cyrilzakka/clinical-trials huggingface dataset:
An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic

The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in participants with heart failure and weakened heart function given a standard dose of diuretic.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Left ventricular ejection fraction \<45%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan within 18 months
* On stable chronic guideline-directed therapy for HF including chronic loop diuretics, ACEi, ARBs, MRAs, ARNI or / and β-blockers as tolerated, with no changes of these medications in the past 2 weeks
* At least an oral dose of 40 mg of furosemide/day or equivalent (20 mg torsemide, 1 mg bumetamide)

Exclusion Criteria:

* SBP \< 115 mm Hg or \> 180 mm Hg at screening or pre-randomization
* Heart rate \< 50 beats per minute (bpm) or \> 120 bpm at screening or pre-randomization
* Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease

Other protocol defined inclusion/exclusion criteria could apply
Spectroscopy From Duodenum

Purpose of this study is to understand the clinical feasibility of duodenal spectroscopy to adenocarcinoma patients.

Pancreatic cancer (PC) is the most lethal of all major cancers with a five year survival rate of 5 %. While stage I and II tumors leads to an improvement in survival, almost all PCs are currently diagnosed at more advanced non-resectable stages since minimally invasive technique which is capable of screening early-stage PC does not exist. Serum CA19-9 is not recommended as a screening technique because of its low sensitivity and specificity. Imaging modalities such as MRI, CT, EUS and ERCP are more accurate but are not appropriate screening tools due to their high cost, discomfort and complications. Therefore, there is a strong demand for a screening tool with high sensitivity and specificity which is highly acceptable for the patient. The investigators would like to look at the spectroscopy technique for pancreatic cancer diagnosis via an upper endoscopy. A definite diagnosis of the patient is made with histology, cytology or imaging diagnosis. Therefore this study can be positioned as a feasibility study.

Eligibility Criteria:
Inclusion Criteria:

* Common inclusion criterion

  * Age is 18 years or older.
  * Informed consent was obtained.
  * Inclusion criterion for normal cohort
  * An upper GI endoscopy is scheduled to check upper abdominal symptoms.
  * No findings of pancreatic disorder as documented by CT or MRI or EUS
* Inclusion criterion for PC suspicious cohort \* A EUS or ERCP is scheduled to suspected pancreatic disorder.

Exclusion Criteria:

* Common exclusion criterion

  * Severe cardiac disease
  * Severe respiratory disease
  * Bleeding disorders
  * Pregnancy
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine

The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

Exclusion Criteria:

* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
* Current use or prior exposure to Galcanezumab or other antibodies to CGRP or its receptor.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder

This study aimed to provide normal reference values of surface electromyography (sEMG) and mandibular kinematics in Chinese young adults, compare the sex differences and assess the diagnosis value of these indices.

Temporomandibular disorders (TMD) are one of the leading causes of craniofacial pain, and a high incidence of TMD in young adults has been reported. Previous studies have used sEMG and mandibular kinematic analysis to diagnose TMD. This was an observational study that healthy young adults with individual normal occlusion were strictly selected by diagnosis standard, and TMD patients with disc displacement were recruited. The sEMG signals of the anterior temporalis (TA), masseter (MM), and sternocleidomastoid and digastric were recorded in the mandibular postural positions (MPP) and during maximal voluntary clenching (MVC) with K7 electromyograph. Mandibular kinematics, including maximum opening and opening/closing velocities, were assessed by K7 kinesiograph.

Eligibility Criteria:
Inclusion Criteria:

* Centred midline and no marked restriction and deviation of mouth opening and closing; ·Overjet and overbite of 1-3 mm, bilateral molar support with molar and cusp relation of Angle's class I;
* Presence of complete permanent dentition, except third molars.

Exclusion Criteria:

* History of local or general trauma;
* Presence of systemic diseases, neurological or psychiatric disorders, muscular diseases, cervical pain, or TMD based on the Research Diagnostic Criteria (RDC);
* Pregnancy;
* Consumption of anti-inflammatory, analgesic, antidepressant, or myorelaxant drugs;
* Presence of parafunctional facets and anamnesis of parafunctional tooth clenching, bruxism, or unilateral chewing;
* Presence of obvious dentition crowding or spacing, malposed, supernumerary or fractured tooth, visible caries, tooth abrasion/hypersensitivity, toothache, periodontal disease, or occlusal discomfort;
* Fixed or removable restorations, tooth filling, or occlusal adjustment that affected the occlusal surfaces;
* Previous or concurrent orthodontic, orthognathic, or TMJ treatment.
Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma

The poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.

FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during the course of CRT might be predictive of the treatment efficiency few months later.

In this study, we propose to perform 4 FDG-PET: first "PET1" before chemo-radiotherapy, second "PET2" during the chemo-radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the end of radiotherapy.

We will investigate the performances of FDG-PET performed during CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be able to optimize the planning treatment during the course of the therapy.


Eligibility Criteria:
Inclusion Criteria:

* Carcinoma épidermoïde of the oesophagus histologically proved, UICC Stage II B, III or IVa (TNM on 2002)
* Decision of treatment by radio concomitant chemotherapy (radiotherapy in classic spreading of 50Gy associated with a platinum chemotherapy.

