linjc16/ctgov huggingface dataset:
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma

Study Overview
=================
Brief Summary
-----------------
This randomized trial is studying the efficacy and safety of the hysterectomy alone compared with hysterectomy and bilateral salpingo-oophorectomy (BSO) for patients with Stage IA endometrial carcinoma.

Official Title
-----------------
The Safety of Ovarian Preservation in Stage IA Endometrial Carcinoma: A Multicenter, Prospective, Randomized Trial

Conditions
-----------------
Endometrial Neoplasms

Intervention / Treatment
-----------------
* Procedure: TH
* Procedure: TH/BSO
* Procedure: BPLND


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FIGO stage: ⅠA, endometrial carcinoma; Female, Chinese women; premenopausal women； ≤ 50 years old; Pathological diagnosis by curettage/hysteroscopy : G1 No prior treatment; Provide written informed consent. Exclusion Criteria: The suspicious metastasis of ovarian; Family history of ovarian cancer; Suffering from other malignancies; Concurrently participating in other clinical trials; Unable or unwilling to sign informed consents; Unable or unwilling to abide by protocol.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total Hysterectomy (TH)<br>Patients may receive total hysterectomy (TH) and bilateral pelvic and para-aortic lymph node dissection (BPLND). | Procedure: TH<br>* Total hysterectomy<br>Procedure: BPLND<br>* bilateral pelvic and para-aortic lymph node dissection<br>|
| Active Comparator: TH and bilateral salpingo-oophorectomy (TH/BSO)<br>Patients may receive total hysterectomy, bilateral salpingo-oophorectomy (BSO) and bilateral pelvic and para-aortic lymph node dissection. | Procedure: TH/BSO<br>* Total hysterectomy and bilateral salpingo-oophorectomy<br>Procedure: BPLND<br>* bilateral pelvic and para-aortic lymph node dissection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (DFS) |  | 3-year DFS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical gynecologic endocrine function | To observe the level of female hormone，i.e., estrogen, FSH, LH | 1-year period | 
| Quality of Life |  | 3-year period | 
| Overall Survival (OS) |  | 3-year OS |
Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the impact of a large-scale urban water supply improvement intervention on cholera and other diarrhoeal diseases. The study uses a step wedge cluster randomised controlled trial (SWcRCT) to measure the effect of the intervention on cholera centre admission rates and confirmed cholera cases. A nested cohort study will examine changes in water-related practices following the intervention.

Official Title
-----------------
Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal in Uvira, Democratic Republic of Congo

Conditions
-----------------
Cholera, Diarrhea

Intervention / Treatment
-----------------
* Other: Improved water supply


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uvira resident admitted to the Uvira Cholera Treatment Centre in Uvira Exclusion Criteria: Any patients admitted during the period of intervention implementation in each cluster
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>Current water supply access | |
| Experimental: Intervention<br>Received water supply improvement intervention designed to improve access to tap water, consisting of community managed public taps, improved tap water distribution network, refurbished tap connections and promotion of new household tap connections. | Other: Improved water supply<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission rate to the Uvira Cholera Treatment Centre |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission rate to the Uvira Cholera Treatment Centre of laboratory confirmed cholera cases |  | 36 months |
Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on BIA

Study Overview
=================
Brief Summary
-----------------
The study was based on the clinical trial BCA-01 (NCT01368640) Generation of prediction equations to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA) and implicates an extension of the study collective. Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand.

Official Title
-----------------
Generation of Prediction Equations to Analyze Body Composition of Obese Adults Based on Bioelectrical Impedance Analysis (BIA)

Conditions
-----------------
Bioelectrical Impedance Measurement of Healthy Adults

