Kornimate/medical-research-clean huggingface dataset:
treatment pathway of patients suffering from a breast cancer related lymphoedema

Conditions: Lymphedema

Summary: this study will assess the benefit of lpg cellu m6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

the main objective of the study is to assess the proportion of successfully treated patients (success rate). that is to say patients having a reduction of excess arm volume ≥ 30% after 5 days of three types of treatment for secondary lymphoedema : group 1: standard intensive decongestive therapy for 5 days (bandages + manual lymphatic drainage). group 2: standard intensive decongestive therapy (bandages + manual lymphatic drainage) + cellu m6 for 5 days group 3: bandages + cellu m6 for 5 days symptomatic treatment of lymphoedema reference is intensive decongestive therapy including manual lymphatic drainage, compression of multicomponent bandaging, therapeutic exercise and skin care (has 2012 isl international society of lymphology, 2013).

Eligibility criteria:
inclusion criteria: * patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (isl) * patients suffering from lymphoedema for 6 months or more * patients with a difference between arms \>10% * patients who had ever had an axillary node dissection * patients hospitalized for intensive standard treatment. exclusion criteria: * primary lymphoedema * venous insufficiency of the upper members * severe arterial obstruction * obliterating arteritis of the upper limbs * bilateral lymphoedema * breast cancer recurrence * another cancer in treatment * decompensated heart failure * pacemaker * acute infection * deep venous thrombosis * skin atrophy of the upper member * bullous dermatosis * acute dermatitis with epidermitis or dermatitis-hypodermitis * infected wound * inflammatory scar or consequence of a recent surgery (\<1 month) * presence of osteosynthesis equipment under the skin with an external part in the upper member to treat * hyperalgesia of the shoulder * pregnancy.

Keywords: lymphedema breast cancer
ustekinumab safety and surveillance program using the ingenix nhi database

Conditions: Psoriasis

Summary: the patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse us health plan. the objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in psoriasis patients treated with ustekinumab, anti-tumor necrosis factor (tnf) biologics, non-anti-tnf biologics, or systemic non-biological treatments.

the participants included in this study will be drawn from the ingenix normative health informatics database, a proprietary research database containing claims and enrollment data dating back to 1993 for members of a large, geographically diverse us health plan. this study will include cohorts of participants who have claims consistent with a diagnosis of psoriasis and who initiate ustekinumab, anti-tnf biologics, non-anti-tnf biologics, or systemic non-biological treatments. participants will be identified by claims bearing codes for dispensed drugs, procedures or diagnoses and followed after the launch of ustekinumab for up to 8 years. a sample of enrolled health plan members without claims evidence of diagnosis or treatment of psoriasis will also be selected. the claims database will be used to estimate the incidence of the primary outcomes of serious infections, tuberculosis (tb) and non-tb mycobacterial infections, malignancies such as lymphoma, and other selected outcomes. potential cases of the study outcome identified through claims may be confirmed through medical record review. no study agents will be administered in this study. all patients will receive standard-of-care treatment as prescribed by their physician.

Eligibility criteria:
inclusion criteria: * complete medical coverage and pharmacy benefits * six months of continuous enrollment prior to the date of cohort entry exclusion criteria: * participants will be excluded if they do not have information on age, gender or enrollment

Keywords: psoriasis ustekinumab anti-tnf biologics non-anti-tnf biologics systemic non-biological treatments
special drug use-results surveillance of tabrecta tablets

Conditions: Non-small Cell Lung Cancer

Summary: this study is an uncontrolled, primary data collection-based observational study to be conducted as a central registration system, multicenter special drug-use results surveillance. as an all-case study, this study will collect all patients treated with tabrecta in a specified post-marketing period. the observation period of each patient is up to 1 year (52 weeks)


Eligibility criteria:
inclusion criteria: * all patients receiving tabrecta for met exon 14 skipping mutation-positive unresectable advanced/recurrent nsclc during a specified post-marketing period exclusion criteria: -

Keywords: nsclc non-small cell lung cancer met exon 14 skipping mutation-positive
a multi-centre clinical trial to evaluate a left-right design in adults with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to validate a left-right design with respect to detecting a difference in efficacy after 3 weeks of treatment between an active treatment and a vehicle in adults with mild to moderate atopic dermatitis


