linjc16/ctgov huggingface dataset:
DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the prevalence and treatment of nausea and/or vomiting in patients with advanced cancer not receiving chemotherapy or irradiation.

Conditions
-----------------
Advanced Cancer, Nausea, Emesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cancer Age ≥ 18 years Ability to read and understand the forms required for the study Life-expectancy more than 2 weeks. Nausea score ≥ 'a little' on the extended EORTC QLQ-C15-PAL (item 9) Exclusion Criteria: Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days. Chemotherapy or radiation therapy within the last 4 weeks Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MRI scan of the cerebrum is needed before inclusion Radiologically confirmed ileus, or strong clinical suspicion evaluated by the study Investigator 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients over 18 years old with advanced cancer defined as metastatic disease, no curable treatment options. The patients may not have received chemotherapy or irradiation within 4 weeks, no operations within 2 weeks and no general anesthesia within 4 days. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-item nausea-score from EORTC-QLQ-C15-Pal at baseline and 1 week | The primary objective is to observe the effect of standard anti-emetics on change in two-item nausea-score from baseline to 24 hours. | From baseline and at 1 week (5-9 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea CAT-score from EORTC-QLQ-C15-Pal at baseline and after 1 week | Change in nausea CAT-score from baseline to 24 hours and 7 days | 1 week (5-9 days) | 
| Nausea at screening from EORTC-QLQ-C15-Pal at baseline | Prevalence of nausea at time of screening, related to age, cancer-diagnosis and gender | At baseline | 
| Emesis at screening from EORTC-QLQ-C15-Pal at baseline | Prevalence of emesis at time of screening, related to age, cancer-diagnosis and gender | At baseline | 
| Change in other parameters from EORTC-QLQ-C15-Pal at baseline and after 1 week | Change in other parameters potentially indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life | From baseline and at 1 week (5-9 days) |
Baseline Investigation of Chronic Hepatitis B Viruses Infections: Who is Eligible for Treated Criteria

Study Overview
=================
Brief Summary
-----------------
Through two-stage stratified cluster sampling, investigators studied the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infection-related liver disease population.

Detailed Description
-----------------
Hepatitis B virus (HBV) infection is a major public health problem worldwide. China has the world's largest burden of HBV infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. While, the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infections is still unknown. In response to the above situation, Sampling applied a two-stage stratified cluster sampling design in 16 Districts and 331 Townships. Investigators wanted to know the one who is eligible for treated criteria based on community in 25 and over years old in Beijing.

Official Title
-----------------
Beijing Center for Disease Prevention and Control

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 25 years old; Residents with medical insurance coverage lived in Beijing more than 6 months . Exclusion Criteria: Persons with pacemakers; Pregnant women; Persons with ascites; The one whose wound was not cured at the right upper abdomen

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- | --- |
| HBsAg positive rate | Complete HBsAg tests for more than 60,000 people over the age of 25 in Beijing | Baseline | 
| Average rate of chronic hepatitis B accepting antiviral treatment | The one who is eligible for HBV treated criteria based on community in 25 and over years old in Beijing. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV, Antiviral Treatment Rate, China, Baseline Investigation
Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)

Study Overview
=================
Brief Summary
-----------------
The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the structural and functional features of skeletal muscle (SkM) exercise capacity (as assessed by VO2 max) parameters of diastolic heart function (as assessed by echocardiography) We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.

Detailed Description
-----------------
Patient Inclusion/Exclusion Criteria: New York Heart Association Class II/III HF with preserved ejection fraction (EF) of >50%. Nonsmokers Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded. Ages between 40-65. We will exclude any women of child bearing potential

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Dietary Supplement: CocoaVia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically Diagnosed Heart Failure with Ejection Fraction of >55% BMI 27-32 No Significant HbA1C fluctuations in past 6 months Exclusion Criteria: Smoking or quit smoking less than 1 year prior to enrollment Substance Abuse Taking Coudmadin or Pradaxa