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults in an age range of 18 to 65 years BMI > 30 kg/m2 Exclusion Criteria: acute and chronic diseases regular intake of medications (except for contraceptives) amputation of limbs electrical implant as cardiac pacemaker insulin pumps artificial joints metallic implants (except tooth implants) claustrophobia pregnancy or breastfeeding period probands who cannot provide an ICF by themselves probands who might be dependent from the sponsor or the inv. site current alcohol abuse frequent hypersensitivity reactions/allergies determ. anamnestically extensive tattoos at arms or legs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| BIA 5 and 50 kHz | Bioelectrical Impedance of 5 and 50 kHz for one body side | 15 minutes | 
| BIA 50 kHz | Bioelectrical Impedance of 50 kHz for all 4 extremities | 15 minutes | 
| Total body water | Total body water (TBW) by deuterium (D2O) dilution | 15 minutes | 
| Extracellular water | Extracellular water (ECW) by NaBr dilution | 15 minutes | 
| Fat-free mass | Fat-free mass by a 4-compartment model based on dual energy x-ray absorption (DXA), air displacement plethysmography (ADP), D2O dilution and weight | 1 hour | 
| Skeletal muscle mass | Skeletal muscle mass (SMM) by magnetic resonance imaging (MRI) | 1 hour | 
| Visceral adipose tissue | Visceral adipose tissue VAT by magnetic resonance imaging (MRI) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete BIA | Bioelectrical Impedance of 1, 1.5, 2, 3, 7.5, 10, 15, 20, 30, 75, 100, 150, 200, 300, 500, 750 and 1,000 kHz for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side. | 15 minutes |
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®

Study Overview
=================
Brief Summary
-----------------
Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and support speech-nerve saving approaches. The aim of this study was to evaluate a patient and procedure profile where TachoSil® is most beneficial.

Official Title
-----------------
Non-Interventional Study on the Use of TachoSil® During Thyroid Surgery

Conditions
-----------------
Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Patients undergoing total or subtotal thyroidectomy Main Exclusion Criteria: Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient

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 |
| --- | --- | --- |
| Assessment of TachoSil® by the Surgeon With Respect to Handling, Utility and Satisfaction in the Operation, Documented Using 10 Point Numerical Rating Scales | Handling (1= very good to 10= very poor) Satisfaction (1= very satisfied to 10= totally unsatisfied) Utility (1= very useful to 10= completely useless) | after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacoeconomic Benefits as Assessed by the Surgeon | Question: What benefits resulted from the application of TachoSil® during this operation? (different categories to be answered with yes/no) | peri- and post-surgery until hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroid, Tachosil, parathyroid, fleece-bound hemostasispathologic processes, hemorrhage, thyroid surgery
Study Evaluating ReFacto AF in Severe Hemophilia A

Study Overview
=================
Brief Summary
-----------------
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Official Title
-----------------
An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: ReFacto AF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory) Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product Age greater than or equal to 12 years History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study Adequate laboratory results Exclusion Criteria: Presence of any bleeding disorder in addition to hemophilia A Concomitant therapy with immunosuppressive drugs Current or historical Factor VIII inhibitor Treatment with any investigational drug or device within the past 30 days

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ReFacto AF|nan|

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
-----------------
Severe, Hemophilia, A
Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography

Study Overview
=================
Brief Summary
-----------------
In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug. Recently, ABS has been shown to produce local hemostasis by implementing topically after major arterial vessel injury. Reducing the compression time during patent hemostasis by facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in adjunct to short-time compression, compared to either short-time compression with conventional sterile gauzes or with a TR band after transradial diagnostic procedures.

Official Title
-----------------
Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial

Conditions
-----------------
Radial Artery Injury, Hematoma, Bleed

Intervention / Treatment
-----------------
* Other: ABS
* Device: TR Band
* Other: CS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients undergoing transradial elective diagnostic coronary procedures between November 2016 and November 2017 at the catheterization laboratory of Acibadem University Kocaeli Hospital were considered to be enrolled in the study. Exclusion Criteria: The only exclusion criteria were an abnormal Barbeau's test before puncture and failure to provide written informed consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABS<br>Ankaferd blood stopper | Other: ABS<br>* Ankaferd Blood Stopper<br>|
| Placebo Comparator: CS<br>Conventional sterile gauze | Other: CS<br>* Sterile Gauze<br>|
| Active Comparator: TR BAND<br>Dedicated hemostatic device | Device: TR Band<br>* Transradial band<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery occlusion assessed by reverse Barbeau's test |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | any kind of bleeding defined as ml after the removal of hemostatic dressings or devices | 2 hours | 
| Hematoma | hematomas larger then >5cm | 24 hours |
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study comparing Indinavir plus Ritonavir plus 2 NRTIs vs. Nelfinavir 1250 plus two nucleoside reverse transcriptase inhibitors (NRTIs) in the treatment of HIV positive patients who have not responded to or are intolerant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) containing treatment.

