Kornimate/medical-research-clean huggingface dataset:
sports, education and consumption of substances in adolescents

Conditions: Cigarette Smoking; Alcohol Drinking

Summary: adolescent substance abuse (sa), which includes the consumption of alcohol, cigarette smoking, the consumption of drugs and other behaviors, is a significant public-health issue in the world today. recent data showed that prevalence of sa among adolescents in croatia and surrounding countries (i.e. former yugoslav republics) is alarming and needs serious intervention. it is hypothesized that participation in physical-exercise-and-sport (pe\&s) will reduce the tendency of young people to abuse substances. however, the literature to date has not consistently validated the perception pe\&s factors are factors which could buffer sa among children and adolescents. one of the probable reasons for evident inconsistencies on findings about relationship between pe\&s and sa is a cross-sectional nature of studies done so far. therefore, the main rationale (i.e. problem) of this study is lack of current knowledge about influence of the pe\&s on sa among adolescents. the main objective of this study is to prospectively investigate the influence of pe\&s on sa among adolescents aged 17 to 18 years old. aims of the project are: (1) to define prevalence and trends of sa among adolescents aged 17 to 18 years old; (2) to define prevalence and trends of pe\&s participation; (3) to establish interrelationships which exist between socio-demographic, psychological, educational-factors, and pe\&s (predictors); (4) to identify multivariate and univariate associations between: socio-demographic and sa, psychological factors and sa, pe\&s and sa, educational - scholastic factors and sa.expected results of the project are: (1) definition of the prevalence of sa among adolescents; (2) definition of the adolescents' participation in pe\&s; (3) identification and interpretation relationships which exist between and within studied predictors of sa (educational factors, socio-demographic factors, pe\&s, psychological factors); (4) identification of the influence of studied predictors on sa.


Eligibility criteria:
inclusion criteria: * children involved in regular scholastic system exclusion criteria: * no
oral thalidomide and tegafur-uracil to decrease hepatocellular carcinoma recurrence

Conditions: Adult Hepatocellular Carcinoma; Recurrent Hepatocellular Carcinoma; Adverse Reaction to Drug; Vascular Endothelial Growth Factor Overexpression

Summary: this single-centered phase ii clinical study is to obtain preliminary information on 1-year recurrence-free survival rate, recurrence-free survival and safety profile of thalidomide in combination with tegafur-uracil in hepatocellular carcinoma after hepatectomy and explore biomarkers(vegf/bfgf) for thalidomide response.

after liver resection to remove the hepatocellular carcinioma completely, the patients with high risk of tumor recurrence will be enrolled into this study. the high risk of tumor recurrence depends on tumor characteristics. the risk factors of tumor characteristics included tumor size \>5 cm in diameter, abscence of encapsulation, vascular invasion and presence of daughter nodules. the patients with high risk of tumor recurrence will have 1 to 3 risk factors. when the patients are enrolled into the study, oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence. the patients will be fillowed uo erevy 3 mnoths.

Eligibility criteria:
inclusion criteria: 1. stage i-iii（tnm: t1-t3） hepatocellular carcinoma 2. previously received curative surgery 3. presence at least one and no more than three of the following risk factors , i.tumor size ≧ 5 cm ii.presence of microscopic or macrovascular venous invasion iii.presence of satellite nodules/addition nodules iv.no capsular formation v.multiple tumors d.performance status of ecog 0, 1 e.age between 20 and 75 years f.no residual or recurrent tumors detected by computed tomography (ct) or echo within 3-6 weeks after surgery g.written informed consent to participate in the trial exclusion criteria: 1. other malignancy with the exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ prior to the entry of study 2. previously received chemotherapy 3. less than 2 weeks since previous radiotherapy/surgery 4. white blood cell (wbc) less than 3,000/mm3 and absolute neutrophil count (anc) less than 1,500/mm3, and platelets less than 100,000/mm3 5. serum bilirubin greater than 1.5 times the upper limit of normal range (uln) 6. alanine aminotransferase (alt) or aspartate transaminase (ast) greater than 5 times the uln 7. alkaline phosphatase greater than 5 times the uln 8. presence of serious concomitant illness which might be aggravated by study medication:uncontrolled infection (active serious infections that are not controlled by antibiotics) 9. hypersensitivity to thalidomide or compounds pregnant or breast feeding women, or women of child-bearing potential unless using two reliable and appropriate contraceptive method
evaluating wound healing with next science gel & wash.