Eligibility criteria:
inclusion criteria: * 1. male and female subjects, 18 years or older * 2. subject with atopic dermatitis with mild to moderate disease severity * 3. two symmetrical and comparable atopic dermatitis treatment areas * 4. female volunteers of childbearing potential must either be surgically sterile or agree to use a reliable method of contraception exclusion criteria: * 1. any condition in the target areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash other than atopic dermatitis, sunburn, hyper- or hypopigmentation, scars * 2. dark-skinned persons whose skin colour prevents reliable clinical assessments * 3. any permanent (or transient within 28 days prior to dosing) disease that may interfere with the subjects safe participation in the trial, with the subjects ability to participate in the trial or with the clinical assessments * 4. pregnancy or breastfeeding
recovery profile comparison between remifentanil-propofol or desflurane anesthesia monitored with bispectral index.

Conditions: Delayed Emergence From Anesthesia

Summary: bispectral monitoring anesthesia with remifentanil-desflurane has a better post-operative recovery than remifentanil-propofol.

it is a randomized, double blind study, involving 40 adult female patients submitted to general anesthesia. the patients were distributed into 2 groups: remifentanil-propofol-based anesthesia and remifentanil-desflurane-based anesthesia groups. bispectral index (bis) monitoring guided the anesthesia by setting target bis range value between 40 and 60. anesthetics were adjusted to reached that. primary outcome was: extubation time (time from anesthetic discontinuation to endotracheal tube cuff). secondary measured outcomes: intra-operative cardiovascular drug use; time to follow command before extubation; protective airway reflex recovery time after extubation. protective airway reflex test recovery was performed at predetermined time intervals (2, 6, 14, 22 and 30 minutes) from the time to follow a standard command until the first demonstrated ability to swallow 20 ml of water in an upright position.post-anesthesia care unit recovery data were also recorded: ramsay sedation scale; vital signs, post-operative pain; morphine consumption.

Eligibility criteria:
inclusion criteria: * female patients over 18 years old classified by the american society of anesthesiologists as physical status i or ii, undergoing elective breast surgery with general anesthesia. exclusion criteria: * history of: illegal drug and alcohol abuse * pregnancy on course or suspicion of * neuromuscular disorders * cerebral vascular disease * dysphagia * dysphonia * gastroesophageal reflux disease * previous larynx and/or upper gastrointestinal tract surgery * allergy to any drug to be used and malignant hyperthermia. * patients who develop hemodynamic instability in the surgery and need blood transfusion were excluded from the study. * patients unable to swallow 20 ml of water in an upright position were also excluded.

Keywords: airway extubation anesthesia recovery period desflurane propofol intravenous anesthesia balanced anesthesia
dose-escalating study of propiverine hydrochloride in children suffering from overactive bladder

Conditions: Overactive Bladder

Summary: the open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.


Eligibility criteria:
main inclusion criteria: * micturition frequency ≥6 micturitions during awake period * urge incontinence episodes ≥1/week * urgency episodes ≥1/day main exclusion criteria: * contraindication to anticholinergic therapy * repeated measurement of post void residual ≥20 ml * nocturnal enuresis * clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus * anatomical abnormalities of the urinary tract

Keywords: propiverine anticholinergics urinary incontinence overactive bladder children dose-finding in children aged 5-10 years
phase 1 study of sk3530 to investigate of the effect of food

Conditions: Erectile Dysfunction

Summary: this study was designed to investigate the food effect of sk3530 on the pharmacokinetics (pks).

the pde5 inhibitor, sk3530, is expected to be taken concomitantly with food. the food interaction studies of other pde5 inhibitors (viagra, levitra and cialis) have already accomplished and the results have provided useful information to the patients. the objective of this study is to compare the pharmacokinetics (pks) of sk3530 and its metabolite (sk3541) under the fasted and fed (low-fat meal and high-fat meal) conditions.

Eligibility criteria:
inclusion criteria: * ages 19 to 50 * body weight of (ibm) ± 20% exclusion criteria: * cardiovascular disease * color-blindness or weakness

Keywords: sk3530 food effect pharmacokinetics
clinical study of ucb combined with uc-mscs in the treatment of bone marrow failure disorders

Conditions: Bone Marrow Failure Disorders

Summary: the multicenter collaborative clinical study conducted a systematic clinical observation in the treatment of bone marrow failure diseases via ucb\&uc-mscs , in order to observe its clinical efficacy and safety.


Eligibility criteria:
inclusion criteria: 1. patients with bone marrow failure disorders, including aplastic anemia, pure red cell aplastic anemia, immune-related pancytopenia, paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, acute arrest of hemopoiesis, and cytopenia of unknown significance; 2. patients with no severe impairment of liver and kidney function (total bilirubin (tbil): ≤ 1.5×uln; alt or ast: ≤ 2.5×uln; alkaline phosphatase: ≤ 3×uln; serum creatinine: ≤ 1.5×uln); 3. the prothrombin time (pt) or activated partial thrombin time (aptt) or international normalized ratio (inr): ≤ 1.5×uln in the absence of anticoagulant therapy; 4. the left ventricular ejection fraction (lvef): ≥50% by cardiac echocardiography 5. hepatitis b surface antigen (hbsag) and hepatitis b core antibody (hbcab) were negative. if any of the above items is positive, the hbv dna titer in peripheral blood must be lower than the detection limit or 1×10\^3 copys/ml; 6. patients with no plans for stem cell transplantation; 7. patients with ecog 0-2; 8. those who voluntarily participate in this clinical study and have signed an informed consent . exclusion criteria: 1. patients who have suffered malignant tumors other than squamous cell carcinoma of the skin, basal cell carcinoma of the skin, malignant melanoma cured by surgery, and carcinoma in situ of the cervix in the past 5 years; 2. patient with severe cardiac insufficiency (e.g. grade ⅲ、ⅳ by nyha classification nyha), and medically uncontrolled hypertension (systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥110 mmhg); 3. patients with severe mental illness; 4. patients with clinically significant infection should be recruited with delay; 5. ast or alt: above 3 times the upper limit of normal, creatinine, total bilirubin, or alkaline: phosphatase (alp): above 1.5 times the upper limit of normal; 6. patients with test positive for hiv, hcv or syphilis; 7. patients with severe allergies or allergic to the active ingredients, excipients of the drug, or blood products in this clinical trials; 8. patients who are pregnant or breastfeeding, or have a childbirth plan in the near future; 9. patients receive allogeneic/autologous hematopoietic stem cell transplantation by the assessment of investigators; 10. there are other conditions that the investigators consider inappropriate for inclusion.
application of an exercise program versus exercise plus manual therapy in the treatment of adhesive capsulitis.

Conditions: Capsulitis of Shoulder; Frozen Shoulder

Summary: the main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation. the researchers will compare both groups (experimental group and control group) using the different techniques. during the sessions, mobility will be evaluated with a goniometer and data will be recorded to monitor progress, maintaining a confidential record of the data.


Eligibility criteria:
inclusion criteria: * men and women from 40 to 60 years old, whether or not they carry out physical activity * intervention through therapeutic exercise and/or joint mobility. exclusion criteria: * children * older people * people with previous shoulder pathology * people with cognitive impairment who cannot complete questionnaires * treatment that does not include exercise or joint mobility * treatment with machines.

Keywords: "adhesive capsulitis" "frozen shoulder" "manual therapy" "therapeutic exercise"
attenuation of d-dimer using vorapaxar to target inflammatory and coagulation endpoints

Conditions: HIV

Summary: advice is a randomised, international, double-blind, placebo-controlled trial. the purpose of the advice study is to compare the safety and efficacy of vorapaxar in reducing d-dimer expression and markers of cellular immune activation over a period of 12 weeks among people with hiv infection who are successfully treated with combination antiretroviral therapy containing an hiv integrase inhibitor. a secondary objective of the study will be to demonstrate that following cessation of vorapaxar in patients with well controlled hiv replication there will be an increase in the levels of d-dimer over a 6 week period. 60 participants from 4 clinical sites in australia and the usa will be recruited and followed for a minimum of 18 weeks.

consenting participants will be screened and within 14 days randomly allocated to receive either vorapaxar (2.5mg) or matched placebo once daily for 12 weeks (phase 1). participants will be seen one week after randomisation and then at weeks 4, 8 and 12 (phase 1). at the week 12 visit, patients will not be dispensed any study treatment. in phase 2 all study treatment will stop for 6 weeks. at week 18 patients will be seen for a final study visit.

