Kornimate/medical-research-clean huggingface dataset:
urine vegf levels in very low birth weight (vlbw) infants

Conditions: Infant, Very Low Birth Weight

Summary: vlbw infants are at risk of developing retinopathy of prematurity (rop). in the first phase of rop there is a down-regulation of retinal vegf-expression because of postnatal relative hyperoxia, followed by an upregulation of vegf mediated through retinal hypoxia, which leads to pathologic vessel formation. vegf acts through binding to the specific receptor flt-1, the soluble form sflt-1 is a specific antagonist of vegf action. erythropoietin, given to vlbw infants to prevent anemia, may stimulate vegf-production in neuronal cells. currently, there are no data published about vegf urine-levels in vlbw infants and it is not known, if urine vegf-levels may serve as a non-invasive marker of rop-risk. further shall be investigated, if erythropoietin-therapy increases urine vegf-levels and if there is a correlation with rop-development.


Eligibility criteria:
inclusion criteria: * gestational age \< 32 weeks * birth weight \<1500g exclusion criteria: * absent written consent by parents * connatal eye malformation

Keywords: rop vlbw epo iugr vegf sflt-1 very low birth weight infants retinopathy of prematurity erythropoietin therapy and risk of rop
mr-hifu for recurrent gynaecological cancer

Conditions: Cervical Cancer; Endometrial Cancer; Uterine Cancer; Ovarian Cancer; Vaginal Cancer; Vulvar Cancer

Summary: the primary objective of this pilot study is to determine whether or not it is feasible to use mrghifu to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. the ultimate goal is to be able not only to offer a viable method of symptom palliation in patients with recurrent pelvic tumours and improve their quality of life; but also to control tumour growth and extend life in a group of relatively young patients with isolated local recurrence.


Eligibility criteria:
inclusion criteria: * patients with recurrent pelvic gynaecological malignancy (cervix and endometrial cancer). * recurrent lesion is painful (nrs\>4) and not suitable for alternative treatments * intended target volume accessible for mrghifu treatment * intended target volume visible on noncontrast mr imaging * distance between target and skin ≥1cm exclusion criteria: * mri contraindicated (e.g. by incompatible metal implants or claustrophobia) * pregnancy * sedation contraindicated * mri contrast agent contraindicated * scar, internal or external fixation device along the beam path or at the target

Keywords: magnetic resonance imaging (mri) high intensity focused ultrasound (hifu) focused ultrasound surgery
alpha 1 anti-trypsin (aat) in treating patients with acute graft-versus-host disease gvhd)

Conditions: Graft-Versus-Host Disease (GVHD) Acute on Chronic

Summary: this phase i/ii trial evaluates the efficacy and adverse effects of alpha 1 anti-trypsin (aat) for the treatment of acute graft-versus-host disease (gvhd) after hematopoietic stem cell transplantation.

primary objectives: i. determine the safety and tolerability of aat in patients with steroid non-responsive acute gvhd. ii. characterize pharmacodynamic effects of aat on pro-inflammatory cytokines, heparan sulfate, and the spectrum of peripheral blood t cells. iii. determine clinical responses of gvhd to aat in patients with steroid non-responsive acute gvhd. outline: this is a phase i/ii dose-escalation study of aat. patients will receive aat intravenously (iv) on study days 1, 3, 5, and 7. patients who experience no toxicity and in whom gvhd is stable or improved after the day 7 dose can continue therapy with aat on days 9, 11, 13 and 15 for a total of 8 doses.

Eligibility criteria:
inclusion criteria: * patients transplanted from related or unrelated, human leukocyte antigen (hla) matched or mismatched donors * patients transplanted with hematopoietic stem cells from any source * patients receiving calcineurin inhibitors as part of graft versus host disease (gvhd) prophylaxis * patients with acute gvhd grades ii-iv developing despite gvhd prophylaxis * patients who have not shown a satisfactory response to methylprednisolone-equivalent doses at 2 mg/kg/day, based on adjusted body weight * signed and dated informed consent exclusion criteria: * patients who have received any systemic agents in addition to steroids for treatment of gvhd * patients unable to give informed consent * patients with manifestations of classic chronic gvhd * patients with evidence of recurrent malignancy * patients with acute/chronic gvhd overlap syndrome * patients whose gvhd developed after donor lymphocyte infusion (dli) * patients with severe organ dysfunction, defined as * on dialysis * requiring oxygen (o2) at more than 2 l/min * uncontrolled arrhythmia or heart failure * veno-occlusive disease (sinusoidal obstruction syndrome) * patients with uncontrolled infections
a study designed to determine if the pharmacokinetic disposition of inhaled insulin exposure is the same for asthmatics and non-asthmatics

