Kornimate/medical-research-clean huggingface dataset:
the effect of exercise in postmenopausal women with low bone density

Conditions: Osteoporosis; Osteopenia

Summary: this clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise program on bone density and falls risk factors in postmenopausal women with low bone density. it is hypothesised that the exercise program will lead to improvements in bone density and falls risk factors such as balance and muscle strength compared with usual care.


Eligibility criteria:
inclusion criteria: * be aged greater than 50 years * be at least 5 years post menopause (defined as the last normal menstrual bleed) * have osteopenia of the hip defined as a dxa t-score between -1 and -2.5 in one or more regions of the proximal femur (total hip, neck or trochanter regions). * have primary osteopenia * be community dwelling (not in residential care) * be able to attend an exercise program 3 times per week over the 12-month period * be able to read and write english exclusion criteria: * secondary causes of bone loss such as osteomalacia, glucocorticoid medication * co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition * physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise * spinal osteoporosis defined as dxa t-score \<-2.5 * a past vertebral fracture * body mass index \> 35 or \< 18. * currently on hormone replacement therapy (hrt) * current smoker * past use of hrt within the past 3 years and for more than 6 months duration * taking medication known to affect bone including oestrogen or steroid hormones * known clinically significant liver or renal disease * cancer within the past 5 years * doing regular strength training and/or weight-bearing exercise at least once per week in past 6 months * unlikely to comply with the intervention protocol

Keywords: osteoporosis exercise low bone density falls
postoperative respiratory and activity monitoring

Conditions: Hypoventilation; Hypoxemia; Postoperative Pulmonary Complications

Summary: this study plans to learn more about specific breathing and activity recommendations for patients after surgery. participants will be monitored after abdominal surgery to identify what activities help them breathe better and reduce complications after surgery.

investigators will study adults undergoing elective abdominal surgery with at least moderate risk for postoperative pulmonary complications. participants will be monitored on their chest and thigh with devices that record their breathing pattern (breath volume and frequency) and body position and movements. these monitors will be placed on their skin in the post-anesthesia care unit (pacu) and will stay on for three days, or until the patient is able to ambulate freely or until their hospital discharge, whichever comes earlier. investigators will analyze the association between the frequency, duration and intensity of various activities (e.g., sitting, walking) and breathing and other clinical complications, in combination with medications received and other hospital course events.

Eligibility criteria:
inclusion criteria: * must be 18 or older * must be undergoing abdominal surgery * must be high-risk for ppcs (ariscat score equal to or greater than 26) exclusion criteria: * anyone under 18 * anyone not undergoing abdominal surgery * anyone that is not high-risk for ppcs (ariscat score less than 26)

Keywords: hypoventilation postoperative activity abdominal surgery mobilization predicted minute ventilation (mvpred) accelerometer chest monitor postoperative pulmonary complications surgical outcomes
acetylated natural nucleotides in treating hand-foot syndrome

Conditions: Hand-foot Syndrome

Summary: the clinical trial is planned to investigate the efficacy and safety of acetylated natural nucleotides in treating anti-cancer medications induced hand-foot syndrome (hfs).


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * pathologically conﬁrmed cancer receiving capecitabine-based anti-cancer therapy (capecitabine with or without other anti-cancer drugs). * with hfs determined by "ctcae v5.0 - ppe" as grade 2 or above. * able to use topical medications and complete questionnaires reliably with or without assistance. * ecog performance score \< 2. exclusion criteria: * has hfs due to other medications and does not recover within 4 weeks prior to baseline. * other skin disorders that will affect efficacy evaluation on the hands and feet, including but not limited to: tinea of feet and hands, hand/foot eczema, palmoplantar pustulosis, palmoplantar keratosis, acrodermatitis continua etc. * uncontrolled intercurrent illness as determined by the investigator including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, uncontrolled hypotension or hypertension, cardiac arrhythmia, or psychiatric illness and social situations that would limit compliance with study requirements. * significantly abnormal lab test: * inadequate hematologic function as indicated by: * absolute neutrophil counts (anc) \< 1,500 /mm\^3 * hemoglobin (hgb) \< 8.5 g/dl * platelet count \< 75,000 /mm\^3 * pt or ptt \> 1.5 x uln (if patients on anticoagulants: pt inr \> 3.5 x uln) * inadequate renal and liver function as indicated by: * albumin \< 2.8 g/dl * total bilirubin \> 1.5 x uln (or \> 2.5 x uln for patients with gilbert's syndrome) * aspartate aminotransferase (ast), alanine aminotransferase (alt), and alkaline phosphatase \> 2 x uln * creatinine \> 2 x uln * any other condition which, in the opinion of the investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
an open-label study with tocilizumab in patients with rheumatoid arthritis in a local environment

