cyrilzakka/clinical-trials huggingface dataset:
Extracapsular Supradiscal Subperiosteal Surgical Procedure for Temporomandibular Joint Internal Derangement Correction: Novel Technique

This study aims to evaluate the efficacy of the ESS technique in correcting TMJ internal derangement, with a focus on functional outcomes and patient satisfaction.

Background: Internal derangement (ID) of the temporomandibular joint (TMJ) is a prevalent condition characterized by disc displacement, leading to pain, restricted mandibular mobility, and reduced quality of life. While non-surgical treatments are often the first line of management, surgical intervention becomes necessary in refractory cases. Traditional surgical methods, such as arthrocentesis and disc repositioning, have shown variable success rates, particularly in advanced stages of disc damage. This study introduces the Extracapsular Supradiscal Subperiosteal (ESS) surgical procedure, a novel technique designed to address these limitations. Therefore, current study aims to evaluate the efficacy of the ESS technique in correcting TMJ internal derangement, with a focus on functional outcomes and patient satisfaction.

Patients and Methods: A prospective study was conducted on 50 patients (47 females, 3 males; age range: 11-50 years) with TMJ ID refractory to non-surgical management. The ESS procedure was performed to reposition the displaced disc and stabilize retrodiscal tissues without violating the joint capsule. Preoperative and postoperative assessments included pain levels, maximum mouth opening (MMO), and subjective patient feedback.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stage 3 or stage 4 internal derangements of TMJ radiological and clinical findings should coincide to set up the diagnosis and predict the treatment plan.

Exclusion Criteria:

* Age less than 11 years old
* Age more than 50 years are excluded
Shear Wave Elastography Technology to Evaluate the Efficacy of ESW in the Treatment of Patients With Chronic Plantar Fasciitis

Inflammation of the plantar fascia is called plantar fasciitis and is common in active or overweight individuals. It can be treated conservatively or surgically. Extracorporeal shock wave therapy has shown significant efficacy in the treatment of plantar fasciitis. Repeated chronic inflammation of the plantar fascia may lead to fibrous edema, thickening and even calcification in the fascia, resulting in thickening of the plantar fascia in patients with chronic plantar fasciitis and affecting the mechanical properties of the plantar fascia (changes in elastic modulus) ). Previous studies rarely involved changes in the elasticity of the plantar fascia before and after extracorporeal shock wave treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Pain at the proximal calcaneal stop of the plantar fascia
2. The pain is severe when waking up in the morning or standing and walking after sitting for a long time, and it is slightly relieved after activities, and it will be aggravated after long walking or standing for a long time
3. Pain time\> 3 months
4. Visual Scoring Scale (VAS)\>4
5. The pain is tingling, sore, or burning, etc
6. There is or no tender point at the bottom of the arch of the foot
7. The patient has not undergone corticosteroid injection therapy or shock wave therapy or surgery
8. X-ray confirmed no calcaneal spurs
9. The patient agrees to participate in this study

Exclusion Criteria:

1. Suffering from calcaneal stress fracture, atrophy of fat pad, compression of the little toe abductor nerve (Baxter's nerve), tarsal tunnel syndrome, sciatica, bone or soft tissue tumor, rheumatism or rheumatoid arthritis, rigidity Those with spondylitis and infection
2. those who disagree with and do not understand the treatment methods or methods of the experiment
3. those with mental disorders
3D U/S Maternal Fetal Bonding in African American Women

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy in African-American women.One-third of participants will receive 3D model and complete questionnaires, one-third will receive a picture of 3D ultrasound of their baby and complete questionnaires, and one-third will only complete the questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Age - Female 19-45 years of age
* Fluent in English
* African American
* Currently pregnant (between 26- and 31-weeks' gestation)
* Have normal 20-week ultrasound

Exclusion Criteria:

* Having received more than 3 ultrasounds prior to study
* Medical need for additional ultrasounds
* Multiple fetuses
* \> 31 weeks gestation
* Is not African American
* Is not fluent in English
MyLeukoMAP™ Genomic Survival Prediction Assay Pivotal Clinical Study

The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.

