Kornimate/medical-research-clean huggingface dataset:
predicting the efficacy and prognosis of rectal cancer patients based on ctdna-mrd technology

Conditions: Rectal Adenocarcinoma; Circulating Tumor DNA; Minimal Residual Disease; Neoadjuvant Chemoradiotherapy

Summary: the purpose of this study is to study the performance of mrd monitoring in predicting the efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore the value of mrd detection in evaluating the prognosis of patients. in this prospective study, 50 patients with stage ii-iii rectal cancer who are planing to receive neoadjuvant chemoradiotherapy will be enrolled. the tumor tissue will be collected by colonoscopy before treatment and blood samples will be collected before treatment and during treatment.the whole blood samples will receive mrd detection. the change rate and clearance rate of mrd during treatment will be calculated, and will be associated with imaging efficacy evaluation, pathological efficacy evaluation,and prognosis, to determine the performance of mrd in predicting and judging the efficacy of neoadjuvant chemoradiotherapy and postoperative recurrence of rectal cancer.

this study is a prospective, observational study. it is expected to enroll 50 patients with newly diagnosed stage ii-iii rectal cancer.before neoadjuvant chemoradiotherapy, tumor tissue will be collected by colonoscopy biopsy for wes and customized panel design, and peripheral blood samples will be collected for baseline mrd detection ( mrd1 ) and during neoadjuvant concurrent chemoradiotherapy ( mrd2-6 ) .peripheral blood sample will be collected 3-4 weeks after radical surgery ( mrd7 ). for patients who achieved ccr after the end of neoadjuvant therapy and adopted the w \& w ( watch and wait ) strategy, the sampling time point was 3 months after the start of watching and waiting ( mrd7 ).

Eligibility criteria:
inclusion criteria: 1. age 18-75 2. rectal adenocarcinoma confirmed by pathology 3. the clinical stage is ii-iii. 4. neoadjuvant chemoradiotherapy + radical surgery is planned ( ccr patients can choose to wait for observation ). 5. ecog 0-1; 6. no distant metastasis ; 7. main organ function is normal ; 8. signed informed consent and willing to accept long-term follow-up； 9. no anti-tumor treatment was received within 4 weeks before baseline sampling ; 10. adequate ' colonoscopy ' tumor tissue samples can be provided for mrd customization, and sufficient whole blood samples need to be provided for baseline mrd detection. - exclusion criteria: 1. unable to provide sufficient tissue / blood samples to meet the research needs ; 2. received radiotherapy, chemotherapy, or other targeted or immunotherapy before enrollment ; 3. patients did not receive neoadjuvant therapy according to the original plan ; 4. patients refused to accept genetic testing. -
a trial of shr-4602 infusion in patients with shr-4602 in subjects with her2-expressing or her2-mutated locally advanced or metastatic solid tumors