Conditions: Asthma; Diabetes Mellitus

Summary: this study will compare the rate and extent of absorption of ti inhalation powder in subjects with asthma and subjects with normal lung function. 24 eligible subjects will be enrolled into the treatment phase of the trial.

visit 1 screening will determine eligibility and obtain informed consent. at visit 2, 3 and 4 subjects inhale 1 dose of 45u ti inhalation powder. at visit 3 subjects inhale 2 puffs (200mcg) albuterol prior to dosing. only asthmatic subjects undergo visit 4 where a methacholine challenge test (mct) is performed followed by inhalation of albuterol then administration of ti inhalation powder. each visit's dosing will occur during a hyperinsulinemic euglycemic clamp. visit 5 is the follow up visit.

Eligibility criteria:
inclusion criteria: non smoking male and female subjects = 18 and = 55 years of age with bmi = 34 kg/m2 fasting blood glucose (fbg) \< 110 mg/dl (6.1 mmol/l). written informed consent asthmatic subjects: clinical diagnosis of asthma along with defined reversibility from pre- to post-bronchodilator spirometry. pulmonary function testing for asthmatic subjects: fev1 \> 70% (nhanes iii), tlc \>70% (its), dlco \>80% (miller) non-asthmatic healthy subjects: fev1 \> 80% (nhanes iii), fev1/fvc \> lln (nhanes), tlc \>80% (its), dlco \>80% (miller), no significant improvement from pre- to post-bronchodilator spirometry. exclusion criteria: unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions change in asthma therapeutic regimen from screening through visit 5 exacerbation of asthma within 8 weeks prior to screening history of diabetes mellitus previous exposure to any inhaled insulin product other than ti inhalation powder or similar formulation inability to perform pft maneuvers meeting recommended american thoracic society (ats) standards of acceptability and repeatability criteria any clinically important pulmonary disease major organ system diseases including seizures, heart failure, uncontrolled hypertension, cancer within the past 5 years, aneurysm, liver disease, anemia or autoimmune disorder clinically significant abnormalities on screening laboratory evaluation female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control

Keywords: asthmatics and non-asthmatic male and female subjects
effects of tamoxifen in premenopausal women with benign breast disease not at high-risk of developing breast cancer

Conditions: Benign Breast Disease; Fibrocystic Disease of Breast; Fibroadenoma; Mastalgia

Summary: the purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy. to do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. established methods of treatment do not yield significant results. this is not only a social burden but also entails high economic cost. as such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.the variability of response and its relation with estrogen receptor status is still a field of active investigation.

Eligibility criteria:
inclusion criteria: * clinical, radiographic and histological diagnosis of benign breast disease. * benign breast disease amenable to hormonal therapy. exclusion criteria: * postmenopausal women. * premenopausal women with pregnancy or other contraindications to tamoxifen. * girls less than 16 years. * very large lesions which require surgery for cosmesis. * high risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy. * lesions like duct ectasia where hormone therapy is not likely to be of benefit. * inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment. * patients unwilling to undergo treatment.

Keywords: fibrocystic breast disease fibroadenoma mastalgia
clinical benefit, safety and pk of raxibacumab in subjects exposed to bacillus anthracis

Conditions: Infections, Bacterial

Summary: this field study is designed such that it may be implemented for any individual who has been administered raxibacumab for treatment of anthrax or for post-exposure prophylaxis including sporadic cases, small anthrax incidents and/or a mass event. this study is designed to describe the clinical effectiveness (including course of illness and survival), safety profile, and raxibacumab pharmacokinetics (pk) from patients who are treated with raxibacumab as part of their clinical care following exposure to b. anthracis. study data and samples for pk and other investigational research will be collected prospectively to the extent possible at pre-specified time points. however, because of the logistical complexities that would likely accompany a mass anthrax event, most data in this study is anticipated to be collected retrospectively. during such a mass anthrax event scavenged blood samples will be utilized where possible to maximize sample analyses for pk and other investigational parameters. therefore, both retrospective and prospective data collection are allowed in this protocol in order to maximize the amount of information obtained in subjects who have been administered raxibacumab. this field study will be the first opportunity to collect data on b. anthracis-exposed patients treated with raxibacumab, to better understand the clinical benefit and safety of the drug and to further inform patient care and treatment choices for management of anthrax

the protocol is a post-marketing requirement from the fda to evaluate the clinical benefit, safety and pharmacokinetic of raxibacumab administered to patients as part of their medical care following exposure to bacillus anthracis.

