Kornimate/medical-research-clean huggingface dataset:
lifestyle on-line intervention in patients with obesity and hypertension

Conditions: Obesity; Hypertension

Summary: this study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). the experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. assessment will include: body composition (bmi), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers). design: randomized controlled trial.

healthy eating and regular exercise play an important role to maintain health while ageing. nutritional education and exercise practice could be monitored by different means, such as internet, face to face and/or through exercise diaries. information and communication technologies (icts) could be a useful tool to promote health, and could be used to work on barriers, such as low motivation and difficulties to maintain exercise or diet. icts also have other important advantages, especially their good cost-benefit relationship and the possibility of increasing the efficiency of interventions, allowing them to reach a wider audience at a lower cost. this study aims to describe a totally self-applied online program to promote healthy lifestyles (nutritional education and exercise practice) for obese participants with hypertension. participants will be recruited from users of a hypertension unit of a public hospital and will be randomized into two groups: experimental group and control group (treatment as usual). the experimental program (3 months) will be composed by 8 modules aimed for promoting healthy eating habits and increase physical activity. assessment will include: body composition (bmi), blood pressure, glucose metabolism variables, and physical activity level (measured with accelerometers).

Eligibility criteria:
inclusion criteria: * overweight or obesity (bmi= 25-35 kg/m2) * hypertension exclusion criteria: * not having access to the internet or lack of information about it. * treatment with more than 3 antihypertensive drugs. * diabetes mellitus diagnosis. * meet the criteria of the dsm-iv-tr of a food disorder. * presenting some type of severe psychiatric disorder. * disability that prevents or hinders physical exercise. * be receiving some treatment for weight loss in another center.

Keywords: exercise nutrition internet obesity hypertension
imaging to improve brain stimulation

Conditions: Depressive Disorder

Summary: this study investigates how brains change as a result of a treatment for depression called repetitive transcranial magnetic stimulation (rtms). people who receive rtms will have pictures of their brains and brain activity taken by a magnetic resonance imaging (mri) scanner before and after their treatment, as well as up to three times during the six-week treatment course. these images will be examined to see if the rtms is placed correctly to help treat their symptoms, and what changes in brain activity are happening during the rtms treatment

veteran patients can be referred to receive a neuromodulation clinic consult at the providence va medical center (pvamc). following this consultation, patients who are to begin rtms therapy for the treatment of major depressive disorder (mdd) will be recruited to participate in this study. about 1 week prior to the scheduled beginning of rtms therapy, research participants who provide informed consent will complete baseline neuropsychological measures. within a few days of completing these measures, and before beginning rtms therapy, participants will receive an mri scan, including structural and functional imaging. participants will have a similar set of mri scans up to three times during the course of rtms therapy, and complete neuropsychological measures at these scanning sessions. a final mri scan will be conducted within a week of completing the rtms therapy course, and neuropsychological measures will be completed at this session.

Eligibility criteria:
inclusion criteria: * veteran beginning tms therapy for the treatment of mdd at the providence vamc neuromodulation clinic * age between 18 and 80 years * able to read, verbalize, understand, and voluntarily sign the informed consent form * structured clinical interview for dsm-5 (scid-5) confirmed diagnosis of mdd exclusion criteria: * contraindications to mri (e.g. implanted metal or electronic devices) * montreal cognitive assessment (moca) score \< 26 * pregnant

Keywords: transcranial magnetic stimulation magnetic resonance imaging
the effectiveness of dual therapy (lopinavir/ritonavir + lamivudine) in treatment-experienced hiv infected patients in the russian federation

Conditions: HIV-1 Infection

Summary: this study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (lpv/r) + lamivudine (3tc)) in treatment-experienced human immunodeficiency virus 1 (hiv-1) infected participants with an undetectable plasma hiv-1 (ribonucleic acid) rna level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the russian federation.


