Kornimate/medical-research-clean huggingface dataset:
cerebrospinal fluid proteom in dependence of intranasal breast milk

Conditions: Hydrocephalus in Infants

Summary: investigation of the cerebrospinal fluid proteom in preterm infants with posthemorrhagic hydrocephalus in our neonatology center with analysis for modulation of proteom in dependence of breastmilk feeding and way of application such as via gavage tube, oral or nasal application.

since the nasal route might be highly effective for neurotrophins and other growth factors the cerebrospinal fluid will be investigated using mass spectrometry to identify modulating effects of intranasal breast milk application on the cerebrospinal fluid proteom.

Eligibility criteria:
inclusion criteria: * preterm infant with hydrocephalus and regular drainage exclusion criteria: * inborn error of metabolism
an observational study of avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced ovarian cancer (oscar 1)

Conditions: Ovarian Cancer

Summary: this multicenter, prospective, observational study will evaluate the safety and efficacy of avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. eligible patients will be followed for approximately 15 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy * initiating avastin in combination with chemotherapy exclusion criteria: * contraindications, warnings and precautions for use as specified in the avastin summary of product characteristics
dt-168 in keratoplasty patients with fuchs endothelial corneal dystrophy

Conditions: Fuchs Endothelial Corneal Dystrophy; Fuchs

Summary: the purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of dt-168 ophthalmic solution in pre-keratoplasty patients with fuchs endothelial corneal dystrophy.


Eligibility criteria:
inclusion criteria: * participant is scheduled to undergo a keratoplasty for management of fecd independent of this study. * ≥30 years of age (inclusive). * documented diagnosis of fecd in the study eligible eye. * confirmation of positive tcf4 allele 18.1 ctg expansion in at least one allele. * capable of giving signed informed consent. exclusion criteria: * any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation. * any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator. * concurrent or anticipated need for treatment for fecd, eg, muro 128 (2% or 5%) during the course of the study in the study eye. provided the subject undergoes a washout of muro drops for at least 24 hours prior to the baseline visit, they will not be excluded. * concurrent or anticipated use of topical corticosteroids in the study eye. * concurrent use with rhopressa®, rocklatan®, or any other ocular rho kinase inhibitor. * known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study. * use of contact lenses in the study eye within 7 days prior to the baseline visit or planned use during the study. * recent (within 30 days of the screening visit) or ongoing participation in any other investigational interventional clinical study. * female participant is pregnant, planning a pregnancy, or breast-feeding. * participant is unwilling to comply with the contraceptive requirements, as per protocol.
correlation between serum vitamin d3 and incidence of uterine leiomyoma

Conditions: Vitamin D Deficiency; Leiomyoma

Summary: the aim of the current study is to evaluate the association between low serum vitamin d level and incidence of uterine leiomyoma in egyptian women as the research hypothesis that low serum vitamin d is considered a risk factor for uterine leiomyoma


Eligibility criteria:
inclusion criteria: 1. age ranging from 20 to 45 years. 2. postmenstrual patients to exclude current pregnancy. 3. parity up to para 3 by either normal vaginal delivery or cesarean section. 4. body mass index (bmi) ranging from 18 to 30 kg/m2. 5. one or more uterine fibroid with a diameter ranging from 3-10 cm. 6. fibroids either subserous, intramural or submucous uterine fibroids exclusion criteria: 1. women aged less than 20 years have a very low incidence of fibroids or more than 45 years as there is an increased incidence of vitamin d deficiency after this age. 2. patients known to be currently pregnant due to change in fibroids volume during pregnancy in addition to vitamin d levels may be lower than baseline for nonpregnant ones. 3. grand multipara \>3 times frequently associated with vitamin d deficiency. 4. cardiac( e.g rheumatic heart diseases), pulmonary( e.g asthma, bronchiectasis ), or hematological disease (including anemia; hemoglobin level below 10gm/dl , thalassemia, sickle cell anemia, and spherocytosis) because of high association between chronic illnesses and multivitamin deficiency. 5. patients who receive pre-operative hormonal therapy (such as gnrh analogue) which may increase vitamin d levels and interfere with the study objectives. 6. patients who will present with a suspected malignant gynecological disease which is usually associated with multiple vitamin deficiencies including vitamin d. 7. patients who will be diagnosed as having cervical or supracervical fibroids and pedunculated fibroids (study will be limited on corporeal fibroid). 8. small fibroid less than 3cm diameter may not be enough size to cause changes in lab results or large ones more than 10 cm diameter. 9. previous myomectomy or hysterectomy. 10. using vitamin supplements or hormonal therapy during or within 6 months of enrolment which may interfere with the accurate results of the study. 11. current lactating or lactating within 6 months prior to enrollment as breastfeeding women have a significantly higher prevalence of vitamin d deficiency. 12. current smokers or history of smoking as it decreases the production of the active form of vitamin d. 13. steroids intake as it increases the 24-hydroxylase level causing vitamin d deficiency. 14. cases diagnosed with any form of malignancy that may be associated with vitamin d deficiency. 15. current treatment with heparin as it interferes with vitamin d activation. 16. patients currently on depo-medroxyprogesterone-acetate (dmpa) contraceptives as it proved benefits in shrinking fibroid size.
phase 3 study comparing iop lowering in oag or oh in japanese subjects c-01-98

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to evaluate safety and efficacy of two different iop lowering medications after twelve months of treatment in japanese subjects.


Eligibility criteria:
adults of japanese ethnicity

Keywords: open-angle glaucoma ocular hypertension poag iris pigmentation japanese
treatment of immune checkpoint inhibitor-related diarrhea and/ or colitis with ustekinumab in cancer patients

Conditions: Cancer

Summary: the goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.

primary objectives: to assess the efficacy of ustekinumab for clinical remission/response of immune-related diarrhea and/or colitis to assess the efficacy of ustekinumab in reducing fecal calprotectin levels secondary objectives: to assess steroid free imdc remission by week 4 and 8 to assess the imdc recurrence by week 4 and 8 to assess the time duration to imdc recurrence and overall survival to assess the efficacy of ustekinumab to achieve endoscopic remission of immune-related diarrhea and/or colitis to identify immune signatures related to gi iraes and those specific to responsiveness to ustekinumab to identify pro-inflammatory immune signatures in serum to assess patient symptom and qol

Eligibility criteria:
inclusion criteria: 1. patients who receive any type of ici therapy 2. patients with ≥ grade 2 immune-related diarrhea and/or colitis according to the common terminology criteria for adverse events (ctcae) version 5.0 within 45 days prior to enrollment in study 3. patients with ability to understand and willingness to sign informed consent 4. patients with a diagnosis of any type of solid tumors on ici systemic therapy 5. no concern for active concomitant gi infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation 6. patient who has been cleared for enrollment by infectious diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive t-spot due to bcg inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment 7. concurrent or prior cancer therapy (non-checkpoint inhibitors) that are not deemed as a significant contributor of the gi adverse event can be allowed in the study. exclusion criteria: 1. patients younger than 18 years of age 2. patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics 3. patients on concurrent immunosuppressive therapies other than what will be given for colitis 4. patients with history of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation 5. pregnant and breastfeeding women 6. women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to enrollment in study 7. patients who develop concurrent non-gi toxicity at the time of study treatment initiation 8. patients have already received other biologic treatment for imdc such as infliximab, vedolizumab
ropivacaine plus magnesium sulphate infiltration

Conditions: Thyroid Diseases; Parathyroid Diseases; Postoperative Pain; Anesthesia, Local

Summary: in the domain of endocrine gland surgery, thyroidectomy is the most common procedure. patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. the other two causes are endotracheal intubation and neck overextension. incisional pain, odynophagia, dysphagia, neck and shoulder pain have all been reported as sources of discomfort.however, it seems that this discomfort has a time limit, with a considerable decrease in pain scores that will last 24 to 36 hours. pain is felt more profoundly within the first few hours after surgery, peaking at 6 hours, with patients requesting further analgesic medication. surgical wound infiltration can inhibit this procedure by preventing the alginate signal from reaching the incision site's receptors. according to the multimodal analgesia trends, magnesium sulfate can be added to the ropivacaine solution. magnesium acts as an nmda (n-methyl-d-aspartate) receptor antagonist, inhibiting cerebral sensitization to peripheral pain stimuli while reducing pre-existing hyperalgesia. it becomes evident that this combination could contribute to attain the maximum analgesic efficacy. so, if any superiority of ropivacaine plus magnesium sulphate over ropivacaine could be demonstrated this would be very helpful in providing sufficient analgesic effects with a low incidence of adverse effects, while enhancing the option of one day surgery.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * surgical indication for total thyroidectomy * surgical indication forparathyroidectomy exclusion criteria: * patients \< 18 years old * prior neck operation * lateral neck dissection * patient with history of chronic opioid use * patient with chronic pain syndromes * patient with allergy to ropivacaine

Keywords: thyroidectomy parathyroidectomy local wound infiltration ropivacaine magnesium sulphate
effect of nurse-led individualized follow-up intervention on patients with nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the incidence of nasopharyngeal carcinomas (npcs) is highly unbalanced around the globe, primarily concentrated in east and southeast asia.there is no well-conducted, larger randomized controlled trials (rct) outlining a gold standard for follow-up programs ensuring early detection of recurrence, good management of symptoms and cost-effectiveness. the primary aim of this randomised, controlled trial is to test whether a nurse-led individually tailored symptom management program will significantly reduce reported symptoms among npc patients following primary treatment compared to physician-led scheduled follow-up. additionally, the investigators will assess patient activation (self-management), anxiety, depression, fear of recurrence, work abilities, recurrence times, changes in health behavior, and health care utilization and costs for the two arms of the study. a nurse-led education program focused on symptom management is provided to patients, along with an electronic platform to report symptoms to nurses and support in symptom management.

it is planned to recruit 250 primary npc patients from fujian cancer hospital's oncology departments during an 18-month period, after completing the chemoradiotherapy for npc. you will participate in a five-year study in which you are randomly assigned to either the nurse-led intervention or the physician-led intervention. regardless of group assignment, you will follow the national nasopharyngeal carcinoma screening program. both the control and intervention arms will use questionnaires, clinical databases, and national registers to collect data for 5 years after inclusion both in the control and intervention groups. the primary and secondary outcomes are measured using questionnaires in both groups, whereas patient reported outcomes (pro) are collected only in the intervention group. relapsed patients will not be asked to complete the remaining outcome questionnaires or pros since they quit the follow-up program to pursue recurrent treatment. if pros reveal a need, or if the patient requires consultation, the nurse or project physician will be consulted.

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent; 2. have completed radiotherapy treatment for loco-regional nasopharyngeal carcinoma without clinical sign of distance metastatis; 3. aged 18 years and above; 4. expected survival ≥6 months; 5. read, understand chinese characters and speak mandarin. exclusion criteria: 1. previous history of other malignancies, mental illness or cognitive impairment (mmse score \< 27 points); 2. unstable medical or psychiatric conditions 3. inability to communicate effectively in mandarin 4. pregnant women or lactating women.

Keywords: nasopharyngeal carcinoma nurse-led individualized follow-up post-radiotherapy
observational study of patients using novomix® 30 or levemir® for treatment of type 1 or type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using novomix® 30 or levemir® under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * levemir® above 6 yrs * novomix® 30 above 18 yrs * patients with type 1 or type 2 diabetes, including newly diagnosed exclusion criteria: * current treatment with novomix® 30 or levemir®
study of acute normovolemic hemodilution (anh) in people with ovarian cancer who are having cytoreductive surgery

Conditions: Ovarian Cancer; Fallopian Tube Carcinoma; Ovarian Carcinoma; Peritoneal Carcinoma; Ovarian Cancer Stage IIIC; Fallopian Tube Cancer Stage IIIC; Ovarian Cancer Stage IV; Fallopian Tube Cancer Stage IV; Fallopian Tube Cancer; Peritoneal Cancer

Summary: participants will be scheduled for primary cytoreductive surgery as part of their standard care. before surgery, participants will be assigned by chance to a study group. depending on which group they are in, they will receive either acute normovolemic hemodilution/anh during surgery or standard surgical management during surgery. the researchers think acute normovolemic hemodilution/anh may decrease the need for allogenic blood transfusion/abt in people having primary cytoreductive surgery.


Eligibility criteria:
inclusion criteria: * adults (≥18 years) * bloods score ≥2 as calculated by surgeon * high preoperative suspicion (or diagnosis) of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage iiic or iv), as determined by ct or mri of the abdomen/pelvis * planned for exploratory laparotomy and primary or interval cytoreductive surgery * preoperative hemoglobin concentration ≥10 mg/dl within 45 days of surgery * patients scheduled for cytoreductive surgery, with or without other planned procedures o note: patients scheduled for diagnostic laparoscopy should not be included exclusion criteria: * a history of active coronary artery disease o patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal lv function within 45 days of surgery. * a history of cerebrovascular disease * a history of congestive heart failure * a history of uncontrolled hypertension * a history of restrictive or obstructive pulmonary disease * a history of renal dysfunction (cr \>1.6 mg/dl) * abnormal coagulation parameters (inr \>1.5 not on coumadin, or platelet count \<100,000 mcl) * presence of active infection * evidence of hepatic metabolic disorder (bilirubin \>2 mg/dl, alt \>75 u/l in the absence of biliary tract obstruction) * preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery * refusal to accept allogenic or autologous blood transfusion

Keywords: ovarian cancer ovarian carcinoma ovarian cancer stage iiic ovarian cancer stage iv fallopian tube cancer fallopian tube carcinoma fallopian tube cancer stage iiic fallopian tube cancer stage iv peritoneal cancer peritoneal carcinoma acute normovolemic hemodilution memorial sloan kettering cancer center 23-392
standardization of d2 lymphadenectomy and surgical quality control: klass-02-qc

Conditions: Gastric Cancer

Summary: gastric cancer is one of the most common cancers in korea. having achieved excellent long-term survival for early gastric cancer patients, there is a growing interest in improving the quality of life of these patients without compromising their prognosis. laparoscopic surgery for early gastric cancer have been found to be safe and feasible with superior short-term outcomes. although laparoscopic gastrectomy with d2 lymphadenectomy is being performed for patients with locally advanced gastric cancer; the completeness of the d2 lymphadenectomy during laparoscopic surgery has not been evaluate and no standardized procedure exists. to conduct a clinical trial comparing laparoscopic d2 lymphadenectomy to the open approach, quality control of d2 lymphadenectomy procedure is necessary.


Eligibility criteria:
inclusion criteria: * patients must have documented diagnosis of gastric cancer * patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by evaluation of preoperative ct-scan, upper endoscopy, or endoscopic ultrasound. * patients undergoing gastric cancer surgery without plans for combined operations, such as resection of another organ for another primary disease. * patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study exclusion criteria: * patients without mental competence * patients who are illiterate * patients who are pregnant * patients \ 80 years old
open label high dose ropinirole (requip) study for patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this research study is to see if subjects with parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of requip as compared to the maximum fda approved dose of dopamine agonist drugs (including requip, mirapex, and permax). requip as used in this study is investigational, which means it has not been approved by the us food and drug administration (fda) at this dose level.


Eligibility criteria:
inclusion criteria: * patients must give written informed consent prior to any specific study procedures. * males or females; females of childbearing age who are not currently pregnant must agree to use a medically accepted method of contraception throughout the study. * age greater than or equal to 25 years. * patients must be on a maximum dose of dopamine agonist drug (pergolide 4mg/day, pramipexole 4.5 mg/day or ropinirole 24mg/day). * stable dose of all medications for 4 weeks. exclusion criteria: * current hallucinations. * history of disabling hallucinations or hallucinations in past requiring treatment. * troublesome edema (swelling). * unstable depression. * female who is pregnant or lactating. * use of an investigational drug with in the last 30 days. * other inclusion or exclusion criteria to be evaluated by the physician.

Keywords: ropinirole parkinson's disease dopamine agonist