linjc16/ctgov huggingface dataset:
Ghrelin and Diastolic Heart Function

Study Overview
=================
Brief Summary
-----------------
In type 2 diabetes mellitus (T2DM) and obese patients the adipose tissue could over-express cytokines, sirtuin-1 (SIRT1), and microRNAs (miRs) implied in the regulation of left ventricle (LV) diastolic function (LV-DF). Ghrelin could modulate these pathways. Thus, in the current study authors will investigate ghrelin expression in T2DM obese patients after abdominal fat excision, and particularly in those with normalization of LV-DF at 1 year of follow-up.

Official Title
-----------------
Ghrelin Expression Could Regulate Diastolic Heart Function in Obese Patients With Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2, Obesity, Abdominal, Diastolic Dysfunction

Intervention / Treatment
-----------------
* Procedure: abdominal plastic intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of T2DM obese patients; T2DM obese patients under anti-diabetic full medical therapy and glycemic control. Exclusion Criteria: clinical diagnosis of type 1 diabetes; T2DM patients in poor glycemic control (HbA1c values of >7%); chronic neurological disorders; heart failure and coronary heart disease or depression of left ventricular ejection fraction (LVEF <55%); severe anemia; thyroid dysfunction; kidney failure; uncontrolled blood pressure (blood pressure > 140/90 mmHg on two occasions 2 weeks apart); inflammatory chronic disease; neoplastic disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 2 diabetes mellitus (T2DM) obese patients without left ventricle (LV) diastolic dysfunction.<br> | Procedure: abdominal plastic intervention<br>* According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.<br>|
| T2DM obese patients with first degree of left ventricle (LV) diastolic dysfunction.<br> | Procedure: abdominal plastic intervention<br>* According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.<br>|
| T2DM obese patients with second degree of left ventricle (LV) diastolic dysfunction.<br> | Procedure: abdominal plastic intervention<br>* According to international guidelines, authors will remove the superficial abdominal fat from the patients enrolled in the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normalization of LV diastolic dysfunction | At 1 year of follow-up authors evaluated the patients (those with first and second degree of LV diastolic dysfunction) that will experience the normalization of LV diastolic function. | 12 months |
PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

Study Overview
=================
Brief Summary
-----------------
The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.

Detailed Description
-----------------
Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.

Official Title
-----------------
Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability

Conditions
-----------------
Neonatal Respiratory Distress

Intervention / Treatment
-----------------
* Device: PNEUMACRIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatient at Oulu University Hospital PICU or NICU Gestational age at birth over 32 weeks Weight 2000-5000g Postnatal age > 12 hours Written informed consent from the parents of legal representative Non-invasive monitoring of oxygen saturation and ECG Exclusion Criteria: Postmenstrual age < 32 weeks Weight at time of the study < 2000g or > 5000g Chest skin lesion preventing safe use of the electrode belt Recent chest surgery within the past 7 days (e.g. thoracotomy)

Ages Eligible for Study
-----------------
Minimum Age: 12 Hours
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility of the PNEUMACRIT belt<br>Neonates will be monitored with a PNEUMACRIT electrode belt for 6 to 24 hours. After the study period, patient parents and nurses will give feedback. | Device: PNEUMACRIT<br>* Monitoring of breathing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (%) of recording time with high quality EIT-signal | Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration | 6-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Staff and parent questionnaires | After the study period, the patient parents and nurses will give feedback on the device and its feasibility with a structured questionnaire including also free text fields | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrical impedance tomography, neonate
A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess efficacy and safety of pirtobrutinib in participants with relapsing multiple sclerosis.

Official Title
-----------------
A Phase 2, Randomized Study of Pirtobrutinib Versus Placebo in Patients With Relapsing Multiple Sclerosis

Conditions
-----------------
Relapsing Multiple Sclerosis, Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Pirtobrutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have been diagnosed with relapsing MS Participants must have one of the following at least 1 documented relapse within the previous year, or at least 2 documented relapse within the previous 2 years, or at least 1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months prior to screening. Exclusion Criteria: Have had a diagnosis of primary progressive MS Have a history of another clinically significant neurological disease Had a relapse of MS within 30 days prior to randomization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pirtobrutinib Dose 1<br>Participants will receive pirtobrutinib orally. | Drug: Pirtobrutinib<br>* Administered orally<br>* Other names: LY3527727;|
| Experimental: Pirtobrutinib Dose 2<br>Participants will receive pirtobrutinib orally. | Drug: Pirtobrutinib<br>* Administered orally<br>* Other names: LY3527727;|
| Experimental: Pirtobrutinib Dose 3<br>Participants will receive pirtobrutinib orally. | Drug: Pirtobrutinib<br>* Administered orally<br>* Other names: LY3527727;|
| Placebo Comparator: Placebo<br>Participants will receive placebo orally. | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New T1 Gadolinium (Gd)-enhancing Lesions on Brain Magnetic Resonance Imaging (MRI) Per Scan |  | Week 8 and Week 12 | 
| Number of New and/or Enlarging T2 Lesions |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of T1 Gd-Enhancing Lesions Per Scan |  | Week 8 and Week 12 | 
| Total Number of Gd-Enhancing Lesions Per Scan |  | Week 8 and Week 12 | 
| Pharmacokinetics (PK): Plasma Concentration of Pirtobrutinib |  | Baseline to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing Forms Multiple Sclerosis
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

Study Overview
=================
Brief Summary
-----------------
A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.

Official Title
-----------------
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

Conditions
-----------------
Neuropathy;Peripheral

Intervention / Treatment
-----------------
* Device: Temporary Peripheral Nerve Stimulation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulnar neuropathy at the elbow Exclusion Criteria: Peripheral neuropathy outside of nerve of interest Patients with any active implanted device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental Intervention<br>Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation. | Device: Temporary Peripheral Nerve Stimulation System<br>* Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.<br>|
| No Intervention: Control<br>Standard of care only. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligibility Rate | Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria | 1.5 years | 
| Recruitment Rate | Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm | 1.5 years | 
| Retention Rate | Evaluation of study feasibility through the number of participants who complete all study activities | 1.5 years |
Arthroscopic Repair Versus High Tibial Osteotomy for Medial Meniscus Posterior Root Tears

Study Overview
=================
Brief Summary
-----------------
The goal of the trial is to compare Arthroscopic repair against Opening wedge high tibial osteotomy for Medial Meniscus posterior root tears

Detailed Description
-----------------
All Patients included in this clinical trial will be informed by written consent will undergo a one week screening to determine the eligibility for study entry. Patients who meet the eligibility requirements will be randomized in a single blinded manner (patients).

Official Title
-----------------
Arthroscopic Repair Versus Opening Wedge High Tibial Osteotomy for Medial Meniscus Posterior Root Tears

Conditions
-----------------
Medial Mensical Tear

Intervention / Treatment
-----------------
* Procedure: Arthroscopic Repair
* Procedure: High tibial osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sex: both sexes. Age: Above 40 Degree of Varus: Neutral to 10 degrees of Varus Exclusion Criteria: History of high energy trauma. Multiligamentous knee Injury.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic Repair<br>Arthroscopic Repair for medial meniscus posterior root tears | Procedure: Arthroscopic Repair<br>* Arthroscopic Repair for medial meniscus posterior Root tears<br>|
| Active Comparator: High tibial osteotomy<br>Open wedge High tibial osteotomy for medial meniscus posterior root tears | Procedure: High tibial osteotomy<br>* Open Wedge High tibial osteotomy for medial meniscus posterior Root tears<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lysholm Score | Validated Arabic form of Lyshlom score | 3 month and 6 month | 
| IKDC Score | Validated Arabic form of IKDC score | 3 month and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection | Occurrence of infection | 3 month and 6 month | 
| Non union | Occurrence of delayed or non union | 3 month and 6 month | 
| Arthrofibrosis | Loss of knee ROM or occurrence of Arthrofibrosis | 3 month and 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medial, Meniscus, Posterior, Root, Tear, High Tibial Osteotomy, Arthroscopic Root Repair, Transtibial Pullout, Arthroscopic Repair, Open Wedge
Efficacy of Methimazole Dosing Algorithm

Study Overview
=================
Brief Summary
-----------------
To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves' disease.

Detailed Description
-----------------
To conduct a prospective observational study in 60 patients with newly diagnosed Graves' disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm and assess for efficacy and safety of MMI dosing administered. Study group size is based on 90% power and projected efficacy of 70% patients reaching target.

Official Title
-----------------
The Efficacy of Cook County Health's Methimazole Dosing Algorithm in the Setting of ne Onset Graves' Hyperthyroidism

Conditions
-----------------
Graves Disease

Intervention / Treatment
-----------------
* Drug: Methimazole Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant adults (>18 years of age) with new diagnosis of Graves' Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm. Exclusion Criteria: Pregnant patients hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc. Graves patients who present with atrial fibrillation, CHF or other end organ damage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methimazole Tablets|Testing dosing algorithm for efficacy.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of euthyroid state | The proportion of patients achieving euthyroid state during the study period | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors influencing achievement of euthyroid state | Identifying variables that correlate with achievement of euthyroid state | 17 weeks |
Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries

Official Title
-----------------
Comparison Between the Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients Undergoing Endoscopic Urological Surgeries: A Randomized Controlled Trial

Conditions
-----------------
Hemodynamic Instability

Intervention / Treatment
-----------------
* Drug: Prilocaine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 65 years old and above. Both genders. Patients scheduled to undergo endoscopic urological surgeries. ASA I and II class. Exclusion Criteria: Patient refusal. Known local anesthetic (LA) allergy. Bleeding disorders. Skin lesions or infections at site of needle insertion. Hypertensive patients. Patients candidate for transurethral resection of the prostate ASA III and VI class

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prilocaine group<br> | Drug: Prilocaine<br>* The patients will receive a single injection of spinal anesthesia using prilocaine plus fentanyl<br>|
| Active Comparator: Bupivacaine GROUP<br> | Drug: Bupivacaine<br>* The patients will receive a single injection of spinal anesthesia using Bupivacaine plus fentanyl<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Incidence of hypotension from local anesthetic injection | Till 30 minutes after spinal anesthesia. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of vasopressor drugs | Total doses of vasopressor drugs used for hypotension treatment | Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia |
Mitral Splay Sign, Its Mechanism and Association With Severity of Regurgitation

Study Overview
=================
Brief Summary
-----------------
To study echocardiography splay sign in mitral regurgitation and its association with mitral regurgitation severity and doppler band artifact ('seagull cry').

Official Title
-----------------
Study of Splay Sign in Mitral Regurgitation and Other Valve Lesions as Related to Its Mechanisms, Predictors of Its Occurence and Association With Severity of Mitral Regurgitation

Conditions
-----------------
Mitral Regurgitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient undergoing echocardiography for clinical indications Exclusion Criteria: poor quality of recorded echocardiography study inability to ascertain severity of mitral regurgitation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mitral splay sign<br>Patients with at least mild mitral regurgitation and splay sign on color doppler echocardiography | |
| no mitral splay sign<br>Patients with at least mild mitral regurgitation and no splay sign on color doppler echocardiography | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of mitral splay sign | Logical, Presence of splay sign -- wide linear color doppler artifact on the level of valve coaptation disproportional to the width of the regurgitant jet | 1 year | 
| Presence of narrow doppler bands | Logical, presence of narrow bands during continuous doppler echocardiography assessed by two echocardiographers (one blinded) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral regurgitation severity | Categorical, Grade of severity of mitral regurgitation assessed by echocardiography by two independent echocardiographers | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
echocardiography, splay sign, seagull cry