Kornimate/medical-research-clean huggingface dataset:
surface refractive index shift and lens absorption/adsorption of tear components of kalifilcon a lenses vs dailies total1 and precision1

Conditions: Habitual Soft Contact Lens Use

Summary: approximately 10 habitual soft contact lens wearing participants will be enrolled in this bilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. all participants will be seen for a screening/dispensing visit at which informed consent will be obtained and eligibility will be assessed. if participants satisfy all eligibility criteria and none of the exclusion criteria, participants will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each investigator.


Eligibility criteria:
inclusion criteria: 1. be 18 years or older and have full legal capacity to volunteer. 2. have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. have no active ocular disease or allergic conjunctivitis. 4. not be using any topical ocular medications. 5. be willing and able to follow instructions. 6. have signed a statement of informed consent. exclusion criteria: 1. participating in a conflicting study in the opinion of the investigator. 2. considered by the investigator to not be a suitable candidate for participation.
high versus normal protein diet in polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the objective of this study is to assess the effects of a high protein (hp) and a normal protein diet (np) on patients with polycystic ovary syndrome (pcos) and body mass index (bmi)-matched controls in a sample of southern brazilian women. patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30% lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks. the investigators hypothesis is that a different diet composition may have influences in changes of the main characteristics of pcos, like hyperandrogenism and metabolic syndrome.


Eligibility criteria:
inclusion criteria: * women of reproductive age * bmi ranging from 18.5 to 39.9 kg/m² exclusion criteria: * use of any drugs known to interfere with hormone levels for at least 3 months before the study * women with known type 2 diabetes, liver or renal disease or thyroid dysfunction * other hyperandrogenic disorders than pcos

Keywords: pcos high protein diet
randomized crossover trial to assess the tolerability of gonadotropin releasing hormone (gnrh) analogue administration

Conditions: Prostate Cancer

Summary: the purpose of this study is to compare how subjects feel after receiving injections of two different types of gnrh six months apart. one injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.

gnrh is given as an injection. injections of gnrh can be uncomfortable, causing a feeling of burning or stinging. the uncomfortable feeling may be caused by differences in the types of gnrh and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).

Eligibility criteria:
inclusion criteria: * male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated; * at least 18 years of age; * life expectancy of at least 1 year; * capable of completing the study questionnaires without assistance. exclusion criteria: * patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated; * known hypersensitivity to triptorelin, leuprolide or any other gnrh or luteinizing hormone releasing hormone (lhrh) agonists, or gnrh or lhrh; * clinically significant systemic disease or condition that would, in the investigator's opinion, lead to undue risk following administration of either triptorelin or leuprolide; * history of alcohol/drug abuse within the past year; * history of significant medical problems that may confound the outcome of this study; * requires concomitant medications that may affect study assessments (e.g., topical medications used for pretreatment of injection site pain); * participated in another investigational drug study within 30 days * judged by the investigator to be unsuitable for enrollment in this study for any reason

Keywords: palliative treatment prostate cancer
an open-label study of the effect of telaprevir in combination with peginterferon alfa-2b and ribavirin in pediatric subjects infected with hepatitis c virus

Conditions: Hepatitis C

Summary: the purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis c virus (hcv) on a telaprevir-based regimen in part a and with dose adjustments if needed before part b.


Eligibility criteria:
inclusion criteria: * males or females ages 3 to 17 years of age * chronic hepatitis c * hepatitis c virus genotype 1a or b at the screening visit * subject is judged to be in good health (besides hcv infection) in the opinion of the investigator. * signed informed consent form (icf), and where appropriate, signed assent form exclusion criteria: * history of or prior evidence of a medical condition associated with chronic liver disease other than hcv * body weight \ 90 kg * prior evidence of hepatic decompensation * contraindications to pegylated interferon/ribavirin (peg-ifn/rbv) * history or other evidence of severe retinopathy or clinically significant ophthalmological disorder * history of non-genotype 1 hcv * participation in investigational drug study as described in study protocol * use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug
impact of a communication strategy in the prevention of depressive symptoms in patients with covid-19

Conditions: Critical Illness; Mechanical Ventilation; Covid19

Summary: the purpose of this study is to compare the effect of an early and integral communication strategy (eics) versus standard care, on the rate of depressive symptoms at 3 months after discharge from the icu, in patients with severe covid-19, their family members and health personnel. evaluating the rate of depressive symptoms at 3 months after discharge from the icu, with a) hospital anxiety and depression, b) posttraumatic stress disorder checklist (s)

we designed a pre-post intervention study, the groups were non-randomly allocated. the study is implementation in 10 chilean hospitals, admitting 350 patients. pre-intervention: the practices of each icu will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center. post-intervention: eics to facilitate communication between the family, patient and health team, through written material, via the web (tablet and webmaster) and by telephone.

Eligibility criteria:
inclusion criteria: * adults\> 18 years old * admitted to the icu * requiring mechanical ventilation\> 12 hrs due to covid-19 exclusion criteria: * patients with therapeutic proportionality is defined early * patients with communication limitations (they do not speak spanish) are excluded.

Keywords: covid-19 depression post-icu non-pharmacological intervention communication strategy
strong people strength training study

Conditions: Heart Diseases; Cardiovascular Diseases; Diabetes; Sedentary Lifestyle; Overweight and Obesity; Depression, Anxiety; Stress; Fatigue

Summary: the strong people strength training study aims to assess whether a community-based progressive strength training program can improve risk factors for diabetes and heart disease in older rural adults.

this study aims to evaluate the effects of a twice weekly, 12-week progressive strength training program, strong people strength training, on cardiometabolic risk factors in a pragmatic, community-based randomized intervention trial among rural men and women 50 and older. we hypothesize that individuals randomized to the intervention group will demonstrate statistically significant and clinically meaningful improvements in cardiometabolic risk factors as well as physical function, quality of life, and physical activity compared to those randomized to the delayed intervention control group.

Eligibility criteria:
inclusion criteria: * age 50 or older * willing and able to get health care provider (hcp) authorization if required (par-q answered yes to any question or 70 and older) exclusion criteria: * strength trained in last 12 months * previous enrollment in strong people * enrolled or planning to enroll in lifestyle program * cognitive impairment * unable to obtain physician authorization
incisional hernia in infants and children

Conditions: Incisional Hernia

Summary: the study of development of incisional hernia in infants and children at a tertiary level experience.

background: incisional hernia in children and infants (ihci) represents a major complication following exploration. the condition is associated with prolonged hospital stay, readmission and the need for another operation to treat the resulting incisional hernia. the incidence is variable worldwide. the leading causes are still indeterminate as well as the management strategy. we aimed at studying ihci at a tertiary level hospital as regard presenting symptoms, methods of management and its impact on the quality of life of patients. methods: a retrospective study included all infants and children presented with incisional hernia. patients were categorized in to two groups according to the age of presentation, group a patients younger than two years of age and group b patients older than two years. all data related to the first operation in addition to data related to repair of the incisional hernia were collected in special charts.

Eligibility criteria:
inclusion criteria: * all infants and children with incisional hernia exclusion criteria: * congenital abdominal wall defects

Keywords: incisional hernia infants children tissue repair wound healing
taxonomy of neurorehabilitation treatments and outcome measures: a multicentre italian study

Conditions: Multiple Sclerosis; Stroke; Parkinson Disease

Summary: the main aims of the observational study are to taxonomize the contents of rehabilitation understanding goals and treatments provided to people with parkinson disease(pd) and multiple sclerosis(ms) and stroke and their impact on the outcomes

in recent years, neurological rehabilitation focused on evaluating patient's problems, with no rationalization of therapeutic interventions. few researches investigated the contribution of the components of a neurorehabilitation program to the clinical outcome in everyday clinical practice. moreover, there is no a standard method to categorize rehabilitative interventions, making difficult to explain why subjects improve and which of the various treatments is more effective. thus, it was decided to build a multicentre network to collect data using a taxonomy tool developed to provide information on the goals of rehabilitation and to categorize rehabilitation interventions

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * diagnosis of parkinson disease * diagnosis of stroke * participants' rehabilitation program must include at least 10 sessions of physical therapy. exclusion criteria: - unable to understand the aim of the study or unable to sign the informed consent form;

Keywords: multiple sclerosis stroke parkinson taxonomy rehabilitation outcome measures
a specialized amino acid mixture on body composition and skin state in overweight and obese class i postmenopausal women

Conditions: Amino Acid; Body Weight Changes; Skin Manifestations; Obesity; Postmenopausal Disorder

Summary: the use of dietary amino acids has been explored for therapeutic and safety intervention of obesity and obesity-induced dysfunction. in particular, 3 molecules have been shown to be effective both in the animal model and in humans, in promoting the loss of fat mass, specifically visceral adipose tissue, and in maintaining free fat mass: arginine, glutamine and leucine (and its metabolite beta hydroxy methyl butyrate, hmb). the aim of this study was to evaluate the efficacy in terms of fat mass, in particular visceral adipose tissue reduction, as primary end point, in obese patients following the administration of specific food for special medical purposes (fsmp) for muscle recovery, consisting of arginine, glutamine and hmb. the secondary end point is the evaluation of skin state, by a validate self-reported questionnaire survey to assess skin, after 4- weeks intake of this fsmp.


Eligibility criteria:
inclusion criteria: * postmenopause * obesity (i class) or overweight exclusion criteria: * taking any medication * having liver, renal and thyroid disease * smoking * drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
high-intensity laser therapy for sacroiliac joint pain

Conditions: Sacroiliac Joint Pain

Summary: effect of high intensity laser on sacroiliac joint pain

effect of high laser in reduction of pain and improve functional disability in adult women

Eligibility criteria:
inclusion criteria: * the presence of pain over the sacroiliac joint with no surgical history. * unmarried. * tender sij on palpation. * workers with an average age of 18-30 years. * body mass index did not exceed 30 kg/m2. exclusion criteria: * if they have infections. .fracture in and around the sij complex. * arthritis of joint. * pregnancy. .smoking girls. .patient not willing to participate in the study. .any history of surgery. lumbar spine disc herniation or back injury. tumor around the joint.
study comparing the pharmacokinetic of biosimilar eptacog alfa with novoseven®, in patients with congenital factor vii deficiency

Conditions: Factor VII Deficiency

Summary: the purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over study, is to compare the pharmacokinetics (pk) of biosimilar eptacog alfa (activated) with novoseven in 24 patients, adult and children (\>12 years), not bleeding, with inherited coagulation factor vii (fvii) deficiency (fvii \<1%). patients will be randomized to receive either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of novoseven 30 μg/kg, or vice versa, with doses separated by a washout period. all patients will be followed 12 months and will receive biosimilar eptacog alfa, on demand, for every bleeding episode that should occur - or - for prophylaxis, with the aim of monitoring of inhibiting antibody formation, lack of efficacy and collection of safety data.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of congenital, severe factor vii deficiency (fvii \ 2 episodes of bleeding/year requiring treatment with fvii infusions, in non bleeding status. * patients for the additional group for immunogenicity should be enrolled when in a bleeding episode requiring treatment with fvii. * male and female subjects * adult and children (\>12 years) * written informed consent. for minor patients, parent/legal guardian will provide consent and, when possible, patient assent will also be obtained. for compromised patients their designated proxy must provide informed consent. exclusion criteria: * any other type of congenital or acquired coagulopathy (except congenital factor vii deficiency), such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy. * antibodies against factor vii * patients entering the pk study group who have not suspended prophylactic regimen with novoseven or aryoseven (biosimilar eptacog alfa) 3 days before starting the trial (receiving first dose of study medication). * patients entering the additional group for immunogenicity study, only, who have been exposed to aryoseven before starting study \[patients who have received novoseven (on demand or in prophylaxis) before starting study are allowed\] * platelet count less than 100.000 platelets/μl (at screening visit) * patients who have received routine (prophylactic) treatment with rfviia in the period between screening visit (visit 1) and visit 2 of this study (first dose administration) * any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism * hiv positive with current cd4+ count of less than 200/μl * liver cirrhosis * known hypersensitivity to the study medication * parallel participation in another experimental drug trial. * parallel participation in another marketed drug trial that may affect the primary end point of the study.
cannabidiol oral solution as an adjunctive therapy for treatment of participants with inadequately controlled dravet syndrome

Conditions: Dravet Syndrome

Summary: this phase 3 study will enroll participants diagnosed with dravet syndrome (ds) who are still experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components (fsmc) per week, despite ongoing treatment with up to three antiepileptic drugs (aeds), and meet the other inclusion/exclusion criteria. following a 28-day baseline period, participants will begin an 84-day treatment period. participants will be assigned to receive twice-daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial. following study completion, all participants will be invited to receive cannabidiol oral solution in an open label extension study (under a separate protocol).


