cyrilzakka/clinical-trials huggingface dataset:
Intravenous Fluid for Pediatric Migraine in the Emergency Department

The purpose of this study is to evaluate the effect of intravenous fluid (0.9% sodium chloride and water) alone on headache pain in children with migraine visiting the Emergency Department.

Migraine is a common and disabling disorder for children. The pain may be severe and relatively few effective medications are approved for use in children. The Emergency Department (ED) remains an important resource for children suffering from migraine whom have not responded to their usual therapy. While a number of effective intravenous therapies have been studied in adults, there has been only one such study in children. As such, emergency physicians have little or no information about the safety and efficacy of these medications in children. However, the conduct of clinical trials where pain is the outcome measure is often limited by a high placebo-response rate. The expectation of treatment can significantly alter the response to medications especially when pain severity is the outcome measure. Moreover, the investigators have found that intravenous fluid alone may help to treat migraine headache in children. The investigators propose a study to examine the response to intravenous fluid hydration as initial therapy comparing a group with expectation of medication and another group without the initial expectation of medication. The results of the study will help to estimate the rate of response to intravenous fluid and to evaluate the placebo-effect (i.e. expectation of treatment) in studies of migraine treatment in the ED. Exposure to additional and possibly unnecessary medications will thus be minimized and the results of future trials more definitive on the effect of the study medication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine or probable migraine (with or without aura) per the International Classification of Headache Disorders (2nd edition)
* Visiting the Emergency Department for migraine treatment
* Emergency Department physician has chosen to administer intravenous medication
* Has taken usual therapy at home or at least one does of either ibuprofen or acetaminophen in the Emergency Department

Exclusion Criteria:

* Other probable cause for headache (e.g. ventriculoperitoneal shunt, neoplasm, intracranial cyst)
* Head trauma causing loss of consciousness within 1 week of presentation
* Fever (temperature \> 38.5 oC)
* Signs or symptoms of meningitis
Vildagliptin in Older Adults With Diabetes and Mild Cognitive Impairment

This study investigates the effect of vildagliptin, an inhibitor of the enzyme DPP-4, on the cognitive functioning of elderly diabetic patients with mild cognitive impairment (MCI) documented at mini mental state examination (MMSE).

In this prospective study, 60 diabetic elderly people were enrolled and divided according to their glycated hemoglobin (HbA1c) values in 2 groups: Group A, (HbA1c \<7.5%, n=30) treated with metformin, and Group B (HbA1c \>7.5%, n=30) treated with metformin plus vildagliptin. We evaluated MMSE, fasting plasma glucose (FPG) and HbA1c at baseline and after 24 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* age \>65 years
* MMSE score ≥18 and ≤23
* diagnosis of diabetes mellitus

Exclusion Criteria:

* heart failure
* coronary heart disease
* stroke
* chronic kidney disease (G3 grade KDOQI)
* liver cirrhosis
* chronic respiratory failure
* depression evaluated by Geriatric Depression (GDS, GDS \>15)
* diagnosis of dementia based on DSM 5 criteria
* anticholinesterase or memantine therapy
NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation

Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy.

The study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Persistent FI (Miller incontinence score \>5)
* Anorectal malformation.

Exclusion Criteria:

* Pregnancy
* Rectal prolapse
* Significant mucosal prolapse
* Inflammatory bowel disease
* Anorectal surgery within the last year Before inclusion
* Anticoagulant medication/bleeding diathesis
* Anorectal sepsis in the past
* Immunodeficiency
* Immunosuppressing therapy
Validation of Progranulin as a Biomarker for Sepsis

Progranulin blood concentrations in patients with sepsis will be analysed in relation to disease status in order to validate progranulin as a biomarker for sepsis. Patients undergoing cardiac surgery will serve as controls.

Single nucleotide polymorphisms with known effects on Progranulin plasma concentrations will be assessed in a separate analysis. Expression levels of microRNAs isolated from plasma, circulating exosomes and blood cells will be determined by next-generation sequencing to characterize epigenetic influences on progranulin plasma levels.

Eligibility Criteria:
Inclusion Criteria:

* Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age \> 18 years

Exclusion Criteria:

* No informed consent
* Age \< 18 years
* Pregnancy
* Immunosuppression (including transplantation)
* Charlson Comorbidity Index \> 0 (healthy volunteers)
Behavioral Parent Training for Families with Deaf and Hard of Hearing Preschoolers

Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation with parents of young DHH children followed in "real world" hearing healthcare clinics will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Parent is age 18 or older
* Parent is custodial guardian of child
* Parent can either speak/understand English or use American Sign Language
* Parent lives in a state with an established referral network for parents of DHH children if additional services are needed
* At baseline, child is between the ages of 3 and 6 years
* At baseline, child lives majority of time in the parent/guardian's home
* Child is deaf or hard of hearing
* Child has used hearing aid(s), cochlear implant(s) and/or bone conduction device(s) for greater than 6 months

Exclusion Criteria:

* Active child protective services case is open
* Parent has already accessed behavioral health services for the child
* Parent participated in formative research for this study
Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer

Background: During emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax. Dexmedetomidine is a selective α2-adrenoreceptor agonist that has sedative, analgesic, and sympatholytic properties. It has been reported dexmedetomidine can attenuate coughing reflex and prevent emergence agitation without delaying recovery and respiratory depression from general anesthesia. The purpose of this study was to investigate the effect of dexmedetomidine compared with midazolam on cough suppression and recovery quality during emergence from general anesthesia after partial and total laryngectomy.

Methods American Society of Anesthesiologists physical status I-II male adults undergoing elective laryngectomy under sevoflurane anesthesia were recruiting and randomly allocated to receive either dexmedetomidine(Group D, n = 60) infusion at 0.5 µg•kg-1 for 10 min before tracheotomy, then adjusted to 0.3µg•kg-1•h-1 or midazolam (Group M, n = 60) infusion at 0.05 mg•kg-1 ten minutes before tracheotomy, then adjusted to 0.02mg•kg-1•h-1. The primary outcome measure was the incidence and severity of cough. Hemodynamics, pain intensity \[Visual Analogue Scale (VAS)\] and Ramsay sedation scale (RSS) were also evaluated at awake, patients returning to ward from post anesthesia care unit (PACU),2h after surgery. postoperative sufentanil consumption, recovery time and the incidence of concerning adverse effects were recorded.


Eligibility Criteria:
Inclusion Criteria:

Subject scheduled for partial or total laryngectomy.

Exclusion Criteria:

Subject has respiratory disease; Subject has pharyngeal paraganglioma; Subject has cardiac disease; Uncontrolled hypertension; Subject has been taking β-adrenoreceptor blockers; Long-term abuse of alcohol (\>6 months),opioids, or sedative-hypnotic drugs; Allergic to dexmedetomidine or midazolam; Subject has neuropsychiatric diseases; Operation time shorter than 1 h or longer than 4 h.
Osteopathic Approach Into Neonatology Ward: the NE-O Model

Background Several studies have shown the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. Despite several results obtained, there is still lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (NICU).

The aim of this research is to provide a guideline on osteopathic approach in treating hospitalized newborns. Specific evaluation tests and treatments have been developed to tailor osteopathic method according to preterm and term infants' needs, NICU environment, medical and paramedical assistance.


Eligibility Criteria:
Inclusion Criteria:

* newborn admitted to neonatal intensive care unit
* informed consent signed from parent or legal guardian

Exclusion Criteria:

* post surgery patients
Effects of Family Planning Education Given to Illiterate Women Via Visual Material Support

This study was conducted to determine the effects of family planning education given to married illiterate women of reproductive age via visual material support on their family planning attitudes and contraceptive preferences.in this study, it was aimed to provide education to married illiterate women of reproductive age using visual materials to change their FP-related attitudes in a positive direction and transform these attitudes into positive fertility behaviors.

The hypotheses of the study were as follows:

H1a: FP education given with visual materials increases positive attitudes toward FP in illiterate women.

H1b: FP education given with visual materials affects the contraceptive preferences of illiterate women.

This study was conducted to determine the effects of family planning education given to married illiterate women of reproductive age via visual material support on their family planning attitudes and contraceptive preferences.

Method: The randomized controlled study was carried out between 31 January and 31 July 2023. The sample of the study consisted of 148 women, including 74 in the experimental group and 74 in the control group. Using a Family Planning Education Booklet prepared for illiterate women, an education program lasting a week in total was held in three sessions. No intervention was made in the control group. Data were collected using a Personal Information Form, a Family Planning Assessment Form, and the Family Planning Attitude Scale. No intervention was made in the control group. The same data collection instruments were administered to the participants in the control group simultaneously with the experimental group in the pretest (day 1) and posttest (day 7) phases.

Eligibility Criteria:
Inclusion Criteria:

* Being able to communicate,
* Not having any visual or auditory problems that could prevent communication,
* Being aged 15-49 and married,
* Not having a diagnosis of chronic illness (e.g., cardiovascular diseases, asthma, epilepsy),
* Not receiving any FP-related education within the last 21 days.

Exclusion Criteria:

* - Being currently pregnant,
* Planning to get pregnant soon,
* Receiving medical treatment for any diagnosed chronic illness.
Corneal Epithelial Wound Healing Difference Between Human Autoserum and Cord Blood Serum

Human serum eye drops have been successfully used in the treatment of severe ocular surface disorders and the enhancement of corneal wound healing. Umbilical cord serum is also proven to be effective in treatment of dry eye and persistent corneal epithelial defects. However, there are limited studies comparing the corneal epithelial wound healing promoting effects between these two blood derived products. The purpose of this study is to test the corneal epithelial wound healing promoting effects between auto serum and human cord blood serum. Primary cultured bovine corneal epithelial cells were used as the model to investigate wound healing, cell proliferation and migration by means of scratch corneal wound healing assay evaluation, MTS assay and Boyden chamber migration assay in response to human serum and umbilical cord serum. The concentrations of EGF, TGF-β1, and fibronectin were also compared between human serum and umbilical cord serum with ELISA kits.


Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women
* Cesarean section for labor
* Complete placenta with umbilical cord retained
* Healthy individual

Exclusion Criteria:

* The retained placenta and umbilical cord were not complete
* Individual with anemia or other hematologic disorder unsuitable for blood donation
Confocal Laser Microlaryngoscopy (CLMx)

The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions.

In order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. While in the operating room, prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard protocol, and the diagnostic results from CLM and the formal biopsy will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy.
* Patient will have vocal fold leukoplakia or other abnormal epithelial changes.
* Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have a history of radiation to the neck.
* Patient must not have a documented reaction to fluorescein
* Patient must not have a previous history of laryngeal cancer.
* Patient must not have a history of allergy or bronchial asthma.
* Patient must not be pregnant or breastfeeding.
More Air - Better Performance - Faster Recovery

The objective of this study is to investigate i) the effect of 3 weeks IMT to adults post-stroke to maximal inspiratory pressure (MIP) and ii) the effects of 3 weeks IMT to the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance, and expiratory function.

Methods/Design: Randomised controlled trial (RCT) comparing IMT to conventional neurorehabilitation (usual practise). 80 patients, with reduced maximal inspiration pressure (MIP) hospitalized at a specialized neurorehabilitation hospital in Denmark will be included.

Background: Stroke results in varying disabilities physical, cognitive, emotional and/or social both in short term and long term. Motor impairments are significantly persistent consequences post-stroke among these are decreased respiratory muscle function, decreased ability to expand thorax and postural dysfunction. These deficits influence the patient's ability in daily activities, fatigue, endurance and quality of life. Inspiratory muscle training (IMT) is training to improve the strength and endurance of diaphragm and the external intercostal muscles. The objective of this study is to investigate i) the effect of 3 weeks IMT to adults post-stroke to maximal inspiratory pressure (MIP) and ii) the effects of 3 weeks IMT to the degree of dependency in activities of daily living, endurance in gait, fatigue, voice volume, phonation endurance, and expiratory function.

Methods/Design: Randomised controlled trial (RCT) comparing IMT to conventional neurorehabilitation (usual practise). 80 patients, with reduced maximal inspiration pressure (MIP) hospitalized at a specialized neurorehabilitation hospital in Denmark will be included. The intervention group will add-on IMT sessions exercising at 30 % of MIP. Patients in the intervention group perform 2 sessions a day (One session of IMT with IMT threshold flute consists of 2 times 15 inspirations in normal breathing rhythm (5-10 min)), 7 days a week for 3 weeks. Training can be with or without supervision of physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* First time brain infarction or brain haemorrhage 0-6 month.
* Able to give written consent and being cognitive and communicative able to understand and participate in the maximal inspiration pressure test (MIP)
* Reduced MIP below gender and age specific normal standard

Exclusion Criteria:

* Diagnosis of myocardial infarction within the last 3 months
* Significant pulmonary disease (severe COPD), saturation below 90 if having COPD for others saturation below 92
* Neurological deficits other than stroke
* Facial palsy that affects proper labial occlusion
* Dizziness or nausea/vomiting during MIP-testing.
Neurocognitive Function Changes with Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

The objective of this randomized controlled study is to assess the neurocognitive outcomes between individuals using immediate-release (IR) tacrolimus (Prograf®) and those who were converted to extended-release tacrolimus (Envarsus XR) among older kidney transplant recipients (KTRs).


