Kornimate/medical-research-clean huggingface dataset:
the effect of the movement imitation therapy in preterm (mit-pb) in motor behavior's quality.

Conditions: Premature Birth; Risk; Early Intervention

Summary: this study aims to assess the effect of a parent-administered intervention program based on mit-pb in preterm with abnormal general movements during the preterm period. we will describe the short and long-term differences between infants exposed to mit-pb and infants who follow current standard care.

the quasi-experimental design has been planned to assess the effect of a physiotherapy program carried out in neonatal intensive care and at home during the first months of life. preterm babies born before 32 weeks gestational age (ga) and/or with less than 1500g showing an abnormal general movement assessment (gma) at 34-36 weeks will be included. standardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (pma), 54 weeks pma, 6 months, and 12 months. a qualitative study has been designed to assess the physiotherapy performance and parents' experience. three different hospitals with similar care protocols and sizes will recruit the sample (n=36). the intervention groups (n=18) will be located at hospital josep trueta of girona and hospital sant joan de déu and the control group (n=18) will be located at hospital parc taulí of sabadell (barcelona).

Eligibility criteria:
inclusion criteria: * preterm infants born before 32w ga and less than 1500g weight. * infants who show abnormal general movements (cs-pr pattern) at 34-36w postmenstrual age (pma). * families able to understand/speak catalan, spanish or english. * families willing to participate who have the informed consent exclusion criteria: * infants with congenital abnormalities and/or genetic disorders * infants with invasive ventilation or continuous positive airway pressure (cpap) at 36 weeks pma. * infants with normal general movements at 34-36 w pma. * families not willing to participate.

Keywords: neonatal therapy general movements high risk neurodevelopment physiotherapy
emotional changes between emergency and intensive care unit and on-site counter staffs after covid-19 infection

Conditions: Psychological Distress; COVID-19 Infection; Anxiety and Fear-Related Disorders

Summary: the emotional and work changes of the staffs and the on-site counter staffs will have a certain impact during this pandemic period. because a large number of critically ill patients are obstructive in emergency and critical care uint. it will induce a huge impact on the deployment of medical team manpower the purpose of this study is to understand the situation of emergency and intensive care unit personnel after covid-19 infection. it will help the hospital superintendent to understand the impact of emotional adjustment on its own work, understand the emotional situation of on-site personnel, future planning and r deployment.

the emotional and work changes of the staffs and on-site counter staffs will have a certain impact during this pandemic period. because a large number of critically ill patients are obstructive in emergency and critical care unit. it will induce a huge impact on the deployment of medical team manpower the purpose of this study is to understand the situation of emergency and intensive care unit personnel after covid-19 infection. it will help the hospital superintendent to understand the impact of emotional adjustment on its own work, understand the emotional situation of on-site personnel, future planning and r deployment. 1. explore the emotional changes of on-site emergency department and critical care unit staffs and on-site counter staffs by filling in questionnaires 2. understand the emotional changes of personnel in various units and on-site counter personnel and how to adjust. 3. arrange the likert scale questionnaire with meleis nursing transitional theory. the different aspects of the questionnaire to quantify the emotional changes of the emergency and critical unit personnel and the on-site counter personnel. each questionnaire takes about 20 minutes to 30 minutes to fill this questionnaire. 4. analyze the emotional adjustment of the staffs in the acute and severe unit that affects their own work and how to affect the relationship between colleagues and medical practice execution. 5. this study uses empirical evidence to analyze and evaluate the emotional changes of emergency department and intensive care unit personnel and on-site counter personnel, understand the rationality of hospital manpower deployment and make the assistance needed

Eligibility criteria:
inclusion criteria: * emergency department and intensive care unit personnel after facing their own infection with covid-19. exclusion criteria: * exclude those who fill in the questionnaire with incomplete information

Keywords: emotional change covid-19 infection personnel emotional adjustment duty and future planning
exercise intervention on conflict monitoring in children with attention-deficit hyperactivity disorder

Conditions: Exercise Intervention

Summary: the study mainly investigates the effect of high-intensity interval training on conflict monitoring in children with adhd by using event-related potential and sloreta techniques.

the present study will have two experiments, one is a cross-section study and the other is intervention study. as for cross-section study, typical developmental children and children with adhd will perform the stroop task while recording their brain waves. the intervention is twice a week for 5 weeks and before and after the intervention, children with adhd will randomly assign to either an exercise group or control group. they will perform the stroop task while recording their brain waves.

