Kornimate/medical-research-clean huggingface dataset:
in vivo lung perfusion for pulmonary metastases of sarcoma

Conditions: Bone Sarcoma; Soft Tissue Sarcoma; Pulmonary Metastases

Summary: sarcoma which has spread to the lungs is most often treated with surgery. even with surgery, most patients will not be cured and will die from their disease, probably because of small cancer cells that are present in the lungs at the time of surgery, but cannot be seen or detected. it is for this reason that we are looking for a better treatment. giving chemotherapy after surgery is generally not recommended because it has significant side effects and no benefit has been proven. this study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. this technique is called in vivo lung perfusion (ivlp). this is a phase i, non-randomized, dose escalation study that will act as a pilot study for a larger prospective, multicenter, controlled clinical trial. patients who have bilateral disease will have one lung undergo ivlp and the other lung will remain untreated with the ivlp (the other lung will be treated as current standard of care - either surgery or radiation) as a control lung. the patients will undergo a posterolateral thoracotomy. lung metastases will be identified by visualization or palpation. after surgical isolation of the lung by proximal control of pulmonary artery and veins, ivlp will be initiated. after 3 hours of ivlp, the lung metastases will be removed in the usual fashion. patients will be cared for post-surgery according to institutional standards. the patients will be followed for up to 2 years. the primary endpoint is safety. secondary endpoints include additional safety endpoints and efficacy.


Eligibility criteria:
inclusion criteria: * diagnosis of soft tissue or osteogenic sarcoma * presence of bilateral pulmonary metastases * 3 or more lung lesions in total * age less than 65 years * ecog 0-2 * absence of extra-pulmonary disease * contralateral disease amenable to surgery or radiation * all lung lesions in the lung to be treated with ivlp can be resected with wedge or segmental resections (non-ivlp treated lung will be treated with radiation or surgery 4-12 weeks prior to ivlp) exclusion criteria: * patient has previously received more than 450 mg of doxorubicin * left ventricular ejection fraction \<50% * history of significant pulmonary disease or pneumonitis * pregnant or lactating females * age 65 years or older, or less than 18 years * inability to understand the informed consent process * hypersenstivity to doxorubicin * current participation in another therapeutic clinical trial * previous lung metastatectomy
management of fetal growth restriction at term: angiogenic factors versus feto-placental doppler

Conditions: Fetal Growth Retardation

Summary: open randomized non-inferiority controlled trial to examine the use of angiogenic factors (instead of feto-placental doppler) for fetal growth restriction at term to reduce the rate of labor inductions, without worsening perinatal outcomes.

pregnant women with estimated fetal weight (efw) \< 10th centile between 36+0 and 37+6 weeks of gestation (wg) will receive complete ultrasonographic assessment consisting of feto-placental doppler, amniotic fluid measurement and biophysical profile assessment. the cases not meeting any exclusion criteria will be offered to participate in this trial. after giving their informed consent a blood sample will be drawn in all of them and they will undergo randomization into two arms. 1. intervention arm: in women allocated to the intervention group, the soluble fms-like tyrosine kinase/placental growth factor (sflt-1/plgf) result will be revealed to the investigators that will act according to the results of sflt/plgf: * fetuses with sflt-1/plgf ≥38, elective delivery will be recommended at ≥37 weeks. * fetuses with sflt-1/plgf \<38, weekly follow up will be recommended until delivery (at ≥40 weeks). 2. control arm: in women allocated to the control group, the sflt-1/plgf result will be blinded to caregivers. routine doppler-based clinical care will be used to counsel women. following the doppler classification: * fetuses with efw below the 3rd centile or below the 10th centile accompanied by any impaired fetoplacental doppler, elective delivery will be recommended at at ≥37 weeks. * fetuses with efw above the 3rd centile without any fetoplacental doppler abnormality, elective delivery will be recommended at at ≥40 weeks. in both arms, fetuses will receive weekly follow-up from randomization to delivery consisting on feto-placental doppler sflt-1/plgf and ctg. if any of the following is present at any time, earlier delivery will be recommended: * sflt-1/plgf ≥38 (only in the intervention group), * absent or reverse end-diastolic flow at the umbilical artery doppler or dv pi\>95th centile * non-reassuring ctg * preeclampsia * diminished fetal movements * biophysical profile ≤ 6 or oligohydramnios (deepest pocket \<2 cm).

Eligibility criteria:
inclusion criteria: 1. pregnant women ≥ 16 years of age. 2. singleton pregnancy. 3. ultrasonographic estimated fetal weight \<10th centile. 4. gestational age between 36+0 and 37+6 weeks. exclusion criteria: 1. major fetal malformations or genetic disorders. 2. fetal death. 3. absent or reverse end-diastolic flow in umbilical artery doppler or dv pi\>95th centile. 4. non-reassuring cardiotocography (ctg). 5. preeclampsia. 6. diminished fetal movements. 7. biophysical profile ≤ 6. 8. oligohydramnios 9. refusal to give informed consent.
the effect of gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early as 1 - 2 days after surgery and this is before any real weight loss has occurred. this suggest that the remission of the diabetes is due to the direct effect of the operation more that the secondary effect of the weight loss. the reason for the major effect on the glucose metabolism after gastric bypass surgery is still unaccounted for. this phd. project will try to unveil some of the mechanisms that could explain the effect of gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes. the hypothesis of the study is that a factor "x" will course the remission of the diabetes. this factor "x" is related to the anatomic changes of the gastro intestinal tract, by eliminating the foods passage through the distal part of the ventricle and the duodenum, in combination with the roux- en-y sling. the phd. project will consist of clinical trails on patients that will undergo gastric bypass surgery. the studies will take place before and within the 1. week after surgery. the investigators will measure different hormones and adipokines in fast and the postprandial state. to discover possible new proteins the investigators will run proteomic on some samples. all the results will be compared to the same parameter on patients undergoing gastric banding, where the anatomy of the intestine hasn't been changed.


Eligibility criteria:
inclusion criteria: * the inclusion criteria in denmark for undergoing gastric bypass and see the above study and cohort description. * well treated hypertension \ 700pmol/l exclusion criteria: * in treatment with antidepressive, dpp-4 inhibitors and intreatment for thyroid problems. * patients treated with insulin.

Keywords: diabetes gastric bypass type 2 diabetes and gastric bypass
non-pharmacological treatment for chronic back pain

Conditions: Low Back Pain

Summary: the working hypothesis is that spa therapy in addition to usual care including home exercises (uche) will result in greater improvements in pain reduction, associated disability and quality of life for chronic low back pain patients. it follows that health resource consumption and linked costs should also be reduced. the primary objective of this study is therefore to compare the therapeutic effect of uche alone versus spa therapy in addition to uche for chronic low back pain.

secondarily, the study will also (i) evaluate the therapeutic effects specific to each spa-centre, (ii) specifically describe effects among subjects who are currently engaged in a professional activity, (iii) evaluate treatment tolerance as well as (iv) per-patient health resource use and associated costs.

Eligibility criteria:
inclusion criteria: * adult patient presenting with chronic low back pain: usual pain of the lumbar region lasting for more than 3 months. this pain may radiate to the buttocks, iliac crest, and does not go past the knee. * patient presenting with a current pain intensity on a visual analogue scale (vas) \> or = 40 mm. * the patient has signed the informed consent * the patient is a beneficiary of a social security programme \[national health insurance\] exclusion criteria: * patients with secondary low back pain * patients with severe depression, psychosis * patients who have already had a spa treatment in the previous 6 months * patients with a contraindication for spa treatment * patients with a professional activity related to hydrotherapy (to avoid any conflict of interest) * patients with sciatic pain beyond the knee (sciatica being a non-indication for spa treatment) * other treatments that may interact according to the judgment of the investigator * patients who live more than 30 km away from the spa

Keywords: low back pain crenobalneotherapy spa therapy mud application water exercises underwater massages
assessment of a weight management program for weight gain in patients with schizophrenia

Conditions: Schizophrenic Disorders

Summary: the purpose of this study is to develop the weight management program, which is combined with healthy diet, proper physical exercise, and behavior modification, related to patient's quality of life. the patients groups are in routine practice with 5-20 mg olanzapine. the study results may be utilized for patients who have gained weight on olanzapine and also other antipsychotic drugs.


Eligibility criteria:
inclusion criteria: * male and female patients between the ages of 18 and 65 years (inclusive) * subjects must meet the dsm-iv criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder * subjects must have been treated with olanzapine (5 to 20 mg/day) for at least 12 weeks prior to study entry and who experienced a weight gain of greater than or equal to 7% of body weight during olanzapine treatment exclusion criteria: * treatment with an injectable depot neuroleptic 14 days before visit 1 * subjects with an panss score greater than 70 * one or more seizures without a clear and unresolved etiology * known diagnosis of dsm-iv substance dependence (except nicotine and caffeine) within the past 2 months, which in the opinion of the investigator is affecting the diet and/or weight of the subject * as a result of liver function test, alt/ast ranges are shown twice the upper limit of the normal reference range
the relationship between upper extremity functionality, trunk control and balance in children with cerebral palsy

Conditions: Cerebral Palsy; Diplegic Cerebral Palsy; Balance; Distorted

Summary: the aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.this study is carried out through eastern mediterranean university faculty of health sciences, department of physiotherapy and rehabilitation, pediatric rehabilitation unit.

23 children with cerebral palsy and 30 healthy children will be included in the study, and the families of all children participating in the study will sign an informed consent form.after signing the consent form from the families of the children included in the study, their demographic information will be recorded and their gross motor function classification system levels will be determined. children's upper extremity functionality will be evaluated with the quality of upper extremity skills test. to determine their functional balance, the single-leg stance test and the four step square test are measured. additionally, balances will be determined by the trunk control measurement scale. evaluations are made using tables and chairs. evaluations take approximately 60 minutes, depending on the condition of the children, and all evaluations will be made one-on-one by the physiotherapist. in the study where power analysis was performed, 50 child evaluations were deemed appropriate. statistical package for the social sciences package program is used to analyze the data. whether the data complies with normal distribution will be evaluated using the shapiro wilk test and histogram graphs. descriptive statistics are given as mean, standard deviation, median, number and percentage. numerical data between groups are compared using student's t test and mann whitney u test. categorical data will be compared using the chi square test. spearman's correlation test was used for correlation analysis, p value \<0.05 will be considered statistically significant.

Eligibility criteria:
inclusion criteria: * between the ages of 8-18, * gross motor function classification system level 1-2, * do not have severe visual or hearing impairment, * does not have any cooperation problems that would hinder communication, * children who have had botulinum toxin-a injection exclusion criteria: * those with gmfc level 3-4-5, * children who had surgery within the last six months were not included in the study.

Keywords: cerebral palsy upper extremity trunk control functionality balance
the pharmacokinetics, safety, and ease of use of a portable metered-dose cannabis inhaler

Conditions: Healthy

Summary: growing evidence supports the use of inhaled cannabis for neuropathic pain; the lack of standard inhaled dosing holds a major obstacle in cannabis becoming a pharmacological treatment for neuropathic pain. the objective of this study is to explore the pharmacokinetics, safety, tolerability, and ease of use of a portable metered-dose inhaler, (i.e. cannahaler) for cannabis in a cohort of 12 healthy volunteers. in a single escalating dose methodology, open-label study, patients will inhale a single 10 ± 0.1 mg / 15 ± 0.1 mg / 20 ± 0.1 mg / 25 ± 0.1 mg dose of cannabis using the kite systems cannahaler cannabis inhaler device. blood samples will be taken at baseline and up to 30 minutes. adverse events will be monitored following the inhalation.


Eligibility criteria:
inclusion criteria: * aged 30-70 years; * healthy * if applicable, negative pregnancy test (β human chorionic gonadotropin pregnancy test). exclusion criteria: * significant cardiac or pulmonary disease, * history of a psychotic or anxiety disorder, * pregnancy, pregnancy attempt or breastfeeding, * presence of a neuropathic or non-neuropathic pain, * low blood pressure, below 90 mm hg (systolic) * diabetes is diagnosed, * first degree family history of psychotic or anxiety disorder, * history of drug addiction, * history of drug misuse, * using the following drugs: rifampicin, rifabutin, carbamazepine, phenobarbital, primidone, * using the following plants: hypericum perforatum, troglitazone, * alcohol consumption up to 12 hours before the study, * abnormal parameters such as heart rate above 100 bpm, blood pressure, below 90 mm hg (systolic), saturation below 91 percent, * cannabis use up to 12 hours before the study, * health condition which could affect or alter the experiment results, * volunteer has a legal guardian. * chronic use of drugs, * age less than 30 or more than 70, * a health condition that could affect the outcome of the trial or constitutes a risk factor for participation in the trial. * the experiment will not include special populations such as pregnant women, children and without judgement.
efficacy of topical morphine in the treatment of severe local pain of chronic wounds

Conditions: Local Pain; Chronic Wounds

Summary: this phase iii study aims to show that topical morphine low doses treats localized pain in chronic wounds, intense and rebellious to systemic analgesics included or not opioids.


Eligibility criteria:
inclusion criteria: * male or female, aged over 18 years * painful chronic wounds (bedsores, wound tumor, arterial ulcers, venous or mixed diabetic ulcer if systolic pressure index \>0.8, necrotic angiodermatitis not graftable), a bottom surface 300 cm² and does not require more than 15 ml of gel by application. when patient has multiple painful chronic wounds, the wound having only the highest pain intensity is considered for evaluation. * ineffective systemic analgesic with or without opioid analgesic established and maintained at the same dose for 3 days before inclusion. if treatment includes morphine, the daily dose should not exceed 60 mg of morphine equivalent and this treatment must be a treatment exclusive background. * patient requiring an analgesic equilibration for intense and rebellious local pain, with a daily average score greater than or equal to 5, on a graduated numerical scale of 0 to 10. the score is defined at the inclusion and corresponds to the pain intensity felt locally by the patient under treatment systemic analgesic with or without co-analgesics. * if analgesics to treat systemic pain is ongoing, it must have been introduced for more than 3 days (according to criteria 3) * if antidepressant treatment is in progress, it must have been established for over a month for a tricyclic and for more than 15 days for other classes of antidepressants. * if an anti-epileptic treatment analgesic is in progress, it must have been established for over 15 days. * signing of the informed consent form. * patient able to respond the self-assessment questionnaires (sufficient understanding assessments, proficiency in french). * patient affiliated to an health insurance plan exclusion criteria: * allergy to morphine or carboxymethylcellulose or history of intolerance to morphine * analgesic at baseline including systemic morphine to greater than 60 mg equivalent dose of morphine treatment * fistulated wound * heavily exuding wound * wound bleeding (spontaneous bleeding) * ongoing radiotherapy on chronic wound * creatinine \> 110 µmol/l, total bilirubin \> 20 µmol/l * not communicating patient * unable to comply with requirement of the protocol (11 days) * patient pregnant or of childbearing age without contraceptive therapy or lactating * person deprived of liberty or under guardianship * only for pharmacokinetic analysis: analgesics at baseline including morphine or hydromorphone or oxycodone or codeine. fentanyl is allowed

Keywords: topical morphine
holotranscobalamin remains unchanged during pregnancy

Conditions: Vitamin B12 Deficiency

Summary: background and objective: plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total tc, holotc) and haptocorrin (total hc, holohc). tc transports cobalamin into the cells. the function of hc is unknown, but in contrast to tc it binds both cobalamins and cobalamin analogues. design and methods: healthy pregnant women (n=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. the protein moiety of tc and hc (total and holo) was measured by in-house elisa methods.

background and objective: plasma cobalamins decrease during pregnancy but it is not fully elucidated how this is reflected in the total and cobalamin saturated transport proteins, transcobalamin (total tc, holotc) and haptocorrin (total hc, holohc). tc transports cobalamin into the cells. the function of hc is unknown, but in contrast to tc it binds both cobalamins and cobalamin analogues. design and methods: healthy pregnant women (n=141) had blood samples drawn at 18th, 32nd, 39th gestation week and 8 weeks postpartum. the protein moiety of tc and hc (total and holo) was measured by in-house elisa methods.

Eligibility criteria:
inclusion criteria: * danish healthy caucasian women \>18 years of age with previous uncomplicated pregnancies and deliveries and presently with a normal pregnancy. exclusion criteria: * \>4 cigarettes smoked per day, * treatment with vitamin b12, folic acid or acetyl salicylic acid, * impaired renal function and clinically significant vaginal haemorrhage before first visit as well as blood haemoglobin \<6.4 mmol/l at first visit.

Keywords: pregnancy holotranscobalamin cobalamin vitamin b12 analogues reference interval
suprascapular nerve block as postoperative analgesia after artroscopic shoulder surgery

Conditions: Pain

Summary: the purpose of this randomized study is to examine the effect of a selective suprascapular nerve block on post operative pain after arthroscopic shoulder surgery. half of the subjects will receive a active nerve block with ropivacain. half of the subjects will receive a placebo nerve block with saline.

postoperative pain management after arthroscopic shoulder surgery traditionally includes opioids and/or an interscalene brachial plexus block(ibpb). opioid consumption often leads to unpleasant side effects including nausea, vomitting and sedation. ibpb offers very efficient pain relief but includes the discomfort of a paralyzed arm. furthermore this approach often also leads to unilateral paresis of the phrenic nerve causing reduced respiratory capacity. the latter offering discomfort and a potential risk in patients with lung diseases or heavy overweight. the suprascapular nerve is the most important nerve to the shoulder and a selective block of this nerve could offer a good pain relief without the mentioned side effects. in this randomized study the investigators wish to examine the pain relieving effect of a selective block of the suprascapular nerve after arthroscopic shoulder surgery. 40 patients are randomized to a block of this nerve with either active drug (ropivacaine) or placebo (saline). all patients will get a pca (patient controlled analgesia) pump for administration of i.v. morphine in doses based on age and weight. patient are being monitored for 6 hours. the primary outcome is reduction in vas at rest from baseline to 30 minutes after nerve block.

Eligibility criteria:
inclusion criteria: * patients planned for arthroscopic shoulder surgery. * age ≥ 18. * asa class ≤ 3. exclusion criteria: * patients with vas never ≥5 mm during the first hour after arrivel to the post anesthesia care unit. * patients unable to cooperate. * patients unable to understand or speak danish. * allergy towards the used drugs. * abuse of alcohol- and/or medicine - investigators assessment. * usage of opioids on a daily basis (not including tramadole). * pregnancy (it is obligatory for all fertile women in the study to take a hcg urine test). * operations involving the clavicle. * operations converted to open surgery.

Keywords: peripheral nerve blocks