cyrilzakka/clinical-trials huggingface dataset:
Iron and Vitamin Adminstration Prior to Joint Replacement to Prevent Transfusion

To establish the efficacy of screening for anemia and treatment of mild anemia with iron and vitamins prior to THR and TKR as a means of increasing hemoglobin and reducing perioperative allogeneic blood transfusion.

Patients with mild anemia will be identified at preoperative clinic visit

* Patients will be screened for inclusion and exclusion criteria
* Eligible patients will have laboratory testing performed as follows: CBC, liver and kidney function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein
* Patients will be assigned to a deficient group or non-deficient group depending upon laboratory hematinic values
* Patients in the "non-deficient' group will be randomized using a computer-generated code to treatment or no treatment
* Treatment will begin within 2 weeks of laboratory testing and 4-6 weeks prior to surgery.
* Hematinic therapy will consist of oral ferric hydrochloride polymaltose 200 mg/d and folic acid 0.4 mg/d; sublingual vitamin B12 1000 µg three times a week
* On the day of surgery laboratory testing will be performed as follows: CBC, kidney and liver function tests, serum iron, transferrin, ferritin, serum folic acid, vitamin B12 and C-reactive protein.
* The same surgical team in each center will operate on all study patients and will be blinded to the preoperative hemoglobin
* Routine postoperative management will be provided as determined by the treating physicians
* Blood transfusion will be decided upon by a study physician at each center blinded to the patients' group assignment and preoperative hemoglobin
* The primary outcome will be perioperative blood transfusion (from 24 hours prior to surgery until hospital discharge)
* Secondary outcomes will be length of hospitalization, postoperative wound infection, walking ability across room at 30 days

Eligibility Criteria:
Inclusion Criteria:

* Age \> 50 years
* Ability to provide informed consent
* Elective THR or TKR
* Mild anemia: Hematocrit 29-39% in men, 29-36% in women

Exclusion Criteria:

* Identified cause of anemia excluding hematinic deficiency
* Known source of blood loss
* Known coagulopathy
* Unstable coronary syndrome in the previous 3 months
* Pathologic fracture, presence of malignancy
* Repeat THR or TKR
* Orthopedic trauma within the previous 3 months
* ASA class ≥ 4
* Creatinine clearance \< 30 ml/min
* AST/ALT \> 2x upper limit of normal
* Preexisting use of hematinic agents
* Planned acute normovolemic hemodilution
* Refusal to receive blood products
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).


Eligibility Criteria:
Inclusion Criteria:

* Subject/legal representative is considered reliable and capable of adhering to the protocol
* Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
* Subject is expected to benefit from participation in SP0994 in the opinion of the investigator

Exclusion Criteria:

* Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
* Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
* Subject is taking benzodiazepines for a non-epilepsy indication
* Subject meets a withdrawal criterion from the previous study SP0993
* Subject is experiencing an ongoing SAE from the previous study SP0993
* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version
Randomized Comparison of Skeletonized Versus Pedicled Left Internal Thoracic Artery

Internal thoracic arteries can be harvested in skeletonized or pedicled technique. Latest research has posed a potential adverse effect of skeletonizing the internal thoracic arteries on graft patency rates and clinical outcome. Prospective, randomized, multi-centre trials are necessary to investigate the impact of harvesting technique of left internal thoracic artery (LITA) on graft patency rates and clinical outcome after coronary artery bypass grafting.

The HARVITA trial compares skeletonized and pedicled harvesting technique of LITA regarding graft patency rates and patient survival.


Eligibility Criteria:
Inclusion criteria:

Primary isolated CABG patients with multi-vessel disease (defined as ≥70 % stenosis of the left anterior descending artery (LAD) and ≥50% stenosis of circumflex and right coronary territory, with or without a ≥50% stenosis of the left main artery).

Exclusion criteria:

* Age \> 80 years
* Planned CABG without LITA use
* Preoperative mediastinal radiation therapy
* Emergency operation
* Minimal invasive coronary artery bypass surgery
* Any concomitant cardiac or non-cardiac procedures
* Previous cardiac surgery
* Known contrast agent allergy
* Severe stenosis of the left subclavian artery/ left-sided subclavian steal syndrome
* Chronic kidney disease (GFR \<60ml/min/1.73m²)
* Life expectancy of less than 5 years
* Pregnancy
* Hyperthyroidism
* Iodine allergy

Intraoperative exclusion criteria:

* Y/T graft off the LITA graft
* LITA sequential grafting
* LITA target vessel other than LAD
Efficacy and Safety of Grass Pollen Sublingual Immunotherapy

The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.

Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.

Eligibility Criteria:
Inclusion Criteria:

* male or female aged 18-50
* patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
* Positive skin prick test and IgE value of at least Class 2+
* RTSS of greater or equal to 14 during pollen season prior tot the start of the study
* Patients must be in general good health
* Patients with normal spirometry
* Informed consent given and willing to comply with the protocol
* Female patients are eligible if they use an accepted contraceptive method
* Negative urine pregnancy test if female

Exclusion Criteria:

* Pregnancy, breast feeding
* Asthma requiring treatment other than beta-2 inhaled agonists
* patients who have taken oral steroids within 12 weeks before screening visit
* patients who have received desensitisation treatment for grass pollen
* treatment by immunotherapy with any other allergen within the previous 5 years
* patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
* patients at risk of non-compliance
* participation in any other clinical study within the previous 3 months
* patients with a past or current disease, which may affect participation in or outcome of this study.
* patients treated with beta-blockers or under continuous corticotherapy
* allergic sensitivity to epithelial allergens the patients is exposed to
* positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
* intention to subject the patient to surgery of the nasal cavity during current study
* Usual contraindications of immunotherapy
* a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season
Assessment of the Endovascular Aortic Aneurysm Repair's (EVAR) Main Body Lateral Movement Impact on the Rate of Reintervention After AAA's Treatment

The strength of movement which are applied on the EVAR are not only cranio-caudal but also lateral. The movement of the EVAR's body within the aneurysm could be an instability's criteria of the EVAR. The investigators would like to show that this lateral movement is a risk factor of reintervention they should follow and suggest a reinforced medical follow-up to avoid complications.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years old
* All patients treated in the vascular surgery department of Besançon for an abdominal aortic aneurysm with an endoprothesis (symptomatic or asymptomatic)

Exclusion Criteria:

* Patient in emergency situation (ruptured abdominal aortic aneurysm)
* Life expectancy supposed to be inferior to 1 year
* Legal incapacity or limited capacity
* Pregnant female
* Patient unlikely to cooperate with the study
* Patient without health insurance
Identification of Mechanism in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy

The study aims to evaluate the molecular mechanism underlying the erythroid response observed in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated with Deferasirox or Deferoxamina.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 and older
2. Diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia
3. transfusion-dependent anemia undergoing chelation therapy with deferasirox or deferoxamine

Exclusion Criteria:

* none
Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients

Heart transplant recipients do not have nerves to their hearts. This protocol tests the hypothesis that bradykinin mediated t-PA release in the coronary arteries will be reduced in heart transplant recipients compared to healthy subjects.

This study will compare heart transplant recipients to healthy controls who are undergoing cardiac cath for standard of care purposes (separate protocol) and compare the coronary arteries to the forearm in transplant recipients (separate protocol) and healthy controls (separate protocol).


Eligibility Criteria:
Inclusion criteria:

1. Heart transplant recipients undergoing annual cardiac catheterization who have participated our protocol: Characterization of brachial arterial t-PA release, vasodilator function, and vascular compliance and correlation with fibrinolytic balance, oxidative stress, and inflammation measures in heart transplant recipients (SCCOR Project 1, Aim 3C). (IRB # 070517)
2. 25 Subjects will have transplant vasculopathy and 25 subjects will be free of transplant vasculopathy, as documented in previous angiograms.
3. Otherwise healthy

Exclusion criteria:

1. PVC \< 30
2. Hypertensive subjects on ACE inhibitors
3. Pregnant or nursing mothers
4. Diabetic with HbA1C \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
5. Cholesterol \> 30 mg/dL above NCEP accepted level based on cardiac risk.
6. Triglycerides \> 200
7. Previously diagnosed obstructive coronary artery disease
8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
9. History of cerebrovascular disease
10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
12. Angiotensin converting enzyme inhibitor use
13. Coagulopathy (INR ≥ 1.5, PTT ≥ 150% of control)
14. Peripheral Vascular Disease
15. Other chronic medical illnesses at the discretion of the investigators

Healthy controls are being enrolled in SCCOR Project 1, Aims 3A and 3B (IRB# 030473 and 061160) and will not be participating under this IRB number.
Incidence of Recurrent Caries Next to Tooth Restorations

The aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration.

The data will be collected from patients who are visiting the dental clinic for a check-up. These data will be retrieved in the patient records. In particular the clinical (mouth) exam and the radiographic images ('RX-bite-wings'), which are routinely taken during these check-up consultations, will be used for the evaluation of recurrent caries. Information regarding medical background, oral hygiene, sugar eating habits and possible parafunctional activities will also be gathered from the patient files. In addition, caries risk of the patients will be assessed using commercial kits for analysis of their saliva (Saliva-Check Buffer, GC, Tokyo, Japan) and dental plaque (Tri Plaque ID Gel, GC, Tokyo, Japan), which are a part of the routine care of the patients at the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up

Exclusion Criteria:

* Patients for who not all necessary data could be registered (incomplete mouth exam records, missing RX-bite wings, etc)
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome

Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.


Eligibility Criteria:
Inclusion Criteria:

* newborn greater than or equal to 35 weeks gestation
* intrauterine opioid exposure
* signs and symptoms of opioid withdrawal

Exclusion Criteria:

* congenital anomalies or suspected genetic condition
* co-morbid conditions that require sedation or analgesia due to clinical condition
* ongoing need for respiratory support
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.

Eligibility Criteria:
Inclusion Criteria:

* A signed informed consent form (ICF). If a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional Standard Operating Procedures.
* Male or female, 18 to 90 years of age, inclusive.
* Expectation, in the judgment of the Investigator, that the patient's cUTI would require initial hospitalization and treatment with IV antibiotics.
* Documented or suspected cUTI or Acute pyelonephritis (AP).

Exclusion Criteria:

* Gross hematuria requiring intervention other than administration of study drug or removal or exchange of a urinary catheter.
* Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization that would interfere with evaluation of response to the study antibiotics.
* Patient requires continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study.
* Receipt of a single dose of a long-acting, potentially-effective systemic antibiotic with activity against Gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization.
* Requirement at time of randomization for any reason for additional systemic antimicrobial therapy (including antibacterial, antimycobacterial, or antifungal therapy) other than study drug, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis.
* Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the patient's participation in the study \[from randomization through the Late Follow-up (LFU) Visit\].
* Any patients previously randomized in this study.
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)

The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Females Age 9 To 15 Years
* Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study
* No Fevers 24 Hours Prior To The First Injection

Exclusion Criteria:

* Participant Had Received A Prior Vaccination With A HPV Vaccine
* Participant Has Allergies To Vaccine Component Including Aluminum And Yeast
* Participant Has (Human Immunodeficiency Virus) HIV Infection
* Participant Is Immunocompromised
* Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection
* Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection
A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers

This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD3 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A subject aged 19 to less than 65 years at the time of the screening visit
* A subject with a body weight of 55kg or higher and a body mass index (BMI) of 18.0 kg/m2 to 29.9 kg/m2, inclusive
* A subject considered appropriate to participate in the study according to the results of lab tests such as the hematological test, blood chemistry test, serum test, urinalysis, etc. and ECG set and conducted by the principal investigator (or a delegated study physician) according to the characteristics of the investigational product
* A subject who agreed to exclude the possibility of pregnancy by having themselves, their spouses, or partners use medically appropriate contraceptive methods and not to provide sperm or egg from the first dose to 7 days after the last dose of IP administration
* A subject who voluntarily signed the informed consent form after listening to and understanding sufficient explanation on the purpose, content of this clinical study, the characteristics of the investigational product, expected adverse events, etc.

Exclusion Criteria:

* A subject who has clinically significant diseases in the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otolaryngeal system, skin system, and ophthalmic system or has had the diseases
* A subject who had gastrointestinal surgery (excluding simple appendectomy or hernia surgery) which may affect the absorption of drugs or have gastrointestinal diseases
* A subject who took drugs that induce and inhibit drug metabolizing enzymes such as barbiturates within one month from the first administration date or drugs that might affect this clinical study within 10 days from the first administration date (subjects may participate depending on the pharmacodynamics and pharmacokinetics such as the interactions with the investigational product, half-life, etc.)
* A subject who participated in another clinical study or bioequivalence study where they were administered the investigational product within 6 months prior to the first dose of the investigational drug
* A subject considered by the principal investigator (or a delegated study physician) as inappropriate to participate in this clinical study due to reasons other than the above inclusion and exclusion criteria
Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy

The aim of this study was to investigate the efficacy of Virtual reality on hand function in Saudi children with hemiplegic cerebral palsy.

The aim of this study was to evaluate the effect of Virtual reality on hand function in children with hemiplegic CP. Forty children with hemiplegic CP were assigned randomly into two groups (A \& B). Control group (A) was received conventional rehabilitation program for the hand. Study group (B) was received conventional rehabilitation program as in group (A) in addition to virtual reality by using the Pablo system.Patients' evaluation was carried out before and after training to assess hand function.

.

Eligibility Criteria:
Inclusion Criteria:

* They had a diagnosis of spastic hemiplegia derived from medical records.
* Scored I-III on the Manual Ability Classification System.
* Not have musculoskeletal disorders that would make it difficult for them to use the VR.
* They had normal or corrected hearing and vision.
* They had no prior experience with the VR.
* They comprehend and follow straightforward instructions to complete the tasks.

Exclusion Criteria:

* They have had upper limb surgery within the last six months.
* They have uncontrollably occurred seizures.
* They have medical conditions that can make using virtual reality dangerous.
* They have attention deficit issues.
The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis

Pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life and can become a chronic problem. The aetiology of pouchitis is not completely understood. A crucial role of the intestinal microbiota has been suggested, but no causative agent has been identified so far. Furthermore, the defensin expression and the epithelial integrity are altered in inflammatory bowel diseases and may play an important role in the development of intestinal inflammation. Therefore, it has been hypothesized that the interaction between an altered microbiota composition, a defective epithelial integrity and changes in innate defense parameters such as defensins has a pivotal role in the development of pouchitis in UC patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with ulcerative colitis undergoing a total colectomy with IPAA for steroid dependent disease, therapy-refractory disease, colorectal cancer or severe dysplasia
* 18-65 years of age

Exclusion Criteria:

* unable to give informed consent
* pregnant or breastfeeding