cyrilzakka/clinical-trials huggingface dataset:
Study of Visceral Fat in type2diabetic Patients and Its Relation to Microvascular Complications

Study the correlation between METS IR and visceral fat in type 2 diabetes and its relation to microvascular complication

The Metabolic Score for Insulin Resistance (METS-IR) is a metabolic index developed with the aim to quantify peripheral insulin sensitivity in humans; it was first described under the name METS-IR by Bello-Chavolla et al in 2018. It was developed by the Metabolic Research Disease Unit at the Institute National de Ciencias Médicas Salvador Zubirán and validated against the euglycemic hyperinsulinemic clamp and the frequently-sampled intravenous glucose tolerance test in Mexican population.It is a non-insulin-based alternative to insulin-based methods to quantify peripheral insulin sensitivity and an alternative to the Homeostatic Model Assessment (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).

Very limited research correlate between visceral obesity and microvascular complications in type 2 diabetic patients and how can the metabolic score for insulin resistance predict visceral obesity and microvascular complications in type2 diabetic patients. In this study the investigators will search for these correlations.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years Both male and female subjects Subjects capable of giving consent and voluntarily willing to participate in the study

Exclusion Criteria:

* Chronic kidney disease patients Any nondiabetic nephropathy patients Patients affected by hypertension Patients affected by ocular disorders Neuropathies of other etiologies like chronic liver disease patients, alcoholics, or drug addicts Critically ill patients of type 2 diabetes mellitus Patients who have not given consent
Predictors of Early Chest Infection in Acute Ischemic Stroke

Pneumonia is a frequent complication of acute stroke and is associated with increased mortality and long-term impairment in the affected subjects. In previous studies, a number of clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation), radiological (e.g., large infarctions in the territory of middle cerebral artery, insular infarction) and biochemical (e.g., increased serum levels of C-reactive protein, decreased levels of CD4+ T-lymphocytes) findings have been reported as risk factors of stroke-related chest infection. The present study (PRECAST) aims to identify a small set out of these previously described risk factors that can predict stroke-related pneumonia with high sensitivity and specificity.


Eligibility Criteria:
Inclusion Criteria:

* acute ischemic stroke
* admission to the neurological intensive care unit or stroke unit within 24 hours after stroke onset
* clearly assessed brain lesion location

Exclusion Criteria:

* previous large (non-lacunar) stroke
* chest infection present already on hospital admission
* mechanical ventilation already on day 1 or 2 after hospital admission
* treatment with immunosuppressive drugs
Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

The primary objective of this research study is to increase adherence of Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). Additionally, this study will examine behavioral, physical, and sociocultural factors associated with treatment engagement.

Insomnia is a debilitating condition that impacts one third of adults, with a majority not having access to proper treatment. Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). is a method that is becoming more accessible and with strong success rate with treatment completion; however, non-completion rates are common, specifically in those with low socioeconomic status (SES).

This study will examine the addition of telehealth coaching to dCBT-I to increase adherence rates. Telehealth coaching will aim to provide support to mitigate the impact of lower health literacy, and will also enhance self-efficacy as a mechanism to promote treatment persistence.

Participants will be recruited from the Henry Ford Health System (HFHS) outpatient network as well as the Medicare/Medicaid data warehouse. Subjects will be screened to determine eligibility, and then will be randomized into one of two insomnia treatment groups (control dCBT-I and dCBT-I with telehealth coaching). Treatment involves 6 weekly dCBT-I sessions. In the dCBT-I with coaching component, those who are at risk for treatment non-completion will be offered two telehealth sessions of brief behavioral therapy for insomnia. Those in the control dCBT-I who are at risk for treatment non-completion will be provided digital sleep education.

At the end of the treatment period, some participants will complete a semi-structured interview to assess for facilitators and barriers to treatment engagement.

Eligibility Criteria:
Inclusion Criteria:

* Determination of insomnia (ISI \>14)

Exclusion Criteria:

* Age \< 18
* Unwillingness/inability to participate
* Bipolar or Seizure Disorders
* Untreated sleep disorders other than insomnia
* Untreated and severe medical or psychiatric disorders
Functional and Radiographic Outcomes of Hallux Valgus Correction by Mini-invasive Surgery With Reverdin-Isham Percutaneous Osteotomy

Minimally invasive surgery (MIS) represents one of the most innovative surgical treatments of Hallux Valgus (HV). However, long-term outcomes still remain a matter of discussion within the orthopaedic community. The purpose of this longitudinal prospective study was to evaluate radiographic and functional outcomes in patients with mild-to-severe HV who underwent Reverdin-Isham and Akin percutaneous osteotomy, following exostosectomy and lateral release.

