linjc16/ctgov huggingface dataset:
Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus

Study Overview
=================
Brief Summary
-----------------
Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus

Conditions
-----------------
Hydrops in Keratoconus

Intervention / Treatment
-----------------
* Drug: Gas SF6 (Sulfur Hexafluoride)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hydrops Exclusion Criteria: Age < 18 years old

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Gas SF6 (Sulfur Hexafluoride)<br>* ONCE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrops resulotion |  | weeks |
Effect of Tegaserod on Gastric Emptying in Patients With Diabetic Gastroparesis

Study Overview
=================
Brief Summary
-----------------
This study will assess gastric emptying in patients with symptoms of diabetic gastroparesis treated with tegaserod over 2 weeks.

Official Title
-----------------
An Open-label Pilot Trial to Assess the Effect of Tegaserod on Improvement of Gastric Emptying in Patients With Diabetic Gastroparesis and Upper Gastrointestinal Symptoms

Conditions
-----------------
Gastroparesis, Diabetes

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females and males 18 to 75 years of age History of type I or type II diabetes mellitus for more than 3 years History of upper gastrointestinal symptoms consistent with diabetic gastroparesis Hemoglobin A1c < 9.5% Delayed gastric emptying Exclusion Criteria: Abnormal endoscopy finding that can explain the presence of gastroparesis symptoms Medical conditions affecting gastric emptying A clinically significant medical condition that would interfere with the patient completing the trial Clinically significant abnormal creatinine level Known allergies to the same class of drug and/or allergies to eggs Severe obesity Other protocol-defined inclusion/exclusion criteria may apply.

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients treated with tegaserod that improve gastric emptying at Week 2 as compared with baseline via a solid phase technetium gastric emptying time (GET) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patients treated with tegaserod relative to: The proportion of patients that normalize gastric emptying |  |  | 
| Symptoms of diabetic gastroparesis including postprandial fullness, early satiety, bloating, nausea and vomiting, and abdominal discomfort |  |  | 
| Volume and symptomatic response to a gastric satiety drink test (GSDT) |  |  | 
| Electrogastrography (EGG) |  |  | 
| The safety and tolerability of tegaserod |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tegaserod, diabetes, diabetic gastroparesis, gastric emptying, gastric retention, electrogastrography
Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.

Study Overview
=================
Brief Summary
-----------------
This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.

Official Title
-----------------
Acute Performance Evaluation of the QDOT Micro™ Catheter Used With nGEN Generator in Treatment of Patients With Atrial Fibrillation.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: QDOT MICRO System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with symptomatic paroxysmal or early persistent AF undergoing a catheter ablation procedure through pulmonary vein isolation. Age 18 or older. Signed the Patient Informed Consent Form (ICF). Exclusion Criteria: If the patient has had a ventriculotomy or atriotomy within the preceding twelve weeks. Presence of a myxoma or an intracardiac thrombus. Presence of prosthetic valves. Presence of active systemic infection Patient with an interatrial baffle or patch Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paroxysmal and Early Persistent AFIB<br> | Device: QDOT MICRO System<br>* QDOT Micro Catheter with nGEN Generator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved Acute Procedural Success | Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all targeted pulmonary veins (PVs) after administration of adenosine/isoproterenol using the nGEN / QDOT Micro Ablation System. The participants without any QMODE+ applications for PVI were considered as a failure. | Up to 104 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | Number of participants with AEs were reported. An AE was any untoward medical occurrence whether or not related to the study device or ablation procedure. | Up to 104 days |
Extracorporeal Membrane Oxygenation (ECMO) and Coronavirus Disease (COVID) 19

Study Overview
=================
Brief Summary
-----------------
The role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.

Detailed Description
-----------------
The main objective of this study is to evaluate the hospital survival of COVID-19 patients supported by venovenous or venoarterial ECMO in a multicenter registry. The secondary objectives are to describe the characteristics of COVID-19 patients who have received ECMO support, to identify the risk factors associated with hospital mortality, to analyze the outcomes after ECMO weaning including survival at day 28 and day 90, and to analyze the utility of a circulatory support mobile unit in a severe pandemic Inclusions are both prospective and retrospective in order to collect data over the whole pandemic

Official Title
-----------------
Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study

Conditions
-----------------
ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2, Acute Refractory Heart Failure Related to SARS-CoV 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All COVID-19 patients, adults or children, Tested positive by RT-PCR for SARS-CoV2 (nasopharyngeal swabs, sputum, endotracheal aspiration, bronchoalveolar lavage or stool sample) and / or with a diagnosis made on chest CT findings, Supported by venovenous or venoarterial ECMO Exclusion Criteria: Temporary legally protected Adults over a set period or waiting for protection supervision, guardianship Patients or proxies who express their opposition to study participation
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 |
| --- | --- | --- |
| Hospital mortality | Hospital mortality | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Day 28 | Mortality Day 28 | Day 28 | 
| Mortality Day 90 | Mortality Day 90 | Day 90 | 
| Ventilator-free days | Ventilator-free days | Day 28 | 
| Intensive care unit-free days | ICU-free days | Day 28 | 
| Hospital-free days | Hospital-free days | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECMO, COVID-19, SARS-CoV2, ARDS, Myocarditis, Heart failure
Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the countries participating in the study. The primary outcome is the incidence of major hypoglycaemic events reported as serious adverse drugs reaction conditions on hypoglycaemic events.

Official Title
-----------------
Observational Study of Safety and Effectiveness of NovoMix® 30 (Biphasic Insulin Aspart) for the Treatment of Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age according to approved label and physician discretion Type 2 diabetes including newly-diagnosed subjects who have never received insulin or an insulin analogue before Exclusion Criteria: Subjects who previously enrolled in this study Subjects who are unlikely to comply with protocol requirements Hypersensitivity to biphasic insulin aspart or to any of the excipients Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>biphasic insulin aspart | Drug: biphasic insulin aspart<br>* Start dose and frequency to be prescribed by the physician as a result of a normal clinical evaluation.<br>* Other names: NovoLog Mix 70/30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major hypoglycaemic events reported as serious adverse drug reactions |  | during treatment |
Effectiveness Study of the International Child Development Program

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of the International Child Development Program (ICDP). Research questions to be answered: Does the ICDP affect children's psychosocial functioning compared to treatment as usual? Does the ICDP change parent-child interaction?

Official Title
-----------------
The Effect of the International Child Development Program - A Randomised Controlled Trial

Conditions
-----------------
Psychosocial Functioning, Child Development

Intervention / Treatment
-----------------
* Behavioral: ICDP
* Behavioral: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SDQ >/= 9, subjective treatment need Exclusion Criteria: Already in treatment

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 4 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 |
| --- | --- |
| Experimental: ICDP<br>International Child Development Program | Behavioral: ICDP<br>* Parent training group<br>* Other names: International Child Development Program;|
| Active Comparator: Treatment as usual<br>Treatment as usual | Behavioral: Treatment as usual<br>* Parent and/or child focused interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychosocial functioning |  | study terminated | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child psychosocial Functioning
Transrectal Ultrasound (TRUS) in Finding Tumors During Robotic-Assisted Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To assess the feasibility and limitations of using a mechanically-manipulated transrectal ultrasound (TRUS) probe for TRUS evaluation during a da Vinci robotic-assisted laparoscopic prostatectomy (RALP). II. To collect TRUS evaluation data during RALP to guide us in deciding whether and how the mechanical manipulation of the TRUS probe will allow sufficient clarity of ultrasound imaging. OUTLINE: Patients undergo TRUS during RALP. After the completion of study treatment, patients are followed up at 7 days.

Official Title
-----------------
Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: ultrasound imaging
* Procedure: robot-assisted laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing Robotic Assisted Laparoscopic Prostatectomy Exclusion Criteria: Known or discovered rectal pathology Bleeding hemorrhoids Rectal stenosis Any prior rectal surgeries Prior rectal radiation Any known rectal disease

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (TRUS)<br>Patients undergo TRUS during RALP. | Procedure: ultrasound imaging<br>* Undergo transrectal ultrasound<br>* Other names: ultrasound test;Procedure: robot-assisted laparoscopic surgery<br>* Undergo robotic-assisted laparoscopic prostatectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications. |  | 7 days post-RALP |
Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression

Study Overview
=================
Brief Summary
-----------------
Patients' subjective complaints about pain intensity are difficult to objectively evaluate, and may lead to inadequate pain management, especially in patients with communication difficulties.

Detailed Description
-----------------
Analgesia nociception index (ANI 0-100) and patient-reported numeric rating scale (NRS 0-10) were trained on a convolutional neural network (CNN) model by linking the patients' facial expression with the score. By applying the predicted pain score by the AI model to evaluate pain, it is intended to measure the intensity of pain in an automatic, fast, and objective way for appropriate pain management.

Official Title
-----------------
Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression Recognition and Analgesia Nociception Index

Conditions
-----------------
Artificial Intelligence, Facial Expression, Analgesia, Pain, Postoperative

Intervention / Treatment
-----------------
* Other: taking a picture of a painful facial expression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 19-75 years who were scheduled for elective laparoscopic abdominal surgery under general anesthesia American Society of Anesthesiology (ASA) class I-II Exclusion Criteria: Patients who have difficulty in communicating and reporting pain Underlying diseases: liver, kidney, brain Patients with BMI greater than 30 and less than 18.5 Alcohol or drug dependent patients Patients with severe or acute respiratory failure Opioid, NSAID allergy Patients who are scheduled to be admitted to the intensive care unit after surgery Patients who undergo cooperative surgery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: taking a picture of a painful facial expression|Immediately after surgery, the patient's facial expression and the NRS score and ANI score reported by the patient are checked together.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial expression | Painful facial expression | immediately preoperative, postoperative time | 
| analgesia nociception index | ANI score | immediately preoperative, postoperative time | 
| numeric rating scale | pain score | immediately preoperative, postoperative time |
Prospectively Assessing Pain After Breast Surgery

Study Overview
=================
Brief Summary
-----------------
Reducing post-operative pain and reducing the use of opioid narcotics are independently valuable goals. Before studying newer techniques that may help us achieve these goals, we need objective data on how much pain normally occurs after breast surgery done with standard-of-care techniques. This study was designed to obtain baseline data.

Detailed Description
-----------------
Breast surgeons may be able to reduce post-operative pain and the need for opioid narcotics by utilizing regional anesthesia techniques (modified regional blocks) during surgery. To test this hypothesis, we need baseline (pre-intervention) data on how much pain patients experience when breast surgery is done without blocks. In this study, we will gather data on (1.) pain pills used after surgery, and (2.) pain scores in the recovery room. This will allow us to establish how much pain normally occurs after axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy, done by a participating breast surgeon. After analyzing this data, our plan is to do a second study, with a new group of patients, to assess whether there is any change in outcome after surgeons implement these new techniques.

Official Title
-----------------
Prospectively Assessing Pain After Breast Surgery

Conditions
-----------------
Pain, Postoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Female, age 18 or older. Scheduled for axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy. Able to take oral narcotics and be willing to adhere to the prescribed regimen. Exclusion Criteria: A history of chronic pain Any previously diagnosed chronic pain syndrome. Prior use of narcotics, on more than 5 days in the past 3 months or 10 days in the past year.

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

Sexes Eligible for Study
-----------------
Female

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores in recovery room | EMR documentation from the recovery room | The day of surgery | 
| Number of narcotic pain pills used after surgery |  | Assessed approximately a week after surgery |
Online Question-answering and Conventional Consultation With a Dermatologist

Study Overview
=================
Brief Summary
-----------------
Comparison of online question-answering system and conventional consultation for dermatological questions: same diagnosis? same information, which had been collected? same recommendations about treatment? what were the relevant differences of the two?

Detailed Description
-----------------
mainly, ICD codes and dermatological diagnosis codes according to the AAD will be used.

Official Title
-----------------
Online Question-answering and Conventional Consultation With a Dermatologist

Conditions
-----------------
Skin Diseases

Intervention / Treatment
-----------------
* Procedure: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - a conventional dermatological consultation after a question in the online question-answering system. Exclusion criteria: -power of veto after information of patient

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observation group<br>observation | Procedure: observation<br>* intervention is the contact with online question answering serice ad subseudd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of online and clinical diagnosis by Spearman's Rho |  | physical consultation date |