linjc16/ctgov huggingface dataset:
An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.

Official Title
-----------------
An Open-label Trial of an Erythropoietin Stimulating System to Determine Increased Red Blood Cell Production in Subjects Diagnosed With Anemia of Chronic Disease

Conditions
-----------------
Anemia of Chronic Disease

Intervention / Treatment
-----------------
* Drug: ESS (medical food/drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: M/F patients 18 years old and over, non-pregnant/lactating Hemoglobin < 10 female,<11 male Ferritin > upper limit of normal for lab indicative of chronic anemia Anemia of chronic disease Crt. < 3.0 Exclusion Criteria: Currently taking other amino acid formulations. Pregnant or unwilling to use adequate birth control for the duration of the study. Excessive alcohol or illicit drug use. Unwilling or unable to sign informed consent. Myocardial infarction within the last 6 months. Patients ever having taken or currently taking an erythropoietin medication. Iron deficiency (add criteria). On dialysis. Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years. Liver cirrhosis (add criteria).

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: ESS<br>Prescription medical food erythropoietin stimulating system | Drug: ESS (medical food/drug)<br>* Prescription medical food erythropoietin stimulating system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglogin/Hematocrit |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell count |  | 28 Days | 
| Reticulocyte count |  | 28 days | 
| IGF-1 |  | 28 days |
A Modified Technique for Laparoscopic Subtotal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its popularity in the past decade due to its minimal invasiveness that results in less operation time, less blood loss and quicker return to normal activity. The standard surgical procedure in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus, dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed by amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel, monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer operative time and higher possibility of conversion to laparotomy due to technical difficulty and excessive blood loss. In order to overcome these difficulties, we introduce a modified surgical technique of LASH which incorporated two methods of vessels ligation and laparoscopic in situ morcellation.

Conditions
-----------------
Subtotal Hysterectomy

Intervention / Treatment
-----------------
* Procedure: A Modified Technique for Laparoscopic Subtotal Hysterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis complete medical record Exclusion Criteria: patients aged below 20 years old uterine malignancy incomplete medical record

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: A Modified Technique for Laparoscopic Subtotal Hysterectomy|incorporation of two methods of vessels ligation and laparoscopic in situ morcellation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time |  | at time of surgery | 
| Intraoperative blood loss |  | at time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | such as ureteral injury, bowel perforation, conversion to laparotomy, recurrent vaginal bleeding | up to 7 days post operation |
Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Subarachnoid hemorrhage (SAH) is the extravasation of blood into the subarachnoid space from traumatic or nontraumatic origin. There is a paucity of data on the burden of SAH in African countries. In this study, we analyzed data from patients in the largest neurovascular center in Senegal to determine the sex- and age-adjusted burden of SAH in Senegal.

Detailed Description
-----------------
The Fann Teaching Hospital (Dakar, Senegal) institutional review board authorized this study. Consent was obtained from adult patients and the parents/legal guardians of children. Patient data were stored in a password-protected Excel spreadsheet, and this spreadsheet was stored on a hard drive. Only the authors had access to the data.

Official Title
-----------------
Disability-adjusted Life Years in a Senegalese Cohort of Patients With Subarachnoid Hemorrhage

Conditions
-----------------
Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese Cohort

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sub-arachnoid Hemorrhage admission Exclusion Criteria: Not admitted for sub-arachnoid hemorrhage
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sub-arachnoid Hemorrhage Patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability Adjusted Life Years | Mortality and Morbidity | 9 years |
A Study to Evaluate the Pharmacokinetics and Safety of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the pharmacokinetic characteristics and safety of YHD1119(Pregabalin SR 75mg) and YHD1119(Pregabalin SR 150mg) in subjects with renal impairment and healthy subjects. YHD1119 is sustained-release (SR) formulation which is made by Yuhan Corporation. Primary endpoints are Cmax and AUClast and secondary endpoints are AUCinf,Tmax, t1/2, CL/F and V/F.

