Kornimate/medical-research-clean huggingface dataset:
ab-101 in combination with b-cell depleting mab in patients who failed treatment for class iii or iv lupus nephritis or other forms of refractory systemic lupus erythematosus

Conditions: Lupus Nephritis - WHO Class III; Lupus Nephritis - WHO Class IV; Refractory Systemic Lupus Erythematosus; SLE

Summary: ab-101 (also known as allonk) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called nk cells. white blood cells are part of the immune system and nk cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies. this clinical trial will enroll adult patients with lupus nephritis class iii or iv either with or without the presence of class v who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus. the primary objective is to assess the safety, tolerability and preliminary activity of ab-101 plus a b-cell depleting mab (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis class iii or iv, with or without the presence of class v, or other forms of refractory systemic lupus erythematosus. patients will be assigned to receive either ab-101 alone as monotherapy or in combination with a b-cell depleting mab (e.g., rituximab, obinutuzumab). all patients will receive at least 1 treatment cycle of ab-101, followed by scheduled assessments of overall health and response status. patients may receive up to 2 cycles of treatment spaced 24 weeks apart.


Eligibility criteria:
inclusion criteria for all subjects (lupus nephritis or sle) * diagnosis of sle according to the 2019 european league against rheumatism/american college of rheumatology (eular/acr) classification criteria * subjects must have had an inadequate response with at least two prior lines of standard of care (soc) treatment. inclusion criteria for ln: * adult subjects with lupus nephritis class iii or iv (with or without the presence of class v) * evidence of active disease on renal biopsy. * all subjects are required to receive adequate concomitant antihypertensive and antiproteinuric therapy with blockade of the renin-angiotensin system inclusion criteria for sle: * total systemic lupus erythematosus disease activity index (sledai-2k score) ≥ 8, and clinical sledai-2k ≥ 4. * british isles lupus assessment group 2004 (bilag-2004) activity score of a in ≥ 1 organ, or a bilag-2004 activity score of b in ≥ 2 organs. * subjects have failed at least two conventional therapies exclusion criteria: * known past or current malignancy * clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to sle * subjects with known active viral infections * severe active cns lupus

Keywords: sle lupus lupus nephritis allonk
does knowing one's estimated colorectal cancer risk influence screening behavior?

Conditions: Colorectal Cancer

Summary: this study is designed to examine the impact of telephone-based colorectal cancer risk assessment on colorectal screening attitudes and behavior among previously unscreened adults ages 50 to 75.

colorectal cancer (crc) remains the 3rd most common cancer in the us. most crcs are preventable, but screening participation remains suboptimal. several factors have been associated with screening compliance, such as perception of crc risk. here we study the impact of telephone-based administration of the national cancer institute colorectal cancer risk assessment tool (ccrat) compared to usual care.

Eligibility criteria:
inclusion criteria: * patient of any participating physician * not having had any colorectal cancer screening test prior * able to speak english exclusion criteria: * personal history of inflammatory bowel disease * personal history of colorectal cancer * personal history of lynch syndrome or familial adenomatous polyposis * have already received colorectal cancer screening

Keywords: cancer screening beliefs colorectal cancer screening
decreased insulin regulated aminopeptidase (irap) levels in gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: this cohort study investigated whether irap levels could be a marker for predicting gestational diabetes mellitus. 80 women were included in the study, including the control group. the study duration was 12 months and the study was completed.

in the cohort study, the study group (gdm group) consisted of 40 pregnant women diagnosed with gdm between 24-28 weeks of gestation with a 2-hour 75-g oral glucose tolerance test (ogtt). while 11 women in the gdm group received insulin treatment, 29 of them provided blood sugar regulation with diet. the 75-g ogtt tests of the 40 pregnant women in the control group were considered normoglycemic while matching with the study group in terms of age, bmi and gestational weeks, and no complications were observed in the pregnant women in this group. pregnant women with preeclampsia, chronic hypertension, pre-gestational diabetes mellitus, any acute or chronic disease, premature birth, premature rupture of membranes (pprom), fetal structural or chromosomal anomalies, multiple pregnancies and fetal growth restriction were not included in the study. the elisa method determined serum irap levels. serum irap levels of pregnant women were measured with enzyme-linked immunosorbent assay. serum levels of irap marker were compared between the groups.

