Kornimate/medical-research-clean huggingface dataset:
a multicentre,study of ibi133 in subjects with unresectable, locally advanced or metastatic solid tumours

Conditions: Locally Advanced Unresectable or Metastatic Solid Tumors

Summary: this is a multicentre, open-label, first-in-human, phase 1/2 study of ibi133 in subjects with unresectable, locally advanced or metastatic solid tumours. phase 1 section includes three parts, ibi133 dose escalation part, and ibi133 monotherapy dose expansion part. the objective of phase 1 section is to identify mtd/recommended dose for expansion (rde) of ibi133 monotherapy . the objective of phase 2 section is to further explore efficacy, safety and tolerability of ibi133 monotherapy at rde in specified tumour population. the treatment cycle of the study is defined as every 3 weeks (21 days).


Eligibility criteria:
inclusion criteria: 1. subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. male or female subjects ≥ 18 years old; 3. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; 4. anticipated life expectancy of ≥ 12 weeks; 5. adequate bone marrow and organ function. 6. has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; exclusion criteria: 1. participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study; 2. prior her3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, t cell engager, and antibody-drug conjugate. 3. prior treatment with an antibody-drug conjugate (adc) which consists of an exatecan derivative that is a topoisomerase i inhibitor (e.g. ds-8201).
cognitive behavioral therapy for mechanical ventilation wean

Conditions: Anxiety; Cognitive Behavioral Therapy; Mechanical Ventilation Complication

Summary: the purpose of this study is to use cbt strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

approximately a third of patients in intensive care are mechanically ventilated. the current weaning standard of care leaves much to be desired in both patient anxiety and time to wean. cognitive behavioral therapy (cbt) is the gold standard treatment for anxiety. the purpose of this study is to use cbt strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

Eligibility criteria:
inclusion criteria: * receiving mechanical ventilation and failed 3 spontaneous breathing trials exclusion criteria: * delirium
green tea intake for the maintenance of complete remission in women with advanced ovarian carcinoma

Conditions: Ovarian Carcinoma

Summary: green tea is extracted from steam treated leaves, allowing the preservation of catechins, the active elements of the infusion. catechins are recognized for their anti-cancer activity. catechins act on the capacity of cancer to disseminate to other organs because of their anti-protease action. proteases are proteins capable of digesting the cancer environment and facilitating the progression of cancer cells to blood vessels which will bring them to distant organs. we know that ovarian cancer responds well to the initial treatment of chemotherapy but tends to recur rapidly. we intend to provide green tea with higher concentrations of catechins to women with complete remission of their ovarian cancer in an attempt to delay cancer relapse. we also intend to identify, with molecular technologies, the proteases involved in ovarian cancer recurrence and response to catechins. our objective is to test the hypothesis that green tea intake may delay ovarian cancer recurrence and to develop tools to predict which women will best benefit of the addition of green tea to their initial treatment.


Eligibility criteria:
inclusion criteria: * patients with ovarian serous carcinoma figo stage iii or iv * patients showing complete response after oncological surgery and chemotherapy (paclitaxel-carboplatin, minimum 5 cycles, maximum 8 cycles), complete response being defined as 1) a negative complete physical examination 2) serum ca-125 levels inferior to 35 u/ml 3) no evidence of diseased assessed by abdomino-perineal ct-scan * patients refraining from drinking tea other than provided by the study * patients who may absorb liquids orally * patients without any other malignancy (except for non-melanoma skin cancer) * patients not involved in an other study * patients who signed up informed consent form. exclusion criteria: * exclusion criteria are implicit from inclusion criteria.

Keywords: chemoprevention green tea relapse free-survival proteases
efficacy and safety of basiliximab, cyclosporine/cyclosporine microemulsion, and steroids in pediatric de novo liver transplant recipients avoiding intraoperative steroids

Conditions: Liver Transplantation; Infection

Summary: systemic infection is still a major concern in young children with liver transplantation. the approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. the treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.


Eligibility criteria:
inclusion criteria: * pediatric patients undergoing primary orthotopic liver transplantation (whole organ or split liver or reduced size) * cadaveric or living donor (related or unrelated) exclusion criteria: * patients who are recipients of multiple solid organ transplants and/or who have previously received transplanted organs * if cold ischemia time of the transplanted organ is \>12 hours * auxiliary liver transplant recipients * fulminant hepatic failure * autoimmune hepatitis * primary sclerosing cholangitis * severe acute systemic infections * hepatitis b surface antigen/hcv/hiv positive * known contraindication to intravenous (i.v.) or per os (orally) (p.o.) cyclosporine or corticoids * non-ability to comply with the protocol * relevant abnormal physical or laboratory findings within 2 weeks of inclusion * relevant severe allergy, hypersensitivity to basiliximab or similar drugs * history/presence of relevant malignancy * pregnancy/breastfeeding * use of any investigational or immunomodulatory/immunosuppressive drug within 4 weeks prior to transplantation.

Keywords: pediatric liver transplantation simulect basiliximab ciclosporin microemulsion steroid reduction pediatric liver transplantation
efficacy & safety comparison of epiduo with doxycycline versus vehicle with isotretinoin in the treatment of severe acne

Conditions: Acne

Summary: non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.


Eligibility criteria:
inclusion criteria: 1. male or female subject of any race, aged 12 to 35 years inclusive 2. subject weighing between 50 and 110 kg 3. subject with severe acne (iga at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies) 4. subject with at least 5 nodules on the face exclusion criteria: 1. subject with clinically abnormal results to blood testings performed at screening 2. subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks 3. female subject who is pregnant, nursing or planning a pregnancy during the study 4. subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings 5. subject with known metabolic or structural bone disease (for 12-17 years old population) 6. subject with bowel disease and/or with hypervitaminosis a 7. subject who presents with treated or untreated depression or has a history of depression including a family history of major depression 8. subject with a wash-out period from baseline for topical treatment on the face less than : corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); cosmetic procedures (1 week); photodynamic therapy and laser therapy for acne (3 months) 9. subject with a wash-out period from baseline for systemic treatment less than: corticosteroids, antibiotics (4 weeks),progesterone for contraception (3 months); spironolactone(3 months); other acne treatments (6 months);cyproterone acetate(6 months)
endothelial dysfunction, inflammation and insulin resistance in congenital hypogonadism and effect of testosteron replacement therapy

Conditions: Hypogonadotrophic Hypogonadism

Summary: the study searched for answers to two questions 1. is there endothelial dysfunction, inflammation and insulin resistance in patients with congenital hypogonadotropic hypogonadism? 2. what is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?


Eligibility criteria:
inclusion criteria: * men * treatment naive * hypogonadotrophic hypogonadism exclusion criteria: * previous history of androgen replacement * chronic metabolic disorders

Keywords: hypogonadism endothelial dysfunction insulin resistance inflammation testosterone replacement therapy
the effect of education given before port catheter infusion on infusion related symptoms

Conditions: Port-A-Cath

Summary: pain, anxiety, anxiety and changes in vital signs are observed in patients during needle insertion into the port catheter.patients and their relatives should be informed by nurses to eliminate these problems and to provide more comfortable infusion to patients.however, studies on the care process for the symptoms that occur before port catheter infusion are limited in the literature.the thesis study planned for this purpose will be carried out to determine the effect of the training given before port catheter infusion on infusion-related symptoms.the research will be conducted as pretest-posttest, randomised controlled.oncology-hematology services and chemotherapy unit of karadeniz technical university farabi hospital.the sample of the study will be determined by simple randomisation method and 64 patient will be included in the study.the data of the study will be collected by patient descriptive information form, visual analogue scale and state and trait anxiety scale, vital signs follow-up chart.


Eligibility criteria:
inclusion criteria: * having a port catheter * the patient has no previous experience with a port catheter, * the patient will receive an infusion from a port catheter for the first time, * the patient's age range is between 18-70, * the patient is literate, * volunteering to participate in the study, * the patient will receive training from the training material for the first time. exclusion criteria: * those with communication, hearing and vision problems, * those with any psychiatric disorder, * those who used any analgesic medication at least 8 hours before

Keywords: pain anxiety education nursing port catheter
tptns for treating patients with premature ejaculation

Conditions: Premature Ejaculation

Summary: background: transcutaneous posterior tibial nerve stimulation is an effective therapy for controlling urinary incontinence. premature ejaculation (pe) and urinary incontinence are anatomically and physio-pathologically similar. based on this, the use of this therapy is considered to be viable for the control of pe. objective: to evaluate the efficacy of transcutaneous posterior tibial nerve electrostimulation for the ejaculatory reflex. patients and methods: phase ii clinical trial. patients with a diagnosis of premature ejaculation who are treated at the colombia boston medical group clinic will be included. the participants will receive 3 transcutaneous posterior tibial nerve stimulation therapies per week for 12 weeks. the ielt (intravaginal ejaculatory latency time) and the pedt (premature ejaculatory diagnosis tool) scale will be evaluated on week 6, at the end of treatment, and three months after completing the protocol.


