cyrilzakka/clinical-trials huggingface dataset:
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children

In Korea, oral chloral hydrate is still widely used for pediatric procedural sedation. The primary objective of the study is to evaluate the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) on the first-attempt success rate of pediatric procedural sedation. The hypothesis of this study is that the intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) will improve the success rate of adequate pediatric procedural sedation (PSSS=1,2,3) within 15 minutes. This is a prospective, parallel-arm, single-blinded, multi-center, randomized controlled trial comparing the effect of intranasal dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) with oral chloral hydrate (50mg/kg) in pediatric patients undergoing procedural sedation. Prior to the procedure, each patient will be randomized in the control arm (oral chloral hydrate) or study arm (intranasal dexmedetomidine and ketamine).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who need procedural sedation (Age \< 7 years)
* ASA (American Society of Anesthesiologists) physical status 1-3

Exclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status 4-5
* History of hypersensitivity to Dexmedetomidine, Ketamine, or Chloral hydrate
* Recent administration of Alpha 2 adrenergic receptor agonist or antagonist
* Cannot administrate oral medication (e.g. Swallowing difficulty)
* Cannot administrate intranasal medication(e.g. Excessive rhinorrhea)
* Unstable vital signs, Unstable arrhythmia
Preemptive Analgesia Using Intravenous Paracetamol

Dental treatment for children should be done in a calm atmosphere and without pain. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models.

There are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.

The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention of postoperative pain in children undergoing dental treatment.

Dental treatment for children should be done in a calm atmosphere and without pain in purpose to achieve a positive feelings and response towards dental treatment.Postoperative pain is the main issue which may cause a negative attitude of the child to dental treatment in future appointment. One of the affective options to deal with this pain is to give analgesic drug before the initiative of treatment which should continue its effect during and may also after treatment which is known as "preemptive analgesia. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models. In double blind clinical trials single or multiple dose of intravenous paracetamol, generally provided significantly better analgesic effect than placebo treatment in adults' patients who had undergone dental, orthopedic or gynecological surgery. There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of prostaglandin synthesis by its selective inhibition of Cox-2 isoenzyme.

At the best of the investigators knowledge, there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.

The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention or modification of postoperative pain in children undergoing dental treatment.

The primary outcome of this study is to investigate the post dental treatment analgesic effect of intravenous paracetamol in children when administered before compared to after dental treatment.

Eligibility Criteria:
Inclusion criteria:

* All children who require a wide treatment of caries
* Children of high score of anxious or who is stressfully

Exclusion criteria:

* Contraindication for paracetamol
* Renal or hepatic insufficiency
* Patient have history of allergy for paracetamol
* Anemia of Hgb less than 10 gr/DL
Association of Dihydropyrimidine Dehydrogenase (DPYD) Variants With Toxicity Related to Capecitabine

The goal of this laboratory research study is to identify possible differences in a gene among patients with breast cancer that cannot be treated by surgery. Researchers want to find out if differences in this gene may increase the risk of side effects from capecitabine.

If you agree to take part in this study, 1 blood sample (about 2 tablespoons) will be drawn for use in genetic research.

If you are unable to provide a blood sample, researchers will collect leftover tissue samples from your previously collected tumor tissue (from the time of the breast cancer diagnosis). The tumor samples will be used for genetic research.

After the blood draw or tissue collection, your participation in this study will be over.

The blood samples for the genetic research will be stored at Myriad Laboratories. Before your blood and/or tissue is sent to Myriad Laboratories for banking, your name and any personal identifying information will be coded to protect your privacy. M. D. Anderson will not have oversight of any leftover tissue and/or blood that will be banked by Myriad Laboratories for additional research.

This is an investigational study. Up to 210 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be registered for protocol ID 01-580 and only patients who were randomized to receive capecitabine will be included in the study.
2. Patients must sign an informed consent for this protocol.

Exclusion Criteria:

1) There are no exclusion criteria.
Randomized, Controlled Trial of Hyperosmotlar Saline for Rotator Cuff Repair Irrigation Solution

The goal of this project is to perform a randomized, double-blinded study investigating postoperative pain after arthroscopic rotator cuff using hyperosmolar saline as opposed to lactated ringer's solution (normal osmolarity) as arthroscopy irrigation solutions. Hyperosmolar saline is an irrigation solution with a higher concentration of solutes that will be used intraoperatively to washout the surgical field. It will be used in place of lactated ringer's solution, which has an osmolarity comparable to that of normal saline. This study will help determine whether or not postoperative pain from rotator cuff repair can be mitigated by altering the osmolarity of the intraoperative irrigation solution. This knowledge is significant because the postoperative pain can be intense, so much so that patients may depend on narcotics for pain relief. Consequently, this study may provide benefit by helping to find new ways to minimize the need for narcotics. The main hypothesis of this is study is that hyperosmolar saline will reduce perceived pain and narcotic use in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years of age

Patients undergoing arthroscopic rotator cuff repair of full thickness, one or two tendon tears

Exclusion Criteria:

Patients younger than 18 years of age

Patients who are pregnant, mentally disabled, or imprisoned

Patients not receiving inter-scalene nerve block (catheters excluded)

Patients undergoing labral repair, capsular release, or distal clavicle excision

Patients with irreparable rotator cuff tears

Patients receiving any repair augmentation or graft

Patients with a known hypersensitivity to sodium lacta
Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success

A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

This study on dental implants with different roughened surfaces will assess its ability to resist countertorque testing at various study time points and demonstrate high success

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching
Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation

Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent AF and Long Standing Persistent AF).

Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of left atrial posterior wall is associated with more freedom from atrial arrhythmia at long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years
2. AF patient undergoing primary catheter ablation (first procedure)
3. Ability to give informed consent

Exclusion Criteria:

1. Previous ablation of AF
2. Bleeding disorder
3. Reversible causes of AF, such as hyperthyroidism and phaeochromocytoma
Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women, 18-40 years of age
* regular menstrual cycle (period 23-35 days)

Exclusion Criteria:

* -Immediate previous use of progestin only contraception within 2 months
* Known or suspected pregnancy
* Acute tromboembolic disorder
* Presence or history of hepatic disease, as long as the liver function values have not returned to normal
* Undiagnosed vaginal bleeding
* Known or suspected sex-steroid influenced malignancies (e.g. breast cancer)
* Hypersensitivity to the active substances or to any of the excipients of the medicines
* Pregnant or breast feeding within 6 weeks
* The use of other medicinal products that might interact with contraceptive steroids and affect the efficacy of contraceptives and/or might may lead to bleeding irregularities (especially medicines that induce the liver enzyme systems such as cytochrome P450). Examples of active substances are: phenytoin, phenobarbital, primidone, bosentan, carbamatzepine, rifampicin and medicinal products or herbal preparations containing ST.John's wort and to a lesser extend oxcarbazepine, topiramate, felbamate and griseofulvin.
Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

The purpose of this study is to assess the changes in physiological parameters and clinical scales resulting from treatment with AOT (action observation training) in subjects with subacute stroke. Furthermore, this study assess the perception of applicability and satisfaction degree for this kind of treatments.

After being informed about the study, all patients give written informed consent and will undergo a 1-week screening period to determine eligibility for study entry. Patient who meet the eligibility requirements will be given clinical and instrumental assessments before the start of treatment (T0) after 3 weeks (T1), at the end of the treatment (T2) and after 6 months (T3). A training program of 4 weeks including 250 videos of every day actions has been developed. Videos includes transitive and intransitive actions. Each week has a five day program, each day is divided in three sessions, in each session there are observation and imitation and attentional questions. AOT is always performed in conjunction with the conventional rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

* Should had experienced first ever ischemic or haemorrhagic stroke
* Fugl-Meyer Assessment \< 55
* normal or corrected to normal visual acuity

Exclusion Criteria:

* presence of severe neuropsychological disorders
* medical conditions likely to interfere with the ability to safely complete the study protocol
* pain in the upper limb assessed with the Visual Analogue Scale (VAS)\> 7
* intracranial metal implants
* history of seizures or epilepsy
* severe cardiopulmonary, renal, and hepatic diseases
* pregnancy
Open Label Extension of LipoLat-CS202

This is an open-label, observational extension of patients who received POLAT-001 in LipoLat-CS202.


Eligibility Criteria:
* Inclusion criteria

  1. Successful completion of 3 months of participation in Study LipoLat-CS202.
  2. Treatment with POLAT-001 in Study LipoLat-CS202.
  3. Able and willing to give signed informed consent and follow study instructions.
* Exclusion criteria

Excluded from the study will be individuals with the following characteristics:

1. The development, during study LipoLat-CS202, of any exclusion criteria from that study (e.g., concomitant medication or co-morbid disease).
Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Belgium in a clinical practice patient population.

This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Belgium. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites.Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment, and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[SVR12\] and sustained virologic response 24 weeks after the end of treatment \[SVR24\]).

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
* Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

• None
GAPP 2 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Type 2 Diabetes Mellitus

This study is conducted Asia, Europe and North America. The aim of this study is to describe insulin therapy adherence and the burden of non-adherence on patient functioning, well-being and diabetes management.


Eligibility Criteria:
Inclusion Criteria:

* PATIENTS WITH T2DM:
* Diagnosed with type 2 diabetes by a healthcare professional
* Currently being treated with insulin medication, excluding premix insulin treatment
* Age at least 40 years
* Diagnosed as having type 2 diabetes over the age of 40
* HCPs:
* Primary care physician, diabetes specialist (diabetologist/endocrinologist) or diabetes specialist nurse/diabetes nurse educator
* Have a minimum of 2 years experience within current speciality
* See a minimum of 20 type 2 diabetes patients per month (40 for diabetes specialists), of which at least 10 per month must be on modern (analogue) inulins
Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)

The purpose of this study is to conduct an Investigator-Sponsored Study to determine the potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent document
* Subjects must be at least 18 years of age or older
* Subject must be willing and able to comply with scheduled visits, arthroscopy, laboratory tests, and other procedures
* Diagnosis of RA based on American College of Rheumatology (ACR) 1987 Revised Criteria
* Active disease at screening visit
* Methotrexate taken continuously for at least 12 weeks at a stable dosage
* Sexually active women of child-bearing potential and men whose partners are women of child-bearing potential are required to use adequate contraceptive methods during participation on this trial
* Treatment with non-steroidal anti-inflammatory drugs (NSAIDS)and oral corticosteroids (less than or equal to 10 mg/day prednisone or equivalent)is accepted

Exclusion Criteria:

* Diagnosis of any other inflammatory arthritis
* History of infected joint prosthesis that is still in situ
* History of allergy to local anesthetic agents
* Pregnant or lactating women
* Current or recent history of uncontrolled clinically significant conditions(e.g..,kidney disease, liver disease, class III or IV congestive heart failure, according to the New York Heart Association)
* History or suspected demyelinating disease of the central nervous system, e.g. multiple sclerosis or optic neuritis
* Current participation in clinical trial
Podocyturia as Predictive Factor for Pre-eclampsia

Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive treatment using aspirin could be administrated in early pregnancy. We hypothesized that podocyturia could be an early indicator of preeclampsia. This is a prospective, non-interventional, monocentric study.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18 years or more
* single pregnancy
* first planned prenatal visit before 16 weeks of gestation
* planned delivery at Hôpital Femme Mère Enfant in Lyon, France
* patient receiving information and non opposition to participate

Exclusion Criteria:

* multiple pregnancy
* pregnancy stopped
* antecedent of nephropathy
* inability to understand information provided
* prisoner or under administrative supervision
* fetal malformation, chromosomal anomalies
* preterm delivery for other reason that any hypertensive disorder of pregnancy or Intrauterine growth restriction
Hypnosis for Transesophageal Echocardiography

The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).

TEE is a widely used diagnostic test in cardiovascular medicine. However, the test may be a source of discomfort to the patient. Patient intolerance of the echocardiography probe limits the duration of the procedure and therefore its diagnostic success. Current strategies to reduce patient discomfort involve global anesthesia, which carries its own side effects and risks of adverse events. Hypnosis may reduce patient discomfort without impairing alertness. The main goal of this study is to determine the additive value of hypnosis to improve patient comfort during TEE.

Eligibility Criteria:
Inclusion criteria:

* Patient with indication for a Transesophageal Echo (TEE)
* Patient competent to provide written informed consent

Exclusion criteria:

* Patient not subscribed to French Social Security System
* Patient non-French speaking
* Age \< 18 years
* Follow-up not possible
* patient declared non competent to give informed consent for the study
* History of severe personality disorder
* Patient with a psychiatric treatment started 30 days before the exam
* Patient pregnant or breast-feeding
* Emergency TEE
* Other indication for general anesthesia
Calcium Balance Studies in Children With CKD and on Dialysis

This is a novel, non-invasive method of assessing Ca balance by natural Ca isotope fractionation.

Detailed description and study protocol will be available to individuals on request.

Eligibility Criteria:
I - For healthy children

Inclusion criteria

* All children \<18 years
* Normal renal function (eGFR 90-120ml/min/1.73m2 \[calculated by Schwartz formula\] in children \>1 year and serum creatinine \<35μMol/L in children \<1 year)
* Weight, height and BMI within 2 SD of normal using WHO growth charts In order to make this study as 'real-life' as possible, free-living UK children on their usual diet and dietary supplementation (including Ca and Vit D), if any, will be included, but analysis will account for medication doses and blood levels.

Exclusion criteria

* Pre-existing bone disease - inherited or acquired
* Fractures in the preceding 6 months
* Glucocorticoid therapy in the preceding year, or a lifetime cumulative steroid exposure ≥6 months
* Bisphosphonate therapy at any time in the past
* Any acute illness in the preceding 2 weeks (when the child is unable to maintain their usual diet or has bed rest)

II - For CKD and dialysis children

Inclusion criteria

* Children of all ages with an eGFR \<60ml/min/1.73m2, including those on dialysis.

Exclusion criteria

* As listed above for healthy children.
plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients

Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms.

Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* hospitalized patients with positive covid-19 swab with respiratory symptoms and CT confirmation of covid-19 chest disease admitted to non ITU recovery area.
* informed consent for plasma infusion
* informed consent to blood samples storing for future studies.

Exclusion Criteria:

* pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study

  * immunoglobulin infusion in the last month

contraindication to transfusion or previous adverse reaction