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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: CocoaVia capsules<br>From baseline to 3 months, patients will consume 2 capsules containing pure epicatechin | Dietary Supplement: CocoaVia<br>* CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol<br>* Other names: Epicatechin consumption;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in exercise capacity | Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max | Baseline and 3 months | 
| Change from baseline in skeletal muscle metabolism | The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy | Baseline and 3 months | 
| Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine | Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples | Baseline and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
with preserved ejection fraction of >55%
Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine specific clinical features, molecular abnormalities, and laboratory-based biological markers of free radical stress that are associated with amyotrophic lateral sclerosis and influence disease severity.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a screening and diagnostic study. Blood and urine samples are collected from patients every 2 months for 1 year. All samples are evaluated for measures of free radical damage and levels of the body's own antioxidant activity.

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinically diagnosed probable or definite, sporadic or familial amyotrophic lateral sclerosis --Patient Characteristics-- Pulmonary: No artificial ventilation required Other: No other neurodegenerative diseases No concurrent or history of unstable medical illness

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
-----------------
amyotrophic lateral sclerosis, motor neuron disease, neurologic and psychiatric disorders, rare disease
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
This study is a post-marketing surveillance in Japan, and it is a local prospective, company sponsored and observational study of patient who have been treated by Adalat CR for hypertension with diabetes and/or chronic kidney disease. The objective of this study is to assess safety and efficacy profile of using Adalat CR in real clinical practice. A total 2,000 patients will be recruited and be observed for 6 months. Then, patient of whom microalbumin urea and serum creatinine are continuously monitored are additionally followed for 6 months.

Official Title
-----------------
Post-marketing Surveillance for Hypertensive Patients With Diabetes and/or Chronic Kidney Disease

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nifedipine (Adalat CR, BAYA1040)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who are administered with Adalat CR for hypertension with diabetes and/or chronic kidney disease (CKD) Exclusion Criteria: CKD with stage 5 CDK with dialysis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Nifedipine (Adalat CR, BAYA1040)<br>* patients who are administrated with Adalat CR for hypertension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of participants with Adverse Events for Safety purpose in real practice |  | After 6 months | 
| General evaluation of patient concerning efficacy of AdalatCR treatment in real practice |  | After 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, Pulse rate |  | After 6 months | 
| Clinical test values, in specially, microalbumin urea and serum creatinine |  | After 6 months | 
| Overall evaluation |  | After 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adalat, Hypertension, Diabetes, Chronic kidney disease
A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States.

Official Title
-----------------
National Cooperative Growth Study (NCGS) of Nutropin AQ, Nutropin, and Protropin in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)

Conditions
-----------------
Chronic Renal Insufficiency, End-Stage Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed with CRI or ESRD and treated with a Genentech GH preparation on or after 1 January 2001 CRI documented using the Schwartz formula indicates a calculated creatinine clearance (CrCl) of <=75 mL/min/1.73 m^2 Ability to keep follow up appointments throughout the study Exclusion Criteria: Subjects receiving a non-Genentech GH preparation Subjects with closed epiphyses Subjects with active neoplasia Current participation in another GH clinical study Current participation in the core study

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |
Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients

Official Title
-----------------
Comparison of Ultrasound Guided Erector Spinae Block and Ultrasound Guided Caudal for Perioperative Analgesia in Pediatric Cancer Patients Undergoing Nephrectomy Surgeries: A Randomized Controlled Study

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Procedure: Erector spinae plane block
* Procedure: Caudal block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II Age >1 and <12 patients undergoing nephrectomy surgeries Exclusion Criteria: patients parental refusal local infection at the puncture site coagulopathy with INR> 1.6 unstable cardiovascular disease patients allergic to medication used development or mental delay impaired liver and renal functions

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- |
| Experimental: Ultrasound guided erector spinae plane block<br>Unilateral erector spinae plane block will be performed under ultrasound guidance | Procedure: Erector spinae plane block<br>* Ultrasound guided erector spinae plane block<br>|
| Active Comparator: Ultrasound guided caudal block<br>Caudal block will be formed under ultrasound guidance | Procedure: Caudal block<br>* Ultrasound guided caudal block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | postoperative morphine consumption | First 24 hours postoperatively |
Enhanced Recovery After Surgery in Major Intrabdominal Procedures.

