Kornimate/medical-research-clean huggingface dataset:
a comparative study of sibling oocytes: icsi vs. the picsi sperm selection method

Conditions: Infertility

Summary: the aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and ivf outcome.


Eligibility criteria:
inclusion criteria: * males aged 18-60 * females aged 18-35 * males with mild ota (oligo terato astheno zoospermia) and at least one failed ivf cycle * males with normozoospermia with at least 2 unexplained failed ivf cycles * females with normal fsh and normal amh values * females who have retrieved in previous cycles at least 6 oocytes exclusion criteria: * couples who have been exposed to heavy smoking, drugs and chronic diseases * males who have undergone testicular surgery (tese) or defined as severe ota * females with egg factor infertility
comparison of hand feeding techniques for persons with dementia

Conditions: Dementia

Summary: the purpose of this study is to test three hand feeding techniques that can be used to provide feeding assistance to persons with dementia - direct hand feeding, hand-over-hand feeding, and hand-under-hand feeding.

proposed aim 1: to collect pilot data related to using three hand feeding techniques for feeding persons with dementia (pwd) in the nursing home (nh) setting: (1) direct hand feeding; (2) hand-over-hand feeding; and, (3) hand-under-hand feeding. primary outcomes are impact on frequency of aversive feeding behaviors, meal intake, and time spent assisting with feeding. proposed aim 2: evaluate implementation of the hand feeding intervention for larger randomized study of feeding techniques. aim 2a: conduct a process evaluation for method of recruiting, screening, and obtaining informed consent of legally authorized representatives (lars)/ assent of pwd. aim 2b: establish fidelity to treatment for all three hand feeding interventions.

Eligibility criteria:
inclusion criteria: * resident of nursing home 6 weeks prior to intervention delivery * 60+ years old * have a legally authorized representative to provide informed consent * medical diagnosis of dementia * required extensive assistance to total dependence for feeding * brief interview for mental status (bims) score of 0-12 exclusion criteria: * positive diagnosis of human immunodeficiency virus (hiv), parkinson's, and/or traumatic brain injury * any swallowing disorder * presence of feeding tube that is sole source for meal delivery * significant auditory or visual impairment

Keywords: feeding difficulty eating difficulty dementia nursing home careful hand feeding
safety and efficacy of adjustable gastric band operations for patients with body mass index (bmi) between 30-40 kg/m2

Conditions: Obesity

Summary: this study is to evaluate the safety and efficacy of gastric banding for patients with body mass index (bmi) between 30-40 kg/m2 with medical conditions related to obesity.

title of study:a prospective study to evaluate the safety and efficacy of lap-band® adjustable gastric band (lagb®) operations for patients with bmi between 30-40 kg/m2 with co-morbidities clinical phase: phase iii new indication for use of the device not yet approved by fda study objectives * to determine the safety and efficacy of the lap-band® adjustable gastric band (lagb®) for patients with bmi between 30-40 kg/m2 with co-morbidities * to determine long-term effects on patients' co-morbidities study variables: morbidity \& mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation design: prospective single center study

Eligibility criteria:
inclusion criteria: * be at least 18 and equal to or less than 60 years of age. * bmi of at least 30 and maximum bmi of 40 with co-morbidities * willingness to comply with dietary restrictions required by the protocol * history of obesity for at least 5 years * history of at least 6 months of documented failures with traditional non-surgical weight loss methods * willingness to follow protocol requirements * if female with childbearing potential, using an appropriate form of contraception exclusion criteria: * age less than 18, age greater than 60 * pregnancy * history of major depressive disorder or psychosis * previous bariatric surgery or previous gastric surgery * presence of achalasia * presence of portal hypertension, cirrhosis, and/or varices * patient with inflammatory disease of the gastrointestinal tract such as crohn's disease * patients with autoimmune connective tissue disorders * patients with acute abdominal infections * any condition that, in the judgment of the investigator, would place a subject at undue risk, or potentially compromise the results or interpretation of the study

