Kornimate/medical-research-clean huggingface dataset:
study of enmd-2076 in patients with relapsed or refractory hematological malignancies

Conditions: Relapsed or Refractory Hematological Malignancies

Summary: to define the maximum tolerated dose of oral daily enmd 2076 in patients with relapsed or refractory hematological malignancies


Eligibility criteria:
inclusion criteria: * patients must have relapsed/refractory hematological malignancy for which no standard therapies are anticipated to result in a durable remission. patients with poor-risk myelodysplasia (mds) \[i.e., ipss ≥ 1.5\] or chronic myelomonocytic leukemia (cmml) are also candidates for this protocol. relapsed/refractory leukemias include acute non lymphocytic leukemia (aml) by who classification, acute lymphocytic leukemia (all), chronic lymphocytic leukemia (cll), or chronic myelogenous leukemia (cml) in blast crisis. patients with agnogenic myeloid metaplasia (amm) are also eligible. patients with relapsed or refractory lymphoma or myeloma may also participate. * age ≥18 years. * adequate performance status * interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents and adequate recovery from prior toxicities. if the patient had a transplant, at least 6 months must have passed before initiation of treatment on this protocol and stable graft versus host disease (no change in severity) for 4 weeks preceding study entry (if applicable). * persistent clinically significant chronic toxicities from prior therapy must have resolved to baseline or nci ctcae grade \< 1 * adequate laboratory results within 10 days of enmd-2076 administration (unless the abnormality is considered attributable to leukemia) exclusion criteria: * pregnant or breast-feeding women. * clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy. * impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, uncontrolled hypertension, or uncontrolled congestive heart failure. blood pressure must be \< 150/90 at the time of enrollment. * receiving any other treatment for their disease * qtc prolongation defined as ≥ 470 ms.

Keywords: leukemia hematologic neoplasms
peng block with two diffirent volume

Conditions: Pain, Acute; Postoperative Pain; Hip Fractures

Summary: hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. pericapsular nerve group block is a newly defined block and targets the hip capsule. the aim of this study is to investigate and compare the perioperative analgesic efficacy of peng blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia.

hip fractures are morbid conditions, especially in elderly patients, and their treatment is usually surgical. pericapsular nerve group block is a newly defined block and targets the hip capsule. the aim of this study is to investigate and compare the perioperative analgesic efficacy of peng blocks applied in two different volumes in patients undergoing hip fracture surgery under spinal anesthesia. 60 asa i-iii patients between 35-90 years of age who will be operated for femoral head/neck fractures will be included in the study. us-guided block procedure will be applied 30 minutes before the start of surgery. the patients will be divided into two groups, group i, peng block 20ml bupivacaine (n:30) and group ii, peng block 30ml bupivacaine (n:30) using the closed envelope method in the operating room. randomization will be performed by one of the researchers for each patient. randomization information of patients will be used for all follow-up and data collection. the anesthetist applying the block will not take any part in collecting the data or performing the analysis. numerical rating scale (nrs) will be used to evaluate pain. patients will be given spinal anesthesia 30 minutes after peng block. the primary outcome measure was determined as pain during positioning. nrs scores will be recorded after entering the operating room before, immediately before, during, and immediately after any analgesic intervention. secondary outcome measures will be determined as the time required for la performance (measured from the start of the position maneuvers to removal of the spinal needle), the quality of the patient position for la performance ("unsatisfactory", "satisfactory", "good", "very good" to define sa). questionnary 15 test will be applied to the patients 24 hours after the operation to measure patient satisfaction and to measure patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients scheduled for total hip replacement surgery under spinal anesthesia * asa(american society of anesthesiology) 1-3 * receiving consent that accept regional analgesia exclusion criteria: * contraindications for spinal anesthesia and peng block * impaired cognition or dementia * multiple fractures
assessing the efficacy of maxidex® and patanol® for the treatment of allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study was to evaluate the efficacy of maxidex and patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an environmental exposure chamber (eec).

this study consisted of 6 visits. visit 1 was the medical screening visit (skin prick test). visit 2 and visit 3 consisted of 2 consecutive eec visits (3 hours in the eec followed by 7 hours in the clinic, 10 hours total, each visit) followed by 7 days of wash-out. visit 2 and visit 3 occurred prior to dispense and the measures obtained during these visits were used as baseline. at visit 4 patients were randomized and dispensed the assigned study medication for 7 days of at-home dosing. visit 5 (day 8 of treatment) and visit 6 (day 9 of treatment) consisted of 2 additional consecutive eec visits (3 hours in the eec followed by 7 hours in the clinic, 10 hours total, each visit). during each eec visit, patients were exposed to either ragweed or cat allergen, depending on their skin prick test results. of the 180 participants enrolled, 170 received at least one dose of study treatment and were randomized to one of the three study treatments.

Eligibility criteria:
inclusion criteria: * at least 1 year history of allergic conjunctivitis. * ability to self administer ophthalmic drops. * ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1. * other protocol-specified inclusion criteria may apply. exclusion criteria: * presence of any ocular infection. * confirmed diagnosis of dry eye. * presence of glaucoma or ocular hypertension. * moderate to severe asthma. * any severe, unstable, or uncontrolled systemic disease. * other protocol-defined exclusion criteria may apply.

Keywords: conjunctivitis ocular allergy
a "physician & patient-powered" cohort registry (my myeloma)

Conditions: Multiple Myeloma

Summary: the aim of this observational study is the creation of a national multiple myeloma registry to monitor the current routine clinical practice in italy and describe the standard of care adopted for the diagnosis and treatment of patients with multiple myeloma in the different italian hematology centers.

in italy, myeloma accounts for 1.3% of all tumour diagnoses in males and for 1.2% of all tumour diagnoses in women. the incidence is 9.5 new cases per 100,000 males and 8.1 cases per 100,000 females. median age at diagnosis is 68 years and approximately 2% of patients experience onset before the age of 4011. therefore is to establish a national disease registry to monitor current routine clinical practice in italy and to describe the standard of care adopted for the diagnosis and treatment of patients with myeloma. national registries have already been established in some countries and a recently-published meta-analysis highlighted certain differences in treatment, survival and the demographic characteristics of patients. an italian national registry is important for analysing the current situation, in order to deal with the changes that lie ahead. in addition to the standard epidemiological registry - as described in the statistical methods section - a patientpowered registry (ppr) will also be established to encourage patient participation.

Eligibility criteria:
inclusion criteria: * patients of both sexes * age ≥ 18 years * diagnosis of active/symptomatic multiple myeloma (according to crab and biological parameters) no earlier than 1st january 2019 * able and willing to sign an informed consent form exclusion criteria: * none considered
resistance training and appetite regulation

Conditions: Obesity

Summary: this study plans to learn more about how resistance training impacts appetite and the brain's response to food. the study will be evaluating how the brain responds to food images as well as how behaviors and hormones change with a 12 week resistance training intervention.

aim 1: to determine if rt impacts neuronal function associated with food intake behavior in a manner favoring reduced ei in overweight/obese adults. hypothesis: compared to pre, post-rt fmri measures will demonstrate ↓ neuronal responses to food cues in the insula, prefrontal cortex, and hypothalamus, brain regions implicated in reward, impulsivity, motivation, and regulation of ingestive behaviors. these changes will be associated with ad libitum ei. aim 2: to determine if rt impacts appetite-related peptides, ratings, and food intake behaviors in a manner favoring reduced ei in overweight/obese adults. hypothesis: compared to pre, post-rt measures will show changes in appetite-related peptides, ratings (↓ hunger ↑ satiety), and behaviors (↓food-related cravings \& impulsivity, ↑ self-efficacy) consistent with ei reduction. changes in appetite regulation indices will be associated with changes in relevant brain networks (aim 1). these changes will also be associated with ↓ ad libitum ei. exploratory aim: to determine if rt impacts neuronal function and appetite-related peptides and behaviors in a manner favoring ↓ ei in non-compensators (top tertile of fat mass loss) as compared to compensators (bottom tertile of fat mass loss). hypothesis: compared to compensators, non-compensators will show ↓ neuronal responses to food cues and default network, and changes in appetite-related peptides, ratings, and behaviors consistent with ↓ ei.

Eligibility criteria:
inclusion criteria: * all ethnic groups * both sexes * age: 18-55 * bmi: 27-40 kg/m2 * weight stable (±5% in last 6 months) * sedentary (\<2 hours of planned physical activity/week by self-report, no rt in previous 12-months) exclusion criteria: * history of cvd * dm * uncontrolled hypertension * untreated thyroid disease * renal disease * hepatic disease * other condition affecting weight/metabolism * unable to exercise * smoker * medications affecting weight * ei or ee in past 6 months * weight loss/gain \>5% in past 6 months * post-menopausal women (defined as age appropriate women with 6 months or more of amenorrhea) * currently pregnant, lactating, \< 6 months post-partum * woman who have undergone oophorectomy * bariatric surgery * major psychiatric disorder * alcohol or substance abuse * depression by history and/or score \>21 on ces-d * history of eating disorders and/or score \>20 on eats-26

Keywords: resistance exercise appetite regulation
airway epithelium gene expression in the diagnosis of lung cancer: aegis clia

Conditions: Lung Cancer

Summary: the primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.


Eligibility criteria:
inclusion criteria: 1. the patient is being evaluated for the diagnosis of possible lung cancer or "rule out lung cancer" and is indicated for bronchoscopy. 2. the patient is undergoing bronchoscopy 3. ≥ 21 years of age 4. patient meets local site's standard of care (soc) for performing diagnostic bronchoscopy 5. the patient is a current or former cigarette smoker (defined as having smoked \>100 cigarettes in their lifetime. exclusion criteria: 1. the pulmonary physician does not recommend that bronchoscopy be performed 2. the patient is unable to be consented into the study or unable to comply with requirements of the study 3. the patient has previously been diagnosed with primary lung cancer 4. immediately prior to bronchoscopy, the patient has been on a mechanical ventilator for ≥ 24 consecutive hours.

Keywords: gene expression lung cancer smoking
epidemiology of injuries caused by the practice of artificial structure climbing

Conditions: Sport Injury

Summary: this study aims to precisely describe epidemiology of injuries than occur during practice of climbing in artificial structure. each participant will complete questionnaires in order to identify injuries. the first questionnaire will be completed at the moment of the inclusion and the second questionnaire will be completed if participant has injuries every 3 months until month 12.


Eligibility criteria:
inclusion criteria: - person who practices artificial structure climbing exclusion criteria: * person who refuses to participate * person under tutorship or curatorship * person who cannot read and write * person who wants to leave reunion island within 12 months
pilot study of probiotics in pre-diabetic adolescents

Conditions: Obesity, Childhood

Summary: this study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.

diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (t2d). probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of t2d. the investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children. the probiotic strains are known to improve glycemic control.

Eligibility criteria:
inclusion criteria: * male or female, 13-19 y. of age at visit 1. * bmi: 99th percentile or greater * acanthosis nigricans * pubertal tanner stage ≥3 exclusion criteria: * secondary diabetes (i.e. post-transplant diabetes mellitus (dm) or cystic fibrosis dm), monogenic forms of diabetes (i.e. mody), autoimmune diabetes or presence of islet autoantibodies. * known severe immunodeficiency, or immune compromised. * current or previous history for insulin or metformin therapy (within last 3 months). * antibiotic or probiotic therapy 3 months prior to enrollment. * start of new dietary intervention within 1 month prior to enrollment. * diagnosed food hypersensitivity or active gastrointestinal disease
postural balance and stability among patients with cervical and back pain

Conditions: Spinal Stenosis; Back Pain

Summary: high percentage of chronic back pain is due to spinal stenosis. the clinical picture is of 'neurogenic claudication' which effects postural balance and stability. if conservative treatment fail to improve symptoms, an invasive treatment which includes spinal decompression can be done. the research is an observational prospective one, pre and post operational intervention. the aim is to examine whether an operational intervention improves quality of life, pain, postural balance an stability among patients. it's important to clarify, that although there is operational intervention, the research is observational. the decision weather to operate or not, is not a part of the research. the investigators assume that since there is a population that independently going through an operation, the investigators can observe this population and evaluate different aspects of the operation outcomes.


Eligibility criteria:
inclusion criteria: * patients suffering from back or neck pain * patients that are candidates for operational intervention exclusion criteria: * pregnant women * patients who had a spinal operation in the past.

Keywords: spinal stenosis spinal decompression postural balance neurogenic claudication
gluing lacerations utilizing epinephrine

Conditions: Lacerations

Summary: minor lacerations are a commonly treated injury in the paediatric emergency department . over the past decade, standard closure of these lacerations has evolved from suture repair to closure with tissue adhesive (also referred to as "skin glue"). local anaesthetic is not routinely used during application of skin glue as it was with sutures. there are, however, several potential advantages to pre-treating wounds with topical let (lidocaine-epinephrine-tetracaine), a liquid gel with anaesthetic and vasoconstrictive properties. some believe let can improve patient comfort, increase the ease of glue application, and lead to better healing when used on lacerations being repaired with tissue adhesive. this study aims to address the question of whether or not pre-treatment with let improves outcomes in minor lacerations repaired with skin glue. the primary hypothesis is that pre-treatment of minor lacerations with let will decrease pain (as measured on a visual analog scale) during repair with tissue adhesive.


Eligibility criteria:
inclusion criteria: * aged 0 to 17 years inclusive; * with a laceration that is less than 3 cm in length (the upper limit recommended for tissue adhesive repair by the manufacturer). * with said laceration on the face, torso, trunk or extremities; * with said laceration deemed by the treating physician to be appropriate for repair via tissue adhesive exclusion criteria: * the wound for study needs debridement or suturing prior to first glue attempt * said wound is an animal or human bite or scratch wound, puncture wound, stellate crush wound, wound crossing mucocutaneous junctions, a scalp laceration, an ear laceration, a wound crossing a joint line, a wound on the fingers or toes, or a wound in an area of concentrated hair such as the eyebrow * the patient has a history of keloid formation or * a known allergy to cyanoacrylates or * is presently taking oral steroids, immunostimulants, anticoagulants or other medications known to impair wound healing or haemostasis; or * has a known diagnosis of diabetes mellitus or vascular insufficiency

Keywords: laceration lacerations let lidocaine epinephrine tetracaine lat lidocaine adrenaline tetracaine tissue adhesive skin glue pre-treatment with let pre-treatment with lat pre-treatment with lidocaine epinephrine tetracaine pre-treatment with lidocaine adrenaline tetracaine use of let with skin glue use of let with tissue adhesive histoacryl
a study evaluating the safety of the nasal pump

Conditions: Dry Eye; Kerato Conjunctivitis Sicca

Summary: the objective of this study is to determine the safety of the tyrvaya nasal pump.

the study is testing the hypothesis that the use of the tyrvaya nasal pump with silicone lubricant does not introduce any additional safety concerns as compared to the safety of the tyrvaya nasal pump without the additional silicone lubricant.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * have provided verbal and written informed consent * willing to comply with all study related visits and procedures exclusion criteria: * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to visit 1.
seroma of the mammary gland

Conditions: Seroma; Breast Cancer; Mastectomy; Breast Implant; Complications

Summary: the study is designed as international, prospective, minimal interventional study in cooperation with eubreast e.v. (european breast cancer research association of surgical trialists). furthermore, it is planned to initiate a registry for postoperative breast seromas.

postoperative seroma formations are one of the most common and serious complications after breast surgery, above all after mastectomy. especially in patients who have opted for breast reconstruction using implants, seromas lead to infections and wound dehiscence which can result in implant and finally breast loss. to date, the cause of seroma development has not yet been clarified. first data of a pilot study of our research group identified an association with immunological-inflammatory processes as a possible cause for seroma development (seroma after simple mastectomy in breast cancer-the role of cd4+ t helper cells and the evidence as a possible specific immune process; pochert et al. 2022). the main objective of the serma (seroma of the mammary gland) study presented here is to identify patient groups who have an increased risk of developing seromas based on immunological/inflammatory processes. based on the findings clinical consequences should be developed in the future, such as more precise risk-adapted patient education and individualized advising regarding the selection of the reconstruction procedure, with the goal of minimizing complication rates. in addition, analyses of the tumor and the microenvironment will be performed to differentiate possible carcinoma-specific immunological processes.

Eligibility criteria:
inclusion criteria study group and control group 1: * written informed consent * age ≥ 18 years * all stages of dcis or primary breast cancer (t1-t4, n0 or n+, m0) including all histopathological subtypes (er/pr positive, er positive/pr negative, her-2/neu positive and triple negative) * surgical procedure planned including ablatio or subcutaneous mastectomy with implant or expander insertion inclusion criteria control group 2 and 3: * written informed consent * age ≥ 18 years * surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy exclusion criteria: * age \<18 years * male sex * breast cancer patients planned for breast conserving therapy * recurrent breast cancer disease * history of breast surgery * diagnosis of lcis only * pregnancy at time of diagnosis * patients with a known immunodeficiency
impact of abdominal incompetence on urinary incontinence after prostatectomy (prostabdo)

Conditions: Prostate Cancer

Summary: the aim of this study is assess deep abdominal wall (ultrasonography of transversus abdominis muscle) before prostatectomy, and look at one year post surgery if patient with several incontinence are the same who have dysfunction (abdominal incompetence) before the surgery.


Eligibility criteria:
inclusion criteria: * male with prostate cancer going to have a robotic-assisted laparoscopic radical prostatectomy exclusion criteria: * neurological patology with bladder impact (sci, parkinson disease, multiple sclerosis....) * urinary incontinence before surgery * surgery for abdominal wallhernia