Kornimate/medical-research-clean huggingface dataset:
a study to assess efficacy and safety of lb54640 in patients with hypothalamic obesity

Conditions: Hypothalamic Obesity

Summary: the goal of this study is to determine how well lb54640 works and how safe it is in patients with hypothalamic obesity (ho). the study will evaluate the effect of lb54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older with ho. patients will take an oral daily dose of either lb54640 (low, middle, or high dose) or placebo through week 14. eligible patients who consent to continue in the study after week 14 will take an oral daily dose of lb54640 through week 56.


Eligibility criteria:
key inclusion criteria: * documented evidence of acquired hypothalamic obesity (ho) * age 12 years and older * weight gain associated with the hypothalamic injury and a bmi of ≥30 kg/m2 for patients ≥18 years of age or bmi ≥95th percentile for age and sex for patients \<18 years of age * male and female participants agree to follow study contraception requirements and use a highly effective form of contraception throughout the study and for 90 days after the study key exclusion criteria: * weight loss \>2% in the previous 3 months for patients ≥18 years of age or \>2% reduction in bmi for patients \<18 years of age * history of major surgical procedure within 30 days * hba1c \>10.9% * fasting glucose level \>270 mg/dl * previous use of mc4r agonists * diagnosis of prader-willi syndrome (pws) or rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (rohhadnet). * diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior * history or close family history of skin cancer or melanoma * current clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results other protocol defined inclusion/exclusion criteria may apply.

Keywords: melanocortin 4 receptor, mc4r mc4r agonism
pharmacokinetics of tigecycline in morbidly obese subjects

Conditions: Obesity

Summary: if tigecycline clearance increases with body size then serum exposure values will be lower in obese class iii compared to normal weight subjects because exposure changes inversely with clearance when the dose is fixed without regard to weight.

not required

Eligibility criteria:
inclusion criteria: subjects fulfilling the following criteria will be eligible: 1. males and females, 18 to 50 years of age; 2. non-smoking or light-smoking (≤ 5 cigarettes per day) volunteers; 3. body mass index: 18.50-24.99 kg/m2 (normal weight) or ≥ 40 kg/m2 (obese class iii); 4. female subjects of childbearing potential (self-reported) either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap, condom) or agree to abstain from sex from time of prestudy screening, during entire study period and 1 month following the study period exclusion criteria: 1. history of significant hypersensitivity reaction to any components of tygacil®; 2. history of significant clinical illness requiring pharmacological management; 3. history of blood donation in the past eight week period; 4. abnormal serum electrolyte or complete blood count requiring further clinical work-up; 5. transaminases (ast or alt) \> 2.5 x upper limit of normal; 6. subjects with stage 4 or 5 chronic kidney disease; 7. positive serum pregnancy test (if female); 8. abnormal electrocardiogram (ecg) as judged by study physician; 9. unable to tolerate venipuncture and multiple blood draws; 10. clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up; 11. unable to independently provide a written informed consent.
pain management in cancer patients using a mobile application

Conditions: Cancer

Summary: the investigators have developed a mobile application (for use on smart phones) to help cancer patients better manage cancer pain. this study is a randomized controlled trial to evaluate the effect of this mobile-based intervention. the investigators' hypothesis is that subjects randomized to the intervention group will have a reduction in pain and pain-related hospitalizations.


Eligibility criteria:
inclusion criteria: * all adult patients, 18 years and above suffering from solid-organ cancer. * diagnosed with moderate or severe cancer pain (i.e. pain intensity score of at least 4/10 on numeric rating scale (nrs)) at the massachusetts general hospital (mgh) palliative care center, as determined by the patient's care provider at the mgh palliative care center. subjects do not need to experience a specific nature of pain for eligibility. * patients must be ambulatory and not currently admitted to the hospital at time of enrollment. * must have a smart phone and be willing to download the study application (phase ii only) * must be able to read and speak english. exclusion criteria: * life expectancy less than 2-months as determined by the palliative care provider * significant medical or psychiatric co-morbidities (other than depression or anxiety) or cognitive impediments that would prevent participant from being able to utilize the program * known history of substance abuse * patients currently on investigational therapies or other study protocols that may have an impact on pain intensity or quality of life which are main outcomes of this intervention.

Keywords: cancer pain
correlation between estimated glomerular filtration rate(egfr) and vascular inflammation measured by positron emission tomography (pet) with 18f-fluoro-deoxyglucose (fdg)

Conditions: Atherosclerosis

Summary: vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. renal insufficiency is close correlation with atherosclerosis and cardiovascular mortality. 18f-fluorodeoxyglucose (fdg) positron emission tomography (pet) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.therefore, the purpose of the study is to demonstrate the correlation between egfr and vascular inflammation detected by 18f fdg-pet.


Eligibility criteria:
inclusion criteria: 1. absence of prior cancer diagnosis or remission from cancer at the time of pet imaging and throughout the follow-up period; 2. \>=30 years of age; 3. no prior history of cardiovascular disease ; and 4. absence of acute or chronic inflammatory or autoimmune disease (based on documented medical history) or use of chronic anti-inflammatory therapy. exclusion criteria: 1. age \<35 years 2. presence of chronic inflammatory disease 3. use of anti-inflammatory medications 4. presence of active malignant cancer (defined as any radiological or pathological evidence of malignant cancer disease or undergoing chemotherapy or radiation therapy within 1 year before initial pet/ct and throughout the inter-scan duration).

Keywords: glomerular filtration rate
bolt: study of the indigo® aspiration system when used in patients with deep vein thrombosis

Conditions: Deep Vein Thrombosis; DVT

Summary: the objective of this study is to demonstrate the safety and efficacy of the indigo aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (dvt) who are eligible for treatment.


Eligibility criteria:
inclusion criteria: * unilateral lower extremity dvt occlusion involving iliac and/or common femoral veins with up to 2 cm extension in the inferior vena cava (ivc) or femoral in combination with iliac veins, including patients with extension of clot into the contralateral common iliac vein note: patients with non-iliofemoral dvt in the contralateral limb, who do not require endovascular treatment, may be enrolled * acute thrombotic or thromboembolic occlusion with symptom duration of 14 days or less at presentation * frontline treatment with indigo aspiration system in the target venous segment per investigator decision * patient is ≥18 years of age * informed consent is obtained per institutional review board requirements exclusion criteria: * contraindication to systemic or therapeutic doses of anticoagulants * contraindication to iodinated contrast venography that cannot be adequately premedicated * complete infrarenal ivc occlusion * in the index leg: prior dvt * prior stent in target venous segment * treatment of index dvt with thrombolytics within 14 days prior to index procedure * pulmonary embolism (pe) defined as either high (systolic blood pressure \< 90 mmhg and/or patient on iv vasoactive medication to support blood pressure), or intermediate high-risk pe, as defined by the european society guideline on management of pe. low risk pe and/or intermediate low risk pe can be enrolled. * known coagulation disorders both acquired (e.g., heparin induced thrombocytopenia, etc.) or genetic (e.g., factor v leiden, etc.), thrombophilia, or hypercoagulable state * pregnant patients * life expectancy \<1 year due to comorbidities * primary brain, metastatic cancer or marrow malignancies * current participation in another investigational drug or device study that may confound the results of this study. studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies. * other medical, behavioral, or psychological conditions that, in the opinion of the investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study * pre-existing malpositioned stent(s) that obstructs the ostium of the index iliac vein and contacts the vena cava wall as demonstrated by venography prior to the index procedure * congenital anatomic anomalies of the ivc or iliac veins
correlation of changes in pao2 and ori in adult patients

Conditions: Hyperoxia

Summary: the oxygen reserve index (ori) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. an ori of 0.00 corresponds to pao2 values of 100mmhg and below and an ori of 1.00 corresponds to pao2 values of 200mmhg and above. this is a prospective, non-blinded, non-randomized study of the oxygen reserve index (ori) in a clinical setting. it is designed to evaluate the correlations with ori and changes in pao2 and the potential use of ori as an early warning of impending arterial oxygen desaturation.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * asa physical status iii or iv * scheduled for an elective surgical procedure requiring endotracheal intubation and the use of an arterial pressure monitoring catheter placed prior to induction of general anesthesia exclusion criteria: * age less than 18 years * adults unable to give primary consent * pregnancy * prisoners
should my new knee rotate?

Conditions: Arthritis of the Knee Joint

Summary: total knee arthroplasty (tka) is the surgical reconstruction of the knee joint in order to relieve pain, restore function and correct deformity. it is a very common surgical procedure with figures showing more than 500'000 arthroplasties performed annually worldwide. total knee arthroplasty is considered one of the most successful types of joint reconstruction in that surgical results usually meet and even exceed expectations. much of the current literature focuses on the issues relating to implant wear as a potential failure mode for artificial knee implants. it has been suggested that knee with mobile or rotating bearing options, such as the comparative device proposed for this clinical investigation, may survive longer than fixed bearing knee designs because of the greater contact surface area possible with more congruent components with unconstrained, mobile component design.

this is a prospective, comparative, randomised, open-label, single center, multiple surgeons clinical study. the scorpio ps superflex and the scorpio ps mobile bearing are to be implanted for evaluation in this study. patients will be randomised to one of two equal sized groups. in the first group patients will be treated with the scorpio ps superflex, whilst in the second group patients will be treated with the scorpio ps mobile bearing implant. evaluations consist of the kss score, chair rise and stair climb tests, radiology assessments, patient questionnaires, at multiple timepoints: pre-operative, 6 weeks, 3 months, 6 months 1 year, 2 years and 5 years post-operatively.

Eligibility criteria:
inclusion criteria: * patients requiring cemented primary total knee replacement. * patients with a diagnosis of osteoarthritis (oa), avascular necrosis (avn) or post-traumatic arthritis (ta) * patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation. * patient who have intact collateral ligaments. * patient who signed the ethics committee approved specific informed consent form prior to surgery. exclusion criteria: * patient where patella will not be resurfaced. * patients with active or suspected infection. * patients with a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. severe osteoporosis, paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. * the patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weightbearing or places an extreme load on the implant during the healing period. * patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule

Keywords: mobile bearing knee prosthesis
postoperative respiratory monitoring after neuraxial opioid administration for cesarean delivery

Conditions: Respiratory Depression

Summary: respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are given.pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia - is challenging to measure clinically.american society of anesthesiologist guidelines recommend suitable respiratory monitoring for 24 hours post cesarean delivery (cd). use of capnograph will enable us to assess breath-by-breathe respiration in a population receiving neuraxial opioids - potentially at risk for respiratory depression. our aim is to assess our ability to capture maternal postpartum respiratory parameters in a cohort following opioid neuraxial administration for cd.

the investigators wish to test the efficacy of capnograph in detection of apnea and respiratory depression in women following cesarean delivery. currently, routine intensive monitoring such as the investigators propose is not performed, and many apneas may go undetected.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status class i or ii * age between 18 and 45 * gestational age greater than 37 completed weeks * singleton pregnancy. exclusion criteria: * contraindication for neuraxial analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy) * allergies to postoperative medication (opioids, nsaids, acetaminophen) * chronic opioid use * opioid administration in the previous 12 hours * inability to adequately understand the consent form * blocked nose or nasal deformity.

Keywords: postoperative respiratory monitoring neuraxial opioid administration for cesarean delivery
24 hour plasma glucose profiles comparing lispro mix 75/25 vs. glargine

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine if twice-daily lispro low mixture (75/25) will result in lower post prandial blood glucose readings versus once-daily glargine plus oral diabetic medications.

the primary objective of this study is to test the hypothesis that a twice daily insulin regimen consisting of insulin lispro (mix 75/25)plus oams will result in a lower 2 hour postprandial plasma glucose, averaged across the morning and evening meals, compared with once daily insulin glargine plus oams at bedtime following 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * have type 2 diabetes * have inadequate overall glycemic control (hemoglobin a1c greater than or equal to 7.0% and less than or equal to 12.0%) at or within 4 weeks prior to visit 1 * have used: * single or multiple oams for at least 3 months immediately prior to entering the study, including metformin, sulfonylurea, meglitinides (repaglinide, nateglinide), or alpha glucosidase inhibitors (acarbose, miglitol); or * insulin (once or twice daily) for at least 3 months immediately prior to entering the study; or * a combination of the above. * are greater than or equal to 21 and less than 80 years of age * as determined by the investigator, are capable and willing to: * comply with their prescribed diet and medication regimen, * perform self blood glucose monitoring, * use the patient diary as required for this protocol, * participate in two 24 hour inpatient assessments exclusion criteria: * have used a thiazolidinedione (pioglitazone or rosiglitazone) during the 3 months prior to entry into the study * are currently treated with a meglitinide without sulfonylurea * have a known allergy or intolerance to insulin lispro mix 75/25, insulin glargine, or metformin * have plasma creatinine greater than or equal to 1.5 mg/dl (for males) or greater than or equal to 1.4 mg/dl (for females) for patients who will be treated with metformin or; greater than 2 mg/dl for patients treated with other oams, as determined by a local laboratory * have received chronic (lasting longer than 2 weeks), systemic glucocorticoid therapy (excluding topical and inhaled preparations) within 4 weeks immediately prior to visit 1

Keywords: diabetes diabetic insulin glargine lispro
comparison of nasal cpap and nasal simv in transient tachypnea of newborn

Conditions: Transient Tachypnea of Newborn

Summary: the investigators aimed to compare the efficacy of nasal simv and nasal cpap in patients with wet lung.

we aimed to compare two types of ventilatory support in cases of transient tachypnea of newborn who are \>35 gestational week.

Eligibility criteria:
inclusion criteria: * \>35 gestational week * wetlung exclusion criteria: * major congenital anomalies

Keywords: efficacy safety nasal simv nasal cpap infants who are >35 gestational week with wet lung
anesthesia for dental treatment in cardiac patients: lidocaine comparative study

Conditions: Arrhythmias; Anxiety

Summary: prospective, randomized double-blinded study to investigate hemodynamic changes in valvular cardiac patients during dental treatment with the use of a local anesthesia containing epinephrine.

patients with valvular disease constitute a group in which local anesthesia must be effective to avoid higher release of endogenous catecholamines that could trigger hemodynamic. the study was conducted in the dental department of the instituto do coração do hospital das clínicas da faculdade de medicina da universidade de são paulo (brazil). patients were allocated into two groups through an aleatory numbered table: pl (plain 2% lidocaine, n= 31) and le (2% lidocaine with 1:100.000 epinephrine, n= 28). the anesthetic amount was registered. dixtal monitor (são paulo- brazil) captured blood pressure, heart rate, oxygenation and electrocardiogram records.

Eligibility criteria:
inclusion criteria: * patients with acquired valvular disease exclusion criteria: * patients having platelets counting lower than 70.000 or inr \> 3

Keywords: anesthesia, local lidocaine dental care arrhythmias, cardiac anxiety
a clinical study evaluating the safety and efficacy of skg0106 in patients with neovascular age-related macular degeneration (namd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: this is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of skg0106 in subjects with namd.


Eligibility criteria:
inclusion criteria: 1. voluntary and able to sign a dated icf prior to any study-related procedures and able to complete the study as required by the protocol; 2. aged ≥ 50 years at screening; study eye: 3. diagnosis of namd as determined by the pi; 4. active cnv lesions secondary to age-related macular degeneration (amd); 5. subjects must have been responsive to anti-vegf therapy as assessed by the pi prior to study treatment exclusion criteria: 1. any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline; 2. retinal pigment epithelial tear in the study eye at screening; 3. current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline; 4. any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye; 5. history of retinal detachment or active retinal detachment in the study eye; 6. any prior gene therapy.

Keywords: amd wet amd wamd namd
thalidomide in treating patients with metastatic neuroendocrine tumors

Conditions: Gastrointestinal Carcinoid Tumor; Islet Cell Tumor; Lung Cancer; Neoplastic Syndrome

Summary: rationale: thalidomide may stop the growth of neuroendocrine tumors by stopping blood flow to the tumor. purpose: phase ii trial to study the effectiveness of thalidomide in treating patients who have metastatic neuroendocrine tumors.

objectives: * determine the safety and efficacy of thalidomide in patients with metastatic low-grade neuroendocrine tumors. outline: patients receive oral thalidomide once daily on weeks 1-8. courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 14-25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed low-grade neuroendocrine tumors * carcinoid tumors * islet cell tumors * metastatic disease * progression of disease within past 4 weeks by radiological evidence * at least 1 bidimensionally measurable lesion by ct scan or mri * bone metastasis not considered measurable if only site of disease * no active brain metastases patient characteristics: age: * not specified performance status: * karnofsky 70-100% life expectancy: * more than 3 months hematopoietic: * wbc at least 3,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin normal * ast no greater than 2.5 times upper limit of normal (uln) renal: * creatinine no greater than 1.5 times uln or * creatinine clearance at least 50 ml/min other: * not pregnant or nursing * negative pregnancy test * fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study * no grade 2 or greater neuropathy * no other clinical circumstances that would preclude study * no other prior malignancy except: * non-melanoma skin cancer * other cancer that has been curatively treated, has had no evidence of recurrence within the past 5 years, and is at low risk for recurrence prior concurrent therapy: biologic therapy: * no prior thalidomide * no concurrent interferon chemotherapy: * no concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy * no concurrent radiotherapy surgery: * at least 4 weeks since prior major surgery other: * no more than 1 prior systemic therapy regimen * at least 4 weeks since prior systemic therapy regimen * no other concurrent therapeutic agent

Keywords: metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor gastrinoma insulinoma recurrent islet cell carcinoma wdha syndrome somatostatinoma pancreatic polypeptide tumor glucagonoma pulmonary carcinoid tumor