cyrilzakka/clinical-trials huggingface dataset:
Comparative Outcomes of Conventional TLIF With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery

Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study

This is an Ambi-directional Cohort Study that studied postoperative outcomes in the population who has back pain and radiculopathy from stable lumbar foraminal stenosis and divided into two groups, one group under conventional Transforaminal Lumbar Interbody Fusion with Posterior Decompression Surgery and the other group under endoscopic foraminotomy surgery. This study was done at Queen Savang Vadhana Memorial Hospital from August 2024 to June 2025. The participants were divided into two groups as mentioned under frequency matching to minimize bias, each group had 26 cases, total number of participants was 52 cases. The control group went under conventional Transforaminal Lumbar Interbody Fusion with Posterior Decompression Surgery and the other group went under endoscopic foraminotomy surgery.

This study hypothesizes that functional outcome postoperatively in patients with stable lumbar foraminal stenosis who underwent endoscopic foraminotomy surgery is non-inferior to that in patients with stable lumbar foraminal stenosis who underwent conventional Transforaminal Lumbar Interbody Fusion with Posterior Decompression Surgery.

The power in this study is 0.8 and the p-value is \<0.05

Eligibility Criteria:
Inclusion Criteria:

* Age 30-80
* Persist radiculopathy and sciatica pain
* Patient that was diagnosed Stable lumbar foraminal stenosis
* Failed conservative for at least 6 months
* Patients who willing to join the study

Exclusion Criteria:

* Patients with unstable lumbar foraminal stenosis
* Patient with spine infection or tumor or fracture
* Patient with BMD less than -2.5 or osteopenia
* Patient with inflammatory joint diseases who on steroids
* Patient who has undergo with surgery that inserted metals in back
* Unable to answer questionnaires
* Cannot tolerate surgery due to severe medical comorbidities
The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation

Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.

To measure total fat mass by DEXA scan, central (visceral) fat accumulation, insulin sensitivity by FSIVGTT, lipid levels, and adipocyte gene expression in subjects with AI receiving increasing doses of hydrocortisone replacement (15 mg, 25 mg, and 40 mg per day in split doses) for 4-months at a time during ad-lib feeding.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with complete adrenal failure as defined as spontaneous serum cortisol of levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak serum cortisol of \< 5 g/dl 60 minutes after a 250 g ACTH stimulation test.
* Subjects who are at their usual weight (weight stable for at least 1 year)
* Subjects on stable replacement doses of any required hormone such as thyroid, sex hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at least 6 months, and 4) have a normal body weight (BMI 19-27 kg/m2).

Exclusion Criteria:

* Possible confounders on body weight and insulin resistance
* Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth.
* Subjects who exercise \> 30 minutes/day, 3 times a week.
* Smokers.
* Heavy alcohol drinkers (\> 2 drinks/ day).
* Subjects with medical diagnosis including diabetes, heart disease, and cancer.
* Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders).
Feedback Reports and e-Learning in Primary Care Spirometry

Spirometry is a biomedical test to measure lung function in subject who (may) have a chronic respiratory condition. Performing the test requires a certain level of training and experience from the health care professional who conducts the test, and sufficient cooperation of the patient. Although the test is widely used in primary care in many countries, the quality of the test performance seems limited and needs improvement in order to avoid false-positive and false-negative test interpretations. In this study, the researchers investigated whether a combination of e-learning and bimonthly written performance feedback to family practice nurses and assistance regarding their spirometry tests improves the rate of adequate tests.


Eligibility Criteria:
Inclusion Criteria for Family Practices:

* collaboration with Elkerliek Hospital Helmond through regional integrated care support service ('QUARTZ')
* purchased spirometer through this support service
* have implemented spirometry as a part of routine patient care

Inclusion Criteria for Patients:

* registered in one of the participating family practices
* performed a spirometry test as a part of routine care during the observation period of the study

Exclusion Criteria for Patients:

* age \< 10 years
Mechanical Ventilation With Neurally-Adjusted Ventilatory Assist in Patients With ARDS

Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical activity of the diaphragm to control the mechanical ventilator, offering inspiratory assistance in proportion to respiratory effort to patients who need artificial ventilatory support. It has been shown to improve the interaction between the patient and the mechanical ventilator in several clinical situations, but no previous studies have tried to use it for patients with a severe type of respiratory insufficiency, called Acute Respiratory Distress Syndrome (ARDS). Patients with ARDS benefit from a mechanical ventilatory strategy that includes low inspiratory volumes (tidal volumes) and limited airway pressures, but the application of such strategy frequently requires high levels of sedation. The investigators' hypothesis is that NAVA can be used for patients with ARDS, and that it will not be associated with excessive tidal volumes or elevated airway pressures.

