cyrilzakka/clinical-trials huggingface dataset:
Multiple Oral Administration of ASP7991 to Non-elderly Male Subjects

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after multiple oral administrations to non-elderly subjects.

In each step (lowest dose, middle dose, highest dose), subjects are randomly assigned in a double blinded manner to receive either ASP7991 (n=9) or Placebo (n=3) and are administered repeatedly. Once daily, the subjects are administered ASP7991 or placebo orally 30 minutes after breakfast with 150 mL water for 7 days. After the each step the sponsor evaluates the safety in the blinded manner for deciding an escalation to the step.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, as judged by the investigator/sub investigator based on the results of physical examination obtained before study drug administration
* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Serum corrected calcium concentration: ≥9.0mg/dL, \<10.4 mg/dL

Exclusion Criteria:

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before screening
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before screening
* Received medication (including marketed drug) within 7 days before hospitalization, vitamin preparation including vitamin D and supplement including calcium or is scheduled to receive medication
* A deviation from normal criteria range of 12-lead ECG (QT evaluation)
* A deviation from the normal range in clinical laboratory tests
* Highly sensitive cardiac troponin T (at screening): ≥0.014 ng/mL
* History of drug allergies
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before admission
* Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury)
* Concurrent or previous endocrine disorders (e.g., hyperthyroidism, aberration in growth hormone)
The Paediatric Virtual Autopsy Trial

In light of declining autopsy rates around the world, post-mortem MR imaging is a promising alternative to conventional autopsy in the investigation of infant death. A major drawback of this non-invasive autopsy approach is the fact that histopathological and microbiological examination of the tissue is not possible. The objective of this prospective study is to compare the performance of minimally invasive, virtual autopsy, including CT-guided biopsy, with conventional autopsy procedures in a paediatric population.

Foetuses, newborns, infants and children that are referred for autopsy at three different institutions associated with the University of Zurich will be eligible for recruitment. All bodies will be examined with a commercial CT and a 3 Tesla MRI scanner, and investigators will be blinded to the results of conventional autopsy. After cross-sectional imaging, CT-guided tissue sampling will be performed by a multifunctional robotic system (Virtobot) allowing for automated post-mortem biopsies. Virtual autopsy results will be classified with regards to the likely final diagnosis and major pathological findings and compared to the results of conventional autopsy, which remains the diagnostic gold standard.

This interdisciplinary study will determine whether virtual autopsy will narrow the gap in information between non-invasive and traditional autopsy procedures.


Eligibility Criteria:
Inclusion criteria:

* Stillborn infants ≥ 16 0/7 weeks of gestational age (GA)
* Live born infants ≥ 16 0/7 weeks GA until adolescents up to 16 years of age, who died of natural- and non-natural cause (trauma, homicide, suicide and intoxication).

Exclusion criteria:

* Deceased infants who are donors of organs
* Lack of parental consent
Rare Iron Overloads Except C282Y Homozygosity : Description and Characterization.

Chronic iron overload is responsible for morbidity and mortality. There are many genetic and acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone for iron. The study explores this specific cause, and aim to characterize this iron overload in term of clinical, biological, genetic and functional specificities.

One of chronic iron overload profiles is a deficit in hepcidin. Hepcidin is the regulating hormone for iron. This specific profile is characterized by an elevated serum iron, an elevated transferrin saturation, and parenchymal damages of iron overload. This disease is not connected with known mutations of iron metabolism genes.

The main objective of this study is the clinical, biological, genetic and functional characterization of rare iron overload phenotypes associated with hepcidin deficiency except C282Y homozygosity.

Eligibility Criteria:
Inclusion criteria:

* Biological profile suggesting hepcidin deficiency:

  * high serum iron (\> 25μmol / l) checked at least 2 times.
  * increased transferrin saturation coefficient (\> 50 %) checked at least 2 times, and calculated from transferrinemia.
* Proved hepatic iron overload: using a dosage of iron hepatic concentration either on hepatic biopsy, or by MRI according to the method of iron overload quantification. A threshold of 100 µmol / g is set.
* Patient's written consent for examination and collection of genetic data to set the diagnosis.

Non inclusion criteria:

* HFE hemochromatosis: C282Y/C282Y homozygosity
* Treatment by iterative phlebotomies (more than 2 phlebotomies)
* Hematological diseases with dyserythropoiesis and/or repeated transfusions
* Low haptoglobin level, suggesting chronic hemolysis or myelodysplasia
* Long-term iron oral and/or parenteral supplementation
Evaluation of an Online Intervention to Help LGBTQ Youth Cope With Bullying

The purpose of this research study is to conduct a pilot randomized controlled trial of a game-based intervention is able to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the feasibility and acceptability of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors among SGM youth; and (2) Using a randomized controlled trial, test the efficacy of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among SGM youth.

