linjc16/ctgov huggingface dataset:
In Utero Capacity Formation and Socio-economic Outcomes

Study Overview
=================
Brief Summary
-----------------
Because of the high returns of schooling in developing countries, policymakers pay a lot of attention to increasing school access. But if the mother is deficient in key micronutrients, brain development can biologically constrain children's demand for education. To execute this strategy, the investigators collect cohort observational data on a previous randomized controlled trial with micronutrient supplements offered to HIV-negative pregnant women in Dar es Salaam, Tanzania, between 2001 to 2003.

Detailed Description
-----------------
This is a cohort study which collected follow-up observational data on households which were offered micronutrient supplements. The followup study outcomes include various socio-economic household characteristics and parental post-natal behaviors.

Official Title
-----------------
The Contribution of Health in Utero to Capacity Formation, Education and Economic Outcomes: Experimental Evidence From Tanzania

Conditions
-----------------
Folic Acid Deficiency

Intervention / Treatment
-----------------
* Other: observational follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
These were individuals from the larger study and this study is an observational follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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 |
| --- | --- |
| observational followup<br>This was an observational follow-up to a larger study in which treatment group was given 20 mg of vitamin B1, 20 mg of vitamin B2, 25 mg of vitamin B6, 100 mg of niacin, 50 μg of vitamin B12, 500 mg of vitamin C, 30 mg of vitamin E, and 0.8 mg of folic acid | Other: observational follow-up<br>* observational follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Cognitive Development |  | During 2011-2012 (1 year) | 
| Children's Health | BMI, Disease Incidence, Self-reported health | During 2011-2012 (1 year) | 
| Parental Postnatal Investment Behavior | Outcomes on parental care: care, cognitive stimulation, within-household time and money allocation | During 2011-2012 (1 year) | 
| Educational Status | School attendance, Student performance (at school), Test Performance | During 2011-2012 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Labor Force Participation | Parent's labor force outcomes: labor status, wages, type of job | During 2011-2012 (1 year) |
6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers

Official Title
-----------------
A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers

Conditions
-----------------
Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers between the ages of 19 or more and less than 40 years (19 =< age < 40) on the day of screening Negative findings in serum / urine hCG test or Subjects who are not pregnant or lactating in women Exclusion Criteria: Administered other drug(s) in other clinical study within 180 days prior to the day of screening

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Somatropin<br>* LG Somatropin<br>|
| Experimental: 2<br> | Drug: Somatropin<br>* LG Somatropin<br>|
| Experimental: 3<br> | Drug: Somatropin<br>* LG Somatropin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability |  | 2years |
A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.

Official Title
-----------------
A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: OPC-18
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma Patients with a measurable lesion by contrast CT Patients with no remote metastasis (extrahepatic metastasis), confirmed by X-ray, CT, MRI, or other means if necessary Patients who have not previously received intra-arterial hepatic chemotherapy Exclusion Criteria: Patients receiving the herbal medicine shosaikoto Patients with autoimmune hepatitis Patients with a history of hypersensitivity to OPC-18 or other interferon preparations

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>FAIT | Drug: OPC-18<br>* OPC-18: 500IU * 3 times a week, sc 5-FU : 500mg infusion for 5days into hepatic artery<br>|
| Active Comparator: B<br>BST | Drug: cisplatin<br>* infusion into hepatic artery with cisplatin 10mg and 5-FU 250mg a day<br>* Other names: low-dose FP treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor effect (tumor size reduction) |  | every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate Overall survival Progression-free survival |  | every 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OPC-18, Interferon-alpha, Fluorouracil
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

Study Overview
=================
Brief Summary
-----------------
Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation. It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal. The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.

Detailed Description
-----------------
The researcher can determine the blanching of vascular lesions after Tandem laser with multiple 532/1064 nm laser pulses treatment. The researcher will select one to four test sites spots for laser treatment. will be Different laser parameters can be used for each test site. The research will evaluate of the test sites at 6-12 weeks for bruising and blanching. Parameters of the test area with the greatest degree of blanching without adverse effects will be utilized for further treatment. If no test area is determined to have blanching without adverse effects, further test sites may be performed.

Official Title
-----------------
Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser

Conditions
-----------------
Vascular Lesion

Intervention / Treatment
-----------------
* Device: Tandem 532/1064 nm Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult age 18 years and older Diagnosis of vascular lesion Exclusion Criteria: Age <18 Pregnancy History of cutaneous photosensitivity Any therapy to the proposed treatment sites within the previous two months Current participation in any other investigational drug or device evaluation

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: Tandem 532/1064 nm Laser<br>Treatment of Vascular LesionsWith a Tandem 532/1064 nm Laser | Device: Tandem 532/1064 nm Laser<br>* Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser<br>* Other names: Treatment of Vascular Lesions;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laser treatment | Treatment of Vascular Lesions With a Tandem 532/1064 nm Laser | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
facial telangiectasia,, leg vein telangiectasia, Port Wine Stain birthmarks
EZIO Compared to Central Venous Lines for Emergency Vascular Access

Study Overview
=================
Brief Summary
-----------------
Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.

Official Title
-----------------
Randomized Study of the EZIO Compared to Central Venous Lines Used for Emergency Vascular Access

Conditions
-----------------
Catheters, Indwelling, Central Venous Line, Intraosseous Needle

Intervention / Treatment
-----------------
* Device: Powered Intraosseous device (EZIO)
* Device: standard central line


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old Requires central access after peripheral access attempts have failed or are not otherwise feasible Exclusion Criteria: Fracture in target bone Not able to sign informed consent Excessive tissue or absence of adequate anatomical landmarks Known or suspected coagulopathies Pregnancy Patients in custody Patients with suspected great vessel injury Not fluid in English

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>EZIO | Device: Powered Intraosseous device (EZIO)<br>* EZIO<br>|
| Experimental: 2<br>Central line | Device: standard central line<br>* placement of a central line<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time taken to place the device |  | ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications |  | ED visit | 
| Costs for each of the two methods |  | Ed visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheters, Indwelling
Lactate Clearance According to the Presence of Hepatic Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction.

Detailed Description
-----------------
Lactate clearance is well known to be associated with mortality in patients with severe sepsis and septic shock. To normalize lactate levels is one of important goals of early resuscitation of sepsis patients. Lactate clearance can be changed by various factors including patient characteristics, severity of shock, and treatment. In particular, hepatic dysfunction might impair the clearance of lactate because liver is a principal organ for lactate metabolism. However, an association between lactate clearance and hepatic failure has not been evaluated during initial resuscitation of patients with severe sepsis and septic shock. The primary goal of this study is to compare lactate clearance in patients with severe sepsis and septic shock according to the presence of hepatic dysfunction. The secondary goal is to evaluate if lactate clearance is associated with mortality even in patients with hepatic dysfunction.

Official Title
-----------------
Lactate Clearance and Mortality in Patients With Severe Sepsis and Septic Shock: Comparison by Hepatic Dysfunction

Conditions
-----------------
Sepsis, Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who presented with septic shock or severe sepsis within 6 hours after emergency department arrival Exclusion Criteria: Terminal malignancy or illness with a expected survival < 4 months Patients who previously signed Do Not Resuscitate or Do Not Intubate orders Patients who do not undergo the early goal-directed therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| No hepatic dysfunction<br>No hepatic dysfunction, total plasma bilirubin ≤ 2.0 mg/dl | |
| Hepatic dysfunction<br>Hepatic dysfunction, total plasma bilirubin > 2.0 mg/dl | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate clearance | [(initial lactate - delayed lactate)/ initial lactate] *100% | at 6-hour from the time of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality |  | within the first 28-day after emergency department arrival | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Lactic acid, Shock, Resuscitation
Ultra Sounded Guided Posterior Transverse Abdominis Plane & Lateral FEMORAL Cutaneous Nerve Blocks Analgesia Post Hip Hemiarthroplasty

Study Overview
=================
Brief Summary
-----------------
COMBINED ULTRASOUND GUIDED POSTERIOR TRANS VERSUS ABDOMINAL PLANE & LATERAL FEMORAL CUTANEOUS NERVE BLOCKS FOR POSTOPERATIVE ANALGESIA AFTER HIP HEMIARTHROPLASTIC SURGERY