The MyLeukoMAP™ Pivotal Clinical Study will assess the accuracy of MyLeukoMAP™, a new molecular blood test, performed within 30 days before scheduled surgical / interventional therapies for Heart Failure, to determine its effectiveness in improving clinical decision support by providing a quantitative prediction of low, indeterminate, or high risk of death one year after surgical / interventional therapies that is not identified by current diagnostic tools.

Patients scheduled for one of 10 different Heart Failure surgical / interventional therapies will be identified and consented. Four clinical parameters will be collected for each patient: age, white blood cell count, blood pressure, and respiratory rate. Blood samples will be collected concurrent with a routine preoperative blood draw, and peripheral blood mononuclear cells (PBMC's) will be isolated. The PBMC samples will be shipped to ResearchDx, Irvine, CA, for testing using the MyLeukoMAP™ genomic survival prediction assay. Patient 1-year postoperative survival/non-survival data will be reported for each patient.

The samples will be tested 1-year after the intervention of the last enrolled patient, and the data will be compared to actual patient 1-year survival to determine the survival prediction accuracy of the assay. The investigators anticipate that the assay will better identify those 20% of patients who currently do not achieve 1-year postoperative survival, and who would have better odds of survival by remaining on medical therapy, but who cannot be identified with current tools.

Eligibility Criteria:
Inclusion Criteria:

Criteria #1: AdHF with NYHA III/IV

Criteria #2: Left Ventricular Ejection Fraction (LVEF) \<35% or \>2+valvular disease severity \& \>low risk Society of Thoracic Surgeons (STS)-score

Criteria #3: Evaluation for interventions including CABG/PCI (Stratum #1, Ischemia), Surgical Valve Replacement/TAVR/Mitra-Clip (Stratum #2, Overload), VT-Ablation/Stellate Gangliectomy (Stratum #3, Arrhythmia), or MCS/HTx (Stratum #4, Contractility)

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Exclusion Criteria:

Criteria #1: No informed consent Criteria #2: \<18 years old

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Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.

Patients undergoing heart surgery at the Heart Institute (InCor) will be randomized and in accordance with a list of random numbers, generated by a computer program, are allocated in one of the treatment groups (conventional or intensive) when the blood glucose value recorded is greater than 200 mg/dl on two consecutive measures in an interval of 30 minutes.Conventional Group (GCon): patients randomized to the conventional group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.

Group intensive (GInt): patients randomized to the intensive group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (NaCl 0.9%) in continuous infusion pump for maintenance of blood glucose between 90 mg/dl and 110 mg/dl.

The insulin dose adjustment will be based on measurements of arterial blood glucose undiluted, held at intervals of one to 4 hours with the use of a monitoring system of glucose and beta-blood ketone (Freestyle Precision Pro, Abbott). The dosage is adjusted according to an algorithm by a team of intensive care nurses, trained for this purpose and assisted by a study physician not involved in the clinical care of patients.

On admission, all patients will receive intravenous glucose solution continuously (200 to 300 g in 24 hours). As soon as possible, the patient will be nurtured according to the routine of Surgical ICU for nutrition in the postoperative period of cardiac surgery patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing heart surgery;
* Age greater than 18 years;
* Sign the informed consent form;
* Capillary blood glucose greater than 200mg/dL ICU admission

Exclusion Criteria:

* Admitted for surgical repair of congenital heart defects;
* Dialytic Chronic renal failure;
* Participation in other research protocol;
* Diagnosis of HIV/AIDS;
* Pregnant.
Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease

A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes (medication and HbA1c\>7% and no cardiovascular disease), coronary artery disease (history of myocardial infarction or revascularisation) or heart failure (NYHA II-III and admitted in a hospital for the condition within 2 years)
* Aged 45 years or older
* Resident in the Päijät-Häme health care district

Exclusion Criteria:

* Classified as ineligible by primary care physician
* Unable to co-operate or participate in health coaching
* Major elective surgery planned within 6 months
* History of major surgery within past 2 years
* Life expectancy \<1 year
* Pregnancy
A Study to Evaluate Raptiva in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy

This is a Phase IIIb, randomized, double-blind, parallel-group, placebo-controlled, multicenter study designed to evaluate the safety and tolerability of efalizumab administered subcutaneously at weekly doses of 1.0 mg/kg in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Plaque psoriasis covering \>=10% of total BSA
* Diagnosis of plaque psoriasis for at least 6 months
* Minimal PASI score of 12.0 at screening
* In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
* Body weight of \<=140 kg
* 18 to 75 years old
* For women of childbearing potential, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study
* Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
* Willingness to enter Study ACD2601g

Exclusion Criteria:

* Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
* History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region
* Clinically significant psoriasis flare during screening or on the day of randomization
* History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
* History of opportunistic infections (e.g., systemic fungal infections, parasites)
* Seropositivity for human immunodeficiency virus (HIV)
* Pregnancy or lactation
* WBC count \<4000/uL or \>14,000/uL
* Seropositivity for hepatitis B or C virus
* Hepatic enzymes \>=3x the upper limits of normal (ULN)
* History of active tuberculosis (TB) or currently undergoing treatment for TB
* Presence of malignancy within the past 5 years, including lymphoproliferative disorders
* Previous treatment with efalizumab (anti-CD11a)
* Diagnosis of hepatic cirrhosis, regardless of cause or severity
* Serum creatinine \>=2x the ULN
* Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
* History of substance abuse within the last 5 years
* Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
Intimate Partner Violence (IPV)Screening in Health Care Clinics in Rural South Carolina

The purpose of this study is to implement universal screening for intimate partner violence (IPV) and to test two clinic-based interventions for women who screen positive for current or recent IPV. The study population will be implemented in Pee Dee region of the state of South Carolina and will include primarily low-income women who seek care at selected primary health care clinics in the region.

In this study, all women 18 and older receiving care at selected primary care clinics will be offered screening for IPV annually. Clinicians will use a structured screening tool to assess physical, sexual, and psychological IPV in a current relationship (IPV+) or IPV experienced by the woman in the past five years (Recent IPV). Clinics will be randomly assigned to implement a clinic-based intervention for women who screen positive for current or recent IPV. Two interventions will be implemented using a factorial design. In the Empowerment-Focused Patient Education Intervention, clinicians will conduct a 7-session intervention focusing on the health and well-being of the woman and attempt to link women's IPV experience with their health. In the IPV Services Intervention, IPV Specialists who are trained advocates from the Pee Dee Coalition Against Domestic and Sexual Assault (PDC) will be based in the clinic to (a) counsel women about IPV including safety planning, (b) provide linkages to PDC services, and (c) link women to clinic-based support groups developed specifically for this project.

We hypothesize the intervention(s) will change (a) clinician screening, referral, and IPV documentation patterns, (b) clinician IPV knowledge and perceived skills in working with women who have experienced IPV and their children (c) women's help-seeking behaviors, risk of poor mental and physical health, and (d) women's risk of subsequent IPV victimization. To evaluate these outcomes, we will survey clinicians and prospectively follow a group of consenting IPV+ women (N=300 in each intervention arm) to assess changes in their help-seeking, health behavior and status, IPV experience over two-years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* female
* 18 - 65 years
* must screen positive for partner abuse
Hirschsprung Disease Genetic Study

Hirschsprung disease is a genetic condition caused by lack of nerve cells in varying lengths of the intestines. This study will investigate the complex genetic basis of the disease, which involves multiple interacting genetic factors.

Hirschsprung disease (HSCR) is a birth defect resulting from the absence of nerve (ganglion) cells in the gastrointestinal tract. Hirschsprung disease has a population incidence of 1/5000 live births and most often occurs as an isolated condition. However, approximately 30% of HSCR cases are associated with other birth defects such as Down syndrome, deafness, hypopigmentation, and congenital central hypoventilation syndrome. Hirschsprung disease is a genetic condition with autosomal dominant, autosomal recessive, and multigenic patterns of inheritance described.

Dr. Aravinda Chakravarti's laboratory has been investigating the genetics of Hirschsprung disease (HSCR) for more than twenty five years. The goal of this research study is to identify genes harboring causative HSCR mutations and to better understand the complex inheritance of HSCR in families by whole genome mapping and sequencing studies. Specifically, the study aims to determine the frequency with which mutations in any human gene lead to familial and isolated forms of HSCR. Further, the study will collect clinical information and investigate possible genotype - phenotype correlations.

Molecular analysis using markers and sequencing, and statistical analysis of these data will be used to identify regions of human chromosomes where putative HSCR disease genes may be located. In addition, the DNA sequence of known and/or suspected HSCR genes will be assessed in individual patients and their family members, in search of causative HSCR susceptibility variants and variants that may affect presentation of the disease and treatment outcomes. Phenotypic information will include pathology, surgical, and other clinical outcomes related to Hirschsprung disease. This study will hopefully lead to a better understanding of the genetics of HSCR and, further down the road, improved diagnosis, treatment, and genetic counseling.

This study asks volunteers to:

1. Complete a medical/family history questionnaire
2. Provide access to some medical records
3. Submit blood samples from the individual(s) affected with Hirschsprung disease and his/her parents (if available)

Eligibility Criteria:
Inclusion Criteria:

- Individuals with Hirschsprung disease and their first degree relatives (any segment length of disease, with or without other congenital anomalies or health problems, single or multiple affected individuals in family)

Exclusion Criteria:

* Unable or unwilling to provide sample for genetic studies
* Individual, parent, or guardian unable to comprehend and provide informed consent
Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake Among Adults With Chronic Disease

In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. This study will investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among adults aged 18-64 years with chronic diseases.

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons aged 18-64 years identified as eligible for free-of-charge influenza vaccination due to a chronic condition. Subjects will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10). Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries with the exception of information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-64 years
2. Must be registered in the Danish nationwide registries as meeting at least one of the following eligibility criteria for free-of-charge influenza vaccination in the Danish public health system:

   1. Chronic lung disease
   2. Chronic cardiovascular disease other than hypertension
   3. Type 1 or type 2 diabetes mellitus
   4. Congenital or acquired immunodeficiency
   5. Impaired breathing due to muscular weakness
   6. Chronic renal or hepatic insufficiency
   7. Other chronic conditions with an increased risk of severe influenza as determined by the treating physician
3. Access to the official, mandatory Danish electronic mailbox system

Exclusion Criteria:

None
Outcomes After Albumin Vs Lactated Ringer's Solution in CABG and AVR Procedures

This is a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome.

This will be a prospective, randomized, double-blinded study to compare the use of albumin versus lactated Ringer's solution in patients undergoing coronary artery bypass graft surgery and in patients undergoing aortic valve replacement surgery and evaluate the incidence of acute kidney injury as a primary outcome. Data will be collected from both EPIC and STS (society of thoracic surgeons) database. STS database extracts data from the electronic medical record and groups it in specific format to evaluate outcomes after cardiac surgery to compare institutional performance to similar institutions and the national average. Patients undergoing coronary artery bypass graft or aortic valve replacement will be randomized to receive either albumin or lactated Ringer's for fluid resuscitation post-surgery. The resuscitation volume will be based on clinical decision after examining all the hemodynamics parameters. This practice coincides with standard of care and current practice. All eligible patients will be randomly assigned to receive either albumin 5% or lactated Ringer's solution in a 1:1 ratio using computer-generated, permutated blocks of 2 - 4. Both solutions will be administered intravenously in 250 mL increments at the discretion of the physician until hemodynamic parameters are met. The IV infusion bag and IV tubing will be covered using opaque bags to allow for blinding.

Eligibility Criteria:
Inclusion Criteria:

* All patients greater than 18 years of age undergoing CABG and AVR procedures

Exclusion Criteria:

* Low ejection fraction (\<20%) End stage renal disease Chronic renal insufficiency Pre-operative Inotropic (eg. Dobutamine) or vasoactive IV infusions (e.g, norepinephrine)

  * Jehovah's Witness Emergent surgery (e.g, intra-aortic balloon pump) Pre-operative acute kidney injury based on AKIN criteria Non English speaking patients
  * Jehovah's Witness population will be excluded regardless of their preference with accepting Albumin because sometimes PRBC are used as part of ongoing resuscitation in bleeding patients and if patients cannot use blood, this will have a much bigger issue with resuscitation and this study is not designed to follow up that population.