Kornimate/medical-research-clean huggingface dataset:
using drug augmentation to treat obsessive compulsive disorder patients who did not respond to previous treatment

Conditions: Obsessive Compulsive Disorder

Summary: this will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. the investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.

arm 1: ssri (fluoxetine 40mg\* once a day) + clomipramine 75mg\* once a day. arm 2: ssri (fluoxetine 40mg\* once a day) + quetiapine 200mg\* once a day. arm 3: ssri (fluoxetine 80mg\* once a day) + placebo once a day. \*or maximum tolerated dose we hypothesize that quetiapine and clomipramine will be effective augmentation strategies for resistant ocd patients in comparison to placebo.

Eligibility criteria:
inclusion criteria: 1. ocd diagnosis 2. ybocs score ≥ 16 (for patients with both obsessions and compulsions) or ≥ 10 (for patients with only obsessions or compulsions) 3. previously signed informed consent to participate in this clinical trial exclusion criteria: 1. patients with clinical or neurological diseases that may be worsen by the medications included in treatment protocol 2. current substance dependence or abuse 3. current psychotic symptoms 4. current suicide risk 5. current pregnancy or intention to get pregnant before the end of the treatment protocol

Keywords: clomipramine quetiapine fluoxetine placebo augmentation obsessive compulsive disorder
vision restoration with a collagen crosslinked boston keratoprosthesis unit

Conditions: Keratolysis

Summary: this is a phase i/ii prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.

the study is a multi-center, parallel, randomized, double-blinded study with subsequent follow-up period of two years. eight-four subjects across twelve sites will be randomized 1:1 to receive either a corneal tissue that have been cross-linked or not cross-linked (no uva light source). cross-linking is a term that refers to the linking of polymers (long chain) molecules by chemical bonds. it is believed that cross-linking the cornea will make the cornea stronger and more resistant to degradation. corneagen (formerly keralink international) (baltimore site) will supply the donor tissue and avedro inc (waltham ma) will supply the riboflavin and the uv light source. staff at corneagenwill administer the riboflavin with dextran solution and perform the cross-linking procedure according to one of randomization groups before shipping the masked donor cornea to study sites for boston keratoprosthesis (b-kpro) implantation.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * willing and able to comply with study assessments for the full duration of the study * age ≥ 18 years * candidate for a boston keratoprosthesis / cornea transplant * in generally good stable overall health * patients with an eye at risk for a cornea sterile ulcer which includes: * autoimmune diseases (mucus membrane pemphigoid, stevens-johnson syndrome, systemic lupus erythematosis, rheumatoid arthritis, or other autoimmune diseases); or * history of previous sterile cornea ulceration requiring a cornea transplant exclusion criteria: * age \< 18 years * inability to provide written informed consent and comply with study assessments for the full duration of the study * no or minimal tear production with evidence of keratinization of the bulbar conjunctiva * corneal or ocular surface infection within 30 days prior to study entry * ocular or periocular malignancy * inability to wear a contact lens due to lid abnormalities or shortened fornix * signs of current infection, including fever and current treatment with antibiotics * pregnancy (positive pregnancy test) or lactating * participation in another simultaneous interventional medical investigation or trial

Keywords: keratolysis corneal melting boston kpro keratoprosthesis
hatha yoga for patients with colorectal cancer

Conditions: Colorectal Neoplasms

Summary: hatha yoga is a traditional practice that encompasses aerobic exercise, breathing techniques, and meditation. it is used in india since centuries to improve well-being and cope with diseases and is gaining more and more interest in europe and the us. while studies have demonstrated benefits of hatha yoga for patients with breast cancer, no studies on patients with colorectal cancer are available yet. the purpose of this study is to investigate the effect of hatha yoga in patients with colorectal cancer.


Eligibility criteria:
inclusion criteria: * colorectal cancer * uicc stage i-iii * between 2 and 48 months post-surgery * age at least 18 years * physical and cognitive ability to follow the yoga intervention exclusion criteria: * uicc stage iv * further active oncological diseases * diagnosed and pharmacologically treated psychiatric disorder except for cancer-related depression or adjustment disorder * pregnancy or breastfeeding

Keywords: yoga colorectal neoplasms quality of life randomized controlled trial
clinical study to evaluate safety, immunogenicity of investigational flu vaccine compared to an approved flu vaccine (qiv) in children previously vaccinated in trial v118_05

Conditions: Influenza

Summary: safety, immunogenicity of an adjuvanted quadrivalent subunit influenza virus vaccine compared to non-adjuvanted comparator influenza vaccine in children previously vaccinated in trial v118_05