Neurally Adjusted ventilatory-Assist(NAVA) is an assisted ventilatory mode that captures the electrical activity of the diaphragm and uses it to initiate and terminate the inspiratory phase, offering inspiratory assistance in proportion to patient effort, cycle by cycle. Studies in animals and humans have shown that NAVA reduces the work of breathing and improves patient-ventilator interaction in comparison with traditional modes. Because it is an assisted mode, its use requires less sedation.

The use of NAVA could contribute to the reduction of complications of prolonged mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) submitted to protective ventilation with low tidal volumes and limited plateau pressure. However, there are no studies with NAVA in the acute phase of ARDS, in which assisted-controlled modes are generally used, allowing for adjustment of tidal volume and/or plateau pressure.

With this project, the investigators intend to evaluate the behavior of NAVA mode in the acute phase of mechanical ventilation in ARDS patients, to assess whether this mode can be used to deliver an assisted lung protective ventilation strategy.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation for more than 24 hours;
* Diagnosis of ARDS
* Clinical indication of lung protective mechanical ventilation by the ICU team;
* Presence of active inspiratory efforts for more than 6 hours

Exclusion Criteria:

* Patients under 18 years;
* Pregnant women;
* Trauma or burns of the face that hinder the passage of gastro-esophageal catheter;
* Nasal pathologies that prevent the progression of gastro-esophageal catheter;
* Ulcers of the esophagus or stomach;
* Documented esophageal varices;
* Tracheostomized patients;
* Instability of the chest wall or diaphragmatic injury;
* Hemodynamic instability, defined as the need to increase vasoactive drugs in the last two hours in order to maintain the mean arterial pressure above 60 mmHg).
Bilateral Essential Tremor Treatment With Gamma Knife

Combined Phase II/III, multi-center, prospective, single-blinded trial.

Ten (10) patients with essential tremor who previously underwent successful and uncomplicated GK thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed at baseline, as well as 3, 6, 12, 24 and 36 months post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 years
* The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder neurologist;
* The patient previously underwent a GK thalamotomy (\> 12 months ago);
* The tremor on the untreated side negatively impacts the patients' quality of life;
* The patient wants treatment of the contralateral side.

Exclusion Criteria:

* Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use);
* Clinically relevant speech impairment (e.g. impairment of intelligibility);
* Inability to comply with the follow-up schedule;
* Refusal of the treating physician.
Targeted Feedback Reports to Improve Acute Coronary Syndromes (ACS) Care

This project is designed to examine the impact of tailored feedback on site performance.

The investigators' objective is to evaluate whether a 'personalized and targeted' feedback, education and performance improvement intervention has a greater impact on adherence to recommended guidelines than standard feedback.

The investigators hypothesize that a site-specific report with centrally identified targets for improvement paired with target specific interventions will enable sites to quickly identify and prioritize salient problem areas, have ready access to an analysis of factors that underlie problems, and formulate an effective action plan. The investigators also hypothesize that those hospitals randomized to receive intervention will be more likely to improve their overall performance, as well as their target specific performance, during the period of observation in direct response to activated QI processes.

Outcomes:

The primary outcome is improvement in the overall composite of all metrics eligible for intervention regardless of their selection as targets.

The secondary outcome is improvement in the composite of targeted metrics.

Outcomes will be assessed in all participating sites, and in among relevant performance subgroups (low performers, academic centers, full service, and among medication versus process metrics).


Eligibility Criteria:
Inclusion Criteria:

* hospitals participating in the ACTION Registry GWTG

Exclusion Criteria:

* sites with low volume of data submission (\< 10 data forms in the past year)
Examining the Impacts of Parent Mightier Play

A randomized controlled trial comparing a group in which only child participants play Mightier video games for 8 weeks (Child Play group) to a group in which child and parent participants play Mightier video games for 8 weeks (Child and Parent Play group).

Mightier is a mobile app-based biofeedback video game platform that facilitates emotion regulation skill-building among children ages 6-14. The technology behind Mightier's mobile app has been validated in two independent sham-controlled randomized controlled trials, where the investigators have seen decreases in clinical symptoms of aggression and disruptive behaviors, as well as lowered family stress without adverse events.

The study utilizes a parallel randomized controlled design comparing groups of participant families whose children play Mightier video games without parent play to groups of participant families in which both children and parents play Mightier video games. Self-report measures will be completed by participant children and parents.

The study consists of three primary phases: Pre-Study, Active Engagement, and Follow-Up. During the Pre-Study Phase, participants will undergo pre-screening and screening to evaluate interest and eligibility for the study, and participants who consent to participate in the study will complete baseline measures and be randomized into treatment groups. Mightier games will be shipped to participants during or shortly after their Pre-Study call. Participants will be instructed to begin Mightier gameplay as soon as Mightier games arrive at their homes, which will begin the Active Engagement Phase of the study.

During the 8-week Active Engagement Phase, participants will be encouraged to play Mightier games in a way that corresponds to their study condition, and they will be offered engagement support in the form of brief weekly check-ins.

After completion of the Active phase, participants will have a brief Follow-up phase, consisting of one video call during which child and parent participants will complete self-report follow-up measures.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 at the time of screening
* Regular access to WiFi (for Mightier gameplay device connection)

Exclusion Criteria:

* Prior Mightier use
* Diagnosed Intellectual Disability (by history)
* Planned medication changes during the 8-week study period
Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L in Children

The aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars.

To our knowledge, no clinical trials in literature have been done to compare anesthetic efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly decayed upper first primary molars. Thus, the purpose of the present study was to fill this knowledge gap.

This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine anesthetic solution where no clinical trials have been conducted on it yet in literature.

Eligibility Criteria:
Inclusion Criteria:

* Medically fit (ASA I, II).
* Mentally capable of communication.
* Children aged 5-7 years, children older than 8 years old will not be included due to physiologic root resorption associated with shedding which may simplify the extraction procedure(25).
* First maxillary primary molar needs extraction due to root caries "beyond possible repair".
* First dental visit.
* Child must give assent prior to participation, as well as approved parental informed written consent.

Exclusion Criteria:

* Children with acute or sub-acute dento-alveolar abscess Children with history of prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.
* Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
Efficacy of Different Anti-Thrombotic Strategies on Device-Related Thrombosis Prevention After Percutaneous Left Atrial Appendage Occlusion

Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.

Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age
* Successful LAAC procedure (device implanted without procedural or bleeding complication).
* Patients contraindicated or unsuitable for long-term OAC.
* History of AF (permanent or persistent or paroxysmal).
* Written informed consent by the patient or designee if the patient is unable to consent

Exclusion Criteria:

* Life expectancy \< 2 years.
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)

A Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects with Acute Myeloid Leukemia- The BATTLE Study

The main goal of this clinical trial is to assess the safety and tolerability of the treatment combination of BL-8040 and Atezolizumab as Maintenance Treatment in Subjects with Acute Myeloid Leukemia.

Additional objectives are:

Assessment of the effect of combination of BL-8040 and Atezolizumab on relapse free survival (RFS) Assessment whether the treatment combination of BL-8040 and Atezolizumab can reduce the Minimal Residual Disease (MRD) as compared to baseline Assessment of the Overall Survival (OS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance Assessment of the Event Free Survival (EFS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance

This study will assess the safety and effectiveness of a combination of BL-8040 and atezolizumab to find out what is the Safety, Tolerability and Efficacy of this treatment combination for maintenance treatment in subjects with acute myeloid leukemia.

This is a single arm, open label, Phase Ib/II study in which eligible subjects will receive maintenance treatment consisting of intravenous (IV) infusion of Atezolizumab on Day 2 of each 21-day cycle and subcutaneous (SC) injections of BL-8040 on Days 1, 2 and 3 of each 21-day cycle. Cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first.

Approximately 60 patients will take part at multiple centers worldwide.

The duration of the treatment period of the study will be up to 2 years and will be followed by one year safety follow up. The study will consist of:

* a screening period of 21 days to allow your doctor to assess your suitability for enrollment into the study
* a treatment period of combination regimen of 21 day cycles for up to 2 years
* a follow-up period of up to 30 days after completion of combined treatment with BL-8040 + Atezolizumab
* an additional follow up period for up to one year after the completion of the treatment

Eligibility Criteria:
Inclusion Criteria:

AML confirmed subjects aged ≥ 60 years who have achieved complete remission (CR or CRi) after induction/consolidation Ara-C based therapy, that have MRD positive status and are not planned for stem cell transplantation.

Exclusion Criteria:

Subjects diagnosed with acute promyelocytic leukemia or with extramedullary AML or subjects who have achieved CR or CRi following treatment for AML. Subjects who have received treatment with hypomethylating agents.
Endophenotype for Alcohol Misuse in Healthy Minority Populations

The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.

We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.

Eligibility Criteria:
Inclusion Criteria:

* Male or female and 21 years of age or older
* Drinks less than an average of 21 drinks/week with no more than 2 binge episodes per week
* Of African descent by self report

Exclusion Criteria:

* Meets DSM-IV criteria for lifetime dependence on any substance other than nicotine
* Subjects who test positive on the urine drug screen for opioids, cocaine, marijuana, or amphetamine at the screening visit
* Subjects who meet current or lifetime DSM-IV criteria for bipolar affective disorder, schizophrenia, or any psychotic disorder
* The presence of unstable or serious medical illness; including history of stroke, seizure disorder, severe liver disease (AST or ALT \> 5X normal at the time of randomization), or unstable cardiac disease
* Needs treatment with any psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication)
* Pre-menopausal female subjects who are pregnant, nursing, or not using a reliable method of contraception
* Insulin-dependent diabetes
* Any medical or psychological condition that could jeopardize the subject's safe participation in the trial as determined by the PI.