Conditions: Rheumatoid Arthritis

Summary: this open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic dmard. tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (mtx). the anticipated time of study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients \>/=18 years of age * moderate to severe rheumatoid arthritis defined as das 28\>3.2 * body weight \</=150 kg * patient on at least 1 non-biologic dmard on a stable dose for at least 8 weeks at any time prior to study start * inadequate clinical response to a stable dose of a non-biologic dmard exclusion criteria: * major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment * rheumatic autoimmune disease other than rheumatoid arthritis (ra) * functional class iv as defined by the acr classification * history or current inflammatory joint disease other than ra * previous treatment with any cell depleting therapy * previous treatment with methotrexate * previous treatment with tocilizumab * previous treatment with any biologic drug that is used in the treatment of ra
gardasil 9 vaccine in preventing hpv infection in patients with hematologic malignancies undergoing donor stem cell transplant

Conditions: Allogeneic Hematopoietic Stem Cell Transplant Recipient; Hematopoietic and Lymphoid Cell Neoplasm

Summary: this phase iv trial studies how well gardasil 9 vaccine works in preventing human papillomavirus (hpv) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. vaccines, such as gardasil 9, may help the body build an effective immune response to kill cancer cells.

primary objectives: i. to determine the immunogenicity of recombinant human papillomavirus nonavalent vaccine (gardasil 9) administered after allogeneic stem cell transplant (sct) in patients with hematologic malignancy by comparing hpv 9-plex competitive luminex immunoassay (9-plex clia) titers before and after gardasil 9 administration. ii. to evaluate the safety and tolerability of gardasil 9 administered after allogeneic sct in patients with hematologic malignancy. outline: patients undergo standard of care allogeneic stem cell transplant. 6-12 months following transplant, patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (im) on day 0 and at 2 and 6 months in the absence of disease progression or unacceptable toxicity. after completion of study intervention, patients are followed up within 3 days.

Eligibility criteria:
inclusion criteria: * all english-speaking adult md anderson patients with hematologic malignancy at 6-12 months +/- 8 weeks post allogeneic stem cell transplantation who will receive usual post-stem cell transplant vaccinations * all patients from approved protocol 2015-0795 will be invited to this vaccine study exclusion criteria: * prior allogeneic sct * platelet count less than or equal to 25,000 k/ul * absolute neutrophil count less than or equal to 500/ul * patients who have ever received hpv vaccination (at least one dose of hpv vaccine) * patients with a prior history of hpv-related malignancy * female patients who tested positive for pregnancy during pre-sct evaluation
follow-up of respiratory sequelae of hospitalized patients with covid-19

Conditions: Covid19; Dyspnea

Summary: the objective of this multicenter observational study is to describe respiratory sequelae of covid-19 patients hospitalized for severe pneumonia requiring oxygen supply.

main objective to assess respiratory sequelae after sars-cov-2 infection in hospitalized patients with severe pneumonia requiring oxygen supply and followed up for 6 months after hospital discharge (see primary and secondary outcomes). secondary objectives to describe pulmonary sequelae according to : * the unit in which the patient was hospitalized, * the maximum oxygen flow rate required during hospitalization, * mccabe score, * age, * tobacco consumption, * biological data (e.g. blood count, crp, fibrinogen, ldh, albumin, d-dimer, ferritin), * number of days from onset of symptoms to hospitalization, * co-morbidities (e.g. diabetes, hypertension, coronary artery disease/heart failure, mild to moderate copd/respiratory failure, overweight), * concomitant treatments (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants, ace inhibitors) * specific drug treatments administered to treat covid-19 infection, * non-drug treatments (invasive ventilation, non-invasive ventilation, postural treatment) to manage respiratory disorders of covid-19 infection. to assess the impact of factors of social inequality on the severity of covid-19 infection. conduct of research patients who have been hospitalized for severe pneumonia due to cov-2 sars infection will be seen in consultation at approximately 3 and 6 months after hospital discharge, as per standard practice.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * sars-cov-2 infection proven by rt-pcr and/or retrospective serology and/or a covid-19 syndrome with evocative chest ct scan * hospitalized for severe pneumonia due to sars-cov-2 infection requiring oxygen supply exclusion criteria: * not hospitalized for a severe covid-19 infection * absence of respiratory symptoms at v1 (3 months after hospital discharge), defined as: absence of residual exertional dyspnea and persistent pulmonary infiltrates on follow-up chest radiography at 1 month (if available), transcutaneous oxyhemoglobin saturation \>94% and normal pulmonary auscultation * patient with pre-existing chronic lung disease prior to the first episode of covid-19: chronic obstructive pulmonary disease confirmed by respiratory function testing with a forced expiratory volume in one second (fev1) \< 50% and/or a diffusing capacity for carbon monoxide (dlco) \< 60%, fibrotic lung disease or chronic respiratory failure (on long-term oxygen therapy) * opposition to participation in the study * patient under legal protection * patient not affiliated to/beneficiary of a social security scheme