Eligibility criteria:
inclusion criteria: 1. male or female subject who has completed their day 181 clinic visit for non-naïve subjects or their day 209 clinic visit for naïve subjects in parent study. 2. individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up exclusion criteria: 1. individuals recently vaccinated against influenza. 2. subjects with contraindications to receive influenza vaccine. 3. please contact the site for additional eligibility criteria.
endometriosis: evaluation of detection and need for algologic care before surgery

Conditions: Endometriosis, Pain

Summary: endometriosis surgery is required when medical treatment fails to release women from pain. however, complete surgery does not work every time to improve patients' symptoms. algological care is one of the options to treat the pain before surgery and their related complications (neuropathy, sensitization, and catastrophism) that could be associated to nociceptive pain. but not all patients could benefit from this pathway and no screening strategy does exist to detect these complications that could be treated prior to endometriosis surgery


Eligibility criteria:
inclusion criteria: * maternal age from 18 up to 50 years old (50 non included). * women affiliated to social coverage insurance * women who understand french * women who signed the written consent * women with impaired quality of life (pain) linked to endometriosis * women with formal radiological signs of endometriosis (mri lesions more than 5 mm or endometrioma more than 20 mm on radiological examinations). * surgical indication for resection of lesions by laparoscopy or robotic surgery for management of pain or impairment of quality of life * patients requiring complete conservative or radical resections of all lesions * indication of surgery validated within dedicated meeting for endometriosis. * purpose of pain associated or not with infertility * date of surgery fixed with sufficient time for algological treatment. maximum delay of 4 months between randomization and surgery exclusion criteria: * women undergoing surgery for the purpose of infertility * patient with previous surgery for removal of deep lesions of endometriosis or endometriotic cysts (history of exploratory laparoscopy accepted) * patient with suspicious lesions on mri or specialized ultrasound. * a patient who needs to be treated for another uterine pathology at the same time. * pregnant women * patient with a desire for pregnancy immediately and/or within one year after surgery * women who refuse clinical examination (some algological tests couldn't be performed without clinical examination) * patient who has already received algological treatment or who should receive it before surgery * patient with previous other psychiatric disorders (depressive symptoms treated) * women without rights

Keywords: endometriosis, algologic care pain, quality of life
validation of continuous transcutaneous carbon dioxide monitoring in va-ecmo patients

Conditions: Carbon Dioxide

Summary: carbon dioxide in patients on veno-arterial extracorporeal membrane oxygenation (va-ecmo) is eliminated via respirator as well as via the oxygenator's membrane of the ecmo machine. consequently, monitoring of end-tidal carbon dioxide tensions is limited, which can result in marked swings towards non-physiological values. hyper- and hypocapnia, however, can have detrimental effects on organ perfusion in a great number of patients supported with va-ecmo. continuous, rapidly applicable monitoring of reliable carbon dioxide measures would therefore be extremely helpful to prevent harmful deviations from the norm. the investigators therefore try to assess the accuracy and the precision of continuously measured non-invasive transcutaneous carbon dioxide partial pressures when compared with tensions determined by blood gas analysis.

after documenting the characteristics of participants, cannulation site, and the cause for ecmo support, transcutaneous, arterial, venous, as well as end-tidal carbon dioxide partial pressure values are measured simultaneously at steady state conditions and compared with each other at various time points over a four-hour observation period. in addition, oxygen tensions are registered transcutaneously and in arterial and venous blood while respirator settings, sweep gas flow, ecmo flow, body temperature, volume status, and the dosage of vasopressors are also being recorded.

Eligibility criteria:
inclusion criteria: * low cardiac output requiring va-ecmo support. exclusion criteria: * age \< 18 years

Keywords: ecmo carbon dioxide elimination organ perfusion low cardiac output monitoring critical care
physical activity, psychopathology, and quality of life in people with psychotic or affective disorders

Conditions: Psychotic Disorders; Affective Disorder

Summary: this longitudinal observational study tests the associations between physical activity, health-related quality of life, and psychopathology symptoms among people diagnosed with schizophrenia or diagnosed with affective disorders. it was assumed that higher levels of physical activity at baseline will be related to better quality of life (across physical, social, and psychological domains), and lower psychopathology symptoms (positive and negative symptoms of psychosis, general psychopathology, and depression severity) at 6-week follow-up measurement. adult participants with a diagnosis of a psychotic disorder or a diagnosis of an affective disorder will be enrolled.


Eligibility criteria:
inclusion criteria: - a diagnosis of a psychotic disorder or affective disorder exclusion criteria: * major cognitive deficits, indicated by total scores \> 8 points, obtained with the montreal cognitive assessment (moca) scale at baseline

Keywords: physical activity quality of life
reversal with low doses of sugammadex in patients undergoing non-cardiac surgery

Conditions: Postoperative Residual Curarization; Neuromuscular Block

Summary: neuromuscular blocking agents (nmba) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.they are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. incomplete recovery from non-depolarising nmbas continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block. hypotheses: 1. administration of sugammadex 0.25 mg/kg at tof ratio 0.3 will successfully reverse (tof=0.9) rocuronium induced neuromuscular block within 10 min. 2. recurrent block (tof ratio \< 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg. the primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose secondary objective is to assess the safety of different doses of sugammadex (recurrent block (tof ratio \< 0.9) after reversal and the occurrence of adverse reactions) sugammadex is a very expensive drug which limits its use i anaesthesia department. by optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. this may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.

doses of study drug will be 0 mg/kg ideal body weight (ibw), 0.25 mg/kg ibw, 0.50 mg/kg ibw, 1.0 mg/kg ibw and 2.0 mg/kg ibw. tof will be measured every 10th second until full reversal.

Eligibility criteria:
inclusion criteria: * patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block. * asa i-iv * signed informed consent exclusion criteria: * patient less than 18 years of age * patient participating in another clinical study which could interfere with tof trial. * patient with neuromuscular disease * patient from icu * bmi \> 30.0 kg/m2 * patient scheduled for local or regional anesthesia only * patient undergoing general anesthesia without rocuronium * patient with hypersensitivity to nmbas or sugammadex. also hypersensitivity to any active substance or to any of the following excipient: hydrochloric acid 3.7% (to adjust ph) and/or sodium hydroxide (to adjust ph) water for injections . * renal dysfunction (gfr\<30 ml/min/1,73m2) * hepatic dysfunction * patient who have received sugammadex in the last 24 h. * pregnant or breastfeeding woman. women in childbearing age must have a negative pregnant test before inclusion. * bradycardia (puls \<40) * hypotension (systolic bp \<90 mmhg)
detection of anemizations in primary care.

Conditions: Anemia; Red Blood Cell Transfusion

Summary: objective: to evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia. methods: the anhemog study is a randomized controlled trial with two parallel arms, intervention and control. it was approved at december 11, 2017. the study randomizes 138 patients with chronic anemia. in the intervention arm, a monthly capillary hemoglobin measurement will be performed with a hemoglobinometer. if a decrease in hemoglobin concentration is detected, an existing transfusion circuit will be followed. social, demographic and quality of life variables will be collected from all participants. hypothesis: the results of the research will have an impact on people with chronic anemia who would receive red blood cell transfusion when needed without delay. the improvement in the times of action would reduce decompensations from chronic diseases, visits to the emergency room and hospital admissions, and therefore would improve the quality of life of these patients. furthermore, the management of the different interventions by the case management nurse (egc), in this regard, improves the current fragmentation of the different levels of care.


Eligibility criteria:
inclusion criteria: * people over 40 years old * had received 2 or more red blood cell transfusions due to chronic disease, during a year. * the health provider in primary care is the institut català de la salut. exclusion criteria: * presenting kidney failure on hemodialysis treatment. * being in palliative care situation * presenting a moderate-severe cognitive impairment, with a pfeiffer scale score higher than 5. * not having a caregiver able to detect signs of decompensation.

Keywords: haemoglobinometry primary care nursing, advanced practice nursing
customized contact lenses

Conditions: Keratoconus

Summary: the overall goal of this project is to improve the visual quality of individuals who have abnormal corneal conditions that alter the shape of their cornea (eg. keratoconus). patients with an abnormal corneal shape have substantial lower and higher order aberrations (distortions in the eye). this results in reduced visual acuity which cannot be corrected by regular sphero-cylindrical correction. compensating for these aberrations has been challenging due to difficulty measuring their wavefront aberrations accurately and, consequently, manufacturing the custom contact lenses with irregular optical profiles. this project is designed to systematically overcome these obstacles with a customized scleral and/or soft contact lens capable of compensating for the lower and higher order aberrations of the eye.


