Kornimate/medical-research-clean huggingface dataset:
trial to evaluate the efficacy, safety and tolerability of bpamz in drug-sensitive (ds-tb) adult patients and drug-resistant (dr-tb) adult patients

Conditions: Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant; Tuberculosis, MDR; Tuberculosis; Drug-Resistant Tuberculosis

Summary: to evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 weeks (24-months) post the start of the following treatment regimens in participants with: drug sensitive tb (ds-tb) patients given bpamz for 17 weeks ( or 4 months) vs. standard hrze/hr treatment given for 26 weeks (or 6 months) and drug resistant tb (dr-tb) patients given bpamz for 26 weeks (or 6 months)

phase 2c multi-center, open-label, partially randomized clinical trial in ds-tb and dr-tb participants. all participants in the below arms will have follow-up for a period of 104 weeks (24 months) from the start of therapy. participants with drug sensitive tb (ds-tb): participants with ds-tb will be randomized to one of two treatment arms. these participants will receive either bpamz daily for 17 weeks (4 months), or hrze/hr combination tablets daily for 26 weeks (6 months). participants will be stratified for co-infection with human immunodeficiency virus (hiv) and cavitation. participants with drug resistant tb (dr-tb): participants with dr-tb will be assigned to receive bpamz daily for 26 weeks (6 months).

Eligibility criteria:
inclusion criteria: * sputum positive for tubercule bacilli (at least 1+ on the international union against tuberculosis and lung disease \[iuatld\]/who scale (appendix 1) on smear microscopy) at the trial laboratory. * participants with one of the following pulmonary tb conditions: ds-tb treatment arm participants should be: * sensitive to rifampicin and isoniazid by rapid sputum based test and * either newly diagnosed for tb or have a history of being untreated for at least 3 years after cure from a previous episode of tb. dr-tb treatment arm participants should be resistant to rifampicin and/or isoniazid. * of non-childbearing potential or willing to practice effective methods of birth control * body weight (in light clothing and no shoes) ≥ 30 kg. * completed informed consent form exclusion criteria: * karnofsky score \<60% * any risk factor for qt prolongation * any planned contraindicated medicines * resistant to fluoroquinolones (rapid, sputum-based molecular screening tests). any of the following lab toxicities/abnormalities: * cd4+ count \< 100 cells/µl (hiv infected participants) * platelets \<75,000/mm³ * creatinine \>1.5 times upper limit of normal (uln) * egfr ≤ 60 ml/min * haemoglobin \<8.0 g/dl * serum potassium less than the lower limit of normal for the laboratory. * ggt: greater than 3 x uln * ast: ≥3.0 x uln to be excluded; * alt: ≥3.0 x uln to be excluded * alp: ≥3.0 x uln to be excluded * total bilirubin: \>1.5 x uln to be excluded; * direct bilirubin: greater than 1x uln to be excluded

Keywords: tuberculosis drug-resistant tuberculosis tb dr-tb pretomanid pa-824 bedaquiline tmc207 moxifloxacin pyrazinamide hrze tb alliance nc-008 drug-sensitive tuberculosis ds-tb
de-escalation study evaluating venetoclax and azacitidine discontinuation in aml responding patients

Conditions: Acute Myeloid Leukemia

Summary: the goal of this clinical trial is to test efficacy and safety of a venetoclax-azacitidine (ven-aza) de-escalation strategy in acute myeloid leukemia responding patients. the main objectives of the study are: * evaluation of the efficacy of ven-aza de-escalation strategy by measuring the effect of ven-aza discontinuation in term of disease-free survival. * evaluation of the other efficacy parameters and safety of ven-aza de-escalation strategy. patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria. participants will: * stop ven-dasa treatment * be closely monitored by regular evaluation of the disease


Eligibility criteria:
inclusion criteria: 1. female/male ≥ 18 years of age; 2. diagnosis of previously untreated aml according to the 2022 international consensus classification of myeloid neoplasms and acute leukemias; 3. ven-aza given as first-line treatment; 4. duration of ven-aza therapy of 12 months (+/- 28 days), regardless of duration of ven-aza cycles and the doses; 5. patients in first composite complete remission (crc) defined as complete remission (cr) or cr with incomplete hematologic recovery (cri) or cr with partial hematologic recovery (crh); 6. absence of detectable minimal residual disease (mrd) performed locally (i.e. mrdneg defined as mcf mrd \<0.1% of cd45 expressing cells with the target immunophenotype in bone marrow, or npm1 or runx1-runx1t1 or cbfb-myh11 mrd copy numbers \<0.1% in the blood); 7. ecog \<3; 8. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 9. affiliated to the french social security or beneficiary of such a health insurance; 10. signed informed consent. non inclusion criteria: 1. ven-aza given as salvage therapy; 2. prior allogeneic stem cell transplant; 3. discontinuation of treatment because of absence or loss of response; 4. patient in emergency situation or unable to give consent; 5. severe medical or mental condition precluding the follow up procedures after treatment discontinuation.
effectiveness of pain control and adverse reactions after intravenous pca in chinese population

Conditions: Postoperative Pain, Acute

Summary: here, we retrospectively analyzed the proportion of intravenous patient controlled analgesia (pca) used in a large tertiary hospital in central china, and then further analyzed the proportion of patients with postoperative pain after standardized pain treatment and the incidence of adverse effects. it aims to answer are: 1. the incidence of poor postoperative analgesia and adverse effects of patients with different types of surgery after standardized postoperative pain management of tj-aps team; 2. it would provide reference for improving the quality of postoperative acute pain management. in addition, it supplements the chinese data on the incidence of poor postoperative analgesia and adverse effects of patients under the aps standardized postoperative analgesia process.

acute pain service (aps) is an important management mode to improve postoperative acute pain, and it has been widely used in hospitals around the world for many years. according to a survey, more than 60% of hospitals in europe and america have aps teams. most of the information on postoperative pain management is mainly based on the research performed in united states, germany and other european countries. moreover, the current clinical research on postoperative analgesia is mainly focused on improving analgesia technology and drugs, while there are few studies on the impact of postoperative pain management (such as aps) on the prognosis of patients, especially the research on large samples. considering that china's population accounts for about 21.5% of the world's population, the united states accounts for about 4.3% of the world's population, and germany accounts for about 1%. therefore, it is necessary to study the current situation of analgesia in china, especially the poor postoperative analgesia and adverse effects after different types of surgery in chinese patients. the 27th national anesthesia academic annual meeting in 2019 reported that only 25.12% of hospitals in china have established aps or similar groups, and only 23.48% provided pain treatment education before surgery, and less than 10% of them are responsible for the whole process of postoperative analgesia services.

Eligibility criteria:
inclusion criteria: * the surgical patients in tongji hospital (central operating room of hankou hospital) affiliated to tongji medical college of huazhong university of science and technology from january 2016 to december 2021 exclusion criteria: * some cases with incomplete patient information records and incomplete patient follow-up data records due to human factors were excluded.

Keywords: postoperative pain acute pain service poor postoperative analgesia postoperative nausea and vomitting
precise design of cell therapy for relapsed and refractory hematological tumors

Conditions: Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors; Hematologic Disease

Summary: this clinical trial aims to evaluate the efficacy and safety of car-t cell therapy in patients with relapsed/refractory hematologic malignancies.

this clinical trial aims to evaluate the efficacy and safety of car-t cell therapy in patients with relapsed/refractory hematologic malignancies. the primary objective is to determine the maximum tolerated dose (mtd), safety profile, and the overall response rate (orr) of car-t cells in these patients. secondary objectives include assessing marrow remission rates and minimal residual disease (mrd) clearance at various time points (2 weeks, 1 month, 3 months, 6 months, and 1 year) in patients with bone marrow involvement, as well as evaluating the changes in multiple sites of involvement through pet-ct or pet-mri before and one year after car-t therapy. the study will also track event-free survival (efs), progression-free survival (pfs), and overall survival (os) rates at 1, 2, 3, and 5 years post-treatment.

Eligibility criteria:
inclusion criteria: patients with relapsed/refractory hematologic malignancies confirmed to express cd19, cd22, cd20, cd7, cd5, cd2, cd79b, bcma, gpcr5d, cd38, cd33, cd123, cd133, cll1, ebv (gp350, lmp1), cmv (gb21, gb280...) or other validated targets (supported by domestic and international preclinical/clinical evidence) who meet the following criteria: male or female, aged ≥18 years and \<75 years; newly diagnosed patients with refractory disease (as defined by respective diagnostic criteria) after chemotherapy; newly diagnosed patients with disease progression during chemotherapy and poor anticipated response to further chemotherapy; patients with relapsed disease (≥1 recurrence) and confirmed residual tumor evidence; patients with relapse after autologous or allogeneic hematopoietic stem cell transplantation (hsct); patients with relapse after car-t therapy; patients with hematologic malignancies deemed incurable by current surgical, radiotherapy, or chemotherapy interventions. exclusion criteria: patients meeting any of the following criteria will be excluded: life expectancy \<12 weeks; genetic testing reveals mutations or structural variants associated with the target antigens; severe graft-versus-host disease (gvhd) requiring immunosuppressive therapy in post-hsct relapse patients; post-hsct relapse \<3 months with no available donor; organ dysfunction: serum creatinine \>2.5 mg/dl; alt/ast \>5× upper limit of normal (uln); total bilirubin \>2 mg/dl; uncontrolled active infection; active hepatitis b/c or hiv infection; anticipated early loss to follow-up (\<3 months post-treatment); failure to provide signed informed consent or lack of ethics committee approval; concurrent systemic conditions that may interfere with study participation; other exclusion criteria deemed appropriate by the investigator.

Keywords: cell therapy hematological tumors
survivor choices for eating and drinking - colorectal cancer

Conditions: Colon Cancer; Rectal Cancer; ColoRectal Cancer

Summary: epidemiologic data suggest that a western dietary pattern after diagnosis of colorectal cancer increases risk of disease recurrence and death. high intake of red and processed meat, dairy, refined grains, and sweets/desserts characterize a 'western dietary pattern'. this study aims to translate the epidemiologic findings into a patient-centered, web-based dietary intervention with text messaging to inform and modify users' dietary choices. the investigators' specific aims are to: 1) develop a web-based dietary intervention with text messaging for colorectal cancer survivors; and 2) conduct a 12-week pilot randomized controlled trial to determine the acceptability and feasibility of the dietary intervention among 50 colorectal cancer survivors. all participants will receive standard of care print materials regarding diet following a colorectal cancer diagnosis. participants in the intervention group will also receive access to a web-based dietary intervention with text messaging for 12 weeks. this study will generate preliminary data on the effect of the intervention on dietary choices among colorectal cancer survivors for future studies.


Eligibility criteria:
inclusion criteria: * diagnosed with colon or rectal adenocarcinoma * completed standard cytotoxic chemotherapy prior to enrollment, if medically indicated * considered disease-free or have stable disease at baseline * able to speak and read english * access to a mobile phone with internet and text messaging capabilities * able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet exclusion criteria: individuals who are already meeting four or more of the six target dietary behaviors will be excluded: * ≥5 servings/day of fruits \& vegetables * ≥3 servings/day of whole grains * ≥2 servings/week of fish * no processed meat * no sugar-sweetened beverages * ≤1 alcoholic drink/d for women and ≤2 alcoholic drinks/d for men.
myocardial injury after elective coronary stenting

Conditions: Coronary Artery Disease

Summary: this pilot study aims to identify patients at moderate to high risk for peri-procedural (type 4) myocardial infarction or injury after after undergoing an elective coronary intervention (pci) as measured by high sensitivity troponin t, who might benefit from more potent antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * stable or unknown coronary artery disease (cad) * elective coronary intervention * minimum age of 18 exclusion criteria: * present acute coronary syndrome (acs) * age under 18 * pregnancy * any additional invasive intervention with potential myocardial injury * non acs conditions responsible for elevation of cardiac troponin, such as acute pulmonary artery embolism, myocarditis or tachycardia.

Keywords: percutaneous coronary intervention cardiac troponin antiplatelet therapy
deep brain stimulation in treating patients with dystonia

Conditions: Dystonia

Summary: rationale: dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. deep brain stimulation may help lessen the symptoms of dystonia. purpose: phase ii/iii trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.

protocol outline: patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (ipg) in the chest and a wire lead in the globus pallidum internal. after the lead has been implanted, the brain stimulation system is tested. patients are examined at 1, 3, 6, 9, and 12 months after surgery. a double blinded evaluation, during which the ipg is either off or on, is carried out at 3 and 6 months. patients are followed every 3 months as long as the brain stimulation system remains in place. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- idiopathic or secondary cervical, segmental, or generalized dystonia not adequately controlled with traditional pharmacotherapy and/or botulinum toxin --prior/concurrent therapy-- all medical therapy must be stable within the past month biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: not specified surgery: no prior destructive neurosurgical procedure other: at least 3 months since prior botulinum toxin injections --patient characteristics-- age: 18 to 75 performance status: not specified hematopoietic: not specified hepatic: not specified renal: not specified cardiovascular: no demand cardiac pacemaker other: no history of substance abuse

Keywords: dystonia neurologic and psychiatric disorders rare disease
advanced non-invasive diagnostics for early cutaneous tumor diagnosis, clinical-therapeutic and economic management

Conditions: Cutaneous Melanoma

Summary: the incidence of cutaneous melanoma (mm) is increasing worldwide. the best therapeutical solution for mm is early diagnosis and efforts over the last 50 years have been directed towards early and precise diagnoses. dermoscopy has improved diagnostic accuracy compared to the naked eye, but is limited by an associated higher number of unnecessary excisions. reflectance confocal microscopy (rcm) is a novel technique enabling in vivo examination of the skin at cellular-level resolution, with excellent diagnostic accuracy. this study hypothesis is that the systematic application of rcm in the triage and management of patients suspicious for skin cancer, may improve diagnostic accuracy and reduce the number of unnecessary biopsy. reducing the burden of unnecessary surgery excisions should benefit the health system, both in saving surgical and pathology procedural associated costs and reducing the overwhelming waiting lists for excisions and consequent risk for delayed diagnoses.


