Kornimate/medical-research-clean huggingface dataset:
study of anti-cd19 icar nk cells in relapsed and refractory b cell lymphoma

Conditions: Refractory B-Cell Lymphoma

Summary: this is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti cd19 icar nk cells in patients with relapsed refractory b cell lymphoma.


Eligibility criteria:
inclusion criteria: 1. cd19 (+) b cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry 2. previously accepted ≥ first-line regimen chemotherapy 3. unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation 4. over 18 years old and under 70 years old 5. the expected survival period is more than 3 months. 6. ecog≤2 7. important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 ml/min; alt and ast≤3 times normal range, total bilirubin ≤ 2.0 mg / dl; 8. blood routine: hgb≥80 g/l, anc≥1×109/l, plt≥50×109/l; 9. the pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year. 10. measurable target lesion exclusion criteria: 1. patients with extramedullary relapse 2. burkitt's lymphoma/leukemia 3. previously received gene product treatment, anti-cd19/anti-cd3 treatment, or any anti-cd19 treatment; 4. liver and kidney function: * total bilirubin \> 2 x uln (gilbert syndrome \> 3 x uln) * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \> 3 × uln * serum creatinine clearance \>60 ml/min 5. serological examination: * absolute neutrophil count (anc) \<0.75x109/l * platelet count (plt) \<50x109/l 6. active hepatitis b (hbv-dna \> 1000 copies / ml), hepatitis c, or uncontrolled infection 7. gvhd ≥ 2 or anti-gvhd treatment 8. im19 car nk cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion; 9. subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks 10. active cns disease (tumor cells in csf, but \< 5 wbcs/ml can be included); 11. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation 12. creatinine \> 1.5 times normal upper limit or alt / ast \> 3 times normal upper limit or bilirubin \> 2 times normal upper limit 13. new york heart association (nyha) graded above or above 14. uncontrollable diabetes 15. suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining 16. any situation that the investigator believes may increase the risk of the subject or interfere with the test results
irinotecan in treating patients with refractory metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: randomized phase ii trial to compare the effectiveness of two regimens of irinotecan in treating patients who have refractory metastatic breast cancer.

objectives: i. assess the antitumor activity and toxicity of two different schedules of irinotecan in the treatment of patients with refractory metastatic breast cancer who have received 1 or 2 previous chemotherapy regimens (up to one prior therapy for metastatic disease and one for adjuvant therapy). ii. compare the time to progression, survival, and quality of life of these patients on these 2 different schedules of irinotecan. outline: this is a randomized study. patients are stratified according to dominant disease (visceral vs nonvisceral), performance status (0-1 vs 2), and prior chemotherapy in metastatic setting (yes vs no). patients assigned to arm i receive irinotecan intravenously over 90 minutes every week for 4 weeks followed by a 2 week rest period. treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. patients assigned to arm ii receive irinotecan intravenously over 90 minutes every 3 weeks for 6 weeks. treatment is repeated every 6 weeks in the absence of disease progression or unacceptable toxicity. quality of life is assessed before and during treatment. patients are followed every 3 months for 2 years, then annually for 1 year. projected accrual: a total of 42-100 patients (21-50 patients per arm) will be accrued for this study within 3.5 years.

Eligibility criteria:
disease characteristics: histologically confirmed adenocarcinoma of the breast with progressing locoregional or metastatic disease measurable or evaluable indicator lesion no uncontrolled cns metastases patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: greater than 3 months hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 0.3 mg/dl above upper limit of normal (uln) ast no greater than 3 times uln renal: creatinine no greater than 1.0 mg/dl above uln cardiovascular: no new york heart association class iii or iv heart disease other: no uncontrolled infection no chronic debilitating disease not pregnant or lactating fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since chemotherapy no more than 2 prior chemotherapy regimens for metastatic disease no more than 1 prior chemotherapy regimen in the adjuvant setting at least 1 prior regimen containing taxane or doxorubicin for metastatic disease or in the adjuvant setting endocrine therapy: not specified radiotherapy: no radiotherapy to greater than 25% of bone marrow no prior treatment with strontium 89 surgery: at least 4 weeks since major surgery other: no concurrent metoclopramide

Keywords: stage iv breast cancer
effectiveness of a cream for treatment of dermatitis in patients whith breast cancer

Conditions: DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER

Summary: it is intended to evaluate the effect of a marketed cream (alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. for this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in primary care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). the main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.


Eligibility criteria:
inclusion criteria: * patients 14 years of age or older * diagnosed with cancer and who are or have recently received radiotherapy treatment. * we will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2. exclusion criteria: * patients with dermal lesions in grade greater than 2. * skin cancer invasion or distant tumor metastasis. * concurrent chemotherapy with rt, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.). * history of hypersensitivity reaction to any of the ingredients of the studio cream. * participants involved in other clinical trials within that month.

Keywords: breast cancer dermatitis
short-time intervention in post-covid syndrome syndrome (sipcov): a pragmatic randomised controlled trial

Conditions: COVID-19

Summary: the present study is a 2-arm pragmatic randomised controlled trial (rct) in which 310 patients who suffer from post-covid syndrome are randomised to either a short-time outpatient-based rehabilitation program (the intervention) or care as usual in a 1:1 ratio. assessments will take place immediately before randomisation (t0), after intervention or care as usual (t1), and 6 months after t1 (t2). patients will be recruited from general practitioners (gp's) as well as social media and self-referral to the involved institutions.


Eligibility criteria:
inclusion criteria: * fulfils pragmatic diagnostic criteria of idiopathic post-covid syndrome: a) confirmed acute covid-19 by a positive pcr for sars-cov-2; b) persistent symptoms at least 3 months following acute covid-19 without symptom-free interval; c) functional disability to an extent that interrupts all or a majority of normal activities (such as work/school attendance, physical exercise, social activities, etc.) * lives in one of the following norwegian counties: oslo, viken, innlandet, vestfold og telemark, agder * informed consent to participation exclusion criteria * other chronic illnesses or demanding life situations that might explain persistent symptoms and disability * sustained organ damage (lung, heart, brain) following acute, serious covid-19 * bedridden * insufficient command of norwegian language
colorectal liver metastases: novel assessment tools for technical resectability

Conditions: Cancer; Cancer Metastatic; Colorectal Cancer; Liver Metastasis Colon Cancer

Summary: the conor study aims to assess whether the use of the limax test and the hepat1ca pre-operative planning magnetic resonance scan impact upon technical resectability decision-making in colorectal liver metastases (clm).

the conor study will occur via 4 workstreams: 1. systematic review of all published criteria for colorectal liver metastases (clm) technical resectability (systematic review protocol published on prospero database: https://www.crd.york.ac.uk/prospero/display_record.php?recordid=136748 2. expert interviews: interviews with liver surgeons and radiologists to assess current standard practice in clm technical resectability decision-making and role for novel assessment tools 3. online questionnaire: online international questionnaire of liver surgeons to assess current standard practice in clm technical resectability decision-making and role for novel assessment tools, in additional to identifying clinical scenarios in which these tools may be of greatest benefit 4. online case-based survey: recruitment of 10-20 participants with 'difficult decisions' regarding technical resectability, and consent to use results from pre-operative assessments to create anonymised online case-based survey. participants will consent to have two additional pre-operative assessments: the limax tests and the hepat1ca magnetic resonance scan. these results from these additional tests will also be used in the online survey, we will recruit international liver surgeons to complete this online survey, where they will be asked to provide an opinion on technical resectability for each individual case scenario, and to specify their operative plan, both before and after seeing the results of these novel assessment tools. we will assess for change in decision-making on resectability, and change in operative plan after seeing these test results. we will also assess for level of agreement between liver surgeons on each scenario, and identify where they difficult decisions persist.

Eligibility criteria:
inclusion criteria: 1. patients over 16 years of age with histologically verified adenocarcinoma of the colon or rectum and radiological evidence of liver metastases 2. discussion at regional hepatobiliary multidisciplinary team meeting 3. hepatobiliary surgical opinion that their case represents a potentially difficult decision regarding technical resectability 4. ability to provide written informed consent exclusion criteria: 1. presence of a medical or psychiatric condition impairing the ability to give informed consent 2. presence of any other serious uncontrolled medical condition 3. patients under 16 years old 4. contra-indications to magnetic resonance scanning
efficacy and safety of fixed dose combination gsp 301 nasal spray (ns) in the treatment of seasonal allergic rhinitis (sar)

Conditions: Seasonal Allergic Rhinitis

Summary: study to evaluate the efficacy and safety of gsp 301 ns compared to placebo ns and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo ns over 14 days of study treatment


Eligibility criteria:
inclusion criteria: 1. aged 12 years and older inclusive of either sex. 2. documented clinical history of sar (for at least 2 years preceding the screening visit \[visit 1\]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen) 3. a 12-hour reflective tnss ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the am assessment at the screening visit (visit 1). exclusion criteria: 1. pregnant or lactating women. 2. plans to travel outside the known pollen area for the investigative site for \> 24 hours during the last 7 days of run in period. 3. history of anaphylaxis and/or other severe local reaction(s) to skin testing. 4. history of positive test for hiv, hepatitis b or hepatitis c infection. 5. documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. 6. subjects with an active pulmonary disorder or infection. 7. subjects with posterior subcapsular cataracts or glaucoma

Keywords: seasonal allergic rhinitis
isolite and dental treatment under conscious sedation

Conditions: Dental Caries

Summary: hypothesis the use of isolite® system does not produce upper airway obstruction in the pediatric population during dental treatment with conscious sedation. purpose: report the changes in airway patency and pediatric patient's behavior when isolite® system is used for dental treatment with conscious sedation. objectives: 1. determine changes in pulse rate 2. determine changes in spo2 3. recognize breath sound's changes possibly associated with airway blockage 4. evaluate if the isolite® system is well tolerate by the pediatric population for dental treatment under conscious sedation 5. relate the use of isolite® with the frequency of head reposition to open the airway.

report the changes in airway patency and pediatric patient's behavior when isolite® system is used for dental treatment with conscious sedation.

Eligibility criteria:
inclusion criteria: * asa i (no systemic disease), asa ii (mid systemic disease-well controlled) * 4-7 years of age * patients english and spanish speaking exclusion criteria: * upper airway infection * craniofacial anomalies

Keywords: pediatric conscious sedation mouthpiece airway isolite system
non-investigational study to evaluate adenovirus serotype 5 (ad5) neutralizing antibodies (nab) in patients with chronic hepatitis b virus (hbv) mono-infection

Conditions: Chronic Hepatitis B

Summary: objectives: primary objective: to identify and preselect patients with chronic hbv mono infection, who are undetectable for anti-ad5 nab, currently being treated with nucleo(t)sides, for participation in the tg1050.02 phase1/1b first in man (fim) study. secondary objectives: to assess the prevalence of undetectable anti-ad5 nab in chronic hbv mono-infected patients. methodology: patients with chronic hbv mono-infection, who are currently being treated with nucleo(t)sides for their hbv infection, will be enrolled in this study to measure ad5 nab levels. a single peripheral blood collection (4 ml) will be obtained and ad5 nab titers will be measured by a central laboratory using a newly validated assay.


Eligibility criteria:
inclusion criteria: * 18 through 65 years of age, inclusive * patients mono-infected with hbv and currently on hbv treatment for at least 2 years with either the nucleos(t)ide tenofovir (tdf) or entecavir (ent) * hbv dna \< lower limit of quantification (lloq) (eg, hbv deoxyribonucleic acid (dna) \< 20 iu/ml using the roche cobas taqman assay) within 6 last months * signed, written independent ethics committee (iec)-approved informed consent exclusion criteria: * patients with either medical history or evidence of cirrhosis, as documented in the medical source, who had: a) any biopsy showing cirrhosis; or b) any transient elastography score of ≥ 10.5 kpa or fibrosure® / fibrotest ® score of ≥ 0.48 with either test result within past 2 years.
the effects of family centered intervention program on preterm infants

Conditions: Infant, Premature

Summary: infant born preterm have an increased risk of adverse long-term developmental outcomes.the risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in moderate and early preterm (\ 34 weeks). there are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. however, there is no study in the literature investigates effect of early intervention program motor performance in subgroups of preterm infants. hence the aim of this study is to evaluate the differences in effects of early intervention program on motor development in early and moderate (\<34 weeks) and late preterm infants.

fifty-two preterm infants corrected age less than 6 months included in this study. they were separated by their birth weeks. babies with gestational ages between 34-36 weeks and 6 days (including the given days) are categorized as late preterm, while those born before 34 weeks are grouped as moderate and early preterm. each group contains 26 infants. first, sociodemographic information and histories of babies are obtaining. ages and contact information of the parents are recording. prenatal and natal risk factors of the mothers are querying. gestational ages and height, weight, and head circumferences of babies at birth are recording. number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.the alberta infant motor scale is using to evaluate spontaneous motor movements of the baby. after the detailed examination, intervention program set up for infants. both groups receive 3 months family based intervention program. after the intervention program, both groups re-examined.

Eligibility criteria:
inclusion criteria: * born before 37 gestational weeks, * accepting to join the study * corrected age 6 months or less exclusion criteria: * having high risk factors (e.g. grade 3 or more intraventricular hemorrhage, pvl, serious seizure) * born after 37 weeks * corrected age greater than 6 months

Keywords: preterm infant physiotherapy
tai chi for chronic non-specific neck pain

Conditions: Neck Pain

Summary: in this study the efficacy of tai chi will be tested in comparison to conventional neck exercises and usual care in a randomized controlled trial. tai chi and neck exercises will be lead by a trained exercise therapist and tai chi instructor, both groups receive 12 weeks of training, once weekly for 60-90 min in a group setting. pain, disability, quality of life, wellbeing, stress perception, psychological distress will be used to determine effects.

see above

Eligibility criteria:
inclusion criteria: * chronic non specific neck pain (3 months at least) * 45mm pain intensity on average on the visual analog scale exclusion criteria: * specific neck pain due to * inflammatory diseases * rheumatic diseases * neurological diseases * prolapse or protrusion * oncological disease * trauma (whiplash) * congenital deformity of the spine * severe comorbidity (somatic, psychiatric) * pregnancy * participation in other clinical trials * regular practice of tai chi, qigong, yoga in the past 6 months * medication with opioids

Keywords: neck pain chronic pain
imipenem/cilastatin/relebactam pk in ecmo

Conditions: Sepsis

Summary: extracorporeal membrane oxygenation (ecmo) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. it is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. there is a need to understand how ecmo circuits affect the pharmacokinetics and disposition of drugs. this study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ecmo.

this is a single center, open-label study to determine imipenem-cilastatin-relebactam pharmacokinetics in critically ill patients receiving ecmo. eight patients with suspected suspected sepsis and who are receiving ecmo will be enrolled. each participant will receive four to six doses of imipenem-cilastatin-relebactam according to current approved prescribing information, followed by ten blood samples to determine concentrations. non-compartmental and population pharmacokinetic analyses will be determined to assess the effects of ecmo on imipenem and relebactam pharmacokinetic parameters.

Eligibility criteria:
inclusion criteria: * age 18 years or older; * on support with veno-venous- or veno-arterial-ecmo; * documented infection or presumed infection as confirmed by the presence of at least one of the following criteria within the past 72 hours: * documented fever (oral, rectal, tympanic, or core temperature \> 38.5° c) * hypothermia (oral, rectal, tympanic, or core temperature \< 35.0° c) * an elevated white blood cell (wbc) count ≥ 12,000 cells/mm3 exclusion criteria: * if female, currently pregnant or breast feeding; * history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam agent (a history of mild rash to a β-lactam followed by uneventful re-exposure is not a contraindication); * severe renal dysfunction defined as a creatinine clearance \< 15 ml/min (calculated by the cockcroft-gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis; * hemoglobin less than 8 mg/dl at baseline; * use of probenecid, valproic acid, or imipenem within 3 days before study drug infusion; * acute liver injury, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 5 times the upper limit of normal, or ast or alt \> 3 times the upper limit of normal with an associated total bilirubin \> 2 times upper limit of normal; * any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator); * any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data; * planned or prior participation in any other interventional drug study within 30 days.

Keywords: beta-lactam pharmacokinetics
couple-based intervention on quality of life in hiv male serodiscordant couples

Conditions: Quality of Life; Hiv; Relationship, Social

Summary: this study aims to provide preliminary evidence of the efficacy of couple-based intervention over usual care in hiv serodiscordant couples in china. the investigators hypothesize that couple-based intervention would be more effective than usual care concerning both partners' quality of life and relationship satisfaction. the investigators also pilot the feasibility, acceptability, and appropriateness of the intervention content and implementation. hiv serodiscordant couples in the intervention arm will receive three sessions of dyadic intervention. in contrast, couples in the control arm will receive usual care.


Eligibility criteria:
the inclusion criteria for couples will be: (a) both partners are males, (b) both partners age over 18, (c) both partners report being a couple for at least three months, (d) one partner is hiv positive and the other partner is hiv-negative (i.e., serodiscordant couples), and (e) both partners are willing to participate. the exclusion criteria for couples will be: (a) either partner cannot complete the assessment due to a low education level or physical or psychological constraint, and (b) either partner has been diagnosed with another life-threatening disease (e.g., cancer).

Keywords: dyadic coping serodiscordant couples randomized controlled trial china