Exclusion Criteria:

* Presence of a second evolutionary cancer in the previous three years
* index of performance OMS \> 2
* Patients badly balanced diabetics
IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?

This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus help direct the biopsy to the most abnormal part of the renal cortex. This should maximize detection and increase the odds of demonstrating the true grade/severity of the histopathological abnormality.


Eligibility Criteria:
Inclusion

* Ability to provide informed consent
* Male and female \>18 years
* Patients undergoing renal transplant ultrasound-guided percutaneous biopsy within 24 months post transplant including patients undergoing biopsy to evaluate a recent rise in serum creatinine so called for cause biopsies and patients undergoing routine protocol (surveillance) biopsies without other evident of renal dysfunction

Exclusion:

* Pregnant women or women who are nursing an infant are not able to participate in this study
* Known patent forearm ovale (PFO)
* Significant heart disease
Digital Impression in Neonates

The goal of this \[clinical trial\] is to \[explore the attitudes of guardians with different educational background regarding the technique of impression registration as well as the compliance to using feeding appliances \] in \[neonates\].

Researchers will compare \[conventional impression technique to digital impression\]


Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral complete cleft lip and palate
* neonates

Exclusion Criteria:

* infants and children
* bilateral cleft lip and palatal
* incomplete cleft lip
Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution

Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques.

Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients managed by radical prostatectomy for prostate cancer between 2000 and 2016.
* Follow up \> 6 years
* Negative pre surgical extension assessment
* Prognostic Grade Groups (OGG) III-IV-V
* Biochemical recurrence defined by 2 consecutive PSA rises ≥ 0,2 ng/mL
* Metastasis positive imaging

Exclusion Criteria:

* Neoadjuvant therapy
* Follow up \< 6 years
* Prognostic Grade Groups (PGG) I-II
* Biochemical recurrence with metastasis negative imaging
Safety and Exploratory Efficacy of HSC835 in Patients With Inherited Metabolic Disorders (IMD)

This study is designed to assess the safety and exploratory efficacy of using HSC835 in patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.

This phase II study is designed to assess the safety of the Novartis product HSC835 and its ability to achieve donor blood stem cell engraftment in patients with certain Inherited Metabolic Disorders who undergo stem cell transplantation. A reduced intensity conditioning will be used prior to transplantation. Patients with Hurler syndrome, MLD, Krabbe or cALD could be eligible for this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Hurler syndrome, Metachromatic leukodystrophy (MLD), Globoid cell leukodystrophy (Krabbe) or Cerebral adrenoleukodystropy (cALD) -Adequate organ function -Availability of eligible donor material

Exclusion Criteria:

* Availability of a matched-related donor who is not a carrier of the same genetic defect -Active infection at screening -Prior myeloablative transplant -Pregnant or nursing women and women of child bearing potential unless using highly effective contraception methods. For the pediatric population, female patients of child bearing potential who do not agree to abstinence or agree to use highly effective contraception methods -Sexually active male patients unless using condoms as contraception -Human Immunodeficiency virus (HIV) infection
Journey of Patients With Vasculitis From First Symptom to Diagnosis

This study seeks to understand the journey that patients eventually are diagnosed with vasculitis experience in the period prior to their formal diagnosis by a healthcare provider. Data elements of interest include average time from the onset of the first symptoms to the time a diagnosis of vasculitis is confirmed. Other aims include identifying factors associated with the time to diagnosis. These factors will be divided into: a) intrinsic factors, or so-called "patient-related factors", such as the type of vasculitis symptoms, patient demographics, socioeconomic status, patients' beliefs regarding the etiology of their symptoms, and other factors, and b) extrinsic factors, or "professional/health system factors", such as healthcare access, referral patterns, testing patterns, and other factors. Understanding such factors can guide future efforts to shorten delays in diagnosis and thereby improve outcomes. All analyses will be done for the population of patients with vasculitis as a whole and by individual types of vasculitis.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of a systemic vasculitis: The V-PPRN includes patients with self-reported Behçet's disease, central nervous system vasculitis, cryoglobulinemic vasculitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss Syndrome, CSS), giant cell (temporal) arteritis (GCA), granulomatosis with polyangiitis (Wegener's, GPA), IgA vasculitis (Henoch-Schönlein Purpura), microscopic polyangiitis (MPA), polyarteritis nodosa (PAN), Takayasu's arteritis (TAK), and urticarial vasculitis.
2. Language requirements: questionnaire will be in English only

Exclusion Criteria:

1. Inability to provide informed consent and complete survey in English
2. Patients with a diagnosis of "other" type of vasculitis
3. Patients with a "missing" diagnosis -
Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.