Official Title
-----------------
A Multicenter, Open-Label, Randomized, Study to Compare the Efficacy and Safety of Indinavir 800 mg b.i.d. Plus Ritonavir 100 mg b.i.d. Plus Two NRTIs vs. Nelfinavir 1250 mg b.i.d. Plus Two NRTIs in HIV-1 Seropositive Patients Who Have Failed or Are Intolerant to an NNRTI Containing Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks
* Drug: Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age HIV positive No active heart disease Exclusion Criteria: Pregnant or breast feeding Unwilling to use birth control or abstinence to prevent pregnancy Received an investigational drug or vaccine within the past 30 days or is planning to receive other investigational study drug/vaccine or interferon while in the study Plan to receive NNRTIs while in the study Received therapy which lowers body's ability to fight infection within the past 30 days or while in the study Alcohol or substance abuse Hepatitis

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

| Intervention/Treatment |
| --- |
|Drug: MK0639, indinavir sulfate / Duration of Treatment: 48 Weeks|nan|
|Drug: Comparator: nelfinavir mesylate / Duration of Treatment: 48 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma viral RNA levels will be measured at predetermined time points to determine mean change |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 cell counts will be measured at predetermined time points to determine change from baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Treatment Experienced
Comparison of Subcostal and Transhepatic Views to Assess Inferior Vena Cava by Echocardiography

Study Overview
=================
Brief Summary
-----------------
Comparison of subcostal and transhepatic views to measure inferior vena cava diameter by echocardiography in intensive care unit patients

Official Title
-----------------
Comparaison échographique Des Voies Sous Costale et Trans hépatique Dans l'évaluation de la Veine Cave inférieure

Conditions
-----------------
Inferior Vena Cava Diameter

Intervention / Treatment
-----------------
* Diagnostic Test: echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient hospitalised in ICU Exclusion Criteria: gardianship contraindication to transthoracic echocardiography

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: echocardiography|echocardiography by subcostal and transhepatic views|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inferior vena cava diameter | measurement of inferior vena cava diameter by 2D et TM mode | up to 1 day after inclusion |
Cardiac MRI in Ischemic Stroke Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective single-center trial is to compare the safety and diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal echocardiography in patients with acute ischemic stroke.

Detailed Description
-----------------
Primary safety objective: Contrast medium-enhanced cardiac magnetic resonance imaging is safe in patients with acute ischemic stroke. Primary outcome: The diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging is comparable to transesophageal echocardiography in patients with acute ischemic stroke.

Official Title
-----------------
Cardiac MRI in Ischemic Stroke Study

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute ischemic stroke detected by brain magnetic resonance imaging. Exclusion Criteria: Known atrial fibrillation or cardiac source of embolism Severe aphasia Acute infection or chronic inflammation Severe arteriosclerosis or stenosis of brain-supplying arteries Contraindications for magnetic resonance imaging or transesophageal echocardiography.

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 |
| --- | --- | --- |
| Sensitivity and specificity of contrast medium-enhanced cardiac magnetic resonance imaging to detect echocardiography-proven cardiac sources of embolism in patients with acute ischemic stroke. |  | < 1 week after ischemic stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of unrecognised myocardial infarction detected by late gadolinium-enhanced cardiac MRI in patients with acute ischemic stroke. |  | < 1 week after ischemic stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI
Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates

Study Overview
=================
Brief Summary
-----------------
Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.

Official Title
-----------------
Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates

Conditions
-----------------
Breastfeeding

Intervention / Treatment
-----------------
* Other: raw mother's own milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted neonates between April 2012 and June 2013 are eligible if they are intended to be breastfeed and hospitalized ≥7 days Exclusion Criteria: - Neonates with parents not fluent in French.

Ages Eligible for Study
-----------------
Maximum Age: 42 Weeks

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| exposed group : early raw mother's own milk<br>The use of raw MOM is considered as early when it begins before day 7. | Other: raw mother's own milk<br>* Infants receive mother's own milk before day 7.<br>|
| unexposed group : no use of raw mother's own milk<br>Neonates who receive, or not, raw MOM before day 7. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal breastfeeding | Maternal breastfeeding is defined as the consumption of any MOM. It is classed as exclusive when all the fed milk will be MOM or partial when it will be completed by other milk or food. | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breastfeeding, mother's milk, breast milk, raw milk, neonate, Neonatal intensive care unit (NICU)