linjc16/ctgov huggingface dataset:
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment

Study Overview
=================
Brief Summary
-----------------
Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for China's national conditions.

Detailed Description
-----------------
Etiological study of Non-immune fetal hydrops(NIFH): Etiological study of NIFH in mid-pregnancy period; Etiological study of NIFH and hygroma colli in first trimester; Value assessment of technology for exome sequencing in diagnosis of NIFH; The accuracy of NIFH intrauterine intervention and its effect assessment: Perinatal outcomes of NIFH ; The effect of intrauterine treatments.

Official Title
-----------------
Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment

Conditions
-----------------
Fetal Hydrops

Intervention / Treatment
-----------------
* Procedure: intrauterine intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases corresponding to diagnosis standards Willing to accept the regular follow-up Exclusion Criteria: Immune hydrops fetalis Multiple pregnancy, except for twin-to-twin transfusion syndrome IV

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: exposure group<br>subjects in this group are those who accept intrauterine intervention | Procedure: intrauterine intervention<br>* choose different surgeries according to different causes<br>|
| No Intervention: control group<br>subjects in this group are those who do not accept intrauterine intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate for the operation |  | 1 week |
Severing Nuchal Cord at the Time of Delivery.

Study Overview
=================
Brief Summary
-----------------
Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the practice of severing the cord, which was encircled once around the neck of the fetus, after delivery of the anterior shoulder and prior to extraction of the body. The study and the control groups will include 30 women, each one. After diagnosis of cord around the neck during labor by ultrasound, the women will inter a randomization process. After delivery of the head, it will be cut intentionally in the study group and left intact in the control group. Neonatal outcome will be assessed.

Detailed Description
-----------------
Umbilical cord often becomes encircled around portions of the fetus, usually the neck. The incidence ranges from 1 loop in 21% to 3 loops in 0.2%. In this study we wish to assessed the practice of severing the cord, which was encircled once around the neck of the fetus, after delivery of the anterior shoulder and prior to extraction of the body. The study and the control groups will include 30 women, each one. After diagnosis of cord around the neck during labor by ultrasound, the women will inter a randomization process. After delivery of the head, it will be cut intentionally in the study group and left intact in the control group. Neonatal outcome will be assessed.

Official Title
-----------------
Study That Clarifies Whether Cord Around the Neck Should be Severed at Delivery.

Conditions
-----------------
Perinatal Outcome

Intervention / Treatment
-----------------
* Procedure: severing cord


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single loop cord around the neck active labor spontaneous vaginal delivery Exclusion Criteria: instrumental delivery cesarean section false positive finding of cord around the neck multiple loop cord around the neck
Sexes Eligible for Study
-----------------
Female

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: severing cord<br>The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body. | Procedure: severing cord<br>* The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.<br>* Other names: Cutting the umbilical cord;|
| No Intervention: Untouched cord<br>The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical Cord pH |  | immediately after delivery |
Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.

Official Title
-----------------
SFOP-OS94: Multicentric Randomised Phase III Trial Comparing Efficacy of Preoperative High-Dose Methotrexate Plus Doxorubicin to Efficacy of High-Dose Methotrexate Plus Etoposide and Ifosfamide, in Children and Adolescents Osteosarcoma

Conditions
-----------------
Osteosarcoma, Localised High Grade Osteosarcoma of the Limbs

Intervention / Treatment
-----------------
* Drug: Etoposide, Ifosfamide, Methotrexate
* Drug: Doxorubicin, Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non metastatic limb osteosarcoma, age less than 20 years, biopsy proven high-grade osteosarcoma, no previous treatment, no contraindication to chemotherapy no previous malignancy, Written informed consent. Exclusion Criteria: juxta-cortical sarcoma and microcellular anaplastic sarcoma, previous anticancer treatment contraindication to chemotherapy previous malignancy,

Ages Eligible for Study
-----------------
Maximum 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

| Intervention/Treatment |
| --- |
|Drug: Etoposide, Ifosfamide, Methotrexate|nan|
|Drug: Doxorubicin, Methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good histological response (5% or less viable cells) after preoperative chemotherapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival, |  |  | 
| Overall survival, |  |  | 
| Toxicity. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteosarcoma
Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Official Title
-----------------
A Randomized, Open-label, Multi-center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Age: 18 years and older- Males with erectile dysfunction- Stable heterosexual relationship- Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use- Other exclusion criteria apply according to Summary of Product Characteristics

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

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

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: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* 10 mg one hour prior to sexual intercourse<br>|
| Active Comparator: Arm 2<br> | Drug: Tadalafil<br>* 10 mg taken approximately 24 hours prior to sexual intercourse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual encounter profile question 2 |  | 4 weeks | 
| Hardness of erection |  | 4 weeks | 
| Other diary based variables |  | 4 weeks | 
| Safety and tolerability |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Diabetes mellitus, Hypertension, Hyperlipidemia, Vardenafil
Phase II Study of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn if BMS-181339 can shrink or slow the growth of the cancer in patients with advanced or recurrent esophageal cancer. The safety of this treatment will also be studied.

Official Title
-----------------
Phase II Study to Evaluate Efficacy and Safety of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer. This Study is an Extension Study for Japanese Registration Only.

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have measurable disease Patients must have experienced on pervious chemotherapy regime Men and Women, with the age 20 years or older ECOG PS: 0-1 Exclusion Criteria: Patients with previous therapy with Taxanes

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Paclitaxel<br>* Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over<br>* Other names: Taxol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | at the end of the study | 
| Safety |  | at the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response duration |  | at the end of the study | 
| Time to progression (TTP) |  | at the end of the study |
Analysis of Trends Over Time of Hepatitis Related Incidence in Panama

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.

Detailed Description
-----------------
In this study, systematic review of the databases of epidemiologic surveillance system (Ministry of Health), for hepatitis related outcomes will be performed. The analysis will be performed by age group, years and country region.

Official Title
-----------------
Time Trend Analysis of the Incidence of Hepatitis- Related Outcomes (Viral Hepatitis A and Unspecified Viral Hepatitis) Reported to the Surveillance System of Panama, 2000-2010

Conditions
-----------------
Hepatitis

Intervention / Treatment
-----------------
* Other: Epidemiologic Surveillance System of the Ministry of Health of Panama


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatitis Cohort<br>Subjects suffering with hepatitis | Other: Epidemiologic Surveillance System of the Ministry of Health of Panama<br>* Systematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of reported hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) |  | In post vaccine introduction period (2008-2010) compared to pre-vaccination period (2000-2007) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by year |  | From year 2000 until year 2010 | 
| Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by age groups |  | From year 2000 until year 2010 | 
| Occurrence of hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) by region |  | From year 2000 until year 2010 |
Observational Study of the Therapeutic Study of Recombinant HIV-1 TAT

Study Overview
=================
Brief Summary
-----------------
The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe, well tolerated and immunogenic. The present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and cellular immune responses. The results of the present study will be key for the design of future phase II trials, particularly for the definition of the optimal schedule for boosting immunizations. All individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. During these visits, which are performed within the schedule indicated for the clinical monitoring of HIV-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be evaluated.

Official Title
-----------------
Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in Hiv-1 Infected Adult Volunteers

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation to the phase I clinical trial ISS T-001

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Without treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the persistence of specific immune responses, volunteers will be monitored for anti-Tat specific antibodies, anti-Tat proliferative response and in vitro γIFN and IL-4 production in response to Tat (Elispot). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop test procedures in order to evaluate humoral and cellular anti-Tat immunity for future efficacy trials. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Tat protein
Risk Factors for Postpartum Psychosis

Study Overview
=================
Brief Summary
-----------------
A range of psychological disorders occur in women in the postpartum period. These include the blues, which occurs in the first days after birth and which is very common and self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in the first weeks after birth; and mild to moderate depression, occurring weeks to months after birth. Studies have been done focused on postpartum psychosis using a retrospective investigation, which gave only a limited material on the prevalence of psychological disorders in postpartum women. The investigators hypothesized that different pathways to psychosis function as the risk factors which may be overlapped, truly independent, mediating, or moderating, in new mothers who are at high risk and/or during the early period of delivery. In addition, the investigators purposed that the temporal sequence of biological, social and demographic variables are also the potential factors contributing to the development of postpartum psychosis.

Official Title
-----------------
Potential Risk Factors for Postpartum Psychosis

Conditions
-----------------
Postpartum Period, Psychosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Chinese Exclusion Criteria: Age < 18 years or > 50 years Gestational age < 32 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Psychoses within the first 3 months postpartum | |
| 2<br>Psychoses > 3 months to 6 months postpartum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of psychoses |  | 3 months and 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antepartum economic level |  | One year before labor and delivery (recorded by antepartum communication) | 
| Antepartum social status |  | One year before labor and delivery (recorded by antepartum communication) | 
| Antepartum psychological level |  | 1 day before birth | 
| Intrapartum complications |  | 1 day after birth | 
| Baby characteristics |  | One minute, 5min, 15min after baby was born | 
| Maternal characteristics |  | One day after birth | 
| Medical caregiver characteristics |  | One day before and after the labor completion | 
| Parturient family characteristics |  | One week before labor and delivery, recorded by investigators through patients' antepartum communication | 
| Intrapartum medical procedures |  | One day after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labor, Psychology, Postpartum Psychology
Centralized Pan-Asian Survey on the Under Treatment of Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The survey will try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the third NCEP ATP guidelines, overall and by country.

Official Title
-----------------
Centralized Pan-Asian Survey on the Under Treatment of Hypercholesterolemia

Conditions
-----------------
Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2 or more risk factors (according to NCEP ATP III guideline) Receiving lipid-lowering drug treatment for at least 3 months without dosage change for a minimum of 6 weeks. Exclusion Criteria: Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site). Previous enrolment or randomisation of treatment in the present study. Participation in a clinical study during the last 90 days.

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 |
| --- | --- | --- |
| The number and percentage of subjects achieving the LDL-C goals according to updated 2004 NCEP ATP Ⅲ guidelines(overall and by country) |  | After collecting all Patient Record Form. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and percentage of subjects achieving the LDL-C goals according to the updated 2004 NCEP ATP Ⅲ guidelines for several subject subsets. |  | After collecting all Patient Record Form. | 
| The association between achievement of LDL-C goals,according to the updated 2004 NCEP ATPⅢ guidelines and patient and physician variables. |  | After collecting all Patient Record Form. | 
| The physician characteristics associated with the allocation of hypercholesterolemia treatment regime. |  | After collecting all Patient Record Form. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, NCEP ATP III guidelines, survey