Eligibility criteria:
inclusion criteria: * singleton pregnancies undergoing a 2-hour 75 g oral glucose tolerance test (ogtt) at 24 and 28 weeks of gestation. exclusion criteria: * preeclampsia, chronic hypertension, pregestational diabetes mellitus, pregnant women with any acute or chronic disease, preterm labor, premature rupture of membranes (pprom), fetal structural or chromosomal anomalies, multiple pregnancies, and fetal growth restriction

Keywords: insulin-regulated aminopeptidase gestational diabetes mellitus glucose transporter 4 insulin resistance glycated hemoglobin
comparison of door-to-door versus community gathering to provide hiv counseling and testing services in rural lesotho

Conditions: HIV/AIDS; Tuberculosis; Diabetes Mellitus; Arterial Hypertension

Summary: the purpose of this trial is to determine if door-to-door is more effective than community gathering in providing voluntary hiv counseling and testing (vct) in communities in rural lesotho. the voluntary hiv counseling and testing will be proposed as an integrated part of a package of proposed services. the package consists of: blood-pressure measurement, blood-glucose measurement, body-mass-index (adults), weight for height (children), catch-up vaccinations, deworming (children) vitamin a (children \& young women), family planning for eligible women, tuberculosis screening and hiv counseling and testing.

12 health centers (clusters) in rural lesotho are matched according to their routine performance in vct and enrollment into chronic hiv/aids care (average numbers tested positive and enrolled into hiv/aids care per month per facility). after matching, 6 health centers are randomly assigned to perform door-to-door vct, whereas the others perform the traditional community gathering approach (called "pitso" in sesotho). within the catchment area of each health center five campaigns in five different, randomly selected villages, are held (one day vct campaign per village). within each cluster another five villages are randomly selected who do not get a particular campaign and serve as a control for each cluster. in each matched cluster-pair, both health centers conduct the five campaigns during the same week (one conducting it as door-to-door, the other one conducting it through "pitsos" (community gathering)). both approaches receive the same resources in terms of finances, time spending doing the vct-campaign and human resources.

Eligibility criteria:
inclusion criteria: * not already known to be hiv-positive * resident in the catchment area of the health center where the campaign is conducted * provision of written informed consent to participate (signed by writing or fingerprint) * in case of children: provision of written informed consent by an adult care-taker

Keywords: home-based hiv-testing voluntary counseling and testing community based testing hiv/aids lesotho
a study of tqa3526 in the treatment of primary biliary cirrhosis (pbc)

Conditions: Primary Biliary Cirrhosis

Summary: tqa3526 is a modified bile acid and fxr agonist. fxr is a key regulator of bile acid synthesis and transport. bile acids are used by the body to help with digestion. it is hypothesized that regular treatment with tqa3526 will improve liver function in persons with primary biliary cirrhosis (pbc).


Eligibility criteria:
inclusion criteria: * 1.18 and 70 years old, male or female. 2.proven as pbc, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors: * history of increased alp levels for at least 3 months prior to day 0 in previously treated pbc patients，or alp levels increased during screening in treatment naive pbc patients； ② positive ama titer (\>1:40 titer on immunofluorescence or m2 positive by elisa) or pbc-specific antinuclear antibodies (anti-gp210 and anti-sp100 positive)； ③ liver biopsy consistent with pbc within 24w prior to randomization； 3.alp value between 1.67 and 10 × uln; 4.taking ursodeoxycholic acid (udca) for at least 12 months (stable dose for ≥ 3 months) prior to day 0, or unable to tolerate udca (no udca for ≥ 3 months) prior to day 0. exclusion criteria: * 1.has other virus infected ; 2.history or presence of other concomitant liver diseases； 3.presence of clinical complications of pbc or clinically significant hepatic decompensation； 4.child-pugh grade b or c in patients with cirrhosis； 5.creatinine (cr) ≥1.5 times the upper limit of normal value and serum creatinine clearance rate \ 5×uln；tbil\>3×uln； 7.patients with a history of severe pruritus within 2 months prior to day 0; 8.history or presence of clinically concerning cardiac arrhythmias, the duration of the study may affect survival; 9.presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine; 10.medical conditions that may cause nonhepatic increases in alp (e.g., paget's disease) or which may diminish life expectancy to \< 2 years.
role of the gut microbiome in the outcome of diffuse large b-cell lymphoma patients treated with car-t cell therapy

Conditions: Diffuse Large B Cell Lymphoma

Summary: despite impressive outcomes in selected patients, significant heterogeneity in clinical response to car-t cell therapy remains. the gut microbiome (gm) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. currently, it is unknown if gm also modulates anti-tumor responses to car-t cells and related toxicities in lymphomas.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. patients affected by histologically confirmed dlbcl. 3. patients amenable for car-t cell therapy as for clinical approved indication (commercial products). 4. patients must provide written informed consent. exclusion criteria: 1. evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results. 2. concurrent second malignancy.

Keywords: gut microbiome car t-cell therapy
cognitive motivational behavior therapy for gamblers

Conditions: Gambling

Summary: this study will evaluate the effectiveness of cognitive motivational behavior therapy (cmbt) in treating pathological gamblers.

pathological gambling is developing into a serious public health problem. the rise in gambling problems has stimulated treatment studies, but little progress has been made. a particular concern is the high dropout rates from treatment studies; gamblers often seek treatment, but fail to complete it and relapse. this study will test the effectiveness of cmbt in helping to increase retention rates in gambling treatment studies. the first step in this study is designed to enhance gamblers' readiness for change. when participants are committed to change, cmbt will then address specific cognitive biases regarding the notion of randomness, which is thought to lie at the heart of gambling problems. behavioral components will also be used to enhance gamblers' coping skills. the participants in this study will be randomly assigned to either cmbt or a gambler's anonymous control group. participants will be assessed prior to and after treatment and at 3- and 6-month follow-up visits. interviews and questionnaires will be used to assess participants.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for pathological gambling * eighth grade reading ability * reside in the albany, ny area exclusion criteria: * diagnosis of serious psychopathology, including psychosis, bipolar disorder, or alcohol or other substance dependence
manual versus oscillating-rotating toothbrushes after root coverage procedure

Conditions: Gingival Recession

Summary: the aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes.

background oscillating-rotating power toothbrushes have been proven clinically efficacious. to the investigators' knowledge, a clinical evaluation of the safety of these toothbrushes after surgical root coverage procedure have not been published. the aim of this study is to evaluate the gingival margin stability with the use of oscillating-rotating toothbrushes compared to manual toothbrushes. methods sixty healthy patients with at least a single miller class i or ii gingival recession underwent surgical root coverage procedure. soft-bristle manual and powered toothbrushes were given to participants randomly assigned to control and test group, respectively. full-mouth plaque score, full-mouth bleeding score, probing pocket depth and recession depth were recorded 1, 3 and 6 months after completion of surgical procedure. longitudinal analyses were performed using linear random-intercept models to take into account within-subject correlations over time. temporal trend differences across treatments by including treatment-time interaction terms were then tested using a global wald test.

Eligibility criteria:
inclusion criteria: * full-mouth plaque score (fmps) ≤25% * full-mouth bleeding score (fmbs) ≤25% * miller class i and ii buccal recession ≥2 mm exclusion criteria: * relevant systemic condition or disease * smokers * teeth with prosthetic crowns or restorations in the cervical area * presence of pulling frenum in the keratinized tissue * previous mucogingival or periodontal surgery in the experimental site

Keywords: toothbrushing oral hygiene dental hygiene
gabapentin for the treatment of pruritus caused by burn injuries in children

Conditions: Pruritus

Summary: children with healing burns often suffer from pruritus that may continue for many months. pruritus can be very distressing to the child and can interfere with sleep, activities of daily living, and rehabilitation therapy. additionally, constant scratching of skin grafts may result in damage that requires further surgery, thus putting the patient at additional risk and adding to health care costs. although the size of the burn injury is a risk factor for pruritus, almost 50% of patients with small burn injuries reported moderate or severe pruritus.

gabapentin has been shown to be effective for the treatment of pruritus in adult patients with brachioradial pruritus, uraemic pruritus and pruritus of unknown origin. although the specific mechanism is unknown, the end result is the downregulation of excitatory neurotransmitter release and decrease in neuronal hyperexcitability. the primary objective of this study is evaluating the effectiveness of gabapentin in reducing the severity of pruritus in children with burn injuries.

