine orally or transdermally * known or suspected correctable causes of secondary hypertension * breast feeding or pregnant women * unstable ischemic heart disease * unstable angina * intracoronary stent placement * coronary bypass within last 6 months * myocardial infarction within last 6 months * congestive failure * cardiac arrhythmias * known cerebral vascular disease * renal disease * evidence of injection site infection * known bleeding disorders * hepatic insufficiency * renal insufficiency * participation in an investigational drug study within 30 day of enrollment * prohibited medications: * clonidine * yohimbine * tricyclic antidepressants * mirtazapine * digitalis * reserpine * guanethidine * non-steroidal anti-inflammatory medication * alcohol or barbiturates within 48 hours of study procedure

Keywords: intrathecal clonidine poorly controlled hypertension