cyrilzakka/clinical-trials huggingface dataset:
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \<18 years) with invasive candidiasis, including candidemia (ICC).

Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \< 18 years) with invasive candidiasis, including candidemia (ICC). To participate in the study, at the time of enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp or (2) in infants 1 month to \< 2 years only, be at high risk of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects will be stratified by age (1 month - \< 2 years; 2 years - \< 5 years; 5 years - \< 18 years). Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are met. Subjects with microbiologically confirmed ICC must have a minimum total treatment duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin pharmacokinetics will be assessed in the first 6 subjects age 1 month - \< 2 years to confirm the recommended dosage regimen. A population PK-PD analysis will be performed in all other enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be either (1) at high risk for candidiasis (1 month - \< 2 years ONLY) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups)
* Male and female patients from 1 month to less than 18 years of age.

Exclusion Criteria:

* Any patients with allergy to the drug; and any pregnant female or lactating.
* Failed previous antifungal therapy or expected to live \< 3 days.
* Patients with documented or suspected Candida meningitis.
Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects

This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.
* Male or female between 18 and 55 years of age.
* A female subject is eligible to participate if she is of non-childbearing potential
* Body weight \> 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
* Demonstrates no evidence of mental impairment.
* No co-morbid Psychiatric Disorders as defined using the Mini International Neuropsychiatric Interview

Exclusion Criteria:

* A positive pre-study drug/alcohol screen.
* A positive pre-study Hepatitis B , Hepatitis C or HIV.
* History of regular alcohol consumption.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Pregnant females, females planning pregnancy or lactating females.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Subjects with a current or a history of psychiatric illness.
* Subjects with any history of suicidal attempts or behavior.
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products.
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice (and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.
Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

The purpose of this study is to determine how teriparatide or denosumab affects the bone of postmenopausal women with osteoporosis after 3 months of treatment, as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, postmenopausal women (no vaginal bleeding for at least 2 years prior to screening) with osteoporosis
* Bone mineral density (BMD) T-score of at least -2.5 at femoral neck (FN), total hip (TH), or lumbar spine (LS) (Lumbar vertebrae L1-L4, with at least 2 evaluable vertebrae), with or without atraumatic fracture after menopause, OR
* BMD T-score of at least -1.5 at FN, TH, or LS (L1-L4, with at least 2 evaluable vertebrae), and 1 or more atraumatic fractures after menopause (vertebral or nonvertebral). Nonvertebral fracture sites allowed are wrist, hip, pelvis, rib, humerus, clavicle, leg (femur, tibia, and fibula, excluding ankle)
* Laboratory values for serum calcium, parathyroid hormone (PTH), and alkaline phosphatase must be within the normal reference range

Exclusion Criteria:

* Has an increased risk of osteosarcoma (bone tumor); this includes Paget's disease of bone, a previous bone tumor, or radiation involving the skeleton
* Has an allergy or intolerance to teriparatide or denosumab and/or is a poor candidate for teriparatide or denosumab treatment (investigator should refer to local product prescribing information)
* Has a history of exposure to DEM or TET therapy in the 12 months prior to screening or a known allergy to DEM or TET
* Has a condition that could put the participant at additional risk of an adverse event (AE) due to the bone biopsy procedure (for example, bleeding disorder)
* Has undergone 2 previous iliac crest bone biopsies (1 in each iliac crest)
* Has a 25-hydroxyvitamin D concentration of \<10 nanograms per milliliter (ng/mL)
* Has currently active or suspected (within 1 year prior to enrollment) diseases that affect bone metabolism, other than osteoporosis (such as renal osteodystrophy, hyperthyroidism, osteomalacia, or hyperparathyroidism)
* Has a history of certain cancers within 5 years prior to trial entry
* Current or recent (within 1 year prior to enrollment) celiac disease, inflammatory bowel disease, gastric bypass, or other malabsorption syndrome
* Has significantly impaired hepatic or renal function
* Has had treatment with systemic glucocorticoids in doses ≥5 mg/day prednisone/day or equivalent in the 6 calendar months prior to screening
* Has taken any intravenous osteoporosis medication
* Has had prior treatment with other bisphosphonates and not been off of them for a specific period of time before trial entry
* Has participated in any other clinical trial studying teriparatide, PTH, PTH analog, or denosumab, or prior or current treatment with teriparatide, PTH, PTH analog, or denosumab
A Study to Compare the Effect of Transipeg 2.95 g or Forlax Junior 4 g in Children With Constipation

The study design combines a long-term safety and a dose range determination objective. The first 8 weeks of the study were primarily intended for the dose range determination, while the later visits were used for the comparison of long-term safety between the groups.


Eligibility Criteria:
Inclusion Criteria:

* Childhood functional constipation
* 6 months to \<16 years of age
* Male or female
* For females of childbearing potential (after menarche): negative pregnancy test
* Moderately severe to severe constipation, defined as stool frequency \<3 stools/week
* Informed consent signed by parent(s) or legal acceptable representative(s), after sufficient oral and written information before entering the study, to be documented by the investigators in the Case Report Form

Exclusion Criteria:

* Functional non-retentive fecal incontinence
* Known metabolic or endocrine disorders (s.a. hypothyroidism)
* Neurologic disorders (s.a. spina bifida or spinal cord anomaly)
* Hirschsprung's disease (congenital megacolon)
* Anal anomaly
* Gastrointestinal surgery
* Drug induced constipation
* Mental retardation
* Cerebral palsy
* Treatment with other laxatives
* Drugs influencing gastrointestinal function (e.g., cisapride, erythromicin, imodium)
* Prior bowel surgery, except appendectomy
* Earlier participation in this trial
* Concurrent participation in any other clinical trial
* Participation in any other clinical study 6 months prior to inclusion
* Any use of a Macrogol within 2 months prior to inclusion
Effect of TENS in Children With Spastic Cerebral Palsy

TENS is cheap and simple tool for physiotherapist, free of many side effects compared with other tools. so The aim of study was record the effect of TENS on calf muscle tone in spastic cerebral palsy children.

The Significance of this study is to determine whether TENS could have an immediate effect on reduction of spasticity in children diagnosed with spastic cerebral palsy by studying the change of spasticity of ankle plantarflexors immediately after applying TENS to the ankle dorsiflexors.

Muscle tone assessment will be applied before and after the application using objective tool which is electromyography and subjectively by using modified Ashworth scale and goniometer, to be insured is there is an immediate effect of TENS on muscle tone of calf muscle or not.

Eligibility Criteria:
Inclusion Criteria:

* The children will be included in this study is according to the following criteria

  1. Cerebral palsy spastic diaplegia.
  2. Their age ranged from 3-10 years.
  3. Both Sexes were included.
  4. The subjects with mild to moderate muscle tone according to MAS in which mild is 1 and 1+ , and moderate is 2.

Exclusion Criteria:

* The subject will be excluded if he/she has one or more of the following criteria:

  1. Children with a history of seizures.
  2. Children who could not lie prone for any cause.
  3. Children who could not react to pain.
  4. Children who had applied any surgical procedure which affect muscle tone or any inhibitory injections like BOTOX.
Fatiguing Arm Exercise Following Stroke

This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue) with the less involved, or so-called non-paretic hand, in people who have experienced a stroke. In previous work the investigators found that non-paretic hand exercise to task-failure increased excitability of the motor cortex in the more involved hemisphere and produced behavioral improvements in the unexercised paretic hand. Importantly, the magnitude of increased brain excitability is greater than what has been observed following brain stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) and lasts longer. This approach could be implemented in the clinical setting and could be accessible to a greater number of people than brain stimulation. The investigators' goals in the current study are to: repeat previous findings in a different group of participants and investigate the neural mechanisms that produce brain and behavioral facilitation in order to inform development of this approach for clinical implementation.

The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.

The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:

1. . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.
2. . Behavioral effects using a motor task involving manipulation and dexterity.
3. . Determine the persistence and consistency of neural and behavioral facilitation.

Eligibility Criteria:
Inclusion Criteria:

* individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
* Non-Veteran Participants are eligible

Exclusion Criteria:

* multiple strokes
* strokes in both hemispheres
* brainstem/medullary/cerebellar stroke
* seizure disorder
* metal implants in head or neck
* pacemaker or other implanted device
* inability to produce any measurable grip force
Neurophysiological and Immunological Effects of the Transition From Combustible to Electronic Cigarettes

The objective of this study is to examine the cognitive, immunological, and neurophysiological effects of transitioning from tobacco cigarettes to electronic cigarettes. The central hypothesis of this study is that this transition will be accompanied by a decrease in peripheral inflammation, which will lead to significant changes in the neurocircuitry underlying interoception and appetite.

Participants who are current cigarette smokers will be randomly assigned to either the experimental or control groups. Following a baseline psychiatric assessment session, subjects will return to the study center for two to three additional follow-up visits.

During the second visit, all subjects will undergo a functional magnetic resonance imaging (fMRI) scanning session, during which they will perform a series of functional neuroimaging tasks designed to examine the neural substrates involved in visceral interoception and eating behavior. Prior to the start of the scan session, blood samples will be collected from each subject, for the measurement of bio-markers related to nicotine use and peripheral inflammation. After the end of the second visit, subjects within the experimental group will be asked to switch from combustible to electronic cigarettes. Subjects within the control group will continue to smoke combustible cigarettes as previously.

During the third visit, which will follow two to eight weeks after the second visit, all subjects will provide a second blood sample and complete a second fMRI scan session. Both groups of participants will complete the same fMRI tasks as they did during the second visit.

Eligibility Criteria:
Inclusion Criteria:

* current cigarette smokers who have smoked for at least one year
* right-handed adults
* able to provide written informed consent

Exclusion Criteria:

* use of anticonvulsant, stimulant, or antipsychotic medication for 3 weeks prior to scanning
* any medical conditions or medications likely to influence cerebral blood flow or neurological function including cardiovascular, respiratory, endocrine and neurological diseases
* any history of drug (other than nicotine) or alcohol abuse within 1 year
* current pregnancy or breast feeding
* primary language other than English
* meeting general MRI exclusion criteria such as magnetic implants or claustrophobia
* Past history of any axis I psychiatric condition, other than major depressive disorder and post-traumatic stress disorder
* Current major depression or post-traumatic stress disorder
* Serious suicidal ideation
Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis

Prophylactic probiotics have been shown to decrease the incidence of Necrotizing Enterocolitis (NEC) in premature neonates. However, there is some resistance to giving live bacteria to small babies. Based on animal data, the investigators hypothesized that heat inactivated probiotics would also reduce NEC.

Preterm neonates, \<1500 gm birth weight will potentially be candidates for study and will be recruited when they begin enteral feeding. The infants will be prospectively and randomly assigned to one of two groups:

1. Treatment group - to receive daily inactivated probiotic prophylaxis starting with the initiation of feeds. 1 tsp powder will be diluted in 2 cc of mother's milk when possible or in Similac Special Care formula 24 cal when mother's milk is not available; and
2. Control group - to receive 2 cc/day of placebo similarly diluted. Supplements will be continued until the infant tolerates enteral feeds of 100 cc/kg/day or reaches 35 weeks post conceptual age (whichever comes LAST). Biotikid, a probiotic mixture, will be heated to 100 degrees C for 10 minutes. Babies will be followed clinically for signs of NEC, and with urine intestinal fatty acid binding protein (IFABP) and fecal calprotectin levels.

The investigators primary aim is to demonstrate that premature neonates who are treated prophylactically with heat inactivated probiotics will have less necrotizing enterocolitis when compared to age matched infants given placebo.

The investigators secondary objectives are to demonstrate the following:

* That the decrease in NEC will coincide with improved intestinal barrier integrity, as reflected by levels of:
* I-FABP in urine
* Fecal Calprotectin

Eligibility Criteria:
Inclusion Criteria:

* Preterm neonates
* ≤1500 gm birth weight

Exclusion Criteria:

* Infants who are not deemed likely to survive more than one week;
* Infants who are not started on enteral feeds by one week of age;
* Infants who have significant congenital malformations or other gastrointestinal problem
A Virtual Prospective Study Exploring Activity Trackers and COVID-19 Infections

Prospective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and SARS-CoV-2 infection


Eligibility Criteria:
Inclusion Criteria:

* Adults 18+ years of age
* Lives in the United States
* Speaks, reads, and understands English
* Willing and able to use and wear a wrist-worn activity device daily, during the day and during sleep, or as much as is possible, for the duration of the study
* Meets minimum software and device requirements for the wrist-worn activity device (Apple iOS 12 and up, Android version 6.0 and up)
* Willing to answer daily, weekly and monthly surveys for the duration of the study
* Willing to provide weekly self-collected saliva samples, plus one additional sample if prompted to do so (up to 9 total samples), and ship back the sample(s) within 24 hours of sample collection

Exclusion Criteria:

* Self-reported previous diagnosis of COVID-19
* Currently participating in any type of clinical trial
* Lives in the District of Columbia (Washington D.C.), Alaska, Hawaii, Arizona, Nevada, U.S. military base located overseas, or U.S. territories (Puerto Rico, U.S. Virgin Islands, Guam, Northern Mariana Island, or American Samoa)
Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)

Management of neonatal pain and sedation often includes opioid therapy. A growing body of evidence suggests long-term harm associated with neonatal opioid exposure. Providing optimal sedation while neonates are undergoing therapeutic hypothermia (TH) may be beneficial but also presents therapeutic challenges. While there is evidence from animal models of brain injury and clinical trials in adults to support the safety and neuroprotective properties of dexmedetomidine (DMT), there are no published large clinical trials demonstrating safety and efficacy of DMT use in neonates with hypoxic-ischemic encephalopathy (HIE) during treatment with TH. This study is innovative in proposing a Phase II, 2-arm trial providing the opportunity to evaluate the use of DMT as compared to the use of morphine for sedation and pain management for babies undergoing TH. We propose to confirm optimal DMT dosing by collecting opportunistic pharmacokinetics (PK) data and determine safety of DMT in this population. These data will inform a larger phase III efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* Neonates ≥36 weeks' gestational age diagnosed with moderate-to-severe neonatal encephalopathy and treated with TH (target temperature 33.5°C) for a planned duration of 72 h.
* Infants requiring sedation and/or treatment to prevent shivering during TH as assessed by the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) scores and a modified Bedside Shivering Assessment Scale.
* Informed consent document approved by the Institutional Review Board (IRB) obtained prior to randomization

Exclusion Criteria:

* Known chromosomal anomalies
* Cyanotic congenital heart defects
* Redirection of care being considered because of moribund condition, or a decision made to withhold full support
Effect of Non-pharmacological Therapy on Cognitive Function of Patients With Cognitive Impairment

Supervised nonpharmacologic therapy improve cognitive function in patients with Mild Cognitive Impairment


Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years and older with Mild Cognitive Impairment according to Petersen Criteria
* Phone number available

Exclusion Criteria:

* Untreated depression
* Evidence of a reversible cause of cognitive decline
* Dementia of any type and stage
* Severe sensory deficit unresolved
* Metastatic cancer
* Hemoglobin level \< 8g/dL
* Chronic Obstructive Pulmonary Disease Gold stage 3 or 4
* Congestive Heart Failure decompensated, unstable angina o Functional Class IV according to New York Heart Association
* Participation in another protocol that prevents its participation in this research
* Chronic use of benzodiazepines, tricyclic antidepressants
* Patients whose place of residence can not attend the sessions
The Association Between Kristeller Maneuver and Pelvic Floor Trauma After Vaginal Delivery

We want to investigate the association between fundal pressure in the second stage and the risk of levator ani muscle (LAM) injury.

We will recruit women immediately following their first vaginal delivery. Women who underwent Kristeller maneuver will be recruit as cases. For each case, a control (no fundal pressure) will be recruit matched by BMI, second stage duration and birthweight. All women will be invited to undergo a postpartum 3D transperineal ultrasound (TPUS). The main outcome measure will be the presence of LAM avulsion at 3D TPUS. TPUS results will be compared between cases and controls.

Eligibility Criteria:
Inclusion Criteria:

* First delivery
* Term pregnancy (37-41w)

Exclusion Criteria:

* Instrumental vaginal delivery
* Multifetal pregnancy
* Previous vaginal or cesarean delivery
* Refused consent and uncooperative patient for effective Valsalva maneuver
* Handicap in lithotomy position
* Women without regular and active contractions
* Epidural analgesia