linjc16/ctgov huggingface dataset:
Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is: How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.

Detailed Description
-----------------
Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI

Official Title
-----------------
Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Procedure: Intravitreal dexamethasone implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with type 1 or type 2 diabetes diabetic macular edema involving the foveal center with CRT >300 μm measured by OCT at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF Exclusion Criteria: uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time previous IDI any condition precluding adequate fundus visualization uncontrolled glaucoma papillary excavation ≥ 0.7
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: Intravitreal dexamethasone implant<br>All patients were included here and received one intravitreal dexamethasone implant 0.7mg | Procedure: Intravitreal dexamethasone implant<br>* Intravitreal implant of dexamethasone 0.7 mg with previous topic anesthesia and iodine drops<br>* Other names: Ozurdex implant;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central retinal thickness | Difference among the baseline and the posterior measurements of the CRT with OCT | Prospective: from baseline to 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best Corrected Visual Acuity | Measurement of Best Corrected Visual Acuity before and after IDI | Prospective: from baseline to 1 month post IDI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic macular edema, Ozurdex, Dexamethasone intravitreal implant
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Pragmatic Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. The findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.

Official Title
-----------------
Effect of Advanced Care at Home vs. Traditional Brick-and-Mortar Hospital Care in Acutely Ill Adults: A Pragmatic Clinical Trial

Conditions
-----------------
Acute Illness

Intervention / Treatment
-----------------
* Other: Advanced Care at Home (ACH)
* Other: Traditional Brick-and-Mortar Hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, 18 years of age and older Present to one of the participating hospitals Have a chief complaint of one of the target diagnoses Are within a certain geographical area (based on zip codes) Have a health insurance plan that covers ACH services Have the capacity to consent or could assent with the consent of a health care proxy who is physically present Exclusion Criteria: Not suitable for ACH or inpatient hospital care as determined by the patient's clinical team Do not have the capacity to consent or assent with the assistance of a health care proxy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced Care at Home (ACH)<br>Patients will receive inpatient hospitalization at home. | Other: Advanced Care at Home (ACH)<br>* Inpatient hospitalization offered in the home setting.<br>|
| Active Comparator: Traditional Inpatient (Brick-and-Mortar) Hospital Care<br>Patients will receive inpatient hospitalization at the hospital. | Other: Traditional Brick-and-Mortar Hospitalization<br>* Inpatient hospitalization offered in the hospital setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is a composite outcome of all-cause mortality | The rate of death | 30 days post-discharge | 
| 30-day readmission | Readmission between discharge from ACH/traditional inpatient hospital care and 30 days post-discharge | 30 days post-discharge |
Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

Study Overview
=================
Brief Summary
-----------------
This observational study is a large-scale, prospective, and multi-institutional observational study. Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.

Detailed Description
-----------------
Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ). The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).

Official Title
-----------------
A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet in Patients With Erosive Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Fexuprazan Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged 19 years to 75 years (on registration date) Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator. Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit. Patient who agreed to participate in this observation study and signed Informed Consent Form Exclusion Criteria: A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations Pregnant and lactating women Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fexuprazan Hydrochloride|Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average score change | Average score change in Reflux Disease Questionnaire | at 0 weeks (up to 3 days) | 
| Average score change | Average score change in Reflux Disease Questionnaire | at least 4 weeks (up to 8 weeks) |
A National Observation Study on Pelvic Floor Dysfunction Diseases in China

Study Overview
=================
Brief Summary
-----------------
In this protocol, our team intend to conduct a nation-wide multicenter cohort research to screening for PFD symptoms in early postnatal women in China. Beside clinically significant symptoms, we will also measure the recovery trend of pelvic muscle function, aiming to determine the clinically significant alterations that are sensitive to predict the PFD risks. This is an observational prospective cohort study, following a natural regular clinical visit process. Patients will voluntarily decide whether to receive PFD related treatments and the types of treatments to adopt. Therefore, we will also be able to compare the effectiveness of treatments.

Official Title
-----------------
A National Observation Study on Pelvic Floor Dysfunction Diseases Based on Electrophysiological Technology and a Newly Established Prevention and Treatment System in China

Conditions
-----------------
Pelvic Floor Dysfunction

Intervention / Treatment
-----------------
* Behavioral: Postpartum pelvic floor rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postpartum women: 42 days+15 days after delivery Age:20-45 Consent to participate in the research. Exclusion Criteria: Refuse gynecological and/or obstetrical examinations. Diagnosed with psychiatric disorders Diagnosed with other severe illnesses Received pelvic floor treatments Other factors that may confound with the research

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Postpartum pelvic floor rehabilitation|biofeedback with Pelvic floor muscle training (PFMT)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence | UI will be diagnosed via gynecological examination and self-reported symptoms | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic organ prolapse | Physical examinations will be performed to diagnose the incidence and degree of organ prolapse (i.e. anterior vaginal wall prolapse, posterior vaginal wall prolapse, uterine prolapse, and vaginal apex prolapse) according to the Pelvic Organ Prolapse Quantification (POP-Q). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic floor dysfunction, postpartum women
A Study of Spoken Language in Mania

Study Overview
=================
Brief Summary
-----------------
This research is being done to find if there are changes with voice and speech during episodes of mania.

Official Title
-----------------
Computational Analysis of Spoken Language in Mania

Conditions
-----------------
Manic Episode, Bipolar I Disorder

Intervention / Treatment
-----------------
* Behavioral: Research interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent before any study procedures are performed English speaker Documented clinical diagnosis for Bipolar I Disorder Undergoing hospitalization, or boarding in the Emergency Department, for mania as determined by primary clinical staff Exclusion Criteria: Positive urine drug screen for amphetamines or cocaine. Expressing paranoid delusions regarding electronic surveillance. Documented clinical diagnosis of developmental delay. Currently involuntarily hospitalized. Deemed at risk for aggression. Failure to comprehend study objectives via comprehension questionnaire. Individuals who have a guardian and are unable to consent for themselves. Current communicable disease requiring isolation.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recording Session During Hospitalization<br>While inpatient, participants will undergo a research interview with recorded audio. | Behavioral: Research interview<br>* Research interview to capture speech data with high quality cardioid headset microphone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acoustic Differences | The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time. | Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment | 
| Syntactical Differences | Audio data will be transcribed using voice to text software and then analyzed for syntactical elements of speech including sentence structure and grammar. | Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment | 
| Semantic Differences | Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level. | Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment |
What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?

Study Overview
=================
Brief Summary
-----------------
Various to-be-discard material from IVF treatment cycle will be collect and examined, aiming to identify potential reasons of successful outcome or cycle failure.

Detailed Description
-----------------
Usually around 2/3 of IVF material will be discarded at the end of each treatment cycle, including immature oocytes, abnormal fertilized zygotes, poor grading embryos, spent culture medium, etc. Next generation sequencing will be performed for DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling, and protein profile will be investigated in a pool sample. By applying various diagnostic tools against those to-be-discard biomaterials, we aim to identify potential underlying reasons of indicating either for an IVF failure or a successful cycle, and try to develop a non-invasive testing method for embryo quality check; better detection of the embryo implantation potential and eventually further increase the IVF clinical outcome.

Official Title
-----------------
What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?

Conditions
-----------------
IVF, Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending the Assisted Reproductive Technology (ART) Unit of the Chinese University of Hong Kong for ART treatment. Participant able to give voluntary, written, informed consent to participate in the study. Exclusion Criteria: Patient using donor gamete in IVF treatment Patient refuses to join and failed to giving consent for any reasons

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA/RNA sequencing data | DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling. Next generation sequencing will be performed to determine the sequence of DNA/RNA for our collected samples. | Through study completion, around 3 year | 
| Proteomic profile | Protein profile will be investigated in a pool sample, treated samples will go for mass spectrometry (MS) data acquisition and finally destined for data analysis and interpretation. | Through study completion, around 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst formation rate | Number of blastocysts out of fertilized oocytes observed 5 days after fertilization | 5 days after fertilization | 
| Clinical pregnancy rate | Clinical pregnancy confirmed by ultrasound | Around 5 weeks after embryo transfer | 
| Live birth rate | Birth of a living infant after embryo transfer | Around 9 months after embryo transfer |
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy

Study Overview
=================
Brief Summary
-----------------
Spleen-persevering distal pancreatectomy (SP-DP) has been widely advocated as a routine procedure for benign or low-grade malignant tumors in the pancreatic body and tail, especially with a minimally invasive approach. Spleen preservation can be accomplished with Kimura technique (KT) or Warshaw technique (WT) Both of the two techniques were proved to be feasible and efficient. However, the perioperative outcomes and long-term benefits between patients with KT and WT in spleen-persevering minimally invasive distal pancreatectomy (SP-MIDP) remains controversial. Several small series have reported a slightly higher prevalence of postpancreatectomy hemorrhage (PPH) in patients who undergo KT than those undergo WT. The exposure of splenic vessels to erosive pancreatic juice and the preservation of splenic vessels itself may explain the higher chance of PPH in KT. Larger volume studies are warranted to confirm this finding and to clarify the clinical significance. This study compared the perioperative outcomes between the two spleen-preserving techniques, with a focus on parameters relating to perioperative patient safety. Especially, the incidence and clinical relevance of PPH in SP-MIDP were evaluated.

Official Title
-----------------
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy: With a Specific Focus on Perioperative Patient Safety

Conditions
-----------------
Distal Pancreatectomy, Spleen Preservation, Postpancreatectomy Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Splenic vessels preservation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathological diagnosis of benign or low-grade malignant pancreas tumors. Exclusion Criteria: incomplete medical records, history of previous splenectomy, high-grade malignant pancreas tumors, conversion to open DP (ODP).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kimura technique (KT)<br>Spleen preservation is accomplished by sparing the splenic vessels. | Procedure: Splenic vessels preservation<br>* preservation the splenic vessels<br>|
| Warshaw technique (WT)<br>Spleen preservation is accomplished by sacrificing the splenic vessels and maintaining vascularity through the preserved short gastric and left gastroepiploic vessels. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major complications | (Clavien-Dindo grade ≥ III) | Within 30 days of SP-MIDP |
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD

Study Overview
=================
Brief Summary
-----------------
The study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD

Detailed Description
-----------------
This study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD. Participants were randomly selected to participate in the study. Then divided into the groups (intervention and placebo). Intervention received supplementation for 12 weeks and placebo received same capsule was made for placebo groups.

Official Title
-----------------
Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With Non-alcoholic Fatty Disease (NAFLD); RCR

Conditions
-----------------
Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Combination Product: Multiviamins and minerals
* Combination Product: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with NAFLD diagnosed Exclusion Criteria: subjects who in the last 6 months received vitamin or mineral supplementation, those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 78 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: Parallel Assignment
Interventional Model Description: Intervention group received multivitamin and minerral
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: effect multivitamin and minerals on NAFLD for 12 weeks<br>The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks. | Combination Product: Multiviamins and minerals<br>* The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>the control group took a placebo prepared with the same shape and size of supplements. | Combination Product: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multivitamin and minerals supplementation has role in reduce liver enzymes | Multivitamin and minerals supplement was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests. | 12 weeks |