Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of odanacatib (0822-059)

Conditions: Osteoporosis

Summary: this study will test the weighted average inhibition of u-ntx/cre (aminoterminal crosslinked telopeptide of type 1 collagen) and auc (0-168 hours) of odanacatib


Eligibility criteria:
inclusion criteria: * male subject between the ages of 50 and 75 years; post menopausal female subjects between the ages of 45 and 75 years * subject is in good general health * subject has no evidence of metabolic bone disorder other than osteopenia or osteoporosis * subject is a non-smoker exclusion criteria: * subject works night shift and is unable to avoid nightshift work during the study * subject has had major surgery, donated blood or participated in another investigational study with in the past 4 weeks * subject has a history of stroke, chronic seizures, or major neurological disease * subject has a history of cancer * subject consumes excessive amounts of alcohol or caffeine
safety and efficacy of combination listeria/gvax pancreas vaccine in the pancreatic cancer setting

Conditions: 2nd-line, 3rd-line and Greater Metastatic Pancreatic Cancer

Summary: test the safety, immune response and efficacy of gvax pancreas vaccine (with cyclophosphamide) and crs-207 compared to chemotherapy or crs-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma


Eligibility criteria:
inclusion criteria: * have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required, mixed histology is not allowed; subjects must have metastatic disease * 2nd line, 3rd line or greater * at least 18 years of age * eastern cooperative oncology group (ecog) performance status of 0 or 1 * anticipated life expectancy \>12 weeks * for women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. a barrier method of contraception must be employed by all subjects (male and female), regardless of other methods. * have adequate organ function as defined by specified laboratory values exclusion criteria: * allergy to both penicillin \& sulfa or suspected hypersensitivity to granulocyte-macrophage colony stimulating factor (gm-csf), dimethyl sulfoxide, fetal bovine serum, trypsin, yeast, glycerol or other component of the therapy options * known history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment * have any evidence of hepatic cirrhosis or clinical or radiographic ascites * have prosthetic heart valves, major implant or device placed in the last 12 months or history of infection with implant/device that cannot be easily removed * rapidly progressing disease * clinically significant and/or malignant pleural effusion * received prior gvax pancreas vaccine or crs-207 * major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia * infection with hiv or hepatitis b or c at screening * valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis * pregnant or breastfeeding * unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, hiv-positive individual) during the course of crs-207 treatment until completion of antibiotic regimen * conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

Keywords: cancer cancer vaccine listeria monocytogenes listeria-based vaccine gvax cyclophosphamide cytoxan immunotherapy mesothelin
the effect of oral azithromycin in the treatment of chlamydial conjunctivitis

Conditions: Chlamydial Conjunctivitis

Summary: chlamydia trachomatis is one of the major causes of sexually transmitted disease and also the leading infectious cause of blindness in the world.treatment of c. trachomatis eye infection has involved for a long time. the efficacy of single dose azithromycin has already been demonstrated as effective in the treatment of both trachoma and adult inclusion conjunctivitis.however, in our clinical experience, some patients of chlamydial conjunctivitis may require augmented single dose azithromycin treatments before c. trachomatis is eradicated. in this way, we would like to known the efficacy of single dose and augmented single dose azithromycin in the treatment of chlamydial conjunctivitis.

medical records of patients with clinically suspected chlamydial conjunctivitis between january 1, 2006 and december 31, 2006 at one cornea specialist's (y.c.h) out-patient clinic were retrospectively reviewed. at this clinic, patients of both sexes with acute, chronic or recurrent follicular conjunctivitis with the symptoms and signs of chlamydial conjunctivitis suspected were tested for chlamydia direct fluorescent antibody (dfa) tests and arranged for next time out-patient clinic follow up 1-2 weeks later. the patients who attended the follow up visit with positive dfa results were treated with oral azithromycin. these patients received a single dose oral azithromycin (400mg\~1000mg, according to their age and body weight) once a week for consecutive two weeks. repeated dfa examinations were performed 4 to 6 weeks later. if the dfa examinations still showed positive results, augmented single dose oral azithromycin once a week for one week was given again till the dfa showed negative results. the occurrence and frequency of adverse events recorded in the medical charts were reviewed as well.

Eligibility criteria:
inclusion criteria: * patients of clinically chlamydial conjunctivitis suspected and proven by direct fluorescent antibody(dfa)results exclusion criteria: * patients with pregnancy or lactation, history of allergy to macrolides, evidence or history of hepatic, renal, hematological or cardiovascular disease

Keywords: oral azithromycin chlamydial conjunctivitis
dynamic scaffold versus lichtenstein open hernioplasty.

Conditions: Inguinal Hernia

Summary: evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing two different techniques: lichtenstein/plug and mesh and proflor. the outcomes of these two groups of patients, respectively the lichtenstein inguinal hernia repair with static flat mesh and the defect obliteration with 3d dynamic scaffold proflor, are compared in respect to defined variables along stages: intraoperative, early and long term postoperative.


Eligibility criteria:
inclusion criteria: eligible patients were individuals aged between 18 and 85 years old, competent to give consent, affected by clinically relevant primary inguinal hernia scheduled to undergo elective inguinal hernia repair and eligible for outpatient surgical procedure with local anesthesia. exclusion criteria: * recurrent inguinal hernia * incarcerated inguinal hernia * hernia not in the inguinal area * signs of obvious local or systemic infection * asa score \> 4 * presenting with unstable angina or nyha class of iv * pregnant * active drug user * immunosuppression, chemotherapy * chronic renal insufficiency * abdominal ascites * infection in area of the surgical field * bmi \>35

Keywords: inguinal hernia repair proflor technique lichtenstein hernia repair
a study of cdx-0159 in patients with prurigo nodularis

Conditions: Prurigo Nodularis

Summary: the purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of cdx-0159 (barzolvolimab) in patients with prurigo nodularis.

the purpose of the study is to explore the safety, clinical effect, pharmacodynamics, and pharmacokinetics of cdx-0159 (barzolvolimab) in patients with prurigo nodularis. there is a screening period of up to 2 weeks, an 8-week double-blind treatment period and a 16-week follow-up period after treatment. patients will receive one dose of cdx-0159 (barzolvolimab) or placebo.

Eligibility criteria:
key inclusion criteria: 1. males and females, 18 - 75 years old. 2. diagnosis of prurigo nodularis by a dermatologist at least 3 months prior to screening with: 1. at least 20 pn nodules with bilateral distribution on both arms and/or both legs and/or both sides of the trunk at screening. 2. an investigators global assessment (iga) score for pn ≥ 3 at screening and baseline (day 1). 3. severe itch, defined as the mean of the daily worst itch nrs (wi-nrs) score of ≥ 7 during the 7-day period immediately prior to initiation of study treatment. 4. documented history of inadequate response to prescription topical medications or for whom topical medications are medically inadvisable. 5. willing to apply a topical moisturizer (emollient) twice daily throughout the study. 6. both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment. 7. willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule. key exclusion criteria: 1. pn due to neuropathy, psychiatric disorders or medications. 2. unilateral lesions of prurigo (eg, only one arm affected) 3. active unstable pruritic skin conditions in addition to pn. 4. women who are pregnant or nursing. 5. known hepatitis b or hepatitis c infection or active covid-19 infection 6. vaccination with a live vaccine within 2 months prior to study drug administration (subjects must agree to avoid vaccination during the study and for four months thereafter). note: inactivated vaccines are allowed such as seasonal influenza for injection. covid-19 vaccination is allowed. 7. history of anaphylaxis. there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: cdx-0159 barzolvolimab
a study of perjeta (pertuzumab) in combination with herceptin (trastuzumab) in participants with metastatic breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy and safety of perjeta (pertuzumab) in combination with herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (cohort 3). objective response rate and clinical benefit will be assessed. pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (iv) on day 1, followed by 420 mg iv every 3 weeks. trastuzumab will be administered at the same schedule the participant was following before entry into the study. an additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg iv on day 1, followed by 420 mg iv every 3 weeks. these participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.


Eligibility criteria:
inclusion criteria: * females greater than or equal to (≥) 18 years of age, with histologically-confirmed her2-positive breast cancer * metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease * less than or equal to (≤) 3 chemotherapy regimens prior to study entry * last trastuzumab dose ≤9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and ≥4 weeks for participants receiving pertuzumab monotherapy * left ventricular ejection fraction ≥55% at study entry exclusion criteria: * previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab * brain metastases * history of any cardiac adverse event related to trastuzumab therapy * any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
anatomical landmarks for chest wall perforators used for partial breast reconstruction

Conditions: Breast Cancer Female

Summary: the aim of this 6-month proof-of-concept study is to map out the chest wall perforators in relation to anatomical landmarks for partial breast reconstruction.

breast conserving surgery is commonly performed in patients with breast cancer. it is important to fill the defect from a breast conserving procedure to achieve good cosmetic outcome. this defect can be filled either by using the adjacent breast tissue or by using perforator flaps; commonly taken from the area posterolateral to the breast or or below the inframammary crease. these perforator flaps can be based on thoracodorsal artery, lateral thoracic artery, lateral intercostal artery or the medial intercostal artery. the identification of these perforators using a hand-held doppler is an important but time-consuming intraoperative step. surgeons often use the information derived from cadaveric studies when identifying these perforators as there is minimal information on the location of these perforators in relation to anatomical landmarks. patients with a bmi of \< 25 kg/m2admitted for elective breast surgery or attending breast outpatients' clinic will be included in the study. patients will be sent information about this study prior to admission or the clinic appointment with a copy of the consent form. participants will have a 30-minute assessment using a hand held doppler and perforators will be mapped against soft tissue and bony landmarks. data will be analysed to identify common anatomical locations for the different chest wall perforators.

Eligibility criteria:
inclusion criteria: * patients undergoing elective breast surgery * age ≥ 18 years * female * bmi ≤ 30 kg/m2 * willing and able to give fully informed consent, * willing and able to comply with the study procedures exclusion criteria: * pregnant patients * previous bilateral breast or axillary surgery * undergoing bilateral oncoplastic procedure or requiring bilateral pre-operative marking * undergoing breast surgery requiring pre-operative marking of some of the landmarks and has had contralateral breast or axillary surgery in the past * surgery planned within 24 hours of screening for eligibility * known history of allergy or contact dermatitis to ultrasound gels
vitamin d level and emergence delirium in children

Conditions: Delirium

Summary: in our study, we aimed to evaluate the relationship between vitamin d levels and postoperative delirium in children who had undergone tonsillectomy and/or adenoidectomy.

patients are assigned to one of two groups. serum 25(oh)d level will be determined as \<12 ng/ml group 1, group 2 with ≥12 ng/ml. asa i-ii children aged 2-10 years who will undergo adenoidectomy and/or tonsillectomy surgery under general anesthesia will be included in the study. in the operating room, the patient will monitored using electrocardiography, pulse oximetry, noninvasive blood pressure measurements, capnography. under anesthesia, blood samples were taken for serum 25(oh)d levels. after extubation, patients will be taken to the recovery room. delirium will be evaluated using the paed (pediatric anesthesia emergence delirium) scale at 10-minute intervals in the recovery unit. in our study, 25(oh)d level was measured.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i and ii tonsillectomy and/or adenoidectomy surgery exclusion criteria: * psychological disorders * emotional disorders * abnormal cognitive development * developmental delay * allergy to the drugs in our protocol
bone marrow angiogenesis in acute myeloid leukemia - evaluated by dynamic contrast enhanced magnetic resonance (mr) image

Conditions: Acute Myeloid Leukemia

Summary: in malignant or neoplastic disease, angiogenesis is defined as the generation of new capillaries from preexisting blood vessels, e.g. by sprouting or by intusseption. through the pioneering work of folkman, it was recognized that angiogenesis plays an important role in tumor development, progression, and metastasis. it is also conceivable that there are forms or developmental stages of leukemia, multiple myeloma, or lymphomas that will progress independently of angiogenesis. synthesis of angiogenesis activators, such as vascular endothelial growth factor (vegf) and other angiogenic factors, such as basic fibroblast growth factor (bfgf), has been demonstrated for leukemia cells, non-hodgkin's lymphoma, and myeloma cells. microvessel density is also significantly elevated over normal controls with progressive increases according to the stages of myelodysplastic syndrome. increased microvessel density (mvd) in the bone marrow was found in patients with multiple myeloma in comparison to normal controls and increased mvd is an adverse prognostic marker in multiple myeloma. however, the functional status of the blood vessel (e.g. permeability) cannot be determined by the above mentioned methods.

in malignant or neoplastic disease, angiogenesis is defined as the generation of new capillaries from preexisting blood vessels, e.g. by sprouting or by intusseption. through the pioneering work of folkman, it was recognized that angiogenesis plays an important role in tumor development, progression, and metastasis. it is also conceivable that there are forms or developmental stages of leukemia, multiple myeloma, or lymphomas that will progress independently of angiogenesis. synthesis of angiogenesis activators, such as vascular endothelial growth factor (vegf) and other angiogenic factors, such as basic fibroblast growth factor (bfgf), has been demonstrated for leukemia cells, non-hodgkin's lymphoma, and myeloma cells. microvessel density is also significantly elevated over normal controls with progressive increases according to the stages of myelodysplastic syndrome. increased microvessel density (mvd) in the bone marrow was found in patients with multiple myeloma in comparison to normal controls and increased mvd is an adverse prognostic marker in multiple myeloma. however, the functional status of the blood vessel (e.g. permeability) cannot be determined by the above mentioned methods.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia (aml) patients with intention to receive induction chemotherapy * dynamic contrast-enhanced magnetic resonance imaging (dmri) performed before, during and after complete course of induction chemotherapy * age and sex matched normal volunteers exclusion criteria: * aml patients with palliative chemotherapy only

