Kornimate/medical-research-clean huggingface dataset:
g-csf alone or combination with gm-csf on prevention and treatment of infection in children with malignant tumor

Conditions: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Lymphoma; Neuroblastoma; Hepatoblastoma; Retinoblastoma

Summary: the purpose of this study is to explore the effect of g-csf combination with gm-csf on prevention and treatment of infection in children with malignant tumor.

g-csf alone or combination with gm-csf on prevention and treatment of infection in children with malignant tumor.

Eligibility criteria:
inclusion criteria: * patients with malignant tumor including acute myeloid leukemia (aml) after complete remission, acute lymphocytic leukemia (all) after complete remission, stage iii or iv lymphoma after partial remission or complete remission, stage iii or iv neuroblastoma (nb) or retinoblastoma (rb). * eastern cooperative oncology group performance status ≤ 2. * did not receive treatment of csfs in two weeks. * without symptomatic infection and with normal values of c-reactive protein or procalcitonin. * the first time of anc \< 1.5\*10\^9/l after chemotherapy. * more than 24 h after the last chemotherapy. * the function of liver was normal. exclusion criteria: * allergic to gm-csf or drugs which expressed in escherichia coli. * patients with infection, diabetes or primary immunodeficiency. * patients infected with hepatitis b, hepatitis c or hiv. * patients confirmed autoimmune thrombocytopenic purpura.
a study of rotigotine patch in adolescent subjects with restless legs syndrome of unknown cause

Conditions: Restless Legs Syndrome

Summary: the purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic restless legs syndrome (rls) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic rls.


Eligibility criteria:
inclusion criteria: * subject is male or female, and is \>=13 and \<18 years of age at baseline * subject's restless legs syndrome (rls) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood * at baseline, subject has a score of \>=15 on the international restless legs rating scale (irls) (indicating moderate-to-severe rls) * at baseline, subject scores \>=4 points on the clinical global impressions (cgi) item 1 assessment (indicating at least moderately ill) * subjects who are receiving supplemental iron have been on a stable dose for at least 1 month prior to screening * female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). abstinence is an acceptable method. subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study medication. exclusion criteria: * subject has a serum ferritin level below the lower limit of normal at visit 1/screening * subject has a hemoglobin level below the lower limit of normal at visit 1/screening * subject has had previous treatment with dopamine agonists or l-dopa within 7 days prior to visit 2/baseline * subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject's well-being or ability to participate in this study * subject is pregnant or nursing * subject is not willing to abstain from caffeine after 4 pm each evening within 7 days prior to visit 2/baseline and for the duration of the study * at visit 1/screening, subject has symptomatic orthostatic hypotension with a decrease of blood pressure (bp) from supine to standing position of \>=20 mmhg in systolic blood pressure (sbp) or of \>=10 mmhg in diastolic * subject has secondary restless legs syndrome (rls) (eg, due to renal insufficiency \[uremia\], iron deficiency, or rheumatoid arthritis) * subject has a lifetime history of suicide attempts (including actual attempt, interrupted attempt, or aborted attempt), or had suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at screening (visit 1) * subject is taking a prohibited concomitant medication. prohibited concomitant medication must have been discontinued at least 2 weeks prior to screening (visit 1)

Keywords: rls rotigotine neupro
journey ahead: enhancing coping and communication for women diagnosed with gynecological cancer

Conditions: Gynecologic Cancer; Ovarian Cancer; Endometrial Cancer; Fallopian Tube Cancer; Cervical Cancer; Uterine Cancer

Summary: this study looks at how well the journey ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.

primary goals of this project are: objective 1: phase 1: to collect feedback from patients on cci online and to assess patient's evaluation of cci online. objective 2: phase 1: to examine the feasibility and acceptability of a cci online. objective 3: phase 1/2: to collect preliminary data on changes in distress and coping associated with participation in cci online.

Eligibility criteria:
inclusion criteria: * diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer or experienced a recurrence in the past 5 years; * diagnosed with high grade stage 2, any grade stage 3 or higher endometrial cancer or experienced a recurrence in the past 5 years; * diagnosed with stage 2 or higher cervical cancer or experienced a recurrence within the past 5 years; * diagnosed with any stage uterine cancer (both sarcoma and carcinosarcoma) or experienced a recurrence in the past 5 years; * at the time of recruitment the patient has received chemotherapy or radiation in the past 5 years, or is less than 5 years post-cancer surgery; * at the time of recruitment, a karnofsky performance status of 80 or above or an eastern cooperative oncology group (ecog) (80) score of 0 or 1; * 18 years of age or older; * english speaking; * has internet access, able to view the online intervention sessions and attend telephone or video/telehealth chats to discuss the session content and provide feedback; * must give informed consent within 5 years of diagnosis. exclusion criteria: -
two phosphate targets in end-stage renal disease trial (target)

Conditions: End-stage Renal Disease

Summary: patients with end-stage renal disease (esrd) who have elevated serum phosphate (p) levels have significantly higher mortality rates compared to those with normal p. in patients receiving conventional dialysis regimens, serum p may be lowered through dietary intervention and use of p binders, though these have potentially important side effects and may adversely impact quality of life. whether lowering p, and / or targeting specific p levels improve survival and clinical outcomes is unknown. despite this uncertainty, over 90% of patients with esrd receive p lowering therapy and guidelines for the care of patients with esrd are increasingly calling for more aggressive phosphate lowering. this intensive p lowering results in extra medications (and their associated side-effects), and higher health care costs. we are uncertain whether the intensification of p control results in measurable benefits to patients with esrd. the overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial of intensive vs liberalized phosphate control among hemodialysis recipients.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 yrs 2. receiving chronic hemodialysis for \> 90 days, 3. dialysis prescription is currently no more than 4 sessions per week and prescribed as 3-5 hrs per session 4. most recent p value 1.30-2.50 mmol/l 5. receipt of a calcium-based p binder exclusion criteria: 1. patient is booked (with a known surgical date) for a live donor kidney transplant in the next 26 weeks 2. planned switch to a dialysis schedule that involves \> 16 hours per week of therapy within the next 26 weeks. 3. planned switch to peritoneal dialysis within the next 26 weeks 4. pregnancy 5. albumin-corrected serum calcium \> 2.60 mmol/l in the past year requiring reduction of the calcium carbonate dose 6. history of calciphylaxis 7. attending nephrologist believes that an otherwise eligible patient is mandated- on clinical grounds- to have a p value that is targeted to \ 2.00 mmol/l 8. attending nephrologist believes an otherwise eligible patient is not a candidate for escalation of the current calcium dose 9. co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein

Keywords: end-stage renal disease hemodialysis mineral metabolism serum phosphate phosphate binders
sym004 in combination with nivolumab versus nivolumab monotherapy in egfr-amplified squamous non-small cell lung cancer

Conditions: Squamous Non-Small Cell Lung Cancer

Summary: this is a phase 1b/2b study investigating the safety and preliminary antitumor effects of sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.


Eligibility criteria:
main inclusion criteria: * signed and dated written informed consent * male or female ≥18 years of age at the time of informed consent * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy \>3 months assessed during screening * histologically or cytologically confirmed, locally advanced or metastatic squamous nsclc main exclusion criteria: * any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment * radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment * prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment * active central nervous system (cns) metastases or carcinomatous meningitis * women who are pregnant * women who are breastfeeding

Keywords: squamous non-small cell lung cancer nsclc
study of 5% vvn001 ophthalmic solution in dry eye disease

Conditions: Dry Eye

Summary: this is a phase 3, randomized, double-masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% vvn001 ophthalmic solution versus vehicle in chinese subjects with dry eye disease.


Eligibility criteria:
inclusion criteria: * provided written informed consent prior to any study-related procedures. * are between 30 and 80 years of age. * have a history of dry eye disease in both eyes. * have been using artificial tears within 30 days of the screening visit * have an eye dryness score ≥50 (0-100 point vas) * have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at visit 1 and visit 2: 1) total cfs (tcfs) score ≥6; 2) any subregion cs score ≥2.5; 3) schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min. * have a bcva in the study eye of ≥4.3 (standard for logarithmic visual acuity charts, 5-mark record). exclusion criteria: * have a known hypersensitivity or contraindication to the ip or components of ip. * have history of uncontrolled glaucoma, iop over 21 mmhg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study. * woman of childbearing potential (wocp) who are pregnant, lactating, or preparing for pregnant.
extension study of rhufab v2 in subjects with neovascular age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: this is a phase iii, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (cnv) secondary to amd who have completed the treatment phase of a genentech sponsored phase i or phase i/ii ranibizumab protocol (fvf1770g, fvf2128g, or fvf2425g).


Eligibility criteria:
inclusion criteria: * signed informed consent and authorization of use and disclosure of protected health information * age \>=50 years * completion of the treatment phase of a genentech sponsored phase i or i/ii ranibizumab protocol (fvf1770g, fvf2128g, or fvf2425g) exclusion criteria: * cnv in either eye due to other causes such as ocular histoplasmosis, trauma, or pathologic myopia * active intraocular inflammation (grade trace or above) in the study eye * current vitreous hemorrhage in the study eye * subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either \>=50% of the total lesion area or \>=1 da in size * intraocular surgery (including cataract surgery) in the study eye within 1 month preceding week 0 * uncontrolled glaucoma in the study eye (defined as intraocular pressure \>=30 mmhg despite treatment with anti-glaucoma medication) * premenopausal women not using adequate contraception * laser photocoagulation (subfoveal, juxtafoveal, or extrafoveal) in the study eye within 30 days preceding week 0 * prior treatment with external-beam radiation therapy or transpupillary thermotherapy (ttt) in the study eye * previous treatment with verteporfin in the study eye within 30 days preceding week 0 * treatment with verteporfin in the non-study eye within 7 days preceding week 0 * history of vitrectomy, submacular surgery, or other surgical intervention for amd in the study eye * previous participation in a clinical trial (for either eye) involving antiangiogenic drugs other than ranibizumab (e.g., pegaptanib, anecortave acetate, protein kinase c inhibitors, etc.) * previous participation in any studies of investigational drugs within 1 month preceding week 0 (excluding vitamins and minerals studies) * discontinuation from a ranibizumab study due to an adverse event judged by the investigator to be possibly or probably related to ranibizumab * history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications * inability to comply with study or follow up procedures

Keywords: amd neovascular age-related macular degeneration
medacta gmk sphere® multicenter post-market outcomes study

Conditions: Osteoarthritis

Summary: this study is to average forgotten knee score (fjs) of those patients receiving the medacta gmk sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in medacta gmk sphere® vs posterior stabilized study (wirb pro num: 20141994) and randomized to the sphere arm, will have their data utilized for this study.


Eligibility criteria:
inclusion criteria: * patients willing to sign the informed consent * patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self evaluations. * male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery. * patients requiring a primary total knee replacement. * patients with a diagnosis of osteoarthritis (oa), traumatic arthritis (ta), or avascular necrosis (avn). * patients with intact collateral ligaments. exclusion criteria: * patients with inflammatory arthritis. * patients that are morbidly obese, body mass index (bmi) \> 40. * patients with a history of total or unicompartmental reconstruction of the affected joint. * patients that have had a high tibial osteotomy or femoral osteotomy. * patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * patients with a systemic or metabolic disorder leading to progressive bone deterioration. * patients that are immunologically compromised, or receiving chronic steroids (\> 30 days). * patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis. * patients with knee fusion to the affected joint. * patients with an active or suspected latent infection in or about the knee joint. * patients that are prisoners.

Keywords: total knee replacement total knee arthroplasty
influence of medical clown activity on milk production of mothers of premature infants

Conditions: Breast Milk

Summary: the aim of this study is to determine whether medical clown activity enables relaxation of mothers of premature infants, and as a result increases their breast milk production.


Eligibility criteria:
inclusion criteria: * nursing mothers of infants born less than 34th week exclusion criteria: * sick mothers * take medication forbidden during nursing
metabolism after orthopedic surgery

Conditions: Orthopedic Disorder; Metabolism and Nutrition Disorder

Summary: this prospective observational study evaluates changes in resting basal metabolic rate in 51 adult patients undergoing elective major orthopedic surgery (hip, knee, or spine surgery).


Eligibility criteria:
inclusion criteria: * age ≥55 * male and female gender * major elective orthopedic surgery (hip, knee, spinal) * signature of the informed consent exclusion criteria: * inability to follow the study protocol * neuropsychiatric disease, developmental disorders
the ibep study: an intervention for lifestyle modification in women with gestational diabetes

Conditions: Gestational Diabetes; Weight Gain During Pregnancy; Weight Loss After Pregnancy

Summary: the ibep study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. the primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (ibep) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (ogtt) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.


Eligibility criteria:
inclusion criteria: * women diagnosed with gestational diabetes between 20 and 34 weeks gestation exclusion criteria: * women on chronic steroid therapy * women with a diagnosis of gdm \ 34 weeks

Keywords: gestational diabetes
postoperative pain after endoscopic tep vs. lichtenstein hernioplasty in inguinal hernia repair

Conditions: Inguinal Hernia; Hernia

Summary: immediate pain reaction and return to work after tep or lichtenstein hernia repair have not been studied. in this multicenter trial the patients are allocated to surgery using tep (n=50) or lichtenstein (n=50) technique. pain and return to work are recorded postoperatively up to one month. immediate and late complications are also analyzed.

patient characteristics are recorded before surgery. the adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (tep) or open lichtenstein hernioplasty. pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). surgical complications and use of pain killers are carefully recorded. clinical examination is performed if necessary.

Eligibility criteria:
inclusion criteria: clinical diagnosis of symptomatic inguinal hernia age 18-80 exclusion criteria: large scrotal hernia bilateral hernia symptom-free hernia inguinal pain without clinical evidence of hernia asa class≥3
safety and pharmacokinetic study of escalating doses of sp-420, an iron chelator, in patients with β-thalassemia

Conditions: Iron Overload; Beta-Thalassemia

Summary: the purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of sp-420. the study will be conducted in patients with β-thalassemia.


Eligibility criteria:
inclusion criteria: * subject has iron-overload secondary to β-thalassemia requiring chronic red blood cell transfusions and iron chelation therapy * subject weighs ≥35 kg * subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first dose of sp-420 and for the duration of the study * serum ferritin ≥700 ng/ml and iron saturation ≥70% within 3 weeks before baseline (day 1) * cardiac t2\* score \>20 msec within 6 months before baseline (day 1) * willing to use contraception during the study exclusion criteria: * pregnant or breast-feeding * serum creatinine greater than the upper limit of normal * platelet count \<100 × 10\^9/l * use of another investigational drug within the last 30 days * significant cardiac, renal, hepatic dysfunction or other clinically significant conditions that, in the opinion of the investigator, would exclude the subject

Keywords: chelation iron overload thalassemia transfusion iron chelation
high protein and high energy intakes and physical activity on growth of extremely low birth weight infants

Conditions: Infant, Very Low Birth Weight

Summary: the aim of this study is to evaluate the effect of increasing amino acid and energy intake during parenteral and enteral nutrition with and without the stimulation of the infant's physical activity, on growth of extremely low birth weight infants .

increasing protein and energy intake above the anabolic capacity of a given individual may result in increased lipogenesis and excessive fat deposition. adults with reduced mobility or with neuromuscular conditions will develop excessive fat deposition if they receive normal to high protein and energy intakes. excessive fat deposition have been demonstrated in preterm infants receiving high energy intakes. given that physical activity in preterms is often reduced for the prematurity itself, the associated sickness and the numerous medications, the investigators speculate that physical stimulation may have a beneficial effect on protein accretion and on lean mass accretion. the investigators further hypothesize that today's recommended daily intakes of proteins and energy cannot be fully incorporated into lean body mass without a concomitant physical activity. in spite of the fact that this notion is well accepted in adult physiology and in the elderly, it has never been tested in preterm infants. this factorial randomised controlled trial will evaluate the effect of increasing amino acid intake (by 1 g/kg/d) and energy intake (by 20 kcal/kg/d) during parenteral nutrition and also of increasing protein intake and energy intake by an extra 1 g/kg/d during enteral nutrition, with and without the stimulation of the infant's physical activity, on growth of extremely low birth weight infants. the investigators aim at demonstrating that increasing energy and protein intake above the standard of care intakes will result in better growth only in association with adequate physical activity, in particular in relation to body composition and lean mass accretion.

Eligibility criteria:
inclusion criteria: * 24 weeks \< gestational age \< 32 weeks * inborn or outborn admitted before 24 hours of age * parenteral or enteral nutrition start before 48 hours of age * parental consent exclusion criteria: * difficulty in starting physical activity stimulation before 10 days of life * death before 36 w pma * diagnosis of necrotising enterocolitis (before 36 w pma) * any major surgery (before 36 w pma) * congenital syndrome, severe malformations * inborn errors of metabolism * parental consent withdrawn

Keywords: preterm infants, growth, nutrition, physical activity