cyrilzakka/clinical-trials huggingface dataset:
Vildagliptin/Metformin in T2DM Patients Starting Basal Insulin

To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.

This study, conducted in T2DM patients failing a dual therapy with metformin/SU in whom the decision to start basal insulin has been taken, will compare vildagliptin+metformin versus the previously used SU+met combination (regimen kept unchanged) in association with basal insulin, up-titrated as per usual algorithms primarily based on FPG to obtain a similar improvement in glycemic control in both arms, on the incidence of hypoglycemic episodes over 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken
* with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization
* with a glycemic target of HbA1c \<= 7%
* with HbA1c at inclusion \>7% and \<=9%
* Patients willing and able to start basal insulin and perform appropriate self monitoring of blood glucose (SMBG)

Exclusion Criteria:

* contraindication for either SUs, metformin or insulin and history of hypersensitivity to vildagliptin
* acute or chronic diseases that interfere with efficacy/safety results of this trial or put patient at risk

Other protocol defined inclusion/exclusion criteria may apply
Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs).

This study aims to assess and compare the safety and effectiveness of Autologous Bone Marrow-Derived MSCs (AutoBM-MSCs) in one group(group A) of SCI who are unlikely to be able to walk independently without treatment after 1 year of SCI, in the other group (group B) to assess the second group of Wharton Jelly derived mesenchymal stem cells ( WJ-MSCs) in the treatment of acute and subacute spinal cord injury (SCI) patients.

The study will be directed by the Cell Therapy Center (CTC) in Jordan, where 20 SCI patients meeting the inclusion criteria will be recruited and divided according to the type of injury into two groups; Group A for patients with complete transection of the spinal cord, and Group B for SCI without a total transaction,10 patients will receive (AutoBM-MSCs)and the other 10 patients with acute and subacute spinal cord injury will receive(WJ-MSCs) by a specialized spine surgeon into the spinal medulla. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and the Spinal Cord Independence Measure (SCIM) version III, in addition to blood tests, MRI, and somatosensory evoked potential (SSEP).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years
* Complete SCI grade AIS-A or -B, or incomplete C
* SCI between cervical levels C5 and thoracic level T11
* At least 12 weeks since time of injury
* Prediction rule score of 10 or less
* Cognitively unaffected
* Motivated for stem cell transplantation

Exclusion Criteria:

* Reduced cognition
* Age under 18 years or above 70 years
* Significant osteoporosis in spine and/or joints
* Pregnancy (Adequate contraceptive use is required for women in fertile age)
* Anoxic brain injury
* Neurodegenerative diseases
* Evidence of meningitis
* Positive serology for HIV, HBV, HCV, or Syphilis.
* Medical Complications that contraindicate surgery, including major respiratory complications.
* Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI.
* Other medical conditions which can interfere with stem cell transplantation
* Inability to provide informed consent.
* Uncorrected vision
* Cardiac abnormalities and uncontrolled hypertension
Ultrasound vs Palpation for Infant Lumbar Puncture

The purpose of this study is to determine if performing an ultrasound to identify the space to insert the needle before performing a lumbar puncture will improve success of the procedure and patient safety.

The investigators are conducting a single-center, prospective two-arm parallel group randomized clinical trial in an urban pediatric emergency department to determine if performing an ultrasound prior to lumbar puncture procedure improves success of the procedure.

Patients will be block-randomized into two groups to receive procedural interspace selection via 1) standard anatomic palpation technique or 2) visualization with pre-procedural ultrasound (experimental group).

1. Standard Anatomic Palpation Technique:

   Participants randomized to this group will receive standard of care treatment with providers using the palpation technique to select an interspace. As variations on the palpation technique exist, the investigators will provide a standardized educational cognitive aid that clinicians can use for this approach.
2. Pre-Procedural Ultrasound:

Clinicians will first use the standard palpation technique to select an interspace for ultrasound evaluation. A select group of pediatric emergency medicine attendings and fellows who have already trained to a mastery standard with the ultrasound protocol will then conduct the pre-procedural ultrasound. The clinicians performing the lumbar puncture will be provided the following information to conduct the lumbar puncture:

i. Assessment for fluid at the level selected (and the number of interspaces above that have fluid without conus present)

ii. Measurements of appropriate angle and depth

iii. Evaluation of any overlying vasculature

Post-Lumbar Puncture:

After the lumbar puncture, infants randomized to both groups will receive a post-procedural ultrasound scan performed by one of the mastery trained ultrasound physicians.