One hundred and eighty patients with mild-to-severe symptomatic HV were treated by MIS. Clinical evaluation was assessed pre-operatively, as well as at 3 and 12 months after surgery and at final follow-up of 48 months, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux grading system. Patient satisfaction and complications were recorded.Further parameters assessed were postoperative pain at rest and during movement by the numerical rating scale (NRS), patient satisfaction using the Visual Analogue Scale (VAS), quality of life, and return to daily activities. Incidence of Chronic Pain Syndrome (CPS), Type of anesthesia and ASA were evaluated and recorded.

Computer-assisted measurement of antero-posterior radiographs was taken pre-operatively, as well as at 3 and 12 months after surgery and at 48-month follow-up, analysing the intermetatarsal angle (IMA), the hallux valgus angle (HVA), the distal metatarsal articular angle (DMAA), and the tibial sesamoid position. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency and the metatarsal index were calculated only preoperatively and at last follow-up. Statistical analysis was carried out using the paired t-test. Statistical significance was set at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to severe symptomatic hallux valgus

Exclusion criteria:

* congenital deformities of the foot
* hallux rigidus
* previous first ray trauma or foot and ankle surgery
* rheumatic, dismetabolic, neurologic, infective, or psychiatric pathologies.
Effectiveness of 20m-MB in KTR Symptom Control

To study the effectiveness of single session 20-minute mindful breathing in symptom control in kidney transplant recipients.

Patients undergoing kidney transplant follow ups in our center are screened based on recruitment criteria. Patients who fulfilled the incusion criteria are recruited. Intervention involves a 20-minute mindful breathing session with uniform script performed by trained personal, while control arm involves standard care without intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adult renal transplant patients aged 18 years and older
* At least one symptom scoring ≥ 4/10 based on the Edmonton Symptom Assessment Scale (ESAS)

Exclusion Criteria:

* Dialysis-dependent
* Medically unstable
* Having serious pre-existing mental health issues
Efficacy and Safety of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) on Maintaining the Patency of Endobiliary Metal Drainage in Patients With Malignant Biliary Strictures : A Double-arm Comparable Study

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, gallbladder cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. When compared to plastic stents, SEMS present a significantly decreased risk of recurrent biliary obstruction. SEMS are also more cost-effective than plastic stents in patients with a life expectancy of longer than 4 months. However, despite their numerous benefits, SEMS become occluded in up to 50 % of patients in the first 6-8 months.

Radiofrequency ablation (RFA) has been used to treat malignancies of the liver since the early 1990s. Other studies have investigated its role in diseases of the colon and esophagus. More recently, this technique has been recognized for its potential in palliative treatment of malignant biliary strictures. RFA uses a high-frequency alternating current to generate heat and achieve coagulative necrosis when in contact with tissue. Within the bile duct, RFA appears to be safe and may result in decreased benign epithelial hyperplasia and tumor ingrowth. However, RFA along with placement of SEMS has not been well studied. On the other hand, newly developed RFA catheter (ELRA®) showed the feasibility and safety in south korea, recently.

The purpose of this study was to investigate the Efficacy and safety of endobiliary RFA by using a novel RF catheter (ELRA®) on maintaining the patency of endobiliary metal drainage in patients with malignant biliary strictures.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction
* older than 19 years old
* Life expectancy \> 3 months
* Inoperable case due to advanced stage or comorbidity
* Informed consent

Exclusion Criteria:

* Inadequate case for ERCP
* Inadequate coagulation (platelet count \< 60,000/µl, PT(INR)\>1.5)
* Abnormal biliary tract system due to previous operation
* Failed endoscopic approach to duodenum or biliary tract
* Pregnancy
* No signed informed consent
Pelvic Floor Physiotherapy Combined With Sexual Therapy in Vaginismus Treatment

Studies on pelvic floor physiotherapy in individuals diagnosed with vaginismus are quite limited in the literature. While current studies have focused on certain physiotherapy modalities, the literature is quite limited in terms of combined rehabilitation programs. There is a need for non-invasive therapy methods that can be an alternative for the patient and client population whose vaginismus problem continues after behavioral therapies. No studies on pelvic floor physiotherapy combined with sexual therapy have been found in the literature. In this context, our study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.

Vaginismus is a sexual dysfunction defined as recurrent or persistent difficulty or impossibility of sexual intercourse due to involuntary contractions of the muscles in the vaginal area in women. This condition is usually associated with excessive tension and spasm of the pelvic floor muscles and adductor muscles when evaluated in terms of these muscle groups.

Sexuual therapy includes the placement of dilators of graduated sizes by the therapist at home or in a clinical setting, guided by both the patient and the partner, for systematic desensitization to vaginal penetration, and sexual education to alleviate the psychological impact of the condition. This method is most frequently used in studies and the reported success rates are quite high.

Various techniques such as breathing and relaxation exercises, local tissue desensitization, vaginal dilators, biofeedback and manual therapy are used within the scope of pelvic floor physiotherapy in the treatment of vaginismus. There are studies in the literature investigating the effectiveness of biofeedback exercises in the treatment of vaginismus with a 100% success rate. It has also been reported that the combined application of pelvic floor exercises with behavioral sexual therapy provides significant improvement. In this study aimed to examine the effectiveness of pelvic floor physiotherapy combined with sexual therapy in individuals diagnosed with vaginismus.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with vaginismus,
* Being between the ages of 20-45,
* Having an active sexual partner in the last 6 months,
* Not being in the accompanying physiotherapy or psychotherapy process.

Exclusion Criteria:

* Diagnosed with or treated for vulvodynia and/or vulvar vestibulitis,
* Having a pacemaker,
* Not being able to give personal consent,
* Having a physical problem that would prevent treatment.
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks

RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.

IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18y
* Intensified adalimumab regime at least 4 weeks prior to enrollment.
* Immunosuppressants are allowed if a stable dose for \> 12w is maintained.
* Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained.

Exclusion Criteria:

* Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
* Pregnant or lactating women.
Assessment of Activities of Daily Living in Adults With Chronic Low Back Pain Using a Nonoperative Treatment Modality

The investigators hypothesize that treatment with non-invasive spinal decompression reduces discogenic low back pain (LBP), decreases visual analog pain scale scores, increases activities of daily living and decreases medication use.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age;
* consented to the physician prescribed protocol;
* presented with discogenic low back pain defined as low back pain for minimum of 12 weeks;
* current CT scan

Exclusion Criteria:

* metastatic cancer;
* previous spinal fusion or placement of stabilization hardware within 6 months;
* instrumentation or artificial discs;
* neurologic motor deficits, bladder, or sexual dysfunction;
* alcohol or drug abuse
* patient's with extremes of height (\< 147 cm or \> 203 cm) and body weight (\> 136 kg).
Efficacy of Green Tea Buccal Tablets in Oral Lichen Planus

Is topical application of green tea polyphenols buccal tablet more effective in treatment of patients with symptomatic oral lichen planus in comparison with topical application of corticosteroids and what is the most effective concentration of polyphenols

* Each patient was informed about the detailed procedure, and educated about benefits of the treatment, the known side effects and follow-up appointments needed. After that, each subject participating in the study signed an informed written consent form.
* Subjects were given freedom to leave the study at any time when they need to. Group A (Experimental group) 200 mg green tea

Where patients in this group will receive a buccal tablet containing 200 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.

Preparation of buccal tablets : Mucoahesive buccal tablets is prepared by a direct compression procedure. Various batches are prepared by varying the chitosan:drug ratio to identify the most effective formulation. The mucoadhesive drug/polymer mixture is prepared by homogeneous mixing of the drug with chitosan , secondary polymer, and D-mannitol, in a glass mortar for 15 min. Then, Mg stearate will be added and mixed for 5 min .The mixture is compressed using a tablet machine (Type EK: O.Erweka apparatus, Frankfurt, Germany) using flat-tip punches and dies with 8-mm-diameter. Each tablet weighed 212 mg with a thickness of 3.1 mm.( Darwish and Elmeshad,2009)

Group B (Experimental group) 300 mg green tea

Where patients in this group will receive a buccal tablet containing 300 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.

Group C (Control group) corticosteroid group:

Where patients are treated with topical corticosteroids 1 mg/g Triamcinolone acetonide (Kenacort-A orabase 20 G Pomad: Deva dermatological product,Turkey) applied topically 4 times a day i.e. following each meal and at bed time for four weeks .

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic lesions.
* OLP lesions with the diagnosis confirmed both clinically and histopathologically.
* Clinical score higher than 3.
* Disease duration of more than 2 months.
* Absence of dysplasia in histological section

Exclusion Criteria:

* Presence of any visible oral lesion other than OLP.
* Pregnant or breast-feeding women,
* Immuno-deficiency diseases.
* Current malignancy or malignancy in history.
* Concomitant treatment potentially effective on OLP within the previous 2 months such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs.
* Severe or recurrent infections.
* Lichenoid reaction.
* Patients presents with skin lesions which may require systemic corticosteroid therapy.
Effect of Flexibility on Postural Stability

Postural stability has an important role for functional movements, injury prevention and the performance of many athletic skills. Therefore, it is very important to understand the factors that affect postural stability. The aim of this study is to investigate the effect of lower extremity flexibility on postural stability in healthy individuals.

Postural stability provides the relationship between the body's center of gravity and the base of support using somatosensory information. Postural stability is a very important determinant for functional movements. It is known that postural stability plays an important role in the performance of many sports skills, protection from injuries and daily life activities. Therefore, it is very important to understand the factors affecting postural stability well.

Joint range of motion, muscle strength and flexibility are among the factors affecting postural stability. Hip, knee and ankle joint movements controlled along the kinetic chain are important in providing postural stability. The aim of the study is to evaluate the effect of lower extremity flexibility on dynamic postural stability in healthy individuals. Healthy volunteers between the ages of 18-25 will be included in the study and flexibility and postural stability assessments will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-25
* Volunteering to participate in the study

Exclusion Criteria:

* Having a diagnosis of neurological, orthopedic, vestibular, rheumatological disorder
* Having a history of musculoskeletal injury or surgery within the last year
* Participating in a regular exercise program
Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy

This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the ureteroscopes and the possible microbiological load.

This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 6 new ureteroscopes are used (3 from Olympus and 3 from Storz) to study the durability of the ureteroscopes and the possible microbiological load.

Before the procedure is started the endoscope is tested for its microbiological load in two different ways:1. Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.

After the procedure is finished, the endoscope is tested for its microbiological load in two different ways:

1. Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.

Transfer all samples to the lab as soon as possible but at least within four hours after collecting the samples.

As for the clinical efficacy during each procedure a detailed questionnaire about the use of each ureteroscope is filled out. This includes the ease of use making mention on quality of the image, torque, flexibility and durability.

Data will be collected through electronic case report forms (eCFRs), with use of an online Data Management system (DMS).

Eligibility Criteria:
Inclusion Criteria:

* Patient presented with a diagnosis to undergo a ureterorenoscopy using a flexible ureterorenoscope
* over 18 years
* has signed informed consent
* the patient is being treated with the designated flexible ureterorenoscope
Integrating Depression Services Into DM Management

The goal of this proposal is to integrate depression services into improving adherence for oral hypoglycemic agents so that a single program can assist patients. The investigators hypothesized that patients in the intervention would demonstrate improved adherence to patients' oral hypoglycemic agents and antidepressants as well as improved clinical outcomes.

Many older patients do not take their medications for Type 2 diabetes mellitus (DM) as prescribed by their physician. Depression is common among patients with Type 2 DM and may be the reason why patients do not take their medications as prescribed. A program in which Type 2 DM and depression are treated together in primary care would improve the health of older patients with both Type 2 diabetes and depression and would be practical in real world practices with competing demands for limited resources. There is an urgent need for research that can bring potentially life-extending strategies to older patients with both diabetes and depression. People can better control their Type 2 DM if they treat their depression and the same strategies can be used to help patients take their medications for both conditions. In this program patients were involved in identifying problems with taking their medicines and working on solutions. The aims of this program were to improve how patients take their medications for Type 2 DM and depression as well as blood glucose control and symptoms of depression over 3 months. To see whether this program works the investigators compared the results of patients receiving this program to those who do not receive the program. Findings may lead to the development of other programs in which depression and chronic medical conditions are treated together.

Eligibility Criteria:
Inclusion Criteria:

* 30 years and older
* a current diagnosis of Type 2 DM
* current prescription for an oral hypoglycemic agent
* current prescription for an antidepressant
* able to communicate in English
* willing to give informed consent.

Exclusion Criteria:

* inability to give informed consent
* significant cognitive impairment at baseline (Mini-Mental State Examination (MMSE) \<21)
* residence in a care facility that provides medications
* unwillingness or inability to use the Medication Event Monitoring System