Eligibility criteria:
inclusion criteria: * women-including pregnant and lactating women, men, and children of all ages who receive treatment with raxibacumab as part of their clinical care for anthrax infection or for post-exposure prophylaxis will be eligible to enroll in this study. * subjects willing and able to adhere to the procedures stated in the protocol * subjects or legally acceptable representative of minors and unconscious adults willing and able to give written informed consent to participate in the study. exclusion criteria: * there are no exclusion criteria for subjects enrolling in this study.

Keywords: raxibacumab anthrax anti-toxin
sinus floor elevation using separately two different xenografts - a prospective randomized clinical trial

Conditions: Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

Summary: the purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.


Eligibility criteria:
inclusion criteria: 1. patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone . 2. men and women over the age of 18 years. 3. patient has signed the informed consent. exclusion criteria: 1. chronic steroid therapy. 2. uncontrolled diabetes. 3. cardiovascular disease. 4. past irradiation of head and neck. 5. maxillary sinus cysts. 6. active chronic sinusitis. 7. smoking more than ten cigarettes per day during the 3 months preceding this study . 8. malignant disease in the 5 years preceding this study. 9. uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia 10. disease that compromise the immune system 11. psychiatric disorder 12. hypersensitivity to titanium, collagen or bovine bone. 13. women who are pregnant or nursing. 14. patients with non-treated periodontal disease. 15. medical and/or general contraindications for intraoral surgical procedures.
fexofenadine hcl - pseudoephedrine hcl combination versus allegra in patients with seasonal allergic rhinitis

Conditions: Rhinitis Seasonal

Summary: primary objective: - to evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine hcl 60 mg - pseudoephedrine hcl 60 mg combination (fex60/pse60) and fexofenadine hcl 60 mg - pseudoephedrine hcl 120 mg combination (fex60/pse120) versus fexofenadine hcl 60 mg (fex60) in patients with seasonal allergic rhinitis (sar). secondary objectives: * to evaluate the efficacy of a twice-daily fex60/pse60 and fex60/pse120 versus fex60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment. * to assess the safety of a twice-daily fex60/pse60 and fex60/pse120 versus fex60.

the study duration for each patient is 3 weeks and 3 days: 1. lead-in period: 1 week 2. treatment period: 2 weeks 3. follow-up period: 3 days

Eligibility criteria:
inclusion criteria: - patients with seasonal allergic rhinitis (sar): patients with a history of sar symptoms during the season when cedar pollen levels are increased for at least 2-years exclusion criteria: * at the start of the placebo lead-in period: * patients who are negative for ige antibody test * expected nasal congestion score is less than 2 * the last 3 days of the lead-in period: * nasal congestion scores are 2 or more and not all 4 * patients with all nasal symptoms (sneezing, rhinorrhea, and nasal congestion). a total score for nasal symptoms (sneezing, rhinorrhea, and nasal congestion) and eye symptom is less than 6 * patients with 2 or more nasal symptoms (sneezing and rhinorrhea) and eye symptoms score is 4 the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cardio-visual stimulation in augmented reality for pain reduction

Conditions: Regional Pain Syndrome; Chronic Pain Syndrome

Summary: the objective of this study is to evaluate the feasibility and efficacy of an augmented reality (ar) biofeedback intervention to alleviate pain symptoms in individuals suffering from chronic pain of the hand and/or the forearm.

chronic pain is a major public health problem with implications for high health care costs, lost productivity and an estimated financial burden of $500 billion. individuals with chronic pain are also at an increased risk of developing an opioid use disorder. chronic pain has previously been associated with a distorted body representation, in particular of the affected body parts. virtual reality (vr) studies using embodiment-, respiration-, and heart-beat related feedback have demonstrated positive effects for induced pain in healthy participants (e.g., increased pain thresholds) and chronic pain in patient populations (e.g., decreased subjective pain, improved functionality, improved physiological markers of pain). based on these studies, the ar intervention evaluated here aims to alleviate subjective pain symptoms and improve physiological pain markers in chronic pain patients using heartbeat-related feedback. this within-subject study will compare subjective pain ratings before, during, and after an ar intervention that provides visual feedback of participants' on-going heartbeat in relation to their affected limb. primary outcomes include subjective reports from participants (perceived efficacy, acceptability, and demand) and the intervention's clinical feasibility, including reports from therapists. secondary outcomes include changes in heart rate and variability.

