linjc16/ctgov huggingface dataset:
The Surveillance of Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Early detection of hepatocellular carcinoma is vita to the prognosis of patient. In this study, the occurrence and development of liver cancer were supervised by imaging examination, and the dysplastic nodules will be distinguished from early hepatocellular carcinoma through macro-imaging and micro-pathological features.

Official Title
-----------------
The Surveillance of Development and Progression of Hepatocellular Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: Imaging examination and/or blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with Hepatitis B and cirrhosis Accept regular imaging examination. Pathological diagnosis of liver cancer. Exclusion Criteria: - Can't tolerate the enhanced imaging examination Poor medical compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Imaging examination and/or blood test|Imaging examination and/or blood test will be performed at a certain time|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective detection of early hepatocellular carcinoma | The occurrence of early hepatocellular carcinoma | 2 years |
Homocyst(e)Ine, Vitamin Status, and CVD Risk

Study Overview
=================
Brief Summary
-----------------
To test the hypotheses that the risk of myocardial infarction and/or stroke is associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.

Detailed Description
-----------------
BACKGROUND: Elevated plasma homocyst(e)ine is a risk factor for vascular disease in middle-aged men. Supplementation with folate, and to some extent vitamins B12 and B6, can reduce plasma homocyst(e)ine levels. There is also evidence from in vitro studies that the adverse atherogenic or thrombotic effects of Lp(a) may be greatly enhanced by homocyst(e)ine. The high prevalence of low levels of folate and vitamins B12 and B6 among the elderly in the United States has led to the hypothesis that a substantial portion of cardiovascular morbidity and mortality among older persons could be prevented by increasing intake of these nutrients to reduce plasma levels of homocysteine. Little is known, however, regarding the relationship of homocysteine, folate, B vitamins, and Lp(a) to cardiovascular disease among the elderly, among whom CVD represents the leading cause of morbidity and mortality. DESIGN NARRATIVE: In this ancillary study to the prospective Cardiovascular Health Study (CHS), a case-cohort design was used to test hypotheses that the risk of myocardial infarction and/or stoke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6. Further, a determination was made whether elevated plasma levels of homocysteine and Lp(a) interacted to increase substantially the risk of myocardial infarction and/or stroke above that due to either factor alone. The sub-cohort was used to study the relationship between the factors under study and progression of sub-clinical atherosclerosis. For each case and sub-cohort member, an aliquot of fasting plasma drawn at baseline was analyzed for homocysteine, folate B12, and B6 concentrations. [Values of plasma Lp(a) were determined at baseline.] Results of these assays were combined with other CHS data to address the hypothesis that the risk of myocardial infarction and/or stroke was associated with elevated plasma levels of homocysteine, and low plasma levels of folate, vitamins B12 and B6.

Conditions
-----------------
Cardiovascular Diseases, Cerebrovascular Accident, Coronary Disease, Myocardial Infarction, Heart Diseases, Hyperhomocysteinemia

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

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies

Study Overview
=================
Brief Summary
-----------------
The telomere system stabilizes the chromosomes. Telomeres are shortened during senescence, in cases of genetic instability and secondary to stress. The investigators aim is to study the telomere system in cord blood and in the placenta immediately after the delivery in pregnancies defined as high risk pregnancies following sterss events such as placental insufficiency, preeclampsia, diabetes. The investigators intend to compare the telomere system in maternal blood to cord blood and to placental biopsies and to study the influence of different stressogenes on this system.

Official Title
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The Telomere System in Cord Blood and in the Placenta in High Risk Pregnancies

Conditions
-----------------
Telomere Length, Mechanisms of Telomter Homeostasis, High Risk Pregnancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Third trimester post delivery Intrauterine growth restriction Preeclampsia Diabetes Control - low risk normal pregnancies Exclusion Criteria: Patients who do not want to participate Known HIV or Hepatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk pregnancy<br> | |
| |Control - Normal low risk pregnancies<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clonidine and Left Ventricular Dysfunction

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: To evaluate the effect of clonidine, a sympathetic modulator, to reverse cardiac remodeling and to improve hemodynamics in diastolic heart failure (DHF). To evaluate the effect of clonidine on neurohormones and quality of life in patients with DHF. The study is a double-blind, placebo-controlled study evaluating the effects of clonidine compared to placebo in patients with DHF. A total of 70 patients with DHF will be randomized in a 1:1 ratio to: placebo (n=35) or to clonidine (n=35) in a dose of 0.075 mg twice a day for the first 6 weeks followed by uptitration to 0.150 mg twice a day for 6 months. The primary outcome is the reversion of cardiac remodeling and hemodynamic parameters evaluated by magnetic resonance imaging (MRI) and echocardiography.

Official Title
-----------------
Evaluation of Effects of Central Sympathetic Inhibition in Elderly With Left Ventricular Diastolic Dysfunction and Preserved Ejection Fraction: A Proof-of-Concept Trial With Clonidine

Conditions
-----------------
Ventricular Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 60 and greater Gender: Both Patients with heart failure New York Heart Association (NYHA) II and ejection fraction over 45%

Ages Eligible for Study
-----------------
Minimum Age: 60 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
-----------------
Heart failure, Diastolic, functionClonidine, Left ventricular diastolic dysfunction with preserved ejection fraction
CLL Empirical Antibiotic Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL.