Study Overview
=================
Brief Summary
-----------------
Enhanced Recovery After Surgery (ERAS) programs have been introduced with aims of attenuating the stress response to surgery and enabling rapid recovery. There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of traditional treatment. However, few studies exist about the implication of ERAS programs in major upper abdominal surgery patients. The aim of this study was to compare morbidity, mortality and length of stay in patients undergoing major intrabdominal surgery, including upper and lower gastrointestinal, receiving either conventional postoperative care or an ERAS program.

Official Title
-----------------
Enhanced Recovery After Surgery (ERAS) Versus Conventional Postoperative Care in Patients Undergoing Major Intra-abdominal Surgery.

Conditions
-----------------
Complication of Surgical and Medical Care.

Intervention / Treatment
-----------------
* Other: ERAS perioperative care
* Other: Traditional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective surgery ASA grade < 4 Exclusion Criteria: Emergency surgery ASA grade > 3

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 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 |
| --- | --- |
| Active Comparator: ERAS patients<br>Patients planned to undergoing major intrabdominal surgery, following the ERAS perioperative care. | Other: ERAS perioperative care<br>* Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.<br>|
| Active Comparator: Control patients<br>Patients planned to undergo major intrabdominal surgery, following the conventional perioperative care. | Other: Traditional<br>* Nasogastric tube until bowel function, late oral eating, opioid analgesics.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity. |  | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality. |  | 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fast-tract surgery, Enhanced recovery after surgery, multimodal surgery.
Adherence of Iron Succinylate Therapy in Pregnancy

Study Overview
=================
Brief Summary
-----------------
According to the World Health Organization (WHO), anemia is the most common disease, affecting >1.5 billion people worldwide. Furthermore, iron deficiency anemia (IDA) accounts for 50% of cases of anemia. IDA is common during pregnancy and the postpartum period, and can lead to serious maternal and fetal complications. Measurement of serum ferritin has the highest sensitivity and specificity for diagnosis of IDA unless there is a concurrent inflammatory condition. The lower threshold value for hemoglobin (Hb) in pregnant women is <11 g/dL during the 1st and 3rd trimesters, and <10.5 g/dL during the 2nd trimester. In postpartum period a Hb concentration <10 g/dL indicates clinically significant anemia. Oral iron therapy is given as the first-line treatment for IDA.

Detailed Description
-----------------
Measurement of serum ferritin has the highest sensitivity and specificity for diagnosis of IDA unless there is a concurrent inflammatory condition. The lower threshold value for hemoglobin (Hb) in pregnant women is <11 g/dL during the 1st and 3rd trimesters, and <10.5 g/dL during the 2nd trimester. In postpartum period a Hb concentration <10 g/dL indicates clinically significant anemia. Oral iron therapy is given as the first-line treatment for IDA. There are several direct and indirect methods to assess adherence to medications, each method has advantages and limits. Many studies have shown that pill counting is more accurate than self-reported adherence.We will investigate the adherence to iron supplementation in pregnant women by using a self-reported adherence questionnaire named SMAQ (Simplified Medication Adherence Questionnaire) Simplified Medication Adherence Questionnaire (SMAQ) Knobel H; Juega J; Carmona A; Kindelan JM; Ruiz I; Gonzalez J; Collazos J; Casado JL; Alonso J; Ocampo A SMAQ is used to assess non-adherent patients. The six-item SMAQ has been developed to assess adherence in HIV-infected patients, and may be applied in most clinical settings.

Official Title
-----------------
An Observational Study to Examine the Iron Treatment in Pregnant Women With Anaemia

Conditions
-----------------
Pregnancy Related, Pregnancy Anemia, Iron Deficiency Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy Anaemia Iron treatment before 3 months of pregnancy Informed Consent Compliant with study procedures Exclusion Criteria: Iron treatment after 3 months of pregnancy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | SMAQ (Simplified Medication Adherence Questionnaire) rating | 9 months |