Eligibility criteria:
inclusion criteria: 1. age between 7 and 12 years 2. diagnosed with adhd by a pediatric psychiatrist, which is not required for td 3. no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness. exclusion criteria: 1. cannot follow the instruction 2. cannot complete all the procedure

Keywords: hiit executive function adhd chronic exercise
study of an artificial human skin medicine for patients with basal cell carcinoma undergoing reconstructive surgery

Conditions: Basal Cell Carcinoma

Summary: phase ii clinical trial evaluating the safety and efficacy of a tissue engineered autologous skin substitute reconstructive surgery for basal cell carcinoma


Eligibility criteria:
inclusion criteria: 1. patients that give their informed consent for study participation. 2. adult (18 years of age or older), of any sex and racial origin. 3. clinical and dermatoscopic diagnosis of basal cell carcinoma with lesions on the scalp, torso or extremities, within a certain size that do not allow for surgical closure by direct suture or flaps. namely, indication for mohs surgery. 4. women with childbearing age or men capable of producing a child, should commmit to use contraceptives of medically proven efficacy. exclusion criteria: 1. locally advanced basal cell carcinoma with evidence of tissue infiltration. 2. lesions in the face. 3. injuries requiring urgent surgical intervention. 4. infected lesions, necrosis, scarcely vascularized injuries or other complications that may interfere with healing and/or integrity of the graft. 5. injuries that have received treatment with radiotherapy. 6. contraindication for mohs surgery. 7. known allergies to biobrane dressing. 8. pregnant or breastfeeding women. 9. coexistence of any other pathology that, in the investigator's opinion, could compromise the healing process or interfere with protocol follow-up. 10. participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.
clinical evaluation of integra® cadence™ total ankle system in primary ankle joint replacement (cadence)

Conditions: Rheumatoid Arthritis; Degenerative Arthritis; Post Traumatic Arthritis

Summary: a post market, prospective, non-randomized, multi-center, open-label,clinical study using survivorship as the reference performance goal to study the safety and efficacy of the cadence total ankle system (tas) when used for primary ankle arthroplasty.


Eligibility criteria:
inclusion criteria: * the patient is skeletally mature. * the patient qualifies for primary total ankle replacement (tar) per the surgeon and has a diagnosis of one of the following: primary arthritis (e.g. degenerative disease), secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved), or systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis). * the patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the informed consent. * the patient reads, understands and signs the institutional review board (irb) approved informed consent. exclusion criteria: * the patient is morbidly obese (defined by body mass index (bmi) \> 40 or bmi of 35 - 40 with significant medical problems caused by or made worse by their weight). * the patient has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (charcot's arthropathy) or vascular disease, loss of musculature or neuromuscular compromise. * the patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection. * the patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope). * the patient is pregnant or plans to become pregnant during the follow up period. * the patient has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors. * the patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy). * the patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
preventing recurrent gestational diabetes with metformin

Conditions: Gestational Diabetes Mellitus

Summary: study hypothesis: intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.

gestational diabetes mellitus (gdm) is a common medical complication of pregnancy and is associated with increased risks to mother and baby. the incidence is increasing reflecting changing pre-gravid female demographics. once one pregnancy is complicated by gdm, subsequent pregnancies are more likely to be affected by the same condition. this reported risk of recurrence is estimated to range between 35 and 80%, with non-caucasian ethnicity being the strongest predictor of gdm recurrence. evidence regarding further predictors of recurrent gdm is conflicting and measures that might prevent recurrence need exploring. metformin is commonly used in the treatment of established gdm and has been shown to reduce the incidence of gdm in the context of polycystic ovarian syndrome.

Eligibility criteria:
inclusion criteria: * singleton pregnancy; * 8-22 weeks gestation * previous pregnancy complicated by gestational diabetes exclusion criteria: * established pre-existing diabetes (including unrecognised diabetes defined as a fasting plasma glucose ≥ 7.0mmol/l and/ or hba1c ≥ 48mmol/mol); contraindications to metformin therapy (creatinine ≥ 130μmol/l/ alanine transaminase ≥ 2.0 x upper limit normal/ previous intolerance to metformin) * planned continued antenatal care/ delivery at centre not included in trial * planned fast for cultural/ religious reasons e.g. ramadan

Keywords: recurrent gestational diabetes mellitus prevention metformin
randomized control trial of intracervical balloon placement vs oxytocin in women with term prom and unripe cervices

Conditions: Premature Rupture of Membrane; Unfavorable Cervix

Summary: this study is designed to determine if an intracervical balloon catheter (ibc) is better than oxytocin for induction of labor in the setting of premature rupture of membranes (prom) or breaking the bag of water prior to onset of labor. the investigators suspect that an intracervical balloon catheter will shorten the time interval from initiation of induction of labor to delivery.

there are not enough studies to support the use of intracervical balloon catheter (ibc) in term prelabor rupture of membranes (prom). prospective randomized studies comparing ibc placement to oxytocin use in induction of labor for term prom do not exist. intracervical balloon catheter has been shown to reduce duration of labor for women with intact membranes undergoing induction of labor. the practice at this institution is to use oxytocin to start contractions when a woman has prom. this study will examine ibc compared to oxytocin use in term prom. this will allow for the evaluation of a cervical ripening method for term prom that may improve women's outcomes. other outcomes for this study are rates of infection during labor, cesarean section, and adverse maternal and/or neonatal outcomes.

Eligibility criteria:
inclusion criteria: nulliparous women, women aged 18-50 years, singleton gestation, vertex presentation, live fetus, rupture of membranes confirmed by sterile speculum examination \> 37 weeks of gestation at time of rupture of membranes, bishop score \< 6 exclusion criteria: multiparous women, bishop score \>6, multifetal gestation, contraindication to labor including placenta previa , maternal fever prior to randomization: t \>100.4 f , known fetal anomalies

Keywords: cervical ripening term premature rupture of membrane intracervical balloon catheter
a study of lnp3794 in subjects with nras/kras mutated advanced or metastatic refractory solid tumors

Conditions: NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

Summary: this is a phase i, open-label, dose escalation study of lnp3794 (bi3011441) in subjects with nras/kras mutated advanced or metastatic refractory solid tumors. the purpose of this study is to evaluate the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered lnp3794 (bi3011441) as monotherapy at selected dose levels.


Eligibility criteria:
inclusion criteria: 1. subjects ≥18 years of age 2. pathologically documented, locally-advanced or metastatic solid malignancy with nras or kras mutation 3. at least one target lesion that can be measured per recist version 1.1 4. eastern cooperative oncology group (ecog) performance status of 0 or 1 5. adequate organ function (bone marrow, hepatic, renal, cardiovascular) 6. documented disease progression despite appropriate prior standard therapies or subjects for whom no standard therapy exists for their tumor type and disease stage 7. reproductive criteria (as defined in the protocol) exclusion criteria: 1. subjects with symptomatic central nervous system (cns) metastases 2. history of another primary malignancy, with the exception of locally excised nonmelanoma skin cancer and carcinoma in situ of uterine cervix 3. known active hepatitis b infection or hepatitis c infection 4. known pre-existing interstitial lung disease 5. known diagnosis of human immunodeficiency virus (hiv) infection 6. history or current evidence/risk of retinal vein occlusion (rvo) or central serous retinopathy; or known risk factors for rvo or central serous retinopathy 7. any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, sponsor, or contract research organization, could affect the subject's participation in the study 8. impaired cardiac function or clinically significant cardiac diseases 9. previous treatment with ras or mek targeting agents 10. chemotherapy, biologic therapy, immunotherapy, radiotherapy, or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study treatment
emotion regulation during rct of cbt vs. mbsr for social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of the study is to investigate the immediate and longer-term impact of cognitive-behavioral group therapy (cbgt) versus mindfulness-based stress reduction (mbsr) for patients with social anxiety disorder.