Keywords: covid19 pneumopathy dyspnea
a lm-302 combined with toripalimab phase ii study

Conditions: Gastric Cancer; Pancreatic Cancer

Summary: a phase ii, open-label, multicenter study evaluating the efficacy, safety, and tolerability of lm-302 combined with toripalimab in cldn18.2 positive patients advanced gastro-intestinal cancer

primary objective: to evaluate the efficacy of the lm-302 + toripalimab regimen in subjects with cldn18.2-positive advanced gastro-intestinal cancer secondary objectives: to evaluate the correlation between cldn18.2 and pd-l1 expression levels and the antitumor activity of the lm-302 + toripalimab regimen.

Eligibility criteria:
inclusion criteria: 1. subjects who fully understand the purpose, nature, methods, and possible adverse reactions of the trial, voluntarily participate in the trial, and have signed the informed consent form (icf) before any procedure begins. 2. male or female subjects aged 18-80 years (both inclusive) at the time of signing the icf. 3. ecog performance score of 0-1. 4. subjects with an expected survival ≥ 3 months. 5. diagnosed histologically or cytologically with local advanced gastro-intestinal cancer 6. cldn18.2-positive subjects. 7. subjects with at least 1 measurable lesion according to recist v1.1. 8. subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose. 9. subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study. exclusion criteria: 1. participate in any other clinical trial within 28 days prior to 1st dosing of investigational medicinal product (imp). 2. subjects with anti-tumor treatment within 21 days prior to 1st dosing of imp. 3. any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of ctcae v5.0. 4. subjects with uncontrolled pain. 5. use of any live attenuated vaccines within 28 days prior to 1st dosing of imp. 6. subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy. 7. subjects on anticoagulants, such as heparin and vitamin k antagonists. 8. subjects who have undergone major surgery or received interventional therapy (excluding tumor biopsy or aspiration) within 28 days before the first dose. 9. subjects with a history of malignancies other than the tumors investigated in this study within 2 years prior to the first dose. 10. subjects who have severe cardiovascular disease. 11. subjects with a known history of autoimmune diseases. 12. subjects who have a history of immunodeficiency disease. 13. subjects with hiv infection, active hbv or hcv infection. 14. child-bearing potential female who have positive results in pregnancy test within 7 days before the first dose or are lactating. 15. subjects who have psychiatric illness or disorders that may preclude study compliance and subject who is judged as not eligible to participate in this study by the investigator.
feasibility trial of traumatic brain injured patients randomized in the prehospital setting to either hypertonic saline and dextran versus normal saline

Conditions: Brain Injuries

Summary: this clinical trial will evaluate the ease of conducting a randomized trial on patients with severe head injury who are cared for by paramedics in the out of hospital setting. the trial will compare two different kinds of fluids that are commonly used to elevate blood pressure and minimize the impact of the brain injury. the two solutions are a salt solution of different concentrations. one is a normal saline solution similar to the consistency of human blood and the other is a higher concentration mixed with a sugar that helps to keep the solution in the blood stream longer. this study is conducted without patient consent at the time of the study enrolment. the study will report on whether this trial is feasible in the out of hospital setting before launching into a larger definitive trial.

the toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (tophr hit) is a randomized, placebo-controlled out of hospital trial of blunt trauma patients with head injuries. the study compares a group receiving normal saline according to a paramedic's protocol, with a treatment group receiving a single dose 250 ml of 7.5% hypertonic saline in 6% dextran 70 (rescueflow biophausia ab, stockholm sweden). the primary objective of this study is to report feasibility in accordance with the methodology described by lancaster and dodds\*, specifically addressing: 1. baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial. 2. randomization compliance rate. 3. ease of protocol implementation in the out-of-hospital setting. 4. adverse rate of hsd infusion. the secondary objectives include measuring the effect of hsd in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to hsd intervention; evaluating effects of hsd on brain atrophy post-injury and neurocognitive and neuropsychological outcomes. \*lancaster, g.a., s. dodd, and p.r. williamson, design and analysis of pilot studies: recommendations for good practice. j eval clin pract, 2004. 10(2): p. 307-12.

Eligibility criteria:
inclusion criteria: * age ≥ 16; * initial assessment of gcs 8 or less; * blunt traumatic mechanism of injury. exclusion criteria: * known pregnancy; * primary injury penetrating; * vsa prior to randomization; * previous intravenous therapy ≥ 50 ml; * time interval between arrival at scene and intravenous access exceeds four hours; * amputation above wrist or ankle; * any burn (thermal, chemical, electrical, radiation) * suspected hypothermia; * asphyxia (strangulation, hanging, choking, suffocation, drowning) * fall from height ≤ 1m or ≤ 5 stairs

Keywords: emergency medical services traumatic brain injury hypertonic saline with dextran fluid resuscitation
efficacy of oral ibandronate in osteoporosis

Conditions: Osteoporosis

Summary: there has been no comparative data between oral ibandronate and oral ibandronate plus active vitamin d


Eligibility criteria:
inclusion criteria: * osteoporotic patients who want to take oral ibandronate exclusion criteria: * patients who are allergic to oral ibandronate or vitamin d patients who have not taken oral ibandronate for the last 2 years
n acetyl cysteine for cystinosis patients

Conditions: Renal Disease; Cystinosis

Summary: this study intends to verify the interference of n acetyl cysteine in the progression of chronic kidney disease in patients with nephropathic cystinosis.

patients with nephropathic cystinosis have an increased oxidative stress and go to end-stage renal disease, even when all steps of the treatment are done. therefore, this study is conducted to verify the interference of the stress oxidative in the progression of the renal disease with the use of an oxidant drug, n acetyl cysteine (nac). the investigators selected patients with good compliance of the treatment. in these patients the investigators evaluate the serum creatinine, creatinine clearance estimated by schwartz formula, cystatin c and a marker of oxidative stress, tbars ( thiobarbituric acid substances). the variables are analyzed 6 months before the introduction of nac and the three months after nac.

Eligibility criteria:
inclusion criteria: * cystinosis patients age under 18 years with good compliance to the treatment with chronic kidney disease 1 to 4 according to kdoqi exclusion criteria: * patients with ckd stage 5

Keywords: renal function before and after n acetyl cysteine cystinosis patients
extracorporeal photopheresis as a possible therapeutic approach to adults with severe and critical covid-19

Conditions: COVID-19

Summary: optimal approach for adult patients hospitalized with severe and critical covid-19 non-responsive to antiviral and immunomodulatory drugs is not well established. the study aim is to evaluate feasibility and safety of extracorporeal photopheresis (ecp) in this setting.

a prospective, single-center investigational study is olanned to be performed at a tertiary referral center for covid-19. patients with covid-19 are screened, and severe or critical covid-19 cases fulfilling pre-defined clinical and biochemical criteria of non-response for \>5 days despite remdesivir, dexamethasone and immunomodulation (tocilizumab, baricitinib, ruxolitinib) are consecutively enrolled. after inclusion, two ecp sessions on two consecutive days per week for 2 weeks are applied. patients are followed up per protocol from study inclusion, and clinical, virological and radiological outcomes are assessed at end-of-treatment (eot)+28 days.

Eligibility criteria:
hospitalized adult (≥18 years at diagnosis) patients with diagnosed covid-19 of any illness duration are eligible, and screened for inclusion during daily on-site investigator visits. patients are consecutively enrolled. inclusion criteria: 1. severe or critical covid-19, 2. clinical and biochemical non-response for \>5 consecutive days, despite remdesivir, dexamethasone and immunomodulatory therapies (tocilizumab, baricitinib or ruxolitinib), with or without covid-19 reconvalescent plasmatherapy, in absence of other causes. exclusion criteria: 1. pregnancy or breastfeeding, 2. allergy or contraindications to 8-methoxypsoralen, 3. pre-covid-19 ecp, 4. written informed consent was not obtainable. clinical non-response is defined when ≥2 of the following are met, compared to baseline: 1. persistent fever (non-contact tympanal measurement of \>38.0°c) for ≥48 hours, despite antipyretics, 2. persistent or failing covid-19 severity, according to world health organization criteria, by ≥1 stratum after ≥48 hours, 3. persistent or failing partial arterial oxygen tension (pao2) / inspired oxygen fraction (fio2), by ≥10% after ≥48 hours, despite respiratory support, 4. radiological progression by infiltrate extension on chest computed tomography (ct), by ≥10% after ≥48 hours, 5. novel requirement of invasive mechanical ventilation, as deemed necessary by an intensive care unit (icu) team. biochemical non-response is defined when ≥2 of the following analytes show persistent or increasing levels by ≥20% after ≥48 hours, compared to baseline: 1. serum lactate dehydrogenase (ldh), 2. serum c-reactive protein (crp), 3. serum ferritin 4. plasma interleukin-6 (il-6), 5. d-dimer.

Keywords: covid-19