Kornimate/medical-research-clean huggingface dataset:
safety and clinical performance of the yukon choice pc, yukon chrome pc & yukon choice flex stents in routine practice

Conditions: Ischemic Heart Disease

Summary: the goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry. patients meeting the selection criteria will be included, in chronological order of their implantation. this registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients. the inclusion period is planned to last 2 years, starting in q1 2023. the study will be complete when data on all patient's follow-up for one year have been collected.

* prospective, observational, noninterventional, multicenter, international clinical registry * allocation: consecutively treated patients, non-randomized * masking: none (open label) * observational model: longitudinal * inclusion period: 2 years * follow-up period: at 1 year * study duration: 3 years patients meeting the selection criteria will be included, in chronological order of their implantation. this registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients. the inclusion period is planned to last 2 years, starting in q1 2023. the study will be complete when data on all patient's follow-up for one year have been collected. list of visits: v0: during hospitalization: consultation baseline, data of the intervention and data at discharge v1: consultation at 30 days follow-up v2: consultation at 12 months follow-up

Eligibility criteria:
inclusion criteria: * any patient who was implanted only with a yukon choice pc, a yukon chrome pc or/and a yukon choice flex stent within previous 2 days. * patient ≥ 18 years old. * male or non-pregnant female patient (note: females of childbearing potential must have a negative pregnancy test prior to enrollment in the study). exclusion criteria: * currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints. * co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the trial. * concurrent medical condition with a life expectancy of less than 12 months.

Keywords: stent ischemic heart disease registry international routine practice
colloid co-hydration and vasoconstrictor infusion for prevention of hypotension during cesarean section

Conditions: Hypotension Symptomatic; Vasoconstriction; Cesarean Section Complications; Obstetric Anesthesia Problems

Summary: this will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section

neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally. the aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. all parturients will also receive colloid co-hydration.

Eligibility criteria:
inclusion criteria: * adult parturients, american society of anesthesiologists (asa) i-ii, * singleton gestation\>37 weeks * elective cesarean section exclusion criteria: * body mass index (bmi) \>40 kg/m2 * body weight \<50 kg * body weight\>100 kg * height\<150 cm * height\>180 cm * multiple gestation * fetal abnormality * fetal distress * active labor * cardiac disease * pregnancy-induced hypertension * thrombocytopenia * coagulation abnormalities * use of antihypertensive medication during pregnancy * communication or language barriers * lack of informed consent * contraindication for regional anesthesia
bioequivalence trial of 2 dose strengths of bi 201335 na soft gelatine capsules

Conditions: Hepatitis C

Summary: the objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg bi 201335 na soft gelatine capsules.


Eligibility criteria:
inclusion criteria: 1. healthy male volunteers without any clinical significant findings and complications 2. age: 20 - 45 years 3. bmi: 18.5 - 25.0 kg/m2 4. signed informed consent exclusion criteria: 1. any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance. 2. any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement. 3. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. 4. history of jaundice 5. surgery of the gastrointestinal tract (except appendectomy). 6. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders. 7. history of relevant orthostatic hypotension, fainting spells or blackouts. 8. chronic or relevant acute infections. 9. history of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement. 10. intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial 11. use of drugs which might reasonably influence the results (pharmacokinetic) of the trial within at least 10 days prior to administration or during the trial. 12. participation in another trial with an investigational drug within two months prior to administration or during the trial. 13. smoking (\>10 cigarettes or \>3 cigars or \>3 pipes/day). 14. inability to refrain from smoking during the trial. 15. alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous \[equivalent to 540 ml\] of sake). 16. drug abuse. 17. blood donation (more than 100 ml within four weeks prior to administration). 18. excessive physical activities (within one week prior to administration). 19. any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement. 20. any history of relevant liver diseases (for instance, disturbances of liver function, dubin-johnson syndrome, rotor syndrome, or previous liver tumours).
study to assess the art impact on the brain outcomes. the arbre study

Conditions: HIV-1 Infection; Cognitive Impairment

Summary: the arbre study is an observational prospective trial aimed at investigating the impact of the therapy initiation with intis on brain outcomes according to the time of therapy initiation. three study arms are considered: 1) early treated hiv-1 infected patients (\ 6 months since estimated date of infection), 3) matched seronegative control group. study assessments will be performed at baseline, 1 month and 12 months. study assessments will comprise comprehensive evaluation of brain outcomes. they will include cognitive functioning, neuroimaging parameters, and functional outcomes.

randomized patients will receive la cab+rpv administration in the hospital (standard of care) or out-of- hospital administration every 2 months (m2, m4, m6, m8,m10, m12). medical visits, rutinary blood tests and pharmacy visits at the hospital of reference will take place every 6 months- at baseline, m1 (if patient has not previously receiving la cab+rpv), m6 and m12.

Eligibility criteria:
the study criteria for participation in the study will be the following: inclusion criteria: * age 18-65 years old * voluntary participation. * signed written consent. * confirmed hiv-1 infection (for arms a and b). * intention to initiate therapy with cart containing an insti. specifically, the regimen included raltegravir, elvitegravir or dolutegravir. exclusion criteria: * prior diagnosis of opportunistic infection involving cns. * current diagnosis of psychiatric disorder. * current or past diagnosis of neurologic disease. * inability to develop any of the tasks required for the study. * pregnancy. * history of suboptimal adherence (for arms a and b).