Official Title
-----------------
A Study to Evaluate the Pharmacokinetics and Safety Following a Single Oral Dose of YHD1119 in Subjects With Renal Impairment and Healthy Subjects

Conditions
-----------------
Healthy Volunteer, Renal Impairments

Intervention / Treatment
-----------------
* Drug: YHD1119 75mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 75 years old, healthy volunteers and renal impairments eGFR >= 60mL/min/1.73m2 60 mL/min/1.73m2 > eGFR >= 30mL/min/1.73m2 written informed consent Exclusion Criteria: AST or ALT > 1.5 * Upper normal range Total bilirubin > 1.5 * Upper normal range Blood CPK > 1.5 * Upper normal range Total Cholesterol >1.5 * Upper normal range Woman who is pregnant or lactating Patients who are difficult to participate in cinical trials judged by Investigators have participated in other clinical trials within 180 days before IP intake

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YHD1119 75mg, 150mg NF<br>CLcr (mL/min/1.73m2) >= 60 Period 1 : YHD1119 75 mg Period 2 : YHD1119 150 mg NF | Drug: YHD1119 75mg<br>* A single oral dose<br>* Other names: YHD1119 150mg NF;|
| Experimental: YHD1119 75mg<br>60 > CLcr (mL/min/1.73m2) >= 30 Period 1 : YHD1119 75 mg Period 2 : NA | Drug: YHD1119 75mg<br>* A single oral dose<br>* Other names: YHD1119 150mg NF;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | 
| AUClast |  | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | 
| Tmax |  | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | 
| t1/2 |  | 0,1,2,3,4,5,6,8,10,12,14,24,48,72hour | 
| CL/F |  | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour | 
| V/F |  | 0,1,2,3,4,5,6,8,10,12,14,24,48,72 hour |
Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The present study is not hypothesis driven but will explore the ability of pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic drugs used in therapy in adult patients with acute myeloid leukemia.

Official Title
-----------------
Population Based Pharmacokinetic and Pharmacodynamic Dosage Model for Cytarabine, Daunorubicin and Etoposide for Acute Myeloid Leukemia

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

Intervention / Treatment
-----------------
* Other: PK-PD analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult men and women with newly diagnosed acute myeloid leukemia Exclusion Criteria: under age 18 years

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| AML patients in induction treatment<br> | Other: PK-PD analysis<br>* The danish medicines agency regards new knowledge in pharmacokinetics and pharmacodynamics as an intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant covariates from the PK study |  | after complete analysis of data | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of the three drugs in patient plasma samples |  | within 3 months of sampling |
The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control

Study Overview
=================
Brief Summary
-----------------
The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in a double blind study.

Official Title
-----------------
The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control

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

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers age 18-80 no chronic disease Exclusion Criteria: Subjects who suffer from chronic pain / pain syndrome use of anti-depressant or anti-psychotic drugs food/ drugs sensitivity breast feeding

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Duloxetine<br>* SNRIs<br>|
| Placebo Comparator: 2<br> | Drug: Duloxetine<br>* SNRIs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of DNIC |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiology of Serotonergic and Adrenergic systems
Anthropometric Measures and Severity of Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastro esophageal reflux symptoms (e.g. heart burn, regurgitation, water brash or atypical symptoms such as hoarseness of voice, asthma and cough) complete upper gastrointestinal endoscopy. Exclusion Criteria: Receiving medication for reflux disease (including proton pump inhibitor, histamine type 2 receptors blocker, prokinetic agents) in the previous month. Pregnant woman. History of upper abdominal surgery. Severe co-morbidity as cirrhosis, end-stage renal disease and heart failure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| obese and overweight<br>Group1 (n=30): overweight and obese (BMI ≥25 and/ or WHtR≥0.5) | |
| average body weight<br>Group2 (n=30): normal weight (BMI ≥ 18 to < 25 and/or WHtR ≥0.4 to <0.5) | |
| Control group<br>Control Group (n= 20): healthy subjects, matched for age and gender, were included in this study. All included controls had average weight (BMI ≥ 18 to < 25 and/ or WHtR ≥0.4 to <0.5) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of anthropometric measures on GERD | evaluate the impact of different anthropometric measures on clinical and endoscopic severity of GERD and its relation to serum leptin. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal Reflux Disease; Anthropometric Measures; Leptin
The Analysis of the Risks of the Personnel Working in Anesthesiology Departments in Turkey