Eligibility criteria:
inclusion criteria: 1. children with partial or deep thickness burn 2. children receiving triple antihistamines for treatment of pruritus 3. children with a pruritus score ≥ 2 (appendix 1) despite triple antihistamine therapy 4. children who are tolerating liquids by mouth or nasogastric tube exclusion criteria 1. children with a medical condition for which gabapentin is contraindicated including children who have demonstrated a hypersensitivity to gabapentin or any of the components of the formulation. 2. children with seizure disorders 3. children with a pre-existing behavioural or developmental disorder 4. children with renal impairment 5. children with severe burns requiring picu admission

Keywords: gabapentin burn injuries in children pruritus
efficacy of nalmefene in patients with alcohol dependence

Conditions: Alcohol Dependence

Summary: the purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. this study is planned to evaluate the efficacy and safety of as-needed use of nalmefene 18.06 mg versus placebo in decreasing monthly heavy drinking days (hdds) and decreasing the total consumption during a period of 6 months in adult patients with alcohol dependence.

Eligibility criteria:
inclusion criteria: in- and outpatients who: * had a primary diagnosis of alcohol dependence according to diagnostic and statistical manual of mental disorders - text revision (dsm-iv-tr) criteria * had had ≥6 hdds in the 4 weeks preceding the screening visit * had had an average alcohol consumption at who medium risk level or above in the 4 weeks preceding the screening visit exclusion criteria: the patient: * had a dsm-iv axis i disorder other than alcohol dependence or nicotine dependence * had an antisocial personality disorder * had risk of suicide evaluated by the suicidality module of the mini-international neuropsychiatric interview (mini) * had a history of delirium tremens or alcohol withdrawal seizures * reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists * reported current or recent treatment with antipsychotics or antidepressants * was pregnant or breast-feeding other protocol-defined inclusion and exclusion criteria may apply.

Keywords: alcohol-related disorders alcoholism mental disorders central nervous system agents
therapeutic strategy in patients treated with methotrexate for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a longitudinal, observational, prospective, multicentre study conducted in metropolitan france, among a representative sample of office-based or mixed practice rheumatology doctors. the aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.


Eligibility criteria:
inclusion criteria: * adult patient, ambulatory, seen in a rheumatology consultation. * with a confirmed diagnosis of ra (acr 1987 or acr/eular 2010 criteria) receiving a disease-modifying treatment with methotrexate as a monotherapy. * with clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the ra . * informed about the computer processing of their medical data and their right of access and correction. exclusion criteria: * patient not treated with methotrexate for their ra. * already treated with a biotherapy or receiving other synthetic dmards (disease-modifying antirheumatic drugs) in combination with methotrexate . * participating in a clinical trial in rheumatology.

Keywords: methotrexate therapeutic strategy
retrospective analysis of patients re-treated with lutetium-177 dotatate (lutathera®)

Conditions: Neuroendocrine Tumor

Summary: this was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (net) re-treated with lutetium-177 dotatate at a single united states institution - the excel diagnostics \& nuclear oncology center in houston, texas. initial treatment was defined as the initial regimen of up to 4 doses of lutetium-177 dotatate received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 dotatate given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment. the study period was from 01 january 2010 to 30 june 2021. the index date was the date of the first ever treatment with lutetium-177 dotatate, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 dotatate received. the index (identification) period was from 01 july 2010 to 31 december 2020 to account for minimum 6-month baseline and follow-up periods. patients were followed from the index date to the occurrence of one of the following events (whichever came first): 1. date of death - the date at which a patient was reported in the database as having died 2. last month active - the last recorded mention of the patient in the dataset 3. end of data window - end of the dataset patient characteristics were assessed at both the index date and the index re-treatment date. real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.


Eligibility criteria:
inclusion criteria * diagnosis of any net * evidence of re-treatment with lutetium-177 dotatate * documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 dotatate, followed by evidence of progression, and then ≥1 subsequent dose of lutetium-177 dotatate * minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose exclusion criteria • \<18 years of age