linjc16/ctgov huggingface dataset:
A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma

Study Overview
=================
Brief Summary
-----------------
The study was designed to evaluate the efficacy and safety of apatinib in the treatment of patients with gastric carcinoma.

Detailed Description
-----------------
The study is a real-world non-interventional retrospective study and will collect the original medical records of patients with gastric carcinoma treated with apatinib from 2015 to 2018 in Henan Cancer Hospital. Clinical data such as patient demographic, history of treatments, tumor biological characteristics and adverse events will be analyzed to evaluate the efficacy and safety of apatinib and explore the risk factors of prognosis in patients with gastric carcinoma.

Official Title
-----------------
A Real World Study of Apatinib in Treatment of Patients With Gastric Carcinoma

Conditions
-----------------
Gastric Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically or cytologically confirmed gastric or residual gastric or gastroesophageal junction carcinoma; Patients received apatinib treatment at least once. Exclusion Criteria: 1. No specific exclusion criteria in this real world study.

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 |
| --- | --- | --- |
| Overall Survival | Overall Survival | 2015-2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective Response Rate | 2015-2018 | 
| Disease Control Rate | Disease Control Rate | 2015-2018 | 
| Progression-Free Survival | Progression-Free Survival | 2015-2018 |
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts- gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer. CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy dose finding study, followed by a phase II part to establish response rates. All subjects receives radiotherapy concommitant. CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses with radiotherapy concommitant.

Official Title
-----------------
Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer

Conditions
-----------------
Stomach Cancer, Gall Bladder Cancer, Bile Ductus Cancer, Pancreas Cancer, Colorectal Cancer

Intervention / Treatment
-----------------
* Other: oxaliplatin, capecitabine, radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Measurable disease according to RECIST ECOG Performance Status 0-1 ANC over 1.5 x 10 9/L Platelets over 100 x 10 9/L Creatinine less than 1.5 x ULN Bilirubin less than 1.5 x ULN ALT less than 2.5 x ULN Signed informed concent Exclusion Criteria: Prior radiotherapy to the same local Prior chemotherapy for locally advanced or metastatic disease Pregnancy or breast feeding Peripheral neuropathy more than grade 1 Uncontrolled diarrhéa Other serious uncontrolled concomitant illness Lymph node metastasis that can not be included in the GTV (gross tumor volume), without exceeding the stipulated radiotherapy doses in organs at risk

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemoradiotherapy<br> | Other: oxaliplatin, capecitabine, radiotherapy<br> <br> |

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
-----------------
Stomach cancer, Gall bladder cancer, Bile ductus cancer, Pancreas cancer, Colorectal cancer, Chemo radiotherapy, Phase I-II, Oxaliplatin, Capecitabine, Response
Evaluation of Non-Invasive Hemoglobin in Trauma Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse oximeter and sensors in a trauma setting

Detailed Description
-----------------
The study aimed to evaluate SpHb's ability to detect critical drops in a trauma population

Official Title
-----------------
Evaluation of Non-Invasive Hemoglobin in Trauma Patients Using FDA-Cleared Masimo Pulse CO-Oximeter

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Device: Radical-7 Pulse CO-Oximeter and sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated 16 years of age or older or greater than or equal to 50 kg body weight if age unknown. Level 1 (highest trauma activation) status at the time of arrival to emergency department (ED). Expected to be admitted to the ICU/IMU for in hospital care. Exclusion Criteria: Moribund patients with devastating injuries and expected to die within one hour of ED admission. Prisoners, as defined as those who have been directly admitted from a correctional facility (a free living individual who is under police observation as a suspect will remain in the study until hospital discharge). Obvious pregnancy in the ED. Received greater than 5 minutes of cardiopulmonary resuscitation (CPR) in the pre-arrival or hospital setting. Has, on the ring, middle and index fingers of both hands, any of the following: finger deformities, injuries, including burns, scar tissue or infection, or any material that may interfere with sensor application or trans-illumination of the site. Has significant bilateral trauma to the arms or forearms.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Subjects<br>Each test subject will receive a Radical-7 Pulse CO-Oximeter and sensor that will remain on the subject for the first 24 hours following ED admission or discharge from the ICU/IMU. | Device: Radical-7 Pulse CO-Oximeter and sensor<br>* Noninvasive device that measures hemoglobin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpHb's Ability to Detect Critical Drops | The ability of noninvasive continuous total hemoglobin (SpHb) to detect critical drops in arterial or venous hemoglobin values, calculated using chi-squared analysis. | Up to 24 hours. |
A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma

Study Overview
=================
Brief Summary
-----------------
To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Official Title
-----------------
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension In The United States.

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Xalacom
* Drug: Xalatan
* Drug: Timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xalacom|nan|
|Drug: Xalatan|nan|
|Drug: Timolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean IOP measurements obtained in the study eye at each time point. |  |  |
Efficacy and Safety of Heme-Iron Polypeptide on Improvement of Anemia

