Kornimate/medical-research-clean huggingface dataset:
the role of vac therapy devices in promoting closure of enterocutaneous fistulae

Conditions: Fistulae

Summary: this study hopes to determine if a negative pressure dressing is superior to a traditional dressing for speeding fistula closure after laparotomy. this study has a broad variety of implications. patient safety is a paramount concern: investigators hope to identify a superior method of wound management which minimizes risk for skin breakdown, sepsis, and morbidity. in addition, patient satisfaction would be improved with a method for faster wound healing. finally,implications exist in the realm of a cost-benefit analysis, for example, although the vac method is more costly, it may save money if it speeds healing and prevents the need for reoperation. alternatively, if the vac method is not shown to be beneficial, physicians can avoid using a more costly device with no proven benefit.

investigators are planning a superiority trial to show that vac use speeds the closure of enterocutaneous fistulae over routine gravity drainage. the investigators' design is a randomized controlled trial with two arms. one of the arms (non-vac) will include patients assigned to a system of ecfoutput management which does not involve negative pressure (for example, an ostomy bag placed over the fistula, wet to dry dressing changes, etc..), and the second arm (vac) will consist of a group of patients assigned to vac negative pressure therapy with regular sponge irrigation with normal saline (the v.a.c.ulta™ negative pressure wound therapy system) . the fistula vac is made from standard sponge supplies and negative pressure suction devices. initial placement will be by the bedside physician in the intensive care unit, the ward, or in the clinic. the patient will be taught basic wound care, and as is typical for those outpatients with wound vacs, a home nursing aide will be arranged. those randomized to no vac therapy will have ostomy bags or wet to dry dressings placed on the skin with no negative pressure applied. again, initial application will be performed by the bedside physician or a wound care nurse. the patient will be taught wound care, with assistance provided as necessary. once a fistula is noted to have closed (effluent = 0cc/day) the dressings or vac will be discontinued, and the date of fistula closure noted.

Eligibility criteria:
inclusion criteria: * post-laparotomy patient developing a new enterocutaneous fistula exclusion criteria: * patient with a prior history of abdominal radiation * patient with a distal obstruction, any entero-atmospheric fistula, or any patient with a history of intra-abdominal or metastatic cancer.
tislelizumab in combination with tace in advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with tace as first-line treatment in patients with unresectable bclc stage c hcc.

this is a multicentric, open-label, single-arm prospective study to assess the efficacy and safety of tislelizumab combined with conventional transarterial chemoembolization(ctace) as first-line treatment in bclc stage c hcc patients without extrahepatic spread. the primary endpoint is time to progression (ttp).

Eligibility criteria:
inclusion criteria: 1. 18-70 years old on the day the patients voluntary to participate in the study and signing in icf. 2. histological or clinical diagnosis of hcc. 3. bclc stage c patients ineligible for surgical resection or liver transplantation. 4. no prior systemic therapy for hcc (including immunotherapy). 5. have at least one uni-dimensional lesion measurable by ct scan or magnetic resonance imaging per mrecist. 6. child-pugh a-b7. 7. ecog ps 0-1. 8. adequate hematological function (absolute neutrophil count ≥ 1.5 x 109/l, platelets count≥50 x109/l, and hemoglobin ≥85 g/l); adequate hepatic function (both ast and alt ≤ 3 uln, serum total bilirubin ≤ 34.2 umol/l or 2mg/dl, serum albumin ≥ 29g/l); adequate renal function (egfr \> 30 ml/min/1.73 m2) 9. for patients with hbv or hcv infection, hbv dna less than 500 iu/ml (2500 copies/ml) or hcv rna detectable. 10. life expectancy of more than 3 months. 11. patients must be able to understand and willing to sign a written informed consent document. 12. patients suitable for tace therapy assessed by investigators. exclusion criteria: 1. tumor thrombus involving main trunk of portal vein or inferior vena cava. 2. prior local-regional therapy before beginning of study treatment (surgery or ablation allowed at bclc stage 0-b) or radiotherapy on liver cancer. 3. disease history of grade 2 or more hepatic encephalopathy. 4. extrahepatic metastasis on baseline imaging. 5. hiv infection or syphilis. 6. prior therapies with any anti-pd-1, anti-pd-l1, anti-pd-l2 or anti-ctla-4 agents. 7. tumor diffuse.

Keywords: tace tislelizumab
volatile organic compounds in exhaled air and sweat of patients treated by immunotherapy for lung cancer: research on biomarkers for early therapeutic response

Conditions: Lung Cancer, Non-small Cell

Summary: the study of volatile organic compounds (voc) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. the volatolomic analysis can be done either by the technique of the mass spectrometry which allows the identification of each voc in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the voc without identifying them. the voc have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases. immunotherapy is a new therapeutic approach used in non small cell lung cancer in a late stage. voc analysis could allow to identify biomarkers of early response to immunotherapy. the study of voc could help in the optimisation of immunotherapy prescription in lung cancer.


Eligibility criteria:
inclusion criteria: * patient aged \> 18 years old * patient with metastatic non-small cell lung cancer with marketing authorisation criteria for immunotherapy * preserved overall condition (performans status 1) * signed informed consent * patient with healthcare insurance non inclusion criteria: * patient with oxygen therapy or invasive ventilation * patient unable to perform a slow vital capacity * systemic corticosteroid therapy more than 10 mg per day of prednisone equivalent * previous treatment with immunotherapy * dermatological therapy interfering with sweat collection (psoriasis, irritant dermatitis, for instance) * patient deprived of liberty by judicial or administrative decision
emergency contraception and body weight: pilot study

Conditions: Contraception; Body Weight

Summary: the purpose of this research study is to determine how body weight changes the drug level of an emergency contraceptive pill containing a hormone called levonorgestrel (lng). this emergency contraceptive is available to women without a prescription, but has recently been found to not work as well to prevent pregnancies in women of higher body weight. the overall goal of this research is to improve the effectiveness of contraception for women, no matter their weight.

to determine if differences exist in the pharmacokinetics (pk) of levonorgestrel-based emergency contraception (lng-ec) in obese and normal body mass index (bmi) users and test whether doubling the dose of lng-ec in obese women increases total and free lng serum concentrations. we enrolled healthy, reproductive-age women with obese and normal bmis received 1.5 mg lng orally and then in a subsequent menstrual cycle, the obese group also received 3 mg lng. total and free lng pk parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5 h. the primary outcome was the difference in total and free lng concentration maximum (cmax) between ecx1 and ecx2 in the obese group.

Eligibility criteria:
inclusion criteria: * subjects are between the ages of 18 and 35 * subjects are in good general health * subjects have regular menstrual cycles (between 21 and 35 days) * subjects are willing to use condoms (if you are sexually active with a male partner), subjects are willing to not have sex with men during the study, or subjects have had a tubal ligation (or have a partner who has had a vasectomy) or subjects have a copper intrauterine device (iud). exclusion criteria: * metabolic disorders including uncontrolled thyroid dysfunction and polycystic ovarian syndrome * impaired liver or renal function * actively seeking or involved in a weight loss program (must be weight stable) * pregnancy, breastfeeding, or seeking pregnancy; recent (8 week) use of hormonal contraception * current use of drugs that interfere with metabolism of sex steroids * smokers.

Keywords: emergency contraception obese bmi normal bmi
proprioception, muscle strength and kinesiophobia after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Reconstruction

Summary: fear of re-injury after anterior cruciate ligament reconstruction surgery (aclr) affects individuals' return to sports and physical activity negatively. the aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

factors such as graft type, patient age, activity level and athletic experience, as well as psychological factors such as psychological readiness for return to sports, fear of re-injury, and motivation during the rehabilitation process, affect returning to sports after aclr. fear is a psychological reaction that occurs after injury and is clearly seen during the period when athletes continue to actively participate in sports. individuals' confidence in their knees and pain after surgery affect their fear of movement. while kinesiophobia provides benefits in protecting injured body parts in the acute phase of pain, it can lead to inactivity, emotional stress and risk of re-injury in the long term. kinesiophobia changes the biomechanics of movements and pain perception. insufficient muscle strength and instability in the knee negatively affect confidence in the knee. the aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

Eligibility criteria:
inclusion criteria: * between the ages of 18-35 * history of acl reconstruction surgery at least 6 months ago exclusion criteria: * history of previous lower extremity surgery * history of lower extremity injury within the last 6 months * having a vestibular or neurologic pathology that would affect balance
genetic predictive model based on single nucleotide polymorphisms in the dna repair pathway and drug metabolis/transport pharmacogenetics in the prediction of response and treatment outcomes in acute myeloid leukemia

Conditions: Patients With Acute Myeloid Leukemia; Patients Receiving Induction/Consolidation Chemotherapy

Summary: the main component in the treatment of acute myeloid leukemia (aml) is consist of anthracycline (such as daunorubicin or idarubicin) and cytarabine. inter-individual variability of transport/metabolism of the chemotherapeutic agent and several genetic pathways involved in the drug action might be associated with different response following the treatment for aml usually consisted of chemotherapy and/or transplantation. one of potential pathways involved in the drug action is dna repair pathway, accordingly single nucleotide polymorphisms (snps) in the dna repair machinery pathway might be a predictive marker for therapy outcomes in aml. several genes were involved in the dna repair machinery which are 1) nonhomologous end joining (nhej) pathway involved in the g1/s phase, 2) homologous recombinational repair (hrr) pathway involved in the s/g2 phase. xrcc4, lig4, mrn and atm are well known genes involved in the nhej pathway, while mre11, rad50, nbs1 (mrn), rad51, xrcc2, xrcc3, rad51b, rad51c, rad 51d, rad52 or rad54 are known to be associated with hrr pathway. a study suggested that the snps in the dna repair pathway was involved in the susceptibility of secondary aml developing after chemotherapy or autologous hematopoietic stem cell transplantation, thus these snp markers could become a predictive marker for secondary aml. however, it has never been investigated for multiple candidate pathways simultaneously with relateively larger number of patients. accordingly, the current study attempts to investigate the potential role of the genotype markers in multiple candidate pathways, esp. focused on the dna repair machinery, with respect to response following chemotherapy or survival of aml patients. total of over 500 archived samples from the patients diagnosed as acute myeloid leukemia at the samsung medical center, seoul, korea will be included, and genomic dnas will be extracted and will be examined for their genotypes of the candidate snps involved in the dna repair pathways. then statistical analysis will be pursued for single marker analysis, haplotype analysis and for the construction of genetic risk model based on the multivariate analysis.


Eligibility criteria:
inclusion criteria: * patients with acute myeloid leukemia * 15 years or older * patients treated with induction/consolidation chemotherapy * patients with available bone marrow sample exclusion criteria: * acute biphenotypic leukemia
a phase 4 study to assess the impact of patient support program on health related quality of life and adherence in subjects with relapsing-remitting multiple sclerosis administered rebif® with the rebismart™ device

Conditions: Multiple Sclerosis; Relapsing-Remitting

Summary: this is a randomized, comparative, and multicenter study to assess the impact of a patient support program (minsupport plus) on health related quality of life (hrqol) and adherence in subjects with relapsing-remitting multiple sclerosis administered rebif® with the rebismart™ device.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 or older * a diagnosis of relapsing-remitting multiple sclerosis according to the revised mcdonald criteria (2010) * treatment with rebif® 22 or 44 mcg subcutaneously three times a week in accordance to the summary of product characteristics * rebif® administered by the rebismart™ device * provided a signed informed consent form exclusion criteria: * has received any components, except for technical support, of minsupport plus prior to study entry * has difficulty reading and/or understanding swedish * has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude * no access to computer * participation in another clinical study

Keywords: multiple sclerosis relapsing-remitting rebif rebismart patient support program
swiss study on spider bites

Conditions: Spider Bite

Summary: about spider bites in middle europe, there are published only a dozen cases. the investigators suspect that they may be much more frequent than reflected by the literature analysis (but much less dangerous than thought by people). from june 1st 2011 to november 30st 2012 the investigators collect clinical data on patients treated for spider bites in switzerland.

inclusion criteria: every human treated for suspected spider bite in switzerland willing to participate this study.

Eligibility criteria:
inclusion criteria: * adult or child treated for a suspected spider bite in switzerland exclusion criteria: * unwillingness to participate to the study

Keywords: humans insect bites
[ksr-001-p02] phase 2b/3 study, evaluate the efficacy and safety of ksr-001 in patients with dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate the efficacy and safety of ksr-001 in patients with dry eye syndrome


Eligibility criteria:
inclusion criteria: 1. male and female who over 19 years old 2. those who have had symptoms of dry eye for at least 6 months (foreign body sensation, dryness, glare, pain pain, blurred vision, etc.) and those whose symptoms do not improve with conservative treatment such as artificial tears 3. those who meet below criteria at least one of two eyes * those who have over than score 4 in corneal staining test * tear secretion test without anesthesia(schirmer test) result would be under 10mm/5min (if the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye) 4. both eyes, the corrected visual acuity is 0.2 or more 5. written consent voluntarily to participate in this clinical trial exclusion criteria: 1. during this clinical trial period, when rebamipide treatment is expected due to gastrointestinal disorder or gastritis 2. within 90 days of the screening visit, if systemic steroid steroids or systemic immunosuppressants were used 3. within 90 days of the screening visit, if there is a history of other ophthalmic surgeries including the use of punctum plugs or puncture closure surgery 4. if it is a clinically significant ophthalmic disease that is not caused by dry eye syndrome and may affect the interpretation of the results of this clinical trial 5. within 90 days of the screening visit, those who have undergone vision correction surgery such as lasik or lasik 6. those with intraocular pressure (iop) exceeding 21 mmhg or with glaucoma undergoing drug treatment 7. those with hypersensitivity to the ingredient of this clinical trial drug 8. patients planning to wear contact lenses during the clinical trial period 9. in the case of one of the following * creatinine level more than twice the upper limit of normal range * ast or alt levels greater than twice the upper limit of normal range 10. history of malignancy (except for cases where there has been no recurrence for more than 5 years after surgery) 11. within 1 year before screening, those who have been diagnosed with alcohol or drug abuse and are receiving treatment 12. in the case of women of childbearing potential, those who do not consent to contraception by a medically accepted method of contraception during the clinical trial period (iud, intrauterine device or ius, intrauterine system), tubal ligation, double blocking method (male condom, female condoms, cervical caps, contraceptive diaphragms, and combination of blocking methods such as contraceptive sponges) 13. pregnant or lactating women 14. within 30 days before participating in the clinical trial, those who have applied other clinical trial drugs or medical devices 15. patients judged by other investigators as unsuitable to participate in this clinical trial
group therapy versus individual therapy for tourette syndrome and chronic tic disorder

Conditions: Chronic Tic Disorder

Summary: chronic tic disorder (ctd) may have a huge impact on life quality. habit reversal training (hrt) and exposure response prevention (erp) are effective therapeutic modalities. this study examined the effect of a combined treatment using both hrt and erp in children and adolescents with ctd. the treatment outcome was examined as an individual treatment compared to a group setting. there was no control group. the study examined both acute outcome and outcome at one year of follow-up. predictive factors for treatment outcome were evaluated.

chronic tic disorder (ctd) may have a huge impact on life quality. habit reversal training (hrt) and exposure response prevention (erp) are known to be effective therapeutic modalities. little is known about the effect of group therapy, the effect of combining hrt and erp training, and of the long-term effect of treatment. this study therefore wanted to examine the effect of a combined treatment using both hrt and erp in children and adolescents with ctd. the participants were randomized to treatment either in groups or in an individual setting. the parents were included in the training programme. the participants were asked to fulfill questionnaires concerning anxiety, mood, life quality, their thoughts about tics and the experienced premonitory urge. furthermore, they were interviewed with the semistructured interview yale global tic severity scale (ygtss). data was obtained from patient files as to examine possible predictors of both acute and long-term treatment effects. the evaluators were a specialized psychologist and a child and adolescent psychiatrist with several years of experience in diagnosing, evaluating and treating tic disorders. a random sample of 10% were audiotaped and evaluated by another rater with extensive experience and expertise in the use of the ygtss. the evaluator was not blinded to the treatment allocation, yet not involved in the treatment of the patient, and blinded to any previous evaluations

Eligibility criteria:
inclusion criteria: * a primary diagnosis of either tourette syndrome or a chronic motor/vocal tics disorder * moderate or greater severity corresponding to a total score on the yale global tic severity scale (ygtss) higher than 13 (higher than nine if only motor or vocal tics were described) exclusion criteria: 1. disorders that required immediate treatment * psychotic disorder * primary severe depression * suicidal ideation or attempts * primary severe anorexia nervosa 2. disorders that makes participation difficult * iq below 70 * a life-time diagnosis of pervasive developmental disorder 3. treatment with hrt or erp during the last six months.

Keywords: habit reversal training exposure response prevention children and adolescents
pulmozyme to improve covid-19 ards outcomes

Conditions: COVID

Summary: this is a randomized double-blind placebo-controlled phase ii trial of recombinant human deoxyribonuclease i (rhdnase i) - pulmozyme - in mechanically ventilated patients with covid-19 pneumonia. patients admitted to the icu with severe covid-19 pneumonia who require mechanical ventilation will be invited to participate in this study. potential subjects will be identified from medical record review or from direct contact with physicians. investigators will check medical history and confirm eligibility. informed consent will be obtained from either the patient or designated healthcare proxy. 60 subjects will be enrolled. after obtaining informed consent, patients will be randomized 2:1 to pulmozyme 2.5 mg bid for up to 28 days or until they are no longer receiving mechanical ventilation, whichever is sooner plus standard of care vs. placebo normal saline 2.5 ml plus standard of care.


Eligibility criteria:
inclusion criteria: * icu admission for pneumonia complicated by respiratory failure. * rt-pcr (or equivalent) confirmed covid-19 infection. * intubated and on mechanical ventilation within 120 hours of initiation of mechanical ventilation. * age ≥ 3 years of age. exclusion criteria: * allergy or known intolerance to pulmozyme or chinese hamster ovary cell products * history of moderate to severe asthma, cystic fibrosis, or severe copd (baseline fev1 ≤ 40% predicted) * active malignancy other than basal cell melanoma or in situ breast cancer * unstable angina * chronic liver disease as judged by the investigator that would pose significant risk to participation * chronic renal disease as judged by the investigator that would pose significant risk to participation * inability to obtain informed consent from patient or legally authorized representative (lar) * pregnant or breastfeeding use of extracorporeal membrane oxygenation (ecmo) * prisoner status * concurrent treatment with other inhaled investigational agent for covid-19\*\* * patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest) * moribund patient not expected to survive 24 hours * active hemoptysis

Keywords: pulmozyme pneumonia ards