Kornimate/medical-research-clean huggingface dataset:
intraarticular ozone therapy for pain control in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to determine whether an intraarticular injection of ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee.

ozone, as a gas made of three atoms of oxygen with a cyclic structure, has been used as a medical therapy from the mid ninetieth century. today, this therapy is a recognized modality in many european and latin american nations for orthopedic problems, infections, ischemic diseases, and skin problems. however, despite of this wide use internationally, there is minimal mention of this treatment modality in the anglo-american literature. the present is the first of a series of studies planned to scientifically test the effectiveness of ozone as a main-stream therapy, introducing it to the anglo-american literature. in this first study we will check whether intraarticular injections of ozone into the knee joint are effective as a therapy for pain control in patients with osteoarthritis of the knee.

Eligibility criteria:
inclusion criteria: - osteoarthritis of knee exclusion criteria: * positive rheumatologic serologic tests * cognitive impairment * adjacent osteomyelitis * bacteremia * hemarthrosis * impending (scheduled within days) joint replacement surgery * infectious arthritis * joint prosthesis * osteochondral fracture * periarticular cellulitis * poorly controlled diabetes mellitus * uncontrolled bleeding disorder or coagulopathy.

Keywords: osteoarthritis knee pain management ozone therapy intraarticular injection
compression bandage in local infiltration analgesia afte total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: purpose: to determine wether a compression bandage prolongs analgesia of local infiltration analgesia after total knee arthroplasty

patients are randomised to receive a compression bandage or a non-compression bandage

Eligibility criteria:
inclusion criteria: * scheduled for total knee arthroplasty * speak and understand danish exclusion criteria: * severe obesity * allergies to local anaesthetics

Keywords: postoperative pain
covid-19 - no health without mental health

Conditions: Covid19; Anxiety

Summary: the corona pandemic is affecting the whole world and since march 12.th 2020 there has been strict qurantene and social isolation interventions in norway. the aim of this intervention is to reduce the negative and fatal effects of the pandemic. the pandemic and the restrictions that follows it is assumed to affect the mental health of the general population. in this research project we want to examine the use and the effects of a digital self-guided psychological intervention with the aim to increase coping and to reduce psychological problems during and after the pandemic. the participants will be randomized to either an intensive group (new module every 3rd day) or to an ordinary group (new module every 5th day).

the intervention was developed in a crossdiciplinary and cross-sectorial team within the framework of the research project intromat, an ict lighthouse research project funded by the norwegian research council. the content of the digital covid-19 intervention was based on four previously developed digital interventions, all based on systematic user-involvement and user-testing, from our group. the person-based approach inspired the development of the intervention. based on the research literature and experience from our existing digital interventions we started the development with establishing guiding principles. the intervention consists of 8 modules.

Eligibility criteria:
inclusion criteria: * read and write norwegian * above 18 years * mild and moderate stress exclusion criteria: * current treatment for mental health disorders * history or present severe mental health disorder
tri-modality sampling using radial probe endobronchial ultrasound for the diagnosis of peripheral pulmonary lesions

Conditions: Lung Nodule

Summary: as the former radial probe endobronchial ultrasound (rp-ebus) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.

this is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.

Eligibility criteria:
inclusion criteria: * patient with peripheral lung nodule less than 30mm on ct scan referred for biopsy * age ≥ 18 * written informed consent after participant's information exclusion criteria: * central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial ebus) * pure ggo lesion * patients at increased risk of bleeding 1. cannot stop agents such as antiplatelet agent or anticoagulant therapy 2. coagulopathy: thrombocytopenia (\ 1.5) * patient with existing or risk of pulmonary and cardiovascular decompensation * intolerance to sedation * vulnerable groups such as pregnant woman, breast feeding, etc. * previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility

Keywords: radial probe endobronchial ultrasound pulmonary nodule forceps biopsy needle aspiration cryobiopsy
a study of usage of paliperidone palmitate in patients with schizophrenia in a hospital setting

Conditions: Schizophrenia

Summary: the purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.

this is a prospective (look forward using periodic observations collected predominantly following patient enrollment), multicenter, observational study (a type of study in which participants are observed or certain outcomes are measured). this study will consist of 6-week observational period during which data will be collected for participants who are hospitalized due to schizophrenia exacerbation and are receiving treatment with paliperidone palmitate (treatment initiated within 3 weeks after admission to hospital). the participant satisfaction will be evaluated at week 6 (or early discontinuation). safety evaluations will include body weight, extrapyramidal symptom (eg, inability to initiate movement and inability to remain motionless) rating scale scores, concomitant therapy and assessment of adverse events.

Eligibility criteria:
inclusion criteria: * participants diagnosed with schizophrenia * participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity * participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital exclusion criteria: * participant has a known hypersensitivity to paliperidone or risperidone * participant has previously been treated with paliperidone palmitate * participant has a history of neuroleptic malignant syndrome * participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months

Keywords: schizophrenia paliperidone palmitate hospital setting schizophrenic disorders
effects of core stabilization approach on patients with upper extremity injuries

Conditions: Upper Extremity Injuries

Summary: the purpose of the study is to determine the effects of the addition of core stabilization exercises to a traditional upper extremity rehabilitation program in upper extremity injuries.

abnormal movement patterns are one of the most challenging problems during rehabilitation of the patients with upper extremity injuries. they usually decrease the functional status of the upper extremity and prevent isolated muscle activations. dysfunction of the kinetic chain system plays an important role in the development of these movement patterns. thus, multi-segmental rehabilitation strategies has recently gained considerable importance in upper extremity rehabilitation. core stabilization is one of the most popular rehabilitation approaches preferred to enhance functional stability of the kinetic chain system and dynamic postural alignment during activities. the purpose of this study is to determine the effects of core stabilization approach on functional status of the upper extremity and the amount of abnormal movement patterns. in addition, the factors affecting the abnormal movement patterns will be determined.

Eligibility criteria:
inclusion criteria: * traumatic distal segment injuries (elbow and wrist) * patients in their subacute stage. exclusion criteria: * multiple joint problems * bilateral extremity problems * reflex sympathetic dystrophy * trunk and lower extremity problems * non-union fractures * malignant ans systemic diseases

Keywords: core stabilization, upper extremity, kinetic chain, movement
trial with taxotere and cisplatin in non-operable adrenocortical carcinoma

Conditions: Adrenocortical Carcinoma

Summary: the trial is a phase ii trial in adrenocortical carcinoma (acc), a rare malignancy with poor prognosis. it will provide results leading to the establishment of the effect of the included drugs. the regimen consists of cisplatin plus taxotere. over a period of 1-2 years this national trial will include 19-36 patients with advanced acc from different centres in denmark. patients not responding to the first line treatment will be switched to the alternative regimen. the primary objective of this trial is to investigate response rate. secondary endpoints are survival, time to progression, best overall response rate and duration of response.

treatment every three weeks, evaluation after 2 cycles, ctc criterias used for toxicity evaluation

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of adrenocortical carcinoma * locally advanced or metastatic disease not amenable to radical surgery resection (stage iii-iv) * radiologically measurable disease * ecog performance status 0-2 * life expectancy \> 3 months * age ≥18 years * adequate bone marrow reserve (neutrophils \> 1500/mm3 and platelets \> 100,000/mm3) * effective contraception in pre-menopausal female and male patients * patient's written informed consent * ability to comply with the protocol procedures (including availability for follow-up visits) * previous palliative surgery, radiotherapy or radiofrequency ablation is acceptable as long as radiologically monitorable disease is verifiable afterwards. exclusion criteria: * history of prior malignancy, except for cured non-melanoma skin cancer, curatively in situ cervical carcinoma, or other cancers treated with no evidence of disease for at least five years. * previous cytotoxic chemotherapy for adrenocortical carcinoma * renal insufficiency (serum creatinine ≥2 mg/dl or creatinine clearance ≤ 60 ml/min) * hepatic insufficiency (serum bilirubin ≥2 x the institutional upper limit of normal range and/or serum transaminases ≥ 3 x the institutional upper limit of normal range; exception: in patients on mitotane, transaminase levels up to 5 x the institutional upper limit of normal range are acceptable) * pregnancy or breast feeding * known hypersensitivity to any drug included in the treatment protocol * presence of active infection * any other severe clinical condition that in the judgment of the local investigator would place the patient at undue risk or interfere with the study completion * current treatment with other experimental drugs and/or previous participation in clinical trials with other experimental agents for adrenocortical carcinoma

Keywords: adrenocortical carcinoma cisplatin taxotere
a study to evaluate subcutaneous durvalumab in patients with non-small cell lung cancer and small cell lung cancer

Conditions: Non-Small Cell Lung Cancer; Small Cell Lung Cancer

Summary: this study has 2 parts: dose finding and dose confirmatory. in part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with non-small cell lung cancer will be enrolled for a 12 month treatment period and 3 months follow up in part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in part 1 of the study. the goal of part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. approximately 90 participants with non-small cell lung cancer will be enrolled; additionally, up to 10 participants with small cell lung cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period. astrazeneca has decided to stop further enrollment and the study was terminated when all patients in part 1 (phase i) completed their last study visit. no safety issues or clinical concerns however, have been identified for this study. part 2 (phase ii) was not initiated.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented unresectable stage iii nsclc that has not progressed following definitive platinum based crt or extensive disease (stage iv) sclc * ecog performance status of 0 or 1 * for participants with sclc: at least 1 lesion, not previously irradiated, that qualifies as a recist 1.1 tl at baseline * absence of egfr mutation or alk rearrangement prior to screening exclusion criteria: * history of allogeneic organ transplantation * autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome, or wegener syndrome * uncontrolled intercurrent illness * history of another primary malignancy * history of active primary immunodeficiency * active infection including tuberculosis, hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * brain metastases or spinal cord compression * persistent toxicities (ctcae grade \>2) caused by previous anticancer therapy, excluding alopecia * receipt of live attenuated vaccine within 30 days prior to the first dose of ip

Keywords: imfinzi durvalumab
nectin-4 targeting adc probe for pet imaging in solid tumors

Conditions: Solid Tumor

Summary: to study the normal physiological distribution of the probe 124i-ev in human body and its ability to detect overexpression of nectin-4 in tumor lesions.

nectin-4 is highly expressed in different types of cancer and is involved in various aspects of tumor proliferation, angiogenesis, metastasis, tumor recurrence, and dna repair. therefore, the development of nuclear medicine molecular probes targeting nectin-4 is of great significance for improving the specificity and accuracy of nectin-4 related cancer diagnosis. ev (enfortumab vedotin) is the first and only drug targeting nectin-4 so far. by exploring the diagnostic efficacy of 124i-ev in tumors with high nectin-4 expression, it will not only provide evidence for the early diagnosis of tumors. at the same time, the nectin-4 expression in tumors can be used to develop effective and precise treatment for patients.

Eligibility criteria:
inclusion criteria: 1. 18-75 years old, male or female; 2. patients recommended by clinicians to undergo pet/ct examination for tumor diagnostic staging; 3. the subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent. 4. normal heart function; 5. good follow-up compliance; 6. presence of at least one measurable target lesion according to recist1.1 criteria 7. women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before the start of the test; fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test. exclusion criteria: 1. serious abnormality of liver, kidney and blood; 2. pregnant patients; 3. pregnant and lactation women; 3) unable to lie flat for half an hour; 4) refuse to join the clinical investigator; 5) suffering from claustrophobia or other mental diseases; 6) other conditions that researchers deem unsuitable for participating in the experiment.
impact of airways function after hfnc evaluated by ios

Conditions: Small Airway Disorders; COPD

Summary: in addition to pharmacological treatment, nonpharmacological treatment with high-flow nasal cannula (hfnc) may play a vital role in the treatment of patients with chronic obstructive pulmonary disease (copd). the impulse oscillation system (ios) is new noninvasive technique to measure the impedance of different portions of the airway with higher sensitivity than that of the conventional pulmonary function test (pft). however, whether ios is an appropriate technique to evaluate the efficacy of hfnc in improving the impedance of peripheral small airways in patients with copd is unclear.

participants with stable copd from the chest medicine outpatient department will be randomized into two groups receiving hfnc or nasal cannula (nc) for 10 min followed by a 4-week washout period and crossover alternatively. we used a novel analytical measurement technique, ios, to detect the difference in airway impedance in the participants after the hfnc or nc interventions. all data, namely ios parameters, transcutaneous partial pressure of carbon dioxide, peripheral oxygen saturation, body temperature, respiratory rate, pulse rate, blood pressure, and pft results at the time of pre-hfnc, post-hfnc, pre-nc, and post-nc, were analysed using spss (version 25.0, ibm, armonk, ny, usa).

Eligibility criteria:
inclusion criteria: * age of 20 to 75 years old * diagnosis of copd made by pulmonologist (kuo yl) if the patient had a long-term smoking or noxious gas exposure history, typical clinical manifestations, and airflow limitation with a postbronchodilator fev1/fvc ratio of \< 0.7 in spirometry,4 and * provision of written informed consent. exclusion criteria: * severe and unstable comorbidities or active malignancy * history of obstructive sleep apnoea syndrome * copd exacerbation within the 4 weeks prior * current use of long-term oxygen therapy or noninvasive ventilation or use within the 6 weeks prior * cognitive impairment or a psychiatric disorder * pregnancy

Keywords: high-flow nasal cannula high nasal flow chronic obstructive pulmonary disease (copd) airway impedance distal airway peripheral airway airway resistance
polish atrial fibrillation (pol-af) registry

Conditions: Atrial Fibrillation

Summary: evaluation of clinical characteristics and pharmacotherapy of hospitalized polish patients with atrial fibrillation (af).

atrial fibrillation (af) is a common arrhythmia associated with increased cardiovascular mortality. an important element of management of patients with af is anticoagulation to prevent thromboembolic events. non-vitamin k oral anticoagulants (noacs) and vitamin k antagonists (vkas) are two main drugs groups used in thromboembolic events prevention. primary objective of the study is to assess the frequency of vkas vs noacs prescription in af patients treatment of with oacs. secondary objective of the study are as follows: assessment of the frequency of appropriate/inappropriate oacs prescription in af patients and assesment of the number of patients with af treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to cha2ds2-vasc score. the pol-af registry is a multicenter prospective analysis of hospital records of patients with af managed in ten cardiology centers. collected data will include demographics, type of af (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic parameters and concomitant medications. each patient will be evaluated regarding to common scales assessing risk of thromboembolic (cha2ds2-vasc) and bleeding (has-bled, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for af treatment) events.

Eligibility criteria:
inclusion criteria: - patients with af hospitalized in a participating center during study period exclusion criteria: * hospitalisation for atrial fibrillation ablation * death during hospitalization

Keywords: atrial fibrillation anticoagulant treatment apixaban dabigatran rivaroxaban vitamin k antagonist stroke prevention
integrated treatment for cocaine and mood disorders - 1

Conditions: Cocaine Dependence; Depressive Disorder, Major

Summary: the purpose of this study is to test whether cognitive behavioral therapy and bupropion hydrochloride will help cocaine users, who are depressed, reduce or end their cocaine use and improve their mood.

the global aim of this study is to evaluate an "integrated" treatment approach for cocaine dependent patients with comorbid unipolar depression. it is hypothesized that a cognitive-behavioral psychotherapy that targets both disorders, in combination with a pharmacotherapy, i.e., bupropion, is expected to provide the best coverage for dual disorders and thus maximize treatment outcomes. specifically, we will conduct a double blind, placebo-controlled clinical trial involving the random assignment of participants into one of four treatment conditions according to a full 2x2 factorial research design. one independent variable will be pharmacotherapy (bupropion versus placebo); the other independent variable will be psychotherapy (integrated cbt versus clinical management). the study will enroll 140 cocaine dependent patients with comorbid major depressive disorder. a secondary objective is to further elucidate "primary" and "secondary" paradigms of depressive illness symptoms in cocaine-dependent adults and better understand how this distinction influences treatment outcome. this will be accomplished by enrolling a subsample of patients with substance-induced mood disorder. taken together, this proposal will examine the feasibility and relative efficacy of a novel integrated treatment model for dually-diagnosed patients.

Eligibility criteria:
inclusion criteria: * generally physically healthy * aged 18-55 * meets cocaine dependence by dsm-iv criteria * meets major depressive disorder or substance-induced depression disorder by dsm-iv criteria. * willing and able to participate in the 12 week treatment study and one year follow up. exclusion criteria: * pregnant or breastfeeding. * taking medications that interact with the study medication (mao inhibitors, anticonvulsants, haloperidol, phenothiazines,selegiline, anesthetics * have other psychiatric diagnoses requiring therapy or medication. * physically dependent on opiates or alcohol. * currently being treated with bupropion hydrochloride (e.g. zyban).

Keywords: cocaine dependence
opioid maintenance medications comparison study

Conditions: Opioid Dependence

Summary: a 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing laam, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.


Eligibility criteria:
inclusion * age 21 to 55 years * diagnosis of opioid dependence by criteria of the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * evidence of recent opioid use on toxicologic screening exclusion * serious medical or psychiatric illness requiring long-term medication * positive pregnancy test