Eligibility criteria:
inclusion criteria: * able to read and understand the informed consent document in english * 18 to 75 years of age * received diagnosis of keratoconus by a clinician * willing and able to follow instructions exclusion criteria: * has best corrected visual acuity of 20/20 or better in the keratoconic eye(s). * normal/typical subjects * is unable to handle, insert, remove or care for the study lenses. * has any active anterior segment disease, pathology, or surgery affecting vision, refraction, or the ability to wear a contact lens * history of ocular pharmacological treatment * history of ocular trauma or surgery causing abnormal corneal curvature or distorted vision history of contact lens intolerance * pregnant at the time of enrollment in the study (self-reported- it has been shown hormonal changes during pregnancy may affect corneal biomechanics negatively) * adults unable to consent * individuals who are not yet adults (infants, children, teenagers under the age of 18 because it has been shown the average age of the appearance of keratoconus is the second decade of life ( 15-18 years of age) * prisoners
the effects of melatonin treatment on bone, marrow, sleep and blood pressure

Conditions: Osteoporosis, Postmenopausal

Summary: melatonin protects your bones while losing fat! this was previously demonstrated by our group. the mechanisms behind these findings are still elusive, and the aim of the present study is to assess the mechanisms. in a double-blinded randomized controlled trial 40 postmenopausal woman are randomized to receive either 10 mg melatonin or placebo nightly for three months. changes in gene expression in marrow cells will be assessed through micro array. markers of bone metabolism will be assessed through biochemical markers. cardiovascular health will be measured by tonometry and 24h blood pressure. the results of the study will contribute with important knowledge about the beneficial effects of melatonin making it an interesting supplement to known treatment regimens against osteoporosis and overweight.


Eligibility criteria:
inclusion criteria: * post-menopausal women between 55 and 75 years exclusion criteria: * severely impaired renal function * severely impaired hepatic function * coagulation factors pp\<0.6 * hypercalcemia (p-ion calcium \>1.32 nmol/l) * previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy) * diseases affecting the calcium homeostasis including untreated thyroid diseases * regular use of medicine affecting the calcium homeostasis, including diuretics, fenemal, lithium, antiepileptica and glucosteroids * selective serotonin reuptake inhibitor (ssri)-products with fluvoxamin * treatment with carbamazepin * treatment with rifampicin * severe malabsorption syndrome including gastric or intestinal resection * alcohol or drug abuse * smokers
heated humidified high flow nasal cannula for children with obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this study is to determine whether heated humidified high flow nasal cannula (hhhfnc) is effective as a treatment of obstructive sleep apnea syndrome (osas) compared to continues positive airway pressure (cpap) treatments in children and to compare their adherence and compliance.


Eligibility criteria:
inclusion criterias: * age: 0-16 years old. * refered for treatment with non invasive ventilation. * diagnosed with osas and ahi\>=5 there are no exclusion criteria

Keywords: obstructive sleep apnea syndrome (osas) heated humidified high flow nasal cannula (hhhnc) continues positive airway pressure (cpap) children non invasive ventilation treatment
apixaban in hemodialysis

Conditions: End-stage Renal Disease

Summary: this study aims to determine the effects of end-stage renal disease on the pharmacokinetics, pharmacodynamics, safety, and tolerability of apixaban. this is a single-center open-label pharmacological study. apixaban will be prescribed at the dose of 2.5 mg twice per day for nine days. the concentration of the drug will be measured with repetitive blood tests the first and the eighth day of administration (non-dialysis days). the same blood tests will be repeated before, during, and after dialysis on dialysis days. if the study shows inadequate or suboptimal efficacy with the 2.5 mg dose, it will be repeated with the 5 mg twice-daily dose.


Eligibility criteria:
inclusion criteria: * age\>18 years * end-stage renal disease on stable hemodialysis treatment (3 weekly sessions of 4 hours) for at least 6 months * no residual kidney function * non-valvular atrial fibrillation exclusion criteria: * age ≥80 years * body mass index (bmi)\ 40 * active bleeding * high bleeding risk (has bled score \>3) * active malignancy * psychiatric disorders * decompensated thyroid disorders * decompensated heart failure * acute myocardial infarction-cerebrovascular accident-head trauma in the last 3 months * previous history of venous thromboembolic disease in the last 6 months * previous history of coagulopathy already treated by vitamin k antagonists (vkas) or novel oral anticoagulants * uncorrected rhythm or conduction disturbances * dual antiplatelet therapy * known liver disease or elevated transaminases \> 2x upper limit of normal * hemoglobin \< 90 g/l * platelets \< 100,000 /ml * known hypersensitivity to apixaban * treatment with a potent inhibitor or inducer of the cytochrome p450 3a4 and/or p-glycoprotein * absence of effective contraception where applicable * drug or alcohol abuse

Keywords: factor xa inhibitors renal dialysis