Kornimate/medical-research-clean huggingface dataset:
effect of the use of a therapeutic conciliation document at the outlet of hospital, on the emergency use of hospital care in patient aged over 75 years old.

Conditions: Iatrogenic Effect

Summary: the drug iatrogenesis represents an important public health problem. in the iatromed project, we want to to assess a specific therapeutic drug conciliation sheet (tdc). this multicenter observational study is focus on 750 patients aged over 75 year old with polymedication. the main objective will be to determine if the use of the tdc, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge

the drug iatrogenesis represents an important public health problem with 5-10% of the grounds of hospitalization after age 65, and more than 20% after 80 years. based on this observation, the health authority has proposed in 2011 the realization of therapeutic drug conciliation particularly in the elderly with multiple pathologies and multiple drugs. taking into account the central role of the family practitioner in prescriptions, and the importance of coordination information such as output of hospitalization (vector of many malfunctions), we have achieved a therapeutic drug conciliation sheet (tdc) based primarily on the information needs by family practitioner after hospitalization of their patients. the issue of this study is to assess the interest for the use of a such tdc on the decrease in the rate of rehospitalization in the target population. to do this, we are proposing a multicenter observational study. randomization would be across the centres. the study would focus on 750 patients more of 75 with polymedication. the follow-up will last 6 months. the main objective will be to determine if the use of the tdc, at the discharge of hospital, allows to reduce the number of use in emergency care within the two month after their hospital discharge. the first secondary objective will be identical to the main objective but rated at 6 months and the second secondary objective will be to assess the impact of the use of the tdc on overall mortality at 6 months.

Eligibility criteria:
inclusion criteria: * age ≥75 years * patients with a medical prescription, including at least three different allopathic molecules including at least a treatment in one of the following therapeutic classes: * cardiovascular treatment: antiarrhythmics, antihypertensive drugs, anticoagulants and antiplatelet all classes * treatment of the central nervous system: analgesics, benzodiazepines, antidepressants, hypnotic, antipsychotic drugs of all classes. * family practitioner identified * trusted personne identified * hospital output project establishes exclusion criteria: * not speaking french patient * short survival time
clinical study to investigate the efficacy and safety of nt 201 compared to placebo in the treatment of chronic troublesome drooling associated with neurological disorders and/or intellectual disability

Conditions: Chronic Troublesome Sialorrhea; Cerebral Palsy; Stroke; Traumatic Brain Injury; Intellectual Disability

Summary: the objective of this study is to investigate the efficacy and safety of nt 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to botulinum neurotoxin treatment and aged 2-17 years.


Eligibility criteria:
inclusion criteria: * male or female child/adolescent age 2-17 years. * any neurological disorder (e.g. cerebral palsy or traumatic brain injury) and/or intellectual disability associated with chronic troublesome sialorrhea for at least 3 months up to the screening. in subjects with intellectual disability (id) without neurological disorders, a diagnosis of id by a specialist, e.g. pediatrician or by a center for developmental medicine is required for inclusion. * severe drooling (modified teacher´s drooling scale \[mtds\] ≥ 6; clothing occasionally becomes damp) as rated by the investigator. * parental consent and the subject's oral or written assent as the subject is able to provide. exclusion criteria: * chronic troublesome sialorrhea not related to neurological disorders and/or intellectual disability. * body weight \< 12 kg. * pharmacological treatment for sialorrhea or concomitant medication known to influence sialorrhea strongly (e.g. anticholinergics with exception of locally applied or short acting drugs used under general anesthesia) within 45 days before baseline and during the entire study period. * any previous known or suspected hypersensitivity to botulinum toxin. * aspiration pneumonia within 6 month before screening. * any previous treatment with botulinum toxin for any body region during the year before screening or within the screening period * prior, concomitant or planned surgery or irradiation to head and neck to control sialorrhea (including salivary gland surgery or salivary gland irradiation) within one year before screening or planned for any part of the entire study period. * concurrent diseases, including hematological, hepatic, renal, gastrointestinal, endocrine, pulmonary, musculoskeletal, or psychiatric diseases or conditions, which in the judgment of the investigator would put the subject at risk while in the study, could influence the results of the study, or negatively impact the subject's ability to participate in the study. * extremely poor dental and/or oral condition that might preclude safe study participation by the judgment of the investigator. * nursing mother or pregnant female subject.
does benign prostatic obstruction cause hypertension?

Conditions: Prostatic Hyperplasia; Hypertension

Summary: the known correlation between benign prostatic hypertrophy (bph) and hypertension could be explained by 3 theoretical pathway models. whether hypertension causes bph, bph causes hypertension or the two are caused by a common factor is currently unknown. in this study it will be investigated whether hypertension is due to the direct effects of infravesical obstruction to urinary outflow in patients with benign prostatic hyperplasia. the approach will be blood pressure measurement in patients who will have a resection of the prostate.


Eligibility criteria:
inclusion criteria: * listed for inguinal hernia repair or hydrocele repair or transurethral resection of the prostate * signed informed consent exclusion criteria: * treatment with antihypertensive medication that has been started within 3 months of inclusion. * treatment with antihypertensive medication that has been started after inclusion and before final blood pressure measurements have been obtained 6 months after operation. * any reason that the investigator deems that the participant will not comply with follow-up.

Keywords: transurethral resection of prostate
nurse smoking cessation of patients with chronic obstructive pulmonary disease (copd) with nicotine replacement therapy (nrt) and behavioral support

Conditions: Smoking; COPD

Summary: this is a smoking cessation study with copd patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.

placebo, controlled, randomized, double-blind trial with 400-1000 smoking copd patients with fev-1 \< 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in denmark. outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air\< 10 ppm. secondary outcomes were change in body-weight, quality of life (sf-36 and sgrq), symptoms, lung function, adverse events.

Eligibility criteria:
inclusion criteria: * copd patients (fev1/fvc\<70% and fev1\<90 % predicted) * smoking 1 cigarette daily or more * willing to follow the protocol exclusion criteria: * used nrt or bupropion the last week * not able or willing to adhere to the protocol * estimated survival \< 1 year

Keywords: smoking cessation nicotine sublingual tablets behaviour support smoking reduction quality of life copd weight
safety and tolerability study of the monoclonal antibody ct-011 in patients with chronic hepatitis c genotype i infection

Conditions: Chronic Hepatitis C

Summary: this study aims to evaluate whether an investigational monoclonal antibody, ct-011, is safe to give and if it helps patients with hepatitis c virus (hcv). monoclonal antibodies are a type of drug that is typically given by infusion into a vein (intravenously). results of this trial will help doctors obtain additional information with regard to the safety and efficacy of ct-011 as a potential treatment for hcv.


Eligibility criteria:
inclusion criteria: 1. patient is between 18 and 60 years of age, both genders. 2. biopsy proven infection with hepatitis c genotype 1. 3. positive for anti-hcv. 4. chronically infected for at least 3 months from diagnosis. 5. ecog performance status ≤ 1. 6. previous therapy with interferon +/- ribavirin or peginterferon +/- ribavirin or ineligibility for this type of therapy or for liver transplantation. exclusion criteria: 1. patients who received any type of anti viral treatment during the 3 months prior to enrollment. 2. any history or active malignancy. 3. history of major organ transplantation with an existing functional graft. 4. patients who received any systemic concurrent therapy within the last 4 weeks. 5. patients progressing to acute liver failure (alf).

Keywords: chronic hepatitis c hcv genotype i infection liver disease
investigation of intraocular pressure (iop) reduction efficacy of travoprost ophthalmic solution in patients with normal tension glaucoma

Conditions: Normal Tension Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to investigate iop reduction efficacy of travoprost 0.004% ophthalmic solution (travatan z®) in subjects with normal tension glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosis of normal tension glaucoma. * must sign an informed consent form. * iop within protocol-specified range. * other protocol-specified inclusion criteria may apply. exclusion criteria: * pregnant and lactating women, or women who intend to become pregnant during the study period. * advanced and serious glaucoma, as specified in protocol. * complicated chronic or recurrent uveitis, scleritis or corneal herpes. * history of ocular trauma, intraocular surgery or laser surgery for the included eye. * ocular-infection and severe ocular complication. * best-corrected visual acuity (bcva) worse than 0.2 decimal. * difficulty in conducting applanation tonometry for the included eye as determined by the doctor. * severe or serious hypersensitivity to prostaglandin analogues or any ingredients used in the study. * use of iop lowering ophthalmic solutions other than travatan z® or oral carbonic anhydrase inhibitor (diamox, etc.) during the study period. * use of any adrenocorticosteroids during the study period. * use of iop lowering ophthalmic solution within the past 30 days. * regarded by doctor as not suitable for study participation. * other protocol-specified exclusion criteria may apply.

Keywords: glaucoma ocular hypertension
long term follow-up of comparison of clopidogrel vs. aspirin monotherapy after drug-eluting stent implantation

Conditions: Coronary Artery Disease; Atheroscleroses, Coronary

Summary: this is an retrospective extended study of a randomized clinical trial (the host-exam trial clinicaltrials.gov identifier: nct02044250). investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.

the host-exam trial (clinicaltrials.gov identifier: nct02044250) was an randomized clinical trial that was performed to compare head-to-head, the efficacy and safety between aspirin and clopidogrel monotherapy in patients who received pci for coronary artery disease and required chronic maintenance antiplatelet therapy. from march 2014 through may 2018, a total of 5438 patients were enrolled, and follow-up was performed upto 24 months after randomization. after this study, randomization was unlocked and patients were followed-up based on the standard protocol. afterwards, the current study was planned to perform a extended follow-up of the host-exam population. the specific drug by the randomization group in the host-exam trial was not mandatory after the initial 24 months, therefore participants received medication according to the current guidelines, and according to the physicians preferences. this is a observational, retrospective analysis of all clinical events after the randomization period. the prescribed medications and any clinical events will be evaluated.

Eligibility criteria:
inclusion criteria: * patients who were enrolled in the host-exam randomized clinical trial exclusion criteria: * none, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information

Keywords: percutenous coronary intervention drug-eluting stent chronic maintenance period
evaluation of functional status and mental functions of adult cerebral palsy patients

Conditions: Cerebral Palsy

Summary: in adult cerebral palsy patients , a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. in this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned.

in adult patients diagnosed with cerebral palsy, a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. in this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned. there are studies about the functional status of adults with cp in the literature; however, there is no study conducted on this subject in our country. in this study, it was aimed to evaluate the functional status and mental functions of adults with cp who applied to our hospital.

Eligibility criteria:
inclusion criteria: * \>18 years old * diagnosed with cerebral palsy * who voluntarily participate the study exclusion criteria: * \<18 years old * who does not give permission to participate the study

Keywords: adult cerebral palsy cerebral palsy functional status mental function
facilitate the return to work of cancer survivors

Conditions: Neoplasms; Return to Work

Summary: cancer patients could experience physical limitations, cognitive symptoms, fatigue and pain, that could be perceived at diagnosis but may also occur during treatment, limiting the person from carrying out their activities of daily living, including work tasks. return to work is a major goal, as it facilitates the patient's ability to deal with the disease and improve general health. at present, there is no path aimed at supporting cancer patients in the return to work process. because of this, the investigators want to assess the feasibility of a multidisciplinary social-health care pathway aimed at manage the difficulties that cancer patients might perceive in the return to work process.

to receive the support from the social-health care pathway, cancer survivors should go to an information desk service (called informa salute) located in the hospital. here, sociodemographic and work-related data will be collected with the aim to organize the tailored social-health support to facilitate the return to work. the social-health care pathway created includes: the local health authority of reggio emilia and the local order of physicians, voluntary non-profit associations, vocational and educational training bodies, social cooperatives, one labor union and one chartered accountant enterprise.

Eligibility criteria:
inclusion criteria: * adults with cancer diagnosis and employed at the time of diagnosis exclusion criteria: -

Keywords: cancer survivors return to work italy occupational therapy comprehensive health care neoplasm
vaginal progesterone supplementation in the management of preterm labor

Conditions: Preterm Labor

Summary: this study evaluates the addition of vaginal progesterone in the management of preterm labor. half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.


Eligibility criteria:
inclusion criteria: * singleton pregnant women with preterm labor, gestational age 24-34 weeks exclusion criteria: * have indicated preterm birth * allergy to progesterone * fetal anomalies * cervical dilate \> 5 cm. * have medical disease * have obstetric complication
quantification of liver iron overload and steatosis using magnetic resonance imaging

Conditions: Iron Overload; Metabolic Syndrome X; Hepatitis B; Hepatitis C; Alcohol Abuse

Summary: iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. the aim of the study is to use a simplified magnetic resonance imaging (mri) technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically.

iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders. assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy. because liver biopsy is an invasive procedure, imaging methods have been developed to detect and quantify hepatic iron content. the aim of the study is to use a simplified magnetic resonance imaging technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically. patients who need a liver biopsy will be proposed to be enrolled in the study. a magnetic resonance (mr) study will be performed using breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence. liver and muscle mr signal will be quantitatively determined and compared to biochemical assessment of liver iron concentration and steatosis quantification.

Eligibility criteria:
inclusion criteria: * adults over 18, * planned liver biopsy (or liver biopsy within 2 months before inclusion) for one of these indications: suspicion of liver iron overload, metabolic syndrome, hepatitis b or c, alcohol abuse. no change in diet, transfusions or iron depletion must have occur between the liver biopsy and the mri. * having given a written informed consent. exclusion criteria: * non cooperating patient, * patient with dyspnea, * patient with contra-indication to mr imaging (pace-maker, heart valve,...).

Keywords: magnetic resonance imaging hepatic iron steatosis
diffusion mri in appendicitis

Conditions: Acute Appendicitis

Summary: in this study, it was aimed to investigate the effect of diffusion-weighted magnetic resonance imaging on diagnosis and surgical decision in patients with suspected acute appendicitis. investigators believe that diffusion-weighted magnetic resonance imaging is a valuable method in the diagnosis of acute appendicitis and in making the decision of surgery.


Eligibility criteria:
inclusion criteria: * patients with suspected acute appendicitis and scanned by diffusion weighted magnetic resonance imaging exclusion criteria: * patients evaluated by ct * younger than 18 years

Keywords: acute appendicitis diffusion weighted magnetic resonance imaging diagnostic accuracy
a comparison of slx-4090 in combination with metformin versus metformin therapy alone in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine whether slx-4090 in combination with metformin therapy will reduce hba1c in patients with type 2 diabetes more effectively than metformin therapy alone.

1. hba1c after 12 weeks 2. fpg after 12 weeks 3. safety and tolerability 4. plasma levels of slx-4090

Eligibility criteria:
inclusion criteria: * hba1c 7-11% * on a stable dose of metformin for at least 6 weeks exclusion criteria: * type 1 diabetes * antidiabetic medication other than or in addition to metformin * fpg \> 270 mg/dl
surgical breast resection with or without axillary lymph node excision in treating women with breast cancer

Conditions: Breast Cancer

Summary: this randomized phase iii trial is studying surgery and axillary lymph node dissection to evaluate if systematic axillary node clearance can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50


Eligibility criteria:
inclusion criteria: women, 50 year or more menopausal women breast cancer macroscopic tumor size of 10 mm or less (measured during operation) no palpable axillary node ( n0) exclusion criteria: previous cancer history life expectancy \< 10 years metastasis

Keywords: breast neoplasms local recurrence survival surgery