cyrilzakka/clinical-trials huggingface dataset:
A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease

Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) presenting for coronary artery bypass grafting (CABG) represent a high-risk group among the cardiac surgical population. Anesthetic management of these patients is challenging due to increased risk of perioperative hypotension and subsequently increased risk of postoperative morbidity and mortality. Post induction hypotension is a modifiable risk that can be largely prevented by adjusting the technique for anesthesia induction. There is no consensus on the use of certain anesthetic induction techniques for patients CAD and left ventricular dysfunction. Anesthesia induction techniques for cardiovascular surgery are usually based on considerations such as hemodynamic stability, effects on myocardial oxygen supply, and demand and minimizing intubation stress response.To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with ketamine in patients with poor ventricular function.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction \< 40%), ASA physical status II-IV that will be scheduled for elective CABG surgery.

Exclusion Criteria:

* Patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (IABP), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study
Impact of Human Embryo Culture System on Live Birth

Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Besides, previous studies with embryos from human and other mammals have shown that a high oxygen concentration may have a negative effect on embryo quality due to the generation of reactive oxygen species, which cause oxidative stress. The embryo culture at low oxygen tension is correlated to better success rates in IVF/ICSI treatments.

The purpose of this study is to evaluate the combined effect of the embryo group culture and the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments. The specific goal is to compare the embryo group culture in a reduced volume of medium at a low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®), whereas the second condition will be applied using a Heracell incubator (Heraeus®).


Eligibility Criteria:
Inclusion Criteria:

* \<38 years (with own oocytes) / \<45 years (with oocyte donation).
* First treatment with own oocytes / any treatment with oocyte donation.
* ≥10 oocytes with a diameter of ≥10 mm.

Exclusion Criteria:

* Diseases that affect endometrial receptivity: endometriosis, hydrosalpinx, ovarian hyperstimulation syndrome, obesity, endocrinopathies, thrombophilia, congenital or acquired uterine anomalies.
* Patients under a treatment with genetic preimplantation diagnosis.
Potential Role of Microbiome in Tuberculosis

Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is a deadly infectious disease and major global public health problem. Recent evidence from animal studies suggests that the microbiome plays a role in TB pathogenesis and immune response. However, until now, no similar study has been performed in humans and thus any influence of the microbiota on TB or vice versa remains unknown.

Tuberculosis is among one of the most difficult to treat infections that require multidrug therapy for prolonged periods, in most cases 6-9 months. Treatment failure is still common and frequently observed (even where adherence to antibiotic therapy is maintained) in 15% of drug-susceptible infections and 31% for drug-resistant cases. Although poor patient compliance and the emergence of drug-resistant Mtb strains are generally implicated as a major cause of TB treatment failure, other factors such as the role of the microbiome in TB pathogenesis and reactivation are poorly considered.

The human microbiome is a consortium/collection of all microorganisms (bacteria, archaea, viruses, and fungi) colonizing different habitats in the human body such as skin, gut, and mucosal surfaces and living in a commensal relationship with each other. Emerging evidence suggests a crucial role of the microbiome in hosts physiology, nutritional status, and development of the functional immune system. Microbial dysbiosis is the change in microbial composition or functional potential that has been implicated both in infectious diseases status as well as the development of non-communicable disease in hosts ranging from immune mediated diseases to intergenerational obesity and even cancers. Microbial dysbiosis at different body sites has also been reported in TB-associated comorbidities such as diabetes mellitus and malnutrition. However, to date, the role of the microbiome and microbial dysbiosis is not clear in the context of TB infections in humans.

Therefore, this study aims to dissect the relationship between the microbiomes and its interaction with the immune system during TB infection, and anti-tuberculosis therapy in humans.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with TB after detailed history collection, clinical examination and laboratory assessment (sputum culture positive).
2. Aged 18 - 65 years.
3. Willing to participate in the study.
4. Healthy controls are those who are free of TB symptoms, healthy on physical examination and with a negative sputum culture result.

