linjc16/ctgov huggingface dataset:
Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

Official Title
-----------------
Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age (18-80) years old. sex:both male and female. intubated and mechanically ventilated patients. Exclusion Criteria: 1.Patient's relatives refusal. 2. burns as admitting diagnoses. 3.patients with any renal pathology(such as chronic glomerulonephritis, pyelonephritis and diabetic nephropathy). 4. pregnancy or lactation. 5. serious central nervous system pathology (acute stroke, uncontrolled seizures, severe dementia). 6. acute hepatitis or severe liver disease (Child-Pugh class C). 7. unstable angina or acute myocardial infarction, left ventricular ejection fraction less than 30%, heart rate less than 50/min, second- or third-degree heart block, or systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam group<br> | Drug: Midazolam<br>* midazolam infusion by 0.03-0.3mg/kg in increments of 1-2.5mg followed by Maintenance dose: 0.03-0.2mg/kg/hour for midazolam.<br>|
| Active Comparator: dexmedetomidine group<br> | Drug: dexmedetomidine<br>* dexmedetomidine infusion 1 µg/kg dexmedetomidine for 10 minutes followed by a continuous IV infusion at 0.2-0.3 µg/kg/hour .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury | urinary kidney injury molecule | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of ICU stay | days of ICU stay | 10 days |
Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain

Study Overview
=================
Brief Summary
-----------------
To study the prevalence of sarcopenia in a pre-retirement group with chronic lower back pain and factors associated between sarcopenia and chronic lower back pain in the pre-retirement group.

Official Title
-----------------
Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain

Conditions
-----------------
Sarcopenia, Chronic Lower Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be a person between the ages of 50 - 59 years with or without chronic lower back pain longer than 3 months, but without any dangerous signs of lower back pain, sciatica pain, and neurological disorder. Be able to walk continuously for at least 10 minutes. Give written consent to join the research project. Exclusion Criteria: Have a history of spinal fracture, spondylolisthesis, scoliosis, or osteomyelitis. Have a neurological disorder or myasthenia gravis. Have a congenital disease such as acute coronary syndrome, cancer, or severe muscular or joint disease that affects the ability to walk continuously for at least 10 meters. Be implanted with a pacemaker or electrical device. Refuse or withdraw from the study.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 59 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of sarcopenia | participants with or without chronic lower back pain, | December2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The associated factors 1 | age | December2019 | 
| The associated factors 2 | body mass index | December2019 | 
| The associated factors 3 | IPAQ | December2019 | 
| The associated factors 4 | EQ-5D-5L | December2019 | 
| The associated factors 5 | Congential diseases | December2019 | 
| The associated factors 6 | Alcohol drinking | December2019 | 
| The associated factors 7 | Cigarette smoking | December2019 | 
| The associated factors 8 | Body muscular mass | December2019 |
Delaying the Onset of Nearsightedness Until Treatment Study

Study Overview
=================
Brief Summary
-----------------
Participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

Detailed Description
-----------------
Participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. These children will be randomized for a pilot study measuring compliance in nightly eye drop administration. The outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

Official Title
-----------------
Delaying the Onset of Nearsightedness Until Treatment Study

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: Atropine Ophthalmic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 6-11 years Refractive error measured in spherical equivalent, one eye meets criterion 6 years old: 0.50 to +0.38 7 years old: 0.50 to +0.25 8-11 years old: 0.50 to plano Anisometropia: spherical equivalent <1.50 D Astigmatism: <1.50 in both eyes Myopia: Less myopic than -0.74 D, both eyes Exclusion Criteria: ● Myopic

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will receive one of three concentrations of atropine (0.01%, 0.03%, or 0.05%)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.01% Atropine<br>0.01% atropine eye drops | Drug: Atropine Ophthalmic<br>* eye drops to be administered once daily<br>|
| Active Comparator: 0.03% Atropine<br>0.03% atropine eye drops | Drug: Atropine Ophthalmic<br>* eye drops to be administered once daily<br>|
| Active Comparator: 0.05% atropine<br>0.05% atropine eye drops | Drug: Atropine Ophthalmic<br>* eye drops to be administered once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance percentage | A comparison of the compliance percentage with eye drop administration | 30 days |
External Cephalic Version (ECV) for Twins With Non-vertex Presenting Twin

Study Overview
=================
Brief Summary
-----------------
In this study, women with a twin pregnancy with the presenting twin in a non-vertex(head) presenting twin undergo an external cephalic version.

Official Title
-----------------
External Cephalic Version (ECV) for Twins With Non-vertex Presenting Twin

Conditions
-----------------
Twin Pregnancy With Antenatal Problem

Intervention / Treatment
-----------------
* Procedure: External cephalic version


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older multiparous no previous cesarean delivery (CD) a non-vertex presenting twin in a term (37 weeks gestation and onwards) dichorionic diamniotic twin pregnancy Exclusion Criteria: contraindication for a vaginal delivery nulliparous monochorionic diamniotic pregnancy

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

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

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: Study group<br> | Procedure: External cephalic version<br>* An ECV attempt is made on the study group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rates of ECV |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and fetal morbidities |  | up to 7 days from enrollment |
Mother-Baby Study - Eating in the Absence of Hunger (EAH)

Study Overview
=================
Brief Summary
-----------------
The study will test a model of biobehavioral mechanisms involved in the development of a system of emotion, attachment, and nutritive intake in the mother-infant dyad and the association of this system with maternal feeding behavior, child eating behavior, dietary intake, and adiposity.

Detailed Description
-----------------
This interventional task is done with children while they are in the long-term observational study, NCT06039878, at approximately ages 18 and 36 months. In the observational study there are 240 participants (120 mothers and 120 children). In this trial only data from the children is collected and therefore only 120 participants are listed.

Official Title
-----------------
Fundamental Biobehavioral Mechanisms Underlying the Integrated Development of Emotion, Attachment, and Nutritive Intake in the Mother-Infant Dyad

Conditions
-----------------
Eating Behavior

Intervention / Treatment
-----------------
* Behavioral: Eating in Absence of Hunger


Participation Criteria
=================
Eligibility Criteria
-----------------
The child is a participant in the observational study (NCT06039878).

Ages Eligible for Study
-----------------
Minimum Age: 0 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eating in the Absence of Hunger (single arm)<br>The researchers will enroll 120 children from the long-term observational study, NCT06039878. | Behavioral: Eating in Absence of Hunger<br>* Researcher gives child free access to palatable foods following a satiating meal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kilocalories consumed |  | Up to approximately 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eating behavior
Multivisceral Resections for Locally Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are: Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications What factors affect prognosis of patients with locally advanced gastric cancer

Official Title
-----------------
Multivisceral Resections for Locally Advanced Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Extent od surgical resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric adenocarcinoma intraoperatively suspected infiltration of surrounding organs (stage cT4bN0-3bM0) partial or total gastrectomy Exclusion Criteria: distant metastases (M1) gastrectomy combined with resection of organs other than spleen, pancreas, or colon
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Extent od surgical resection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Type and severity of complications graded by Clavien-Dindo scoring system (from 0 to 5, higher scores mean worse outcome) | up to 90 days | 
| Survival | Overall survival | Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reoperations | Reoperations | up to 90 days | 
| Length of postoperative hospital stay | Hospital stay | Up to 6 months | 
| Rate of readmissions | Readmission | One year from surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, locally advanced cancers, multivisceral resections, splenectomy, pancreatectomy, colectomy
Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The investigators will use machine learning to identify features on bone marrow smears and select features that are related to gene mutations, gene expression, or prognosis. The investigators will then use genome-wide transcriptomic profiling to investigate gene expression that is associated with patients' outcomes. The investigators will design a next-generation sequencing panel with unique molecular index and assess its feasibility and robustness in detecting measurable residual disease and optimize the panel/platform/bioinformatic pipeline. Finally, The investigators will use machine learning to integrate bone marrow smear features, gene mutations, gene expression, and measurable residual disease to construct a comprehensive risk assessment system that is based on multi-omics data. The investigators believe that such a platform will help physicians to design the most appropriate treatment strategies for individual patients, not only advancing the concept of precision medicine but also improving patients' prognoses.

Official Title
-----------------
Multi-omics Approach of Risk Stratification for Patients With de Novo Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with acute myeloid leukemia at the National Taiwan University Hospital Ever enrolled in 201802021RINC、202109078RINB、201709072RINC Exclusion Criteria: Nil

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 |
| --- | --- | --- |
| Overall survival |  | From date of diagnosis until the date of death from any cause, assessed up to 30 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myeloid leukemia, Machine learning, Artificial intelligence, Risk stratification
Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.

Official Title
-----------------
A Multi-Center, Randomized, Double Masked, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: BRM421 Ophthalmic Solution
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Have a reported history of dry eye prior to enrollment; Have a history of use or desire to use eye drops; Exclusion Criteria: Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; Have used any eye drops within 2 hours of Visit 1; Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Be a woman of childbearing potential who is not using an acceptable means of birth control;

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
Interventional Model Description: Double Masking
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BRM421 Ophthalmic Solution<br> | Drug: BRM421 Ophthalmic Solution<br>* A topical drop of BRM421 ophthalmic solution.<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* A topical drop of vehicle (minus active) ophthalmic solution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Sign: Change From Baseline in Total Corneal Fluorescein Staining Score | 0-12 Ora scale, higher scores mean a worse outcome. | 1-2 weeks | 
| Ocular Symptom: Change From Baseline in Visual Analog Scale (VAS) | 0-100 Visual Analog Scale, higher scores mean a worse discomfort. | 1-2 weeks |
The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma

Study Overview
=================
Brief Summary
-----------------
This work will evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024.

Detailed Description
-----------------
Background: Adrenocortical Carcinoma (ACC) is a rare malignancy of the adrenal cortex. The annual incidence of ACC is thought to be between 0.5-2.0 cases per million. Adjunctive therapy with mitotane may be offered post- surgically to minimise risk of recurrence. Aims: Evaluate the adverse effects of mitotane treatment in patients treated for ACC with mitotane therapy. All of the individuals were treated at Ruijin Hospital between May 2023 and May 2024. Methods: Cortisol, ACTH, Gastrointestinal reactions and CNS Toxicity will be measured. SPSS v27 and GraphPad Prism v9.3.1 will be used for analysis and illustrations. Patients will be included, within ACC with mitotane. Data will be tested for normality, described as Mean± SD, compared using paired sample t-test with 5% p-value for significance and 95% confidence interval (CI).

Official Title
-----------------
The Adverse Event of Mitotane Therapy in Patients With Adrenocortical Carcinoma

Conditions
-----------------
Adrenocortical Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old and ≤ 75 years Diagnosis of Patients with adrenocortical cancer Gender: males and females Provide written informed consent Satisfactory compliance Exclusion Criteria: Patients with renal insufficiency (Cr>2 times the upper limit of normal). Patients with a history of liver cirrhosis. Patients who are currently using corticosteroids. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%). Patients with stroke and acute myocardial infarction in the past 6 months. Patients during pregnancy and lactation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of adverse effects | Adverse effects will be documented using the NCI CTC AE v5 | from starting mitotane treatment until discontinuation of mitotane (since this is very variable from patient to patient no specific number of days or weeks can be entered (standard therapy would be about 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor treatment response | According to RECIST (version 1.1). | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mitotane, Adverse effect