Keywords: obesity, 50 lbs overweight
study with medical nutrition product ptm202 in pediatric diarrhea

Conditions: Acute Diarrhea

Summary: the purpose of this study is to determine whether a medical nutrition product, ptm202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children


Eligibility criteria:
inclusion criteria: * males or females between 6 months and 5 years of age * acute diarrhea (\<48 hours) without interfering co-morbidities * guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on day 7 for a final evaluation * guardian is willing and able to report to the investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase. * written informed consent must be obtained prior to admission to this study. * the subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea. exclusion criteria: * suspected or confirmed cholera * suspected dysentery * symptom duration \>48 hours at screening * vomiting severity that is like to make administration and retention of test article impossible * severe malnutrition (defined as weight for height of less than -3 sd below median, per who standards (6). * child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening. * history of hypersensitivity or allergy to milk or egg
nivolumab combined with ipilimumab followed by nivolumab monotherapy as first-line treatment for patients with advanced melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine the effects of combination treatment of nivolumab with ipilimumab followed by nivolumab monotherapy in patients with previously untreated advanced melanoma.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * potential subjects must have advanced melanoma (stage iii or iv as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery. * potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease. note: prior adjuvant or neoadjuvant melanoma therapy (including anti-ctla-4, anti-pd-1, anti-pd-l1, anti-pd-l2, or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways, such as anti-cd-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. these drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved. * potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the mri (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). potential subjects must not have received intravenous steroid treatment (\>10 mg/day) intravenously for at least 2 weeks prior to study drug administration. exclusion criteria: * leptomenigeal metastases * subjects with autoimmune disease. subjects with type i diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * all side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to grade 1 or baseline before administration of study drug.
nigella sativa as an adjuvant therapy in the treatment of pediatric pneumonia

Conditions: Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pneumonia

Summary: nigella sativa is the world's oldest immunomodulator. the main active component in nigella sativa is thymoquinone. research shows thymoquinone has antioxidant, anti-inflammatory, and antimicrobial effects. based on these observations on the pharmacological activities of nigella sativa, the potential therapeutic efficacy of n. sativa was proposed in cap.

the aim of this work is to assess the benefit of oral nigella sativa oil supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with pneumonia admitted to the pulmonology unit, pediatric department. primary outcome: 1- the duration of clinical manifestations of pneumonia including time taken for normalization of respiratory rate, temperature, and oxygen. saturation, chest in drawing, hypoxia, lethargy, and inability to feed 2- the duration of hospital stay. secondary outcome: 1. discharge or death of the patient. 2. occurrence of pneumonia complications.

Eligibility criteria:
inclusion criteria: * signs and symptoms of lower respiratory tract infections (lrti) (lrti was defined as ≥ 1 of the following: new or different cough or sputum production, chest pain, dyspnea, tachypnea, or abnormal auscultatory findings). * focal findings on chest x-ray indicating pneumonia. exclusion criteria: * children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorder impacting respiration i.e. genetic, metabolic, neuromuscular disorders....etc, children with chd affecting the pulmonary blood flow

Keywords: nigella sativa oil pneumonia
effects of weekly dosing of d-cycloserine on cognitive function in individuals with schizophrenia

Conditions: Schizophrenia

Summary: the study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. the study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and side-effects.

this is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 2, 3. 4, 5, 6, 7, 8 \& 10 of once-weekly oral d-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia. specific aims: 1. assess the effects of a single dose of d-cycloserine 50 mg on cognitive functioning compared to placebo. 2. assess the effects of repeated weekly dosing of d-cycloserine on cognitive functioning at week 8 compared to placebo. 3. assess the effects of repeated weekly dosing of d-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo. 4. assess the persistence of learned information in a no-treatment follow-up assessment at week 10 in the d-cycloserine group compared to the placebo group. 5. assess effects of weekly d-cycloserine dosing on positive \& negative symptoms at week 8 compared to placebo. 6. assess tolerability and side effects of weekly d-cycloserine compared to placebo. 7. assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo. 8. assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 18-65 years 3. diagnosis of schizophrenia or schizoaffective disorder, depressed type 4. stable dose of antipsychotic for at least 4 weeks. 5. able to provide informed consent 6. able to complete a cognitive battery exclusion criteria: 1. current treatment with clozapine 2. dementia 3. seizure disorder 4. unstable medical illness 5. active substance abuse 6. pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.

Keywords: schizophrenia cognition d-cycloserine memory
validating a new point-of-care device for estimation of blood count in pregnant women

Conditions: Blood Loss

Summary: postpartum hemorrhage is a well-known complication of delivery and the leading cause of maternal mortality worldwide. in developed nations, a complete blood count (cbc) is commonly collected as a means to assess or base treatment for blood loss. the hemi device is a point-of-care device designed to provide hematocrit, followed by the stage of hemorrhagic shock using artificial intelligence algorithms. the ultimate goal of the product is to provide an accurate hematocrit from easily attainable samples such as vaginal blood during hemorrhage to remove yet another barrier to access for actively bleeding women. the purpose of this study is to compare the hematocrit of vaginal blood using the hemi device with standard venipuncture.

this will be a prospective cohort study. the investigators will recruit 41 pregnant women admitted for delivery. following delivery, a sample of vaginal blood will be collected and the hemi device will be used to obtain hematocrit. these results will be masked to the clinical team until the time of data collection. a cbc will also be collected via venipuncture at this time. this study will be comparing hematocrit levels by standard clinical laboratory versus results from the device.

Eligibility criteria:
inclusion criteria: * pregnant women between the ages of 18-50 * admission for vaginal delivery * singleton pregnancy * term gestation (\>=37 weeks) exclusion criteria: * pregnant women \ 50 years * incarcerated patients * patient unwilling or unable to provide consent * enrolled in another trial that may affect outcome

Keywords: vaginal delivery
calcitriol plus paclitaxel in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. calcitriol may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug. purpose: phase i trial to study the effectiveness of combining calcitriol with paclitaxel in treating patients who have advanced solid tumors.

objectives: * determine the toxic effects and maximum tolerated dose of calcitriol when combined with paclitaxel in patients with advanced solid tumors. * determine the effect of administration of calcitriol on the pharmacokinetics of paclitaxel in these patients. * determine the effect of administration of paclitaxel on the pharmacokinetics of calcitriol in these patients. outline: this is a dose-escalation study of calcitriol. during course 1, patients receive oral calcitriol daily on days 1-3 of weeks 1-6 and paclitaxel iv over 1 hour on day 1 of week 1 and day 3 of weeks 2-6. during course 2 and subsequent courses, patients receive oral calcitriol daily on days 1-3 and paclitaxel iv over 1 hour on day 3 of weeks 1-6. treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (mtd) is determined. the mtd is defined as the highest dose giving an estimated probability of dose-limiting toxicity of no more than 0.30. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven advanced cancer not curable by standard therapies * brain metastases allowed following definitive radiotherapy patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 mg/dl * sgot no greater than 4 times normal renal: * creatinine no greater than 2.0 mg/dl * calcium no greater than 10.5 mg/dl other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study * no active infection or serious concurrent condition * no symptomatic peripheral neuropathy greater than grade 1 prior concurrent therapy: biologic therapy: * at least 3 weeks since prior regional or systemic biologic therapy chemotherapy: * at least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 3 weeks since prior radiotherapy surgery: * not specified

Keywords: unspecified adult solid tumor, protocol specific
motivate to improve outcomes for older veterans with musculoskeletal pain and depression

Conditions: Chronic Back Pain; Depression; Aging; Musculoskeletal Pain

Summary: the proposed study seeks to evaluate effectiveness, implementation processes, and cost of motivate among older veterans with chronic musculoskeletal (msk) pain and comorbid depressive symptoms.

investigators will conduct a randomized controlled trial (rct) at two large va facilities, to establish the effectiveness and scalability of motivate, a remotely delivered behavioral intervention for older veterans with comorbid musculoskeletal (msk) pain and depressive symptoms. the central hypothesis is that motivate will improve important patient-centered outcomes among older veterans with co-occurring msk pain and depressive symptoms.

Eligibility criteria:
inclusion criteria: * aged 60 and older * english- speaking * self-reported msk pain (include clbp +/- radiating symptoms, oa, fibromyalgia) on most days for the past 3 months that interferes with daily activities * pain intensity that is 4+/10 on the numerical pain rating scale * pain interference threshold 5+ on peg-3 * depressive symptoms, 10+ on phq-9 * capable of participating in home-based activity * interested in participating in a non-pharmacologic program exclusion criteria: * aged 59 or less * no telephone * not english speaking * unwilling to be randomized to either study arm * not interested in participating in a non-pharmacologic program * self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen * significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam * self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe oa\* (resulting in inability to participate in physical activity intervention) * illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries) * suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)

Keywords: chronic back pain depression veterans aging musculoskeletal pain
panther study of terumo aortic knitted and woven grafts, and cardiovascular patches

Conditions: Aneurysm; Dissection; Aortic Root Aneurysm; Aortic Root Dissection; Carotid Artery Injuries; Aortic Arch; Bypass Extremity Graft; Occlusive Vascular Disease; Aortic Diseases

Summary: the purpose of this registry is to collect safety and performance data on all commercially available terumo aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice. data will be collected both retrospectively and prospectively.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study: all patients: * patient meets the minimum age as per local regulations at time of consent * patient requires treatment with study device(s) according to the ifu(s) * patient is willing and able to comply with all soc procedures and study visits * patient or their legally authorised representative (lar) has given written informed consent to participate in study, including consent to collect data retrospectively * for prospective emergency patients, retrospective consent is permissible * for retrospective patients who are deceased at time of enrollment, local ec regulations relating to consent process should be followed. retrospective patients only: * patient has a minimum of 1 year post-operative follow-up data available, or complete data to death. * patient implant date is no more than 5 years prior to study start date. exclusion criteria: * any patient who meets any of the following exclusion criteria will be excluded from participation in the study: * patient is unable or unwilling to comply with the soc procedures or follow-up regime * patient is contraindicated per the device ifu * patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure

Keywords: vascular surgery
apioc sphere and apioc astigmatism

Conditions: Myopia; Hyperopia; Astigmatism

Summary: vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the apioc™ sphere or the apioc™ astigmatism contact lenses.


Eligibility criteria:
inclusion criteria: 1. the subject must provide written informed consent. 2. the subject must appear willing and able to adhere to the instructions set forth in this protocol. 3. at least 18 years of age and no more than 35 years of age. 4. ≤ 4.00 d (diopters) of corneal astigmatism. 5. ≤ 2.50 d of refractive astigmatism. 6. refractive error range +4.00 ds to -6.00 ds (diopters sphere) 7. flat and steep keratometry readings within 40 to 48 d. 8. clear, healthy corneas with no irregular astigmatism. 9. normal, healthy conjunctiva in both eyes. 10. free of active ocular disease. refractive error is permitted. 11. be a current or former (within the last 12 months) contact lens wearer. 12. best-corrected near and distance visual acuity better than or equal to 20/25. exclusion criteria: 1. irregular corneal astigmatism. 2. presbyopia 3. corneal scarring unless off line-of-site and well healed. 4. pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear. 5. recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. use of artificial tears less than 3 drops per week is permitted. 6. systemic disease that would interfere with contact lens wear. 7. currently pregnant or lactating (by self-report). 8. history of strabismus or eye movement disorder, including exophoria at near that is 4 d or greater than at far, and a receded near point of convergence break that is 6 cm or greater. 9. active allergies that may inhibit contact lens wear. 10. upper eyelid margin at or above the superior limbus. 11. history of ocular or lid surgery. 12. immediate family members or significant others of doctors or staff at the clinical site.