The purpose of this research study is to conduct a pilot randomized controlled trial of a game-based intervention is able to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among sexual and gender minority (SGM) youth. The goals of the proposed study are to: (1) Test the feasibility and acceptability of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors among SGM youth; and (2) Using a randomized controlled trial, test the efficacy of a game-based intervention to increase help-seeking-related knowledge, attitudes, and behaviors, reduce health risk factors/behaviors, and increase resiliencies among SGM youth.

Eligibility Criteria:
Inclusion Criteria:

* Must identify as lesbian, gay, bisexual, queer, transgender or another sexual or gender minority
* must have bullying experience
* must have access to a computer and email

Exclusion Criteria:

* Residence outside of United States
* Not within the age range
Pre-procedure Planning for Radiofrequency Ablation Using CT or MR/US Fusion

The purpose of this study is to determine whether fusion technique of pre-radiofrequency ablation (RFA) cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA in patients with liver tumor in comparison with ultrasonography guidance alone.

RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors in comparison with conventional US alone technique.

Eligibility Criteria:
Inclusion Criteria: all conditions should be satisfied for inclusion.

* referred to Radiology in our institution for liver tumor RFA
* available pre-RFA liver CT or liver MR imaging within 6 weeks

Exclusion Criteria: patients with any of following condition should be excluded.

* any contraindication of liver RFA
* any patients who received treatment between pre-RFA imaging and planned RFA
* patients referred for palliative purpose.
Safety on Switching Between Different Botulinum Toxin-A

Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA.

With this study investigators would like to evaluate retrospectively if switching from one toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin to another was maintained.

A data base was designed to capture all data that were considered relevant to the treatment evaluation. The data were transcribed directly from participants medical records. For the purpose of the study, data from the two subsequent visits where a different type of toxin was given will be collected and evaluated . In order to collect the pre and post status in terms of safety and efficacy, for each participant, data corresponding to the 6 previous and posterior months after the switch of the toxin will also be collected or data corresponding to the previous and posterior visit after the switch of the toxin will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* children diagnosis of cerebral palsy with respect to Rosenbaum criteria,
* children having received repeated injections with two different types of toxinA treatment into their lower limb(s)

Exclusion Criteria:

* children without repeated Botulinum toxin type A injections
* children having received repeated injections with same type of toxinA
The Effect of Percutaneous Dilatational Tracheostomy on Intracranial Pressure

Percutaneous dilatational tracheostomy (PDT) is a common bedside alternative to surgical tracheostomy in intensive care unit patients. Intracranial pressure measurement is a vital parameter that should be monitored when performing any procedure including PDT in these patients. During PDT, changes in intracranial pressure may occur depending on the position applied, hypercarbia and hypertension that may develop during the procedure. However, the effect of PDT procedure on intracranial pressure is controversial. It is imperative to ascertain the impact of PDT on intracranial pressure, along with the factors that influence its fluctuations during the procedure. This is of particular significance in order to avert the occurrence of deleterious conditions that may be engendered by elevated intracranial pressure. The aim of current study was to evaluate the effect of PDT procedure on intracranial pressure.

Since the study is a prospective observational study, the investigators will not be the decision-making physicians about the treatments applied to the patients. The optic nerve sheath diameter measurement method by ultrasonography will be used to determine intracranial pressure.Intracranial pressure measurement will be performed in neutral position before PDT, after the patient is positioned for the procedure, immediately after the procedure and immediately after the patient is placed in neutral position. Demographic characteristics, comorbidity status, PDT indication, intensive care unit hospitalisation diagnosis, intracranial pathology data, haemodynamic data, arterial blood gas parameters will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for PDT

Exclusion Criteria:

* Age \<18
* Patients with glaucoma
* Patients with optic nerve damage
* Patients in whom PDT is contraindicated (coagulopathy, infection at the site of intervention, etc.)
Evaluation of Fast Track Rehabilitaion in Mini-invasive Lombar Arthrodesis

Mini invasive spine surgery have become very common in the past years. Posterior arthrodesis associated to liberation have good functional results and doesn't present much complication cases.

So that's why St Joseph Hospital spine surgeon have made the hypothesis that this kind of surgery can be associated to fast track surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient accepting fast track réhabilitation for transforaminal lumbar interbody fusion
* age \>18 hears

Exclusion Criteria:

* Age \>75
* ASA score \>2
* long distance between house and hôpital
* socially isolantes
* pathology needed conventional hospitalisation
* psychiatric pathology
Effectiveness of Microcurrents Therapy in Overactive Bladder.

The purpose of this study is to investigate the effect on the overactive bladder in women using a care protocol plus the application of microcurrent patches during 1 hours per session compared to the effect of the same protocol plus placebo electric stimulation.

The design of this study is a multicentric, parallel, randomised, triple blind clinical trial with placebo control.

The size of the sample will be 56 participants who come to referral hospitals. They will be randomized in two groups: control or experimental.

The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.

The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p \<0.05

Eligibility Criteria:
Inclusion Criteria:

* Women, over 18 years of age and with urinary incontinence (3 or more times per week) or overactive bladder (8 or more emptied per day, and / or 2 or more at night) who have received, or not, active / alternative treatment for this pathology.
* Under competent cognitive conditions to participate in the study and trained to complete the study questionnaires.
* Without contraindications for a treatment with microcurrents: Pacemakers, pregnant women, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.

Exclusion Criteria:

* People with lifestyle habits (diet, amount of fluid ingested) extreme or singular (eg person who consumes 5 liters of water a day).
* Presence of urinary fistula.
* Men. Men will be excluded to avoid the potential influence of prostate problems, the main causes of the symptoms described.
* Urinary tract infection, or relapses: 5 or more infections in the last 12 months.
* Participants with bladder stones.
* Hematuria during the trial period.
* Pregnancy or plans for it during the study.
* The patient has had a hysterectomy.
* Pathology of the central or peripheral nervous system.
* Diabetes without controlled and guaranteed medical treatment its stabilization.
* Diabetes that affects the peripheral nerves.
* Treated with anticoagulant.
* Current use of anticholinergics and beta adrenergic use in the last 4 weeks.
* Currently treated with botox injections for the bladder or in the last year.
* Current treatment with interstim or interstim device currently implanted.
* Obstruction of the bladder outlet.
* Urinary retention.
* Painful bladder syndrome / interstitial cystitis.
* Treatment with more than two antidepressants and / or multiple benzodiazepines, as well as anti-epileptics.
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States

This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with Rotarix within 60 days of vaccination in a real life setting (routine use) in the US. This study will also include monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination.

This study involves three cohorts, one exposed and two control cohorts: infants who receive Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B).

This is a combined prospective and retrospective cohort study. Prospective component of the study identifies and compares study outcomes following Rotarix and IPV vaccination in the Exposed cohort and Unexposed cohort A, respectively.

Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.


Eligibility Criteria:
Inclusion Criteria:

For Exposed cohort:

* Infants aged less than 1 year at study entry.
* Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
* Have complete medical coverage and pharmacy benefits.
* Received at least one dose of Rotarix from 1 August 2008.
* Infants receiving Rotarix liquid formulation will also be eligible.

For Unexposed cohort A:

* Infants aged less than 1 year at study entry.
* Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
* Have complete medical coverage and pharmacy benefits.
* Received at least one dose of IPV vaccine from 1 August 2008, with or without RotaTeq vaccination.
* Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination within the same year.

For Unexposed cohort B:

* Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
* Had complete medical coverage and pharmacy benefits.
* Received at least one dose of IPV vaccine.
* Vaccinated between 1 January 2006 (inclusive) and 31 July 2008 (inclusive).
* Not received any dose of rotavirus vaccination.
* Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination.

Exclusion Criteria:

For Exposed cohort:

• Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period.

For Unexposed cohort A:

• Subject has received any dose of Rotarix prior to the first IPV vaccine during the study period.

For Unexposed cohort B:

• Subject has received any dose of rotavirus vaccines prior to the first IPV vaccine.
ESWL Versus ESWL and Endoscopic Treatment

The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for treatment of pain in chronic pancreatitis.

The combination mode of ESWL and ERCP is an established method of treatment of painful obstructive calcified chronic pancreatitis. However, the investigators notice that patients after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of patient care, without improving the outcome of the pancreatic pain.

So the investigators design such a prospective and randomized controlled trial. People diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random numbers.

ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions will be repeated if necessary, until stone fragmentation is obtained. Patients in the endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.

Follow-up will consists of telephone interview1 after treatment and clinical examination every 6 months thereafter. Data collected will include clinical presentation, ESWL, endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6 months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical examination.

Eligibility Criteria:
Inclusion Criteria:

* painful chronic pancreatitis(abdominal pain attack during the preceding 12 months);
* at least 1 calcified stone greater than 5 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct with upstream duct dilation;
* no ERCP or ESWL carried out before admission

Exclusion Criteria:

* suspected to have malignant tumors;
* history of pancreatic surgery or gastrojejunostomy (Billroth II);
* pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan;
* age below 18 years;
* pregnancy or lactation;
* refuse to write informed consent
Biomarkers in Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.
* Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.

OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* One of the following karyotypes:

  * t(8;21) and WT c-kit
  * t(8;21) and mutant c-kit
  * Normal karyotype

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified