Kornimate/medical-research-clean huggingface dataset:
adh1 and adh2 disease monitoring study (dms)

Conditions: Autosomal Dominant Hypocalcemia

Summary: a global, multi-center, disease monitoring study (dms) in participants with autosomal dominant hypocalcemia type 1 (adh1) or autosomal dominant hypocalcemia type 2 (adh2) designed to characterize adh1 and adh2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

the adh1 and adh2 dms is designed to better understand the disease burden of adh1 and adh2, how participants with adh1 or adh2 are managed with standard of care practices in a real-world setting, and how standard of care treatment impacts adh1 and adh2 symptoms. the study will include adult and pediatric participants with a confirmed clinical diagnosis of adh1 or adh2. each participant's data will be collected over a period of up to 5 years. in addition, retrospective (or past) data will be collected.

Eligibility criteria:
key inclusion criteria: * have a documented activating variant or variant of uncertain significance of the casr gene causative of adh1 or documented activating variant or variant of uncertain significance of the gna11 gene causative of adh2 associated with a clinical syndrome of hypoparathyroidism prior to enrollment note: acceptable documentation includes casr or gna11 genetic analysis report. if no prior documented casr or gna11 gene variant or variant of uncertain significance, potential participants can undergo casr and gna11 gene variant analysis at screening. * be willing and able to provide informed consent or assent after the nature of the study and its details have been explained, and prior to any research-related procedures * be willing and able to provide access to prior medical records including imaging, biochemical, and diagnostic and medical history data, if available * be willing and able to comply with the study visit schedule and study procedures key exclusion criteria: * have serious medical or psychiatric comorbidity that, in the opinion of the investigator, would present a concern for participant safety or compromise the ability to provide consent or assent, or comply with the study visit schedule and study procedures * enrollment in an interventional clinical study at the time of dms screening visit note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: autosomal dominant hypocalcemia type 1 (adh1) autosomal dominant hypocalcemia type 2 (adh2) hypocalcemia musculoskeletal diseases muscular diseases musculoskeletal abnormalities calcium metabolism disorders metabolic diseases hypoparathyroidism hypocalcemic seizures hypercalciuria nephrocalcinosis nephrolithiasis calcium sensing receptor casr gene casr gene mutation casr mutation gna11 gene gna11 gene mutation gna11 mutation
catheter ablation using a novel navigation and imaging system

Conditions: Paroxysmal Atrial Fibrillation

Summary: the objective of the envision study is to collect data on the use of the verafeye navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of paroxysmal atrial fibrillation (paf).


Eligibility criteria:
inclusion criteria: * subject is 18 years of age at the time of consent, or of legal age to give informed consent specific to state and national law * subjects is eligible for a catheter ablation procedure with the verafeye system as navigation and imaging system in the treatment of paf (according to verafeye system ifus, current international and local guidelines and per physician discretion) * subject is able to understand and willing to provide written informed consent * subject is able to and willing to complete all study assessments associated with this clinical study at an approved clinical investigational center exclusion criteria:
validation of a pharmacokinetic pharmacodynamic model to administer propofol in obese patients

Conditions: Obesity

Summary: the purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model to administer propofol in obese patients. our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing weight and that mathematical models to administer drugs in obese patients can be developed to accurately predict dose schemes in this population.

propofol is the most frequently used iv anesthetic today. propofol tci is commonly used for induction and maintenance of general anaesthesia in obese and non obese patients. however, current propofol pk models, used in tci devices, were derived from studies that did not include obese patients. a controversial issue for propofol dose adjustment in this population has been the selection of an adequate size descriptor to scale pk parameters, as drug administration based on total body weight can result in overdose, and conversely, administration based on ideal body weight can result in a sub-therapeutic dose. in a previous study from our group, we developed a pk model capable of characterizing the influence of obesity on propofol disposition. the purpose of this study is to validate this model to administer propofol in obese patients.

Eligibility criteria:
inclusion criteria: * imc \> 35 kg m-2 * scheduled for laparoscopic bariatric surgery * asa i-ii patients * between 18 and 60 yr of age. exclusion criteria: * patients with allergy to study drugs * uncontrolled hypertension * heart block greater than first degree * take any drug acting in the central nervous system within 24 hrs before surgery.

Keywords: anaesthetics iv propofol pharmacokinetics pharmacodynamic
repeat insult patch test of skin irritation/sensitization for cetaphil daily facial cleanser

Conditions: Skin Irritation

Summary: determine if cetaphil daily facial cleanser is a contact sensitizer or irritant to the skin


Eligibility criteria:
inclusion criteria: * not currently under a doctor's care * free of dermatological or systemic disorder which would interfere with the results * free of any acute or chronic disease * will complete a preliminary medical history form and are in general good health * can read, understand, and sign informed consent exclusion criteria: * under 18 years old * currently under doctor's care * currently taking any medication * history of acute or chronic disease * diagnosed with chronic skin allergies * pregnant or lactating
nalbuphine versus morphine for mucositis pain in pediatric cancer patients

Conditions: Acute Myeloid Leukemia; Stem Cell Leukemia

Summary: evaluation of safety and efficacy of nalbuphine versus morphine patient controlled analgesia (pca) for mucositis pain in pediatric cancer patients

the investigators will compare between using of pca morphine (group a) and using of pca nalbuphine (group b) in the following items over the first 7 days of initiation: 1. pain intensity vas every 12 hours and during the performing of mouth care for each patient over the first 7 days. 2. total opioid consumptions for each patient every 24 hours and the total consumption of the entire 7 days since initiation. 3. number of active and total pushes of pca buttons every 24 hours and the sum up of the active and total pushes of pca buttons for each patient over the 7 days. 4. patient satisfaction at the end of the 7 days. patient satisfaction score pss was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14). 5. serious adverse events. (nausea and vomiting, pruritus, respiratory depression, urinary retention, sedation, bradycardia, hypotension).

Eligibility criteria:
inclusion criteria: * newly diagnosed primary aml or hsct and all with oral mucositis grade iii or iv presenting in the study period. * age above 5 year and below 18 years * written informed consent from parents/guardian exclusion criteria: * history of mental retardation * known or suspected allergy to any narcotics * presence of any other co-morbidity: * kidney (crcl \<50) * liver (liver enzymes more than 10 folds) * chest (spo2 \<92% on room air) * cardiac disease (ejection fraction \<40%) * terminal patients who scheduled for palliative care
investigation of early hormonotherapy efficacy of prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.

the primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. control group (randomised study) will be treated with hormonotherapy, when psa recidive appear (on demand treatment). secondary purposes will be to compare psa dinamics and quality of life data in the groups.

Eligibility criteria:
inclusion criteria: * preoperative psa\>20ng/ml * postoperative psa \>0.2 ng/ml * gleason \> 7 * pt3b * signated infomed consent exclusion criteria: * neoadjuvant hormonaltherapy before rp * r1 rp * n+ rp * unstable cncomitant conditions

Keywords: prostate cancer
the effect of fes and therapeutic exercise on sci patients skeletal muscles, sitting balance, posture and quality of life

Conditions: Spinal Cord Injuries

Summary: aim of the current study is to evaluate the effect functional electrical stimulation and therapeutic exercise on traumatic spinal cord injured participants'skeletal muscle characteristics, sitting balance, lung function and quality of life.


Eligibility criteria:
chronic spinal cord injury (12 months post injury) injury in cervical region resulting in tetraparesis able to sit on a custom made chair without support does not have any contraindications for functional electrical stimulation
the internal prospective validation of the cancer admission score (cas) prediction model

Conditions: Oncology

Summary: the goal of this single center prospective observational study is to determine the agreement between the cancer admission score (cas) predicted disposition and the actual disposition in patients with an active cancer diagnosis visiting the emergency department (ed). the main question it aims to answer are: is the performance of the cas good enough to play a potential role in the ed care process. for each participant the cas will be calculated and compared to the actual outcome.

