Kornimate/medical-research-clean huggingface dataset:
amphia premature infant pain study

Conditions: Premature Infant; Breast Feeding, Exclusive; Puncture Skin

Summary: last thirty years, many research was performed concerning pain in the newborn. these investigations showed us the negative effects of pain in the neonatal period. our research concerns the choice of analgesics for the premature newborn during a heel lance. newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. they can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose. the primary objective of the amphia premature infant pain study, is to investigate whether there is a difference in pipp-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. our hypothesis is that the pipp-score will be lower in newborns receiving breast milk compared to sucrose. and the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.


Eligibility criteria:
inclusion criteria: * born at a gestational age between 32+0 and 36+6 weeks, * being nourished with breast milk * the necessity for a clinical blood sample. exclusion criteria: * perinatal asphyxia, * birth trauma, * condition of cardio-respiratory instability, * condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease, * drug abuse of the mother * and application of sedative medication to mother or child.

Keywords: heel lance premature breast milk
biomarkers and validation of selected outcome measures (cmtnsmod)

Conditions: Charcot-Marie-Tooth Disease, Type IA

Summary: cmt is a rare disease for which novel treatments are being developed. evaluation of intervention efficacy is hampered by slow progression and lack of sensitive outcome measures. primary goal of the project is to identify and validate rna and protein derived biomarkers in blood of cmt patients for selected outcome measures over 2 years. the investigators expect to develop more responsive outcome measures and circulating biomarkers to improve assessment of intervention efficacy in forthcoming therapeutic trials.

novel treatments are being developed for cmt. intervention efficacy evaluation is hampered by slow disease progression and lack of sensitive outcome measures. the investigators have previously shown that biomarkers from skin identified in a cmt1a rat model can be translated to cmt1a patients. primary goal is to identify circulating biomarkers correlating with disease severity and progression. 210 young, adolescent and adult patients affected by genetically confirmed cmt1a, will be evaluated with different clinical outcome measures, assessing impairment, disability and quality of life: patients will be re-evaluated at 12 (n=147) and 24 months (n=103) with the same measures to assess disease progression. a number of candidate markers correlating with disease severity have been identified in blood samples from the rat model of cmt1a. at 0-12-24 months a blood sample will be drawn from affected cmt1a patients. the investigators will purify total mrna from blood samples, and validate the 10 strongest regulated markers identified in the rat model via qrtpcr in blood of cmt1a patients. protein biomarkers will also be analysed. marker expression at baseline and at follow up will be correlated with clinical severity and progression. in this translational project (rat/human) the investogators expect to develop more responsive outcome measures and circulating biomarkers to improve assessment of intervention efficacy in forthcoming therapeutic trials.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cmt1a * genetic confirmation of pmp22 duplication (for adults patients) * children aged 3-11, adolescents aged 12-17 and adults aged 18-65 years * signed informed patient consent exclusion criteria: * other causes of neurological and psychiatric disorders * severe internistic disease * patient known or suspected to be alcohol / drug abuser * pregnancy, breast feeding period * permanent vitamin c intake * participation an interventional clinical study up to 4 weeks prior to inclusion

Keywords: biomarkers cmt1a charcot-marie-tooth disease
a study to evaluate the efficacy and safety of eculizumab in guillain-barré syndrome

Conditions: Guillain-Barre Syndrome

Summary: this is a phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe gbs, defined using the hughes functional grade (fg) scale as progressively deteriorating fg3 or fg4/fg5 within 2 weeks from onset of weakness due to gbs. this study will be conducted only at sites in japan.

eligible participants will be randomized to receive intravenous (iv) infusion of eculizumab or placebo at a 2:1 ratio. all participants will be on concomitant iv immunoglobulin g (ig) therapy as per standard of care.

Eligibility criteria:
inclusion criteria: * participants who meet the gbs criteria. * participants who were able to run prior to onset of gbs symptoms. * participants with onset of weakness due to gbs \< 2 weeks before screening. * participants unable to walk unaided for ≥ 5 meters (progressively deteriorating fg3 or fg4 to fg5). * participants who are already on ivig or deemed eligible for and who will start ivig. * participants who can start their first dose of study drug before the end of the ivig treatment period. exclusion criteria: * participants who have previously received or are currently receiving treatment with complement modulators. * participants who have been administered another investigational product within 30 days or 5 half-lives (whichever is longer) prior to providing consent or are currently participating in another interventional study. * participants who have received rituximab within 12 weeks prior to screening. * participants who are being considered for or are already on plasmapheresis. * participants who have received immunosuppressive treatment during the 4 weeks prior to providing consent.

Keywords: eculizumab soliris alexion c5 inhibition therapy
the efficacy and safety of tofacitinib (tf) with iguratimod (igu) on ra

Conditions: Arthritis, Rheumatoid

Summary: ra is a common autoimmune disease that causes joint damage.it is necessary to reach the standard as soon as possible and give effective drugs according to the patient's disease activity to avoid disability. tofacitinib(tf) is a new type of oral tyrosine kinase inhibitor (jaki) for the treatment of moderate to severe active ra. however, there is alack of chinese data on the joint scheme, long-term use, maintenance and stop of tf in the real world. we will use the new jak combination regimen to treat ra patients, and carry out long-term clinical follow-up for 30 weeks.

objective: to observe the clinical efficacy and safety of tf combined with/ without igu for 30 weeks in patients with moderate to severe active ra with different clinical characteristics and subgroups by using a prospective cohort , and to find the best combination scheme of tf.

Eligibility criteria:
inclusion criteria: patients who meet the following inclusion criteria will be eligible to participate in the study: 1. patients who meet ra standards in 1987 and 2010 or era standards in 2012; 2. age \> 18 years old; 3. the extrapulmonary manifestations of ra were stable; 4. patients with nsaids tolerance; 5. das28-esr is highergreater than 2.6. exclusion criteria: patients who meet any of the following criteria will be excluded from the study: 1. patients with acute and chronic infection; 2. platelet count \< 80\*10\^9/l, or white blood cell \< 3\*10\^9/l; 3. alt or ast is 2 times higher than the upper limit of normal value; 4. renal insufficiency: serum cr ≥ 176 umol/l; 5. pregnant or lactating women (breastfeeding); 6. have a history of malignant tumor (the cure time is less than 5 years); 7. patients with severe hypertension and cardiac insufficiency; 8. other diseases or conditions in which immune suppressants cannot be used; 9. people who are allergic to tf.

Keywords: tofacitinib iguratimod
biological factors predicting response to chemotherapy in advanced non small cell lung cancer

Conditions: Non Small Cell Lung Carcinoma

Summary: the primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to who criteria, in patients with non-small cell lung cancer by studying the transcriptome (mirnas and mrnas) and the single nucleotide polymorphism (snps) by using high throughput techniques.


Eligibility criteria:
inclusion criteria: * histological diagnosis of non-small-cell lung cancer (nsclc) * obtention of a biopsy of the tumour according to the procedure defined in the protocol * nsclc of any stage to be treated by standard conventional first-line chemotherapy, as defined in the elcwp guidelines (www.elcwp.org) * presence of at least one assessable lesion * availability for participating in the detailed follow-up of the protocol * signed informed consent. * age above 18 years exclusion criteria: * patient who was previously treated with chemotherapy for nsclc or who has any contra-indication precluding the administration of conventional chemotherapy for nsclc * nsclc treated by exclusive surgery or radiotherapy * a history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)

Keywords: non small cell lung carcinoma chemotherapy response prediction
the effect of acute intermittent hypoxia on motor learning

Conditions: Incomplete Spinal Cord Injury

Summary: the goal of this study is to examine the effect of repetitive acute intermittent hypoxia on motor learning abilities in able-bodied individuals for subsequent study in individuals with incomplete spinal cord injury.


Eligibility criteria:
inclusion criteria: * 18 to 70 years old (the latter to reduce likelihood of heart disease); * medically stable with medical clearance from physician to participate; * motor-incomplete spinal cord injuries at or below c2 and at or above l5; * ais a-d at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, als, tumors, acute transverse myelitis, etc.); * more than 1 year since isci to minimize confounds of spontaneous neurological recovery; * ability to advance one step overground with or without assistive devices; exclusion criteria: * severe concurrent illness or pain; * recurrent autonomic dysreflexia; * history of cardiovascular/pulmonary complications; * concurrent physical therapy; * pregnant at time of enrollment or planning to become pregnant; * untreated painful musculoskeletal dysfunction, fracture or pressure sore; * history of seizures or epilepsy; * recurring headaches; * concussion within the last six months; * depression or manic disorders * metal implants in the head, or pacemaker.

Keywords: spinal cord injury motor adaptation acute intermittent hypoxia
dose-finding and safety of 2 intradermal men-acyw135-conjugate vaccines

Conditions: Meningococcal Disease

Summary: invasive meningococcal disease is a worldwide problem with serious repercussions for those affected. vaccination is recognized as the best way to combat it. the cost of vaccination is prohibitive in many low-resource settings at home and abroad. by harnessing the special immunologic properties of the skin, a dose reduction may be achieved by intradermal administration of the vaccine. the cost savings associated with dose reduction will increase availability of the vaccine.


Eligibility criteria:
inclusion criteria: meningococcal c naive subjects are required to fulfill all of the following criteria: * age ≥ 30 years * good health according to the investigator * willingness and ability to adhere to the study regimen * able to give informed consent meningococcal c experienced subjects are required to fulfill all of the following criteria: * age ≥ 18 years * good health according to the investigator * willingness and ability to adhere to the study regimen * able to give informed consent exclusion criteria: meningococcal c naïve subjects should not have: * known previous invasive meningococcal infection * known or suspected previous vaccination against meningococcal disease * known or suspected allergy against any of the vaccine components * close contact in the last 60 days with a person known to be neisseria positive * history of unusual or severe reactions to any previous vaccination * family history of guillain-barré syndrome * known or suspected immune deficiency, either congenital or acquired * administration of plasma or blood products less than three months prior to inclusion in the study * pregnancy (breastfeeding is allowed) * fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant) * any infectious disease * bleeding disorders or use of anticoagulants * participation as a subject in another trial in the last 3 months meningococcal c experienced subjects should not have: * known or suspected allergy against any of the vaccine components * known previous vaccination with a quadrivalent meningococcal vaccine (either conjugate or polysaccharide) * close contact in the last 60 days with a person known to be neisseria positive * history of unusual or severe reactions to any previous vaccination * family history of guillain-barré syndrome * known or suspected immune deficiency, either congenital or acquired * administration of plasma or blood products less than three months prior to inclusion in the study * pregnancy (breastfeeding is allowed) * fertile female not conforming to prescribed contraceptive use (await first menstruation after vaccination before getting pregnant) * any infectious disease * bleeding disorders or use of anticoagulants * participation as a subject in another trial in the last 3 months
a study to assess the long-term performance of smartset® hv and smartset® ghv bone cements in primary total hip replacement

Conditions: Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis

Summary: the purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, smartset® hv and smartset® ghv, in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be randomly allocated to smartset® hv or smartset® ghv and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments


Eligibility criteria:
inclusion criteria: i) male or female subjects, aged between 18 and 75 years (inclusive). ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) subjects requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component. exclusion criteria: i) subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) women who are pregnant. iii) subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. iv) subjects who have participated in a clinical study with an investigational product in the last 6 month(s). v) subjects who are currently involved in any injury litigation claims. vi) subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's instructions for use.

Keywords: hip bone cement
mometasone vs budesonide in crs with polyposis

Conditions: Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis

Summary: the principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from crswnp who have never been operated.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic rhinosinusitis with nasal polyps * absence of active infection at start of study exclusion criteria: * diagnosis of chronic rhinosinusitis without nasal polyps * diagnosis of recurrent acute bacterial rhinosinusitis * previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries) * cystic fibrosis or ciliary dyskinesia * allergy to corticosteroids * pregnant or lactating women * contra-indication to intranasal steroids
renal effects of melatonin trial in chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: this will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.

investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.

Eligibility criteria:
inclusion criteria: * are between ages 18 and up with chronic kidney disease (ckd) i-iii (stage 3 kidney disease, kidney dysfunction) * random urine microalbumin of 30 mcg or greater (protein in the urine) * have ability to complete a sleep survey * currently not on melatonin therapy. exclusion criteria: * end stage renal disease * ckd stage iv (stage 4 with severe kidney dysfunction) * severe liver disease * chronic dialysis therapy

Keywords: chronic kidney disease
long-term follow-up study of psoriasis patients

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the long-term safety and profile of psoriasis patients who have completed participation in a previous study and who received treatment with medi-507.

this study will evaluate the long-term safety and lymphocyte repletion profile of psoriasis patients who have completed participation in a previous study and who received treatment with medi-507. patients must have had an alc \> 30% lower than baseline (defined as baseline prior to any medi-507 exposure); or an absolute cd4 count of \< 250 cells/ul. this study will also evaluate the development and durability of anti-medi-507 antibodies.

Eligibility criteria:
inclusion criteria: * the patient has previously completed participation (i.e., completed per protocol, including any long term follow-up; or discontinued from the study due to withdrawal of consent, loss to follow-up, or other reason) in a medimmune, inc. study of medi-507 in psoriasis in which they received medi-507 (or placebo for patients who participated in a blinded placebo-controlled study of medi-507, and for whom the treatment assignment in that study has not been unblinded at the time of entry into this study) * the patient had an absolute lymphocyte count (alc) \> 30% lower than baseline (defined as baseline prior to any medi-507 exposure; or, for patients whose treatment assignments have not been unblinded at the time of entry into this study, drug exposure) at his/her final visit (excluding any long-term follow-up visits) in the most recent medimmune, inc. study in which the patient participated; or the patient had an absolute cd4 count of \< 250 cells/ul at his/her final visit (including any protocol-specific long-term follow up) in the most recent medimmune, inc. study in which the patient participated. * written informed consent obtained from the patient exclusion criteria: * there are no exclusion criteria.

Keywords: previously enrolled on a medi-507 for psoriasis
role of hyoscine bromide in latent and active labor

Conditions: Labor, First Stage

Summary: the purpose of this study is to determine whether hyoscine bromide decreases the duration of the active phase of labor.


Eligibility criteria:
inclusion criteria: * age: 18 or more. * term pregnancy. * cephalic presentation. * oxytocin perfusion not present at the time of inclusion. * uterine dynamic established. * abscence of high risk factors or very high risk factors for pregnancy. * written informed consent exclusion criteria: * induction of labor. * presence of risk factors. * patients with hypersensitivity to the active substance or to any of the excipients or any contraindication reflected in technical report.
comparison of plaster of paris against tubigrip for the treatment of lateral ankle sprains

Conditions: Ankle Injuries

Summary: until now very few studies have been done to compare the efficacy of tubigrips or plaster of paris in the treatment of lateral ankle sprains, the investigators aim to compare the tubigrip against plaster of paris in the treatment of lateral ankle sprains.

200 patients were enrolled after meeting inclusion criteria.all patients gave the verbal as well as written consent for inclusion in the study. the hospital committee ethical review board gave the permission for this study. only 126 patients agreed to participate in the study. after informed consent was obtained the patients were randomized such that each patient was allocated to use either a tubigrip (group a) or plaster of paris (group b)using the block randomization. the patients in tg group receive the tubigrip treatment and the patients in pop group were given a below knee plaster cast. patients were instructed to follow up at 2 weeks and then at 6 weeks. the functional score and pain were used as outcomes of the study

Eligibility criteria:
inclusion criteria: * age 18-40 years * grade 1 and 2 ankle sprains * permanent residents in place of study * no concomitant bone pathology * have not been recruited in other trial simultaneously exclusion criteria: * patients with age \<18 years * injury \>48 hours, fractures * multiple injuries * any neurological or musculoskeletal illness * any co-morbid associated with long term disabilities * grade 3 lateral ankle sprains

Keywords: lateral ankle sprain plaster of paris tubigrip
effect of bright light on sex hormones and ovulation in humans

Conditions: Anovulation

Summary: the study investigated whether bright artificial light may influence menstrual cycle and ovulation conclusively, and what underlying hormonal changes for this effect are.

several studies have shown a shortening of the menstrual cycle following light therapy in women with abnormally long menstrual cycles or with winter depression, which suggests that bright light may influence sex hormones and ovulation. the study was designed to investigate this possibility. twenty-two women with slightly lengthened menstrual cycles and without clinically evident endocrine abnormalities completed a study lasting for two menstrual cycles separated by an off-protocol episode of at least 1 menstrual cycle. bright light therapy was administered for a week at home during one experimental cycle, and dim light during another cycle (placebo-controlled, crossover, counter-balanced order). daytime blood sampling and ultrasound scan were performed before and after a week of light therapy, on the \~7th and 14th days after menstruation onset. ultrasound examination was repeated further to document ovulation. serum was assayed for thyroid-stimulating hormone, prolactin, luteinizing hormone, follicle-stimulating hormone, and estradiol. the preliminary results were reported at the sltbr meeting in june, 2005.

Eligibility criteria:
inclusion criteria: * age 19-40 years * mean menstrual cycle 28-38 days * good general health * generally normal sleep-wake regimen * motivated for free participation exclusion criteria: * low cooperation * medications known to interfere with hormone release * clinically evident endocrine abnormalities including the signs of * hyperandrogenism * travel over several time zones during two months prior the study

Keywords: menstrual cycle light therapy sex hormones ovulation