Keywords: acute myeloid leukemia age and sex matched normal subjects dynamic mri bone marrow perfusion tumor angiogenesis
continuous versus discontinuous design of encircling lesions during ablation for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.

the number of pulmonary vein isolation (pvi) therapy for atrial fibrillation (af) is increasing. durable pvi is cornerstone for long-term freedom of af. in one previous study continuous ablation was suggested to be more efficient in durable pvi. however, this hypothesis has not been proven in randomized fashion. the current study is to confirm whether continuous versus discontinuous design of encircling lesions are comparable under the same conditions of power delivery. the study design is a two-centre prospective randomized trial to compare the acute efficacy by using the above described approaches.

Eligibility criteria:
inclusion criteria: * patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment. exclusion criteria: -

Keywords: catheter ablation atrial fibrillation contact force continuous ablation
evaluation of sleep apnea and cardiac rhythm abnormalities after surgery under general anesthesia

Conditions: Obstructive Sleep Apnea; Arrhythmia

Summary: higher risk of cardiac and respiratory post-operative events is observed in patients with unrecognised obstructive sleep apnea (osa). the efficiency of a simple method of osa screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia (oxygen desaturation index) will be assessed. these sleep respiratory analyses will be compared with the research of arrhythmia, in order to show if they are linked to the hypoxemia events. aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory postoperative complications will be assessed in osa patients.


Eligibility criteria:
inclusion criteria: * orthopaedic, urologic, vascular, digestive surgery * under general anaesthesia or sedation * age \> 45 years old * stop-bang score\>3 exclusion criteria: * head and neck surgery, planned prolonged mechanical ventilation after surgery (\>24h) * severe copd * post-operative icu planned * diagnosed osa or other sleep disorder breathing

Keywords: hypoxia perioperative outcomes
management of robertsonian translocation pgt-sr attempts

Conditions: Robertsonian Translocation

Summary: to analyze if a probe strategy choice for pgt-sr studies of robertsonian translocations (rt) influences the fate of embryos? few studies discussed the importance of probe choices. however, those who did, demonstrated that analysis with locus specific probes improve a diagnosis of dubious results, and addition of a centromeric probe could affect the accuracy of diagnosis


Eligibility criteria:
inclusion criteria: * adult patient whom carrying robertsonian translocations in the context of pgt-sr management * age \> 18 years exclusion criteria: - age \< 18 years

Keywords: several years of miscarriages abortions and primary infertility fish with 2 probes fish with 3 probes
daily iron vs every-other-day iron for pediatric patients with ida

Conditions: Iron Deficiency Anemia

Summary: iron deficiency anemia (ida) is a prevalent global health issue affecting a significant proportion of the population, including children. while daily oral iron supplementation is a common approach to treat ida, concerns regarding side effects and compliance have led to exploration of alternative dosing schedules, such as every-other-day. this study aims to investigate the efficacy and safety of daily versus every other day oral iron supplementation in the management of ida in pediatric patients.

this is a prospective open-label randomized controlled study. patients will be randomized into two groups, one group (investigational) will receive oral iron every other day (every 48 hours) and the control group will be prescribed daily oral iron. data will be collected prospectively including compliance assessment, side effect profile, hemoglobin (cbc), iron stores, hepcidin levels and other monitoring as relevant for best patient care. at the time of enrollment and following randomization patients will commence treatment with oral iron. duration of treatment will be 3 months. laboratory monitoring will also commence at the time of enrollment along with ongoing evaluation of signs and symptoms of anemia, side effects of oral iron therapy, compliance with oral iron therapy. duration of monitoring will be 6 months. a medication diary will be provided to all subjects of each group to track their intake of their oral iron supplementation.

Eligibility criteria:
inclusion criteria: * confirmed iron deficiency anemia * pediatric patients (1-18 years of age) without regard of gender, race, ethnicity nor language. * able and willing to take oral iron (tablet or liquid). exclusion criteria: * pregnant or lactating patients * known allergies or intolerance to oral iron formulations * concomitant chronic medical conditions affecting iron metabolism * short gut syndrome * celiac disease * inflammatory bowel disease * cancer * chronic kidney disease * blood transfusions in the past 3 months * iv iron administration in the past 3 months * oral iron supplementation in the past 2 weeks