linjc16/ctgov huggingface dataset:
HOW DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANTATION?

Study Overview
=================
Brief Summary
-----------------
The aim of the researchers was to evaluate the adequacy of graft function in the postoperative period of patients who underwent renal transplantation and encountered hypotension in the intraoperative period.

Official Title
-----------------
DOES HEMODYNAMIC REGULATION AFFECTS GRAFT FUNCTIONS DURING RENAL TRANSPLANT?

Conditions
-----------------
Renal Transplant Failure and Rejection, Hypotension

Intervention / Treatment
-----------------
* Other: renal transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing renal transplantation Exclusion Criteria: patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypotension<br> | Other: renal transplantation<br>* patients undergoing renal transplantation<br>|
| normotension<br> | Other: renal transplantation<br>* patients undergoing renal transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | baseline | 
| Mean Arterial Pressure |  | baseline | 
| Systolic Blood Pressure |  | during the surgery | 
| Mean Arterial Pressure |  | during the surgery | 
| graft function |  | immediately after the surgery |
Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity

Study Overview
=================
Brief Summary
-----------------
Memantine is a drug for the management of Alzheimer's Disease (AD) due to its promising neuroprotective properties. We hypothesize that Memantine possesses a beneficial role against chemotherapy-induced neuronal damages.

Official Title
-----------------
Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Memantine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed diagnosis of stage III colorectal cancer performance status < 2 according to Eastern Cooperative Oncology Group (ECOG) score adequate renal function (glomerular filtration rate ≥ 90) Exclusion Criteria: preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br> | Drug: Memantine<br>* oral<br>|
| Placebo Comparator: Control<br> | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria |  | 6 months |
Deep Learning Signature for Predicting Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of a PET/ CT-based deep learning signature for predicting aggressive histological pattern in resected non-small cell lung cancer based on a multicenter prospective cohort.

Official Title
-----------------
Positron Emission Tomography/ Computed Tomography (PET/CT) Based Deep Learning Signature for Predicting Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer

Conditions
-----------------
Non-small Cell Lung Cancer, Spread Through Air Space, Visceral Pleural Invasion, Lymphovascular Invasion

Intervention / Treatment
-----------------
* Diagnostic Test: PET/CT-based Deep Learning Signature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section CT scans; (2) Pathological confirmation of primary NSCLC; (3) Age ranging from 20-75 years; (4) Obtained written informed consent. Exclusion Criteria: (1) Multiple lung lesions; (2) Poor quality of PET-CT images; (3) Participants with incomplete clinical information; (4) Participants who have received neoadjuvant therapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PET/CT-based Deep Learning Signature|Deep Learning Signature Based on PET-CT for Predicting the Aggressive Histological Pattern in Resected Non-small Cell Lung Cancer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operating characteristic curve | The area under the receiver operating characteristic curve (ROC) of the deep learning model in predicting the presence or absence of the aggressive histological pattern. The aggressive histological pattern includes spread through air space (STAS), visceral pleural invasion (VPI), and lymphovascular invasion (LVI). And the model will output all predictive values (presence or absence) of the three kinds of aggressive histological patterns. | 2023.5.1-2023.10.31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The sensitivity of the deep learning model in predicting the presence or absence of the aggressive histological pattern. The aggressive histological pattern includes spread through air space (STAS), visceral pleural invasion (VPI), and lymphovascular invasion (LVI). And the model will output all predictive values (presence or absence) of the three kinds of aggressive histological patterns. | 2023.5.1-2023.10.31 |
Effects of Sufentanil on the Intraoperative Hemodynamics

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, controlled trial. A total of 92 patients will be randomized to receive sufentanil or remifentanil during extracranial-intracranial bypass surgery.

Official Title
-----------------
Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial

Conditions
-----------------
Intraoperative Hypotension

Intervention / Treatment
-----------------
* Drug: Sufentanil
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo elective extracranial-intracranial bypass surgery American Society of Anesthesiologists grade 1,2,3 Age > 18 years old Exclusion Criteria: Refuse to participate to the study American Society of Anesthesiologists grade 4 Body Mass Index < 18.5 kg/m2 or > 35 kg/m2 Allergic history of opioid pregnant MAO Inhibitor user Severe respiratory insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 19 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: sufentanil group<br>sufentanil is administered for analgesic during general anesthesia | Drug: Sufentanil<br>* Induction: sufentanil TCI 0.3 ng/ml Maintenance: sufentanil TCI 0.05-0.5 ng/ml<br>|
| Active Comparator: remifentanil group<br>remifentanil is administered for analgesic during general anesthesia | Drug: Remifentanil<br>* Induction: remifentanil TCI 3 ng/ml Maintenance: remifentanil TCI 0.5-5 ng/ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hypotension | Target systolic blood pressure < 90% | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inotropic requirements | cumulative doses of inotropics during surgery | During surgery | 
| Incidence of bradycardia | heart rate < 40/min | During surgery | 
| Incidence of tachycardia | heart rate > 100/min | During surgery | 
| Maximum systolic blood pressure | maximal systolic blood pressure | During surgery | 
| Minimum systolic blood pressure | minimal systolic blood pressure | During surgery |
Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital

Study Overview
=================
Brief Summary
-----------------
An intensive care unit (ICU) is a specialized unit within the hospital where patients who need immediate medical attention are admitted both during office hours and off hours.1 Literatures report reduced working efficiency because of long working hours, unavailability of 24/7 intensivist staffing and the absence of the same level of hospital services like laboratory investigations during off hours affecting outcome of the patients. 2-6 High intensity staffing model and shorter workhours can improve the outcome.7 However, these are not always feasible in ICUs of low and middle income countries like Nepal. Any variations in outcome depending upon time of ICU admission may impact the workforce planning, medical insurance, and healthcare policy. The aim of this study was to compare the outcomes of patients admitted to the ICU during office hours and off hours in terms of ICU mortality, duration of mechanical ventilation and length of stay.

Official Title
-----------------
Admission Time and Outcomes of Patients Admitted to Intensive Care Unit in a Tertiary Level Teaching Hospital

Conditions
-----------------
FOCUS of Study: Time of Admission to ICU and Outcome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - age >= 16 years Exclusion Criteria: Patient who were discharged on request, left against medical advice, had withdrawal of active life support

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Admitted during office hours<br> | |
| Admitted off hours<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay |  | Each patient will be followed till death or discharge alive from ICU whichever occurs earlier | 
| days of mechanical ventilation |  | Each patient will be followed till death or liberation from Mechanical ventilation whichever occurs earlier | 
| In ICU mortality |  | each patient will be followed till death or discharge from ICU whichever is earlier |
Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.

Study Overview
=================
Brief Summary
-----------------
To determine whether there is a role for the selective serotonin reuptake inhibitors fluoxetine versus desmopressin in the treatment of nocturnal enuresis in children who have not responded to standard nonpharmacological urotherapy, and whether there are side effects involved.

Official Title
-----------------
Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis. A Randomised Controlled Trial

Conditions
-----------------
Nocturnal Enuresis, Enuresis, Enuresis, Nocturnal

Intervention / Treatment
-----------------
* Drug: Fluoxetine 20 MG
* Drug: Desmopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 7 years Severe enuresis with at least (50%) seven wet nights out of 14 Failed treatment The enuresis alarm was either ineffective or considered impractical due to the family circumstances. Exclusion Criteria: Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions Patients with psychiatric disorders and behavioral disorders including depression, attention-deficit/hyperactivity disorder. Untreated constipation Contraindications to fluoxetine or desmopressin treatment

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fluoxetine<br>selective serotonin reuptake inhibitors fluoxetine 20 mg for 12 weeks | Drug: Fluoxetine 20 MG<br>* fluoxetine<br>|
| Active Comparator: desmopressin<br>0.2 mg desmopressin tablet for 12 weeks | Drug: Desmopressin<br>* desmopressin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The children will be non-responders, partial responders, or full responders to therapy | The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society ICCS definitions (i.e., if the reduction of enuresis frequency was below or above 50% or 90%, respectively) | three months |
Gastric Volume in Patients on GLP-1 Medications

Study Overview
=================
Brief Summary
-----------------
Evaluating gastric volume in patients on GLP-1 RA medications

Official Title
-----------------
Gastric Volume in Patients on GLP-1 Medications

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Other: None - observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting Diabetic On GLP-1 RA Exclusion Criteria: Prior surgery that affects gastric anatomy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic, in GLP-1 RA<br> | Other: None - observational<br>* Observational<br>|
| Diabetic, not on GLP-1 RA<br> | Other: None - observational<br>* Observational<br>|
| Non-diabetic, not on GLP-1 RA<br> | Other: None - observational<br>* Observational<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric volume in pediatric patients on GLP-1 RA |  | single observation |
Long-term Safety of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria

Study Overview
=================
Brief Summary
-----------------
This study is designed to provide continued access to BCX9930 for subjects currently receiving treatment with BCX9930 in a BioCryst-sponsored clinical study for paroxysmal nocturnal hemoglobinuria (PNH) who, in the opinion of the investigator, would benefit from continued treatment with BCX9930 and who do not have access to other treatment options.

Official Title
-----------------
An Open-label Study to Evaluate the Long-term Safety of BCX9930 Monotherapy in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Previously Received BCX9930 in a BioCryst-sponsored Study

Conditions
-----------------
Paroxysmal Nocturnal Hemoglobinuria

Intervention / Treatment
-----------------
* Drug: BCX9930


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-lactating female subjects Are receiving treatment with BCX9930 in another clinical study of PNH and, in the opinion of the investigator, have benefited from treatment with BCX9930 and would benefit from continued treatment with BCX9930, and who do not have access to other treatment options Exclusion Criteria: Any clinically significant medical or psychiatric condition including alcohol or drug dependency that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject An ongoing adverse event, including a laboratory abnormality, or other unacceptable toxicity that, in the judgment of the investigator, compromises the ability of the subject to continue study-specific procedures or it is considered not to be in the subject's best interest to continue or benefit-risk assessment is no longer in favor of the subject's continued treatment

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: BCX9930<br>All subjects receive BCX9930 for 96 weeks | Drug: BCX9930<br>* Taken orally at 400 mg twice daily (BID)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with treatment emergent adverse events (TEAEs) | Proportion of subjects with TEAEs. Safety assessments include graded TEAEs / serious TEAEs, lab abnormalities, changes to vital signs, and physical examination findings. | Week 96 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BCX9930, Factor D inhibitor, Proximal complement inhibitor, Oral therapy, Paroxysmal nocturnal hemoglobinuria
A Long-term Extension Study to Evaluate Safety, Tolerability, and Efficacy of AL002 in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
A long-term extension study to evaluate the safety, tolerability, and efficacy of AL002 in participants with Early Alzheimer's Disease.

Detailed Description
-----------------
This is a Phase 2, randomized, parallel-group, long-term extension (LTE), dose-blind, multicenter study to evaluate the long-term safety and efficacy of AL002 in participants with Early Alzheimer's Disease. The study is a multicenter, global trial that will enroll participants who completed the planned treatment period in AL002-2 (parent study).

Official Title
-----------------
A Multicenter, Long-term Extension Study to Evaluate the Safety, Tolerability, and Efficacy of AL002 in Participants With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: AL002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of the Planned Treatment Period in the AL002-2 study. The participant is willing and able to give informed consent. Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week Exclusion Criteria: Participants deemed not able to provide consent or assent by the Investigator or by local regulations. Participants who were prematurely and permanently discontinued from treatment in the parent study for safety reasons. Participation deemed inappropriate per Investigator discretion.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: AL002 Dose 1<br>AL002 every 4 weeks | Drug: AL002<br>* Administered via intravenous (IV) infusion<br>|
| Experimental: AL002 Dose 2<br>AL002 every 4 weeks | Drug: AL002<br>* Administered via intravenous (IV) infusion<br>|
| Experimental: AL002 Dose 3<br>AL002 every 4 weeks | Drug: AL002<br>* Administered via intravenous (IV) infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by number of/incidence of Adverse Events (AEs), including AESI and SAEs. |  | Through study completion, up to 49 weeks | 
| Safety and tolerability as measured by the number of MRI abnormalities. |  | Through study completion, up to 49 weeks | 
| Effect of Immunogenicity as measured by ADAs titers. |  | Through study completion, up to 49 weeks |