linjc16/ctgov huggingface dataset:
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas

Study Overview
=================
Brief Summary
-----------------
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study

Detailed Description
-----------------
Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks The patients will be observed and followed to determine whether there is regression of NHL after antiviral treatment. Conventional chemotherapy should be initiated shortly in cases without regression.

Official Title
-----------------
Interferon-free Antiviral Treatment of HCV-Positive Genotype 1b Related Indolent Non-Hodgkin Lymphomas Patients Using Daclatasvir and Asunaprevir: A Pilot Study

Conditions
-----------------
Hepatitis c

Intervention / Treatment
-----------------
* Drug: Daclatasvir+ Asunaprevir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 to 70 years of age Who had chronic HCV genotype 1b infection An HCV RNA level of 105 IU per milliliter or higher Being diagnosed to be low grade B cell non-Hodgkin lymphoma Exclusion Criteria: Patients with hepatitis B virus infection, Other liver diseases HIV infection, Pre-existing HCV variants in the NS5A domain included Q30R, L31 M/V, and Y93C/N Evidence of cirrhosis, as documented by means of either liver biopsy or assessment of imaging results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Daclatasvir + Asunaprevir<br>Prospectively collect cases with NHL (n=10), having HCV genotype 1b related NHL, who will be treated with ASV (200 mg twice daily) + DCV(60 mg once daily) for 24 weeks . | Drug: Daclatasvir+ Asunaprevir<br>* HCV clearance and complete regression of NHL by ASV+ DCV<br>* Other names: DCV;ASV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV clearance and complete regression of NHL by ASV+ DCV | patients who had undetectable HCV RNA levels at or after week 4. Viral relapse was defined as confirmed detectable HCV RNA levels during the post-treatment follow-up period in patients who had had undetectable HCV RNA levels at the end of treatment | 2years |
The Effect of Oxytocin on Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
The investigators have seen that oxytocin lowers satiety in healthy subjects. Patients with dyspepsia suffers from decreased accommodation and increased satiety postprandially. The investigators now want to examine whether oxytocin may diminish symptoms in these patients.

Detailed Description
-----------------
Patients will come twice for a slow satiety drinking test. Once they will get saline infusion and once oxytocin 40 mU/min. At the same time they register satiety on a VAS scale.

Official Title
-----------------
The Effect of Oxytocin on Satiety in Patients With Dyspepsia

Conditions
-----------------
Dyspepsia, Lack of Satiety

Intervention / Treatment
-----------------
* Drug: oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dyspepsia Exclusion Criteria: Age > 65 years Cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin, satiety<br>Oxytocin is given as infusion to examine if this decreases satiety compared to saline during a drinking test | Drug: oxytocin<br>* 40mU/min as infusion of oxytocin<br>* Other names: syntocinon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety | The investigator want to examine whether oxytocin leads to lower satiety scores after intake of the same volume of nutrient | 2 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, satiety, dyspepsia
A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.

Official Title
-----------------
An International, Cross Sectional, Non-interventional, Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

Conditions
-----------------
Neuroendocrine Tumors, Carcinoid Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-patients 18 years of age and older, who have agreed to participate in the study Diagnosed with a Neuroendocrine tumour (NET) and receiving treatment with Somatuline Autogel Exclusion Criteria: Subjects for whom there are reasons that may hinder the conduct of the study (patients who have difficulty expressing themselves or who are unable to complete the questionnaires, or with insufficient data in the their files will not be enrolled in the study).

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 |
| --- | --- | --- |
| Subject's overall satisfaction regarding control of diarrhea | Use of questionnaires to assess patient satisfaction (Likert scale). | Day of survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on daily activities of the clinical manifestations of diarrhea | Use of questionnaires to assess symptom severity and impact on patient's daily activities (CGI-S). | Day of survey |
Multiple Ascending Dose Study of HM12460A in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 multiple ascending dose (MAD) study, conducted in subjects with Type 2 Diabetes Mellitus.

Official Title
-----------------
A Phase 1, Multiple Ascending Dose, Glucose Clamp Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM12460A Compared to Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Biological: HM12460A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Female subjects must be non-pregnant and non-lactating Exclusion Criteria: Recurrent severe hypoglycemia or hypoglycemic unawareness or recent severe ketoacidosis, as judged by the Investigator Pregnant or lactating women Participation in an investigational study within 30 days prior to dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Single dose subcutaneous administration (Dose A) | Biological: HM12460A<br>* HM12460A is a long-acting insulin<br>|
| Experimental: Cohort 2<br>Single dose subcutaneous administration (Dose B) | Biological: HM12460A<br>* HM12460A is a long-acting insulin<br>|
| Experimental: Cohort 3<br>Single dose subcutaneous administration (Dose C) | Biological: HM12460A<br>* HM12460A is a long-acting insulin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | An adverse event is any undesirable and unintended medical event occurring to a subject in a clinical study, whether or not related to the investigational products. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of HM12460A | - Maximum concentration of HM12460A over the entire dosing period | 1 month | 
| AUC of HM12460A | - Area Under the Curve of HM12460A over the entire dosing period | 1 month |
Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Study Overview
=================
Brief Summary
-----------------
Ketamine seems an obvious choice in the setting of an emergency department in laceration repair. Lidocaine is the local anesthetics widespread used. Ketamine leads to dissociative amnesia. Theoretically , lidocaine is not useful in laceration repair using ketamine. However, lidocaine is used with ketamine in many emergency department. The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure

Official Title
-----------------
Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine

Conditions
-----------------
Conscious Sedation Failure During Procedure, Analgesia, Anesthesia

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who need suturing for laceration under procedural anesthesia using ketamine Exclusion Criteria: contraindication to ketamine and lidocaine patients involved to other studies more or equal to American Society of Anesthesiologist (ASA) class III not alert

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 10 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 |
| --- | --- |
| Experimental: Lidocaine<br>Proper amount of lidocaine will be injected lacerated wound. dosage form: fluid dosage: not exceeding 1mg/kg frequency: once duration: n/a | Drug: Lidocaine<br>* Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.<br>|
| Placebo Comparator: Normal saline<br>Normal saline will be used as a placebo for lidocaine | Drug: Normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Hospital of Eastern Ontario Pain Scale (CHEOPS | The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound. | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation scale | The investigators will measure sedation scale with Ramsey Sedation Scale. | up to 1 hour | 
| Complication | The investigators will measure complication with continuous oxygen saturation by pulse oximetry (SpO2) and ECG monitoring and record the monitoring result every 5 minutes. | up to 1 hour | 
| Satisfaction of parents and clinicians | The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale | up to 1 hour |
Exploration of Autonomic Nervous System by Photoplethysmography

Study Overview
=================
Brief Summary
-----------------
The autonomic nervous system state (ANSS) and the autonomic nervous system state index (ANSSi) - two indices derived from the pulse photo-plethysmography analysis - have been recently advocated as a measure of sympathetic activity in the anesthetized patients, but their validity has not been yet demonstrated. We will conduct a study aiming to assess if ANSS and ANSSi reflect autonomic nervous system modulation on cardiovascular system in healthy humans under general anaesthesia.

Conditions
-----------------
Intervention Affecting Autonomic Nervous System

Intervention / Treatment
-----------------
* Procedure: autonomic nervous system analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18 and 50 years American Society of Anaesthesiologists status I and II Exclusion Criteria: hypertension requiring pharmacological treatment or chronic cardiovascular disease arrhythmic cardiac disease (atrial fibrillation, atrial flutter, ectopic beats >5% of normal sinus beats) history of alcohol or drug abuse obesity (BMI>30) diabetes or other endocrine pathology (thyroidal or adrenal) peripheral neuropathy or any kind of chronic neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: autonomic nervous system analysis|electrocardiographic and pulse-photoplethysmographic waves of patients under general anesthesia for laparoscopic cholecystectomy will be recorded on a laptop pc for offline analysis of autonomic nervous system modulation a three main time point: 1) at baseline, before general anesthesia induction, 2) five min after tracheal tube placement, 3) five min after pneumoperitoneum insufflation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| autonomic nervous system activity during laparoscopic cholecystectomy (measured by pulse-photoplethysmography and heart rate variability analysis) | assessment of autonomic nervous system activity measured by pulse-photoplethysmography and heart rate variability analysis | 120 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| agreement of photoplethysmography and heart rate variability | assessment of agreement between pulse-photoplethysmography and heart rate variability as a measure of autonomic nervous system activity | 120 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autonomic nervous system, heart rate variability, laparoscopic surgery, general anesthesia, photoplethysmography
The Timing of Prophylactic Antibiotics in Cesarean Section and the Risk of Post-operative Febrile Morbidity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the timing of prophylactic antibiotic administration for cesarean section (immediate preoperative versus intraoperative administration) impacts the rate of postoperative febrile morbidity. The specific aim of the project is to test the hypothesis that preoperative antibiotic administration will decrease the rate of composite postoperative febrile morbidity.

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Drug: Timing of prophylactic antibiotic administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age > 36 weeks Ability to understand requirements of the study Elective/non-emergent cesarean section selected as route of delivery by treating physicians Exclusion Criteria: Known fetal anomaly Exposure to antibiotics within 7 days of admission, including intrapartum group B streptococcal (GBS) prophylaxis Emergent cesarean delivery (i.e. for fetal distress, maternal distress, obstetric hemorrhage) Overt maternal intrapartum infection requiring antibiotics Prolonged rupture of membranes (>18 hours)
Sexes Eligible for Study
-----------------
Female

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Timing of prophylactic antibiotic administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Nursing Students' Personality Traits and Competence in Workplace Violence Management

Study Overview
=================
Brief Summary
-----------------
Aim: The aim of this study was to determine the relationship between nursing students' personality traits and competence in workplace violence management. Background: Violence against nursing students is a growing concern in nursing education, clinical practice, and professional development and needs to be managed. Design: A cross-sectional study. Methods: This study was conducted with 321 nursing students in the summer of 2022.

Official Title
-----------------
Relationship Between Nursing Students' Personality Traits and Competence in Workplace Violence Management in Turkey: A Cross-sectional Study

Conditions
-----------------
Violence, Exposure to Violent Event, Nursing Student, Personality, Workplace Bullying

Intervention / Treatment
-----------------
* Other: A questionnaire with 47 items


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being in the nursing students at the research university, Being in the >18 years age, Agree to participate in the study Exclusion Criteria: Being in the <18 years age, Disagree to participate in the study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nursing students<br> | Other: A questionnaire with 47 items<br>* A form consisted of questions on introductory characteristics (age, sex, and class, among others), Big Five Inventory (BFI) to evaluate personality traits, and Management of Workplace Violence Competence Scale for Nursing Students in Areas of Clinical Practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine nursing students' personality traits | İn this study personality traits of nursing students was examined using the Big Five Inventory (BFI), and management of workplace Vvolence competence of nursing students was examined using the Management of Workplace Violence Competence Scale for Nursing Students in Areas of Clinical Practice. | 1 month | 
| To determine nursing students' competence in workplace violence management |  | 1 month | 
| To determine the relationship between nursing students' personality traits and competence in workplace violence management |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exposure to violence, nursing student, personality, violence, workplace
Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
The study will be conducted to investigate the pharmacokinetics of ceftaroline during continuous and intermittent renal replacement therapy.

Official Title
-----------------
Multiple-dose Pharmacokinetics of Ceftaroline During Continuous and Intermittent Renal Replacement Therapy in Patients Requiring Renal Replacement Therapy

Conditions
-----------------
Infection During Renal Replacement Therapy

Intervention / Treatment
-----------------
* Other: Ceftaroline in CRRT
* Other: Ceftaroline in IRRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years, able to give written informed consent Suspected or proven bacterial infection requiring parenteral antibiotic therapy. Renal replacement therapy (continuous or intermittent) Exclusion Criteria: Known hypersensitivity to ceftaroline or other cephalosporins, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents. An expected survival of less than two days. Known pregnancy Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study Ceftaroline as monotherapy for resistent species or fungal infections. Other reasons oposing the study participation on the discretion of the investigators

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRRT<br>Ceftaroline levels are measured in patients receiving intermittent renal replacement therapy | Other: Ceftaroline in IRRT<br>* Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy<br>|
| Experimental: CRRT<br>Ceftaroline levels are measured in patients receiving continuous renal replacement therapy | Other: Ceftaroline in CRRT<br>* Plasma levels of ceftaroline will be measured in patients receiving CRRT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of renal replacement therapy on the area under concentration curve of ceftaroline plasma concentration levels. | Pharmacokinetic samples are drawn on multiple timepoints from each patient during his participation. | day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal replacement therapy, HD, CVVH, ceftaroline, pharmacokinetics