linjc16/ctgov huggingface dataset:
Radiolabeled Glass Beads Used for Treating Patients With Primary Liver Cancer When Surgery is Not an Option

Study Overview
=================
Brief Summary
-----------------
Fewer than 15% of hepatoma patients are suitable candidates for surgical removal of their cancer. The purpose of this protocol is to provide supervised access at Oregon Health and Science University to Y-90 treatment to provide these patients access to an alternate therapy. The radioactive beads are placed directly near or into the liver tumor with the intention of destroying the tumor cells.

Detailed Description
-----------------
Patients receive Y-90 (yttrium) glass microspheres via percutaneous hepatic arterial infusion. Patients amy be retreated between 30-90 days after initial infusion. After completion of therapy, patients are followed for 30 days and then every 3 months for up to 2 years.

Official Title
-----------------
A Humanitarian Device Exemption Use Protocol of TheraSphere for Treatment of Unresectable Hepatocellular Carcinoma

Conditions
-----------------
Liver Cancer, Hepatoma

Intervention / Treatment
-----------------
* Device: Yttrium 90 (TheraSphere)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of HCC Cancer is unresectable ECOG Score 0-2 Age of 18 yrs or over Able to give consent Exclusion Criteria: Contraindication to angiography and selective visceral catheterization Portal hypertension with portal venous shunt away from the liver Evidence of potential delivery of > 16.5 mCi of radiation to the lungs Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow Significant extrahepatic disease representing an imminent life-threatening outcome Severe liver dysfunction or pulmonary insufficiency Active uncontrolled infection Significant underlying medical or psychiatric illness Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>yttrium 90 (TheraSphere) administration | Device: Yttrium 90 (TheraSphere)<br>* Y-90 embedded glass microspheres<br>* Other names: TheraSphere;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response after treatment based on tumor marker and lab results, CT scan and patient's symptoms. | Tumors will decrease in size | 2 weeks, 1 month and then every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver tumor, cancer, hepatoma, yttrium
An Observational Study of Avastin (Bevacizumab) in Combination With Paclitaxel in First-Line Treatment in Patients With HER2-Negative Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate the use in clinical practice, efficacy and safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up to 2.5 years.

Official Title
-----------------
A Non-interventional Study of Avastin in Combination With Paclitaxel for First Line Treatment in HER2 Negative Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Locally recurrent or metastatic breast cancer No prior treatment for metastatic or locally recurrent disease Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Exclusion Criteria: History or clinical evidence of brain metastases Pregnancy Uncontrolled hypertension ( systolic > 150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease Major surgical procedure or significant traumatic injury within 28 days prior to enrolment

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | approximately 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage/schedule/number of cycles of Avastin treatment in clinical practice |  | approximately 2.5 years | 
| Safety: Incidence of adverse events |  | approximately 2.5 years |
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders

Study Overview
=================
Brief Summary
-----------------
Amniotic fluid (AF) is a complex structure with a changing content by gestational time. AF pH can be affected by both maternal and fetal conditions such as preterm ruptures of membranes, prematurity and fetal distress. While fetal urine is the major content of AF since 20th gestational week, fetal lung liquid (FLL) also acts as a minor content. Secretion of FLL depends on chloride transport and postnatal clearance of FLL is provided by active reabsorption of sodium (Na) ions. Down-regulation of epithelial Na channels (ENaCs) and an increase of pulmonary compliance accompany to pulmonary adaptation developing at the first hours of life. Lower genomic expression of Na channels in airways is shown to be associated to respiratory distress syndrome (RDS) in preterm. Although pH and electrolyte value of AF is thought to be relevant to fetal and maternal conditions such as gestational age, antenatal steroids and preterm birth, there is no study about this topic in the literature.

Official Title
-----------------
The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders

Conditions
-----------------
Respiratory Distress Syndrome, Transient Tachypnea of Newborn

Intervention / Treatment
-----------------
* Device: Blood Gas Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepted to participate with informed consent Normal healthy pregnancies Exclusion Criteria: Congenital abnormalities Chromosomal abnormalities Blood contaminated AF Declined to participate

Ages Eligible for Study
-----------------
Maximum Age: 25 Hours

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Neonates with respiratory distress | Device: Blood Gas Sampling<br>* analyzing amniotic fluid by blood gas device<br>|
| Control Group<br>Healthy Infants | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Predictive Value of Amniotic Fluid pH and Electrolytes on Neonatal Respiratory Disorders |  | 8 months |
EndoRings Colonoscopy for Adenoma Detection

Study Overview
=================
Brief Summary
-----------------
Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy. EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal

Official Title
-----------------
EndoRings Versus Standard Colonoscopy for Adenoma Detection

Conditions
-----------------
Adenoma

Intervention / Treatment
-----------------
* Device: EndoRings
* Device: Standard colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for colonoscopy (screening, surveillance, diagnostic) age ≥ 45 years ability to give informed consent Exclusion Criteria: pregnancy age <45 years known colonic strictures chronic inflammatory bowel disease active inflammation s/p colonic resection bleeding disorder

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EndoRings<br>Colonoscopy is performed with the EndoRings attached | Device: EndoRings<br>* EndoRings-assisted colonoscopy<br>|
| Active Comparator: Standard Colonoscopy<br>Standard colonoscopy without any additional devices | Device: Standard colonoscopy<br>* Standard colonoscopy without any additional devices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate |  | during colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EndoRings, Adenoma, Polyp, Colonoscopy, Endoscopic device, Colon cancer screening
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.

Official Title
-----------------
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Yoga
* Behavioral: Qigong


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women ≥ 65 years of age Chronic low back pain since 6 months at least Functional Rating Index (FRI) ≥ 2 last 7 days Informed consent form signed Exclusion Criteria: Disc prolapse with acute neurological symptoms Previous spinal operations Severe organic or psychiatric disease conditions, not allowing to participate in the trial Use of opioids Drug- and alcohol-addiction Participation in another clinical trial within the last 6 months Participation in yoga or qigong training within the last 12 months Planned physical therapy within study duration

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waiting Group<br> | |
| Active Comparator: Qigong<br> | Behavioral: Qigong<br>* 12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months<br>|
| Active Comparator: Yoga<br> | Behavioral: Yoga<br>* 24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional rating Index (FRI) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Rating Index |  | 6 months | 
| Visual Analogue Scale |  | 3, 6 months | 
| FFb-HR |  | 3, 6 months | 
| Pain medication |  | 6 months | 
| Falls |  | 6 months | 
| Tinetti Test |  | 3, 6 months | 
| SF 36 |  | 3, 6 months | 
| Geriatric Depression Scale |  | 3, 6 months | 
| Adverse events |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly patients
Troponin I and T and Adverse Outcomes in Patients With and Without Diabetes Mellitus After Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
Elevated levels of troponin are associated with future MACE. Data on the prognostic value of high sensitive troponin T (hs-TnT) as compared to high sensitive troponin I (hs-TnI) in diabetic and non-diabetic patients are sparse. We aimed to assess the risk for MACE according to gender and diabetes status and to compare the prognostic value of hs-TnT and hs-TnI with regards to clinical outcomes in diabetic and non-diabetic patients undergoing percutaneous coronary intervention (PCI).

Official Title
-----------------
A Sex-specific Analysis of the Predictive Value of Troponin I and T in Patients With and Without Diabetes Mellitus After Successful Coronary Intervention

Conditions
-----------------
Coronary Artery Disease, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Percutaneous coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Percutaneous coronary intervention Exclusion Criteria: unsuccessful percutaneous coronary intervention
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male, with DM<br> | Other: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>|
| Male, without DM<br> | Other: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>|
| Female, with DM<br> | Other: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>|
| Female, without DM<br> | Other: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | All-cause death, non-fatal myocardial infarction, non-fatal stroke | 8 years |
The Effect of Obesity on Lung Functioning

Study Overview
=================
Brief Summary
-----------------
This research study is looking at the effects of weight loss, due to surgery or structured weight-loss program on lung function, inflammation in your body and lungs, asthma and asthma symptoms. This study is important because we will be better able to understand the effect of weight on lung functioning and asthma. Approximately 20 research subjects will be enrolling in this study at National Jewish. Adults with asthma who has elected to undergo weight-reduction surgery may qualify for the participation. Involvement will last about 1 year.