Official Title
-----------------
A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors

Conditions
-----------------
Chronic Lymphocytic Leukaemia (CLL)

Intervention / Treatment
-----------------
* Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 ECOG performance status of 2 or less. CLL with a diagnostic score of 4 or 5. Clinical stage A disease. No disease progression over a minimum of 1 month prior to commencement of therapy. Less than 2 adverse prognostic factors. Absence of adverse cytogenetics. Expected survival > 6 months. Able to give informed consent. No clinical evidence of active infection at the time of study entry. No known allergy to any of the study medications. Renal and liver function tests within normal limits. Exclusion Criteria: Disease progression during screening period. Known positivity for HIV types 1 or 2. Active infection at the time of screening. Pregnancy or lactation. Females of childbearing potential† and males not willing to practice an effective method of contraception whilst receiving the antibiotic regimen and for 4 weeks after the last dose. Concomitant medication likely to produce serious interaction with study drugs including warfarin type oral anticoagulants and anti-epileptics.

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 |
| --- | --- |
| Experimental: Antibiotic regimen<br> | Drug: metronidazole, clarithromycin, ciprofloxacin and lansoprazole<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate [Complete Remission (CR) + Partial Remission (PR)] |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CTCAE grade 2 or above treatment related toxicity |  | From day 1 to 6 weeks | 
| Bone marrow Minimal Residual Disease (MRD) status in patients who achieve CR |  | 6 months |
Reliability of the Smartphone Inclinometer App and Flexicurve

Study Overview
=================
Brief Summary
-----------------
The presedent study evaluates intra-rater and inter-rater reliability of the Smartphone inclinometer app and the flexicurve, on the thoracic kyphosis

Detailed Description
-----------------
Sixty subjects ranging from 17to 24 years of age were evaluated by two independent evaluators using the Flexicurve and the Smartphone inclinometer app to measure thoracic kyphosis

Official Title
-----------------
Reliability of the Smartphone Inclinometer Application and Flexicurve on Thoracic Kyphosis

Conditions
-----------------
Disorder, Kyphosis Deformity of Thoracic Spine

Intervention / Treatment
-----------------
* Other: Realibility


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 30 degree toracic kyphosis, 18-30 age year old, individuals to willing participate in the study Exclusion Criteria: Skolyoz (Cobb angle 10< ), rigid thoracic kyphosis, congenital spine disease, training with professional sports

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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: Flexicurve-Smartphone İnclinometer Application<br>Measurement of thoracic kyphosis | Other: Realibility<br>* measurement of the thoracic kyphosis with flexicurve and Smartphone inclinometer app<br>* Other names: İntra rater and inter rater;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| İntra-İnterrater reliability fleksicurve and smartphone inclinometer app on thoracic kyphosis | 60 participant (35 male, 25 female) who have over 30 degree thoracic kyphosis were evaluated by two raters for finding correlation between flexicurve and smartphone inclinometer app. | 1 Year |
Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.

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

Intervention / Treatment
-----------------
* Drug: depot medroxyprogesterone acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women 18-40 years old A diagnosis of endometrioma with diameter of at least 3 cm. Candidates for laparoscopic cystectomy Exclusion Criteria: Patients' refusal to participate Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis Use of estrogen-suppressive drugs in the preceding 3 months, such as: Oral contraceptives, GnRH analogues, Progestins, Danazol Pathology report present no endometriosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: depot medroxyprogesterone acetate<br> | Drug: depot medroxyprogesterone acetate<br>* DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)<br>|
| No Intervention: No depot medroxyprogesterone acetate<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation |  | Within the first 2 weeks and 3 months after surgery |
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).

Official Title
-----------------
A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

Conditions
-----------------
Clostridium Difficile Infection

Intervention / Treatment
-----------------
* Drug: SMT19969
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Clinical diagnosis of CDAD plus laboratory diagnostic test No more than 24 hrs antimicrobial treatment for current CDAD episode No more than 3 episodes of CDAD in prior 12 months No previous episode of CDAD within 30 days of study enrollment Female subjects of childbearing potential must use adequate contraception Exclusion Criteria: Life-threatening or fulminant colitis Concurrent use of antibiotics or any other treatments for CDAD History of inflammatory bowel disease (ulcerative colitis, Crohn's disease) Participation in other Clinical research studies within one month of screening

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMT19969<br>200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day | Drug: SMT19969<br> <br> |
| Active Comparator: Vancomycin<br>125 mg capsule four times a day for 10 days | Drug: Vancomycin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the clinical outcome by assessment of sustained clinical response | Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy | 30 days post End of Therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and faecal concentrations of SMT19969 | Using laboratory analysis | 40 Days | 
| To assess the safety and tolerability of SMT19969 compared with vancomycin | Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study | 40 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CDAD, Clostridium Difficile
Lactate to Treat Hypoglycemia

Study Overview
=================
Brief Summary
-----------------
Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.

Official Title
-----------------
Comparison of Two Strategies of Hypoglycemia Correction in ICU

Conditions
-----------------
Hypoglycemia

Intervention / Treatment
-----------------
* Drug: Lactate
* Drug: Glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypoglycemia under 0.6 g/L Exclusion Criteria: hepatic failure hyperlactatemia above 5 mmol/L

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactate<br>infusion of 66 mmol of lactate | Drug: Lactate<br>* Infusion of 66 mmol of lactate<br>|
| Active Comparator: glucose<br>infusion of 33 mmol of glucose | Drug: Glucose<br>* Infusion of 33 mmol of glucose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of the glycemia |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bispectral index variation |  | 60 minutes | 
| Maximum change in glycemia |  | 30 minutes | 
| Changes in growth hormone and cortisol |  | 180 minutes | 
| Need for glucose infusion for persistent hypoglycemia |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypoglycemia, lactate, glucose, ICU