Kornimate/medical-research-clean huggingface dataset:
phase iii study in first-line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy.

Conditions: Metastatic Colorectal Cancer

Summary: the main purpose of this study is to demonstrate the superiority of s 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.


Eligibility criteria:
inclusion criteria: 1. has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). primary tumour localisation must be known. 2. ras status based on local biological assessment of tumour biopsy must be available. if ras status is not available at the time of randomisation, tumour biopsy must be available for ras status determination (based on local biological assessment). 3. patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin 4. patient is not a candidate for curative resection of metastatic lesions. 5. no previous systemic anticancer therapy for unresectable metastatic colorectal cancer. 6. ecog (eastern cooperative oncology group) performance status ≤2. 7. adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol' exclusion criteria: 8. pregnancy, breastfeeding or possibility of becoming pregnant during the study. 9. participation in another interventional study within 4 weeks prior to the randomisation . 10. patients who have not recovered from clinically relevant non-hematologic ctcae grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation. 11. symptomatic central nervous system metastases. 12. major surgery within 4 weeks prior to the randomisation. exclusion criteria related to s 95005 administration: 13. history of allergic reactions attributed to compounds of similar composition to s 95005 or any of its excipients. 14. any contraindication present in the smpc of trifluridine/tipiracil exclusion criteria related to bevacizumab administration: 15. any contraindication present in the smpc of bevacizumab exclusion criteria related to capecitabine administration: 16. any contraindication present in the smpc of capecitabine

Keywords: metastatic cancer colorectal colorectal cancer colon rectum metastasis
ectoin® mouth wash (eml03) in the prevention and treatment of radiation-induced oral mucositis

Conditions: Oral Mucositis Due to Radiation

Summary: this prospective non-interventional comparator study is to collect data on the clinical effectiveness and compliance of ectoin® mouth wash solution (eml03) and to proof superiority to a well-established medical device on the market in the prevention of radiation-induced mucositis. the study doesn´t intervene with routine treatment strategy.


Eligibility criteria:
inclusion criteria: * individuals regardless of gender older than 18 years * patients diagnosed with squamous cell carcinomas \[scchn\] without metastases of other nonhead and nonneck tumors * patients receiving radiotherapy with a karnofsky performance index \>70% * absence of any sign of oral mucositis at baseline (visit 1) * a definitive or postoperative treatment * radiation therapy dosage: limitation dose rate of 60-70 gy * radiotherapy of 6-7 weeks duration exclusion criteria: * subjects younger than 18 years * hypersensitivity to ectoin® or any of the other ingredients of the mouth wash * pregnancy or breastfeeding women * any disease that can, in the opinion of the treating physician, affect the outcome of the observational trial * patients who had a history of previous radiotherapy in head-neck region or chemotherapy * massive alcoholic anamnesis * massive smoker \>20 cigarettes per day at present

Keywords: ectoin oral mucositis radiotherapy medical device non interventional study mouth wash §23b medical device act
postpartum oxygen inhalation for the treatment of postpartum haemorrhage

Conditions: Postpartum Hemorrhage

Summary: in the aetiology of postpartum uterine atony, hypoxia is considered an important factor although some suggest that peripheral oxygen saturation is not influenced by oxygen inhalation in women during the first and second stages of labor. enhancing oxygen delivery to myometrium through additional inhaled oxygen may improve uterine contractions. therefore, it is reasonable to consider that oxygen inhalation may promote myometrial contraction and prevent postpartum haemorrhage (pph) due to uterine atony. the tendency for the uterus to relax in women encountering respiratory problems immediately after cesarean section under general anaesthesia further strengthened this theory. the aim of this study was to evaluate the effectiveness of oxygen inhalation immediately after vaginal delivery on blood loss. the investigators hypothesized that inhaled oxygen helps to maintain uterine retraction during immediate postpartum period and hence reduces vaginal blood loss.


Eligibility criteria:
inclusion criteria: * gestational age between 37 and 42 weeks; * singleton pregnancy; * live fetus; * cephalic presentation; * neonatal birth weight of 2500-4500 g; * parity between one and five; * maternal age \< 35 years old; * vaginal birth exclusion criteria: * blood pressure ≥ 140/90mmhg; * placenta previa; * placental abruption; * a history of any bleeding during pregnancy; * a history of curettage; * cesarean section or any uterine scar; * a history of postpartum hemorrhage; * polyhydramnios; * signs or symptoms of maternal infection; * known uterine anomalies; * history of any drug use during labor; * abnormal placentation; * coagulation defects; * instrumental deliveries; * hemoglobin concentration \< 8 g/dl; * history of anticoagulant drugs; * beta-mimetic medications during pregnancy; * prolongation of the first stage of labor \> 15 hours

Keywords: blood loss oxygen inhalation
intervention development for newly diagnosed youth with hiv

Conditions: HIV

Summary: this study is an exploratory qualitative investigation of the challenges, strengths, and needed areas of support associated with receiving an hiv diagnosis among youth living with hiv. qualitative interviews will be conducted with health care providers who work with adolescents living with hiv and focus groups will be conducted with adolescents who are living with hiv (ages 16-24). one third of the focus groups will be conducted in spanish. findings from this study will be used to create an outline and development plan for a culturally-sensitive and developmentally appropriate intervention (or set of interventions) for youth recently diagnosed with hiv.

providers will participate in one interview of approximately one-hour duration; these interviews are expected to occur over a 2 month period. following the completion of the provider interviews, participants will participate in one 2-hour focus group. a total of 6 focus groups (2 at each of the 3 study sites) are anticipated to occur over a 6-8 week period. the complete study duration is expected to take 12 months. part a - provider interviews - 15 clinical providers, 15 mental health providers, 15 case managers (1 provider from each category per atn site resulting in a total of 45 interviews). part b - focus groups - 36-48 youth living with hiv. it is estimated there will be 6-8 participants per group and we will conduct two groups at each of three different sites (one male specific group and one female specific group) for a total of six focus groups. one third of the focus groups will be conducted in spanish. the provider interviews will be comprised of participants who are clinical providers, mental health providers, and case managers with at least 1 year of experience working with hiv+ youth; one from each category will be interviewed from all 15 atn sites. the focus groups will be comprised of participants who are between the ages of 16 and 24, diagnosed hiv+ and aware of their hiv diagnosis for between 12-24 months, and receive services at three selected atn sites or their community partner. focus group participants will be balanced to reflect the diversity (i.e., age, pregnant and parenting women, msm, mono-lingual spanish-speaking, etc.) of the clinic populations.

Eligibility criteria:
inclusion criteria: * diagnosed hiv+ and aware of their hiv status for between 12-24 months * between the ages of 16-24 (inclusive) * gives informed consent for participation exclusion criteria: * presence of serious psychiatric symptoms (active hallucinations, thought disorder) * visibly distraught (suicidal, homicidal, exhibiting violent behavior) * intoxicated or under the influence of alcohol or other substances at the time of study entry * acquired hiv through perinatal infection

Keywords: hiv
safety and efficacy of botulinum toxin type a to treat lower urinary tract symptoms due to benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: this study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin type a (botox®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.


Eligibility criteria:
inclusion criteria: * clinical enlargement of the prostate gland * body weight ≥ 50 kg or 110 lbs exclusion criteria: * history of chronic prostatitis * history of two or more urinary tract infections in the past year or one in the last 6 months * history of bladder stones * history of previous prostate surgery * history of bladder cancer or prostate cancer * any previous or current usage of botulinum toxin therapy of any serotype for any urological condition * botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry
comparison of three tissue acquiring techniques during eus guided biopsies of solid tumors.

Conditions: Solid Tumor

Summary: the study's aim is to prospectively compare three different tissue acquisition techniques during eus guided solid lesions biopsies.

endoscopic ultrasound guided fine-needle aspiration (eus-fna) has been used since 1990's for the diagnosis and staging of esophageal, gastric, duodenal, pancreatobiliary, rectal mediastinal lesions and intra-abdominal lymphadenopathy. studies have shown a variable range of specimen adequacy when performing pancreatic biopsies with the standard fine needle aspiration (fna) needles with this modality. there are several factors that affect the overall diagnostic yield of this procedure, such as endosonographer experience, presence of cytopathologist during the procedure, the needle diameter and the number of passes. in this study we will compare the yield of recently available fine biopsy needles (fnb) using three different techniques to obtain samples from solid lesions. the three techniques to be compared in this study are: stylet slow pull (sp) vs dry suction (ds) vs wet suction (ws). wall cells. in the "suction technique" the stylet of the needle can be left in place or removed before puncturing the lesion. once the needle is inside the target, negative pressure is applied through a 10 or 20 cc syringe connected to the needle. the wet suction technique consists of flushing of the needle with 5 ml of saline solution to replace the column of air within the lumen of needle with saline solution before needle aspiration. once the needle is flushed, negative pressure is applied with a 10 or 20 cc syringe connected to the needle. in the slow pull technique, the stylet is left in place in the needle and is slightly retracted prior to puncturing the lesion. once the needle is inside the target, the stylet is pushed completely into the needle to remove any contaminant cells and several back and forth movements are done while slowly withdrawing the stylet.