Official Title
-----------------
The Effect of Medical and Surgical Weight Loss on Pulmonary Physiology and Airway

Conditions
-----------------
Obesity, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥18yr) who report a physician's diagnosis of asthma and have taken any asthma medication within the last 2 weeks. Obesity (Body Mass Index (BMI) ≥40, or ≥35 with comorbidities, as per published guidelines for qualification for bariatric surgery). Planned weight-loss surgery or structured weight-loss plan. Exclusion Criteria: Tobacco use within one month. Qualifying lung-functioning. Qualifying oxygen saturation levels. Use of systemic corticosteroids (Prednisone) within one month. Presence of another chronic lung disease besides asthma (COPD, bronchiectasis, ILD, sarcoidosis, etc). Presence of another chronic systemic inflammatory disease (rheumatoid arthritis or other connective-tissue disease, chronic infection such as osteomyelitis, inflammatory bowel disease, chronic active hepatitis, etc). Subjects with osteoarthritis, stable coronary artery disease, hypertension, or diabetes mellitus will not be excluded. Presence of malignant neoplasm within the last 3 years (with the exception of non-melanoma skin cancer). Clinically significant left or right ventricular dysfunction. Severe pulmonary hypertension (high blood pressure). Untreated obstructive sleep apnea: Subjects with a current diagnosis of sleep apnea not being treated with CPAP or BiPAP will be excluded. Subjects with a current diagnosis of sleep apnea being treated adequately (as determined by the investigators) will be included. Prader-Willi syndrome A known endocrinopathy causing obesity (e.g., Cushing's Syndrome).

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Bariatric Surgery, Weight Loss Surgery, Asthma
Surveillance of Effectiveness/Safety of Artemether-lumefantrine in Patients With Malaria

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the pediatric and adult patients (U.S. and foreign residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to their demographics, including evaluation of their malaria immune status, treatment effectiveness, prior and concomitant medication use, and the occurrence of adverse events in association with artemether-lumefantrine treatment, based on the information collected in the CDC Malaria Case Surveillance Report Form.

Official Title
-----------------
Surveillance for the Effectiveness and Safety of Artemether-lumefantrine in Pediatric and Adult Patients With Malaria

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Other: Artemether-lumefantrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any male or female infant, child or adult patient diagnosed with malaria who received artemether-lumefantrine and was reported to the CDC. Malaria may be clinically suspected or confirmed (microscopically, and/or by polymerase chain reaction [PCR], and/or rapid diagnostic test [RDT]). Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Artemether-lumefantrine<br> | Other: Artemether-lumefantrine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Resolution of clinical signs and symptoms after artemether-lumefantrine treatment start |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event, serious adverse event after artemether-lumefantrine treatment start |  | 4 weeks | 
| Pregnancies after artemether-lumefantrine treatment start |  | Up to delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artemether-lumefantrine, demographics, malaria
A Study of MK0217A and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the safety, tolerability, and effectiveness of an investigational drug and dietary supplement to reduce the risk of vitamin D insufficiency and deficiency during treatment of osteoporosis in men and postmenopausal women.

Official Title
-----------------
A 15-Week, Double-Blind, Randomized, Active-Controlled, Multi-Center Study With 24-Week Extension to Evaluate the Safety, Tolerability, Efficacy of Alendronate 70 mg Plus Vitamin D3 2800 IU Combination Tablet in Men and Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or postmenopausal women who are osteoporotic Exclusion Criteria: Vitamin D deficiency Other disease of bone or mineral metabolism Digestive disease causing malabsorption Other medical conditions that are not adequately treated

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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: MK0217A, alendronate sodium (+) cholecalciferol / Duration of Treatment: 24 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability; primary parameter assessed is the proportion of patients who develop hypercalcuria |  |  |