Eligibility criteria:
inclusion criteria: * be over 18 years of age * present permanent chronic pain (for more than 3 months), secondary to a peripheral pathology (traumatic, orthopedic or neurological), located in the hand or forearm. exclusion criteria: * pregnant women * people in emergency situations * persons unable to give informed consent * persons who are mentally or linguistically unable to understand the research test instructions * individuals who are not available to complete the entire study protocol * cognitive impairments that prevent the use of the equipment * psychiatric disorders * patients with seizure disorders * patients with central hemineglect * pain secondary to central nervous system pathology * patients with arrhythmia * patients with head tremors or head shaking.
use of acupressing in reproductive medicine

Conditions: Fertility Disorders; Anxiety State

Summary: the objective of this preliminary study is therefore to assess the feasibility, safety and reduction of perioperative anxiety thanks to acupressing. in addition, patients undergoing oocyte retrieval often present postoperatively with nausea, abdominal pain and discomfort. acupuncture could also help these patients.

infertility can lead to the realization of follicular puncture or oocytes in order to obtain an embryo for medically assisted procreation. it is a long treatment for the couples concerned and this intervention, relatively simple in young patients, is associated with a very high level of anxiety. according to studies, the incidence of preoperative anxiety ranges from 11% to 80% in adult patients. in patients undergoing outpatient surgery, anxiolytics are not administered before anesthesia in outpatient surgery, as this would risk altering their "fitness for the street" and preventing their return home. studies have shown a benefit of acupressing in the treatment of preoperative anxiety. this technique could therefore be an alternative to drug anxiety before surgery. acupressing could also help these patients.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * scheduled to undergo an oocyte retrieval in outpatient surgery * anxiety score ≥ 3 when they arrived in the outpatient unit * subject is willing and able to provide informed consent * covered by a national healthcare insurance non-inclusion criteria: * ear's pavilion infection * wrist infection * previous treatment with auriculotherapy or acupuncture * with a planned intervention that does not allow the delay of 45 min delay (+/- 15 min) between the acupuncture treatment and the stai assessment * being deprived of liberty or under guardianship exclusion criteria * patient having recourse to any treatment or method of anxiolysis the morning of the procedure, after having given her consent * patient wishing to withdraw from the study

Keywords: acupressing oocyte women fertility
to evaluate the feasibility, preliminary safety and performance of rezūm system in bph treatment in china

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: a real world study to evaluate the feasibility, preliminary safety and performance of rezūm system in bph treatment in china rezūm rws study

this rws study is to evaluate the feasibility, preliminary safety and performance of rezūm system in bph treatment in china, to generate local real world data from a chinese bph population. the rezūm system is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with bph. it is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. the rezūm system is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

Eligibility criteria:
inclusion criteria: * the subjects will provide written informed consent form and agree to data collection. * the subjects who were diagnosed as bph and treated by rezūm procedure in hainan medical pilot zone will be enrolled in this study. exclusion criteria: * this is a retrospective study without any formal exclusion criteria.
value of prothrombin fragment f1+2 in the diagnosis of pulmonary embolism in patients with chronic obstructive pulmonary disease (copd) exacerbation

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Embolism

Summary: to access the clinical usefulness of f1+2 in the diagnosis of pe in patients with aecopd who require hospitalization. specifically, to determine whether f1+2 may have an additional value in the subgroup of patients with an abnormal d-dimer,to determine whether it may increase the proportion of patients in whom pe can be safely ruled out and to determine the sensitivity, specificity and npv of f1+2 at various cut-off values.


Eligibility criteria:
inclusion criteria: * copd exacerbation * able to give informed consent * able to perform spirometry exclusion criteria: * known malignancy * known hypercoagulable state * receiving anticoagulant treatment * pregnancy * renal failure * allergy to iodine
effect of chronic intranasal oxytocin administration on sexual function in pre- and postmenopausal women

Conditions: Female Sexual Dysfunction

Summary: the purpose of this study is to determine whether intranasal oxytocin is effective in comparison to placebo in improving female sexual dysfunction in pre- and postmenopausal women.


Eligibility criteria:
inclusion criteria: * willingness to attempt sexual intercourse and/ or masturbation at least two times per week * ongoing relationship for at least 3 months * female subjects aging 40 years and more, male subjects must be older than 18 * the participation in this study should be of free choice to male partners * willingness to perform a pregnancy test every month (for pre-menopausal subjects) * willingness to use contraception during the study period (for pre-menopausal subjects) * normal findings in the urogenital tract unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant exclusion criteria: * primary sexual dysfunction * sexual abuse * severe psychiatric diseases * untreated conditions and medication intake with associated reduction of sexual function. * in male partners: any severe andrological or related medical problem.