Conditions: HER2-expressing or HER2-mutated Locally or Metastatic Solid Tumors

Summary: to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of shr-4602 in subjects with her2-expressing or her2-mutated locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. ecog ps score 0 or 1 3. life expectancy ≥ 12 weeks 4. adequate bone marrow and other vital organ functions 5. adequate liver function tests 6. her 2 exprission advanced solid tumor exclusion criteria: inclusion criteria 1. ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. ecog ps score 0 or 1 3. life expectancy ≥ 12 weeks 4. adequate bone marrow and other vital organ functions 5. adequate liver function tests 6. her 2 exprission advanced solid tumor exclusion criteria 1. active brain metastases, carcinomatous meningitis/leptomeningeal metastases. 2. have received surgery (eg. major surgerical treatment for cancer), chemotherapy, molecular targeted therapy, immunotherapy, cell therapy, or radiotherapy within 4 weeks prior to the first dose of investigational drug (palliative radiotherapy within 2 weeks prior to the first dose). 3. participated in another clinical study with the last dose of study drug received in less than 4 weeks prior to the first dose. 4. subjects with toxicities and/or complications from prior treatment not recovered to nci-ctcae grade ≤ 1. 5. history of pleural fluid, ascites, or pericardial effusion requiring intervention within 2 weeks prior to the first dose. 6. history of active autoimmune diseases. 7. history of hereditary or acquired bleeding disorders or thrombotic tendency 8. active hepatitis b (defined as hepatitis b virus surface antigen \[hbsag\] positive and serum hbv-dna copy ≥ 500 iu/ml), hepatitis c 9. history of severe infection within the past 30 days, including but not limited to bacteremia, severe sepsis, pneumonia requiring hospitalization 10. other malignancies currently or within the past 5 years, except for cured cervical carcinoma in situ 11. allergy to any component or excipient of the shr-4602 product, 12. history of severe medical, psychiatric, or social conditions deemed by the investigator to be likely to interfere with a subject's ability to understand, consent, cooperate and participate in the study. 13. patients with grade≥2 peripheral neuropathy, except for those with mild symptoms that do not require treatment
nutritional status and medication treatment in home-dwelling older adults

Conditions: Malnutrition; Aged; Polypharmacy

Summary: the project "nutrition and medication management in home-dwelling older adults" consist of two separate studies witch are described in the same study protocol. this is the first study in this project. the second study is described separately; identification: 2017/12883-2 malnutrition is common in older adults. the causes are many and include adverse drug effects. loss of appetite, nausea, or dry mouth are adverse drug effects, which may contribute to malnutrition. knowledge about possible relations between drug treatment and nutritional status is scarce. the objectives of the project is to describe nutritional status, drug treatment and the prevalence of potentially inappropriate medication in home-dwelling elderly receiving home care service in two norwegian municipalities.

recruitment by a the home nurse service. an informed content from the participant (or a close relative for those not able to give an informed consent) is required. a nurse will visit the participants and ask for information about six items concerning: food intake, weight loss, mobility, psychological stress, neuropsychological problems. the height and weight will be measured. a photo of the medicine prescription card will be taken. the investigators have created an online solution for collection of these sensitive data, including photos of the medication prescription card. the data will automatically be stored in a secure database at the university of oslo (tsd), for further analyses.

Eligibility criteria:
inclusion criteria: * home-dwelling * be admitted to home-nursing service, every second week or more often. * age 70 or older * medication administrated by home nursing service. * informed consent by patient or close relative (next of kin) exclusion criteria: • patient or next of kin denies inclusion

Keywords: nutritional status polypharmacy home-dwelling potentially inappropriate medication use
efficacy transverse abdominal plane (tap) block renal transplant surgery

Conditions: Renal Insufficiency, Chronic; Acute Pain; Kidney Transplantation; Anesthesia, Conduction

Summary: the objective of this study is to evaluate the efficacy and safety of transverse abdominal plane block in patients undergoing renal transplant surgery.adult renal transplant recipients will be prospectively randomized to receive a standard general anesthetic technique supplemented with ropivacaine 0.375% 20 ml tap block or sham block with 20 ml 0.9% saline. both groups will receive patient-controlled morphine analgesia. patient assessment will occur in the postanesthetic care unit and at 1, 2, 4, 6, 12, and 24 hours. the primary outcome is total morphine consumption in the first 24 hours after renal transplantation. other outcomes asses include pain scores, presence of nausea or vomiting, excessive sedation, and respiratory depression.


