Kornimate/medical-research-clean huggingface dataset:
transarterial infusion of pd-1 antibody plus tace-haic for unresectable hcc: a single-arm, phase 2 clinical trial

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is a common disease in east asia. less than 20% of newly diagnosed patients can undergo radical resection. for those with unresectable bclc c stage, transarterial chemotherapy and targeted therapy are recommend to prolong survival. recently, folfox (oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (haic) exhibited high response rate for unresectable hcc. transartery infusion of agents provide promising outcome when compared systemic infusion. furthermore, our pilot study showed tace combined haic (tace-haic) had better tumor response, with low progression disease rate. whether tace-haic plus hepatic artery infusion pd-1 antibody would improve survival for unresectalbe bclc c stage patients is still unknown. a single arm, phase 2 clinical trial is aimed to answer this question.


Eligibility criteria:
inclusion criteria: * bclc c stage with unresectable diseasehigh-recurrence risk factor; * child-pugh a or b (7 score) liver function; * anticipated survival more than 3 moths exclusion criteria: * pregnant woman or sucking period; * with other malignant cancer; * received anti-hcc therapy before this study
evaluating the efficacy vardenafil 10 mg vs tadalafil 10 mg in in subjects with erectile dysfunction (ed)

Conditions: Erectile Dysfunction

Summary: evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ed


Eligibility criteria:
inclusion criteria: * age between 18 and 64 years * heterosexual males * erectile dysfunction for more than 6 months exclusion criteria: * penile anatomical abnormalities * spinal cord injury * history of surgical prostatectomy

Keywords: erectile dysfunction vardenafil
triomune bioequivalence with innovators

Conditions: HIV/AIDS

Summary: the null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of triomune and brand-name stavudine/lamivudine/nevirapine in hiv-infected africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absorption into the systemic circulation of triomune and brand-name stavudine/lamivudine/nevirapine in hiv-infected africans. this is a non-inferiority study.

generic antiretroviral therapy is the mainstay of hiv treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. we compared the steady-state pharmacokinetics of lamivudine, stavudine and nevirapine in hiv-infected subjects who were receiving a generic formulation (triomune®) or the corresponding brand formulations (epivir®, zerit®, and viramune®). an open-label, randomized, crossover study was carried out in 18 hiv-infected ugandan subjects stabilized on triomune-40. subjects received lamivudine (150 mg), stavudine (40 mg), and nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. at the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. the main outcome measures were the mean auc0-12h and cmax. bioequivalence was defined as a geometric mean ratio between the generic and brand-name within the 90% confidence interval of 0.8-1.25.

Eligibility criteria:
inclusion criteria: 1. hiv-infected men and non-pregnant women; 2. on triomune for at least 4 weeks; 3. 18 years or greater; 4. residing within 15km of kampala city center exclusion criteria: 1. unable to sign or understand informed consent 2. concurrent medication known to interact with any of the components of triomune 3. patients with active tb, malabsorption, nausea, emesis, abdominal discomfort, chronic diarrhoea, documented active clinically relevant hepatitis; 4. patients expected to change their drug regimen or dosage during the study 5. those planning to move out of kampala in the next two months; 6. hemoglobin \<7.0 mmol/l (men) or \<6.5 mmol/l (women); 7. alanine aminotransferase or aspartate aminotransferase \>5 times the upper limit of normal; 8. serum creatinine \> 1.5 times the upper limit of normal

Keywords: hiv;bioequivalence;triomune
effects of high dietary fiber supplementation in diabetic chronic kidney disease