Study Overview
=================
Brief Summary
-----------------
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Heme-Iron Polypeptide on Improvement of Anemia. The investigators measured Improvement of Anemia parameters , including hemoglobin, transferrin saturation, serum iron, and ferritin, and monitored their blood pressure.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Dietary Supplement: Heme-Iron Polypeptide
* Dietary Supplement: Placebo
* Dietary Supplement: Heme-Iron
* Dietary Supplement: Organic Iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 19-60 years old Hemoglobin concentration less than 13g/dL(men), 12g/dL(women) Able to give informed consent Exclusion Criteria: Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery Participation in any other clinical trials within past 2 months History of alcohol or substance abuse Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heme-Iron Polypeptide<br> | Dietary Supplement: Heme-Iron Polypeptide<br>* Heme-Iron Polypeptide (1g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (1g/day)<br>|
| Active Comparator: Heme-Iron<br> | Dietary Supplement: Heme-Iron<br>* Heme-Iron (1g/day)<br>|
| Active Comparator: Organic Iron<br> | Dietary Supplement: Organic Iron<br>* Organic Iron (1g/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemoglobin | Hemoglobin was measured in study visit 1(0 week) and visit 5(4 week). | 4 weeks | 
| Changes in transferrin saturation | Transferrin saturation was measured in study visit 1(0 week) and visit 5(4 week). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum iron | Serum iron was measured in study visit 1(0 week) and visit 5(4 week). | 4 weeks | 
| Changes in ferritin | Ferritin was measured in study visit 1(0 week) and visit 5(4 week). | 4 weeks |
Late Acquired Malaposition and Different Polymers

Study Overview
=================
Brief Summary
-----------------
The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

Detailed Description
-----------------
please see brief summary

Official Title
-----------------
Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography

Conditions
-----------------
Late Acquired Stent Malaposition

Intervention / Treatment
-----------------
* Procedure: Everolimus-Eluting Stent (EES)
* Procedure: Zotarolimus-Eluting-Stent (ZES)
* Procedure: Biolimus-Eluting-Stent (BES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES Exclusion Criteria: chronic renal failure (serum creatinine ≥ 2.5mg/dl) restenotic lesions

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Everolimus-Eluting-Stent (EES)<br>Patients treated with EES | Procedure: Everolimus-Eluting Stent (EES)<br>* Patients treated with EES<br>|
| Active Comparator: Zotarolimus-Eluting-Stent (ZES)<br>Patients treated with ZES | Procedure: Zotarolimus-Eluting-Stent (ZES)<br>* Patients treated with ZES<br>|
| Active Comparator: Biolimus-Eluting-Stent (BES)<br>Patients treated with BES | Procedure: Biolimus-Eluting-Stent (BES)<br>* Patients treated with BES<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stent struts with late acquired malaposition |  | 1 year after stent implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of stent struts with late acquired malaposition |  | 2 years after stent implantation |
Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.

Detailed Description
-----------------
This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 70 cases will be collected from approximately 10 study sites and correlated to the ChemoFx drug response marker results. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy. Overall Survival will be measured from the start of chemotherapy to the actual date of death.

Official Title
-----------------
Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Other: ChemoFx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case has an original pathology report showing stage III, IIIa, IIIb, IIIc, IV, IVa, IVb, or recurrent endometrial cancer. Case includes a pathology or cytology report from initial diagnosis showing disease of one or more of the following histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.). Case has been identified for pattern of response evaluation. Case must have a commercial ChemoFx drug response marker final report. Exclusion Criteria: Cases of patients who were deceased prior to 1 cycle of chemotherapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Late stage endometrial cancer<br> | Other: ChemoFx<br>* Chemoresponse Marker Assay<br>|

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
-----------------
Late Stage
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

Study Overview
=================
Brief Summary
-----------------
The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.

Official Title
-----------------
Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.

Conditions
-----------------
Uterine Myoma

Intervention / Treatment
-----------------
* Drug: Triptorelin 3.75 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: submucous myoma diagnosed by vaginal ultrasonography and confirmed by diagnostic hysteroscopy premenopausal status Exclusion Criteria: present or past history of cancer pregnancy presence of associated multiple polyps presence of > 2 myomas associated nonhysteroscopic surgical procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH agonist pretreatment<br>triptorelin 3.75 mg, im, monthly, three times | Drug: Triptorelin 3.75 mg<br> <br> |
| No Intervention: No pharmacological treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. |  | Just finished the surgical procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minutes (surgical procedure time), milliliters (fluid absorption during the procedure). |  | Just finished the surgical procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uterine myoma, GnRHa, Hysteroscopy, Cold loop
Epidemiology of Sleep Disordered Breathing in Children

Study Overview
=================
Brief Summary
-----------------
To collect fundamental data regarding the distribution of measures of sleep disordered breathing (SDB) in a pediatric population, prevalence of clinically significant SDB in children, risk factors, and associated co-morbidity.

Detailed Description
-----------------
BACKGROUND: Developing strategies for recognizing and treating children with Sleep Disordered Breathing (SDB) was not possible in the absence of essential epidemiological data that addressed the distribution of measures of SDB in pediatric populations. The potential public health importance of this was underscored by preliminary data that suggested that risk of SDB was increased in susceptible populations, in particular in African Americans and in children born prematurely. DESIGN NARRATIVE: The design was that of a cohort study with a nested case control arm. Sleep disordered breathing was evaluated in 850 children with in-home state-of-the art respiratory monitoring techniques. A number of risk factors were evaluated: sociodemographic characteristics; anthropometry; upper and lower airway size and function (questionnaire, spirometry, and reflectometry); perinatal exposures (from neonatal records); family history; and home environment (passive smoking; sleep patterns, maternal-child stress indices). Behavior, cognitive skills, attention, and health-related quality of life were assessed with standardized instruments to assess co-morbidities (potential SDB outcomes). Analysis of the longitudinal data provided cognitive-developmental trajectories that were evaluated in relationship to SDB. The case-control arm confirmed and extended the findings of the in-home assessments with comprehensive laboratory polysomnography, cephalometry, and objective measures of sleepiness (Multiple Sleep Latency Tests) in three groups of children: definite SDB by home assessment; equivocal SDB; and no SDB. Collection of comprehensive polysomnographic data helped to identify which measures best discriminated symptomatic (e.g., snoring, sleepy) from asymptomatic children. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Sleep Apnea Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |