Kornimate/medical-research-clean huggingface dataset:
phase ii study of dietary cholesterol for smith-lemli-opitz syndrome

Conditions: Smith-Lemli-Opitz Syndrome

Summary: objectives: i. examine the intestinal absorption of dietary cholesterol in patients with smith-lemli-opitz syndrome. ii. measure the effect of dietary cholesterol on plasma sterol composition. iii. quantify basal cholesterol synthesis, turnover of cholesterol and 7-dehydrocholesterol, and the effects of dietary cholesterol on these parameters. iv. identify fecal bile acid excretion quantitatively and qualitatively in these patients. v. compare the incorporation of deuterated water into plasma cholesterol, 7-dehydrocholesterol, and other intermediates, and assess the effect of dietary cholesterol on this incorporation.

protocol outline: patients are treated with 2 dietary regimens for 1 to 3 weeks: high cholesterol and cholesterol-free. cholesterol is provided in the form of egg yolk. the absorption and metabolism of cholesterol are evaluated with plasma and fecal studies. deuterated water is given to patients followed by analysis of deuterium in plasma cholesterol and other intermediates, including 7-dehydrocholesterol.

Eligibility criteria:
protocol entry criteria: smith-lemli-opitz syndrome

Keywords: smith-lemli-opitz syndrome genetic diseases and dysmorphic syndromes rare disease
assessing the efficacy of virtual reality analgesia (vra) in adult patients for pain control during spinal injections (si)

Conditions: Pain

Summary: a three-group parallel randomized controlled trial to evaluate the efficacy of virtual reality analgesia (vra) to decrease patient procedural pain and anxiety in the adult patients undergoing spinal injections (si).


Eligibility criteria:
inclusion criteria: * adult requiring spinal injections * adult \> 18years * adults with intact vision who can attend vr intervention exclusion criteria: * anyone \< 18 years * adults who are not attentive to vr secondary to poor concentration, poor cognition to external stimuli * adults who request moderate iv sedation * adults with photic-induced seizures

Keywords: virtual reality spinal injection adult analgesia google cardboard oculus
improving african american glaucoma patient involvement in visits and outcomes

Conditions: Glaucoma

Summary: this is a research project about services provided to african american patients with glaucoma. the goal of the project is to improve communication between providers and african-american patients about glaucoma.


Eligibility criteria:
inclusion criteria: * african american * age 18 or older * able to speak and read english * mentally competent to participate * not blind (are at least 20/400 in their better seeing eye) * on one or more glaucoma medications * report being less than 80% adherent to their glaucoma medications on a visual analog scale exclusion criteria: * \< 18 years of age
iron deficiency anemia, iron supplementation and genomic stability in infants

Conditions: Anemia; Iron-deficiency

Summary: this study compares weekly versus daily administration of iron for prevention of anemia in 6 months old infants. one third of the infants that are exclusively breast fed will not receive iron, the second third will receive iron weekly and the last third will receive iron daily. half of the infants that take infant formula will receive iron weekly and the other half will receive iron daily.

iron deficiency is the most prevalent nutritional deficiency and the main cause of anemia. it's estimated that 43% of pre-school children worldwide are anemic, in argentina a national survey carried out in 2007 (last survey), showed that 34.5% of children less than 2 years old were anemic and that 50.8% of children 6 to 9 months old were anemic. although there is a consensus on iron supplementation as a preventive strategy for anemia in infants, there is a poor adherence due mainly to mild gastrointestinal adverse effects and low prescription rates from pediatricians. on the other hand, the excess of iron can lead to genomic instability with structural and functional alterations on proteins, lipids and dna. weekly administration of iron has been proposed as an alternative of similar efficacy and higher effectiveness in older children and pregnant women, but sufficient evidence for infants is lacking.

Eligibility criteria:
inclusion criteria: * 3 months old infants, clinically healthy, born to term (\>37 weeks), that weighted at birth between 2500 and 4000 g, that have normal prenatal records. exclusion criteria: * anemic or iron deficient infants, or that have a chronic pathology, or that have undergone an acute pathology in the previous 15 days. children that are receiving antibiotics or vitamin supplements.

Keywords: infant primary prevention
central mechanisms of intervention for low back pain

Conditions: Low Back Pain

Summary: body-based interventions have consistently shown clinical effectiveness in patients with back pain. the primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. participants will be randomly assigned to receive one of the interventions or be in a control group. the central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. the completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.

170 participants will be randomly assigned to receive one of the interventions or be in a control group. the investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. the investigators will collect fmri and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.

Eligibility criteria:
inclusion criteria: * aged 18 to 40 years * able to read and understand spoken english exclusion criteria: * previous participation in a conditioning program specific to trunk extensors in the past 6 months * any report of back or leg pain in the past 3 months * any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder * history of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction * consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation * performance of any intervention for symptoms induced by exercise and before the termination of their participation or the protocol * recent illness * any contraindication to mri e.g.: pacemakers, metal implants which are not mri compatible (e.g. aneurysm clip), pregnancy and severe claustrophobia.

Keywords: spinal manipulation body-based intervention experimental pain
clinical and functional outcome of the gemini sl fixed bearing ps knee prosthesis

Conditions: Osteoarthrosis of Knee

Summary: this is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the gemini sl fixed bearing ps knee prosthesis in longterm follow-up under routine conditions. primary outcome of the study is the 10-year survival rate of the gemini sl fixed bearing ps knee prosthesis with revision for any reason as the endpoint.

the gemini sl fixed bearing ps knee prosthesis combines clinical proven design features with state-of-the-art-technology in order to achieve a high standard clinical performance, surgical efficiency and safety. currently, no mid- and longterm clinical data are available for the gemini sl fixed bearing ps knee prosthesis. therefore, the study is designed to generate clinical data of the gemini sl fixed bearing ps knee prosthesis in the 10-year follow-up under routine condition.

Eligibility criteria:
inclusion criteria: * signed patient informed consent * implantation of a gemini sl fixed bearing ps knee prosthesis * age between 18 and 80 years exclusion criteria: * body mass index (bmi) \> 40 kg/m² * foreseeable life expectancy under 5 years * comorbidities and known medical circumstances which would affect the clinical or functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation * patient who is mentally not able to understand the study and the study conduct * patients who will be foreseeable non-compliant to the planned routine interventions and study related follow-ups * prisoner * pregnant women
study to evaluate treatment of dabrafenib plus trametinib in subjects with braf mutation-positive melanoma that has metastasized to the brain

Conditions: Melanoma and Brain Metastases

Summary: this is a multi-cohort, open label, phase ii study with dabrafenib (gsk2118436) and trametinib (gsk1120212) combination therapy in subject with braf mutation-positive melanoma that has metastasized to the brain. this study will evaluate the safety and efficacy of 4 cohorts. cohorts will consist of; v600 e, d, k, r mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ecog scores from 0-2.


Eligibility criteria:
inclusion criteria: * ecog performance status range of 0-2 * histologically confirmed cutaneous metastatic melanoma of v600 e, k, d or r. * may be systemic naïve or received up to two previous systemic treatment regimens for metastatic melanoma. * must be able to undergo mri and have at least one measurable intracranial lesion for which specific criteria have to be met. exclusion criteria: * prior treatment with any braf inhibitor or any mitogen-activated protein/extracellular signal-regulated kinase inhibitor. * anti-cancer therapy or investigational anti-cancer therapy or chemotherapy without delayed toxicity within treatment specific timeframe. * treatment with stereotactic radiosurgery or treatment with whole-brain radiation within treatment specific timeframe. * any presence of leptomeningeal disease or any parenchymal brain metastasis * history of another malignancy, some exceptions may apply. * a history or evidence of cardiovascular risk- specific criteria have to be met * a history or current evidence/risk of retinal vein occlusion or retinal pigment epithelial detachment - specific criteria have to be met.

Keywords: braf v600k mutation metastatic melanoma braf v600r mutation braf v600d mutation braf v600e mutation brain metastases braf inhibitor intracranial
additional glp-1 analogue on csii treatment for poorly controlled type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: background: continuous subcutaneous insulin infusion (csii) has been demonstrated to be an effective clinical tool for intensive insulin therapy in type 1 diabetic patients. type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (glp-1) levels. injection of glp-1 receptor agonists are associated with improved glycemic control. nevertheless, the clinical effects and mechanisms are still unclear when additional supplement of glp-1 analogue in cooperation with intensive csii treatment for poorly controlled type 2 diabetes patients. this study is designed to understand the complementary pharmacological effects of glp-1 analogue on intensive csii treatment. methods: sixty poorly controlled type 2 diabetes patients will be admitted to the ward for 6 days csii intensive treatment. following the normalization of blood glucose at first 3 days, the patients are randomly assigned with combined therapy with exenatide injection or saline for another 3 days. the clinical assessments of insulin requirement, insulin secretion, insulin resistance glycemic excursions and cytokines will perform immediately during or after the study.

in the poorly controlled type 2 dm, insulin therapy is the treatment of choice to make sugar on target. actually, however, the general control rate is not good and partially due to the complex etiology in type 2 dm. glp-1 deficiency is the mostly emphasized in modern practice. in order to study the effect of glp-1 analogue in insulinized type 2 dm patients, investigators have to optimize the insulin therapy in the first priority. continuous subcutaneous insulin infusion (csii) or insulin pump is a viable choice for patients with type 1 or type 2 dm who want close-to-physiologic insulin treatment. by means of the insulin pump therapy, standardized sugar control profile in type 2 dm patients could be achieved in a short time. investigators can further evaluate the clinical response under glp-1 analogue or not.

Eligibility criteria:
inclusion criteria: * age \> 20 years old * dm diagnosed \> 2 years * hba1c level of 8% to 12% * receiving insulin premixed insulin twice daily and total insulin daily dose \> 0.6 u/kg/day exclusion criteria: * severe comorbidity, including chf, cva, liver cirrhosis, copd, cushing's syndrome etc. * psychologic problems, including anxiety * incorporation, including personal and familial factors

Keywords: glp-1 analogue csii insulin type 2 diabetes mellitus
a study to evaluate and compare injections of autologous dermal and epidermal cells into the balding scalp of subjects with hair loss (ca-0002012)

Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Summary: to evaluate the ability of injections of ji gami(tm) and ji gami(tm) do to induce hair growth in male and female subjects with hair loss


Eligibility criteria:
inclusion criteria: * male and female volunteers 18 to 65 years old, inclusive * hair loss consistent with ≥ grade iii-vertex, iv, va, v, and vi, based on norwood-hamilton scale providing there is bridging of hair in the anterior edge of the vertex circle. * have no clinically significant disease or abnormal laboratory results taken at the screening visit. exclusion criteria: * known sensitivity to dmem/f-12 or any component of the study material. * known hypersensitivity to clindamycin hydrochloride, amphotericin b or streptomycin sulfate. * subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening. * a history of drug or alcohol abuse within 1 year of study enrollment. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * any clinically significant abnormal laboratory parameters. * a positive result at screening for human immunodeficiency virus (hiv 1 or 2), hepatitis b or c, htlv i/ii. * dermatologic condition in donation and/or study areas. * prior surgery in the treatment area. * insufficient hair or scarring in the donor area that might impact cell growth. * any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Keywords: androgenetic alopecia male pattern baldness female pattern baldness hair loss baldness
ultrasound-guided peng block vs femoral nerve block for analgesia before spinal anesthesia in hip fracture surgery

Conditions: Proximal Femur Fracture; Hip Fracture; Pain Management; Spinal Anesthesia

Summary: this study will compare two types of ultrasound-guided nerve blocks-pericapsular nerve group (peng) block and femoral nerve block (fnb)-to evaluate their effectiveness in reducing pain before spinal anesthesia in patients who will undergo surgery for proximal femur fractures. proximal femur fractures will continue to be common, especially in older adults, and often will cause severe pain that will make it difficult to position patients for spinal anesthesia. both nerve blocks will aim to reduce pain, improve comfort during spinal anesthesia, and decrease the need for postoperative pain medication. a total of 60 adult patients who will undergo proximal femur fracture fixation under spinal anesthesia will be enrolled and randomly assigned to receive either a pericapsular nerve group (peng) block or a femoral nerve block before the procedure. the study will monitor patients' pain scores using the visual analog scale (vas) at multiple time points, including during positioning and throughout the first 24 hours after surgery. it also will evaluate how long it will take before the patients require rescue pain medication, and how much total pain medication will be needed.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * scheduled for proximal femur fracture fixation under spinal anesthesia * classified as american society of anesthesiologists (asa) physical status i, ii, or iii * ability to understand and use the visual analog scale (vas) * provided written informed consent exclusion criteria: * coagulopathy * local infection at the injection site * known allergy to local anesthetics or magnesium sulfate * severe cardiopulmonary disease \[american society of anesthesiologists (asa) ≥ iv\] * preexisting diabetic or other neuropathies * chronic opioid use * contraindication to spinal anesthesia * cognitive impairment or inability to comprehend visual analog scale (vas)

Keywords: pericapsular nerve group block (peng) femoral nerve block (fnb) ultrasound-guided nerve block spinal anesthesia hip surgery regional anesthesia
a real-world study of chidamide in combination with pd-1/pd-l1 antibodies and anti-angiogenic agents in advanced mss colorectal cancer

Conditions: Colorectal Cancer Metastatic

Summary: this is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in microsatellite stable advanced colorectal cancer patients.


Eligibility criteria:
inclusion criteria: 1. aged≥18 years 2. histology-confirmed metastatic crc (mcrc); 3. ecog 0\~2 4. at least one efficacy evaluation 5. life expectancy of at least 3 months. exclusion criteria: 1. lack of follow-up data. 2. chidamide stopped after less than two cycles. 3. serious comorbidities that interfere with the efficacy or safety analysis
multisite virtual reality intervention for speech anxiety

Conditions: Public Speaking; Speech Anxiety

Summary: exposure-based cognitive behavior therapy is an efficacious treatment for speech anxiety and has been delivered effectively in a virtual reality (vr) environment. the present multicenter study (conducted through the exposure therapy consortium) is designed to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism.

the goal of this multicenter clinical trial is to examine predictors of vr exposure therapy outcomes for college students with public speaking anxiety following a positive or negative mood induction. the overarching aim of the present study is to evaluate whether trait versus state positive affectivity is a more effective predictor of exposure therapy outcomes. further, the investigators will examine whether the predictive significance of trait positive affectivity can be accounted for by examination of baseline levels of self-efficacy, hope, and optimism. state affect is manipulated at an experimental level with affect induction procedures; trait positive affectivity is measured at baseline. the study involves three phases: (1) initial screening, (2) in-person assessment and brief exposure intervention for a subset of participants with elevated public speaking anxiety, and (3) a one-week follow-up assessment conducted online. students who choose to participate and screen high on a public speaking anxiety scale will be assigned to a positive or negative mood induction condition prior to undergoing vr-based exposure therapy. public speaking and social anxiety outcomes are measured immediately post-intervention and one week later. the one-week follow-up assessment represents the primary outcome.

Eligibility criteria:
inclusion criteria: * self-report of 18 - 70 years of age * current student at a participating university * ability to read english to provide informed consent * familiarity with a computer keyboard and mouse or a touch screen device (e.g. phone, tablet). * for phase 2: speech anxiety scale score of ≥ 18 on the personal report of communication apprehension, public speaking subscale (prca-ps) exclusion criteria: * previous participation (i.e., no participant may take the survey more than once).
a double-blind, placebo-controlled study of levetiracetam in epilepsy patients with generalized tonic-clonic seizures (except partial seizures evolving to secondarily generalized seizures)

Conditions: Epilepsy; Generalized Tonic-Clonic Seizures

Summary: the purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in japanese and chinese epilepsy patients aged ≥16 years and with uncontrolled generalized tonic-clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.


Eligibility criteria:
inclusion criteria: * an epilepsy patient with generalized tonic-clonic seizures that are classifiable according to the ilae classification of epileptic seizures (epilepsia, 1981) * a patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to and during the combined baseline period exclusion criteria: * presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures * diagnosis of lennox-gastaut syndrome * confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imagining features * a history of convulsive or non-convulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to visit 1

Keywords: levetiracetam epilepsy generalized tonic-clonic