cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation

This single-institution randomized controlled trial prospective will enrolled 48 patients scheduled for an aortic valve replacement. The objective of the present investigation is to determine the role of Polaramine® on reducing hemodynamic instability after separation from cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play an important role reducing dysfunction of the autonomic nervous system and hemodynamic stability after separation from CPB.

Vasoplegic syndrome is recognized as a common complication after CPB. Its incidence ranges from 5% to 25% after cardiac surgery requiring CPB. Such syndrome is related to an inflammatory reaction, which is attributed to the CPB. This syndrome is typically characterized by a combination of different parameters with low specificity and sensitivity, such as low systemic vascular resistance leading to a hypotension imposing perfusion of vasopressors with high or normal cardiac outputs.

Investigators preliminary data suggest that vasoplegic syndrome might be related to heart manipulation during surgery. Tearing maneuvers performed on the heart chambers trigger peaks pressure stimulating, consequently, baroreceptors and finally resulting in arteriovenous vasodilation via neurogenic and endogenous pathways. According to investigators initial investigation, such reaction appears to be related to basophils degranulation and release of vasoactive substances.

The hypothesis of the present trial is that a reduction of basophils degranulation and release of vasoactive substances via an antihistaminic could lower the incidence of the vasoplegic syndrome. This study aims to determine the effect of an antihistamine (dexchlorpheniramine (Polaramine®)) administered intravenously before CPB, on the vasoplegic syndrome incidence after separation from CPB.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 and older
* Post menopausal women
* Patients scheduled for an aortic valve replacement with a traditional sternotomy and CPB

Exclusion Criteria:

* Patients with a left ventricular ejection fraction lower than 40%
* Patients with pulmonary arterial hypertension higher than 50mm of Hg,
* Redo cardiac surgery,
* Atrioventricular and intraventricular conduction disturbances
* Epilepsy or convulsions
* Atopic disease
* Women of childbearing potential
* Patients at risk of glaucoma
* Patients with therapy interacting with dexchlorpheniramine (Polaramine®).
* Patients unable to provide a signed informed consent
Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery

Nalbuphine has been used as an adjuvant to bupivacaine in intrathecal, epidural, caudal anesthesia and peripheral nerve blocks showing an increase in the efficacy and the duration of postoperative analgesia.The aim of this study is evaluation of the effect of nalbuphine when used as an adjuvant to a local anesthetic mixture in peribulbar block undergoing cataract surgery

44 patients (22 in each group) scheduled for elective cataract surgery using peribulbar block. Patients of Group N received local anesthetics received 6 ml of 0.5% bupivacaine 1 ml hyaluronidase (75 IU), and 4mg of Nalbuphine in 1 ml of saline (total 8 ml) and patients of Group C received 6 ml of 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and1 ml saline (total 8 ml).

Addition of nalbuphine to bupivacaine in peribulbar block is associated with reduced the time of onset of globe akinesia, increased the duration of globe akinesia and analgesia with better postoperative pain relief

Eligibility Criteria:
Inclusion Criteria:

* patients aged 40-60 years.
* both sex.
* ASA physical status Ι\&II.
* Patient with axial globe length below 26

Exclusion Criteria:

* Refusal of the patient to participate in the study.
* Coagulation abnormalities(INR\>1.4).
* More than ASA II.
* High myopia with axial length more than 26 mm.
* Mentally retarded patients and failure of proper communication as in deafness .
* Morbidly obese patients(BMI\>35)
* Patients with glaucoma (increased IOP\>20mmgh)
* Patients with history of hypersensitivity to study drugs
Italian Non-Interventional Study of FLT3 Mutated AML Patients

This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations

This is an observational study involving a retrospective and prospective collection of clinical and molecular data. Patients will follow their regular diagnostic and clinical practice. Thus, no additional procedure/blood withdrawal will be performed.

The study will be conducted as follows:

1. Retrospective phase: clinical and molecular data of AML patients with FLT3+ mutations detected at diagnosis or at any refractory/relapse state will be collected.
2. Prospective phase: clinical and molecular data of each new FLT3+ AML patient identified in participating centers at diagnosis or at any refractory/relapse state will be collected prospectively. Every effort will be done to include all consecutive patients, in order to avoid selection bias.

For patients with a mutation found at the time of disease relapse, any effort will be done to collect all the clinical and molecular information since the time of diagnosis.

The Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected, and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative.

The secondary objective of the study is to investigate the association between different FLT3 mutations and the clinical, molecular and biological information.

Eligibility Criteria:
Inclusion criteria:

1. AML patients
2. Male or Female
3. Aged ≥ 18 years
4. FLT3 mutations (ITD or TKD) positive tests performed at diagnosis or at relapse.
5. Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria:

1. To be currently involved in experimental clinical protocol, or have been treated with experimental drugs are not exclusion criteria.
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

To improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (defined as: 1) improvement of FC III or IV to FC II; 2) improvement of FC II to FC I; or 3) maintaining FC II or I)

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults (≥ 18 years of age)
2. Documented diagnosis of PAH (all of the following): i. RHC demonstrating mPAP \> 25 mm Hg and PCWP

   ≤ 15 and PVR \> 3 ii. FEV 1 \> 50% predicted normal iii. V/Q and/or CT scan excluding the thromboembolic etiology
3. Diagnosis of PAH \< 3 years
4. Need for PAH specific treatment
5. Desire to participate and signs an informed consent

Exclusion Criteria:

Any of the criteria below:

1. Poor mental function, drug or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
2. Prior participation in this program
3. Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)
Reduction of Rocuronium-induced Injection Pain With Aspiration of Blood

The goal of this clinical trial is to learn about reduction of rocuronium injection pain in participants receiving general anesthesia. The main question aims to answer is whether diluting rocuronium with blood can reduce rocuronium injection pain. Rocuronium is a rapid onset muscle relaxant used in general anesthesia. Lidocaine is a local anesthetic. Researchers will

• inject diluted rocuronium in participant's intravenous catheter during induction. • record withdrawal movement and rocuronium onset time and duration measured by train-of-four (TOF).

Researchers will compare between rocuronium diluted with blood, lidocaine and normal saline to see if blood can reduce rocuronium injection pain.

This clinical trial uses a random table for sequential randomization, randomly assigning subjects to 3 groups, each consisting of 40 participants.

Researcher will confirm the patency of peripheral intravenous lines before induction. If peripheral intravenous lines cannot be used, they will be readministered at another injection site. If there are difficulties in peripheral intravenous injection, the participant will need to withdraw from this clinical trial. The neuromuscular monitoring device (NMT) is installed before the start of the clinical trial to monitor the effects of the drug. To avoid influencing the final results, fentanyl and 2%lidocaine will not be administered before injecting rocuronium. Anesthesia induction begins with the administration of oxygen through a mask to assist breathing. Initially, propofol is injected at a dose of 1.5 to 2mg/kg. Once the participant is confirmed to have lost consciousness, researchers will inject diluted rocuronium immediately, with an injection speed of 10 to 15 seconds. The dose of rocuronium for each participant is 0.8 mg/kg. The first group is pre-diluted with 2mL of normal saline, the second group with 2mL of 2%lidocaine, and the third group with 2mL of the participant's blood. To avoid clotting of blood, the procedure of the third group involves using a syringe containing rocuronium to withdraw 2mL of blood from the vein, followed by simultaneous injection into the intravenous line. The NMT is used to monitor the drug's effects, defining the onset time as the time from rocuronium injection to the disappearance of train-of-four (TOF) count T1 and the duration of action as the time from rocuronium injection to the appearance of TOF count T1.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the written informed consent form.
* Males and females aged 18 to 65.
* Undergoing endotracheal intubation under general anesthesia.
* Anesthesia physical status classification II or below.

Exclusion Criteria:

* estimated glomerular filtration rate less than 60
* History of cirrhosis or liver failure
* Neuromuscular disease or neurological symptoms
* Mental illness
* Arrhythmia
Switching From Insulin to Sulfonylurea in Diabetes Associated With Variants in MODY Genes

The purpose of this study is to switch from insulin to oral sulfonylurea in patients with apparent type 1 diabetes or maturity onset diabetes in the young that are insulin treated. The molecular cause will be DNA variants in the HNF1A, HNF4A, or HNF1B genes that are of unknown significance (VUS, class 3) or known to be pathogenic (class 4 and 5).

Maturity onset diabetes in the young (MODY) is characterised by monogenic diabetes due to beta-cell dysfunction, with typical onset of diabetes before age of 25 years. There are 14 known forms of MODY, ranging from rather common to extremely rare.

About 1% of patients in the Norwegian Childhood Diabetes registry may have disease causing MODY mutations, according to a study recently published by the investigator's group and others.

MODY associated mutations in the transcription factors HNF1A, HNF4A, and HNF1B leads to activation of the potassium channel causing depolarisation of the beta-cell membrane, which is crucial for excretion of insulin. By treating patients with HNF1A-MODY, HNF4A-MODY, and HNF1B-MODY with sulfonylurea class of drugs, these channels will close, causing depolarisation of the beta-cell membrane, and release of insulin. Hence, these patients can often stop insulin treatment when they are treated with sulfonylurea class drugs.

Due to high throughput sequencing, a number of rare variants in these genes have been discovered. In many cases, bioinformatic tools are not sufficient to correctly classify these variants. In the present study, we intend to identify rare variants in the HNF1A, HNF4A, and HNF1B genes in patients with insulin dependent diabetes identified through the Norwegian Childhood Diabetes registry or the Norwegian MODY Registry with possibly disease causing HNF1A, HNF4A, or HNF1B mutations with sulfonylurea to see if they can reduce or even stop insulin treatment, and regulate their diabetes with sulfonylurea only. All variants will be investigated by bioinformatics tools as well as functional assays (tests for DNA-binding, transcriptional activation, nuclear localisation, protein expression). Primary endpoints are efficacy of sulfonylurea treatment measured by insulin requirement or not and level of HbA1c. Secondary endpoints are tolerance of sulfonylurea and effect on insulin secretion by oral and intravenous glucose tolerance tests. Bioinformatics and functional characterisation will be compared with success to reach primary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes and DNA sequence variant of unknown significance (VUS, class 3) or pathogenic (class 4, and 5) in the HNF1A, HNF4A, or HNF1B genes
* On insulin treatment
* Willing and able to provide informed consent (parents if younger than 16 years of age)

Exclusion Criteria:

* Known anaphylactic response to sulfonylurea
* Diabetes and DNA sequence variant in the HNF1A, HNF4A, or HNF1B genes that are known to be non-pathogenic (class 1-2)
* Not willing or able to provide informed consent (parents if younger than 16 years of age)
Consequences From Use of Reminiscence: a Randomised Intervention Study in Ten Danish Nursing Homes

Reminiscence is the systematic use of memories and recollections to strengthen self-identity and self-worth. The study aim was to investigate the consequences for nursing home residents and staff of integrating reminiscence into daily nursing care. Ten nursing homes were randomised into either an Intervention Group, who implemented reminiscence, or a Control Group, who continued with usual care. Data were collected at baseline and again 6 and 12 months after the intervention start. Results suggested that use of reminiscence can improve residents' quality of life and possibly delay progression in dementia symptoms. Nursing staff can experience greater satisfaction with personal and professional roles and develop a more positive view of the residents.


Eligibility Criteria:
Inclusion Criteria:

* nursing homes in the Mid-Jutland Region with at least one 35 residents who were willing to particpate in study
* signed informed consent from residents/relatives

Exclusion Criteria:

* nursing homes that already used reminiscence on a systematic basis
* nursing homes with recent organisational changes/extensive staff training
* residents in protected-environment units, were bed-ridden/terminally ill or on short-term placement.
Cerebral Oxygenation in Total Hip Arthroplasty Patients

We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.

The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18-80 years old undergoing unilateral total hip arthroplasty
* Hypotensive epidural anesthesia

Exclusion Criteria:

* Contraindication to controlled hypotension and/or neuraxial anesthesia.
* Severe pulmonary hypertension or pre-op systolic blood pressure reading \>150 mm Hg
* Moderate to severe valvular stenosis.
* History of stroke, dementia, or post-op delirium
* Prior OSA diagnosis
* History of benzodiazepine use (regular use for longer than 3 months)
* Chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis)
* History of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is OK)
* Parkinson's disease
* Severe chronic pulmonary disease
* Total anterior hip approach being used
* Hip resurfacing procedure
* Non-English Speaking\*

  * Questionnaires being used to assess mental status are only validated in English.
Transdermal Nitroglycerin and Nifedipine in Preterm Labor

One of the important complications of pregnancy is preterm labor (PTL) and delivery. There are different tocolytic agents to enhance the time of delivery. The aim of this study was to compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted with diagnosis of PTL. Group one have received transdermal GTN whereas group two have received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as gestation age at the time of delivery have been monitored and evaluated in both groups of patient. Our main goal has been delay of delivery to have the most beneficial effect of primary corticosteroid administration for fetus.


Eligibility Criteria:
Inclusion Criteria:

* GA between 24 to 34 weeks
* early-onset signs of delivery (≥4 uterine contractions during 20 minutes, ≥1 centimeters (cm) of dilation and effacement over 80%).

Exclusion Criteria:

* maternal or fetal life-threatening conditions which require emergency termination
* multiple pregnancy
* premature rupture of membrane
* fatal anomaly or intra-uterine fetal death
* cervical dilation ≥4 cm
* any tocolytic treatment in previous days and positive allergy to GTN
Assessment of the Safety and Performance of a Patellofemoral Brace

Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged ≥18 years old
* Subject has patellofemoral syndrome
* The current condition of his/her knee allows the subject to keep a regular physical activity
* Subject has been informed and is willing to sign an informed consent form
* Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (18 weeks)
* Subject is affiliated to the French social security regime

Non-Inclusion Criteria:

* Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
* Subject has worn a support (knee brace or articulated orthosis) in the last month during his/her sport practice
* Subject has any medical condition that could impact the study at investigator's discretion
* Subject has a known hypersensitivity or allergy to the components of the device (polyamide, cotton, elastane, elastodiene, polyester)
* Adult subject to a legal protection measure
Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI

To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.

To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.

Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-37
* BMI 19-34 kg/m2
* Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL
* Estradiol (E2) less than 80 pg/mL
* Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10
* Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation
* Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy

Exclusion Criteria:

* Severe male factor (total count less than 10 million sperm)
* Systemic diseases not limited to diabetes
* Pregnancy within 3 months
* More than 1 prior cycle of gonadotropin treatment
* Any ovarian cyst \>15mm that has persisted for \> 1 month
* Endometrioma and/or Endometriosis-stage III or IV
* Submucosal uterine fibroids; untreated endometrial polyps \>1 cm;abnormal reproductive tract bleeding
* Intolerance or allergy to study drug
* Substance abuse (including alcohol and tobacco)
* History of chemotherapy (except for gestational conditions) or radiotherapy
* Minors and those adults not capable of consenting on their own