Eligibility criteria:
inclusion criteria: 1. ages between 18-80 years old 2. sex: male or female 3. patients who require eus and tissue sampling of solid solid lesions (size \>1 cm) anywhere in the following locations: lymph nodes, stomach, esophagus, colon, small intestine, pancreas, liver, spleen or kidney. 4. patients who are able to give consent exclusion criteria: 1. pregnant female 2. coagulation disorders (platelets \ 2) 3. patients with acute pancreatitis in the immediate 2 weeks prior to the procedure. 4. cardiorespiratory dysfunction that precludes sedation. 5. unable to provide informed consent
comparison of set-up reproducibility between prone and supine intensity modulated radiotherapy (imrt) for the adjuvant treatment of breast carcinoma after lumpectomy

Conditions: Breast Carcinoma

Summary: 10 patients will be treated alternating daily between prone and supine position for breast radiotherapy to compare set-up accuracy. prone treatment will be given on the odds days and supine treatment on the even days.


Eligibility criteria:
inclusion criteria: * female patients * multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer * minimum 18 years * informed consent obtained, signed and dated before specific protocol procedures. exclusion criteria: * mastectomy * need for axillary irradiation * bilateral breast irradiation * previous irradiation at the same time * pregnant or breastfeeding * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. * patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
testing a visual thermometer in newborns and young infants

Conditions: Hyperthermia; Hypothermia

Summary: "severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and disability among newborns in lmics. filtered sunlight phototherapy (fspt) was developed, tested and shown to be safe and efficacious in the treatment of jaundice, because effective electric-powered conventional phototherapy is often unavailable10,11. however, fspt currently requires at least hourly temperature monitoring by healthcare providers (hcps) because infants receiving fspt are prone to both hypothermia and hyperthermia. 20 years ago, a liquid crystal thermometer, thermospottm (maternova, providence, ri) was developed primarily for use in lmics. it was designed to detect hypothermia and is most sensitive in cold infants and not as sensitive as needed for detecting hyperthermia or fever. the purpose of this pilot study is to determine the accuracy and useability of this lctd for a wider spectrum of temperatures when used in a large group of infants in a high-income country. if the device performs well in this study, we plan to study it in a low- and middle-income country in africa."


Eligibility criteria:
inclusion criteria: * infants 0-6 months (\<7 months) presenting to masonic emergency room or inpatient ward, their parent or caregiver who provide verbal consent in english or through a medical interpreter. exclusion criteria: * any infant undergoing active resuscitation * any infant for whom physician deems study enrollment would interfere with their care * any infant whose parents or caregiver decline enrollment * any nurse or other healthcare provider who declines participation * parents who do not understand english, and do not have a medical interpreter at the bedside.

Keywords: temperature monitoring liquid crystal thermometer hypothermia hyperthermia lctd infant temperature infant hyperthermia infant hypothermia neonate hyperthermia neonate hypothermia neonate temperature
role of qrx-3 in chronic kidney disease patients in outpatients clinics

Conditions: Chronic Kidney Disease Stages 3-5; Diabetic Kidney Disease; Hypertensive Kidney Disease

Summary: qrx-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of nad within the kidney cells, is expected to improve baseline renal function when given over a period of one year . the result of the change in renal function will be compared to control without the medication during that same period .


Eligibility criteria:
inclusion criteria: * patient with chronic kidney disease stage 3-5 * estimated glomerular function by mdrd of less than 60mls/min * patients with declining renal function ( as measured by egfr by mdrd ) * rate of decline of egfr over the last one year of less than 20% * negative serology markers for ckd etiology * provider perceived adherence to study follow- up exclusion criteria: * rapid rate of decline in kidney function of \> 10 % over 3 months * symptomatic renal failure * presence of any suspected acute renal failure superimposed * presence of cast , hematuria, or abnormal urinalysis outside of simple uti * no known reversible cause of renal decline

Keywords: ckd estimated gfr (egfr) proteinuria random urine protein creatinine ratio creatinine change
evaluation of the impact of prehabilitation on recovery following open surgery for abdominal aortic aneurysm

Conditions: Abdominal Aortic Aneurysm

Summary: this is a pilot, prospective, randomized control trial that aim to provide a first estimation of the 3-month post-operative variation in the functional recovery of patients who benefited from an outpatient pre-habilitation program and patients who did not benefit from it.

