cyrilzakka/clinical-trials huggingface dataset:
Early Surgical Intervention Combined With Weight-supported Walking Training

To determine the efficacy of a novel combinatorial treatment involving early surgical intervention and long-term weight-bearing walking training in spinal cord injury (SCI) patients clinically diagnosed as complete or American Spinal Injury Association Impairment Scale Class A (AIS-A).

In the present study, the investigators reported the efficacy of a novel combinatorial approach involving early surgical intervention and long-term weight-bearing walking training in SCI patients clinically defined as complete or AIS-A. The surgical intervention involves the intradural decompression (via durotomy), and, in some cases, intraspinal decompression (via myelotomy). In addition, the investigators had developed a weight-bearing walking training program named "Kunming Locomotion Training Program (KLTP)" to train the patient to walk actively for a duration of 6 hours per day, 6 days per week for a minimum of 6 months (6-6-6 KLTP). The investigators reasoned that early surgical intradural and/or intraspinal decompression would release the intraspinal pressure and, therefore, spare surrounding tissues that would otherwise degenerate during the course of secondary injury. The investigators further reasoned that long-term weight-bearing walking training would "retrain" the residual spinal pathways facilitating recovery of locomotor function, and that a combination of the two would result in even greater functional recoveries.

Eligibility Criteria:
Inclusion Criteria:

* injury levels included cervical, thoracic and lumbar spinal levels;
* neurological examination was AIS-A;
* diagnosis of SCI was confirmed by MRI.

Exclusion Criteria:

* penetrating injuries that caused complete transection of the spinal cord;
* patients with severe brain injuries or other neurological disorders;
* patients with lower motoneuron diseases;
* patients with other conditions including pregnancy, and significant medical, infectious, and psychiatric conditions.
Characterizing the Electroencephalogram Signature of Fentanyl During Induction of General Anesthesia

While historically anesthesiologists rely on pharmacokinetics to track the loss of consciousness, new research in anesthesiology has identified the salient features of the electroencephalogram (EEG) that correlate to states of sedation and unconsciousness induced by different anesthetic drugs. While the EEG features of many sedative-hypnotic anesthetics have been well- characterized, the opioid analgesic drugs have not been analyzed in detail in this way. A characterization of the EEG signatures of opioid analgesic drugs could be useful in monitoring and titrating the effects of these drugs.

Fentanyl is one of the most commonly used opioid analgesic drugs. Prior to induction of general anesthesia, fentanyl is frequently administered to blunt the nociceptive response to intubation. A typical scenario is to administer 2 to 4 mcg/kg of fentanyl first, followed by a sedative hypnotic drug such as propofol to induce general anesthesia. In this study, we propose to administer a total of 4 mcg/kg of fentanyl, administered in 2 boluses, before administering a sedative hypnotic drug. At this dose, fentanyl will serve to blunt nociception during intubation, but will also contribute to intraoperative pain management. During this time, we will record the EEG using standard EEG-based anesthetic monitors that are routinely used in the operating room. We will assess the patient's level of responsiveness using an auditory task and ulnar nerve stimulation. These measurements will allow us to identify the EEG signatures of fentanyl for future use in EEG-based anesthetic monitoring. During this study we will measure EEG and responses to auditory and ulnar nerve stimuli during induction of general anesthesia in surgical patients. The anesthetic will be administered according to a typical sequence in which fentanyl is first administered, followed by a sedative hypnotic drug for induction of general anesthesia. The primary difference is that, in this study, we will record the EEG and response data for a short period of time after initial administration of fentanyl and prior to administration of a sedative hypnotic drug to induce general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

-Undergoing surgery anticipated to take 2 hours or longer

Exclusion Criteria:

* Craniofacial abnormalities
* Allergies to fentanyl, bisulfite, eggs or egg products, latex, soybeans, soybean oil BMI ≤ 30 (kg/m2)
* Known or suspected difficult intubation
* Known or suspected need for rapid sequence induction and intubation
* History of obstructive sleep apnea requiring CPAP
* History of uncontrolled gastroesophageal reflux disease (GERD)
* Opiate use within 24 hours
* History of opiate abuse within 3 years
Pharmaco-proteomic Platform to Evaluate Drug Interactions in Liver Transplant Patients

The goal of this observational study is to enhance the ability to forecast kidney failure in liver transplant patients in the ICU under multidrug treatment by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. The main outcomes it aims to develop are:

1. Design the multidrug web computing platform with available information on drug pair interactions (DDIs).
2. Integrate the proteomic and clinical data of liver transplant patients into the IT platform.
3. Implement the multidrug web platform to predict the clinical evolution of liver transplant patients.

The aim of this project is to enhance the ability to forecast kidney failure for liver transplant patients in the ICU by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. This integrated platform enables the prediction of the development of AKI in patients who have undergone OLT. Through the integration of mathematical models, the platform captures complex interactions between multiple drugs and proteomics data from patients, contributing to an improved predictive capacity for AKI outcomes.

By leveraging proteomic insights, personalized therapeutic interventions can be devised, promoting safer and more effective treatments. This research seeks to empower medical professionals with comprehensive information to navigate the complex landscape of drug interactions and personalized treatment strategies, ultimately contributing to improved patient outcomes and healthcare practices in the realm of liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Liver transplant patients undergoing surgery at UC Christus Hospital

Exclusion Criteria:

* Patients on renal replacement therapy
* Patients for whom no clinical or pharmacological registry is available
(Withdrawal) Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia

Sarcopenia is particularly common in patients with chronic liver disease, especially in patients with decompensated cirrhosis, where the prevalence can be more than 50%. Sarcopenia is an important risk factor for a significant increase in mortality in cirrhotic patients, and is closely associated with a high incidence of complications such as hepatic encephalopathy, ascites, and infections . Recent studies have found that TIPS not only significantly improves clinical symptoms caused by portal hypertension, but may also have a positive effect on skeletal muscle mass and function in patients. Although the effect of TIPS in improving sarcopenia has been preliminarily confirmed, its mechanism is not yet fully understood. Therefore, there is an urgent need to explore the mechanism of action of TIPS to improve sarcopenia and provide guidance for clinical treatment options.

According to whether the sarcopenia improved or not in patients after TIPS, patients were divided into sarcopenia group and non-sarcopenia group, and the relationship between FGF21 levels and sarcopenia improvement in patients after TIPS was analyzed by analyzing the differences between the two groups. During the follow-up of patients after TIPS, blood samples were collected to test serum FGF21 levels and imaging examinations were performed to assess the improvement of sarcopenia; changes in nutritional status, muscle strength and function indicators were analyzed in the process of sarcopenia improvement; changes in serological indicators were analyzed in the process of sarcopenia improvement, with a focus on the serum FGF21 level; the combination of the serum FGF21 level and the muscle strength and function indicators, and evaluate their value in the prognosis of TIPS.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with liver cirrhosis and needing TIPS surgical treatment;
2. Aged between 18-75 years old;
3. Able to understand and sign the informed consent form and willing to cooperate in completing the examinations and follow-up visits.

Exclusion Criteria:

1. Combination of serious cardiovascular and cerebrovascular diseases (such as acute myocardial infarction, severe heart failure, etc.);
2. Suffering from malignant tumors and in the active stage;
3. Recent (within 3 months) history of major surgeries or traumas;
4. The presence of mental illness or cognitive disorders, which are unable to cooperate with the study;
5. Undergoing other special treatments that may affect the results of the study (such as certain specific immune-suppressing agents, hormones, etc.)
Effect of Date Fruit Consumption in Later Pregnancy

EFFECT OF DATE FRUIT CONSUMPTION IN LATER PREGNANCY ON LENGTH OF GESTATION LABOR AND DELIVERY OF NULLIPAROUS WOMEN

This randomized, controlled study was conducted at the Gynecology and Obstetrics department of Pak Emirates Military Hospital for Six months duration from Jan 2021 to June 2021. Ethical consent for the study was taken from the Ethical Committee. All participants have signed the written consent. Healthy primigravida's at more than 37 weeks of gestation with no prenatal complications (low-risk pregnancies) or chronic diseases were invited to contribute in the analysis.