Keywords: brain hiv-1 infection
efficacy and safety of camrelizumab in real-world study

Conditions: Non-small Cell Lung Cancer

Summary: this observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of chinese nsclc patients.

camrelizumab is a humanized antibody for cancer immunotherapy. the national medical products administration (nmpa, china) approved camrelizumab as a first-line treatment of certain patients with nsclc. this is a multicenter non-interventional study, nsclc patients who have been treated with camrelizumab will be included. the main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. histopathological diagnosed confirmed non-small cell lung cancer; 3. have received at least one camrelizumab injection between august 1, 2019 and december 31, 2020; 4. traceable cases. exclusion criteria: 1. patients who have received other immunotherapy at the same time; 2. patients who were participating in other intervention studies; 3. patients with other malignant tumors; 4. the researcher believes that the patient is not suitable to participate in this study with any other conditions .
tobramycin inhalation powder (tip) in cystic fibrosis subjects

Conditions: Cystic Fibrosis

Summary: lung infections are a chronic problem for patients with cystic fibrosis (cf). some patients with cf may have a type of bacteria called pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. tobramycin inhalation solution (tobi) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. tobramycin inhalation powder (tip) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a t-326 inhaler. the purpose of this research study is to determine if tip is safe and effective when compared to placebo (a powder with no medicine) treatment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cystic fibrosis patients with pseudomonas aeruginosa infection. * male and female subjects between 6 and 21 years of age at the time of screening. * fev1 at screening must be between 25% and 80% of normal predicted values. exclusion criteria: * known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Keywords: tobramycin inhalation powder
guided self-help for parents of children with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: cognitive-behavioral based guided self-help for parents of children with attention-deficit/hyperactivity disorder (adhd) is investigated in a feasibility and effectiveness study. the treatment is offered under routine-care conditions of the health-care system in germany. practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.

self-directed interventions may overcome many of the barriers associated with accessing face-to-face services, as there is lowered stigma and significantly reduced or eliminated cost, transport, and timing difficulties. families can complete self-directed programs at home, in their own time and at their own pace. furthermore self-administered programs are often very cost-effective and their use can ease the financial burden of mental health of the community. these parenting programs can be particularly effective by reaching the populace. moreover in primary care settings where financial resources, time and expertise might be lacking to provide behavioral interventions, self-directed programs might be a promising tool for disseminating effective parenting interventions more widely. bibliotherapy is one form of self-directed therapy. in bibliotherapy a selected book is thought to meet the specific need of the person to be treated and reading is used as the therapeutic technique. in opposition to pure self-help programs, bibliotherapy in terms of guided self-help provides patients (or parents) with written instructions as well as therapeutic contacts at regular intervals. during these contacts, problems and questions can be discussed to give further support. self-help interventions have already proven to be effective for adults with anxiety or affective disorders as well as for depressive adolescents. however there has only been little research concerning the reduction of children's behaviour problems through parental self-help programs under minimal contact conditions.

Eligibility criteria:
inclusion criteria: * child diagnosis of adhd exclusion criteria: * language or reading difficulties of participating parent

Keywords: program evaluation adhd
attachment preterm in the loire infant follow-up team

Conditions: Preterm Birth

Summary: the purpose of this study is to describe the attachment representations of children born prematurely at age 3 and 5 with regard to their neurocognitive and behavioral development.

whether they are born at term or prematurely, from birth, children seek contact with caregivers and establish privileged relationships with them. these attachment relationships are gradually established and, from the end of the first year, interindividual differences can be observed according to temperament, quality of interactions with adults and responses to children's needs for proximity and comfort. prematurity is a situation that can disrupt parent-child interactions. the physiological characteristics of the premature infant attenuate and distort his/her stress signals. visual interactions are shorter, alertness is more labile and reactivity is less clear than that of babies born at term. in such situations of stress and trauma, maternal sensitivity and responsiveness can be affected. in addition, changes in the quality of mother-child interactions have been reported, with more controlling maternal behavior. this maternal trend has been associated with behavioral disorders in children, such as eating disorders or lack of interest in social communication. more frequent disruptions of maternal caregiving associated with relational withdrawal in the child have also been shown in the case of prematurity. we hypothesize that the experience of establishing relationships with parents in a context of extreme prematurity can alter the development of secure attachment representations in the child and that maternal representations and their possible interactions with prematurity factors prevent or contribute to the development of insecure or disorganized attachment in the child. we also hypothesize that disorganized attachment representations are associated with somatic, environmental, affective, and neurodevelopmental complications (motor, cognitive and behavioral).