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent for participation in the study
* Patients who have regular outpatient follow-up at the Massachusetts General Hospital (MGH) transplant center
* ≥1 year since the latest kidney transplantation
* On IR tacrolimus as maintenance therapy
* At a stable therapeutic tacrolimus level (5-10 ng/ml) over the last ≥3 months
* Stable kidney function \[\<20% variability between the last two estimated glomerular filtration rate (eGFR)\]
* Utilizing English or Spanish as the primary language

Exclusion Criteria:

* Dual organ transplantation
* Rejection within the last three months
* History of moderate to severe dementia (defined by Dementia Severity Rating Scale ≥19)
* History of Parkinson's disease
* Decompensated liver disease
* Active cancer
* Uncontrolled depression or anxiety
* Blindness
* Deafness
* Intellectual disabilities
* Pregnancy
* eGFR \<15 mL/min/1.73 m2 at the time of enrollment
* Total bilirubin \>3.0 mg/dL
Efficacy of Intravenous Levetiracetam in Neonatal Seizures

A new anticonvulsant, levetiracetam will be studied to treat seizures in newborn infants. Current treatments for the brain damaging complication of neonatal seizures are unsatisfactory.

Monitoring for seizure detection will be tested at five (5) US sites and one (1) international site using the internet.

This project aims to improve the treatment of neonatal seizures. Current treatments are poorly effective and have significant side effects.

Levetiracetam (LEV) has great potential as a treatment for neonatal seizures but is not approved for use in children less than 2 years of age.

This study aims to obtain essential data regarding the efficacy and safety of LEV in this vulnerable and under researched population and simultaneously to develop EEG monitoring systems that facilitate seizure detection and research.

Specific aims are:

1. To determine the efficacy of intravenous LEV in terminating neonatal seizures when given as first line therapy.
2. To obtain dose escalation data by studying the additional efficacy of a further dose in non responders.
3. To obtain additional pharmacokinetic data to confirm findings from our previous pharmacokinetic study.
4. To obtain further safety data of LEV in neonates.
5. To prove the feasibility of centralized remote monitoring of continuous EEG monitoring in the Neonatal Intensive Care Unit (NICU) via the internet and test a promising automated neonatal seizure detection algorithm.

The study design is a phase 2b randomized blinded controlled study.

Eligibility Criteria:
Inclusion Criteria:

1. Newborns admitted to any of the study sites with electrographic seizures seizures.
2. Term infants gestational age \>36 weeks less than 2 weeks of age.
3. Greater than 2200 grams.
4. Infants for whom parental consent to participate in the study is obtained.

Exclusion Criteria:

1. Infants who are already receiving anticonvulsants
2. If serum creatinine is greater than 1.6mM
3. If seizures are due to correctable metabolic abnormalities (i.e. hypoglycaemia, hypocalcemia, hyponatremia)
4. Subjects in whom death seems imminent, as assessed by the neonatologist.
Low Back Pain Intensity and Core Muscle Strength After Different Delivery Modes

Cesarean delivery (CD) may trigger an increase in low back pain (LBP) intensity and induce core muscle weakness. This study will assess the correlation between low back pain intensity and core muscle strength of transverse abdominis and Lumbar multifidus among women who underwent CD and compare it with those who experienced vaginal delivery.

Cesarean delivery (CD) is one of the most common surgical procedures in obstetrics, and it is also one of the oldest medical procedures. The rise in the rate of cesarean sections is one of the most striking hallmarks of modern obstetrics.

In Egypt, the prevalence of CD has increased dramatically over the last decade, with the most recent Egypt Demographic and Health Survey (EDHS) reporting a rate of 52 percent, implying that cesarean sections may be overused or utilized for improper reasons.

The two deep local core muscles are the transversus abdominis and the lumbar multifidus muscles. The definition of Core muscle strength is the active ability of these muscles to not only produce but also, maintain stresses to provide stability for the spine through management of the intra-abdominal pressure.

LBP prevalence in mothers undergoing cesarean delivery was higher compared to its counterpart in mothers undergoing vaginal delivery. The related mechanisms for LBP during the postpartum period following cesarean or vaginal deliveries may be overweight and obesity, postural adaptations, and stressful positions that mothers assume during either delivery or lactation.

Eligibility Criteria:
Inclusion Criteria:

1. All women are either primiparous or multiparous.
2. Their ages ranged from 18 to 35 years.
3. All participants had a body mass index (BMI) of not more than 29.5, and a waist-to-hip ratio of not more than 1.
4. Participants were assessed between the 6th week to the 12th week postnatal.
5. All participants were able to continue all assessment procedures.
6. They were medically stable.

Exclusion Criteria:

1. Women who were below 18 years old or above 35 years old.
2. Women who had a (BMI) above 29.5 or a waist-to-hip ratio above 1.
3. Women who did not continue all assessment procedures.
4. Women who had a past history of specific LBP as those who were diagnosed with spondylolisthesis, lumbar disc prolapse, or structural scoliosis.