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to investigate the analysis of the risks faced by the personnel working in the field of Anesthesiology and Reanimation in Turkey

Detailed Description
-----------------
There are many potential risks in operating room such as anesthetic gas exposure, chronic noise, fair, intensive working conditions, frequent guardians of the doctors and anesthesia staff. Those are effects the staff of anesthesia such as doctors, anesthesia assistants, anesthesia nurses. They usually suffer from hard working, fatigue and exposing anesthetic gases effects them as well. These reasons cause some undesirable adverse effects. The scientific dates are really limited in uour country. We aimed to ask questions the anesthesia staff and determine the environment conditions and the other risk in operating room that effects the staff. For t his purpose we prepared a questionaire and send to their e-mail address.

Official Title
-----------------
The Analysis of the Risks of the Personnel Working in Anesthesiology Departments in Turkey

Conditions
-----------------
Exposure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anesthesia doctors anesthesia nurses anesthesia technic personal Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 analysis of the risks in the operating room | This a questionnaire study. We prepared a questionnaire and send it to anesthesia staff by e-mail address. their reply will evaluated | during 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
operating room,, risk factors, anesthesiologists
Pharmacokinetics Study of NI-071

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess equivalence of pharmacokinetics between NI-071 and infliximab(the comparator) in Japanese healthy volunteers

Official Title
-----------------
A Clinical Pharmacokinetics Study of NI-071

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

Intervention / Treatment
-----------------
* Biological: NI-071
* Biological: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, clinical laboratory tests, etc.) Body Mass Index (BMI) of 18.5 to 25.0 kg/m2, and a total body weight of 50 to 80 kg Exclusion Criteria: Subjects with a following past History or concomitant diseases Chronic or recurrent infectious disease Demyelinating disease Congestive heart failure lymphoproliferative disorder or myelodysplastic syndrome Malignancy Interstitial lung disease Subjects with active or latent tuberculosis or history of tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NI-071<br> | Biological: NI-071<br>* 100mg/vial<br>|
| Active Comparator: Infliximab<br> | Biological: Infliximab<br>* 100mg/vial<br>* Other names: Remicade;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK : Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK : Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) |  | 8 weeks | 
| Safety : Incidence of Adverse Events |  | 8 weeks | 
| Safety : Incidence of Anti-Drug Antibodies(ADA) |  | 8 weeks |
New Data Analysis Methods for Actigraphy in Sleep Medicine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.

Detailed Description
-----------------
An Actical™ is a watch-like device attached to the wrist that uses an accelerometer to measure movement nearly continuously over several days. The American Academy of Sleep Medicine practice parameters report that actigraphy is a useful tool for detecting sleep in healthy individuals, assessing specific aspects in insomnia and restless legs syndrome, circadian-rhythm disorders, and excessive sleepiness. Concurrent with these recommendations is an increased interest in the use of actigraphy as a tool for objectively measuring fatigue. With improved high-end statistical methods for analyzing this data, actigraphy has the potential to become more important as an objective diagnostic tool for determining fatigue, sleep abnormalities and assessing response to treatment.

Official Title
-----------------
New Data Analysis Methods for Actigraphy in Sleep Medicine

Conditions
-----------------
Obstructive Sleep Apnea, Restless Leg Syndrome, Insomnia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presenting to the Washington University Sleep Medicine Center for evaluation of obstructive sleep apnea syndrome, restless legs syndrome, or insomnia Older than 18 years of age Ability to consent to participation in the study Willingness to wear the Actical™ for two 7 day periods and to return the equipment promptly Exclusion Criteria: Inability to provide valid consent Pregnancy Night or rotating shift workers

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 |
| --- | --- | --- |
| Define an object oriented data model for actigraphy and patient level data. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Disorders, Obstructive Sleep Apnea, Restless Leg Syndrome, Insomnia, Actigraphy