Eligibility criteria:
inclusion criteria: 1. age 18 years and older (male and female). 2. hiv-1 infected patients on any triple haart with plasma hiv-1 rna level \<50 copies/ml for at least 6 months (two consequently plasma hiv-1 rna levels) transferred as medically appropriate to lpv/r + 3tc as decided by the physician in the routine clinical settings. or hiv-1 infected patients who were switched on the dual therapy (lpv/r + 3tc) no more than 60 days ago. 3. cumulative haart experience at least 6 months. 4. authorization (consent) for use/disclosure of data signed by the patient. exclusion criteria: 1. contraindications to lopinavir/ritonavir and lamivudine 2. previous participation in this program

Keywords: antiretroviral therapy
a study of gr1802 in participants with chronic sinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: the goal of this clinical trial is to learn if gr1802 works to treat severe chronic rhinosinusitis with nasal polyps (crswnp) in adults. it will also learn about the safety of gr1802. the main questions it aims to answer are: 1. does gr1802 reduce the need for surgery and systemic corticosteroid use？ 2. what medical problems do participants have when taking gr1802? researchers will compare gr1802 to a placebo (a look-alike substance that contains no drug) to see if gr1802 works to treat crswnp. participants will: take gr1802 or a placebo once every 2 weeks for 13months. visit the clinic once every 2 weeks for checkups and tests. keep a diary of their symptoms and the dosage and number of times they use mometasone furoate nasal spray.

a randomized, double-blind, placebo-controlled, multi-center clinical trial was designed. the clinical trial was divided into 4 stages: screening/introduction period, double-blind treatment period , maintenance treatment period and safety follow-up period. the clinical trial aimed to evaluate the efficacy, safety and immunogenicity of gr1802 injection in crswnp participants.

Eligibility criteria:
inclusion criteria: * diagnosed as crswnp and treated with systemic glucocorticoid within 2 years before screening; and/or those who had undergone surgery for nasal polyps before screening. * an endoscopic bilateral nps at screening/lead-in period and the baseline period of at least 5 out of a maximum score of 8 (with a minimum socre of 2 in each nasal cavity). * nasal congestion/blockade/obstruction with moderate or severe symptom severity at at screening period (score 2 or 3 ) . * willing to sign an informed consent, able to comply with clinic visits and study-related procedures as per protocol. exclusion criteria: * biologic therapy within 5 half-lives or within 10 weeks before baseline. * anti-il-4rα antibody before screening. * an experimental drug within 5 half-lives or 1 months before baseline. * systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 2 months or 5 half-lives before baseline. * initiation of allergen immunotherapy within 3 months before screening. * participants receiving leukotriene antagonist/modifier before screening unless on continous treatment for at least 30 days. * participants with fev1 50% or less of predicted normal were excluded. * participants who have undergone any intranasal and/or sinus surgery within 6 months before screening. * acute sinusitis or upper respiratory infection within a defined time period before screening. * a nasal cavity tumor (malignant or benign). * evidence of fungal rhinosinusitis. * presence of another diagnosis associated with nasal polyps (i.e., eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, young's syndrome, cystic fibrosis). * rhinitis medicamentosa. * nasal septal deviation occluding at least one nostril. * antrochoanal polyps. * pregnant or lactating woman.
high frequency percussive ventilation in covid-19 patients

Conditions: COVID-19; Acute Respiratory Failure

Summary: high frequency percussive ventilation (hfpv) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure. hfpv is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle. the high-frequency breaths create shear forces causing dislodgement of the airway secretions. furthermore, the hfpv breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway. in addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange. in acute care and critical care settings, hfpv intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where hfpv breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator. the most common indications for hfpv use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments. this study aims to assess the lung physiological response to hfpv in terms of aeration and ventilation distribution in patients with acute respiratory failure due to sars-cov-2 infection and requiring high flow oxygen therapy through nasal cannula


Eligibility criteria:
inclusion criteria: * acute respiratory failure with a nasal swab positive for sars-cov-2 * need for high-flow oxygen through nasal cannula exclusion criteria: * life threatening cardiac arrythmia * pneumothorax * acute spinal injury * chest trauma * hemodynamic instability * chest or abdominal surgery in the previous 7 days * pregnancy * enrollment in other study protocols
respreeza® self-administration and learning program (amaretti study)

