linjc16/ctgov huggingface dataset:
UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

Detailed Description
-----------------
A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS

Official Title
-----------------
A Non-interventional Observational Study of Infectious Complications in Cancer Patients

Conditions
-----------------
Aspergillosis, Candidemia, C. Difficile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer patients with Infections Exclusion Criteria: No Infections

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 |
| --- | --- | --- |
| To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients | To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence | To determine the overall incidence of different infections, including bacterial, fungal and viral infections in cancer patients receiving chemotherapy and / or hematopoietic stem cell transplantation. To describe the natural history of such infections in cancer patients. To monitor the adherence of Myeloma institute for research and therapy(MIRT) health care workers to the MIRT standard operational procedures (SOPs) To identify risk factors for the development of specific infections. To validate surrogate markers as early diagnostic tools for various infections. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspergillosis, Candidemia, Candidiasis, C. Difficile, cytomegalovirus, respiratory syncytial virus (RSV), Influenza, CONS
Comparison of Continuous Non-invasive Arterial Pressure (CNAP) With Invasive Arterial Pressure Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the Continuous Non-invasive Arterial Pressure (CNAP) monitor with the gold standard of invasive arterial pressure monitoring during: induction and maintenance of general anaesthesia intensive care unit treatment of postoperative patients with an ASA 3 or 4 status

Detailed Description
-----------------
The CNAP monitor continuously measures blood pressure using a finger cuff. It showed a good agreement to invasive blood pressure measurements during anaesthesia induction and maintenance during surgery. In critical ill patients cardiac arrhythmia is probably a confounding factor affecting accuracy and interchangeability of CNAP. As systolic arterial CNAP pressure in comparison to mean pressure shows no statistical interchangeability with invasive measurements, mean pressure should be considered when making therapy decisions. A problem is the missing standard criterion for comparison of continuously devices with invasive pressure.

Official Title
-----------------
Accuracy of the CNAP™ Monitor (Continuous Non-invasive Arterial Pressure) Versus Invasive Radial Arterial Monitoring in Surgical Patients

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 BMI < 35 kg.m² Patients capable of giving informed consent patients undergoing elective surgical procedures in supine position under general anesthesia perfusion of the examined arm evidenced by a positive Allen's test Exclusion Criteria: Patients not competent or unwilling to provide informed consent Patients with history of neurological, neuromuscular seizure Patients where IBP cannula, CNAP™ finger-cuff and CNAP™ upper arm cuff cannot be placed on the same arm

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensive Care treatement<br>ASA status 3 or 4 patients with invasive blood pressure measurement on the intensive care unit | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bias and percentage error of CNAP compared with invasive arterial pressure measurement |  | 1.) Induction of general anaesthesia. 2.) Maintanance of general anaesthesia. 3.) Intensive Care Treatement after surgery |
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis

Study Overview
=================
Brief Summary
-----------------
Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.

Official Title
-----------------
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Histologically/laparoscopically confirmed endometriosis Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the previous month for at least 6 months VAS of 6 or more at baseline Failure, completion or intolerance of standard treatment modalities (oral contraceptive therapy, danazol, Depo-Provera, Depo-Lupron) Patients must give written informed consent. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program. Exclusion Criteria: Pregnant and/or lactating female Users of other angiogenesis inhibitors Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin, carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart in user of oral contraceptive therapy Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and Danazol within the past 3 months Use of norethindrone acetate (Aygestin) in the prior month Seizure disorder Hepatitis, or any active infection (upper respiratory infection, PID, etc) History of thromboembolic disease. Baseline neutropenia (ANC < 1000/mm^3) Any severe physical or metal illness that would interfere with the completion of the protocol Illicit drug or alcohol abuse

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

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

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 |
| --- | --- |
| Other: Thalidomide<br>Thalidomide was administered and pain reports were recorded over the course of 6 months. | Drug: Thalidomide<br>* Pill form, 50mgs with increasing dosage up to a maximum of 250 mg qd based on pain reports, taken once daily for 14-16 weeks with one 6 month follow-up appointment.<br>* Other names: Thalomid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain report |  | 6 months |
The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

Study Overview
=================
Brief Summary
-----------------
This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.

Official Title
-----------------
Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

Conditions
-----------------
Uterine Sarcoma

Intervention / Treatment
-----------------
* Drug: doxorubicin, ifosfamide, cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed uterine sarcoma (rereading in reference centers) Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma All stages <= stage III (FIGO modified for endometrial carcinoma) Full surgical exeresis Age >= 18 years and physiological age <= 65 years Negative extension check-up (thoracic and abdomino-pelvic TDM) Performance status (PS) <= 2 (ECOG) Normal haematologic functions (absolute neutrophil count > 1,500/mm3, platelets > 100,000/mm3) Serum creatinine < 1.25 x ULN Good hepatic check-up (total serum bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN) Absence of neuropathy > grade 1 Left ventricular ejection fraction > 50% (by isotopic or ultrasound scan determination) Written informed consent Exclusion Criteria: Low grade endometrial stromal sarcoma Time since surgery > 8 weeks Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones) Antecedents or evolutive psychiatric disorder Concurrent active infection or other serious uncontrolled systemic disease Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: doxorubicin, ifosfamide, cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival |  |  | 
| Evaluation of global toxicity of the treatment in each arm |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uterine sarcoma non metastatic
Minor Troponin Elevations in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This study aims at identifying the etiology of troponin-T elevations in patients with atrial fibrillation visiting the emergency department.

Detailed Description
-----------------
The aim of this study is to identify the factors associated with minor cardiac troponin-T elevations in patients presenting in emergency department (ED) with atrial fibrillation (AF) diagnosis , and the possible implications it has on the patients prognosis. Data on 3394 patients from the Turku university hospital catchment area with diagnosis of AF on admission to ED and minor troponin-T elevation were analyzed. Patients were classified into three groups according to the troponin-T value: troponin <15ng/l, 15-50ng/l and 51-100ng/l. Individual patient records were reviewed.

Official Title
-----------------
Etiology of Minor Troponin Elevations in Patients With Atrial Fibrillation Visiting Emergency Department

Conditions
-----------------
Atrial Fibrillation, Myocardial Ischemia

Intervention / Treatment
-----------------
* Diagnostic Test: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: two troponin T tests within 72 hours of ED admission Prior diagnosis of AF or AF at admission Exclusion Criteria: Age < 18 years

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br> | Diagnostic Test: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality, myocardial infarction, ischemic stroke | Major adverse cardiac or cerebrovascular event within one year | 12 months |
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.

Detailed Description
-----------------
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome will be evaluated during a double blind, placebo controlled study. This study is an expansion of RLP042019 NCT04078841 Treating Post-Lyme Disease Syndrome With Acetogenins

Official Title
-----------------
A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

Conditions
-----------------
Post-Lyme Disease Syndrome (PLDS)

Intervention / Treatment
-----------------
* Dietary Supplement: RLP
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A positive two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment. Must be able to swallow a mixed powder drink. Exclusion Criteria: 1 .Non Positive Western Blot test. 2. Positive Western Blot test where the individual has not been treated with antibiotics. -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RLP<br>ReaLife+ | Dietary Supplement: RLP<br>* RLP nutraceutical<br>|
| Placebo Comparator: Inert<br>Inert brown powder to look similar to RLP | Other: Placebo<br>* Inert brown powder<br>|
| No Intervention: Control<br>Not given RLP or the placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Global-10 | PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 . | 6 months | 
| IHT Blood Test Assessment | Outcome measure of positive or negative for antibodies; IgG P93 Ab. IgG P66 Ab. IgG P58 Ab. IgG P45 Ab. IgG P41 Ab. IgG P39 Ab. IgG P30 Ab. IgG P28 Ab. IgG P23 Ab. IgG P18 Ab. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lyme
The Recovery Profiles After Robotic or Open Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
In the present study, The investigators investigated the effect of surgical methods on the recovery of patients after robotic surgery and open thyroidectomy