Conditions: Kidney Disease

Summary: loss of kidney function results in accumulation in the blood of molecules that are either excreted or metabolized by the kidney. collectively, these molecules are termed uremic retention molecules (urms) or toxins. it is increasingly recognized that colonic bacterial metabolites like p-cresyl sulfate and indoxyl sulfate that are absorbed from the colon and excreted by the kidney may contribute to the pool of compounds implied in uremic toxicity. indeed, these urms have been linked to increased levels of inflammation markers, chronic kidney disease (ckd) progression, cardiovascular disease and overall mortality in ckd and/ or hemodialysis patients. therefore, interventions that target the production or absorption of urms from the gut might decrease inflammation and oxidative stress that are commonly seen in the uremic milieu. the national health and nutrition examination survey iii (nhanes iii) data show that high dietary fiber intake is associated with decreased serum levels of c-reactive protein (crp) in those with and without ckd and these associations are much stronger in the ckd population. a possible explanation of this effect is that a high fiber diet in ckd patients modulates the bacterial production, intestinal absorption and finally the serum levels of urms like p-cresyl sulfate and indoxyl sulfate, which in turn results in decrease in inflammation. objectives: hypothesis: 1. higher serum levels of markers of inflammation such as high sensitivity c-reactive protein (hscrp), interleukin 6 (il-6) and tumor necrosis factor (tnf) -α seen in stage 4 ckd (estimated glomerular filtration rate 15-29 ml/min/1.73 m2) compared to stage 2 ckd (estimated glomerular filtration rate 60-89 ml/min/1.73 m2) is partly explained by the higher circulating levels of urms (p-cresyl sulfate and indoxyl sulfate) in stage 4 ckd, and 2. dietary supplementation in stage 4 ckd with 30g/d of a soluble fiber psyllium (brand name-metamucil tm) will decrease circulating urms levels and thereby, decrease serum levels of inflammation markers and urinary levels of transforming growth factor (tgf)-β, a marker of kidney fibrosis.


Eligibility criteria:
inclusion criteria: * patients with or without diabetes and stage 1 or 2 ckd (estimated glomerular filtration rate \> 60 ml/min/1.73 m2) with urine dipstick positive for protein or urinary albumin/ creatinine \> 30 mg/g of creatinine; or * stage 3 or 4 ckd (estimated glomerular filtration rate \< 60 to 15 ml/min/1.73 m2). exclusion criteria: * pregnant women * prisoners * bowel obstruction * enrolled in other interventional studies.

Keywords: kidney disease fiber dietary intervention
the study to assess ami treated with balloon angioplasty.

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the effectiveness and safety of the cypher™ (cypher select™) (sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (tvf) in subjects treated for acute myocardial infarction as compared to a bare metal stent.

this is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the cypher™ (sirolimus-eluting) stent as compared to the bare stents. patients with de novo native coronary artery lesions will be treated with the cypher™ (sirolimus-eluting) stent or a bare stent. subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.

Eligibility criteria:
inclusion criteria: 1. have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following: 1. st segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial leads with reciprocal st depression 2. new or presumably new left bundle branch block (lbbb) 2. the culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. the culprit site must be visualized before the stent implantation; exclusion criteria: 1. killip class \> 2 upon arrival to the cath-lab; 2. significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff; 3. evidence of massive thrombus in the infarct related artery distally to the culprit lesion; 4. documented left ventricular ejection fraction \<=30%; 5. target lesion is located in an arterial or venous by-pass graft; 6. ecg documented evidence of prior myocardial infarction; 7. patient who received thrombolytic therapy for the current ami before enrollment in this study.
epidemiological and scientific evaluation of egfr mutation status in patients with newly diagnosed locally advanced or m

Conditions: Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer

Summary: the primary objective of the study is to collect epidemiological data on egfr mutation status (m+, m-) in a population of predominantly caucasian ethnicity and to correlate egfr mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). in particular, the study will aim to determine the frequency of egfr m+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with egfr mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

an nis registry for the epidemiological and scientific evaluation of egfr mutation status in patients with newly diagnosed locally advanced or metastatic nsclc (stage iiib/iv non-small cell lung cancer)

Eligibility criteria:
histologically confirmed locally advanced or metastatic nsclc (stage iiib/iv). mixed histology of small cell and non-small cell lung cancer

Keywords: egfr mutation ,newly diagnosed nsclc, locally advanced or metastatic nsclc
esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in patients

Conditions: Sleep Disturbance

Summary: to explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies

postoperative sleep disturbance (psd) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery. benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration.esketamine is an nmda receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. for patients undergoing surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative sleep disturbance and anxiety is worth exploring.

Eligibility criteria:
inclusion criteria: 1. age 20-65 years old; 2. asa classification is grade i-iii; 3. elective surgery is proposed 4. bmi of 19-30 kg/m2; 5. patients who agreed to enroll in this study voluntarily exclusion criteria: 1. those who are known to be allergic to the drug ingredients in this study and their allergic constitution; 2. allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs; 3. history of neurological diseases; history of chronic pain; drug and alcohol addiction; a long history of opioid use; opiates were given 48 hours before surgery; 4. asa rating of iv or v; 5. coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities; 6. history of gastrointestinal disease (peptic ulcer, crohn's disease, ulcerative colitis); 7. respiratory insufficiency, respiratory failure; 8. patients who refused to use intravenous pca for analgesia; 9. pregnant or lactating women; 10. bmi\ 30kg/m2; 11. poor compliance, unable to complete the experiment according to the study plan; 12. participants who have participated in clinical trials of other drugs within the last 4 weeks; 13. any circumstances deemed unsuitable for inclusion by the researcher for any reason.

Keywords: esketamine remimazolam anxiety gastroenteroscopy
study to evaluate frozen versus refrigerated mmrv (combined measles, mumps, rubella, and varicella) investigational vaccine (v221-016)

Conditions: Measles; Mumps; Rubella; Varicella

Summary: the purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.


Eligibility criteria:
inclusion criteria: * healthy children 12-23 months of age exclusion criteria: * previously had measles, mumps, rubella, or varicella * compromised immune system
wellpath-prevent: a mobile intervention for middle-aged and older adults hospitalized for suicidal ideation or attempt

Conditions: Suicide, Attempted; Suicidal Ideation; Depression

Summary: the goal of this project is to test whether wellpath-prevent (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).

r61 phase: in this "proof-of-concept" phase, interventionists will administer 12 weeks of wellpath-prevent in 40 middle-aged and older adults who have been discharged after being hospitalized for suicidal ideation or suicide attempt. the interventionist will help the patient incorporate the appropriate data (i.e., triggers, negative emotions, cognitive reappraisal techniques) into the tablet, train the patients on how to use the tablet, and coach them during the 12 weeks. there will be 4 assessments: at study entry (admission/during hospitalization), hospital discharge, 6, and 12 weeks. an eeg will be conducted upon entry into the study, at week 6, and at week 12. r33 phase: 75 middle-aged and older adults who have been recently discharged after a hospitalization for suicidal ideation or attempt will be recruited and randomized to an optimized version of wellpath-prevent (week 6 and week 12 duration based on r61 results) or to attention control-usual care with a tablet (ac-uc). there will be 5 assessments: at study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks. participants who exit the study prior to completion will be invited to have an assessment before termination as close to the scheduled time point as possible. psychiatrically re-hospitalized participants will not be dropped from the study but will have an additional assessment and will continue the assessments as scheduled based on their initial hospitalization.

Eligibility criteria:
inclusion criteria: * 50-90 years old * diagnosis (based on a modified scid-5 clinical trials version to assess dsm-5 diagnoses): any dsm-5 except: current diagnosis of psychotic disorder; diagnosis of dementia * recent hospitalization for suicidal ideation or suicide attempt; at hospital admission, columbia suicide severity rating scale (cssr-s) ≥ 2, "non-specific active suicidal thoughts." * we will also include patients on psychotropics and on after-care community psychotherapy. exclusion criteria: * current diagnosis of psychotic disorders; diagnosis of dementia * cognitive impairment (mmse ≤ 24) * acute or severe medical illness (i.e., delirium; decompensated cardiac, liver or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry * aphasia, sensory problems, and/or inability to speak english.

Keywords: older adults middle aged adults
a study to assess the efficacy of gefapixant (mk-7264/af-219), in participants with chronic cough (mk-7264-006)

Conditions: Chronic Cough

Summary: this is a randomised, double-blind, placebo-controlled, crossover, single centre study of gefapixant (af-219/mk-7264) in participants with idiopathic or treatment resistant chronic cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective cough frequency.


Eligibility criteria:
inclusion criteria: * history of cough for more than 8 weeks * normal chest radiograph * idiopathic or treatment resistant cough (idiopathic defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip \[treatment-resistant\]). exclusion criteria: * current smoker * individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history * treatment with an angiotensin-converting-enzyme inhibitor (ace-inhibitor) as the potential cause of a participant's cough, or requiring treatment with an ace-inhibitor during the study or within 4 weeks prior to day 0 * forced expiratory volume (fev1)/forced vital capacity (fvc) \<60%
safety and tolerability of ziprasidone in children and adolescents with bipolar i disorder (manic or mixed)

Conditions: Bipolar Disorder

Summary: the purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar i disorder (manic or mixed)


Eligibility criteria:
inclusion criteria: * participation in double-blind treatment study a1281132, meeting specific criteria of duration and safety exclusion criteria: * imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study a1281132; significant prolongation of qt interval in study a1281132.

Keywords: children and adolescents with bipolar i disorder (manic or mixed)
characterization of corticospinal excitability during progressive skin cooling

Conditions: Hypothermia Due to Cold Environment

Summary: this study characterizes the changes in corticospinal excitability that accompany basic cold stress via skin cooling that result in reduced skin or core temperature and shivering.

cold stress is known to impair both fine and gross motor movement. reductions in performance may have life threatening consequences in survival situations where maintenance of muscle control is necessary. much of the effects cooling has on muscle performance is directly due to its effects on muscle tissue itself, whereas less is known about the effects on the central nervous system. therefore, the purpose of the study was to characterize corticospinal excitability that accompanies basic cold stress via progressive skin cooling, resulting in reductions in skin (tsk) or core (tco) temperature and shivering.

Eligibility criteria:
inclusion criteria: * healthy adult * right handed * pass magnetic stimulation safety checklist * pass medical screening questionnaire exclusion criteria: * left handed * any adverse responses to cold exposure (raynaud's syndrome) * cardiorespiratory disease

Keywords: body temperature, skin temperature, cooling
exploratory study investigating urodynamic parameters during catheterisation

Conditions: Spinal Cord Injuries; Enlarged Prostate With Lower Urinary Tract Symptoms

Summary: the objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.

the investigation is an explorative open single arm investigation including 30 male subjects. 10 healthy volunteers, 10 patients with sci and 10 patients with bph. the healthy volunteers included into the study will have an information visit and three study visits - an inclusion visit (visit 0), a visit 1 measuring endpoints while spontaneous voiding of the bladder (0-7 days after visit 0) followed by a visit 2 measuring endpoints while emptying the bladder using a standard ic (4-15 days after visit 1). (visit 0 and visit 1 can be the same day). the subjects with sci and enlarged prostate will have an information visit and two study visits. - an inclusion visit (visit 0) where a urine culture is analysed and prophylactic antibiotic is prescribed per the result of the analysis. (most ic users have bacteria in the urine and to decrease the risk of acquiring a urinary tract infection from the urodynamic examination, urine cultures are performed and prophylactic antibiotics will be prescribed per the result). the second visit (visit 1) is conducted while the patient is on antibiotic treatment measuring all endpoints while emptying the bladder with a standard ic (4-15 days after visit 0 while subject is on prophylaxis antibiotics). the investigation is conducted at one site and is an explorative study, estimated to last eight (8) months. due to the explorative nature of the investigation, no primary endpoint is defined but explorative endpoints are divided into three categories dependent on their relation to bladder, urethra or urine.

Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. be at least 18 years of age and have full legal capacity 3. be male 4. for healthy volunteers: willing to comply with not using analgesics up to 24 hours prior to study visit 5. for healthy volunteers: negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture 6. for sci and bph patients: use intermittent catheter daily and have used intermittent catheters for at least 2 months exclusion criteria: 1. symptoms of urinary tract infections (frequent urination, stinging and pain at urination) 2. participate in other clinical investigations related to urinary tract system during this investigation (inclusion → termination) 3. for healthy volunteers: abnormalities, diseases or surgical procedures performed in the lower urinary tract
surgical treamtment of pseudarthrosis of the humerus (study of a series of 53 cases)

Conditions: Humerus Fracture

Summary: pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). it represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting. the aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used.

the management of pseudarthrosis of the humerus remains a subject of controversy. given our results, the investigators think that osteosynthesis by plate associated with bone grafting and/or decortication remains the most suitable for the treatment of aseptic pseudarthroses of the humeral shaft while treatment with ilizarov is most appropriate in septic pseudarthrosis. however, the best treatment for pseudarthrosis of the humerus remains that of treating the initial fracture. and better control of pseudoarthrogenic risk factors (tobacco++).

Eligibility criteria:
inclusion criteria: * - adult men and women \&gt; 18 years old with pseudarthrosis of the post-fractured humeral diaphysis treated in the orthopedic surgery and traumatology department. exclusion criteria: * - unusable files. * patients lost to follow-up. * patients who did not accept therapeutic treatment.

Keywords: humerus pseudarthrosis screwed plate external fixator