Conditions: Alpha-1 Antitrypsin Deficiency

Summary: according to the respreeza® summary of product characteristics, the initial infusions must be administered under the supervision of a health professional experienced in the treatment of alpha-1 antitrypsin deficiency, although subsequent infusions may be administered at home by the person responsible for care or by the patient. clinical data on self-administration of respreeza® are however limited and the grounds for self-administration are left to the assessment of the attending physician, who needs to ensure that appropriate training is delivered. in this context, csl behring would like to run a clinical study in order to assess the effectiveness of a home self-administration learning program in terms of switching to self-administration, and the long term maintenance of this administration.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥18 years old). * patients suffering from aatd treated by respreeza® through a peripheral vein at home for at least 3 month (consecutives or not). the 3-month period of treatment with respreeza® does not necessarily correspond to the 3 months prior to inclusion. * patient accompanied by a third person at home * patients deemed to be suitable by the investigator for self-administration. * patients with a life expectancy of over 3 years. * patients who have been informed verbally and in writing via the information leaflet and who have signed the informed consent form. exclusion criteria: - in order to reflect the reality of everyday practice, no non-inclusion criteria are intended except for patient refusal to take part in the study.
pain phenotyping in knee oa: a pilot trial

Conditions: Osteo Arthritis Knee; Chronic Post-operative Pain

Summary: osteoarthritis (oa) is disease in which the joint breaks down, causing pain. the decision to surgically replace the knee, a procedure called total knee arthroplasty (tka), depends on x-ray results as well as pain and dysfunction. despite tka resulting in good outcomes for most patients, between 1 in 10 and 1 in 5 patients remain in significant pain - i.e., are 'tka non-responders'. two pain conditions - myofascial pain syndrome (mps) and central sensitization - frequently coexist with signs of oa and may contribute to a tka non-responder profile. mps, caused by knots within skeletal muscle, can contribute to an oa patient's pain and dysfunction. in central sensitization, faulty pain sensing leads to increased pain sensitivity. however, there is currently no established process to identify these sources of pain and potential associated tka non-responder risk. our research aims conduct a pilot study to examine the impact of pain diagnosis tools to help orthopedic surgeons identify potential tka nonresponders. this new approach may increase healthcare efficiency (reduce tka waitlist and length of hospital stay), and help patients receive the right care at the right time.


Eligibility criteria:
inclusion criteria: * adult patients aged 18 or older * on the waitlist for tka (unilateral) for knee osteoarthritis exclusion criteria: * undergoing revision or non-elective surgery * unable to provide informed consent and follow study procedures
study of transbronchial cryobiopsy in monitoring complications of lung transplantation

Conditions: Lung Transplant Rejection

Summary: the goal of this randomized controlled trial is to compare the diagnostic efficacy and safety of transbronchial cryobiopsy (tbcb) and traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection , so as to establish the evidence-based medical basis for the effectiveness and safety of tbcb for monitoring after lung transplantation, it is expected to provide a better auxiliary examination method for lung transplantation. the main questions it aims to answer are: (1) histopathological evaluability of specimens; (2) safety of tbcb; (3) size and quality of specimen, and number of attempts to obtain five samples. participants will undergo tbcb with 1.1 mm flexible cryoprobe or traditional transbronchial lung biopsy with biopsy forceps.


Eligibility criteria:
inclusion criteria: * age among 18-65 years old * after unilateral or bilateral lung transplantation, patient with unexplained pulmonary function decline, acute/chronic clinical lung injury or new pulmonary infiltrates * or patients requiring monitoring of rejection after lung transplantation * the patient should undertake routine preoperative examinations for lung cryobiopsy, including routine blood test, coagulation function, electrocardiogram, and chest ct, and the patients have no contraindications to cryobiopsy exclusion criteria: * patients intolerable to undertake lung biopsy due to severe cardiopulmonary insufficiency or being weak * the patient is allergic to lidocaine and midazolam * the patient has recent active massive hemoptysis, or the proposed biopsy site has a high risk of bleeding, such as bronchial artery penetration or suspected renal cancer lung metastasis * unstable angina, congestive heart failure, severe bronchial asthma or multiple bullae * severe hypertension and arrhythmia, hemodynamic instability and severe respiratory failure (pao2\<60mmhg after oxygen therapy or mechanical ventilation) * the patient has coagulation disorder and unable to stop taking anticoagulants, antiplatelet drugs, aspirin or non-steroidal anti-inflammatory drugs before lung biopsy * suspected aortic aneurysm * the patient does not agree to participate in this study * participating in other studies within three months and not withdrawing or ending * the researchers think that the patient are not suitable for inclusion
modified duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy

Conditions: Pancreatic Fistula

Summary: the aim of this study is to compare surgical outcomes of modified one-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy

duct-to-mucosa and invagination pancreaticojejunostomy are two most commonly used anastomotic techniques after pancreaticoduodenectomy, with comparable incidence rate of pancreatic fistula (pf). we modified the conventional two-layer duct-to-mucosa pj into one-layer pj. the aim of this study is to examine if the investigator's modified duct-to-mucosa pj can reduce pf after pd when compared to invagination pj. this trial is a single-center, randomized, controlled, patient- and observer- blinded study, whose primary aim is to assess whether a modified duct-to-mucosa pj (trial group) is superior to an invagination pj (control group), in terms of clinically relevant pf and other complications. a total of 380 patients, who are to undergo elective pd, will be recruited and randomized intraoperatively into either of the two groups. the primary efficacy endpoint is the incident rate of clinically relevant pf. secondary outcome measures are: entry into adjuvant therapy, mortality, surgical complications, non-surgical complications, hospital stay. patients will be followed up for 3 months. statistical analysis will be based on the intention-to-treat population. the duration of the entire trial is estimated to be two years.

Eligibility criteria:
inclusion criteria: * written informed consent obtained； * both sexes between 18 and 80 years old； * patients scheduled to elective open pancreaticoduodenectomy. exclusion criteria: * patients with asa score \>=4; * patients who had a previous pancreatic operation; * patients with an immunodeficiency; * patients who underwent an emergency operation; * pregnant patients； * patients who was found that pancreaticoduodenectomy was not suitable。
radiation dose escalation in locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: this is a one arm study where patients with locally advanced rectal cancer will receive neoadjuvant treatment with escalated dose radiotherapy (with 3d conformal radiotherapy, up to 59,4 gy) and radiosensitizing chemotherapy. then, patients will operated (total mesorectal excision) after 8 weeks of interval. primary endpoint will be pcr (pathologic complete response).

introduction: rectal cancer is a highly prevalent disease all over the world. in brazil, it is the second most common cancer among women (after breast tumors), with an estimated incidence of 17.2 cases per 100,000 inhabitants and is the third most common cancer in men (after prostate and lung cancers), with an estimated incidence of 15.4 cases per 100,000 inhabitants. goals: the aim of this study is to evaluate the pathologic complete response (pcr) of patients with locally advanced rectal cancer (larc) treated with neoadjuvant radiochemotherapy (rct) employing anticancer drugs at standard dose and interval extended to surgery with or without adjuvant neoplastic therapy. procedures: neoadjuvant chemoradiotherapy with radiation dose escalation associated with radiosensitizing therapy and surgery with a total mesorectal excision (tme), 8 weeks after completing neoadjuvant treatment.

Eligibility criteria:
inclusion criteria: * locally advanced rectal cancer, 0-15 cm from anal verge, ct3/4 or cn+ exclusion criteria: * metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor

Keywords: rectal cancer radiotherapy escalated dose interval
feasibility of immunotherapy plus chemotherapy administration to patients with bronchial cancer in a hospital-at- home setting

Conditions: Bronchial Cancer

Summary: this observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy-chemotherapy combo for bronchial cancer in maintenance phase of first row metastatic treatment. the feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated. a cost-benefit analysis will be done to compare hospital-at-home programme and classical day hospitalization.

those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. this type of management has particularly developed in the context of the covid pandemic and recommendations for good practices in hospital-at-home immunotherapy have recently been drafted by fitc (société française d'immuno-thérapie du cancer). these recommendations open the way for administration of immunotherapy and chemotherapy combo in hospital-at-home. at the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy-chemotherapy combo. to follow up on the feasibility study of home immunotherapy (imhadom) carried out at ch pau from march 2019 to march 2021, the sponsor propose to evaluate with descriptive study the feasibility under the same conditions of chemotherapy-immunotherapy in patients treated in the maintenance phase of a first metastatic row. this study will be proposed to all the patients in maintenance phase of first row treatment with at least one positive tumoral imaging assessment (stable disease or partial response) for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting. the patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year.

Eligibility criteria:
inclusion criteria: * patients aged 18 and over, * with bronchial metastatic cancer treated in first row maintenance phase by immunotherapy-chemotherapy combo, * having at least one assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response), * without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy * eligible for a home-based hospitalization exclusion criteria: * frail patients requiring a frequent medical assessment thus day hospitalization cares

Keywords: immunotherapy chimiotherapy bronchial cancer home-based hospitalization