the goal of this single center prospective observational study is to determine the agreement between the cancer admission score (cas) predicted disposition and the actual disposition in patients with an active cancer diagnosis visiting the emergency department (ed). the main question it aims to answer are: is the performance of the cas good enough to play a potential role in the ed care process. the first part of this study is an observational part. for patients with cancer that are presented to the emergency department (ed) the cancer admission score (cas) will be calculated by the model both after triage and after the first blood results are in. furthermore, the expected disposition will be asked to the attending nurse after triage and after the first blood results. finally, the actual disposition will be written down after the patient has left the ed, in combination with ed length of stay (los) and the time for the attending physician to reach a decision about the disposition (time-to-disposition) and the time for a patient to leave the ed (time-to-leave). the second part is the interventional part. in this part we introduce an early bed reservation intervention. the cas is still calculated for the patient. if the cas is 80% or higher based on the triage, the attending physician will be alerted and a call to the bed coordinator will be placed to reserve a bed in advance. after the first blood results are known the second cas will be calculated, if this drops below 70% the reserved bed can be canceled by the attending physician. similar to the first part, the expected disposition from the attending nurse after triage and after first blood results will be collected. finally, the actual disposition, ed los, time-to-disposition and time-to-leave will be noted.

Eligibility criteria:
inclusion criteria: * patients with solid or hematological malignancies and receiving systemic therapy or having received systemic therapy within the last 3 months. * presented at or admitted from the emergency department for the oncology, hematology neuro- or lung-oncology clinical unit. exclusion criteria: * \<18 years old * only received a surgical intervention as cancer treatment * admitted to the ed for the surgical department

Keywords: cancer care emergency care prediction model admission
determining changes in brain structure associated with symptoms of late-life depression

Conditions: Late-Life Depression

Summary: this study will determine the changes in brain structure and function that are responsible for mood and cognition changes that are sometimes associated with late-life depression.

the goal of this research study is to investigate the relationships among late-life depression (lld), cognitive impairment and progressive neurodegeneration. the guiding hypothesis is that lld patients have evolving cognitive impairments as a consequence of distinct underlying neuropathological changes, which frequently are expressed as mild cognitive impairment (mci). these neuropathological and cognitive changes are risk modifiers, lowering brain reserve capacity, and in turn, increasing risk of developing alzheimer's disease (ad). in order to pursue this goal we will enroll lld, mci, and normal control subjects to enrich our existing cohort to include a total of 150 elderly, non-demented, non-depressed subjects, 60 non-depressed mci subjects and 270 lld subjects. using the joint infrastructure of the university of pittsburgh's advanced center for intervention and services research for late-life mood disorders and the alzheimer's disease research center, we will complete a detailed neurobehavioral evaluation, including clinical, neuropsychological, neuroimaging and biological markers, using these data to evaluate the factors associated with the development of mci or dementia. subjects will be studied annually for at least three years, allowing us to use longitudinal data to evaluate a series of linked hypotheses that postulate the pathways by which elderly, depressed patients develop cognitive impairment, and which may lead some to develop dementia.

Eligibility criteria:
inclusion criteria: * diagnosis of a mood disorder exclusion criteria: * major acute medical illnesses or injuries known to have significant direct effects on cognitive functioning (e.g., metastatic cancer, multiple sclerosis, traumatic brain injury). * uncorrectable sensory handicap (e.g., blindness), because they are unable to complete the cognitive test battery. * exclusion criteria for mr scans include: cardiac pacemaker, aneurysm clip, cochlear implant, pregnancy, iud, shrapnel, history of metal fragments in the eye, neurostimulators, weight of 250 lbs. or more, or claustrophobia.

Keywords: late-life depression mild cognitive impairment dementia
single-stage integra reconstruction in burns

Conditions: Thermal Burn

Summary: this is a prospective, descriptive, pilot case series involving patients with significant burns who are candidates for reconstruction with integra®. subjects would have a small area of the wound would, at the time of excision, have the smallest sheet of thin integra® (125 cm2) placed and be immediately autografted with a 3:1 meshed split-thickness skin graft. of note, 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area, so for even the smallest burns in our proposed trial, this area would represent a small portion of the patient's area of injury. the remaining injury areas would be covered with standard-thickness integra® only.

integra®, a synthetic dermal substitute, has been utilized in burn care for decades. typically, 10-14 days after integra® placement, a patient returns to the operating room, the top silastic layer of the integra® is removed, and an autograft - a split-thickness skin graft harvested from the patient - is applied directly on top of the incorporated integra®. the result is regarded to be a cosmetically and functionally superior result to that which would have been obtained had the wound bed itself been autografted at the time of excision, as opposed to being covered by integra® and autografted during a second operation. integra® use in single-stage procedures to cover defects without grafting has shown benefit when defects are fairly small, e.g. fingertip injuries, and small head and neck skin cancer resections. while single-stage reconstruction with integra® has been demonstrated with standard thickness integra®, this decreased thickness would increase the likelihood of graft survival due to the decreased distance of nutrient diffusion.

Eligibility criteria:
inclusion criteria: * english-speaking adult burn patients greater than 18 years old, admitted with burn injuries eligible for integra® reconstruction at the discretion of the burn attending physicians. exclusion criteria: * patients with isolated hand or face burns - these burns are treated with sheet grafts (unmeshed); the 3:1 mesh grafts would not be used on these cosmetically sensitive areas. if they have hand and/or face burns in addition to other areas, they will not be excluded. however, the study itself will not be performed on the hands or face. additionally, patients unable to present to our clinic for routine follow-up due to geographic limitations or otherwise will be ineligible.
study on smoking cessation and cost outcomes in the duke smoking cessation program

Conditions: Nicotine Dependence

Summary: the purpose of this study is to conduct an observational assessment of natural outcomes within the duke smoking cessation program (dscp), "quit at duke." this assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.

the purpose of this study is to conduct an observational assessment of natural outcomes within the dscp, "quit at duke." this is an observational study (n=3000) on patients being treated at the dscp. no interventions are conducted, and data analyzed is collected in the course of clinical care at clinic visits to the duke smoking cessation program (dscp). phone calls are also conducted to determine response to medications and abstinence status up to 12 months following a quit attempt. outcomes of variables including: demographic variables, evaluation responses, feasibility data, and abstinence rates will be analyzed using general regression models using an anova-based design. because no intervention is being conducted, there are no safety concerns related to the study.

Eligibility criteria:
inclusion criteria: * age 18 or older * being treated at the duke smoking cessation program * fluent in written and spoken english. exclusion criteria: n/a

Keywords: nicotine addiction cigarette smoking
the effects of co2 pneumoperitoneum at different temperature in laparoscopic surgery

Conditions: Benign Neoplasm of Cervix Uteri; Gynecological Laparoscopy

Summary: objective: it is recommended to heat and humidify co2 in laparoscopic surgery to prevent postoperative pain and hypothermia but information about its effects on hemodynamic and respiratory parameters is limited. the investigators aimed to investigate the effects of standard and heated-humidified co2 on hemodynamic and respiratory parameters. study design: one hundred patients who underwent laparoscopic hysterectomy for benign pathology were divided into two groups: group cd (cold-dry) patients were administered standard co2, while group hh (heated-humidified) patients were administered 95% humidified insufflation at 37°c. hemodynamic and respiratory parameters, body temperature, pain score and blood count parameters were recorded.

the sample consisted of 100 american society of anesthesiologists (asa) physical status i-ii patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology. the patients were divided into two groups according to a randomization scheme created by a computer: group cd (cold-dry) patients were administered dry co2 via insufflator at room temperature (21°c), while group hh (heated-humidified) patients were administered 95% humidified co2 insufflation at 37°c. the study was planned as a randomized and double-blind study, where patients were not informed of their group.during the operation and in the postoperative period, the patients were followed up by two different anesthetists. all patients were given information and training on the anesthesia method, the use of the patient-controlled-analgesia (pca) device and the visual analog scale (vas) the day before the operation. the patients' demographic data (age, weight, height, etc.) and their basal systolic, diastolic and mean blood pressures and heart rates were measured prior to the operation and recorded on the case report form.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-ii patients aged 40-65 who underwent laparoscopic hysterectomy for benign pathology. exclusion criteria: * patients with chronic obstructive pulmonary disease, asthma, advanced liver and kidney disease, infection, bleeding disorder and drug allergies

Keywords: gynecological laparoscopy standard co2 heated-humidified co2 hemodynamic parameters respiratory parameters