cyrilzakka/clinical-trials huggingface dataset:
Ropivacaine Concentration and Rebound Pain

The goal of this clinical trial is to see if the concentration of a local anesthetic (ropivacaine) in peripheral nerve block is related to the severness of pain after surgery of distal radius fractures in adults.

The main questions it aims to answer are:

* Is concentration of ropivacaine related to severeness, duration and type of postoperative pain?
* Is concentration of ropivacaine related to analgetic consumption after surgery?
* Is concentration of ropivacaine related to block sucess rate during surgery and patient satisfaction after surgery?

Researchers will compare ropivacaine 3.75 mg/ml and 7.5 mg/ml used in brachial plexus peripheral nerve block. Participipants are randomized to one of the two concentrations. The peripheral nerve block is standard anesthetic treatment for distal radius fractures scheduled for volar plate surgery at Oslo University Hospital. All other treatment for the condition will be the same as standard treatment.

Participants will answer a questionnaire regarding pain, physical function, medication and life quality at different points of time after surgery, up to 6 weeks after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with distal radius fracture, scheduled for volar plate surgery
* Surgery up to 20 days after fracture trauma
* 18 to 80 years old (inclusive)
* ASA 1, 2 or stable ASA 3
* Body Mass Index (BMI) 18 to 40 kg/m2 (inclusive)
* Weight of 50 kg or more
* Ability to communicate sufficiently in a scandinavian language
* Capable of giving a signed informed consent
* Ability and willingness to understand og be compliant to the study

Exclusion Criteria:

* Contemporaneous painful injuries
* Existing long-term pain
* Peripheral nerve damage in the arm with radius fracture
* Patients who prior to fracture trauma use opioids, psycothropic drugs or medication, with or without prescription, with significantly sedative effect on regular basis.
* Excessive use of alcohol (more than 15 units of alchol per week for men, more than 8 units of alchol per week for women, or patients reporting to be incapable of avoiding alcohol as long as they use strong opioids).
* Progressive neurologic disease (inclusive diabetic neuropathy).
* Skin infection at the site for brachial plexus nerve block
* Other contraindications for brachial plexus nerve block
* Contraindications for ropivacaine, paracetamol, etoricoxib, dexamehtasone or oxycodone
* Previous allergic reaction to local anaesthetics or etoricoxib, dexamethasone, oxycodone or paracetamol.
* Pregnant or breast-feeding women at surgery day (they do not get excluded if they become pregnant in the follow up period after intervention and surgery)
COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses

Given the current lack of effective COVID-19 treatment, it is necessary to explore alternative methods to contain the spread of the infection, focusing in particular on its mode of transmission. The modes of person-to-person transmission of SARS-CoV-2 are direct transmission, such as sneezing, coughing, transmission through inhalation of small droplets, and transmission through contact, such as contact with nasal, oral and eye mucous membranes. SARS-CoV-2 can also be transmitted directly or indirectly through saliva. The use of antiviral mouthrinses may be used as adjunctive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Covid-19 infection by the patient's general practitioner and hospital doctor
* Clinical signs started less than 8 days ago.
* Virological confirmation
* Understanding and acceptance of the trial.
* Written agreement to participate in the trial

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Inability to comply with protocol
* Lack of written agreement
PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor

Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially presented with brain tumors, and predict the prognosis in the patients diagnosed with primary high graded astrocytoma or oligodendroglioma.

Materials and methods: Simultaneous MRI-PET (FDG) will be prospectively obtained in patients (n = 60) initially presented with brain tumors by using integrated MRI-PET (Biograph mMR, Siemens, Germany). We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies. We will use the imaging protocols including whole body MRI-PET and advanced brain tumor imaging (DWI, PWI and DCE). In addition, we will analyze the imaging parameters to see whether the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.

Expected results: We expect that whole body MRI-PET is useful for the differential diagnosis of primary and metastatic brain tumors, and the multiparametric information from DWI, PWI, DCE and PET can be used for the tumor grading and prognosis prediction of the primary brain malignancies.

Eligibility Criteria:
Inclusion Criteria:

* We will inculude the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.

Exclusion Criteria:

* We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies.
Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development

Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine deficiency on neuromotor development are well established: randomized controlled trials of iodine supplements given to iodine deficient mothers before pregnancy or during early pregnancy improve motor and cognitive performance of their offspring. However, the potential adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear. Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in iodine deficiency.

Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid function, pregnancy outcome, birth weight, infant growth and cognitive performance.

Study design: Double-blind randomized controlled multicentre trial. Study population: Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be recruited at two research sites, namely St. Martha's hospital in Bangalore, India and Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be recruited.

Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and the other half to placebo throughout pregnancy.

Main study parameters/endpoints: Differences between group means in indicators of thyroid function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor development.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years;
* Gestational age: ≤ 14 weeks (as judged by the date of the last menstrual period);
* Single pregnancy;
* Non-lactating;
* Planned residence in the area for the duration of the study (3 years).

Exclusion Criteria:

* TSH levels outside the normal range
* History of serious medical conditions such as HIV, hypertension, diabetes, renal, hepatic or cardiovascular disease, thyroid disorders, mental disorders;
* Use of iodine supplement.
A Study of Insulin Peglispro in Healthy Male Japanese Participants

The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Participants are overtly healthy male Japanese.
* Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m\^2), inclusive.

Exclusion Criteria:

* Participants have known allergies to insulin peglispro or related compounds.
* Participants have a fasting venous blood glucose \>108 milligrams per deciliter (mg/dL) (\>6 millimoles per liter \[mmol/L\]).
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.

Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are in general good health, experiencing moderate to severe pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures

Exclusion Criteria:

* Allergies to study medications
* History of multiple drug allergies
* Unable to stop excluded medications
* Clinically significant laboratory abnormalities at Screening
* Significant medical condition at Screening
* Women who are pregnant or breast feeding
AiM Covid Self Monitoring

The objectives of this study are to test the level of accuracy of the prediction models that could be used as a 'digital test' to evaluate whether an individual is infected with COVID-19, based on their symptoms reported in the "AiM COVID-19" app


Eligibility Criteria:
Inclusion Criteria:

* Participants resident in India
* Voluntary completion of the self-test and evaluation.

Exclusion Criteria:

* People can not use mobile app
* Below 18 years old
Evaluation of Cerebral Venous Return With Internal Jugular Vein Blood Flow in Gynecological Laparoscopic Surgery

The steep Trendelenburg position (STP) provides an advantage in laparoscopic procedures as it optimizes the surgical image. In laparoscopic operations, the need for CO2 pneumoperitoneum (PP), together with this non-physiological position, raises concerns about the patient's physiological homeostasis. Although most patients seem to tolerate the combination of STP and PP, this method carries risks of ICP (intracranial pressure) and brain perfusion. The head-down position increases arterial pressure as well as CVP, thereby disrupting cerebral venous drainage and increasing hydrostatic pressures in the cerebral vascular system. This increases cerebrovascular resistance and decreases cerebral blood flow by increasing ICP and cerebral edema. Systemic CO2 absorption from pneumoperitoneum causes hypercarbia. Hypercarbia can increase cerebral blood flow through cerebral vasodilation.

Seventy-four percent to 95% of cerebral venous drainage in the supine position is provided by IJVs. Studies have shown that IJVs, which are responsible for most cerebral venous drainage, exhibit changes in diameter and blood flow due to TP. These studies were generally conducted on moderate TP and on healthy volunteers. In this study, we aim to evaluate the effects of a steep Trendelenburg position (25°) and pneumoperitoneum on IJV blood flow in patients undergoing operation under general anesthesia


Eligibility Criteria:
Inclusion Criteria:

ASA I-II physical status age between 18 and 65 years planned gynecological laparoscopic surgery. -

Exclusion Criteria:

history of head and neck surgery history of cerebrovascular disease ASA III-IV physical status

-
Machine Learning Versus Traditional Scores in Predicting Erythrocyte Need

In this study, we compared perioperative bleeding prediction scores with our machine learning-based prediction system in predicting the need for erythrocyte suspension during cardiovascular surgery.

The success of ML algorithms in predicting perioperative blood product use in CABG remains an under-tested topic. Unnecessary preparation of blood products or not being able to supply them when necessary is critical for both patient safety and the effective use of hospital resources \[8\]. Bleeding amounts and blood product use strategies can vary with institute protocols. Scoring systems that determine the general framework may not perform well due to local factors. ML algorithms can be created locally according to previous patient data of each clinic and can improve themselves with learning mechanisms, suggesting significant potential in this field.

In the current study, a new estimation system created with the ML algorithm was compared with the known estimation systems. Comparing the ML algorithm with 6 different classical scoring systems is important in terms of demonstrating the potential of this technology.

The aim of this study is to investigate whether the model created with ML in predicting perioperative blood product consumption in cardiovascular surgeries is superior to predictive scoring systems that have proven themselves in the literature. Secondary aim is to compare the predictive value of using more than one scoring system in combination.

Eligibility Criteria:
Inclusion Criteria:

* Data from patients who underwent isolated CABG surgeries in the cardiac and vascular surgery operating rooms between 01.01.2023 and 01.01.2024 were evaluated.

Exclusion Criteria:

* Missing Data
* Emergency surgery
* İntraoperative mortality
5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)

Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial


Eligibility Criteria:
Inclusion Criteria:

* mid and low rectal cancer (AV\<15cm)
* stage II, III, preop long-course CCRT, then ileostomy repair
* about 1\~12 months after operation (no stomy)
* about 1\~6 months after ileostomy repair
* major LARS

Exclusion Criteria:

* recurred rectal cancer
* stage IV
* IBD
* uncontrolled preoperative fecal incontinence or constipation
THAL-DEX Incorporated Into Double PBSC Autotransplantation for Untreated Multiple Myeloma (MM)

The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then continued throughout the subsequent treatment phases until the day before the second autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis, are response rates to the different treatment phases (induction, first and second ASCT), best response whenever achieved, duration of response (DOR), time to progression (TTP), progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes (DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities and imaging features, as detected by 18F-FDG PET/CT.


Eligibility Criteria:
Inclusion criteria:

* Confirmed diagnosis of symptomatic MM based on standard criteria.
* No prior or current systemic therapy for MM, with exception of steroids.
* At least 18 years and less than 65 years of age.
* Presence of quantifiable M protein in serum or urine.
* Durie \& Salmon stage II-III or I with disease progression.
* Adequate organ function (heart, lung).
* No previous deep vein thrombosis and/or recurring thrombophlebitis and/or pulmonary embolisms, confirmed by doppler ultrasound or computed tomography scan.
* Willing and able to comply with the protocol requirements.

Exclusion criteria:

* Diagnosis of smouldering or asymptomatic MM, plasmacell leukemia, solitary plasmocytoma of the bone o extramedullary plasmocytoma.
* Diagnosis of non-secretory MM.
* Prior or current systemic therapy for MM, with exception of steroids.
* More than 65 years of age.
* Female subjects pregnant.
* Non adequate organ function (heart, lung).
* Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism.
Myoma Microvascularization Analysis Using Sonovue Before and After Uterine Artery Embolization

Contrast-enhanced ultrasound is supposed to improve the detection of myomas as well as improve the follow-up after specific treatments like embolization. It will also help the investigators better understand the mechanism of success or failure for embolization and could reduce the amount of particles injected by determining the endpoint of the procedure in order to treat the myomas while preserving the myometrium.

Before embolization of the uterine artery, 40 patients with unique or multiple myomas will be included prospectively in our study and evaluated with sonography before and after injection of Sonovue (2.4 ml) (Bracco Int Milano Italy). Pelvic ultrasound with contrast enhancement will be done the day after and six months after the procedure.

Microvascularization of the myomas and the endometrium will be described. Some tiny myomas which are not visible on conventional sonography could be identified for a perfect matching with MRI detection.

Eligibility Criteria:
Inclusion Criteria:

* Uterine myomas with solid tissue (greater diameter lower than 15 cm)
* The embolization is planified during the 15 days after the contrast ultrasonography
* Written informed consent is signed

Exclusion Criteria:

* Intracavitary uterine mass possibly due to a polyp or endometrial cancer
* Necessity of using the endovaginal way of ultrasonography because of the myoma's size and accessibility
* Menopause
* Pregnancy and breastfeeding
* Recent cardiac affection
* History of acute cardiac disease
COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)

There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode.

Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.


Eligibility Criteria:
Inclusion Criteria:

SARS-CoV-2 confirmed by RT-PCR

* Adults \> 18 years
* Signed consent form
* Affiliated to the French health system

Exclusion Criteria:

* Pregnant women
* Hospitalized patients
* Individuals subject to legal protection
* Imprisoned individuals
* Individuals who have expressed an opposition to participate, or who do not wish to donate blood samples
Oral Iron in Children With Chronic Kidney Disease

This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.


Eligibility Criteria:
Key inclusion criteria:

* Age 1-21 years old (muscle strength will be assessed only in children \>3 year old)
* Estimated glomerular filtration rate (GFR) \< 90 ml/min/1.73m2 by bedside Schwartz formula \[height (cm) \*0.413 / serum creatinine (mg/dL)\]
* Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit
* Hb less than 11.5 g/dL in children younger than 5 years Hb less than 12.0 g/dL in children 5-12 years Hb \<12.5 g/dL in children 12-15 yrs and females \>15 yrs. Hb \<13.5 g/dL in males \>15 years (all at the previous clinic visit)

Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms

Key exclusion criteria:

* Transferrin saturation \<5%
* Serum ferritin \< 10 ng/mL
* Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
* Blood transfusion within 4 months prior to enrollment
* Children on hemodialysis
* Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
* Pregnancy and breast-feeding