cyrilzakka/clinical-trials huggingface dataset:
HemoSonics-UVA HemoSonics-UVA Cardiac Surgery Clinical Study Protocol

This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the University of Virginia Health System and will involve patients undergoing cardiac surgery requiring bypass.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for cardiac surgery involving bypass circuit
* Subject is older than 18 years
* Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
* Patients with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
* Patients with history of active liver disease
* Patients on emergency cases
* Patients on heparin anticoagulation before the beginning of the study
Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects

A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 18 to 70 years, inclusive
* BMI: 18.5 to 38 kg/m2
* Body weight great or equal to 45.5 kg
* Subjects with hepatic impairment
* Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
* Healthy subjects to the extent possible matched to the first four subjects with hepatic impairment with regard to age, body weight, and sex, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any major surgery within 4 weeks of study drug administration
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Subject has required additional medication for hepatic encephalopathy within 12 months (6 months for severe hepatic impairment) prior to dosing
* Presence of severe ascites or edema in subjects, as judged by the PI
ACTRAMAT-D: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation

In France The prevalence of Pregnancy Loss after 12 weeks of gestation is around 3%. This situation is probably associated to a risk of post-traumatic stress disorder.

As a part of the medical staff midwives are often confronted with this situation, however they can have difficulties to identify short and long term effects of a post-traumatic stress disorders.

The purpose of the present study is to estimate and analyze the prevalence of short-term (1 month) post-traumatic stress disorder in women with pregnancy loss after 12 weeks of gestation.The symptoms of post-traumatic stress disorder will be tracked using the Impact of Event Scale-revisited and the Peritraumatic Dissociative Experiences Questionnaires.The diagnosis of post-traumatic stress disorder will also be clinically confirmed by a psychiatrist during a specific consultation.


Eligibility Criteria:
Inclusion Criteria:

* loss pregnancy after 12 weeks of gestation
* consent to participate in the clinical study

Exclusion Criteria:

* no french speaking
* psychiatric disease
* participation in another clinical study
Pediatric Delirium

Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.

Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 3 months to 9 years
* Scheduled to undergo a myringotomy
* American Society of Anesthesiologists (ASA) classification of I - II.

Exclusion Criteria:

* Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.
* Anyone age 10 years or older.
* Anyone with an ASA classification of III or higher.
* Non-English language speaker for whom short form consent is not available.
Safety of Sofosbuvir ,Daclatasvir in HCV Patients and RAVS in Resistent and Relapsed Cases

To identify side effects of Sofosbuvir/ Daclatasvir treatment regimen of chronic HCV GT-4 infection.

* To assess the occurrence and the prevalence of RAVs in patients with treatment failure and relapse after sofosbuvir and daclatasvir with assessment of their types .
* To examine the GT4 subtypes by phylogenetic analysis and baseline sequence variability among subtypes and their potential impact on treatment outcome and development of viral resistance in patients who received a regimen of Sofosbuvir/ Daclatasvir for treatment of chronic HCV GT-4.
* To assess the differences in patient demographics across GT4 subtypes.

Hepatitis C virus (HCV) chronically infects approximately 120-130 million individuals worldwide .Mortality related to HCV infection has been estimated at approximately 300,000 deaths per year..

Direct antiviral agents (DAAs) effectively eradicate HCV and rapidly improve residual liver functions. Current HCV eradication rates have exceeded 90% in a very short time .

Hepatitis C virus genotype 4 (GT4) is genetically diverse, with 17 confirmed subtypes, and comprises approximately 13% of infections worldwide \[3\]. In Egypt, GT4 accounts for approximately 90% of infections, with subtype 4a predominating .

Sofosbuvir and daclatasvir are generally well tolerated with only a few adverse effects reported.

Hepatitis C virus resistant associated variants (RAVs) are seen in most patients who do not achieve sustained virological response (SVR). These resistance-associated mutations depend on the class of direct-acting antiviral drugs used and also vary between hepatitis C virus genotypes and subtypes.

Donaldson et al performed an analysis on four phase III clinical trials in search of common RAVs against sofosbuvir, discovering L159F, C316N, and V321A were associated with virological failure. Interestingly, this study also verified S282R mutation as associating with failure.

NS5A RAVs can be very common, with Y93H detected in up to 15% of the population and L31M in up to 6.3%. Other RAVs tend to also be fairly common detected in approximately 0.3%-3.5% of the population

Eligibility Criteria:
Inclusion Criteria:

* Anti HCV positive patients either chronic HCV or liver cirrhosis. • Detectable HCV RNA by quantitative polymerase chain reaction (PCR) prior to treatment

Exclusion Criteria:

* Co-infection with hepatitis B virus .
* Presence of malignancy before treatment.
* End-stage liver disease (Child score more than 9).
* Major co-morbid disease e.g heart failure
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* female patients, \>=18 years of age;
* breast cancer;
* bone metastases;
* moderate to severe pain;
* adequate renal function.