Eligibility criteria:
inclusion criteria: * end-stage renal disease undergoing cadaveric renal transplantation exclusion criteria: * contraindications to the use of morphine * contraindications to the use ropivacaine * peripheral neuropathy * inability to use a patient control analgesia device

Keywords: renal transplantation acute pain regional anesthesia tap block
efficacy and tolerance of peg-interferon alpha 2a added to tenofovir and emtricitabine in aghbe positive hbv-hiv co-infected patients

Conditions: Hepatitis B; HIV Infections

Summary: hbe seroconversion is an important goal for anti-hbv treatment, since it is associated with a non progressive liver infection and a better clinical outcome. however, the rate of hbe seroconversion is low in hiv-hbv co-infected patients, mostly treated by tenofovir and emtricitabine. this study will evaluate the efficacy and the safety of a one-year peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching hbe seroconversion.

many hbv-hiv co-infected patients are currently treated with dual activity drugs such as tenofovir and emtricitabine, often in combination. however, despite the potent antiviral activity of these drugs, the rate of hbe seroconversion is quite low, and not always sustained over time. hbe seroconversion is an important goal for anti-hbv treatment, since it is associated with a non progressive liver infection and a better clinical outcome. on the other hand, treatments with antiviral and immuno-modulator activity such as peg-interferon, are infrequently used in co-infected patients, despite promising data in the field of hbv mono-infection with increased rates and sustained hbe seroconversions. this pilot study will evaluate the efficacy and the safety of a one-year peg-interferon alpha 2a additional treatment (180 micro-g once a week, by injection), in 55 patients already treated by tenofovir and emtricitabine for at least 6 months, and who did not reached hbe seroconversion

Eligibility criteria:
inclusion criteria: * hiv infection * karnofsky above 80 per cent * stable arv since 4 months * cd4 above 200 per mm3 * arn vih below 10000 copies per ml * hepatitis b chronic with : positive antigenaemia hbe and negative antihbe, positive dna hbv before or under tenofovir treatment, dna hbv negative or below 10000 copies per ml at w-8. * previous treatment by tenofovir and lamivudine or emtricitabine more than 6 months exclusion criteria: * hiv 2 infection * hepatitis c or d * opportunistic infection * alcool consummation more than 50g/d * cirrhosis * pregnancy or plan of pregnancy * breastfeeding * immunosuppressive or modulating of the immune response treatment * other hepatitis b treatments than tenofovir, lamivudine or emtricitabine since 6 months * malabsorption * exclusive hiv therapy with truvada * evolutive cancer under chemotherapy

Keywords: hiv and hepatitis b coinfection peg interferon tenofovir emtricitabine hepatitis b e antigens treatment experienced
rewarding sexually transmitted infection (sti) prevention and control in tanzania

Conditions: Sexually Transmitted Diseases

Summary: this project evaluates the effect of a combined economic and psycho-social intervention to reduce risky sexual activity and its consequences. the main hypothesis to be tested is that risky sexual activity and resulting sexually transmitted infections (stis) can be reduced through an intervention of counseling, regular sti testing, and positive reinforcement using cash rewards. the intervention is being implemented in a population of young people in rural tanzania where more conventional behavioral change interventions have had limited effect in battling a generalized hiv epidemic.


Eligibility criteria:
inclusion criteria: * plan to live in study area for next 12 months exclusion criteria: * pregnant
a study of rituximab in frontline therapy for glomerulonephritis

Conditions: Glomerulonephritis

Summary: this study included patients with glomerulonephritis who planned to receive rituximab treatment, and observed the efficacy and safety of rituximab in different glomerulonephritis in the real world. according to the pathological types of glomerulonephritis, they were divided into two cohorts : membranous nephropathy ( mn ) group or minimal change disease / focal segmental glomerulosclerosis ( mcd / fsgs ) group.

a total of 100 patients with glomerulonephritis who planned to receive rituximab treatment were enrolled in the study. according to the pathological types of glomerulonephritis, they were divided into mn cohort and mcd / fsgs cohort, with 50 patients in each cohort. all eligible patients who meet the inclusion and exclusion criteria will be invited to participate in this study.

Eligibility criteria:
inclusion criteria: * primary mn, mcd/fsgs patients confirmed by biopsy * consistent with nephrotic syndrome ( urinary protein\>3.5g/d and serum albumin\< 30g/l), and the researchers consider that immunosuppressive therapy is needed * estimated glomerular filtration rate ( egfr≥60 ml/min/1.73m2 ) * patients providing written informed consent before initiation of any study-related activities exclusion criteria: * previous treatment of rituximab * active bacteria, fungi, tuberculosis, viral infection * secondary mn, mcd, fsgs ( such as active hepatitis, systemic lupus erythematosus, drugs, malignant tumors, genetic or diabetic nephropathy, etc. ) * severe cardiac insufficiency, cardiac function in nyha grade iii above * severe hypertension ( blood pressure\>180/110 mmhg ) that cannot be controlled by drug treatment * pregnant or lactating female patients * uncontrolled concurrent diseases, including but not limited to： 1. hiv infected ( hiv antibody positive ) 2. hbv or hcv infection 3. evidence of severe or uncontrolled systemic diseases ( such as severe mental, neurological, epilepsy or dementia ) * those currently undergoing clinical trials of other drugs * other patients considered unsuitable for inclusion by the researchers

Keywords: mn;mcd/fsgs;rituximab
single ascending dose study investigating the safety, tolerability, and pk of xc130-a10h in healthy adult subjects

Conditions: Parkinson's Disease

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (sad) study. up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. in each cohort, subjects will receive a single oral dose of xc130-a10h or matching placebo on day 1. safety, tolerability, and pharmacokinetics will be assessed throughout the study. dose escalation will not take place until the principal investigator, sponsor, and medical monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

this is a randomized, double-blind, placebo-controlled, parallel group sad study conducted at one study center. up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. in each cohort, subjects will receive a single oral dose of xc130-a10h or matching placebo on day 1. dose escalation will not take place until the principal investigator, sponsor, and medical monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort. safety (i.e., adverse events \[aes\], physical examinations, pulse oximetry, vital signs, orthostatic vital signs, 12-lead electrocardiograms (ecgs), clinical laboratory tests, columbia suicide severity rating scale \[c-ssrs\], and mini-mental state examination \[mmse\]) will be assessed throughout the study. blood samples will be collected through 48 hours post-dose for the pk assessment of xc130-a10h and the metabolites.

Eligibility criteria:
major inclusion criteria: * healthy, adult, male or female of non-childbearing potential only, 18-75 years of age. * body mass index (bmi) ≥ 18 and ≤ 32.0 kg/m2 at screening. * medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ecgs. * understands the study procedures in the informed consent form (icf), and is willing and able to comply with the protocol. major exclusion criteria: * mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study. * history or presence of clinically significant medical, surgical or psychiatric condition or disease. * history of any illness that, in the opinion of the pi, might confound the results of the study or poses an additional risk to the subject by their participation in the study. * history of clinically significant hypotension. * history of orthostatic hypotension in the 12 months prior to screening. * clinically significant hypertension at screening. * history or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.
knowledge attitudes behaviours and practices regarding hiv of sex workers in the french antilles

Conditions: Hiv

Summary: the aim of the study was to determine the knowledge attitudes, behaviours and practices of sex workers regarding hiv in martinique, guadeloupe and saint martin.


Eligibility criteria:
inclusion criteria: * sex worker living in the french antilles exclusion criteria: * refusal to participate
predictive model of recovery in patients with chronic nonspecific neck pain undergoing manual therapy and exercise

Conditions: Chronic Nonspecific Neck Pain

Summary: the aim of this study is to develop a predictive model to identify which patients with chronic nonspecific neck pain are more likely to benefit from manual therapy and exercise program, or usual care.


Eligibility criteria:
inclusion criteria: * chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis; * adults between 18 and 65 years of age and literate in portuguese; exclusion criteria: * history of cervical trauma and/or history of surgery in the prior 6 months; * clinical signs of infection, tumor, neurological, inflammatory or systemic diseases; * pregnancy

Keywords: chronic nonspecific neck pain disability predictive model rehabilitation pain intensity
performance-based reinforcement to enhance cognitive remediation therapy

Conditions: Substance-Related Disorders; Mental Disorders

Summary: the purpose of this study is to investigate whether monetary reinforcement for performance will enhance the effects of cognitive remediation therapy for substance users seeking treatment at an outpatient facility.

forty individuals seeking treatment for an alcohol or cocaine use disorder at the substance abuse treatment unit (satu) will be randomized to receive cognitive remediation therapy with or without additional compensation based on performance. participants will use the computerized cognitive remediation program (psscogrehab 2012) three times per week for four weeks. the primary outcome measure will be an improved performance on the computerized tasks, with secondary outcomes of changes in cognitive functioning (e.g., attention, concentration, memory) as measured by neuropsychological tests between baseline and post-treatment.

Eligibility criteria:
inclusion criteria: * 18 to 60 years old * primary alcohol and/or cocaine abuse/dependence diagnosis * abstinence from all drugs/alcohol for 30 days * mild cognitive impairment * sufficiently stable and plan to commit to 4 weeks of outpatient treatment * fluent in english and 6th grade reading ability exclusion criteria: * severe cognitive impairment indicative of dementia * untreated bipolar or psychotic disorder * have current legal case pending such that incarceration during 4-week study is likely

Keywords: cognitive remediation therapy substance abuse treatment
focusing implementation to bring effective reminders (fiber)

Conditions: Colorectal Cancer

Summary: fiber is 4-year study that will evaluate the implementation of a large-scale population-based colorectal cancer screening patient reminder and coordinated follow-up program. the crc screening program began in 2007 with kaiser permanente northwest (kpnw),a not-for- profit, integrated health system in oregon and washington. fiber consists of 1)a practical randomized controlled trial at the start of the program, followed by 2) a longer-term cohort study as all remaining eligible patients receive the program, and 3)a qualitative evaluation. fiber will evaluate the factors that are associated with implementation success across multiple levels: patient, primary care provider (pcp) team, specialists (gastroenterologists, general surgeons, pathologists), and other health plan staff and systems.


Eligibility criteria:
inclusion criteria: * kpnw members since 2005 * men and women, aged 50-80 who were due for crc screening during a 24-month period of time. exclusion criteria: * kpnw members who were part of a previous quantitative study.

Keywords: colon rectal cancer screening
prospective registry on intravascular lithotripsy

Conditions: Calcific Coronary Arteriosclerosis

Summary: multicenter, international, all-comers registry aims to provide insights in the current application of ivl technology in patients with calcified coronary lesions undergoing pci using ivl technology.

the primary objectives are: 1. to analyze the trends of ivl use overall and according to clinical/anatomical indications 2. to evaluate the rates of procedural success, defined as success in facilitating stent delivery with \<30% residual stenosis and without in-hospital 3. to describe the cumulative hierarchical incidence of mace defined as: cardiac death, non-fatal target vessel myocardial infarction (mi), or clinically driven target lesion revascularization (tlr) at 30-days following the index procedure the secondary objectives are: 1. to describe the rate of mace at 3-, 6- and 12-months following the index procedure 2. to assess the rates of all causes mortality, clinically driven target lesion revascularization (tlr) or target vessel revascularization (tvr), any revascularization (non tlr, non tvr) and arc-defined stent thrombosis at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure 3. to describe the rates of target lesion failure (tlf) (see end-points definitions section) 4. to describe the rates of device crossing success (see end-points definitions section) 5. to describe the rates of serious angiographic complications (see end-points definitions section) 6. to assess predictors of clinical outcomes based on patient and procedural characteristics 7. to analyze current standards of practice regarding ivl technology in a real-world multinational cohort (technique, training, local protocols).

Eligibility criteria:
inclusion criteria: * age \>18 years-old * ability to provide written informed consent exclusion criteria: * patient has any comorbidity or condition that, in the opinion of the investigator, compromises the subject's ability to give written informed consent * patient belongs to a vulnerable population subject is a member of a vulnerable population , including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Keywords: calcific coronary lesions intravascular lithotripsy debulking complex percutaneous coronary interventions