Eligibility Criteria:
Inclusion Criteria:

* Patient is less than 90 days old.
* Patient is receiving a lumbar puncture

Exclusion Criteria:

* Patient is clinically unstable
* Patient had a previous lumbar puncture in the past 24 hours
* An outside consultant (not working in ED) is performing the LP
* Patient has developmental delay or neurological impairment
* There is no legal guardian present
* The legal guardians speak neither English nor Spanish
* There is no ultrasound personnel available to enroll
The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery

The aim of this clinical trial is to determine the effectiveness of listening to white noise on the sleep quality, comfort level, satisfaction level of patients after lumbar disc herniation surgery. The main hypotheses are:

* Is there a difference between the sleep quality of patients who listen to white noise and those who do not?
* Is there a difference between the comfort levels of patients who listen to white noise and those who do not?
* Is there a difference between the satisfaction levels of patients who listen to white noise and those who do not?

The main tasks that the participants will be asked to do will be explained and Their informed consent will be obtained. The two research groups will be compared.

This study will be conducted with a total of 60 patients who underwent surgery for lumbar disc herniation at a hospital in Istanbul. Participants in the study who had lumbar disc herniation surgery will be divided into two groups: intervention (n = 30) and control group (n = 30), according to the randomization method created with computer-based random numbers.

On the 0th and 1st postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.Patients in the control group will be monitored according to their routine clinical procedures. Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. Patients in the control group will also be followed up at the same times and with the same forms. Descriptive Characteristics Form, Informed Consent Form, The Richards-Campbell Sleep Questionnaire, General Comfort Questionnaire,Visual Analog Scale for Satisfaction Level will be used in data collection.

Eligibility Criteria:
Inclusion Criteria:

* underwent lumbar disc herniation surgery
* hospitalized for at least 48 hours
* agreed to participate in research

Exclusion Criteria:

* chronic sleep problems and taking medication
* Not filling out the questionnaire
Serum Lipids and Glucose Levels in Relation to CVD Outcomes in Patients With Ischemic Heart Failure

Current prospective cohort study is to evaluate the association between fasting lipid profiles (including total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, triglycerides, apolipoprotein A, apolipoprotein B and lipoprotein(a)) and fasting plasma glucose at admission with cardiovascular disease outcomes (including fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke, re-hospitalization due to heart failure, revascularization by percutaneous coronary intervention or coronary artery bypass grafting, or cardiovascular mortality) and all-cause mortality.in patients with ischemic heart failure and left ventricular ejection fraction \< 45 % evaluated by echocardiography during 12 months follow-up.


Eligibility Criteria:
Inclusion Criteria: 1.Diagnosed as coronary artery disease by coronary angiography; 2. Left ventricular ejection fraction \< 45% evaluated by echocardiography during index hospitalization.

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Exclusion Criteria: Coexistent malignant diseases; stage 3 or more of chronic kidney disease; liver dysfunction with ALT or AST higher than 3 times of normal limit range; do not want to participant in current study

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Auditory-somatosensory Stimulation to Alleviate Tinnitus

The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.

This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.

The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.

Eligibility Criteria:
Inclusion Criteria:

1. Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
2. Hearing thresholds better than 50dB HL at peak tinnitus frequencies.
3. Able to modulate their tinnitus with a somatic maneuver
4. BothersomeTinnitus.

Exclusion Criteria:

* No participation in a tinnitus treatment regimen within the past four weeks
* Retrocochlear pathology/ VIIIth nerve lesion
Comparative Effects of Closed Kinetic Chain Exercises and Mobilization Exercises in Elderly Females With NFF

This study investigates the additional benefits of Mobilization Exercises and Closed Kinetic Chain Exercises (CKCE) in elderly individuals with post-operative neck of femur fracture. The researcher employs a randomized controlled trial which will involve 49 participants aged above 65 years with post-operative neck of femur fracture.

Participants are divided into two groups:

one receiving Mobilization Exercises, and the other receiving Closed Kinetic Chain Exercises. Outcomes are assessed over a 6 week period, focusing on pain intensity, Range of motion, risk of fall by goniometer, visual analogue scale (VAS) and dynamic gait index (DGI) scores. Data will be analyzed using SPSS-23. The study will conclude whether CKCE or Mobilization exercises offer a significant benefit in pain reduction, prevent risk of falls and range of motion.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by Orthopedic Surgeon with neck of femur fracture by x ray findings
* Patients undergone surgical treatment for neck of femur fracture within one year.
* Patients administer in groups after 12 weeks of post-operative period
* X-ray reexamination with no fracture or dislocation before treatment
* Ability to walk normally or with crutches
* Patients walk without any assistance before injury
* Un-displaced neck of femur fracture according to Garden Classification
* Operated on using internal fixation
* Only females were included
* Aged 65 years or older

Exclusion Criteria:

* Bilateral hip fracture
* Bedridden patient before fracture
* Patient who have undergone any previous surgery of lower limb
* Neurological Condition
Clinical Validation of the Point-of-Care MSD Influenza Test

The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).

This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influenza B. Nasal swabs from subjects presenting at the clinical care facility with ILI will be collected and tested on the MSD Influenza Test. Results from the Test will be compared to results obtained from viral culture performed on a second nasal swab at a reference laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Any subject (all ages) presenting with ILI (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza.
* Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.

Exclusion Criteria:

* Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
* Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
Efficacy of COMB (Comprehensive Behavioral) Model of Treatment of Trichotillomania

This pilot study is being conducted in order to help make the case for later, more systematic research on the effectiveness of the Comprehensive Behavioral (COMB) model of treating trichotillomania (compulsive hair pulling). The goals are to standardize COMB treatment techniques in the form of a clear written manual for therapists; determine whether therapists can use these guidelines in a consistent manner in making treatment decisions; develop and test the reliability of measures of how well therapists are conducting the treatment; and collect preliminary data on the acceptability of the treatment to patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Primary Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnosis of Trichotillomania (TTM)

Exclusion Criteria:

* Current suicidality or severe depression
* Current psychosis
* Current alcohol or substance abuse
* Concurrent psychotherapy for TTM
* Psychotropic meds (for any disorder) that have not been stable for \>4 weeks
SHARE Project Define

The overall goal of the current study is to define modifiable intervention targets that are developmentally- and culturally-relevant in pathways between cumulative stress and self-management outcomes - alcohol use and HIV - among Young People Living with HIV (YPLWH).

This is a correlational, longitudinal cohort study that will seek to evaluate the association of cumulative stress with self-management of alcohol (i.e. hazardous drinking) and HIV (viral suppression) among YPLWH. The study will enroll up to 175 participants between the ages of 18-29 who currently reside in Florida and are living with HIV.

In the Model phase, individuals will participate in two assessment timepoints, including baseline assessment with a two-week sleep diary completion and 9-month follow-up assessment with another two-week sleep diary completion. The aim of the model phase is to define key modifiable intervention targets by longitudinally evaluating multiple components of sleep health, and emotion and behavioral regulation among YPLWH to determine potential pathways between cumulative stress and alcohol and HIV outcomes, in the context of individual factors relevant to YPLWH (e.g., age, race/ethnicity, cannabis and other substance use, cognitive functioning, education), with an additional cross-project moderator aim to explore age, biological sex and gender, race/ethnicity, other substance use, and mental health as moderators.

In the Adapt phase, 42 of N=175 will participate in 60-90 minute focus groups, that will focus on adapting developmentally and culturally scalable measures of cumulative stress, sleep health, and emotion/behavior regulation for screening and intervention targeting, and creation of a community-informed toolkit of the adapted measures.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and 0 months to 29 years and 11 months
* Currently reside in Florida
* Report having had at least 1 alcoholic drink in the last 30 days
* Able to read and understand English
* Have internet access via smartphone, tablet or computer
* Be diagnosed as HIV positive and;
* Willing to provide informed consent.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults
* Individuals who are not diagnosed as HIV+
* Prisoners
* Pregnant women
Effects of Egg Ingestion on Endothelial Function in Adults With Coronary Artery Disease

The purpose of this study is to determine the effects of daily consumption of eggs or egg substitute for 6 weeks on endothelial function and on cholesterol and lipoprotein levels in participants with clinically established coronary heart disease (CHD).

Restriction of dietary cholesterol, and thus the avoidance or restriction of egg intake, is routinely recommended to patients with coronary disease. However, the relative importance of dietary cholesterol to serum lipids has become a subject of active debate. Eggs provide a complete array of amino acids and an array of micronutrients, and are low in total fat. Epidemiological and clinical studies have showed that dietary intake of omega-3 fatty acids decreases the risk of coronary heart disease (CHD). Endothelial function testing represents a uniquely valuable means of assessing aggregated influences on cardiac risk by gauging physiologic responses of the vascular endothelium. In prior studies the investigators have shown that daily egg ingestion for 6 weeks did not adversely affect endothelial function in healthy adults or in hyperlipidemic adults. The investigators now propose a prospective, randomized, single-blind crossover study to assess the effects of eggs, egg substitute and high-carbohydrate American breakfast on endothelial responses and serum lipids in participants with clinically established CHD.

Eligibility Criteria:
Inclusion Criteria:

1. Males age greater than 35 years;
2. Post-menopausal females not currently on hormone replacement therapy;
3. Non-smokers;
4. CVD as defined by the presence of at least one coronary stenosis \>50% determined angiographically or a documented history of myocardial infarction.

Exclusion Criteria:

1. Failure to meet inclusion criteria;
2. Anticipated inability to complete study protocol for any reason;
3. Current eating disorder;
4. Use of lipid-lowering or antihypertensive medications unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning;
5. Regular use of high doses of vitamin E or C;
6. Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;
7. Regular use of fiber supplements;
8. Diabetes;
9. Sleep apnea;
10. Restricted diets by choice (i.e., vegetarian, vegan);
11. Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; current use of warfarin.
Indiana University Gastrointestinal Motility Diagnosis Registry

Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders

Develop a registry (list of patients) of patients seen the clinics with motility disorders. Motility diagnosis based on billing diagnostic codes are not accurate. Motility diagnosis will be made by physicians with specialized in GI Motility, based on clinical consensus of diagnostic criteria. The information gathered from the database will be used to help promote future clinical research in the GI motility and Neurogastroenterology Unit at Indiana University School of Medicine.

Gastrointestinal motility symptoms are very common. It encompasses a wide range of problems, such as dysphagia, heartburn, nausea, emesis, food regurgitation, abdominal distension, weight loss, postprandial bloating, constipation, and diarrhea. An accurate diagnosis is essential in order to promote cost-effective treatment and future research to benefit patients with GI motility disorders

Specific Aims

1. Primary Aim: Identification of patients by accurate motility diagnosis
2. Secondary Aims:

   1. To develop Patient Reported Outcome (PRO) measurements in patients with small intestinal bacterial overgrowth (SIBO)
   2. To develop Patient Reported Outcome (PRO) measurements in patients with gastroparesis

Eligibility Criteria:
Inclusion Criteria:

1. Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology
2. Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table

Exclusion Criteria:

1. Coexisting medical conditions that may limiting participation in clinical research trial
Carpal Bone Erosion in Rheumatoid Arthritis :Diagnostic Value

Rheumatoid arthritis (RA) is a systemic inflammatory disease characterized by proliferative hyper vascularized synovitis which primarily affects synovial joints. Synovium of bursa; tendon sheaths; attachment sites of cartilage, ligament, and tendons to the bone; soft tissue; and bones can be mentioned among the other areas under influence of RA. Changes happen to be symmetrical and may present as fusiform soft tissue swelling, regional osteoporosis, marginal-central erosions, cartilage damage, joint destruction, narrowing of joint space and fibrous ankyloses. Wrist, metacarpophalangeal and metatarsophalangeal joints are the first sites to be affected .Over the past few years, an increasing number of rheumatologists have started to use US in the clinical setting of the early arthritis clinic. While US allows for an accurate and non-invasive multisite assessment of joint involvement in patients with RA, time for US examination is not infinite


Eligibility Criteria:
Inclusion Criteria:

* 1. RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.\[8\] 2. SLE patients fulfilled the 2019 ACR\\EULAR classification criteria for SLE.\[9\] 3. Age above 18 years old. 4. Patient cooperative and can answer questions. 5. Patients who are able and willing to give written informed consent.

Exclusion Criteria:

* 1. Age below 18 years and above 60 years. 2. Uncooperative patients. 3. Patient not able and willing to give written informed consent.