Detailed Description
-----------------
TO EVALUATE THE EFFECTIVENESS OF POSTOPERATIVE ANALGESIA FOR HIP HEMIARTHROPLASTIC SURGERIES BY USING ULTRASOUND GUIDED POSTERIOR TRANS VERSUS ABDOMINAL PLANE & LATERAL FEMORAL CUTANEOUS NERVE BLOCKS

Official Title
-----------------
Effectiveness Of Ultra Sounded Guided Posterior Transverses Abdominis Plane & Lateral Femoral Cutaneous Nerve Blocks For Analgesia After Hip Hemiarthroplasty

Conditions
-----------------
Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiarthroplaty surgery ASA 1 - ASA 4 Exclusion Criteria: ALLERGIC TO LOCAL ANESTHETICS PATIENT REFUSAL

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAIN MANAGEMENT | POSTOPERATIVE ANALGESIA | 2 DAYS |
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B

Study Overview
=================
Brief Summary
-----------------
This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2 crossover method.

Official Title
-----------------
Pharmacokinetic Study of YM150 - The Verification ot the Bioequivalence Between YM150 Formulation-A and YM150 Formulation-B -

Conditions
-----------------
Healthy Volunteer, Pharmacokinetics of YM150

Intervention / Treatment
-----------------
* Drug: YM150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight: ≥50.0 kg, <80.0 kg BMI: ≥17.6, <26.4 Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests Exclusion Criteria: Received any investigational drugs within 120 days before the study Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study Received medication within 7 days before the study A deviation from the assessment criteria of physical examinations or laboratory tests A deviation from the normal reference range of coagulation test [PT (INR) or aPTT] History of drug allergies Upper gastrointestinal disease within 7 days before the study Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases Concurrent or previous malignant tumor Previous treatment with YM150

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: formualation-A to -B sequence group<br> | Drug: YM150<br>* oral<br>|
| Experimental: formulation-B to -A sequence group<br> | Drug: YM150<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of YM150 and its metabolites measured by blood sample |  | for 3 days after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by AEs, vital signs, 12-lead ECG and lab tests |  | or 3 days after drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, bioequivalence study
The Effect of GnRH on Pitutitary Hormones in Menstrual-Cycle Mood Related Disorders

Study Overview
=================
Brief Summary
-----------------
The normal menstrual cycle is produced by a series of hormonal signals that starts with the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. The hypothalamus is located in the brain and is often referred to as the master gland. GnRH then acts on the pituitary gland and causes it to release two hormones, follicle stimulating hormone (FSH) and lutenizng hormone (LH). LH and FSH act on the ovary and cause it to release the hormones directly involved in menstruation, estrogen and progesterone. The purpose of this research study is to evaluate the hypothalamic-pituitary-gonadal axis activity as measured by pituitary hormones, FSH and LH in response to intravenous doses of gonadotropin releasing hormone (GnRH) in menstrual cycle-related hormones.

Detailed Description
-----------------
This protocol is designed to accompany clinical protocol #81-M-0126, The Phenomenology and Biophysiology of Menstrually Regulated Mood and Behavior Disorders, as well as the submitted protocol, The Phenomenology and Biophysiology of Climacteric and Menopause-Related Mood and Behavioral Disorders. Its purpose will be to evaluate hypothalamic-pituitary-gonadal axis regulation as measured by pituitary gonadotropin, i.e., follicle stimulating hormone (FSH) and luteinizing hormone (LH), response to intravenous administration of gonadotropin releasing hormone (GnRH) in menstrual cycle-related mood disorders.

Official Title
-----------------
Pituitary Gonadotropin Response to GnRH Stimulation in Menstrual, Climacteric and, Menopause-Related Mood and Behavioral Disorders

Conditions
-----------------
Depressive Disorder, Healthy, Mental Disorders, Mood Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Age 18-65. Female. Use of barrier methods of birth control. Not pregnant. Not taking ongoing medications. No medical illnesses.
Sexes Eligible for Study
-----------------
Female

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
-----------------
Depression, FSH, GnRH, LH, Menopause, Menstrual Cycle