Kornimate/medical-research-clean huggingface dataset:
gastric cancer rad001 study

Conditions: Gastric Cancer

Summary: the purpose of this study is to determine dose limiting toxicities (dlt) and maximum tolerated dose (mtd) of rad001, as well as to assess tumor response and overall survival.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven adenocarcinoma of the stomach. patients who have adenocarcinoma of the gastroesophageal junction will be eligible if the majority of the tumor bulk is below the junction. * metastatic or loco-regionally advanced disease * patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral ct /mri scan. see section 11.2 for the evaluation of measurable disease. * age \>= 18 years. * life expectancy of greater than 12 weeks. * ecog performance status \ = 60%). exclusion criteria: * patients who have received more than one line of palliative chemotherapy are allowed, provided that (i) the prior chemotherapy does not contain taxane, cisplatin or carboplatin; (ii) 4 weeks have elapsed prior to the start of the current study treatment, and that (iii) they have recovered from adverse events due to previous treatment \[except alopecia\]. * patients who have had radiotherapy or major surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to treatment administered more than 4 weeks earlier. * patients who are on cyp3a4 modifiers are excluded from the study * patients with known brain metastases. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to rad001. significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry. * patients with severe concurrent medical illness such as severe impairment of lung function should be excluded from studies of rad001. * uncontrolled intercurrent such as, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements. * poorly controlled diabetes mellitus * high ldl cholesterol or triglyceride level * pre-existing neuropathy of \>= grade 2 * patients with a history of second malignancies are eligible they have been disease free for at least 5 years and are deemed by the investigator to be at low risk of recurrence. par8entswith the following cancers are eligible if diagnosed and treated within the past 5 years: cervical carcinoma in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin * pregnancy or lactation.
different surgical drilling protocols in posterior maxilla

Conditions: Missing Teeth

Summary: sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the oral and maxillofacial surgery department, faculty of dentistry, mansoura university, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants

16 dental implants were inserted in 16 patients were divided into two groups: group a: 8 dental implants were inserted using undersized drilling technique and group b: 8 dental implants were inserted using single drilling technique. then the dental implants were assessed for 6 months regarding clinical evalution: regarding these parameters after immediately dental implants loading,3 months and 6 months. implant stability, implant probing depth, bleeding index. radiographic evaluation: immediately after implant loading and 6 months after loading regarding bone density and marginal bone loss.

Eligibility criteria:
inclusion criteria: * patients with missed one or more posterior maxillary tooth. * be older than 18 years and of residual bone height more than10 mm. * patients with good oral hygiene and willing to participate in the follow-up sessions. * patients with adequate mesio-distal width and inter-arch space. * patients without any para-functional habits such as clenching and bruxism. exclusion criteria: * patients whose proposed surgical site had any pathological lesion or root tips. * drug or alcohol abuse. * patients with uncontrolled systemic diseases. * pregnant patients. * tobacco use more than fourteen cigarettes daily.
high sensitive c-reactive protein to albumin ratio in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: assess the use of hs- c-reactive protein to albumin ratio (hs-car) in prediction of in-hospital short-term major adverse cardiac events (maces) in acute coronary syndrome (acs) patients

observational study conducted at coronary care unit(ccu) in sohag university hospital it included patients with acs diagnosed according to aha/accf guidelines (according to symptoms, ecg findings and serum troponin levels), who had admitted to the ccu. venous blood samples were instantly collected on admission to the hospital. hs-crp , serum albumin level were measured. hs-car is calculated and the patients divided into two groups: group a ( patients with high hs-car) and group b ( patients with low hs-car) in-hospital mace was regarded as the end point of our study. it was defined as acute heart failure, cardiogenic shock, reinfarction, all-cause death, serious arrhythmia and cardiac death

Eligibility criteria:
inclusion criteria: * all patients aged 18 year or older presented by acs not candidet for primary percutaneus coronary intervention ( pci ) . exclusion criteria: * • patients aged \< 18 years old * patients who have egfr \<60 ml/kg /m2 * patients who have malignancies * patients who have chronic heart failure (nyha class \>ii) * pateints who have chronic liver disease * patients who have nephrotic syndrome * patients who have acute cerebrovascular stroke * pregnant women * patients who have recent infection

Keywords: high sensitive c-reactive protein to albumin ratio
a phase 1 study to compare the pk and safety of naproxcinod in hepatic impaired patients and matching healthy subjects

Conditions: Liver Disease

Summary: this is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.

this is an open-label, non-randomized, parallel-group study that will be conducted at two study sites. patients with hepatic impairment and matched healthy subjects will receive naproxcinod 750 mg bid for 6 days and qd for the last day.

Eligibility criteria:
inclusion criteria: * male or female, age 40 to 75 years with stable hepatic insufficiency conforming to child-pugh classification b or * male or female, age 40 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health exclusion criteria: * current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except lose dose aspirin * history of renal impairment * diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months * clinically relevant abnormal ecg * alcohol or drug abuse within the last 6 months * any significant or chronic disease (except hepatic insufficiency for the patient cohort) which may interfere with study evaluations

Keywords: hepatic impairment
effects of passive blood-flow-restriction on muscle atrophy and pain after elective total knee arthroplasty

Conditions: Osteoarthritis in the Knee

Summary: this study investigated the effects of passive blood-flow-restriction training after elective total knee arthroplasty surgery on muscle atrophy and postoperative pain.

this is the first study invesigating the effects of passive blood-flow-restriction training on muscle atrophy and postoperative pain after elective total knee arthroplasty surgery.

Eligibility criteria:
inclusion criteria: * the study includes all patients with a medical indication for surgical treatment of the lower extremity (total or partial knee arthroplasty) who are eligible for either inpatient or outpatient rehabilitation. * all participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving comprehensive explanation, counseling, and information. * all patients have consented to the surgical procedure and received medical clearance for surgery from both the orthopedic and anesthesiology departments. exclusion criteria: * acute or chronic infections of the extremities * open wounds on the lower extremity * pregnancy and breastfeeding * patients who are unable to understand the patient information and study design (e.g., due to language barriers), or whose compliance is deemed insufficient by the study team
a study to compare two anti-hiv drug combinations in hiv-infected patients who have previously received anti-hiv treatment

Conditions: HIV Infections

Summary: the purpose of this study is to compare the safety and effectiveness of 2 anti-hiv drug combinations in hiv-infected patients. both combinations will include nevirapine (nvp), 2 nucleoside reverse transcriptase inhibitors (nrtis), and at least 1 protease inhibitor (pi). one combination will include a new protease inhibitor, abt-378, combined in a capsule with ritonavir (rtv).

patients receive 1 of the following: 1. abt-378/rtv plus nvp plus 2 nrtis; or 2. investigator-selected pi(s) plus nvp plus 2 nrtis.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 12 years old. * are hiv-positive and have a viral load (level of hiv in the blood) of 1,000 - 100,000 copies/ml. * are currently taking an anti-hiv drug combination that includes 1 pi and 2 nrtis, and that has not been changed in at least 12 weeks. * are naive to (have never taken) at least 1 nrti, other than zalcitabine or abacavir. * agree to abstinence or use of an effective barrier method (e.g., condom) of birth control. exclusion criteria patients will not be eligible for this study if they: * have an active illness. * have received treatment for any active opportunistic (aids-related) infection within 30 days of study entry. * have ever received a nonnucleoside reverse transcriptase inhibitor (nnrti). * have received investigational (not yet approved by the fda) drugs within 30 days of study entry. * have received treatment with a pi other than their current pi. * are receiving chemotherapy for cancer. * are pregnant or breast-feeding.

Keywords: drug therapy, combination nevirapine hiv protease inhibitors ritonavir reverse transcriptase inhibitors anti-hiv agents abt 378
bay63-2521:long-term extension study in patients with pulmonary arterial hypertension

Conditions: Hypertension, Pulmonary

Summary: patients who have completed the 12 weeks treatment of the patent-1 trial (study number 12934) will be asked to participate in this long term extension study with bay63-2521.


Eligibility criteria:
inclusion criteria: * patients who have completed 12 weeks of treatment in the double blind trial patent 1 exclusion criteria: * patients who have an ongoing serious adverse event from patent 1 that is assessed as related to bay63-2521 are not allowed to participate in the extension trial.

Keywords: pulmonary arterial hypertension ph stimulator
a study of the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy or postherpetic neuralgia

Conditions: Painful Diabetic Neuropathy and Post Herpetic Neuralgia

Summary: the purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (dpn) or postherpetic neuralgia (phn)


Eligibility criteria:
inclusion criteria: * diagnosis of dpn or phn * score on the numeric rating scale of at least 4/10 exclusion criteria: * hospitalized patients * neurologic disorders unrelated to dpn or phn or any severe pain that may confound the assessment of dpn- or phn-related pain
a phase ii trial of lapatinib (tykerb) + pemetrexed (alimta) in advanced non small cell lung cancer with an initial dose finding phase

Conditions: Lung Cancer, Non-Small Cell

Summary: this phase ii study is a single-arm, two-stage, multicentre study to determine the clinical activity of lapatinib in combination with pemetrexed in patients with non-small cell lung cancer (nsclc) who have received one prior cytotoxic chemotherapy regimen. there will be a short safety run in portion of the study to determine the optimal treatment regimen (otr) for the combination, since these two drugs have not previously been used together. approximately 27 patients will be enrolled into the first stage of the study and if sufficient responses are seen an additional 27 patients will be enrolled into the second stage giving an overall evaluable patient number of 54. patients will be treated with pemetrexed plus lapatinib at the determined otr to disease progression, death or withdrawal from the study treatment for any reason. safety and efficacy assessments will be performed on all patients at 6-week intervals, as well as at the end of treatment. patients withdrawn from study treatment with stable disease will be assessed every 6 weeks until progression. thereafter, patients will be followed for survival at approximately 12-week intervals until death or to a maximum of 5 years after last patient is enrolled, whichever comes first.


Eligibility criteria:
inclusion criteria: * signed informed consent; * patients must be 18 years old; * subjects must have stage iiib or iv nsclc . * recurrent or persistent nsclc following one previous line of cytotoxic chemotherapy. * eastern cooperative oncology group (ecog) performance status (ps) 0-2; * life expectancy of 12 weeks; * have adequate organ function baseline laboratory values for inclusion; exclusion criteria: * history of other malignancy. subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible; * known history of or clinical evidence of central nervous system (cns) metastases or leptomeningeal carcinomatosis except for individuals who have previously treated cns metastases, are asymptomatic, and have had no requirement for steroids or antiseizure medication for = 3 months prior to study enrollment. * peripheral neuropathy of grade 3 or higher; * concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, and tumor embolization). * prior exposure to pemetrexed or an egfr inhibitor in combination with 5-fu or a 5fu prodrug.

Keywords: non small cell lung cancer (nsclc) pemetrexed, lapatinib (gw572016),
study of me-401 in subjects with relapsed or refractory indolent b-cell non-hodgkin's lymphoma (nhl)

Conditions: Indolent B-cell Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of me-401 in the treatment of japanese participants with relapsed or refractory indolent b-cell non-hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * patients aged 20 years or older at the submission of the written informed consent form * patients that have undergone therapy after at least 2 prior systemic therapies (anti-cd20 ab, chemo, and so on) for relapsed or refractory b-cell nhl * patients who have not undergone phosphatidylinositol 3-kinase (pi3k) inhibitors to date * patients who have not undergone bruton's tyrosine kinase (btk) inhibitors to date * patients with eastern cooperative oncology group performance status (ecog ps) "0 or 1" exclusion criteria: * patients with relapsed or refractory b-cell nhl who is categorized into small lymphocytic lymphoma (sll), waldenström's macroglobulinemia (wm), lymphoplasmacytic lymphoma (lpl) by who classification * patients who have been histologically confirmed fl grade 3b transformation from follicular lymphoma (fl) to an aggressive lymphoma at least once * patients with lymphomatous involvement of the central nervous system * patients with uncontrolled clinically significant illness * patients with active interstitial lung disease or a history thereof
a clinical study on the analysis of risk factors for the occurrence of pd-1/pd-l1 inhibitor-associated liver injury in lung cancer patients

Conditions: Immune Checkpoint Inhibitors; Liver Injury

Summary: the goal of this observational study is to investigate the risk factors of pd-1/pd-l1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury. the main questions it aims to answer are: * exploring risk factors for liver injury. * constructing a predictive model for the occurrence of liver injury in pd-1/pd-l1 inhibitor-related liver injury. * improving immunotherapy protocols for lung cancer patients.

pd-1/pd-l1 inhibitors have achieved surprising results in lung cancer treatment and have been approved by the fda for the treatment of different types of lung cancer. their overall toxicity is lower than that of standard chemotherapy, but a number of immune-related adverse events have been reported clinically. liver injury is one of the leading causes of death from adverse events due to pd-1/pd-l1 inhibitors. the occurrence of immune-related liver damage has an important impact on the tumor treatment and prognosis of patients. most of the current domestic and international studies focus on the overall description and study of pd-1/pd-l1 antibody-related adverse events, and there is no definitive description of the risk factors for the development of immune-related liver injury in lung cancer patients. the aim of this project is to review the clinical data of lung cancer patients treated with pd-1/pd-l1 inhibitors from 2020.01 to 2024.06, to investigate the risk factors of pd-1/pd-l1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury, and to take measures to prevent the occurrence of fatal immune liver injury, which is of great significance to the immunotherapy of clinical tumor patients. it is of great significance to the immunotherapy of clinical tumor patients.