Official Title
-----------------
The Recovery Profiles After Robotic or Open Thyroidectomy

Conditions
-----------------
Postoperative Sorethroat, Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: surgical procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing robotic thyroidectomy or open conventional thyroidectomy Adults 19 to 70 years of age American Society of Anesthesiologists Physical grade 1-2 Exclusion Criteria: Patients who underwent surgery on the neck and in the laryngeal area before Patients who do not understand or can not express pain scale Patients with sore throat and cough before surgery If intubation is difficult or repeated intubation is performed Patients who are using opioids or analgesics as chronic agents.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| robotic thyroidectomy group<br> | Procedure: surgical procedure<br>* In robotic thyroidectomy group, patients are received surgery using robotic system. In open thyroidectomy group, patients are received conventional open surgery.<br>|
| open thyroidectomy group<br> | Procedure: surgical procedure<br>* In robotic thyroidectomy group, patients are received surgery using robotic system. In open thyroidectomy group, patients are received conventional open surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative sore throat | none, mild, moderate, severe | postoperative 1 hour |
Study of an Extended Release (ER) Tablet, Single and Repeated Dosing

Study Overview
=================
Brief Summary
-----------------
The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.

Official Title
-----------------
A Two-part, Single-centre, Open (Part A) Single Blind (Part B), Randomised, Placebo-controlled Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Doses With and Without Food and Multiple Ascending Oral Doses of AZD1305 Extended-release Tablet in Healthy & Elderly Subj

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

Intervention / Treatment
-----------------
* Drug: AZD1305
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A body mass index (BMI=weight/height2) of 19 to 27 kg/m2 Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator Exclusion Criteria: ECG findings outside normal range Potassium outside normal reference values

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD1305 ER tablet | Drug: AZD1305<br>* ER tablet, administered as single and repeated doses.<br>|
| Placebo Comparator: B<br>Placebo tablet | Drug: Placebo<br>* Tablet, administered as single and repeated doses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, ECG, vital signs, physical examination, laboratory variables, body temperature and weight |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | During all dosing visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD1305, safety, pharmacokinetics, multiple ascending doses, Safety and pharmacokinetics
Spontaneous Preterm Birth Marker Test

Study Overview
=================
Brief Summary
-----------------
The prediction of preterm birth is beneficial because it initiates early treatment to minimize risk. It defines a population at risk to provide particular treatment and may lead us to a better understanding the mechanisms of preterm birth. The understanding of the mechanisms and etiology consequently leads to the possibility of early intervention and effective management aiming at preventing preterm birth. Five most common interventions for preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest, progesterone, and tocolytic therapy. However, there are insufficient evidence showing the efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm birth; the use of certain tocolytics needs to be considered against the possible adverse effects. The early detection of pregnant women with high risk for preterm delivery would be the ideal solution to prevent preterm birth. However, to date, there is inadequate literature and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.

Official Title
-----------------
Spontaneous Preterm Birth Marker Test (SPBMT): Preterm Prediction Prospective Study

Conditions
-----------------
Preterm Delivery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation. Exclusion Criteria: Subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.

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

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

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 |
| --- | --- | --- |
| Cervical length | Cervical length <15, 20, 25 mm | 6-12 months | 
| Biomarkers (serum) | subjects with feral fibronectin ≥50 ng/mL, >10 mg/L of cervical phIGFBP1; elevated Interleukin-6 as compared to term birth; significantly present of other biomarkers. | 6-12 months | 
| Lipid analysis (serum and DBS) | Lipid profiles of preterm birth compared to term birth. | 6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spontaneous preterm birth, lipids, biomarkers