Exclusion Criteria:

* bisphosphonate treatment within 3 weeks of study enrollment.
Zhaoqing Myopia Study

Myopia is a common cause of vision loss, being particularly prevalent in children in East and Southeast Asia. The investigators will assess prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of myopia and other ocular abnormalities in school-aged children in both urban and rural settings in Southern China.

Myopia is a common cause of vision loss, being particularly prevalent in East and Southeast Asia. It is still not entirely clear whether and how visual experience in an urban environment with less outdoor exposure could have an impact on the development and progression of myopia. Zhaoqing has a relatively stable population of 4,084,600, which are representative of the Chinese population in term of demographic and socioeconomic characteristics.

Therefore, the investigators will conduct a longitudinal cohort study in both urban and rural settings to examine prevalence and incidence of myopia, identify digital biomarkers associated with myopia, and validate algorithms for the detection and/or predition of incidence and progression of myopia and other ocular abnormalities in school-aged children in Zhaoqing.

Eligibility Criteria:
Inclusion Criteria:

* All first-grade students from 10 primary schools in urban counties, and from 10 primary schools in rural counties, Zhaoqing city.

Exclusion Criteria:

* No.
Workflow Validation of an In-home Auto-titrating Mandibular Positioner

The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.

One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the device.

Eligibility Criteria:
Inclusion Criteria:

1. Minimum 18 years of age
2. Participant has been deemed suitable for oral appliance therapy
3. Prescription for oral appliance
4. Adequate range of motion
5. Adequate dentition
6. Ability to understand and provide informed consent
7. Ability and willingness to meet the required schedule

Exclusion Criteria:

1. Loose teeth or advanced periodontal disease
2. Full dentures or dental implants
Therapy of Fifth Metacarpal Neck Fractures - Comparing Functional Treatment With Reposition and Finger Splinting

The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture.

This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture.

Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software "Randomizer" by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment, while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Both groups will receive the allocated bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.

Eligibility Criteria:
Inclusion Criteria:

* Fifth Metacarpal Neck Fractures
* Patient age between 18 and 70 years

Exclusion Criteria:

* Palmar angulation \>50° in first lateral x-ray
* Pathologic fracture
* Intraarticular fracture
* Patients unable to consent
* Polytraumatized patients
* Pregnancy
* Compound fractures
* Multiple hand injuries
* Patients initially presenting more than 7 days after injury
Oral Status of Patients Suffering From SCHIZophrenia Followed at Charles Perrens Hospital

The aim of the study is to describe the oral health status of patients suffering from schizophrenia and schizoaffective disorders in a psychiatric institute in France.

Schizophrenia concerns 21 million people in the world and 600 000 in France according to the World Health Organization. This pathology decreases the patient's quality of life and one patient out of two will try to commit suicide and 10% will die. Oral health is an important factor for general well being. The litterature shows that schizophrenic patients tend to visit less dental surgeries than the general population. Patients will often visit the surgery in emergency and dentist often choses to extract instead of a restorative solution. Thus, schizophrenic subjects are 3,4 more likely to become edentulous compared to the general population.

This is a cross-sectional epidemiological study on patients suffering from schizophrenia and and schizoaffective disorders in a psychiatric institution. A dental assessment will be conducted to provide clinical data on oral health. (DMFT, hygiene, mouth dryness, prosthesis) and a survey of their diet, medication, oral quality of life, social security coverage and patients view regarding dental care (Anxiety and Healthcare renunciation).

This is an observational study (oral examination and survey), so no treatment will be compared. The oral health status will be evaluated during one single oral examination and survey during the patient's stay at hospital.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenic patients and patients with schizoaffective disorders at the Charles Perrens Hospital
* Willing to participate in the study
* 18 years old and above

Exclusion Criteria:

* Patients mentally unable to participate or refusing to participate in this study.
* Patient hospitalized under duress
* Minor
* Patients unable to read, speak or write French
The Effect of Casein Phosphopeptide Amorphous Calcium Phosphate on Affected Dentine

Teeth selected for intervention with Atraumatic Restorative Treatment will receive Glass Ionomer restorations (control) or MI varnish (test) before receiving the Glass Ionomer restoration

Patients selected to participate in the study will be randomly assigned into 2 groups.

Group 1 (test): who will receive casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) + ART in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.

Group 2 (control): Who will receive ART only in the teeth selected, excavating only the caries infected dentine and preserving the caries affected dentine.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy patients.
2. Patients with an age range of 6-8 years old for clinical evaluation.
3. Patients ranking definitely positive or positive on Frankl scale.
4. Patients having at least 1 symptomless primary molar with caries extending to the dentine (International Caries Detection and Assessment System (ICDAS II) code 4, 5 \& 6).
5. The presence of the permanent successors when examined by periapical X-ray.
6. Patients who will agree to participate in the study. For the ex-vivo sample

   1. Patients with an age range of 9-11 years old.
   2. The selected teeth should have more than half of their roots physiologically resorbed when examined by periapical X-ray.