Conditions: Chronic Wound

Summary: this is a 12-week, single-site, open-label prospective study in adult with a chronic wound diagnosis. subjects will be randomized in equal numbers to either the control treatment arm, antimicrobial control treatment arm, or next science treatment arm and will receive this treatment until the wound is completely healed or they are exited from the study. subjects will have a weekly in-office debridement visit for up to 12 weeks.

this is a 12-week, single-site, open-label prospective study in adult subjects ages 18 years of age and older with a chronic wound diagnosis. there will be 15 completed subjects with up to 18 enrolled. subjects will be randomized in equal numbers to control group (mepilex foam dressing); antimicrobial control group (mepilex ag foam dressing); or next science group (torrentx irrigation, blastx application, and mepilex foam dressing). subjects will receive this treatment until the wound is completely healed or they are exited from the study. subjects will have a weekly in-office debridement visit for up to 12 weeks. for the next science arm, torrentx will be used during in-office debridement whereas blastx will be applied once during the in-office visit and then mid-week with dressing change. dna and plate count analysis will be taken at maximum of 5 time points: baseline/randomization visit, maximum of 3 treatment visits (visits 3, 5, and 9), and visit 13/study exit (if applicable), with cultures taken pre- and post- debridement. wound measurements will be taken via imaging from silhouette camera system at every in-clinic visit.

Eligibility criteria:
inclusion criteria: 1. male or female 18 years or older 2. presence of full-thickness chronic wound for more than one month (i.e. chronic) 3. ulcer must be greater than 1 cm2 to enable biofilm sampling 4. he/she is determined to not require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period 5. willing to comply with all study procedures and be available for the duration of the study 6. provide signed and dated informed consent exclusion criteria: 1. subjects unable to provide signed and dated informed consent 2. male or female less than 18 years old 3. presence of a full-thickness chronic wound for less than one month 4. subjects with a history of bleeding dyscrasia or with medical conditions that would make a bleeding complication likely 5. subjects whose wound is less than 1 cm2 6. he/she requires endovascular or surgical arterial intervention during the study period 7. subject with known allergic reaction to the study products ingredients 8. wound, in the investigator's clinical judgment, is not amenable to management solely with the techniques described in this study (i.e., should be managed in addition with hyperbaric oxygen, vacuum suction, or other adjunctive methods)

Keywords: biofilm eps matrix antimicrobial
extension study of patients with infantile-onset pompe disease who were previously enrolled in protocol aglu01602

Conditions: Glycogen Storage Disease Type II

Summary: pompe disease (also known as glycogen storage disease type ii) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in patients with pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. the overall objective of this study is to evaluate the long-term safety and efficacy of myozyme treatment in patients with infantile-onset pompe disease.


Eligibility criteria:
inclusion criteria: * the patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed * the patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol * the patient must have completed protocol aglu01602. exclusion criteria: * patient has experienced any unmanageable adverse event (ae) in protocol aglu01602 due to myozyme that would preclude continuing treatment with myozyme

Keywords: glycogen storage disease type ii gsd-ii pompe disease pompe disease (late-onset) acid maltase deficiency disease glycogenosis 2 glycogen storage disease type ii (gsd-ii)
evaluation of a robotic assistance module against positive and negative obstacles for driving electric wheelchair

Conditions: Neurological Disorder

Summary: the device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. this module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. the robotic assistance module is programmed to detect positive and negative obstacles.

the device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. this module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type. the robotic assistance module is program to detect positive and negative obstacles. this study "swadapt3" follows "swadapt1" and "swadapt2" with patients with neurological disorders, regular drivers of electric wheelchairs, in the same conditions: each patient included tested a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. this evaluation was carried out in 3 standardized test circuits of increasing difficulty, one week apart. at each session, the patient performed the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Eligibility criteria:
inclusion criteria: * aged over 18, * having read the information note and freely consented to participate in the study, * suffering from neurological disorders such as cerebro-lesion or neuro-degeneration, * having benefited from an electric wheelchair prescription and/or learning to drive, * the physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module. exclusion criteria: * understanding difficulties preventing the realization of the protocol, * motor disorders of the upper limb requiring additional driving technical assistance, * patient who has expressed difficulties impacting their internal and/or external driving safety, * pregnant, parturient or breastfeeding women, * a person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research, * minors, * a person in an emergency situation, unable to express his prior consent.
a study of avastin (bevacizumab) in combination with chemotherapy in patients with breast cancer progressing after first-line therapy with avastin and chemotherapy (tania)

Conditions: Breast Cancer

Summary: this randomized, open-label, parallel-group study will assess the efficacy and s afety of avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with avastin and chemotherapy. patients will be randomized to receive either avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * female patients, \>/= 18 years of age * histologically confirmed her2-negative breast cancer * disease progression during or following first-line treatment with avastin and chemotherapy for locally recurrent or metastatic breast cancer * avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy * ecog performance status 0-2 * at least 28 days since prior radiation therapy or surgery and recovery from treatment exclusion criteria: * anti-angiogenic therapy or anti-vascular endothelial growth factors other than avastin for first-line treatment * active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years * inadequate renal function * clinically relevant cardio-vascular disease * known cns disease except for treated brain metastases * chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day) * pregnant or lactating women
intraperitoneal aerosol high-pressure chemotherapy for women with recurrent ovarian cancer

Conditions: Recurrent Ovarian Cancer

Summary: this trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

this study aims to investigate the therapeutic efficacy of pipac using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. the primary objective of this study is to determine the clinical benefit rate (cbr) according to recist criteria after three cycles of pipac with cisplatin and doxorubicin.

Eligibility criteria:
inclusion criteria: * at least 2 lines of previous chemotherapy * recurrent ovarian cancer * patient is mobile * informed consent exclusion criteria: * ileus * necessity of parenteral nutrition

Keywords: ovarian cancer, recurrent, chemotherapy, intraperitoneal
a study of tarceva (erlotinib) or placebo in combination with platinum-based therapy as first line treatment in patients with advanced or recurrent non-small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this 2 arm study will compare the efficacy and safety of sequential treatment with tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xauc)on day 1, followed by tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by tarceva or placebo monotherapy.the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * advanced (stage iiib/iv)non-small cell lung cancer; * measurable disease; * eastern cooperative oncology group (ecog) performance status 0 or 1. exclusion criteria: * prior exposure to agents directed at the her axis; * prior chemotherapy or systemic anti-tumor therapy after advanced disease; * unstable systemic disease; * any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix; * brain metastasis or spinal cord compression.
dose-escalation study of scd-101 in sickle cell disease

Conditions: Sickle Cell Disease; Sickle-Beta Zero Thalassemia

Summary: the purpose of this study is to determine the safety and clinical effects of scd-101 when given to adults with sickle cell disease.

this is single site, dose- escalation study of scd-101 in participants with homozygous sickle cell disease (s/s) or s/beta 0 thalassemia. all participants will be monitored for safety, tolerability, and dose-limiting toxicities. the study is divided into two parts. part a is an open-label, non-randomized, non-placebo-controlled dose escalation study with a 28-day treatment phase and 14-day follow-up phase with five cohorts . part b is a randomized, placebo-controlled, confirmatory 2x2 crossover cohort with a 28 day washout between periods, and a 28-day follow-up phase.

Eligibility criteria:
inclusion criteria: 1. male or female, 18-55 years of age 2. homozygous sickle cell disease or s/beta 0 thalassemia 3. hemoglobin f ≤10% 4. hemoglobin ≥ 6.0 g/dl and ≤ 9.5 g/dl 5. female participants of child bearing potential and male participants whose partner is a female of child bearing potential must be willing to use approved contraception during the trial and for 3 months following the end of treatment. only barrier methods or complete abstinence are acceptable for this study. participants using hormonal contraception (including morning-after-pill) and iud are excluded unless willing/able to change to an acceptable form of contraception. 6. ability to adhere to the study visit schedule and other protocol requirements 7. ability to understand and the willingness to sign an informed consent document exclusion criteria: 1. red blood cell transfusion within 3 months of enrollment 2. hydroxyurea treatment within 6 months of enrollment 3. painful or other acute sickle cell event that required a hospitalization within 4-weeks of enrollment 4. ast and/or alt \>3x upper limit of normal and/or creatinine \>2x upper limit of normal or any other significant renal or hepatic impairment 5. estimated creatinine clearance (crcl) \< 60 ml/min (cockcroft- gault formula) at screening. 6. qtc interval of \>470 msec at trial entry and participant with congenital long qt syndrome. 7. no other significant sickle cell or non-sickle cell illness that would confound the results of the trial 8. any condition that, in the view of the investigator, places the participant at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial 9. participant pregnant or nursing an infant or planning pregnancy during the course of the trial 10. history of allergic reactions attributed to sorghum or compounds of similar chemical or biologic composition (such as nicosan, niprisan, jobelyn or xickle). 11. other investigational drug use within 3 months of enrollment 12. promis fatigue questionnaire 8a t-score ˂ 44.3

Keywords: homozygous sickle cell disease s/beta 0 thalassemia
hip fracture prevention follow-up of elderly women in primary health care

Conditions: Fragility Fracture

Summary: researchers plan a 2022 follow-up of medical records data to investigate fracture incidence and survival for 1248 women, born 1902-1931, in a comparative fracture prevention study with 435 participants from an intervention area and 813 participants from two control areas. in 2022 researchers want to assess patient records data in intervention and control areas and compare a) survival b) risk factors for osteoporotic fractures (wrist, upper arm, vertebral, pelvic, hip) c) physical activity, exercise and drugs that affect fracture risk.

researchers plan a 2022 follow-up of medical records data to investigate fracture incidence and survival for 1248 women, born 1902-1931, in a comparative fracture prevention study with participants from an intervention area (vislanda, n=435) and control areas (emmaboda n=395 and tingsryd (n=418). fragility fracture prevalence after 40 years of age was 33% in the 1248 participants with mean age 79 years at baseline 2001. participants with 2-4 risk factors (age ≥80, body weight \<60kg, previous fragility fracture or impaired rise-up ability) provided prospective data with framo (fracture and mortality) index as an outcome measure and this index identified 80% of hip, fragility fractures or death within a 2-year follow-up period. hip fracture incidence 2004-2005 was not significantly lower in the intervention area but the trend of the odds ratio (0.33) was in line with significantly fewer falls and improved recovery in the intervention area. in 2022 researchers want to assess patient records data in intervention and control areas and compare a) survival b) risk factors for osteoporotic fractures (wrist, upper arm, vertebral, pelvic, hip) c) physical activity, exercise and drugs that affect fracture risk. data analysis will be blinded for participation in intervention or control groups and statistical methods include cox regression and kaplan-meier's survival analyzes. birth cohort differences in outcomes will be analysed by using lexi's diagrams.

Eligibility criteria:
inclusion criteria: invitation letter was sent out to all women in three predefined geographical areas of south sweden born 1902-1931 exclusion criteria: participants who themselves or their significant others did not read or understand swedish were excluded.

Keywords: osteoporosis