Eligibility criteria:
inclusion criteria: * children born in the neonatal reanimation department of angers and nantes university hospitals * extrem preterm infants (term of birth less than or equal to 28 weeks of amenorrhea) * children included in the regional monitoring network for vulnerable newborns (réseau grandir ensemble en pays de la loire, rge) * children with a follow-up consultation at age 3 scheduled as part of the classic rge follow-up on the angers and nantes university hospitals * informed consent dated and signed by the parents or the holder of the parental authority * affiliated to a social security scheme exclusion criteria: * child with severe neurocognitive impairment or severe autism trait-type behavioral disorder in the 2-year rge follow-up evaluation

Keywords: prematurity attachment
effect of combination therapy on knee osteoarthritis pain in postmenopausal women

Conditions: Non Specific Knee Osteoarthritis Pain

Summary: the aim of this study is to investigate the efficacy of combination therapy on knee osteoarthritis pain in postmenopausal women

osteoarthritis (oa) is the most common musculoskeletal condition affecting the quality of life of older adults. the prevalence of oa is very high 45% in females in comparison to males, especially after menopause due to the hormonal changes. in the physical therapy practice, therapeutic ultrasound (us) is one of the most frequently applied electrotherapeutic modalities in orthopedics physiotherapy. simultaneous application of two therapeutic modalities at the same site is described as combination therapy (ct). the most commonly used ct is us \& transcutaneous neuromuscular electrical stimulation (tens )where this approach was effective in pain modulation .the use of combination therapy is highly preferable because of the advantageous effect both electro-therapy and ultrasound provide simultaneously. there are no current studies on using combination therapy in the treatment of pain in mild to moderate knee osteoarthritis in post-menopausal women and we don't know the proper treatment dose.the study is designed as a prospective, randomized, pre-posttest, controlled trial.where we have two groups intervention group and control. the intervention group will recieve strengthening exercises in addition to combination therapy 10 minutes for each session, 3 times per week, for 3 weeks.the control group will recieve the same strengthening exercises as intervention group and sham combination therapy 10 minutes for each session, 3 times per week, for 2 weeks.

Eligibility criteria:
inclusion criteria: * forty women who suffer pain out of mild to moderate knee osteoarthritis * their age will range from 55 to 65 * at least one year after last menstruation. * their bmi will be ranged from 25 to 35 kg/m2 exclusion criteria: * neurological disorders. * cardiovascular disorders. * severe knee osteoarthritis * areas of the body where cancerous lesions exist. * any skin impairment at site of application as inflammation, lesion, wounds, infection and swelling. * pacemaker and any metallic implants.
scarring in stratagraft-treated vs. autograft-treated burn wounds: a clinical and histological investigation

Conditions: Burn Scar; Scar

Summary: the purpose of this study is to describe and better understand the scars of subjects that have been treated with stratagraft tissue vs autograft.

this study will recruit patients who have previously been participants in the strata2016 study protocol. the patients will have comprehensive scar examinations conducted including the use of imaging, scar scale scores, pain and itch scales, scar volume measurements, and non-invasive skin measurements resulting in quantitative metrics of skin elasticity, stiffness, and color. tissue biopsies will also be collected for histologic investigations into the scar. each patient will have a biopsy taken of the autografted site, the stratagraft site, and an area of normal, un-injured skin.

Eligibility criteria:
inclusion criteria 1. participant in strata2016 clinical trial 2. ≥ 18 years of age exclusion criteria 1. unable to provide informed consent 2. known allergy to lidocaine 3. scars are not appropriate for investigation based on clinical judgement by the principal investigator

Keywords: stratagraft
epidemiologic study to assess the igra positivity in populations with a high tb burden

Conditions: Tuberculosis, Pulmonary

Summary: the purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (igra) positivity, at site level, and to build capacity to conduct a future tb vaccine efficacy study.


Eligibility criteria:
inclusion criteria: capable of giving signed informed consent and informed assent (as appropriate), which includes compliance with the requirements listed in the informed consent form (icf) and informed assent form (iaf) between 15 and 34 years of age (inclusive) participants who agree to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and have no current plans to relocate from the study area for the duration of the study. exclusion criteria: history of active tb within the last 24 months (i.e., 24 months from end of treatment to day of screening, based on history \[no documentation required\]) history of previous administration of an experimental mtb vaccine unstable / uncontrolled chronic condition according to the judgment of the investigator -
midodrine in the recovery phase of septic shock

Conditions: Septic Shock

Summary: the aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. the investigators hypothesize that the oral drug can reduce central line days and icu length of stay.

the investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. the investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of icu stay and length of time that intravenous vasopressors are required. the investigators plan to enroll and consent patients at the onset of septic shock. once iv vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. the investigators will analyze length of stay in the icu, time on vasopressors, time needing a central line, and hospital length of stay.

Eligibility criteria:
inclusion criteria: * • patients aged 18-99 years old * admitted to uva medical icu with diagnosis of septic shock. exclusion criteria: * pregnant females, patients with childbearing potential will have urine pregnancy testing after consent * patients \< 18 years * prisoners * patients already taking midodrine * patients with cirrhosis and child-pugh class c (child-pugh score \> 9)_ * patients with increased intraocular pressure and glaucoma * patients with allergy to midodrine * non-english speaking patients * patients without enteral access * patients where the attending physician does not feel map goal of \> 65 mmhg is physiologically acceptable.