Kornimate/medical-research-clean huggingface dataset:
solx titanium sapphire laser for trabeculoplasty

Conditions: Glaucoma; Glaucoma, Open Angle

Summary: use of the titanium sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.

this is a multi-center, outpatient study assessing equivalence of the titanium sapphire laser (tisalt) to the argon laser (alt) in the ability to reduce iop in patients having primary open angle glaucoma in eyes with poorly controlled iop on maximally tolerated medications and/or prior failed glaucoma surgery. approximately 120 patients are to be enrolled in the study, with approximately equal numbers of patients enrolled at each of the investigational sites. the investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy and/or patients with previously failed laser trabeculoplasty. one half of the eyes will be randomized to treatment with the argon laser (alt) as the concurrent control group and the other half will be treated with titanium sapphire (tisalt) laser.

Eligibility criteria:
inclusion criteria:clinical diagnosis of open angle glaucoma * patient is aged 18 years or older, with 2 sighted eyes. * eye to be treated have average iop greater or equal to 22 mmhg, measured at 2 pretreatment visits. * eye to be treated either exhibits: * poorly controlled open angle glaucoma and on maximal tolerated medical therapy * or poorly controlled open angle glaucoma and failed previous laser trabeculoplasty (180° available to treat if previous alt; can treat over previous slt) exclusion criteria: patients are not eligible for enrollment if any of the following exclusion criteria are met: * eye to be treated has any of the following: 1. evidence of glaucoma other than open-angle glaucoma; 2. severe paracentral or generalized field defect; 3. any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork. 4. prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy. * patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent. * patient is pregnant. * patient might require other ocular surgery within the 6-month follow-up period. * patient has a medical history that suggested the potential for complications from tisalt. * having concurrent treatment with systemic steroids.

Keywords: glaucoma glaucoma, open angle intraocular pressure trabeculoplasty laser laser, surgery
open-label extension study of setmelanotide

Conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway

Summary: this is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the mc4r pathway.


Eligibility criteria:
key inclusion criteria: * males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which rhythm plans further clinical development. * agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after. * demonstrated clinical benefit in the previous setmelanotide study, as determined by the investigator. key exclusion criteria: * any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the united states (i.e., patients eligible for commercial setmelanotide (imcivree®). * any new or worsening depression resulting in suicidal thoughts and/or behaviors. * discontinuation from a previous setmelanotide study. * history or close family history (parents or siblings) of melanoma. * pregnant and/or breastfeeding women other protocol defined inclusion/exclusion criteria may apply.

Keywords: setmelanotide rm-493 obesity melanocortin 4 receptor hypothalamic obesity
effect of different biomimetic materials on white spot lesions in enamel

Conditions: White Spot Lesion

Summary: this study will be conducted to evaluate: 1- the remineralizing effect of different biomimetic materials (zinc carbonate hydroxyapatite nanoparticles, poly-amido amine (pamam) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- the clinical efficacy of these agents on disappearance of these white spots.


Eligibility criteria:
inclusion criteria: * total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment. * these patients will be selected according to age groups between 15-25 years old * good oral hygiene * free of destroying habits for dental tissues exclusion criteria: * bruxism * soft drinks consumption * acid regurgitation, etc.). * selected teeth having any cracks, malformations, dysplasia or caries.
minimizing nausea and vomiting during spinals for cs

Conditions: Nausea; Vomiting

Summary: in parturients undergoing cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.

the hypothesis of this study is as follows: in parturients undergoing cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief. the study group will receive phenylephrine infusion \[dilution 100micrograms /cc\] rate of infusion 50micrograms /hour, approximately 30ml/hour to be started immediately after the placement of the spinal anesthetic patient will also be given .4mg \[1cc of glycopyrrolate\], with the starting of the infusion the control group, will receive phenylephrine infusion \[dilution 100micrograms /cc\] rate of infusion 50micrograms /hour, approximately 30ml/hour to be started immediately after the placement of the spinal anesthetic patient will also be given a placebo \[1cc of n saline\], with the starting of the infusion following the administration of the study drug/placebo, the patient will be monitored for severity of nausea , vomiting and pain at 5 minutes intervals from placement of the spinal to delivery of the baby, and then at 15 minutes intervals from delivery of the baby till the end of the surgery ( the cesarean section)

Eligibility criteria:
inclusion criteria: 1. pregnant 2. american society of anesthesiologists risk classification i and ii 3. age \> 18 years 4. non-laboring 5. patients with elective cesarean sections exclusion criteria: 1. non- english speakers 2. height \< 4' 11" 3. bmi \>40 kg/ mm 4. antiemetic drug use in the 24 hours prior to cesarean delivery, 5. hypertensive diseases of pregnancy 6. chronic hypertension receiving antihypertensive treatment 7. any other physical or psychiatric condition that may impair their ability to cooperate with study data collection.
phase i of infusion of selected donor nk cells after allogeneic stem cell transplantation

Conditions: Hematological Malignancy

Summary: the goal of our study will be to determine the clinical and biological safety of infusing immuno-selected nk (natural killer) cd3-/cd56+ cells, early after allogeneic transplantation with colony stimulating factor (g-csf) mobilized peripheral blood stem cells and reduced intensity conditioning (ric), as a potential substitute to usual "donor lymphocyte infusion" (dli), that contain the whole range of immune effectors. the trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-il2) activation of selected nk cells in vitro prior to re-infusion.

in the mid 90's, it has been shown that donor lymphocyte infusions (dli), when given for chronic myelocytic leukemia (cml) that has relapsed after conventional allogeneic stem cell transplantation (sct), result in a high incidence of durable cytogenetic and molecular remissions. however, regular documented effects are the occurrence of secondary aplasia and/or graft-versus-host disease (gvhd) including the post ric situation. these effects are related to the high content of cytotoxic t cells in the dli. attempts to deplete cd8+ t-cells from dli have been conducted with promising results but are not totally satisfactory. more recently the infusion of r-il2 ex-vivo activated autologous or allogeneic nk-selected cells have been studied and the safety established in patients presenting various malignancies. indeed, nk are thoroughly characterized in terms of genotype, phenotype and function. although a handful of clinical-grade reagents and devices exist that give access to the human nk cell compartment, an immuno-selection device exists that allows for the selection of nk cells from various types of hematopoietic cell collections in view of clinical applications: the process produces cd3-/cd56+ cells in two steps and have been used in the previous experiences.

Eligibility criteria:
inclusion criteria: 1. patient treated with allogeneic stem cell transplantation * presenting an hematological malignancy with an intermediate, high or very high risk index according to the disease risk index developed by the dana farber cancer institute * donor: hla matched related or unrelated (10/10) donor * graft: peripheral stem cell transplant * reduced intensity conditioning as used in the current transplant program: fludarabine, iv busulfan and thymoglobuline 2. age above 18 and under 70 3. eastern cooperative oncology group (ecog) 0-1 or karnofsky index ≥ 70 % 4. survival expectation \> 6 months 5. affiliation to social security 6. signed informed consent from donor and patient exclusion criteria: 1. active grade \>= 2 acute gvhd or corticotherapy ≥ 0.5 mg/kg/day at time of nk cell infusion 2. active infection 3. psychiatric disorder occurring after transplant 4. pregnant or breast-feeding women or without contraception

Keywords: hematological malignancy stem cell transplantation
safety and efficacy study of jtt-705 in combination with simvastatin 40 mg in patients with low high-density lipoprotein (hdl) levels

Conditions: Dyslipidemia

Summary: the purpose of this study is to evaluate safety of jtt-705 and to demonstrate efficacy of jtt-705 compared with placebo when co-administered with simvastatin 40 mg in patients with low hdl


Eligibility criteria:
inclusion criteria: * patients having lipid values as indicated below: * hdl-c ≤ 1.0 mmol/l (40 mg/dl) * tg ≤4.5 mmol/l (400 mg/dl) * patients with chd or chd risk equivalent * male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception) exclusion criteria: * body mass index of ≥ 35 kg/m2 * females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception * concomitant use of medications identified in the protocol
recognition and early intervention for alcohol and substance abuse in adolescence in adolescent

Conditions: Alcoholism; Substance Abuse; Alcohol Dependence; Alcohol-Related Disorders; Substance Use Disorders; Adolescent Behavior; Adolescent Problem Behavior

Summary: assist mini-intervention is applied in an electric form in adolescent outpatients to see if it

all 14-20-year-old patients admitted to the kuopio university hospital (kuh) adolescent psychiatric outpatient clinic during 2017-2028 are requested to participate. at admission (baseline), the patients are interviewed by the research nurse and asked to fill out questionnaires. the interview includes a semi-structured diagnostic interview (scid). the participants are interviewed again in six months (follow-up), and the interview is identical to the one conducted in the admission phase.

Eligibility criteria:
inclusion criteria: admitted to the kuopio university hospital (kuh) adolescent psychiatric outpatient clinic during the years 2016-2019 exclusion criteria: unable to understand the questionnaires

Keywords: alcohol substance abuse mini-intervention adolescent
early detection of multiple myeloma to fight cancer disparities: a screening and patient navigation program

Conditions: Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Summary: this project will pilot the expansion of the existing taussig outreach program's community outreach and patient navigation model to study the multiple myeloma (mm) screening program. this involves analyzing community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. this study also aims to gauge the current and general understanding of mm. this study seeks to recruit participants in the pilot screening program to promote early detection. participants who have abnormal results will receive patient navigation for further diagnostics and testing.

multiple myeloma (mm) is a hematologic cancer of antibody-producing plasma cells. multiple myeloma is always preceded by a pre-malignant condition called monoclonal gammopathy of undetermined significance (mgus) or smoldering multiple myeloma. despite multiple therapeutic advances, there remains no cure for multiple myeloma. the disease is treated and monitored throughout a person's lifetime. this is why screening for early detection of this disease is important; however, mgus and smoldering multiple myeloma are only diagnosed when they are found incidentally on labs during tests for unrelated symptoms. there are no current universal screening guidelines for mm. among those who may benefit from mm screenings include african american/black individuals, as it is twice as common in this population compared to caucasian/white individuals. this study aims to develop a screening program specifically targeting underserved african american/black individuals. this project will expand the existing taussig community outreach screening program to include screening for multiple myeloma.

Eligibility criteria:
inclusion criteria: * participant self-identifying as, or perceived as, black and/or african-american * 50 years of age or older exclusion criteria: * participants who do not self-identify as black and/or african american * under the age of 50 years
support via online social networks to promote safe infant care practices

Conditions: Breastfeeding; Infant Death; Sudden Infant Death Syndrome Without Mention of Autopsy

Summary: this study aims to improve adherence to american academy of pediatrics safe sleep (ss) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (bf); and reduce black/white disparities in these practices through the use of private facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant wic clients and new parents.


Eligibility criteria:
inclusion criteria: * currently enrolled in wic, or it not, then have either medicaid or no health insurance * must be english speaking * must be pregnant and less than 30 weeks gestation * must live in the united states * must have regular access to facebook and short message service (sms) texting (mobile phone) exclusion criteria: * not planning to live in same home as infant after birth. * prenatal diagnosis expected to impact on infant care practices in a manner not compatible with study goals, including contraindications to feeding any breastmilk or supine infant sleep positioning. * known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process. * meets the definition of a minor according to applicable state law. * participants who consent to participation in the study, must complete the agile onboarding process before they reach 30+0 weeks gestation. * currently or previously received a todaysbaby educational program (randomized to a todaysbaby program through either the smarter, or supersonic study), either in their current or a previous pregnancy.

Keywords: safe sleep breastfeeding social media
exablate blood-brain barrier disruption with carboplatin for the treatment of rgbm

Conditions: Recurrent Glioblastoma

Summary: the purpose of this study is to evaluate the safety and feasibility of the exablate model 4000 type 2 system when used as a tool to open the blood-brain-barrier (bbb) in subjects with recurrent glioblastoma (rgbm) undergoing carboplatin monotherapy.

this is a phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (bbbd) combined with intravenous carboplatin for the treatment of rgbm using the exablate neuro model 4000 type 2 system. adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. eligible subjects will undergo up to 6 cycles of exablate bbbd procedures in conjunction with carboplatin chemotherapy.

Eligibility criteria:
inclusion criteria: * must be between 18-80 years old * histologically confirmed glioblastoma * planned for carboplatin monotherapy * be willing and able to provided written informed consent/assent * tumor progression after first line therapy * recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy * women of childbearing potential is confirmed not pregnant. male and female subjects utilize highly effective contraception * able to communicate verbally exclusion criteria: * acute intracranial hemorrhage * ferrous metallic implanted objects in the skull or brain * prior toxicity with carboplatin chemotherapy * women who are pregnant or breastfeeding * cerebellar spinal cord or brain stem tumor * known active hepatitis b or hepatitis c or hiv * significant depression not adequately controlled * cardiac disease or unstable hemodynamics * severe hypertension * history of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage * active drug or alcohol use disorder * known sensitivity to gadolinium-based contrast agents * known sensitivity or contraindications to ultrasound contrast agent or perflutren * unable to undergo mri or contraindications to mri such as non-mri compatible implanted devices * difficulty lying supine and still or severe claustrophobia which cannot be managed with medication * severely impaired renal function * right to left or bi-directional cardiac shunt * cranial or systemic infection requiring antibiotics * known additional malignancy that is progression or require active treatment

Keywords: exablate focused ultrasound carboplatin
sleep assessment in cml

Conditions: Sleep Disorder; Chronic Myeloid Leukemia

Summary: patients with cml report on fatigue, and many of them report on sleep disturbances. the investigators wish to objectively assess the patient's sleep using a sleep "wrist watch" (actigraph) , and correlate data with their perception of sleep quality. a matched participants group will serve as control. the control group is defined as participants not having cml or any other malignancy and without any known sleep disturbances.

the investigators will contact the cml patients cohort (about 50) and ask them to join the study. those consenting will be briefed on the use of an actigraph wrist device, which the patients should wear for a week. in addition, patients will fill quality of life, depression and anxiety questionnaires. during the assessment week they will be asked to fill in a short "sleep diary" to be correlated with the objective actigraph results. the investigators will analyze objective data and compare to the subjective report of patient's sleep and compare these results with a matched cohort of the control participants. the investigators will analyze the quality of life, anxiety and depression scores also. the main objective of the study is to try and find a correlation between cml and sleep disturbances, several previous studies found sleep disturbances in reported questionnaires, but the sleep parameters were never studied objectively. also most of the studies concentrated on the fatigue as the main symptom, in our study the investigators will focus on sleep quality and quantity as a primary symptom. the quality of life questionnaire will be whoqol-bref questionnaire. the anxiety questionnaire will be hamilton anxiety rating scale. the depression questionnaire will be beck depression inventory. the sleep watch that will be used is called actigraph/actiwatch and it is fda approved device, this device will help the investigators assess and observe the objective sleep parameters like length of sleep, time to fall asleep, number of awakenings at night. there will be no intervention in the study, the results will not alter the treatment the patients receive. but if some patients will be found to have a severe depression or anxiety they will be referred to psychiatric consult. the study will be with the collaboration of professor iris haymov, sleep researcher from the max stern academic college of emek yezreel.

Eligibility criteria:
inclusion criteria: * cml patients * without known sleep disturbances that are not related to the disease exclusion criteria: * malignancy other than cml * known sleep disturbances * pregnant women
effect of dried fruit on cardiometabolic risk factors

Conditions: Cardiovascular Diseases; Metabolic Syndrome

Summary: this is a 2-period randomized crossover study with free-living subjects on self-selected diets. the objective of this study is to compare the effects of ¾ cup of a blend of dried plums, figs, dates and raisins (dpfdr) with an isocaloric and macronutrient matched snack food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who are representative of the u.s. population and at risk for cardiovascular disease (overweight/obese, elevated ldl-cholesterol, prehypertension, and/or prediabetes). the investigators hypothesize that the inclusion of dpfdr in the diet will decrease blood pressure and ldl-cholesterol, and improve artery function (assessed by standard blood pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial stiffness) compared to the control group and baseline.


Eligibility criteria:
inclusion criteria: * body mass index of 25-36 kg/m2 and, at least one of the following: * ldl-c above 116 mg/dl (3.0 mmol/l) * systolic blood pressure 120-159 mmhg * diastolic blood pressure 80-99 mmhg * increased waist circumference: ≥94 cm for men and ≥80 cm for women * elevated glucose (≥ 100 mg/dl and \< 126 mg/dl) * triglycerides: above 150 mg/dl (1.69 mmol/l) and below 350 mg/dl (3.95 mmol/l) * low hdl-cholesterol: \<40 mg/dl (\< 1.03 mmol/l) for men and \< 50 mg/dl (\<1.29 mmol/l) for women) exclusion criteria: * allergies to the test foods * history of cardiovascular disease, stage ii hypertension (bp 160/100 mmhg), kidney disease, diabetes or inflammatory diseases such as gastrointestinal disorders and rheumatoid arthritis * use of medication/supplements for elevated lipids, blood pressure, or glucose