a. aims the overall goal of this research is to elucidate the neural bases of two specific forms of emotion regulation - cognitive regulation (cr) and attention regulation (ar). cr and ar are thought to be important mechanisms underlying therapeutic change associated with cognitive-behavioral therapy (cbt) and mindfulness-based stress reduction (mbsr) for generalized social anxiety disorder (sad). we seek to test whether changes in cr and ar underlie the therapeutic effects of cbt and mbsr, which have been shown in the clinical science literature to be effective treatments for sad. we will examine cr and ar in healthy controls (hcs) and in participants with generalized sad at baseline, as well as in participants with sad after they have completed a randomized controlled trial (rct) with three treatment arms: cbt, mbsr, or waitlist (wl). this work will address 3 aims: aim 1 will examine the efficacy of cr and ar in individuals with sad versus hcs; aim 2 will investigate the immediate and longer-term impact of cbt versus mbsr for sad; and aim 3 will examine treatment-related changes in cr and ar and test whether these changes mediate the effects of cbt versus mbsr. the broad, long-term objective of this research is to contribute to advances in clinical interventions targeting individuals suffering from sad, as well as a wide range of other anxiety and mood disorders.

Eligibility criteria:
inclusion criteria: * clinically diagnosable social anxiety disorder (generalized subtype per dsm-iv-tr criteria) * aged 21-55 * working fluency in english * residence in the bay area. * eligible for fmri scans (right-handed, no metal in body, etc.) exclusion criteria: * left-handed * medication use in the last 3 months * pervasive developmental disability * acute suicide potential * inability to travel to the treatment site * schizophrenia or other psychotic disorder * history of bipolar disorder * current primary major depression * current substance dependence * comorbid diagnoses of major depressive or other mood or anxiety disorders are acceptable only if clearly secondary to the diagnosis of social anxiety disorder.

Keywords: social anxiety treatment cognitive-behavioral therapy mindfulness-based stress reduction emotion regulation randomized controlled trial neuroimaging functional magnetic resonance imaging mediators mechanisms
safety of rivipansel (gmi-1070) in the treatment of one or more vaso-occlusive crises in hospitalized subjects with sickle cell disease

Conditions: Sickle Cell Anemia; Sickle Cell Disease; Sickle Cell Disorders; Pain Crisis; Vaso-occlusive Crisis

Summary: this is an open label extension study in subjects with sickle cell disease (scd) who have completed the double blind phase 3 study (b5201002).

this is an open label extension study in subjects who are 6 years of age or older with sickle cell disease (scd) who have completed the double blind phase 3 study (b5201002). this study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (voc) events in hospitalized subjects with scd.

Eligibility criteria:
inclusion criteria: * completion of study b5201002. * documented diagnosis of scd. * at least 6 years of age. * male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. * diagnosis of voc necessitating iv opioids and admission to the hospital. * able to receive the first dose of rivipansel within 24 hours from administration of the first dose of iv opioids for this hospitalization. exclusion criteria: * non-compliance with study procedures in the double blind study (b5201002). * occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in study b5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study. * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results. * clinically significant deterioration in renal function in study b5201002. * pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception. * active use of illicit drugs and/or alcohol dependence.

Keywords: rivipansel gmi-1070 selectin inhibitor scd voc
bulkamid treatment of stress incontinence in women with urinary stress incontinence and not suitable to tvt-procedure

Conditions: Urinary Stress Incontinence; Treatment

Summary: the aim of this prospective, randomized study of bulkamid treatment is to investigate the efficacy of bulkamid treatment in women with urinary stress incontinence not suitable to tvt-procedure because of suspected isd.

the aim of this prospective, randomized study is to investigate the effect of bulkamid injection for women with urinary stress incontinence and not suitable to tvt-procedure because of suspected isd and compare this treatment with no or traditional treatment. the primary endpoint for efficacy will be reduction of leakage during pad-test at 2 months compared with pad- test before injection. secondary endpoints will be patient satisfaction measured at both 2 and 12 months using a questionnaire and the number of side effects.

Eligibility criteria:
inclusion criteria: ability to understand the information and to give informed consent. * at least 50 years of age * history of urinary leakage during low grade physical activity. a woman with genuine stress incontinence has urinary incontinence during running or jumping. women with suspected isd have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. walking, standing up from a chair, and coughing are regarded as low grade of physical activity. * a positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine * no hypermobility of the urethra during cough test. * low pressure of the urethra (optional?) * with a of average miction volume of minimum 150 ml and at least one volume of more than 250 exclusion criteria: * women with hypermobility of the urethra during coughing and positive bonney's test * women suitable for a tvt procedure. * positive urinary culture * urge incontinence