Eligibility criteria:
inclusion criteria: - patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), \>= 18 years old exclusion criteria: * (i) the presence of an unequivocal aspect of melanoma or of any other malignant skin cancer, * (ii) lesion located on a skin area where reflectance confocal microscopy cannot be performed (for example: skin folds, mucosa, etc.), * (iii) lesion larger than 2 cm in its largest diameter * (iv) lesion where rcm examination is hampered for over the 30% of its surface (for example, for presence of crusting, oozing, erosion, ulceration, etc.).

Keywords: diagnostic accuracy number needed to excise reflectance confocal microscopy histopathology dermoscopy early diagnosis
evaluation of the safety of intraarticular aquamid reconstruction injection for knee osteoarthritis in humans

Conditions: Osteoarthritis, Knee

Summary: as the use of aquamid reconstruction as an intraarticular device on humans is a relatively novel treatment, it is relevant to assess the safety profile of the device in a safety study to evaluate the safety of the device. this is a retrospective single center cohort study of patients with osteoarthritis of the knee(s) that have been treated for knee oa referred to a clinical evaluation at our department. the study consists of one clinical visit, at which the patients medical history will be taken and upon informed consent adverse events data is collected from medical records. the study is retrospective.


Eligibility criteria:
inclusion criteria: * previously treated with intra-articular aquamid reconstruction in the knee for knee osteoarthritis and referred to our clinic for evaluatino of possible adverse device events. exclusion criteria: - there are no exclusion criteria
tissue doppler ultrasound during spontaneous breathing and non-invasive ventilation in the post-extubation period.

Conditions: Acute Respiratory Failure; Non-invasive Ventilation

Summary: the aim of the present investigation will be to evaluate diaphragmatic excursion velocity during non-invasive ventilation and spontaneous breathing at both inspiration and expiration. this analysis will be performed through diaphragmatic tissue doppler assessment.

early weaning from invasive ventilation, in patients admitted to intensive care, is associated with a marked reduction in ventilator-associated pneumonia, length of stay in intensive care unit and hospital, total duration of mechanical ventilation and decrease in overall mortality. moreover, in case of need of protected extubation, non-invasive ventilation has allowed to prevent re-intubation and decrease hospital mortality compared to the simple administration of oxygen through a facial mask, in particular when applied immediately after extubation. the diaphragmatic tissue doppler imaging (tdi) is an ultrasonographic technique derived from ultrasound evaluation of the heart's motility. it can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive. the aim of the study is the evaluation of the diaphragmatic excursion velocity variations using diaphragmatic tissue doppler, measured in venturi mask and non-invasive ventilation in the post-extubation period, in order to compare the diaphragm stress variations during the two different modes. method patients after extubation will be randomly submitted to a spontaneous breathing test in venturi mask and in facemask or helmet niv. each trial will last 20 minutes. during the last minute of each trial a tissue doppler diaphragm examination will be performed to assess the speed speed of muscle displacement, acceleration and deceleration. inclusion criteria: invasive mechanical ventilation \> 24h with consequent extubation. exclusion criteria: refusal to grant consent, pregnancy, age \< 18 years, haemodynamic instability, difficult management of secretions, required inotropic and / or vasoactive drugs at high doses. during the study, vital parameters will be given.

Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation \> 24h with consequent extubation exclusion criteria: * refusal to grant consent * pregnancy * age \>18 years * haemodynamic instability * difficult management of secretions * required inotropic and / or vasoactive drugs at high doses

Keywords: diaphragmatic tissue doppler non invasive ventilation spontaneous breathing post-extubation
the use of statically determinate force system in closure of anterior open bite in adults.

Conditions: Anterior Openbite

Summary: the aim of the current study was to evaluate and quantify the cephalometric changes produced by maxillary and mandibular extrusion arches in closure of anterior open bite in non-growing patients.


Eligibility criteria:
inclusion criteria: * adult patients with anterior open bites more than 1 mm, permanent dentition except for the third molars which were extracted if erupted exclusion criteria: * frankfort to mandibular plane angle \> 40 * congenital craniofacial malformations or temporomandibular joint disorders, * patients with severe gum show during smiling or increased incisal show at rest.