Exclusion Criteria:

1. Patients with special health care needs (physical, mental or medical).
2. Primary molars that are mobile, ankylosed or have periapical pathology on initial examination clinically and radiographically.
Procalcitonin (PCT) as a Diagnostic Marker of Bacterial Infection in the Patients Admitted for Fever and/or Inflammatory Syndrome to the Internal Medicine Department

Levels of PCT (a marker of bacterial infection) are highest during sepsis: in fact, PCT is normally produced by the C cells in the thyroid gland. PCT was initially studied by Assicot1 for distinguishing between bacterial meningitis and viral meningitis. The CALC-I gene codes for PCT. In the absence of infection, the extrathyroid mRNA expression of the CALC-I gene is repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells. Infection induces the ubiquitous expression of the CALC-I gene. PCT is not transformed into calcitonin in parenchymatous tissues. In a context of sepsis, the whole body acts as a neuroendocrine gland. Sepsis upregulates PCT mRNA expression much more than that of other cytokines.

PCT is used in critical care departments as a diagnostic marker, a guide to treatment (antibiotics are withdrawn if the level falls) and a prognostic marker.

There are few data on the diagnostic use of PCT in an internal medicine department. The available studies yielded contradictory results and only one prospective study has been performed . The objective was to study PCT in non-infectious, inflammatory pathologies and to establish whether PCT could distinguish infections from other inflammatory pathologies in patients in an internal medicine department. In a ROC curve analysis, a PCT threshold of 0.35 µmol/l gave the greatest specificity (88%) and sensitivity (72%). Other studies have been performed but featured small sample sizes and a retrospective design.

Of the various studies performed in internal medicine departments, none included patients presenting with a suspected bacterial infection (according to the clinician's interpretation) and lacking information on their bacterial status. In fact, these diagnoses are a core component of hospitalisation in internal medicine departments for fever or inflammatory syndrome. The investigators intend to include all patients, including those lacking information on their microbiological status).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or over hospitalized in the internal medicine department at Amiens University Hospital, presenting with fever (\>38.5°C) and/or inflammatory syndrome (CRP \>5 mg/l) and having given their consent will be included.

Exclusion Criteria:

* Haemodialyzed patients.
* Age under 18.
* Legal guardianship.
* Refusal by the patient, or inability to give consent.
* Patients on antibiotics for more than 12 hours at the time of the PCT assay (the half-life of PCT is 22 hours, and the level falls rapidly when antibiotics are administered).
* PCT assays more than 12 hours after hospitalisation.
Splenic Hilar Nodes in Splenic Flexure Cancer

Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.


Eligibility Criteria:
Inclusion Criteria:

* All splenic flexure cancer patients

Exclusion Criteria:

* No consent to data utilization
Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study

This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.


Eligibility Criteria:
Inclusion Criteria:

1. Subject or subject's legally acceptable representative has provided informed consent.
2. Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
3. Children with vertebral fractures or osteonecrotic lesions according to the following criteria:

   1. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions on MRI of the hips and/or knees identified through routine clinical screening at least 8 weeks following chemotherapy initiation OR
   2. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions of the hips and/or knees on MRI that are identified at any time in the first 12 months after chemotherapy initiation following presentation with back pain (in the case of vertebral fractures, identified by lateral spine x-rays) and/or hip pain (in the case of osteonecrotic lesions, identified by MRI) and/or knee pain (in the case of osteonecrotic lesions, identified by MRI).

Exclusion Criteria:

1. Any child for whom the treating physician feels participation is not advised.
2. Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
3. Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
4. Children with renal failure (eGFR\<60ml/min/1.73m2).
5. Children with untreated vitamin D deficiency (vitamin D \<50nmol/L).
6. Children with hypocalcemia.
7. Children planning dental procedures and/or dental surgery during the course of the study.
8. Children with asthma who are acetylsalicylic acid (ASA) sensitive.
9. Children with a documented history of atrial fibrillation.
10. Currently pregnant or planning a pregnancy during the study.
11. Currently breastfeeding or planning on breastfeeding during the study.
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia

The purpose of this study is to determine whether low-dose ketamine infusion is effective in suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed opiate dependence according to ICD 10 and/or DSM 4;
* Duration of substance abuse more than 1 year
* No or minor co-morbidities;
* Grade I-II according to physical status classification system of American Society of Anesthesiologists.

Exclusion Criteria:

* Current history of long acting opiate or poly-substance abuse;
* Acute medical or surgical condition;
* Pregnancy;
* Breastfeeding.