Kornimate/medical-research-clean huggingface dataset:
peg-rhg-csf in elderly patients with small cell lung cancer receiving chemotherapy

Conditions: Small Cell Lung Cancer; PEG-rhG-CSF

Summary: evaluation of the efficacy and safety of jinyouli in preventing neutropenia in multiple chemotherapy cycles in elderly patients with small cell lung cancer through a multicenter, open, one-arm study subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria, chemotherapy regimen: etoposide: 100 mg/m2, d1-3, carboplatin: auc=5, d1, q21d, prophylactic use test 48 h after chemotherapy drug peg-rhg-csf.


Eligibility criteria:
inclusion criteria: * age ≥ 70 years old, gender is not limited; * small cell lung cancer patients diagnosed by histopathology or cytology; * ecog = 0-1; * the estimated survival period is more than 3 months; * no obvious signs of hematological disease, defined as hb≥90g/dl, wbc≥4.0×10\^9/l, anc≥2×10\^9/l, plt≥100×10\^9/l before enrollment. and no bleeding tendency; * no obvious abnormalities were observed in the electrocardiogram examination; * liver function tests alt, ast, tbil indicators are within 2.5 times the upper limit of normal values. if due to liver metastasis, the above indicators should be within 5 times of the upper limit of normal. if ldh is elevated due to non-tumor causes, ldh should be ≤ 2.5 times the upper limit of normal; if ldh is elevated due to tumor, it can be enrolled; * renal function test bun, ua within 1.5 times the upper limit of normal value, creatinine clearance rate\> 60ml / min; * subjects (or their legal representatives/guardians) must sign an informed consent form indicating that they understand the purpose of the study, understand the necessary procedures for the study, and are willing to participate in the study. exclusion criteria: * there are currently uncontrollable infections, body temperature ≥ 38.0 ° c; * patients with previous malignant tumors that have not been cured or have bone marrow metastasis; * patients with prophylactic antibiotics; * accepting other test drugs at the same time or participating in other clinical trials; * those who are allergic to this product or other genetically engineered e. coli-derived biological products; * the patient has any myelodysplastic and other blood system diseases; * patients who have received hematopoietic stem cell transplantation or organ transplantation; * the patient has a severe mental or neurological condition that affects informed consent and/or adverse reaction presentation or observation.
multiple versus single dose of ivermectin for the treatment of strongyloidiasis

Conditions: Strongyloidiasis

Summary: ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. as strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite. aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.


Eligibility criteria:
inclusion criteria: * male and female patients older than 5 years and weighting \> 15 kg * current residence in non-endemic areas * either direct diagnosis of s. stercoralis infection and positive serology at any titer or positive serology at "high" titer, irrespective of results of direct tests exclusion criteria: * pregnant or lactating women * subjects suffering from cns diseases * disseminated strongyloidiasis * immunocompromised patients. * lack of informed consent * previous treatment with ivermectin (in the last year)

Keywords: strongyloidiasis strongyloides stercoralis ivermectin
the clinical comparison of senofilcon a and stenfilcon a contact lenses

Conditions: Myopia

Summary: the objective of this study is to compare the clinical performance of senofilcon a lens with the stenfilcon a lens each for one week of daily disposable wear.

the purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon a lens with the stenfilcon a lens. in particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.

Eligibility criteria:
inclusion criteria subjects will only be eligible for the study if: * they are of legal age (18) and capacity to volunteer. * they understand their rights as a research subject and are willing and able to sign a statement of informed consent. * they are willing and able to follow the protocol. * they agree not to participate in other clinical research for the duration of this study. * they have a contact lens spherical prescription between -1.00 to - 6.00d (inclusive) * they have a spectacle cylindrical correction of -0.75d or less in each eye. * at dispensing, they can attain at least 0.10 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. * they currently use soft contact lenses or have done so in the previous six months. * they are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day). exclusion criteria subjects will not be eligible to take part in the study if: * they have an ocular disorder which would normally contra-indicate contact lens wear. * they have a systemic disorder which would normally contra-indicate contact lens wear. * they are using any topical medication such as eye drops or ointment. * they have had cataract surgery. * they have had corneal refractive surgery. * they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * they are pregnant or lactating. * they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. * they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. * they currently wear either myday (daily) or the acuvue oasys (2 weekly) lens.
evaluation of viral status of patients with plantar warts included in vraie study, non-responder to study treatment

Conditions: Plantar Warts

Summary: the principal objective of the study is the evaluation of the role of human papilloma virus (hpv) in plantar warts (prevalence, genotype), resistant or not, treated or not, cured or not. this epidemiological study is an ancillary study of the prospective, randomized controlled, clinical study vraie (sponsor: aphp) comparing 5 usual strategies in the management of plantar warts.


Eligibility criteria:
inclusion criteria: * male or female patient aged 18 years or more. * clinical evaluation * number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm, whether previously treated or not * in treated patients, all potentially active treatment on warts since at least one month should be stopped. * effective contraception for women of childbearing age * immunocompetent patients * patient with one or more warts on soles and board feet. * myrmecie : rounded warts, deep, covered with a stratum corneum more or less thick; after stripping, appear black points, very specific; often painful to pressure. they are lonely, single or not. they could regroup galley thick. the stripping can them to individualize. * mosaic : plate small warts, superficial, often sitting on the heel or forefoot. little painful, they are often ignored by the patients when they appear * patient affiliated to the french social security.viral exclusion criteria: * patient suspected to be immunocompromised * patient aged under 18 years * patient refusing to sign the consent * pregnant or lactating women * plantar calluses * known hypersensitivity to imiquimod (aldara®) or any excipients of the cream (isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, purified water) * known hypersensitivity to 5 fluoro-uracil (efudix®) or any excipients of gel (stearyl alcohol, vaseline, polysorbate 60, propyleneglycol, purified water - conservatives: methyl parahydroxybenzoate, propyl parahydroxybenzoate) * contra-indication to pomade m.o cochon® (known allergy to any components) * known hypersensitivity to blenderm® * extra plantar concomitant warts (to exclude risk of endogenous recontamination by an extra plantar site) * plantar hyperhidrosis making impossible adhesion of plaster.

Keywords: hpv
dehydroepiandrosterone effects on hiv-1 replication

Conditions: HIV Infections

Summary: this study's purpose is to learn how dehydroepiandrosterone (dhea) affects the hiv virus, the immune system, hormone levels, body composition and quality of life.


Eligibility criteria:
inclusion criteria: * evidence of hiv-1 infection * hiv rna \<50 copies/ml * stable antiretroviral treatment regimen for at least 8 weeks * age 18 years or older * normal pap smear and mammograph within 1 year (females) * normal prostate-specific antigen level with in one year, age adjusted (males) exclusion criteria: * active opportunistic infections or malignancy other than localized cutaneous ks lesions * concurrent or prior use within the past 8 weeks of dha, testosterone, other anabolic steroids, corticosteroids, megestrol acetate, growth hormone, il-2, or thalidomide * diagnosis of aids dementia complex (stage ii or higher) * active substance abuse (e.g., alcohol or injection drugs) * evidence of severe liver dysfunction or hepatic transaminases greater than 3x the upper normal limit * pregnant or breast-feeding * history of endocrinologically-responsive tumors (e.g., breast, ovarian, uterine, or prostatic cancer, or malignant melanoma)

Keywords: hiv dhea immune system hormones body composition quality of life
evaluating the hypothesized mechanism of action of n-acetylcysteine for bipolar disorder

Conditions: Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder

Summary: this research study evaluates the effects of anfda-approved medication nac in individuals with bipolar disorder. participants in the study will will be assigned to two medication conditions and will take both nac and a matched placebo. the order in which they take each medication will be random. study medication will be taken for 14 days. there will be 5 study visits, with 2 mri brain imaging scans completed. questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.


Eligibility criteria:
inclusion criteria: 1. ages 18-60 years 2. meet dsm-5 criteria for bipolar i or ii disorder 3. able to provide informed consent and read, understand, and accurately complete assessment instruments 4. willing to commit to medication treatment and follow-up assessments 5. meets dsm-5 criteria for any mood episode (i.e., major depressive, hypomanic, manic), current or in partial remission 6. prescribed daily use of at least one fda-approved mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, 2nd generation antipsychotic) 7. willing to abstain from antioxidant supplements (e.g., coenzyme q-10, vitamin e) for the duration of the study. exclusion criteria: 1. a primary psychiatric diagnosis other than bd (e.g., schizophrenia) 2. meet dsm-5 criteria for substance use disorder (other than tobacco use disorder) within the past 6 months. 3. any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study 4. any history of brain injury with loss of consciousness greater than 5 minutes 5. any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months) 6. any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant 7. hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range 8. renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range 9. concomitant use of nitroglycerine, carbamazepine, or any other medication deemed to be hazardous if taken with n-acetylcysteine (nac). 10. medication dose changes of ≥ 20% ≤ 2 weeks prior to testing 11. women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception 12. current suicidal or homicidal risk 13. baseline scores greater than 35 on the montgomery-asberg depression rating scale or greater than 25 on the young mania rating scale 14. has taken nac in the last month or experienced adverse effects/allergic reaction from it at any time 15. significant claustrophobia and/or past negative experiences with mri 16. presence of non-mri safe materials in the body (e.g., ferrous metal implants, pacemaker)
the use of l-carnitine and coq10 supplements in the treatment of cyclic vomiting syndrome (cvs)

Conditions: Cyclic Vomiting Syndrome

Summary: this is a study with the principle goal being to learn about the use of l-carnitine and coq10, two vitamin supplements that are currently being used to treat cyclic vomiting syndrome, largely initiated by parents. we want to learn how effective these supplements are compared to standard treatment, at what dose, and what onset of action in order to initiate future prospective study on these supplements.


Eligibility criteria:
inclusion criteria: * 3 discrete episodes of vomiting * normal health between episodes * stereotypical clinical pattern * no abnormal test results to account for vomiting (see exclusion criteria) exclusion criteria: * abnormal ugi with small bowel follow-through revealing an anatomic anomaly, inflammatory or obstructive * significantly abnormal endoscopic biopsies (moderate to severe esophagitis, h. pylori) * abnormal abdominal ultrasound revealing hydronephrosis, cholelithiasis, pancreatitis * positive screening for endocrine disorder (diabetic ketoacidosis, addison's) * positive screening for inborn errors of metabolism (hypoglycemia, lactic acidosis, hyperammonemia, organic acidemia, amino aciduria, elevated beta-ala, porphobilinogen)

Keywords: learn l-carnitine co-enzyme q10 effective these supplements compared standard
medtronic hugo™ robotic assisted surgery (ras) system in hernia surgery (enable hernia repair)

Conditions: Inguinal Hernia; Ventral Hernia

Summary: a prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the medtronic hugo™ ras system. subjects will be followed through two years. this study will be conducted using up to ten investigative sites in the united states (us).


Eligibility criteria:
inclusion criteria: * adult subjects (age ≥ 22 years) as required by local law * subject has been indicated for one of the following hernia repairs: (a.) primary or incisional ventral hernia(s). multiple small hernia defects are allowed with total distance of combined defects being \< 10cm (b.) inguinal (unilateral or bilateral) hernia(s). * subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure * the subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form exclusion criteria: * patients for which minimally invasive surgery is contraindicated as determined by the investigator * patients with a recurrent hernia * subjects with femoral hernia defects * subjects with ventral hernia defect(s) located in m1, m5, or l4 * patients with emergent hernia repair * ventral hernia is cdc (center for disease control) grade 2 or higher * use of component separation techniques to close the hernia defect * inability to close the hernia defect * hernia defect is ≥ 10 cm * patient has bmi \> 40 * patients with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the investigator * patients diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care * female patients pregnant at the time of the surgical procedure. * patients who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity) * patients who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study * patients with active infections including but not limited to pneumonia, urinary tract infection, cellulitis, or bacteremia
japanese dose-response study of rimonabant in obese patients

Conditions: Obesity

Summary: the primary objective is to verify the dose-response relationship of rimonabant on body weight change. the secondary objectives are to compare the effect of 3 doses of sr141716 to placebo, on body weight loss and on secondary criteria associated with comorbidities, and to evaluate the safety and the pharmacokinetics of sr141716.


Eligibility criteria:
inclusion criteria: * body mass index ≥25 kg/m² * viceral fat area ≥ 100 cm² * diet therapy for more than 8 weeks before start of the placebo observation period * stable weight (variation \< ±3kg within 8 weeks before start of observation period) * at least 2 criteria of the following 3 comorbidities: impaired glucose tolerance or type 2 diabetes, dyslipidemia (hypertriglyceridemia and/or low hdl-choresterol), hypertension

Keywords: weight loss
effect of a hybrid rehabilitation program on walking, quality of life & cardiovascular risk in people with pad

Conditions: Peripheral Arterial Disease

Summary: peripheral arterial disease (pad), a disabling condition, affects 800,000 canadians. people with pad suffer from poor quality of life due to leg pain, which makes walking difficult. they also have a high risk of heart disease. in november of 2017, the university of ottawa heart institute (uohi) launched canada's first specific walking rehabilitation and cardiovascular risk reduction program dedicated to patients with pad. an on-site, supervised exercise program to improve walking endurance and quality of life in pad has been shown to be successful. however many patients are not able to participate in the on-site program due to barriers such as transportation, parking, or other commitments. recently, a home-based walking program has also been shown to significantly improve walking endurance and quality of life among people with pad. it was decided that a hybrid program, that has a short on-site program followed by a home-based program may allow more patients to participate and have the highest chance of success. the goal is to develop a new hybrid program for medical care in pad patients in order to: (a) improve their walking distance, (b) improve their quality of life and (c) improve their cardiovascular risk. as part of this study the investigators will enrol 25 participants with pad. participants will be studied at baseline (before their first on-site class) and at 3 month follow up (after their last home program phone call).


Eligibility criteria:
inclusion criteria: * intermittent claudication with pad documented by: * abi ≤0.90 or \>1.40;(14) or * anatomic evidence of lower extremity arterial stenosis ≥50% (by lower extremity angiography, ct angiography, mr angiography or ultrasound) * ability to participate in the study (ability to walk) * willingness to provide informed consent exclusion criteria: * they have had previous lower extremity amputation * they are unable to walk * they have critical limb ischemia or open lower extremity wounds. * patient is unable to read and understand english or french * patient is unable, in the opinion of the qualified investigator or referring physician, to comprehend and participate in the exercise intervention.

Keywords: pad
preventive effect of clopidogrel on the systemic sclerosis development risk

Conditions: Scleroderma; Systemic Sclerosis

Summary: systemic sclerosis (ssc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. no curative treatment is available. pre-clinical abnormalities can be found such as specific autoantibodies. the association of raynaud phenomenon and ssc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. the aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.

in this study, platelet activation is targeted as it could play a key role in the pathogenesis of ssc. it has been shown in several publications that platelets are activated in ssc with a correlation between the level of activation and disease activity. secondary to this activation, soluble and membrane effectors were increased, and induced vascular damages and fibrosis. the results obtained in the laboratory (cnrs umr-5164) directly involved platelets in this mechanism by inducing the thymic stromal lymphopoietin (tslp) production by endothelial cells and by showing the pro-fibrotic effect of tslp. in vivo data in ssc murine model recently obtained, confirmed the preventive role on fibrosis of clopidogrel. the early control of this platelet activation could prevent the course of events leading to ssc. the therapeutic strategy assessed in this study will be the oral administration of clopidogrel (75 mg per day) during two years to subjects presenting an association of specific dysimmunity and raynaud phenomenon (rp). the administration of clopidogrel will be double-blinded versus placebo. subjects will be included and treated during a 2-year period and will be followed for a period of 36 months after treatment, i.e. a total of 60 months. the follow-up will be every six months mainly comprising clinical examination, patient reported outcomes and blood sampling.

Eligibility criteria:
inclusion criteria: * patient over 18 years old, and less than 85 years old. * patient with positive aan (aan ≥ 1/160) with the following specificity: anti-scl70 or anti-centromere or anti-rnapoliii, or any other auto-antibodies related to systemic sclerosis * patient with rp reported by the subject and confirmed by the physician. * patient affiliated to a health insurance system. * patient who accepts to participate to the study and signs an inform consent form. exclusion criteria: * patient with an ssc diagnosis according to acr/eular 2013 criteria. * patient with skin fibrosis at screening. * patient with antiplatelet treatment at screening. * patient with contraindications to clopidogrel. * patient treated by immunosuppressive agent at screening. * patient treated by anticoagulants at screening * pregnant or breastfeeding women. * women of childbearing age refusing effective contraception method during the study treatment (24 months). * incompetent adults (i.e. individuals under the protection of a conservator)

Keywords: systemic sclerosis clopidogrel platelet prevention primary care
correlation between continuous glucose monitoring and intermittent glucose monitoring values and pregnancy outcomes

Conditions: Insulin Resistance

Summary: we wish to find out if in non-diabetic pregnancies, as well as diabetic pregnancies, additional data obtained by continuous glucose monitoring improves perinatal risk prediction.

patients are recruited for 3 day continuous glucose monitoring (cgm) plus self-blood glucose monitoring followed by routine diabetes screening at 26-28 weeks gestation to determine if maternal blood glucose excursions correlate with deviation from optimized birth weight.

Eligibility criteria:
inclusion criteria: - pregnant patients under 28 weeks gestation exclusion criteria: - pre-gestational diabetes