open surgery of abdominal aortic aneurysms (aaa) is the reference treatment in a large number of cases. this is a heavy procedure performed in patients around 70 years of age. in post-operative open aortic surgery, a stay in aftercare and rehabilitation is often necessary, especially in fragile patients. the goal is to increase the patient's overall functional status to allow him to move away from the threshold below which he loses his independence for activities of daily living. the pre-habilitation protocol includes 3 parts : 1. oral nutrition ensures adequate caloric and protein intake to support muscle anabolism 2. muscle building over a few sessions with a liberal physiotherapist to learn exercises and then independently 3. cardio-respiratory endurance. for the experimental group: initial visit with adaptive rehabilitation physician, 6-8 weeks prior to surgery: * clinical examination with wood classification - limits and restrictions. * assessment of environmental resources * definition pre-habilitation protocol and post-operative rehabilitation pathway * application of the ambulatory pre-approval protocol defined with the adaptive rehabilitation physician. for the control group: support without pre-approval with application of other common practices of the service. follow up of both groups: post-operative follow-up visits with the surgeon (gathering the necessary information for comparative follow-up). mail-out of world health organisation disability assessment schedule (whodas) 2.0, euro qol (eq)-5d-5l and dijon questionnaires at 3 and 6 months post-operative.

Eligibility criteria:
inclusion criteria: * patient with an abdominal aortic aneurysm (thoraco-abdominal aneurysm type 4/supra renal/juxta-renal/sub renal) treated with conventional surgery. * surgical indication of aneurysm by size (50-55mm) exclusion criteria: - patient requiring urgent management that does not allow for a pre-authorisation protocol of at least 6 weeks.

Keywords: aaa prehabilitation quality of life physical therapy open surgery
safety, tolerability and efficacy of spd503 in treating adhd in children aged 6-17

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to determine the effects of spd503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with adhd.


Eligibility criteria:
inclusion criteria: * subjects with a primary diagnosis of adhd * minimum baseline visit adhd-rs-iv score of 24 and a baseline cgi-s score =\>4 * male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements * subject weighs \> 55 lbs and is not morbidly overweight exclusion criteria: * subject has a comorbid psychiatric diagnosis (except odd) with significant symptoms such as any severe comorbid axis ii disorders or severe axis i disorders * subject has a history of seizure disorder * subject has any specific cardiac condition or family history of significant cardiac condition * subject is pregnant, lactating or within six month post-partum
safety and efficacy of rad001 in chinese patients with advanced pulmonary neuroendocrine tumor

Conditions: Lung Neuroendocrine Neoplasm

Summary: the present study is designed to collect safety/tolerability data and explore the efficacy of rad001 in advanced pulmonary neuroendocrine tumor in chinese patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed carcinoid tumors * newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible exclusion criteria: * patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible) * received cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment * patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (t1a) prostate cancer or treated early stage (dcis or lcis) breast cancer * prior therapy with rad001 or other mtor inhibitors (sirolimus, temsirolimus, everolimus) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: phase ib, rad001, advanced pulmonary neuroendocrine tumor
impact of cyp3a4*1g polymorphism on metabolism of fentanyl in chinese patients undergoing lower abdominal surgery

Conditions: Pain; Surgery

Summary: purpose: this study aimed to investigate the impact of cyp3a4\*1g genetic polymorphism on metabolism of fentanyl in chinese patients undergoing lower abdominal surgery. methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. genotyping of cyp3a4\*1g was carried out by direct sequencing. the plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (hplc-uv). the visual analog scale (vas) was used for pain evaluation at rest during patient-controlled analgesia (pca) treatment 0 h, 12 h and 24 h after operation. pca fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.


Eligibility criteria:
inclusion criteria: * aged 20-65 years * anesthesiologists (asa) physical status i or ii; * with ±20% of ideal body weight; * received pca administration; * agreed to participate the research exclusion criteria: * history of chronic pain; * psychiatric diseases; * diabetes mellitus; * severe cardiovascular diseases; * kidney or liver diseases; * alcohol or drug abuse (according to the criteria of dsm-iv); * pregnancy or at lactation period; * consumed drugs (1week) or foods (3 days) known to inhibit or induce the expression of cyp3a4 enzymes prior to surgery; * refused pca administration; * disagree to participate to the research

Keywords: gene polymorphism cyp3a4 fentanyl hplc analgesics
radial artery access with ultrasound trial

Conditions: Coronary Artery Disease

Summary: radial artery access for cardiac catheterization can require multiple attempts. multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery access. this study will test if the addition of ultrasound guidance reduces the number of attempts and time required to access the radial artery.


Eligibility criteria:
inclusion criteria: * adult patients presenting for cardiac or peripheral catheterization with planned radial approach. * barbeau's or allen's test indicating at least some degree of collateral circulation in palmar vessels * functional ultrasound equipment with ultrasound trained attending operator exclusion criteria: * inability to provide informed consent * femoral access * emergency procedure (shock, stemi) * end-stage renal disease on hemodialysis * previous ipsilateral puncture within 1 week

Keywords: transradial catheterization ultrasound radial artery