The criteria of exclusion included all primigravida and non-primigravida with prenatal problems. Prenatal complications included placenta praevia, rupture of membranes, multiple pregnancies, diabetes, hypertension and additional health problems, fetal abnormalities, fetal growth restriction or any contraindication to delivery by vagina.

The females who met the eligibility criteria were contacted and provided information related to the analysis. In the preliminary phase of contact with potential volunteers, the study was presented as a participant's usage of dates to expedite delivery. The randomization arrangement was performed by means of sealed envelopes numbered from 1 to 10, equally allocated by randomization to the date-consumers and the group of control. Therefore, they will be allocated to dates consumer or control group recipients.

Eligibility Criteria:
Inclusion Criteria:

* All primigravidas at 37 or more weeks gestation with low risk pregnancies

Exclusion Criteria:

* Any antenatal complications Preterm pregnancies
Study for Wait and Watch Suitable in Rectal Cancer

One of the standard treatment options offered to patients of locally advanced rectal cancer is neoadjuvant (treatment given before surgery) radiotherapy \& chemotherapy followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the wait and watch strategy is also an option. This is another standard treatment option for patients of locally advanced rectal cancers. In this, the patient is monitored after treatment completion. In this study, investigators are only going to observe the patient's response to treatment, monitor their side-effects due to treatment and assess their quality of life using standardized quality of life questionnaires. No additional tests or hospital visits will be required as a part of this study. The patient will be followed up, as per standard follow-up protocol, for at least 2 years after the completion of their treatment.

The standard treatment options offered to patients of locally advanced rectal cancer are neoadjuvant (treatment given before surgery), radiotherapy \& chemotherapy, followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the watch and wait or non-operative management is an option. In this, the patient is monitored after treatment completion. In this study, investigators will only observe the patient's response to treatment, monitor their side effects due to treatment, and assess their quality of life using standardized quality-of-life questionnaires. The patient will be followed up, as per standard follow-up protocol, for at least two years after the completion of their treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years.
* Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines \[3,1\]
* Biopsy-proven adenocarcinoma (non-signet or non-mucinous) T1-4a or N0-2, plus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ)
* Non-circumferential disease with CCL less than 7 cm
* Lower - mid rectum starting upto 7 cm from Anal verge
* Previously treated with the intent of wait-and-watch with TNT or LCRT with or without brachytherapy and completed TNT part of treatment till March 2024(for retrospective cohort).
* Patients not consenting to ongoing interventional studies, such as the SCOTCH study or any future studies, will be considered and offered
* Consent to be on standard regular follow-up and answer quality of life questionnaires
* Patients on lost to follow up will be included if they have completed treatment and taking follow up locally, accepting telephonically to participate.

Exclusion Criteria:

* Not eligible as per the above inclusion criteria
Budget Impact of Harmonic FOCUS in Thyroidectomy

Study Design Multinodular Goiter (MNG) patients requiring surgery were referred to the Endocrine Surgery Unit.

Indirect laryngoscopy was routinely performed preoperatively to assess normal motility in vocal folds (VF). Ultrasounds (US) study was performed the month previous to surgery to evaluate thyroid volume. Eligible patients met the following criteria: to have MNG, age between 18 and 80 and consent to be included in the study. Exclusion criteria included previous neck surgery, vocal fold impairment, permanent or transitory NSAID or analgesic treatment, coagulation disorders and any cognitive impairment.

Eligible patients were proposed to enter a randomized study with 2 arms in which we compared the use of two harmonic scalpel devices: ACE14S and Harmonic Focus (Ethicon Endo-Surgery, Cincinnati, OH, USA).

The main endpoint was operative time. Secondary endpoints were total and relative (%) time of use of the device along thyroidectomy, recurrent laryngeal nerve (RLN) injury and hypocalcaemia (both persistent or temporary), number of ligatures, length of skin incision, postoperative pain according to a visual scale of pain, QOL after thyroidectomy (EuroQOL) and budget impact analysis.

All patients were operated on by 2 surgeons, one senior (responsible for the Endocrine Surgery Unit) and one junior under supervision.

Randomization Randomization was performed the same day of surgery at the OR by using a closed envelope. Patients were randomized to Group I (ACE14S) or Group II (HF) and allocated in a 1:1 proportion; they reminded blinded until the end of the study about the device used.

The haemostasis device was communicated to the surgeon previous to start surgery. Medical staff of the Endocrine Surgery Unit collected clinical data.

Surgical Technique Total thyroidectomy (TT), defined as total bilateral extracapsular lobectomy 9, was performed using HF or ACE14S for vessel division. Monopolar and bipolar forceps for cutting and coagulation were routinely used. Ties were used under surgeon's criteria according to size of the vessels and/or the need to obtain haemostasis in the vicinity of the RLN when bipolar forceps were not considered safe enough.

OBJECTIVE:

To disclose the potential advantages and outcomes of the new Harmonic Focus (HF) device compared to Harmonic Scalpel ACE14S (ACE-14S) in benign thyroid surgery.

STUDY DESIGN:

Controlled randomized study.

METHODS:

Harmonic Focus was compared to former ACE14S device in patients undergoing total thyroidectomy for Multinodular Goiter. The primary endpoint was time of surgery. Secondary endpoints were time of use of the device, % of use along the procedure, number of ligatures, blood loss, hypocalcaemia, recurrent laryngeal nerve impairment, postoperative pain and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Multinodular goiter (MNG), age between 18 and 80 and consent to be included in the study

Exclusion Criteria:

* previous neck surgery
* vocal fold impairment
* permanent or transitory NSAID or analgesic treatment,
* coagulation disorders
* any cognitive impairment.
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.

This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-70 years of age;
* chronic hepatitis B;
* Hepatitis B Virus (HBV) DNA \>100,000 copies/mL.

Exclusion Criteria:

* previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months;
* evidence of decompensated liver disease;
* history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis;
* coinfection with hepatitis A, C or D, or HIV.
The Study Guide Cluster Randomized Control Trial

Spaced education is a promising theory-driven strategy to improve clinical competence. Our aim is to improve the clinical competence of Family Physicians, an outcome associated with the quality of care delivered to Canadians.

Research Question: Among family medicine residents, does enhanced feedback through an app providing alerts and test questions (spaced education), compared to the same app without alerts and enhanced feedback (no spaced education), improve competence as measured by the certification examination? In building this proposal for a definitive trial, the investigators have support from coast to coast. In addition to key clinician educators, the team includes knowledge users from the organization responsible for the certification examination in Family Medicine, methodologists and experienced researchers who study how mobile apps can promote engagement with clinical information. The team has the right blend of expertise in medical education and cluster randomized trials.

Approach and Methods: The investigators will follow an organizational participatory research approach, and propose a cluster randomized controlled trial. Setting: All incoming family medicine residents in Canada will be eligible to participate. Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education). Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education). The primary outcome will be scores on the certification examination. This routinely collected data will be provided to the team by the College of Family Physicians of Canada.

Expected Results and Conclusion: Spaced education will improve examination scores. This will inform educational practice by providing evidence to optimize the training of residents.

Eligibility Criteria:
Inclusion Criteria:

* incoming family medicine residents in Canada (July 2017)

Exclusion Criteria:

* not a family medicine resident
* did not start residency on July 1, 2017
SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California

The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months.

A number of epidemiological studies, systematic reviews, and consensus reports highlight the importance of non-pharmacological, sociobehavioural interventions to address the health, psychological, and social effects of caregiving for persons living with dementia, and the need for tangible information and resources.

The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months. It is hypothesized that no differences (comparable effects) between the programs in their efficacy/effectiveness and moderating conditions.

Focus groups (\~25 participants) will be conducted to ascertain program acceptability and satisfaction.

The analyses will include a multiple linear mixed-effects modeling for our trial outcomes, and thematic analyses for our focus group interview data.

Eligibility Criteria:
Inclusion Criteria:

* English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia

Exclusion Criteria:

* Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity