cyrilzakka/clinical-trials huggingface dataset:
Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia

Background:

Analgesia remains to this day a challenge for anesthesiologists. Dexmedetomidine, a potent central alpha-2 agonist, has been shown to have analgesic and opioid sparing effects. The classic analgesic strategy focuses on opioid administration guided by estimated time of elimination and hemodynamic response (increase in blood pressure and heart rate). This technique is not sensitive and forces the anesthesiologist to be one step behind nociception, the patient's unconscious response to pain.

PMD-200 (Medasense, Israel) displays the Nociceptive level (NOL)-Index as marker of nociception. The NOL-Index ranges from 0 (no nociception) to 100 (intense nociception) and the recommended analgesic range during surgery is from 10 to 25 (Medasense recommendations).

The goal of this study is to compare two analgesia strategies guided by the NOL Index (range 10-25) using either remifentanil TCI (target controlled infusion) alone or remifentanil TCI associated with a continuous dexmedetomidine infusion.

Methods:

A total of 100 patients will be included and informed consent will be acquired. This bi-center study will take place at Erasme University Hospital (primary center) and Saint-Pierre University Hospital. Patients will be randomized into either two groups: remifentanil and placebo versus remifentanil and dexmedetomidine. Both groups will be monitored using the PMD-200 that will guide the analgesic therapy strategy. Investigators and patients will be blinded to dexmedetomidine and placebo administration. The primary outcome will be intraoperative remifentanil consumption. Secondary outcomes will include postoperative opioid administration, opioid associated complications, hemodynamics, and hospital length of stay.


Eligibility Criteria:
Inclusion Criteria:

- American Society of Anesthesiologists (ASA) grades 1-2 undergoing scheduled stomatological, cervical, and thyroid surgery anticipated to last at least two hours

Exclusion Criteria:

* ASA score \>2
* Preoperative organ dysfunction
* Patients with non-regular cardiac rhythm
* Implanted pacemakers
* Emergent surgery
* Pregnancy or lactation
* Allergy or intolerance to any of the study drugs
* Participation in another interventional study
* Patient refusal
Italian Data Registry of Patients Undergoing Peripheral Nerve Block Performed in the Emergency Departments

This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.

Pain in emergency departments (EDs) is often inadequately treated. The consequences of inadequate treatment of pain defined as "oligoanalgesia," can have a negative impact on patient outcomes. The main reasons for this include lack of appropriate pathways, incorrect habits and aversion to opioid use. Pain is a symptom present in 78% of patients entering emergency departments, and among the main causes is trauma. A multimodal approach to pain treatment is more effective and minimizes side effects such as nausea, vomiting, and drowsiness due to the use of some drugs such as opioids. Over the past fifteen years, numerous studies have demonstrated the effectiveness of pain treatment using Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) even outside the operating room. This data registry aim is to describe the practice of Point-of-Care Ultrasound Guided Regional Anaesthesia (POCUS-GRA) in emergency departments of nosocomial hospitals where, the organizational structure, has already provided for the implementation of peripheral nerve blocks (PNB) in common clinical practice for the treatment of acute pain due to bone fractures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* NRS\>3
* Patients with traumatic fractures of ≤2 districts (radiologically confirmed (RX or CT). Districts are:

Chest (one hemilateral) Pelvis (one hemilateral) Femur Leg Ankle Foot Shoulder Humerus Forearm Hand/fingers

- Presence of written informed consent to the study.

Exclusion Criteria:

* Intubated patients
* Patients with known dementia
* Patients with delirium (assessed by Confusion Assessment Method)
* Pregnant patients
* Patients with allergies to local anesthetics
* Patients unable to adequately communicate pain
Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus

Randomized double-blind placebo-controlled clinical trial. Consists of the administration of 5,000 IU of vitamin D3 vs Placebo in patients with gestational diabetes mellitus during eight weeks. The objective is to analyze the effects of the intervention on the biochemical parameters that are part of the glycemic profile (insuline, HBA1c, glucose)

Two groups of patients diagnosed with gestational diabetes mellitus. Once the selection criteria are verified, they will be assigned randomly in one of the two arms,one of them will recive 5,000 IU of vitamin D and the other one placebo (talcum food grade). Baseline measurements of vitamin D, glucose,insulin, HBA1c, calcium, phosphorus. At the end of the eight weeks will be determined again the aforementioned biochemical parameters.