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification and contraception, including clinical diagnosis of refractory ds and onset of seizures according to protocol-specified criteria * is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the institutional review board before the conduct of any study procedure * in the opinion of the investigator, the subject and/or parent(s)/caregiver(s) are able to keep accurate seizure diaries and the participant is able to take study drug and comply with the protocol, including dosing, medications and diet exclusion criteria: * medical history is outside protocol-specified parameters * clinically significant history of allergic reactions or significant sensitivities to cannabinoids or to any of the other ingredients in the study drug * inadequate supervision by parents or guardians * history or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters * signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results

Keywords: treatment-resistant seizures
primary thromboprophylaxis in patients with malignancy and central venous catheters

Conditions: Venous Thromboembolism; Cancer

Summary: the purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent vte among cancer patients with cvc.

trim-line is a double blind randomized controlled trial comparing rivaroxaban 10mg po daily vs placebo in patients with active cancer and indwelling cvc. this will involve 9 centers across canada.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older with a new or existing diagnosis of cancer and a cvc inserted in the last 72 hours. exclusion criteria: 1. cvc in place for \>72 hours 2. patient requires anticoagulation for other indications 3. concomitant use of dual antiplatelet therapy 4. major bleeding event in the last 4 weeks 5. patients receiving concomitant systemic treatment with strong inhibitors of both cyp 3a4 and p-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir). 6. known pregnancy or plan to become pregnant in next 3 months 7. severe renal insufficiency (creatinine clearance \<30 ml/min (defined by cockcroft-gault) in the previous 3 months 8. documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months 9. known thrombocytopenia (platelet count \< 50x 109/l) in the previous 3 months 10. known allergy to rivaroxaban 11. life expectancy \<3 months 12. history of condition at increased bleeding risk including, but not limited to: 1. cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks. 2. chronic hemorrhagic disorder 13. primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only 14. refused or unable to obtain consent
application of chemical sensors for diagnosis of inflammatory bowel diseases and irritable bowel syndrome by respiratory samples

Conditions: Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Summary: discriminating irritable bowel syndrome (ibs) from inflammatory bowel disease (ibd), especially with mild disease activity, is common clinical challenge. most of the patients with suspected ibs have to go invasive procedures (colonoscopy/gastroscopy). in order to avoid invasive investigations, there is a search for noninvasive markers with the capacity to distinguish between ibs and ibd. dr hossam haick (department of chemical engineering, technion) developed a system that combines nano-metals produced in his laboratory with electrical devices (transistors). the combination between a nanomaterial and an electrical transistor induces a change in its electrical behavior upon exposure to the material being examined; that is, a change in its electrical properties. the change in its electrical behavior is translated into a computerized graphic signal. the electronic nose is composed of an air pump, a filter for filtering external contaminants and an array of sensors. each sensor transmits a signal according to the materials it "knows" how to identify. thus, it is possible to characterize most of the substance families characteristic of a certain disease, and the same system is designed for differential diagnosis of different diseases. the purpose of the investigators study is to use the "electronic nose" to find bio-markers that will help to diagnose ibd and ibs without using invasive procedures. the plan is to collect 200 samples (50 ibs' 50 crohn's disease, 50 ulcerative colitis and 50 controls). the patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire. the samples will analyzed in the laboratory of dr. haick.

the plan is to collect 200 samples (50 ibs' 50 crohn's disease, 50 ulcerative colitis and 50 controls). the patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire. the samples will analyzed in the laboratory of dr. haick.

Eligibility criteria:
inclusion criteria: * patinets with ibd or ibs exclusion criteria: * age under 18 y/o pregnancy, malignant and infectious diseases