linjc16/ctgov huggingface dataset:
Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population. The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.

Detailed Description
-----------------
Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE. Moreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.

Official Title
-----------------
Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery

Conditions
-----------------
Hypovolemia, Heart Failure, Diastolic Dysfunction, Systolic Dysfunction, Venous; Return (Anomaly)

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery. Exclusion Criteria: Not signed consent.

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 |
| --- |
|Diagnostic Test: Echocardiography|Preoperative transthoracic echocardiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypovolemia | Screening of preoperative level of venous return | One hour before surgery | 
| Heart failure | Screening of incidence of preoperative systolic and diastolic function | One hour before surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, diastolic dysfunction, venous return, Left ventricular filling pressures
Longitudinal Evaluation and Real-world Evidence of NT201

Study Overview
=================
Brief Summary
-----------------
This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.

Official Title
-----------------
LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants

Conditions
-----------------
Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face

Intervention / Treatment
-----------------
* Drug: IncobotulinumtoxinA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older. Planning treatment with incobotulinumtoxinA. Exclusion Criteria: Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins. Currently pregnant, breastfeeding, or intending to become pregnant during study participation. Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients. Any infection and/or inflammation at the planned injection points. Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.

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 |
| --- | --- |
| Facial treatment with incobotulinumtoxinA in treatment naïve participants<br> | Drug: IncobotulinumtoxinA<br>* IncobotulinumtoxinA injections for aesthetic indications.<br>* Other names: BOCOUTURE®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change | Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change from first treatment visit to the 4-to-6 weeks timepoint. | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of FACE-Q Satisfaction with Decision Scale mean change | Explore the effectiveness of the incobotulinumtoxinA injections in treatment naïve participants for facial cosmetic procedures during up to 3 years continuous treatment exposure, as measured by assessment of FACE-Q Satisfaction with Decision Scale mean change from first treatment visit to the 4-to-6 weeks timepoint. | Up to 3 years |
Developing Criteria for Cortical Resections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain.

Detailed Description
-----------------
The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. During surgery small pieces of abnormal (unusual) brain tissue may be removed. We analyze these specimens using more advanced microscopic and electrophysiologic techniques than are usually applied to such tissue specimens. In addition, some tissues can be maintained in laboratory conditions to allow analysis over the longer term. No extra brain tissue is taken to perform these studies. The tissue analysis is performed by the research team and are compared to the routine (normal) electrical recordings that are taken during this type of brain surgery. Currently there are no instructions telling a doctor how much brain tissue should be cut out to prevent the spread of tumors or epilepsy. We are hoping that the results of this study help us to better know how much brain tissue needs to be removed to prevent the spread of tumors or epilepsy.

Official Title
-----------------
Developing Functional and Structural Criteria for Cortical Resections

Conditions
-----------------
Epilepsy, Tumor

Intervention / Treatment
-----------------
* Procedure: Tissue sample (procedure/screening)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical candidates with epilepsy or brain tumor(s)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tissue sample (procedure/screening)|Tissue sampling|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure electrical activity in tissue sample |  | at tissue aremoval time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor, Epilepsy, Surgery, Brain
Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19

Study Overview
=================
Brief Summary
-----------------
Patients confirmed COVID-19 with gastrointestinal manifestations will be included. Characteristics and outcomes will be described for them.

Detailed Description
-----------------
Patients diagnosed as confirmed Covid-19 according to WHO and Egyptian Ministry of Health and Population (MOH) definitions will be included.The following will be done for all patients: Demographic characters; age, sex, presence of co-morbidities such as hypretension, diabetes mellitus, obstructive lung diseases, ischemic heart diseases...etc, history of contact to covid-19 patients or recent travelling abroad.Clinical Characteristics: By recording of clinical manifestation such as fever, cough, shortness of breath, sore throat, change in taste or smell, nausea,vomiting and diarrhea will be done. Complications and the type of treatment received by the patients will also be described including mechanical ventilation. Laboratory data will also be included : blood picture, liver enzymes, ESR,CRP, serum ferritin, D-dimer and troponin. Follow up of the patients will be done until improvement, deaths or complications to determine disease outcomes.

Official Title
-----------------
Characteristics and Outcomes of Gastrointestinal Manifestations of COVID-19

Conditions
-----------------
Infectious

Intervention / Treatment
-----------------
* Diagnostic Test: Laboratory tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Covid-19 with GIT manifestations Exclusion Criteria: Patients refuse to participate
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Covid-19<br>COVID-19 patients presented with gastrointestinal manifestations | Diagnostic Test: Laboratory tests<br>* Laboratory tests such as CBC, Liver function and CRP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical data questionnaire | Clinical characteristics of age, sex, comorbidities and symptoms. | 2 months | 
| Tests such as CBC | Laboratory characters | 2 months | 
| liver function test | Laboratory characters | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, characteristics, Outcome, Egypt
Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .

Study Overview
=================
Brief Summary
-----------------
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.

Official Title
-----------------
Diagnostic Accuracy of Renal, Carotid, and Aortic Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery.

