Kornimate/medical-research-clean huggingface dataset:
a study to compare analyte levels in blood collected using an investigational collection device with a commercial predicate

Conditions: Diabetes; Anemia

Summary: this study will compare blood collection from the forearm using an investigational device, tap20-c to blood collection from the finger tip. the blood collected from the forearm and from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin a1c.


Eligibility criteria:
inclusion criteria: healthy subject group 1. male and female volunteers 18 years of age or older. 2. voluntary written consent to participate in this study. diabetic subject group 1. male and female volunteers 18 years of age or older. 2. have been diagnosed with type 1 or type 2 diabetes mellitus by self-report. 3. voluntary written consent to participate in this study. exclusion criteria: 1. subjects who are pregnant or nursing mothers by self-report. 2. subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins. 3. subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested. 4. subjects with a missing index or middle finger on either hand or a missing forearm 5. subjects who have known allergies to titanium.
clinical performance of two frequent replacement silicone hydrogel multifocal contact lenses

Conditions: Presbyopia

Summary: the purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational lid233309 contact lenses and oasys multifocal (mf) contact lenses in a daily wear dispensing trial.

subjects will be expected to attend 7 office visits for an individual duration of participation of 28 to 40 days.

Eligibility criteria:
key inclusion criteria: * current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months. * manifest cylinder equal to or less than 0.75 diopter (d) in each eye. * able to wear contact lenses within the available power range with a near add of +0.75 d to +2.50 d in each eye. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * currently pregnant or lactating. * history of amblyopia, strabismus, or binocular vision abnormalities. * habitual oasys mf contact lens wearers or daily disposable contact lens wearers. * monovision contact lens wearers and wearers of contact lens in one eye only. * other protocol-defined exclusion criteria may apply.

Keywords: multifocal myopia hyperopia
safety and efficacy study of jtt-705 in combination with atorvastatin 20 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 atorvastatin 20 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
ganitumab in locally advanced unresectable adenocarcinoma of the pancreas

Conditions: Adenocarcinoma of the Pancreas; Locally Advanced; Unresectable

Summary: this study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of amg 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. approximately 150 subjects will be randomized in a 1:1 ratio to amg 479 and gemcitabine, or gemcitabine and placebo. randomization will be stratified by ecog (0 or 1). gemcitabine will be given on days 1, 8, and 15, followed by amg 479 on days 1 and 15 of every 28 day cycle. treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

this study is a phase 2, multicenter, randomized, double-blind, active placebo-controlled trial of amg 479 or placebo in combination with gemcitabine as first-line therapy for locally advanced unresectable adenocarinoma of the pancreas. approximately 150 subjects will be randomized in a 1:1 ratio to amg 479 and gemcitabine, or gemcitabine and placebo. randomization will be stratified by ecog (0 or 1). gemcitabine will be given on days 1, 8, and 15, followed by amg 479 on days 1 and 15 of every 28 day cycle. treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or start of a new anti-cancer therapy.

Eligibility criteria:
inclusion criteria: * subjects must have histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is unresectable, per institutional practice * radiologically measurable and/or non-measurable disease as defined by recist version 1.1 * eastern cooperative oncology group (ecog) score of 0 or 1 * men or women \>/= 18 years of age * adequate organ function exclusion criteria: * early (stage i) or metastatic (stage iv) disease * islet cell, acinar cell carcinoma, non-adenocarcinoma, (eg, lymphoma, sarcoma, etc), adenocarcinoma originating from biliary tree or cystadenocarcinoma * external biliary drain * currently treated or previously treated with biologic, small molecule, immunotherapy, chemotherapy (ie, including gemcitabine), or other agents for pancreatic cancer * currently treated or previously treated with radiotherapy, or chemoradiotherapy for pancreatic cancer

Keywords: adenocarcinoma pancreas pancreatic cancer local unresectable stage ii stage iii
ecv - epihunter clinical validation

Conditions: Absence Seizures; Absence Epilepsy

Summary: the goal of this prospective study is to validate a wearable eeg seizure detection solution compared to video eeg. subjects that undergo a clinical video eeg are asked to additionally wear a wearable eeg headband for up to 2 periods of 4h during the video eeg.


Eligibility criteria:
inclusion criteria: * subjects should have an indication of having absence seizures * subjects should be admitted for video eeg monitoring as part of their clinical practice * age \> 4 years exclusion criteria: * head circumference should be compatible for wearable eeg device (40-70cm) * the subject should be able to understand instructions and refrain from removing the device from its head
a study to evaluate the safety and effectiveness of the cryo-touch ii device for the treatment of forehead and/or glabellar lines

Conditions: Facial Wrinkles; Skin Aging

Summary: a prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of the cryo-touch ii device for the treatment of forehead and/or glabellar lines


Eligibility criteria:
inclusion criteria: 1. subject is a male or female, 30 to 70 years old. 2. subject is willing and able to give written informed consent. 3. subject has a forehead wrinkle rating by the investigator/designee of at least "2" in animation on the 5-point wrinkle scale (5ws) which upon physical manipulation/separation of the skin demonstrates a reduction in wrinkle severity. subject may also have a glabellar score of "1" or higher in animation on a 4-point scale. 4. subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study. 5. subject is in good general health and free of any disease state or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation. exclusion criteria: 1. subject is currently enrolled in an investigational drug or device study. 2. subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device. 3. subject has a clotting disorder or has used an anticoagulant (e.g., coumadin, clopidogrel, etc.) within seven (7) days prior to administration of the device. 4. subject has used aspirin, or non-steroidal anti-inflammatory drugs (nsaids, e.g., ibuprofen, and naproxen) within seven (7) days prior to administration of the device. 5. subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites. 6. subject has undergone another facial cosmetic procedure at or above the level of the cheekbones within the past six (6) months. 7. subject has any of the following conditions: 1. history of facial nerve palsy, 2. marked facial asymmetry, 3. ptosis, 4. history of neuromuscular disorder, 5. chronic dry eye symptoms, 6. allergy or intolerance to lidocaine, 7. other local skin condition (e.g., skin infection) at target treatment site, 8. any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation. 9. chronic medical condition that in the investigator's opinion would affect study participation (such as diabetes, hepatitis, hiv, etc.). 10. any chronic condition contraindicated for the use of nerve mapping device including heart disease, use of a cardiac pacemaker, and pregnancy. 8. subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
safety and effectiveness of juvéderm® voluma xc injectable gel for cheek augmentation

Conditions: Mid-facial Volume Deficit Related to Aging

Summary: multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of voluma xc for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.


Eligibility criteria:
inclusion criteria: * male or female, 35-65 years of age * zygomaticomalar region, anteromedial cheek, submalar region, and/or overall mid-facial volume deficit assessed by the treating investigator as grade 3, 4, or 5 on the photometric mid-face volume deficit scale (mfvds) * desire cheek augmentation to correct age-related volume deficit in the mid-face * accept the obligation not to receive any other facial procedures or treatments affecting facial volume deficit at any time during the study exclusion criteria: * received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs \[oral/injectable corticosteroids or non-steroidal anti-inflammatory drugs (nsaids)\], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection \[study device injections may be delayed as necessary to accommodate this 10-day wash-out period.\] * have undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures at any time during the study * have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study * have begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the treatment area within 90 days prior to enrollment or be planning to begin use of such products at any time during the study. * have very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads * have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy, partial lipodystrophy, inherited disease, or hiv-related disease * have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine (or any amide-based anesthetic), hyaluronic acid products, or streptococcal protein, or have plans to undergo desensitization therapy during the term of the study * have noticeable acne scarring, an active inflammation, infection, cancerous or pre-cancerous lesion, or unhealed wound or have undergone radiation treatment in the area to be treated
study of lenacapavir and emtricitabine/tenofovir disoproxil fumarate (f/tdf) for prevention of hiv in people who inject drugs (hptn 103)

Conditions: Pre-Exposure Prophylaxis of HIV Infection

Summary: the goals of this clinical study are to look at how lenacapavir (len) passes through the body and to assess the safety of len and emtricitabine/tenofovir disoproxil fumarate (f/tdf) for pre-exposure prophylaxis (prep) in people who inject drugs (pwid) in the united states (us). the primary objectives of this study are to characterize the pharmacokinetics (pk) of len and to evaluate the safety of len and f/tdf for prep in us pwid.


Eligibility criteria:
key inclusion criteria: * urine drug screen positive for any drug of misuse including, but not limited to, opioids (eg, fentanyl, heroin), stimulants (eg, cocaine, amphetamines), psychoactive drugs (eg, benzodiazepines), or a combination of these drugs. * evidence of recent injection (eg, track marks). * self-report of injection paraphernalia sharing in the prior 30 days. * hepatitis b virus (hbv) surface antigen (hbsag) negative. * negative local rapid hiv-1/2 antibody (ab)/antigen (ag) test, central hiv-1/2 ab/ag, and hiv-1 rna quantitative nucleic acid amplification testing (naat). * estimated glomerular filtration rate (gfr) at least 60 ml/min at screening according to the cockcroft-gault formula for creatinine clearance (clcr). key exclusion criteria: * self-reported history of previous positive results on an hiv test. * any reactive or positive hiv test result at screening or enrollment, even if hiv infection is not confirmed. * coenrollment in any other interventional research study or other concurrent studies that may interfere with this study (as provided by self-report or other available documentation) without prior approval from the medical monitor/joint clinical management committee while participating in this study. * past or current participation in hiv vaccine or hiv broadly neutralizing antibody study unless individual provides documentation of receipt of placebo (ie, not active product). * prior use of long-acting systemic pre-exposure prophylaxis (prep) (including cabotegravir (cab) or islatravir studies). * acute viral hepatitis a or acute or chronic hepatitis b or c infection. * have a suspected or known active, serious infection(s) (eg, active tuberculosis, etc). * evidence of moderate or severe liver fibrosis or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, variceal bleeding). in individuals with active hepatitis c, fibrosis-4 (fib-4) score \> 3.25 (formula provided below). note: other protocol defined inclusion/exclusion criteria may apply.
expressive writing for reducing stress and diabetic symptoms in diabetes patients

Conditions: Diabetes Mellitus; Stress; Depression

Summary: this study will determine whether the psychological benefits of expressive writing extend to diabetic patients, how long the benefits will last, and whether additional expressive writing "booster" sessions will lead to greater and more sustained improvement in diabetes symptoms and well-being.

diabetes is one of the leading causes of blindness, kidney failure, and nontraumatic lower extremity amputation in the united states. conditions such as stress and depression have been shown to worsen diabetic symptoms. data indicate that expressive writing (an activity during which individuals deal with stressful experiences by writing about them on paper) has beneficial effects on psychological and physiological outcomes. this study will determine whether diabetes patients can benefit from expressive writing. this study will also determine the duration of the benefits and the effectiveness of booster sessions in improving their diabetic symptoms. participants will be randomly assigned to engage in expressive writing or neutral writing for 18 months. participants in the expressive writing group will write about traumatic or stressful events; participants in the neutral writing group will write about neutral topics that do not affect them emotionally. some participants in the expressive writing group will receive an additional 4 months of booster sessions of expressive writing. all participants will undergo interviews, blood collection, physical exams and complete clinical scales on their disease status, quality of life, and psychological well-being; these assessments will occur at study entry, every 4 months during the study, and at the end of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus made after age 24 exclusion criteria: * diabetes-related emergency room visit within 3 months prior to study entry * use of psychiatric medication within 3 months prior to study entry * visual or manual limitations that preclude reading and writing * use of insulin within the first year of diabetes diagnosis * pregnancy or plan to become pregnant

Keywords: diabetes emotions blood glucose expressive writing
positional cloning of the gene(s) responsible for alagille syndrome

Conditions: Alagille Syndrome

Summary: the goal of the project is to identify and clone the gene(s) responsible for the alagille syndrome (ags) by a positional cloning approach. the first step towards this goal is to define the smallest genomic candidate region for ags at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. in a collaborative effort with clinician-investigators studying the alagille syndrome, metaphase chromosomes and genomic dna from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. characterization of genes involved in alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease. recently, we and others found that mutations in jagged1, a notch1 receptor are responsible for alagille syndrome.

the goal of the project is to identify and clone the gene(s) responsible for the alagille syndrome (ags) by a positional cloning approach. the first step towards this goal is to define the smallest genomic candidate region for ags at 20p12 and to begin to identify genes within this region which are, by definition, candidate genes for the disease. in a collaborative effort with clinician-investigators studying the alagille syndrome, metaphase chromosomes and genomic dna from affected individuals will be studied for subchromosomal deletions and for mutations in the candidate genes. characterization of genes involved in alagille syndrome could provide important insight into the pathophysiology of the disease, the development of normal liver and treatment of this disease.

Eligibility criteria:
all enrolled affected subjects, whose samples will be analyzed in this study, must meet the criteria for the clinical diagnosis of alagille syndrome (syndromic bile duct paucity) which include liver biopsy findings consistent with alagille syndrome and at least 3 of the 5 primary clinical criteria: cholestasis, characteristic face, posterior embryotoxon, "butterfly" vertebrae and cardiac findings.

Keywords: chromosomal deletion mutations paucity of bile ducts physical map transcript identification alagille syndrome syndromic bile duct paucity
evaluation of the efficacy and safety of inhaled nitric oxide as adjunctive treatment for cerebral malaria in children

Conditions: Malaria, Cerebral

Summary: the purpose of this study is to assess if adding inhaled nitric oxide to other malaria treatments can improve the outcome of cerebral malaria in children aged 2months to 12 years.

despite very effective antimalarial treatment, there is a residual and unacceptable high mortality rate of malaria, especially amongst young children. recent progress has been made in understanding the role of nitric oxide (no) in severe malaria, indicating that no supplementation is likely to have a beneficial action in severe malaria possibly through down-regulation of inflammatory cytokines like tnf. of the various ways to supplement no, ino appears to be the safest since it is very well studied in critically ill patients and does not cause systemic vasodilation. the safety of no inhalation has been clearly demonstrated through its wide use in the treatment of persistent pulmonary hypertension in neonates and pulmonary hypertension in children and adults. extensive data on its safety has been collected. this study is a phase 2 clinical trial that aims at demonstrating the efficacy of ino when added to antimalarial treatment to treat cerebral malaria. this study will also provide a better understanding of the pathophysiological mechanisms involved in severe malaria.

Eligibility criteria:
inclusion criteria: * age between 2 months and 12 years. * with malaria infection confirmed by a malaria antigen test and/or a positive blood smear examination * and sustained coma: achieving a blantyre coma score less than 3 for 2, or more, hours after ruling out and treating hypoglycemia (blood glucose less than 2.2 mmol/l), ruling out meningitis, and ruling out and treating active clinical seizures. exclusion criteria: * refusal to participate * other cause of coma (toxic or pre-existing severe neurological disease) * terminal respiratory failure (due to brainstem coning) * coagulopathic * clinically unstable enough to preclude venipuncture and phlebotomy * severe malnutrition defined by edema or a weight-for-height minus 3 sd; * evidence of pre-existing brain injury * advanced aids defined by who clinical staging 4;

Keywords: severe malaria children adjunctive treatment
intravenous insulin in patients with diabetes after percutaneous coronary intervention (pci)

Conditions: Diabetes Mellitus; Percutaneous Coronary Intervention

Summary: the purpose of this study is to evaluate the effects of intravenous insulin/24 hours to normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant defense) and inflammation (c-reactive protein (crp) and scd40l) in diabetic patients submitted to pci with stent.


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus submitted to percutaneous coronary intervention with stent bare metal * age: 18-80 years old exclusion criteria: * restenosis * drug elution stent * acute coronary syndrome at last 30 days * use anti inflammatory, antibiotic, vitamin e * inflammatory disease or oncologic

Keywords: patients with diabetes mellitus submitted to percutaneous coronary intervention with stent