Eligibility criteria:
inclusion criteria: * over 18 years of age and less than 50 years of age with no cardiovascular risk factor other than age. * having been diagnosed with primary premature ejaculation according to the american psychiatric society's diagnostic and statistical manual. * agreeing to participate and providing signed informed consent. * stable relationship for over 6 months, with frequent intercourse at least once per week. exclusion criteria: * diagnosis of erectile dysfunction according to the international index function erectile (iife-5) (score under 21). * a premature ejaculatory diagnosis tool (pedt) score under 8. * use of treatment for premature ejaculation during the study or over the 6 months prior to beginning the study. * use of pacemaker or heart defibrillator. * epilepsy or convulsions * venous insufficiency (varices) or cutaneous wounds or injuries on the lower extremities. * congenital or acquired anatomical abnormalities of the penis. * taking medications that affect ejaculation control, including psychiatric medications, opioid analgesics, and medications for pathologies of the prostate such as alpha-blockers. * psychological or psychiatric disorders that prevent the patient from undergoing the treatment or recording the measurements as established. * difficulty going to the clinic 3 times per week as required by the protocol. * patients with pre-coital premature ejaculation. * use of barrier contraceptive methods or local anesthetics.
furosemide stress test to predict successful liberation from rrt

Conditions: Acute Kidney Injury

Summary: the proposed study will evaluate if a standardised dose of furosemide administered in the 12 hours after rrt liberation can predict successful liberation in critically ill patients. the dose that will be administered is in accordance with the prescribing information.

response to furosemide administration is commonly used in clinical practice to assess a patient's potential for rrt liberation. however, this administration is not standardized and practices varies greatly. rapid recognition of unsuccessful rrt liberation is crucial to avoid further complications such as fluid overload or acid-base and electrolyte disorders. the fst corresponds to the intravenous administration of 1 mg/kg (1.5 mg/kg in previously exposed patients) of furosemide and the assessment of resulting diuresis in the following two hours. fst is able to predict progression from aki stage i and ii to stage iii with a high sensitivity (87.1%) and specificity (84.1%), area under the roc curve 0.87. however, the ability of fst to predict rrt liberation has never been formally assessed.

Eligibility criteria:
inclusion criteria: * receiving continuous or intermittent rrt for aki * having an indwelling urinary catheter * clinical decision by physician in charge to attempt rrt liberation * lnformed consent signed by the patient himself / legal representative or authorization received from independent physician exclusion criteria: * electrolyte disturbances or hemodynamic instability precluding the use of furosemide (sodium \> 155 mmol/l and/or potassium \ 7.50 and/or mean arterial pressure \< 60 mmhg) * known furosemide allergy * urine output ≥ 100 ml/h for at least two hours * recent (\< 24 hours) fst * known end-stage chronic renal disease at icu admission * withdrawal of life support decision taken before inclusion * patient already participating in conflicting research study * patient having already participated in this current study * any other contraindication of furosemide

Keywords: renal replacement therapy acute kidney injury furosemide stress test
immunotherapy for men with objective disease progression on protocol d9902 part b (nct00065442)

Conditions: Metastatic Androgen Independent Prostate Cancer

Summary: this is an open label, phase 2 trial of apc8015f immunotherapy in men with objective disease progression on protocol d9902 part b (nct00065442)


Eligibility criteria:
inclusion criteria: * objective disease progression * subjects must have been enrolled in the apc-placebo arm of d9902b (nct00065442) exclusion criteria: * infection requiring iv antibiotics * treatment with anticancer interventions within 14 days prior to enrollment * any medical condition which could compromise the study's objectives (discretion from sponsor)
crosslinking in infectious keratitis

Conditions: Infectious Keratitis

Summary: microbial keratitis is an infection of the cornea that is associated with risk of permanent visual impairment. it can be caused by bacteria, virus, fungus, protozoa and parasites. the common risk factors for infectious keratitis include ocular trauma, contact lens wear, recent ocular surgery, preexisting ocular surface disease, dry eyes, lid deformity, corneal sensation impairment, chronic use of topical steroids and systemic immunosuppression .

the spectrum of bacterial keratitis can also be influenced by geographic and climatic factors. the treatment usually consist of topical administered antibiotics .the emergence of multidrug-resistant bacteria is a concern that might complicate the treatment and cure of infectious keratitis. collagen cross linking (cxl) using ultraviolet-a (uv-a) and riboflavin in a treatment that was developed to increase the biochemical strength of the cornea the procedure is based on using riboflavin as a photosensitizer, which generates reactive oxygen species when activated by uv-a at 365 or370 nm. the standard technique (epi-off) also called dresden protocol includes removal of the epithelium in order to expose the underlying stroma to riboflavin, which is otherwise incompletely absorbed by the epithelium because of tight junctions. the area of corneal epithelium removed has a diameter of 6.0 to 8.5 mm. a crosslinking procedure without epithelial removal could also be performed (epi-on). it would likely be less painful compared to the standard procedure. the crosslinking process generates reactive oxygen species that can damage the cell walls of pathogens. cxl induces formation of new covalent bonds thereby rendering the corneal stroma biomechanically stronger and more resistant to enzymatic digestion . this can potentially limit the spread of infection. furthermore, cxl-induced apoptosis could contribute to the reduction of inflammatory response during corneal infection .

Eligibility criteria:
inclusion criteria: * patients with proved bacterial, fungal, acanthamoeba microbial keratitis . * patient willing to comply with all study procedures . exclusion criteria: * severe corneal scarring or opacification . * patients with viral infectious keratitis * prior herpetic infections . * patients with any coexisting ocular pathology,ocular surface disease . * patients with autoimmune disease. * pregnant women . * corneal thickness of less than 400 microns .
chronic intermittent cold exposure on weight loss

Conditions: Obesity

Summary: 1. to test whether chronic intermittent cold exposure is more effective in programmed body weight loss when compared to conventional programmed weight loss. 2. to measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle and circulating markers) of treatment with chronic intermittent cold exposure and conventional treatment 3. to measure tissue specific changes of weight loss and the treatment with chronic intermittent cold exposure in glucose uptake rate in adipose organ (white and brown adipose tissue), liver, myocardium, skeletal muscle and brain 4. to measure tissue specific biochemical indicators before and after treatment with chronic intermittent cold exposure from white adipose tissue and skeletal muscle. 5. to compare changes in body composition and fat distribution after weight loss using chronic cold exposure or using conventional method


Eligibility criteria:
inclusion criteria: * bmi \> 30 (inclusive) * body weight less than 120 kg * weight stability for 3 months * plasma triglyceride concentration less than 3.0 mmol/l * plasma hdl-cholesterol more than 0.9 mmol/l in males and more than 1.0 mmol/l in females * blood pressure less than 140/90 mmhg (inclusive) * normal glucose tolerance or impaired glucose tolerance but not diabetes (fasting glucose \< 7.0 mmol/l or 2 h glucose in the oral glucose tolerance test \< 11.1 mmol/l) exclusion criteria: * smoking * frequent weight loss attempts * pregnancy or lactation * diabetes mellitus * hypo/hyperthyreosis * cardiovascular disease, stroke or neurological disorder * medication (antihypertensive and antidiabetic drugs, lipid lowering drugs, antidepressants, corticosteroids) * claustrophobia * any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results. * presence of any ferromagnetic objects that would make mri imaging contraindicated

Keywords: weight loss brown adipose tissue white adipose tissue muscle, metabolism cold exposure
preemptive analgesia with pregabalin in heart surgery

Conditions: Postoperative Pain

Summary: background: postoperative pain after cardiac surgery has high incidence and is associated with worse morbidity. pregabalin is a new antiepileptic drug used in patients with chronic pain and has been studied even more in postoperative. objective: evaluate whether preemptive pregabalin use compared with placebo decreases pain perception in patients undergoing cardiac surgery in the first 24 hours and 2 months after hospital discharge; evaluate analgesic consumption in the immediate postoperative period; evaluate differences in blood gas parameters between groups; evaluate anesthetic recovery by qor-40; assess incidence of serious adverse events (reintubation and mental confusion); incidence of delirium through the cam-icu questionnaire; assess adverse drug events (nausea, vomiting, pharmacodermia, allergic reactions). method: randomized, triple-blind, placebo-controlled clinical trial. expected results: postoperative pain control with a drug that could cause fewer side effects, may lead to faster clinical improvement, fewer medications and fewer procedures, and lower healthcare costs with a decrease in intensive care unit (icu) stay.


Eligibility criteria:
inclusion criteria: * patients who will undergo median sternotomy due to the need for cardiac surgery (valvular or myocardial revascularization); * patients between 18 and 70 years old; * patients able to swallow tablets and agree to participate in this clinical trial. exclusion criteria: * patients with chronic renal failure with creatinine clearance less than or equal to 30 ml/min; * patients with known hypersensitivity to pregabalin; * hemodynamically unstable patients using vasoactive drugs the day before surgery; * unconscious and/or sedated patients, or without cognitive discernment to use the visual analog scale; * patients previously submitted to sternotomy; emergency surgery; * patients with neurological diseases; anticonvulsant drug users.