Conditions
-----------------
Cardiac Surgical Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >= 18 years undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement Exclusion Criteria: chronic kidney diseases (estimated GFR < 60 ml/min/1.73m2) prior carotid endarterectomy known carotid artery stenosis of 50% or greater dissection or aneurysm involving renal or carotid arteries scheduled aortic or aortic valve surgery heart transplant intraaortic balloon pump, ventricular assist device, or exctracorporeal membrane oxygenation support.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury - Lassnigg grade-minimal |  | 2nd postoperative day |
Bacteriotherapy to Improve Underarm Odor

Study Overview
=================
Brief Summary
-----------------
The goal is to improve the underarm odor by changing the microbiome. The autochthonous bacterial community is replaced by a non-smelling microbiome, by daily application of bacteria in a spray.

Detailed Description
-----------------
Participants are recruited and selected based on their initial underarm odor and underarm microbiome. The participants use two sprays: one spray containing the bacteria, and the other nothing (placebo). Participants do not know which spray they have. They use one spray during one month, and meanwhile take samples of their underarm microbiome (for sequencing), volatome (for GC/MS analysis) and odor (for odor panel analysis). Samples are stored in the freezer and brought to the university after one month, when they receive the second spray. The bacterial spray contains bacteria that are correlated with good underarm odor.

Official Title
-----------------
Bacteriotherapy to Improve Underarm Odor

Conditions
-----------------
Bromhidrosis

Intervention / Treatment
-----------------
* Biological: Bacterial spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above average underarm malodor microbiome dominated with malodorous bacteria Exclusion Criteria: not healthy microbiome with too high levels of Staphylococcus

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: two groups of 30 people, one month of bacterial spray use and the other month placebo.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo arm<br>Placebo spray used during one month | Biological: Bacterial spray<br>* Bacterial spray containing bacteria that do not cause underarm malodor<br>|
| Active Comparator: Treatment arm<br>Bacteria spray used during one month | Biological: Bacterial spray<br>* Bacterial spray containing bacteria that do not cause underarm malodor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved underarm odor | Odor panel and GC/MS results provide insights on underarm odor development | 1 month |
Autologous Platelet Lysate in Corneal Epithelial Defects

Study Overview
=================
Brief Summary
-----------------
Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.

Detailed Description
-----------------
Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.

Official Title
-----------------
The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects

Conditions
-----------------
Persistent Corneal Epithelial Defect

Intervention / Treatment
-----------------
* Biological: Platelet Lysate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitive ability to understand and sign the consent form. Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops). Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body. Good compliance with the study regimen and availability for the duration of the entire study period. Exclusion Criteria: Corneal ulcers which developed tissue scars. Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 78 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Lysate<br>Autologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks. | Biological: Platelet Lysate<br>* Eye drops of Platelet Lysate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops | Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the efficacy by clinical judgment | Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Persistent corneal epithelial defect, Platelet Lysate
Safety Study of Repeat Doses of SUSTOL in Adults

Study Overview
=================
Brief Summary
-----------------
This is a repeat-dose, single-arm, open-label study that will evaluate the potential impact of subject-reported injection-site reactions (ISRs) on activities of daily living (ADL) in adult subjects with cancer receiving SUSTOL® (granisetron) extended-release injection, for subcutaneous use for prevention of chemotherapy induced nausea and vomiting (CINV) for up to 4 sequential cycles of chemotherapy (Moderately Emetogenic Chemotherapy [MEC] or Anthracycline and Cyclophosphamide [AC] combination regimen).

Official Title
-----------------
A Phase 4, Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy

Conditions
-----------------
Chemotherapy-Induced Nausea and Vomiting (CINV)

Intervention / Treatment
-----------------
* Drug: SUSTOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has cancer and is scheduled to receive MEC or AC regimen for at least 4 cycles of chemotherapy, and is prescribed SUSTOL for CINV prevention. Has an Eastern Cooperative Oncology Group performance status of 0 or 1. Has life expectancy of greater than 6 months. Able to receive standardized doses of dexamethasone for the prevention of emesis. Females are eligible only if not pregnant, not lactating, not planning to become pregnant during the study. Exclusion Criteria: Has hypersensitivity to granisetron, any component of SUSTOL, or any other 5-HT3 Receptor Antagonists. Severe renal impairment (creatinine clearance [CLcr] <30 mL/min). Symptomatic primary or metastatic central nervous system (CNS) disease. Has participated in an interventional clinical study within 30 days of Cycle 1 Day 1. Investigator assessment that subject would not be a good fit for the trial.

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Drug: SUSTOL<br>* SUSTOL 10 mg Subcutaneous (SC) on Day 1 of up to 4 cycles.<br>* Other names: Granisetron extended-release injection for subcutaneous use;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with potential impact of subject-reported ISRs on ADL in adult subjects with cancer administered SUSTOL. |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTX-100, APF530
Effects of Synbiotic Supplementation in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome and insulin resistance will be measured every 7 weeks during the study course.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Synbiotic
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report BMI : 25≥ BMI ≥ 40 Exclusion Criteria: Use antibiotic 2 weeks before recruitment to the study A history of alcohol consumption Pregnancy & Breast feeding , Professional athelets A history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synbiotic<br>Each synbiotic capsule (Protexin, UK) contained 2 × 108 CFU of seven strains of friendly bacteria (Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus bulgaricus), prebiotics (FOS [Fructooligosaccharide]), and probiotics culture (Magnesium stearate [source: mineral and vegetable], and vegetable capsule [hydroxypropyl methyl cellulose]) | Dietary Supplement: Synbiotic<br> <br> |
| Placebo Comparator: Placebo<br>250 mg Maltodexterin | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR |  | 28 weeks |