linjc16/ctgov huggingface dataset:
Urinary Aquaporin 2 Excretion After NSAID in Fasting Healthy Human

Study Overview
=================
Brief Summary
-----------------
We wanted to test the hypothesis that prostaglandin inhibition reduces the down regulation of u-AQP-2 induced by fasting

Official Title
-----------------
Urinary Aquaporin 2 Excretion After NSAID in Fasting Healthy Human

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: NSAID


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Genders; both mal and female (2) Age; 18- 65 years old (3) BMI; below 30 (4) Females had to bee in oral contraceptive treatment Exclusion Criteria: (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose) (3) Albuminuria or glucosuria (4) Cancer (5) Arterial hypertension (6) Alcohol abuse (7) Use of tobacco (8) Medical treatment, except oral contraceptives (9) Pregnancy or breast feeding (10) Medicine abuse (11) Donation of blood less than 1 month before the study.

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


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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FeNa |  |  | 
| U-AQP-2 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AQP-2, NSAID, Urinary concentrating ability
Local Infiltration Analgesia for Hip Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.

Official Title
-----------------
Effectiveness of Ultrasound Guided Hip Infiltration With Local Anesthetic Solution for Pain Control After Hip Arthroscopy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Infiltration of local anesthetic
* Procedure: Normal Saline Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hip arthroscopy ages 18-80 Exclusion Criteria: history of neurological disease diabetes pregnancy neuropathy chronic narcotic use allergy to local anesthetic solution inability to give consent or cooperate with the study protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infiltration of local anesthetic<br>30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. | Procedure: Infiltration of local anesthetic<br>* 30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.<br>|
| Placebo Comparator: Normal Saline Injection<br>injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance. | Procedure: Normal Saline Injection<br>* injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative opioid consumption. | Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period. | Within 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores in recovery room. | Mesures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 24 hour period after discharge from recovery room. | Within 24 hours of the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip arthroscopy, post operative analgesia
Microtransplantation in Older Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.

Official Title
-----------------
International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)

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

Intervention / Treatment
-----------------
* Biological: microtransplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: de novo acute myeloid leukemia age 60-90 have HLA mismatched donor Exclusion Criteria: have no suitable donor or donor refused patient refused to accept donor cells

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 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: MST（microtransplantation）<br> | Biological: microtransplantation<br>* HLA mismatched donor mobilized prepheral stem cell infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft versus host disease |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2 years | 
| leukemia free survival |  | 2 years | 
| complete remission rate |  | 2 months |
Building Resilience for Healthy Kids

Study Overview
=================
Brief Summary
-----------------
School based, mental-health intervention focused on improving self-efficacy and coping skills in children aged 9-13 years. The overall premise of our intervention is that by teaching children these skills they will in-turn become more resilient when faced with life-stressors and/or adverse events.

Detailed Description
-----------------
Healthy Kids is a 1:1 health coaching intervention delivered in school-settings. Students meet weekly with their assigned health coach and together they identify both strengths and areas for improvement with respect to resilience, developing resilience skills, and setting resilience goals. Topics discussed include coping skills, self-efficacy, and interpersonal relationships. The program was developed using the social determination theory (SDT), goal theory, and elements from the social-ecological model. SDT was used within the intervention to promote and facilitate behavior change. Goal theory was also utilized to develop strategies to support youth short- and long-term goal setting. Finally, weekly discussions about resilience and goal setting activities accounted for elements of the social-ecological model which acknowledges that behaviors are not independent factors, but are influenced by multiple levels of one's personal and social environment.

Official Title
-----------------
Building Resilience for Healthy Kids

Conditions
-----------------
Mental Health Wellness 1

Intervention / Treatment
-----------------
* Behavioral: Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children in participating school Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Coaching<br>1:1 Health coaching with student | Behavioral: Coaching<br>* Child will receive 1:1 coaching with health coach.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child & Youth Resilience Measure - Revised (CYRM-R) | Assessment of a child's resiliency. Scores range from 17 (low resiliency) to 85 (high resiliency) | 12 weeks |
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The effectiveness of Bottle PEP in patients with Chronic Obstructive Pulmonary Disease

Official Title
-----------------
The Effectiveness of Bottle-PEP in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: BottlePEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with COPD Stable Disease Exclusion Criteria: Neuromuscular disease Recent pneumothorax Major surgery in the last 6 months

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bottle PEP<br>Bottle PEP is a positive expiratory system that is applied via a tube of more than 5 mm of thickness and a bottle filled with water about 10 cms. | Other: BottlePEP<br>* Positive expiratory device with a bottle<br>|
| No Intervention: Control<br>No interventions will be applied. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in the first minute | Pulmonary function tests that are done with a spirometry to measure forced expiratory volume | 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking test | 6 minute walking test is a field test that measures the distance a patient walks during a 6 minute period. | 6 months after intervention | 
| St. George's Quality of Life Score | Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. This score has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys. | 6 months after intervention |
HOLT-ED: Holter-monitoring in End-stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

Detailed Description
-----------------
Background: The risk of dying of a cardiovascular disease is 10-20 times increased in patients dependent on dialysis treatment compared to the general population. 1/3 of these deaths is caused by arrhythmia and 'sudden cardiac death'. Purpose: Investigate the prevalence and type of arrhythmia in patients dependent on dialysis treatment, including the association with patient- and dialysis related factors and cardiovascular outcomes. Methods: 7-days Holter-monitoring with Cortrium C3+ holter-monitor in 540 patients dependent on dialysis treatment in the Capital Region of Denmark. Continous blood glucose monitoring in a subgroup. 1-year follow-up via national registers. Endpoints: Prevalence of atrial fibrillation Prevalence of other arrhythmia (tachycardia, bradycardia, AV-block) Follow-up outcomes: sudden cardiac death, cardiovascular disease and cardiovascular death

Official Title
-----------------
HOLT-ED: Holter-monitoring in End-stage Renal Disease - Does Burden of Arrhythmia Assessed With Systematic Holter Electrocardiogram Monitoring Affect Cardiovascular Outcomes? - A Prospective Cohort Study

Conditions
-----------------
Kidney Failure, Chronic, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Kidney Diseases, Renal Insufficiency, Chronic, Renal Insufficiency

Intervention / Treatment
-----------------
* Device: Holter-monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dialysis-treated end-stage renal disease Age ≥ 18 years Competence to understand the study rationale necessary for written informed consent Exclusion Criteria: Pre-existing pacemaker implantation

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Holter-monitor|7-day holtermonitoring of each patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sudden cardiac death / lethal arrhythmia | Risk of sudden cardiac death or lethal arrhythmia within one year | 1-year follow up | 
| Cardiovascular death | Risk of cardiovascular death within one year | 1-year follow up | 
| All-cause mortality | Risk of all-cause mortality within one year | 1-year follow up | 
| Myocardial infarction or death attributable to myocardial infarction | Risk of Myocardial infarction or death attributable to myocardial infarction within one year | 1-year follow up |
A Bioavailability Study on Dronabinol

Study Overview
=================
Brief Summary
-----------------
This study is a two part study

Detailed Description
-----------------
This study is a two part, open label, randomized, four periods cross-over study with a washout of at least 1 week between subsequent dosing occasions

Official Title
-----------------
A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers

Conditions
-----------------
THC

Intervention / Treatment
-----------------
* Drug: Chewing Gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, non-smoking male and female subject, aged between 18 and 55 year of age (inclusive) with a BMI ≥18.0 kg/m2 and ≤ 30.0 kg/m2. Exclusion Criteria: Smokers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewing gum<br>Chewing gum with various doses of dronabinol | Drug: Chewing Gum<br>* During the study healthy subjects will receive single doses of the various strengths of dronabinol<br>|
| Active Comparator: Capsule (Marinol)<br>Marinol is a product manufactured by AbbVie Capsule with various strengths of Marinol | Drug: Chewing Gum<br>* During the study healthy subjects will receive single doses of the various strengths of dronabinol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence | based on Peak Plasma Concentration (Cmax) | up to 48 hours post-dose | 
| Bioequivalence | based on Area under the plasma concentration versus time curve (AUC) | up to 48 hours post-dose |
Individual Workload Perception Scale - Revised (IWPS-R)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the psychometrics of the Individual Workload Perception Scale (IWPS).

Detailed Description
-----------------
The purpose of this study is to validate the psychometrics of the Individual Workload Perception Scale (IWPS) designed to measure the perception of individual workloads of inpatient registered nurses.

Official Title
-----------------
Evaluation of a Tool to Measure a Nurse's Individual Perception of Workload

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurses

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registered Nurses, Workload, Clinical staff nurses that are currently working
Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the safety of dianicline.

Official Title
-----------------
An International 7-Week, Double-Blind, Placebo-Controlled, 2-Parallel Group Study to Assess the Efficacy of Dianicline 40 mg BID as an Aid to Smoking Cessation in Cigarette Smokers

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: dianicline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients over the legal age smoking at least 10 cigarettes per day for at least 2 months Exclusion Criteria: Insufficient level of motivation Another participant in the household Patients with current psychotic disorder or major depressive disorder The investigator will evaluate whether there are other reasons why a patient may not participate.

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
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients |  |  | 
| exhaled carbon monoxide testing |  |  | 
| and plasma cotinine measurements |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire of smoking urge |  |  | 
| Hughes and Hatsukami Minnesota Withdrawal Scale to measure nicotine withdrawal |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, cessation, tobacco, smoking cessation, tobacco use cessation
Fampridine Pregnancy Exposure Registry

Study Overview
=================
Brief Summary
-----------------
This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.

Detailed Description
-----------------
There are no mandatory physician visits. The registry will collect pregnancy outcome data from the participants health care provider during the prenatal follow up (6-7 months gestation), pregnancy outcome (4 weeks after estimated delivery date) and finally the pediatric follow up (at 4 weeks and 12 weeks post birth).

Official Title
-----------------
Fampridine Pregnancy Exposure Registry

Conditions
-----------------
Multiple Sclerosis, Pregnancy

Intervention / Treatment
-----------------
* Drug: Fampridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Documentation that the patient was exposed to prolonged-release fampridine since the first day of her last menstrual period (LMP) prior to conception or at any time during pregnancy. (If exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure.) The outcome of the pregnancy must not be known at the time of report. Key Exclusion Criteria: None NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fampridine|As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous abortions |  | < 22 weeks of gestation | 
| Elective or therapeutic terminations |  | Up to 9 months of pregnancy | 
| Ectopic pregnancy |  | Up to 9 months of pregnancy | 
| Fetal death including still births |  | >22 weeks of gestation or weighing 500 grams | 
| Live born infants |  | During delivery time ( at expected average 9 months of pregnancy) | 
| Premature births |  | Delivered before 37 Weeks of gestation | 
| Maternal death |  | During pregnancy, labor or delivery | 
| Neonatal death |  | Prior to 28 days of life | 
| Birth Defects |  | Delivery time (expected 9 months of pregnancy) |