Eligibility Criteria:
Inclusion Criteria: Patients with a single pregnancy.

* Patients diagnosed with GDM, which were diagnosed by a glucose tolerance curve 100 grams of glucose, with two altered results from the following: fasting\> 95 miligrams / deciliter, 1 hour\> 180miligrams / deciliter, 2 hour\> 155miligrams / deciliter, 3hous\> 140 miligrams / deciliter.
* Gestational age between 24 -30 weeks confirmed with ultrasound of the 1st or 2nd trimester
* Age between 18 and 40 years.

Exclusion Criteria: Patients with pre-existing diabetes mellitus

* Patients with predictive factors for vitamin D hypovitaminosis such as: use of anticonvulsants, renal disease, glomerular filtration rate \<60milliliters / minute, thyroid disease or any other pre-existing endocrinological disorders.
* Hypercalciuria\> 300 miligrams / day
* Patients taking vitamin D supplementation during the 6 months prior to the study (does not include polyvitamins with lower vitamin D concentrations \<500 IU)
* Active and passive smoking patients.
Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis

This study aimed to compare intraarticular ozone injection, prolotherapy, or dexmedetomidine effectiveness in knee osteoarthritis patients.

Osteoarthritis (OA) is a heterogeneous group of disorders of different etiologies with similar biological, morphological, and clinical manifestations and outcomes. The intraarticular injection has been recommended to alleviate the pain in the knee joint.

Ozone therapy has long been used in the management of OA. Furthermore, it has been shown to not cause a significant inflammation process or cartilage degradation. Prolotherapy is a procedure where a natural irritant is injected into the soft tissue of an injured joint. Dexmedetomidine is a selective α2-adrenergic agonist with considerable sedative and analgesic actions.

Eligibility Criteria:
Inclusion Criteria:

* Age from 30 to 65 years.
* Both genders.
* Patients diagnosed with stage 1-3 osteoarthritis according to the Kellgren-Lawrence Classification System (K-L).

Exclusion Criteria:

* Patient refusal.
* History of knee trauma within the past month.
* Rheumatic disease.
* Pregnancy.
* Any surgical intervention of the knee.
* Severe cardiovascular disease.
* Morbid obese patients (body mass index (BMI) of \>35 kg/m2).
* Local infection at the site of injection.
* Bleeding diathesis.
Rx for Better Breast Health

This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing \[MI\] and tailored newsletters) on obese (body mass index \[BMI\] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.

The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Females 18 years or older
* Primary diagnosis of breast cancer
* Fluency in English
* B.M.I. \>= 30
* Available for follow-up for 12 months

Exclusion Criteria:

* Clinical evidence of metastatic disease
* Not diagnosed with primary breast cancer
* Lack fluency in English
* B.M.I. \< 30
Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve

To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
2. The diagnosis of HCC should be established either by cyto/histology
3. Patients must be \> 20 years of age.
4. ECOG score \< 2.
5. Signed informed consent.
6. Female patients at child-bearing age must have negative pregnancy test.

Exclusion Criteria:

1. Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
2. Patients with advanced second primary malignancy are not eligible.
3. Patients with active infection are not eligible.
4. Patients with pregnancy or breast-feeding are not eligible.
5. Patients with brain metastases are not eligible.
ACS-NSQIP Calculator for Liver Surgery

The American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP) calculator has been endorsed by the surgeons' community to counsel patients and relatives regarding estimated postoperative complications. However, it does not include organ-specific risks. The aim of this study was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay (LOS) in patients undergoing hepatectomy for liver tumors

This is an observational retrospective study conducted in a tertiary-referral university hospital. An established classification of complications, including post-hepatectomy insufficiency and bile leak, was adopted. The endpoint was the rate of complications, mortality and LOS as expected by the ACS-NSQIP calculator and as observed within 90-day after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who underwent surgery for a liver tumor at our Institution between the defined period of time

Exclusion Criteria:

* Any patient with missing data
Preoperative Staging of Endometriosis With MRI

The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons.

The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing either a surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Women with strong suspicion of deep infiltrating endometriosis, with already planned surgery

Exclusion Criteria:

* Contra-indications for MRI; claustrophobic patients; patients in bad condition; pregnancy
Motivational Intervention for Physical Activity in Psychosis

The purpose of this study is to determine whether motivational intervention is effective in promoting exercise habit in patients with psychosis.

The current study aims to investigate the beneficial effect of motivational intervention in promoting exercise habit in patients with psychosis. Outpatients will be recruited and will be randomized to a 12-week motivational intervention program. They will be assessed for their clinical symptoms, cognitive function, physical fitness, and quality of life. All patients will have cognitive function assessments at baseline, 12 weeks after the completion of the program and 6 months. The primary hypothesis of the current study is that motivational intervention can help patient to develop exercise habit in patients with early psychosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed to have psychotic disorders
* Cantonese-speaking Chinese (to enable cognitive testing)
* Ability to understand the nature of the study and to give written informed consent

Exclusion Criteria:

* Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders
* Comorbid substance dependence
* Unstable psychotic symptoms
* Known pregnancy
* A history of brain trauma or organic brain disease
* Known history of intellectual disability or special school attendance
Volume Effect in Peng Block for Total Hip Replacement

This study is to investigate whether a different volume of ropivacaine, with the same prescribed dosage based on body weight, can affect block efficacy, duration and side effects in the first 24 hours postoperatively.

patients were divided into 3 groups on the basis of the volume of anesthetic given to perform the block. in every patient was assessed the nrs, the side effects, if any, and the need for analgesic drugs in the first 24 hour after surgery

Eligibility Criteria:
Inclusion Criteria:

* ASA I, ASA II, ASA III
* Age≥18
* Total hip replacement surgery in spinal anesthesia
* Informed consent

Exclusion Criteria:

* ASA IV
* INR\>1.3
* platelet values\<100\*10\^3/ml a
* patients on anticoagulant or antiplatelet therapy
* general anesthesia for total hip replacement surgery
* patients on chronic opioid therapy
* altered sensitivity or motility
* Patients in chronic opioid therapy
* Refuse to sign informed consent form
* Unable to sign informed consent form
* Know allergies to medication used for analgesia
Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.


Eligibility Criteria:
Inclusion Criteria:

* Patients with upper or lower respiratory tract infection.
* Patient is male or female ≥ 18 years of age.

Exclusion Criteria:

* Known hypersensitivity to or previously intolerant of macrolides.
* Illness severe enough to warrant hospitalization or parenteral therapy.
* Concomitant use of any of the following medications:

  * Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
  * Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
  * Colchicine
  * Digoxin
  * Some antiretrovirals: zidovudine and ritonavir.
* Severe immunodeficiency and chronic disease conditions.
* Renal or hepatic impairment.
Conscious Pregnancy: Supporting Maternal Cardiometabolic Health With Mindfulness

A pilot randomized control trial (RCT) to examine the efficacy of a culturally tailored mindfulness intervention upon fasting cardiometabolic factors (including markers of glycemic control) and inflammatory gene expression in n=60 (n=30 intervention, n=30 wait-list control) low-income Spanish-speaking Latina pregnant women. The study will be conducted in partnership with MOMS, a nonprofit community organization that serves low-income pregnant and postpartum women.

Prenatal health interventions have the potential to shape the future health of both mothers and offspring. Given that the Latino population is disproportionately affected by high rates of obesity and type 2 diabetes, targeted prenatal health interventions that support Latina metabolic health are fundamental to reduce the burden of Latino health disparities within and across generations. Research in primarily non-Hispanic White populations suggests that prenatal mindfulness interventions can not only improve maternal mental health outcomes and well-being, but additionally can support systemic physiological health, such as improved glycemic control and reduced gestational weight gain. However, research on the acceptability and feasibility of mindfulness programs for Latino populations is limited, especially among those who are Spanish-speaking and affected by poverty. Focus groups conducted with this target population, have highlighted a strong interest in mindfulness programs, with a need for novel hybrid instruction format (live classes + digital at-home content). Accordingly, the investigators have developed an adapted, hybrid version of the validated 6-week Mindfulness Awareness Practices (MAPs) training program in Spanish and English.

Here, the investigators plan to pilot and examine the efficacy of this culturally tailored mindfulness intervention upon cardiometabolic factors, including inflammatory gene expression and glycemic control markers, in a low-income Spanish-speaking Latina pregnant population (n=60; n=30 intervention, n=30 wait-list control). Specifically, the investigators will examine the intervention impact on cardiometabolic markers (e.g., fasting glucose and insulin, Hemoglobin A1c (HbA1c), C-reactive protein (CRP), lipids), and inflammatory gene expression measurement. Maternal mental well-being, pregnancy and birth outcomes will also be assessed. In addition, the investigators will examine the feasibility and acceptability of pre-post intervention continuous glucose monitoring (CGM) in n=5 mindfulness group participants.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton, intrauterine pregnancy
2. 1st or 2nd trimester at enrollment
3. Fluent in Spanish
4. Self-identify as Hispanic/Latino
5. Low-income

Exclusion Criteria:

1. Having regular mindfulness practice
2. T1 or T2D diagnosis
Pulmonary Fibrosis and Telomerase Mutation Study

This study is an observational and retrospective study of patients with pulmonary fibrosis associated or not with telomerase mutation.

The purpose of this study is to describe in detail the cases with telomerase mutation in terms of features on CT scan, respiratory function and evolution, in comparison to control subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family history.

Two "control" subjects will be enrolled for one subject with telomerase mutation.

The data are all the results of investigations conducted for the diagnosis of idiopathic pulmonary fibrosis and during routine follow up of patients.

The CT scans will reviewed centrally to homogenize the description.

Eligibility Criteria:
Inclusion Criteria:

* Diffuse interstitial lung disease on CT scan
* Telomerase mutation analysis

Exclusion Criteria:

* Presence of connective tissue disease, or pneumoconiosis or drug induced lung disease
A Pilot RCT on the Feasibility of an Online Quiz Game to Promote Tobacco-related Knowledge, Attitudes and Behaviours Among Primary School Students

The goal of this pilot RCT is to test the feasibility of an online quiz game to promote tobacco-related knowledge, attitudes and behaviours in local primary 5-6 school students. The main question it aims to answer is:

* Feasibility of intervention
* Acceptance of intervention by schools, teachers, parents and teachers
* Adherence to the 4-week intervention
* Functional online quiz platform
* Satisfaction of students and parents towards intervention Researchers will compare the questionnaire results from students to see if students doing tobacco-related questions on the online quiz platform will have better tobacco-related knowledge, higher anti-tobacco attitudes and lower intention to smoke.

Students will engage in an online quiz competition for 4 weeks on tobacco-related topics for the intervention group and on healthy eating for the control group. They will complete pre-test and post-test questionnaires before and after the online quiz competition.


Eligibility Criteria:
Inclusion Criteria:

* Primary 5-6 students from local primary schools
* Able to read and communicate in Chinese
* Have a digital device for online access to the quiz game at home

Exclusion Criteria:

-
Intracervical Balloon Placement With Nitrous Oxide Administration

This randomized controlled trial aims to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor.

This is a single center randomized controlled trial aimed to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor. Pregnant women requiring labor induction will be randomly assigned to receive either nitrous oxide or oxygen during the Foley balloon placement. The primary outcome measured will be the success rate of the Foley balloon placement, with secondary outcomes including patient comfort, pain levels during the procedure, and any adverse effects. The study seeks to determine if nitrous oxide can improve the success rate of Foley balloon placement compared to oxygen and to evaluate the overall patient experience and safety associated with its use in this context.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to labor and delivery for induction of labor (term inductions, medically indicated preterm inductions).
* Pregnant patients who are eligible for intracervical balloon placement.

Exclusion Criteria:

* Pregnant patients with contraindications to receiving nitrous oxide.
* Inability to safely self-administer nitrous oxide
* Allergy to nitrous oxide
* History of malignant hyperthermia,
* Concomitant administration of magnesium sulfate
* Less than 35 weeks gestational age
* Non-reassuring fetal heart tracing
* Use of intravenous or intramuscular opioid within 4 hours
* Vitamin B12 deficiency
* Gas-trapping conditions such as pneumothorax or small bowel obstruction
* Patients requesting neuraxial anesthesia
* Non-English speaking patients.