Eligibility criteria:
inclusion criteria: 1. hiv-1 positive by licensed diagnostic test 2. aged ≥40 years 3. plasma hiv rna \<50 copies/ml for at least 24 weeks 4. screening cd4+ cell count \> 50 cells/mm3 5. treated for at least 12 weeks with a suppressive regimen of combination antiretroviral therapy that does not include hiv protease inhibitors and/or nnrtis (except rilpivirine) 6. plasma d-dimer \>200ng/ml (\>0.2μg/ml or \>0.2mg/l) fibrinogen equivalent units or \>100ng/ml (\>0.1 μg/ml or \>0.1mg/l) d-dimer units in the absence of established cause (deep vein thrombosis/embolism) 7. provision of written informed consent exclusion criteria: 1. absolute neutrophil count (anc) \<1000 cells/μl 2. hemoglobin \<10.0 g/dl 3. platelet count \<75,000 cells/μl 4. ast and/or alt \>2.5 x uln 5. estimated glomerular filtration rate \<30ml/min/1.73m2 ) using ckd-epi (chronic kidney disease epidemiology collaboration) equation 6. history of myocardial infarction or unstable atherosclerotic disease 7. history of ischemic stroke or transient ischaemic attack (tia) 8. active peptic/duodenal ulcer or other bleeding disorder within the previous 12 months 9. intent to have surgery within the 6 month period after randomisation 10. current use of aspirin or p2y12 antiplatelet therapy 11. use of anticoagulants, (eg. heparin or warfarin), fibrinolytic therapy, chronic use (more than 5 consecutive days) of nonsteroidal anti-inflammatory drugs (nsaids), strong cyp3a4 inhibitors or inducers. see manual of operations for full list of medications to avoid. 12. participants unlikely to be able to remain in follow-up 13. pregnant or nursing mothers 14. in the clinical judgement of the investigator, participation in this trial is deemed inappropriate as this may conflict with the well-being of the participant.

Keywords: hiv, d-dimer, hs-crp, activated t-lymphocytes
do elastic abdominal binders reduce post operative pain and blood loss?

Conditions: Postpartum Hemorrhage; Pain

Summary: this is a pilot study investigating the use of abdominal binders after cesarean sections. the researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. blood loss and pain control are both concerns after giving birth. it is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.


Eligibility criteria:
inclusion criteria: * cesarean section at term (at least 39 weeks gestation) scheduled in advance * singleton gestation confirmed by ultrasound in the current pregnancy * body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy) * none of these pregnancy complications in the current pregnancy: 1. bleeding disorder or use of anticoagulants other than low-dose heparin 2. abnormal placenta (placenta previa or accrete) 3. preoperative hemoglobin less than 10 mg/dl 4. chorioamnionitis (intrauterine infection) * no chronic pain syndrome (defined as participating in formal chronic pain management within the past year) * able to read english and understand spoken english exclusion criteria: * onset of labor prior to time when the cesarean was scheduled * complications during performance of cesarean or discovered during cesarean: 1. placenta accreta, increta, or percreta 2. vasa previa 3. cesarean hysterectomy required for severe hemorrhage 4. organ damage during cesarean (cystotomy, enterotomy, ureteral injury)
a trial of a video game intervention to recalibrate physician heuristics

Conditions: Wounds and Injuries

Summary: the objective of this study is to compare the efficacy of a video game designed to recalibrate physician heuristics in trauma triage with a standard educational program.

treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. most of this under-triage occurs because of physician decisions (rather than first-responder decisions). existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. these strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. the investigators have developed an adventure video game (night shift) to serve as a novel method of recalibrating physician heuristics in trauma triage and will compare its efficacy with a standard educational program.

Eligibility criteria:
inclusion criteria: * physicians who care for adult patients in the emergency department. * physicians who work at a non-trauma center. * physicians who work at a level iii/iv trauma center. exclusion criteria: * physicians who work at a level i/ii trauma center. * physicians who do not practice in the us.

Keywords: decision making heuristics
scoring model for predicting outcome in patients with cardiogenic shock

Conditions: Cardiogenic Shock

Summary: this study aims to develop a predictive model for the outcomes of patients with cardiogenic shock

this retrospective observational study will enroll patients with cardiogenic shock admitted to the cardiac care unit. patient characteristics, clinical events during hospitalization, and laboratory examination findings will be collected and analyzed to determine factors associated with mortality. a nomogram will be developed accordingly and will undergo both internal and external validation.

Eligibility criteria:
inclusion criteria: * patients with cardiogenic shock * admitted to the cardiac care unit (ccu) exclusion criteria: * non-cardiogenic shock in origin * post open heart surgery

Keywords: cardiogenic shock epidemiography outcome