Eligibility criteria:
inclusion criteria: 1. lung cancer patients who have received at least one and more pd-1/pd-l1 inhibitor treatments; 2. gender is not limited, age 18-80 years old exclusion criteria: 1. severe liver injury prior to immunotherapy (elevation of transaminases, alkaline phosphatase, and glutamyl aminotransferase more than 5 times the upper limit of normal). 2. patients who, in the opinion of the investigator, are not suitable for participation in the study.

Keywords: pd-1/pd-l1 inhibitor lung cancer
a clinical study with the medical device powerspiral for deep enteroscopy

Conditions: Small Bowel Disease

Summary: the objective of the samisen study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed olympus motorized spiral enteroscope (powerspiral).

the main objective of this registry is to collect data on the safety and performance of the new motorized powerspiral device during post-market clinical follow-up. it is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. as clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the new device.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. patients with small bowel disease indicated for deep enteroscopy exclusion criteria: 1. age under 18 years 2. female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period 3. any contraindication to standard enteroscopy 4. concurrent participation in another competing clinical study
opioid induced bowel dysfunction in patients undergoing cesarean section

Conditions: Constipation; Pain, Postoperative

Summary: constipation is common in pregnant women. surgery, anaesthesia and opioid analgesics may further impair bowel function. the aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.


Eligibility criteria:
inclusion criteria: * • elective caesarean section in spinal anaesthesia * normal full term single pregnancy * age 18 years or more * bmi 20 - 35 kg/m2 * written informed consent obtained exclusion criteria: * • not normal or full term pregnancy * age less than 18 years * allergy to study drugs * substance misuse other contraindication to used study drugs no informed consent

Keywords: constipation oxycodone caesarean section
intravascular stents fracture effects

Conditions: Durability of Implanted Intravascular Stents; Hemodynamic Effect of Implanted Intravascular Stents

Summary: the goal of the study is to evaluate long term durability and hemodynamic effect of implanted stents in the aortic arch and in pulmonary artery branches.

patients who underwent trans-catheter implantation of balloon expanded stents in the aortic arch and in branch pulmonary arteries will be evaluated by physical examination with blood pressure values measurement of upper and lower limbs. echo-doppler cardiography will be performed for flow velocity analysis. zoomed fluoroscopy will be performed and recorded in two orthogonal views to evaluate stent integrity or stent fracture. it is our intention to include 20 patients in this study from our follow-up clinic.

Eligibility criteria:
inclusion criteria: -patients who underwent stent implantation for coarctation of the aorta and for branch pulmonary artery stenosis exclusion criteria: -pregnancy
blood flow-restricted resistance exercise to promote muscle strength and use in adults with incomplete spinal cord injury

Conditions: Spinal Cord Injury Cervical

Summary: recovery of arm and hand motor control is critical for independence and quality of life following incomplete spinal cord injury (isci). blood flow-restricted resistance exercise (bfre) has emerged as a potential treatment addressing this need, but treatment guidelines and research reporting effectiveness are sparse. the purpose of this work is to provide case reports of people with cervical isci who use bfre supplemented by electrical stimulation (es) to increase the strength and functional use of selected upper extremity muscles.


Eligibility criteria:
inclusion criteria: * incomplete cervical spinal cord injury * resting blood pressure between 80/50 mmhg and 150/90 mmhg for at least three consecutive days * native speaker of english exclusion criteria: * recent history of deep vein thrombosis or cardiovascular disease including uncontrolled hypertension or a blood-clotting disorder * routine experience of orthostatic hypotension as defined as a drop in systolic/diastolic blood pressure greater than 20/10 mmhg when engaging in physical activity * severe cognitive, communication, or behavioral disorder as determined by treatment team

Keywords: blood flow-restricted resistance exercise physical therapy rehabilitation electrical stimulation