Exclusion Criteria:

1. Already on anti-TB treatment or previously treated for TB.
2. Severely anemic (Hb \< 10g/dL).
3. Having diarrhea or other major gastrointestinal disorders.
4. Using or have used aminoglycoside or quinolones antibiotics in the past one month.
5. Using a medically prescribed diet or nutrition supplement.
6. Pregnant or lactating women.
7. Patients with liver or renal dysfunction, or having any other chronic disease condition.
8. Multidrug resistance TB patients
A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.

This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are treated with a stable dose of metformin. Patients will be randomized to receive either subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or 20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen throughout the study. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, with stable metformin treatment for \>=3 months;
* stable weight +/-10% for \>=3 months before screening.

Exclusion Criteria:

* type 1 diabetes mellitus;
* treatment with any anti-hyperglycemic medication other than metformin monotherapy during last 3 months;
* use of weight-lowering medications in the last 3 months;
* uncontrolled hypertension.
Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories.

Multi-center, prospective, open label, single arm post-market study to assess the real-world safety and efficacy of BD NRFit™ Spinal Needles, BD NRFit™ Spinal Introducer Needles, and BD NRFit™ Syringes used in an on-market fashion.

This is a multi-center, prospective, open label, single arm post-market study that will enroll approximately 180 participants in order to have a minimum of 150 treated participants who will receive a spinal anesthesia procedure as part of their routine medical care. Participants will be followed from the time of enrollment for up to 10 days (± 3 days) post spinal anesthesia procedure for evidence of adverse events including Post Dural Puncture Headache (PDPH). This can be done via phone if the participant is discharged from the hospital. The site staff must take advantage of the time window of ± 3 days only when the 10-day post-procedure occurs during the weekends or holidays. Any adverse event or complication must be diagnosed and confirmed by a study physician.

A minimum of 50 participants for each of the two needle tip types (Quincke and Whitacre tip) will be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD NRFit™ Spinal Needles, NRFit™ Spinal Introducer Needles, and NRFit™ Syringes as part of their routine medical care.
2. Expected to be available for observation through the study period (10 days, ± 3 days, post procedure\*).
3. Able and willing to provide signed and dated informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant (Note: Consent of guardian or parent may be required for participants under the age of 18 years; participant assent may be required as well).

Exclusion Criteria:

1. Coagulopathy or bleeding disorder, where it is in the opinion of the investigator makes regional anesthetic of increased risk.
2. Subjects with a history of neurological impairment of the trunk or lower extremities.
3. Infection at the site of needle insertion.
4. Previous spine surgery at the level involved in the study procedure.
Treatment of Social Phobia

Social phobia is a very common and debilitating disorder, with public speaking anxiety being the most common fear. Psychologists have found that treating patients for their fear of public speaking, through cognitive-behavioral treatment (talk-based therapy) or exposure treatment (where participants participate in actual public speaking sessions), not only helps patients overcome this fear but also helps them overcome their more general social fears. However, little is known about how this change occurs during therapy. This study tries to identify the factors that contribute most to successful therapy.

Patients are assigned randomly (like tossing a coin) to 1 of 3 groups. Group 1 will receive cognitive-behavioral treatment and Group 2 will receive exposure treatment. Group 3 will not receive treatment. Study leaders will monitor patient response to treatment through behavioral tests and assessments.

An individual may be eligible for this study if he/she:

Has social phobia with public speaking anxiety.

The primary goal of the present study is to identify the mediators and moderators of change in the treatment of social phobia and, in so doing suggest a common mechanism of action for all brief psychosocial interventions. Perceived self-efficacy of social behavior, negative cognitive appraisal (estimated social costs), and perceived emotional control will be considered as potential mediators; avoidant personality disorder and the generalized subtype of social phobia will be considered as potential predictors for poor treatment outcome.

Social phobia is a very prevalent and debilitating disorder, with public speaking anxiety being the most common fear among socially phobic individuals. Although there are a number of effective psychosocial treatments for social phobia (e.g., cognitive-behavioral treatments and exposure therapy) very little is known about the underlying mechanism of therapeutic change (i.e., the mediators of change), and the variables that are predictive of treatment outcome (i.e., the moderators of change). Furthermore, it is unclear why treating individuals for their public speaking anxiety can generalize to other untreated social fears.

Patients are randomly assigned to either a comprehensive cognitive-behavioral treatment for social phobia (n=43), a performance-based exposure treatment for public speaking anxiety without cognitive intervention (n=43), or a waitlist control group (n=43). Clinician ratings, behavioral tests, cognitive assessments, subjective ratings, and physiological measures are employed to determine the degree of therapeutic gains in various social phobia domains. The main hypothesis is that perceived emotional control will mediate treatment outcome and generality of effectiveness independent of the specific treatment condition.

Eligibility Criteria:
Inclusion Criteria:

-

Patients must have:

Social phobia with public speaking anxiety.
Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement

evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically.

twenty-one participants were enrolled of which 13 patients (8 females and 5 males) were suffering from maxillary ridge atrophy and 8 patients (5 females and 3 males) had mandibular ridge atrophy; a total of 42 implants were performed using the ridge expansion technique. The expansion was performed using the conventional disk technique, piezoelectric corticotomy, and self-threading expanders. Implants were placed and loaded with fixed partial denture after 4 months for the mandible and 6 months for the maxilla. Implant stability quotient (ISQ) was measured at T0 (implant placement) and TL (loading). Crestal bone levels were measured at different times: T0, TL, and T12 (12 months). Evaluation of prosthetic and surgical complications was carried out. Data were analyzed and compared using analysis of variance and paired t-tests at a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* ridge of 2 to 4 mm of initial alveolar crest width
* bone height of at least 8 mm from vitastructures

good oral hygiene.

Exclusion Criteria:

patients who smoke more than 10 cigarettes per day diabetes mellitus, osteoporosis, and periodontal disease.
Tooth Development in Molar Incisor Hypomineralisation

Molar incisor hypomineralization has been defined as a qualitative developmental enamel defect affecting one or more permanent first molars, often including the permanent incisors. The development of the teeth with the developmental defect remains unclear.

The aim of this study is to evaluate tooth development in children with MIH using the Cameriere and Haavikko methods on panoramic radiographs and to determine the accuracy of these methods. The first null hypothesis of this study was that there would be no difference in tooth development between children with MIH and children with healthy structure of teeth, and the second null hypothesis was that Cameriere and Haavikko methods could estimate dental age with the equal accuracy.

This study was planned to evaluate tooth development in a cohort of 8- to 12-year-old children diagnosed with MIH who applied to the Department of Pedodontics, Faculty of Dentistry, Tokat Gaziosmanpaşa University, for dental examinations or treatment between June 1, 2023, and June 1, 2024.

The study group (Group 1) was determined according to gender and chronological age group from children who were diagnosed with MIH as a result of dental examination and met the inclusion criteria. The control group (Group 2) was selected from children matched to MIH cases according to gender and chronological age, without signs of hypomineralisation and met the inclusion criteria.

The chronological age of the children was calculated using Microsoft Excel 2013 (Microsoft, Redmond, WA, USA). The following formula was applied:

"\[(date of panoramic radiography) - (documented date of birth)\] / 365.25" Tooth development was determined on panoramic radiographs taken with a single device (J. Morita Mfg. Corp., Kyoto, Japan) using the Cameriere and Haavikko methods.

The data were analyzed using the IBM Statistical Package for the Social Sciences (SPSS for Windows, version 26.0, SPSS Inc., Chicago, IL, USA). Data from the two dental age estimation methods were analyzed for each gender and age group within Group 1 and Group 2. The Kolmogorov-Smirnov test was applied to assess normality. The Spearman correlation coefficient was employed to examine the relationship between chronological and dental age, and the Paired Samples T-test and Wilcoxon Signed-rank Test were used to compare the difference. The Independent Samples T-test and Mann-Whitney U test were utilized to compare chronological and dental age based on MIH presence. Intraclass Correlation Coefficient (ICC) was calculated to assess inter- and intra-observer reliability. Quantitative data are presented as mean ± standard deviation and median (minimum-maximum), while categorical data are presented as frequency (percentage). Statistical significance was set at the 0.05 level.

Eligibility Criteria:
Inclusion Criteria:

must have parental consent must have high-quality panoramic radiographs

Exclusion Criteria:

systemic disease tooth agenesis hyperdontia
Monitoring Subjects With Fluid-Management Issues In the Home Environment

This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.

The study has the following objectives:

Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational

Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation

Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.
* Subject will have a current prescription for a diuretic medication.
* Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
* Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria:

* Subject is participating in another clinical study that may affect the results of either study.
* Subject is unable or not willing to wear electrode patches as required.
* Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
* Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
* Subject is considered by the PI to be medically unsuitable for study participation.
Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot

Pediatric flexible flatfoot is sometimes asymptomatic but it can also cause physical impairment, pain, and difficulty walking. We evaluate the radiographic effectiveness of intervention of subtalar arthroereisis with endorthesis for pediatric flexible flatfoot with final follow-up at skeletal maturity.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* age ≥ 14 years at the time of the visit
* patients who underwent subtalar endothesis for the treatment of the pediatric flexible flatfoot from January 2011 to March 2015.

Exclusion Criteria:

* age \<14 years at the time of the visit
* patients with comorbidities that make it difficult to return to the hospital for consultation or who have removed the device for discomfort
* female patients who do not exclude (by self-declaration, as clinical practice) a state of pregnancy
Gathering Records to Evaluate Antiretroviral Treatment-South Africa

To achieve global goals for the treatment of HIV, most high-prevalence countries are experimenting with and scaling up differentiated service delivery models (DSD). A handful of efforts have been formally described and evaluated in the literature; many others are being implemented formally or informally under routine care, without a research or evaluation goal. For most countries, however, we have little evidence on the big picture-the proportion of clinics offering alternative models, eligibility criteria and the proportion of patients considered eligible, the number of patients actually participating, health outcomes such as viral suppression, empirical resource utilization compared to traditional care, variations among the models, duration of patient participation, fidelity to model guidelines, effects on clinic efficiency, and sustainability without external donor support.

AMBIT a set of data synthesis, data collection, and data analysis activities aimed at generating information for near- and long-term decision making and creating an approach and platform for ongoing evaluation of differentiated models of HIV treatment delivery in the future. The project will collect and analyze a wide range of existing data sets pertinent to DSD. This protocol is for an analysis of existing medical record data collected by the Department of Health, implementing partners, and other completed, ongoing, or new evaluations, trials, and observational studies. Outcomes to be reported include coverage/uptake of DSD, patients' outcomes, and distribution of each model. There will be no study interaction with individual patients, providers, caregivers, or others for this analysis.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 15 years old
* Patients accessing care for HIV within the data collection period
* In any HIV transmission risk group

Exclusion Criteria:

* None
Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population

The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?

Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis.

The Investigators will enroll all the consecutive pediatric patients (\< 16 years old) treated with rivaroxaban (dosage based on patient's body weight - 0.9 mg/Kg/Day) due to intracardiac thrombosis (ICT) suspected by echocardiography and confirmed with cardiac computed tomography (CCT) or magnetic resonance (CMR) imaging. All the participants will be treated with enoxaparin for 7 days before the rivaroxaban implementation. The treatment will last for 3 months.

The participants will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. Bleeding severity will be assessed utilizing the Bleeding Assessment Scale in Critically Ill Children (BASIC). CCT/CMR will be repeated to confirm the thrombosis resolution. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the effective resolution of the thrombosis, or it will be continued for another 3 months if there is no resolution of the thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Intracardiac thrombosis demonstration at echocardiography and CMR/CCT confirmation
* Given informed consent from the parents or tutors

Exclusion Criteria:

* \< 38 weeks of gestational birth
* \< 10 days of oral feeding and body weight
* \< 2.6 Kg
* Any major or clinically relevant bleeding event or abnormal coagulation test results within 10 days prior to the enrollment for the whole population