Gut microbiota as well as the signature of the 16S plasma bacterial DNA and bacterial metabolites of patients on the date of transplantation and during the first year after transplantation will be analyzed. The phenotype of the patients' T lymphocytes will be analyzed at the same time. These data will be correlated with the occurrence of acute cell rejection during the first year of transplantation

Eligibility Criteria:
Inclusion Criteria:

* Patients called for a kidney transplant
* Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids
* Patient having signed the informed consent

Exclusion Criteria:

* Multiple grafts combined or sequential
* Induction therapy with polyclonal antibodies
* HIV or active viral infection such as hepatitis B or C
* Active bacterial infection
* Pregnancy or breastfeeding at time of inclusion
* Patient unable to express their consent
Healing Touch & Guided Imagery for Posttraumatic Stress Disorder Symptoms

This is a randomized controlled 2 year trial at Camp Pendleton, CA to determine whether a complementary medicine intervention (Healing Touch with Guided Imagery, HT+GI) reduces Posttraumatic Stress Disorder (PTSD) symptoms as compared to treatment as usual (TAU) in returning combat-exposed active duty military with significant PTSD symptoms. Secondary aims will evaluate the effect of HT and GI on measures of depression, hostility, and general health status in this population.

The study enrolled 123 active duty subjects from the Marine Corps Base Camp Pendleton in Southern California with at least one or more symptoms of PTSD .

Eligibility Criteria:
Inclusion Criteria:

1. Female or male subjects 18 years or older
2. Post-deployment from a combat zone
3. Identified by post-deployment health re-assessment to have PTSD symptoms
4. Referred by Camp Pendleton
5. Subjects who are willing to sign a consent
6. Subjects who are willing to participate for the length of the study

Exclusions:

1. Female subjects who are now pregnant or nursing
2. Subjects who are receiving healing touch or using guided imagery from other sources
3. Subjects who have any major health condition that may interfere with participating in this study
The Impact of Theory-based Messaging on Covid-19 Vaccination Intentions

Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about its side effects or safety. It is important to identify ways to communicate information about the vaccines that facilitate informed decisions rather than promoting uptake through coercion. This study will assess whether theory-based messages can change beliefs and increase intentions to receive a COVID-19 vaccine in Scotland. The messages will be based on publicly available information about the need for COVID-19 vaccination and the safety of the vaccines, and structured to address specific types of treatment beliefs. Participants will be randomised to either a group shown the messages or a control group shown general information messages about the COVID-19 virus and vaccination programme. By comparing the two groups we aim to test what impact the theory-based messages have on intentions and beliefs about COVID-19 vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the trial
* Aged 18 years or above
* Resident in Scotland

Exclusion Criteria:

* Received at least one COVID-19 vaccination dose
The Pharmacokinetic Interaction Between CKD-501 and Sulfonylurea

To assess the pharmacokinetic Interaction between CKD-501 and sulfonylurea (Glimepiride) in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults aged between 20 and 45 during screening period
* Weight more than 45kg and within ±20% range of Ideal Boby Weight
* Agreement with written informed consent

Exclusion Criteria:

* Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
* Subject has a history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases, gastrointestinal surgical histories except for an appendectomy) affects the ADME of drug
* Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug
* Inadequate laboratory test result

  * AST(SGOT) or ALT(SGPT) \> 1.25 x upper limit of normal range
  * Total bilirubin \> 1.5 x upper limit of normal range
* Clinically significant allergic disease(except for mild allergic rhinitis is not needed medication)
* Subject with known for hypersensitivity reactions to glitazones or sulfonylureas
* Previously participated in other trial within 60 days
* Medication with drug-mediated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days
* Subject has taken abnormal meals which affects the ADME of drug
* Impossible to taking the institutional standard meal
* Previously donate whole blood within 60 days or component blood within 20 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation

The present project project is divided in two parts. The primary aim of the part 1 of this study is to evaluate emotional control abilities of children with Prader-Willi syndrome (PWS) aged from 9 to 15 years and to study repercussions of this supposed lack of abilities on cognitive capacities and behavioral troubles. The study also evaluate influence of the emotional symptomatology of patients on quality of parents' life and on the care of parents and scholar/institutional caregivers. In the second part of this study, the study evaluate the feasibility and the tolerance to a non-invasive device supposed to reduce emotional symptoms in this disease.

Prader-Willi Syndrome (PWS) is a rare genetic disorder involving a variety of clinical, behavioral and cognitive symptoms. 83 to 97% of patients have episodes of temper tantrum, associated with an important emotional lability. These different cognitive and behavioral limitations are barriers to the social integration of patients. The PWS also has repercussions on well-being and quality of life of the family. Thus, the present project focuses on the characteristics of emotional control related to the anger of children with PWS and its behavioral, cognitive and social implications. In addition, at a therapeutic level, our project assumes that transcutaneous electrical nerve stimulation (t-VNS), a non-invasive, safe and inexpensive method, could be effective in reducing the severity of behavioral disorders such as temper tantrums while improving cognitive performance and social communication in the PWS.

Eligibility Criteria:
Inclusion Criteria:

* Age from 9 to 15 years old
* Prader-Willi syndrome with identified genotype.
* No psychiatric disorder neither PWS.
* Severe global symptomatology attested by a CGI-S score

Exclusion Criteria:

* Identified psychiatric or behavioral disorders
* Severe visual or hearing impairment.
* Sleep apnea syndrome treated with non-invasive ventilation,
* Epileptic seizures
* Cardiac disorders.