linjc16/ctgov huggingface dataset:
A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.

Official Title
-----------------
A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention / Treatment
-----------------
* Drug: Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged between 0-65 years Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1 Patients with advanced MDS Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females Current participation in another clinical trial Contra-indication to one of the drug of the regimen Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide|Fludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate at one year after allo-SCT |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Even free survival | Overall Survival Leukemia Free Survival Graft Versus Host Disease Regimen related toxicity | two year |
Mean Values of Oxidative Stress Parameters in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Determination of the mean value of oxidative stress parameters in normals and of the plasma and serum levels, resp. of malondialdehyde, glutathion and superoxide dismutase in healthy subjects.

Detailed Description
-----------------
In certain situations, free radicals can be generated in an exaggerated manner and can injure tissues and organs by interacting with lipids, proteins, or DNA. So, oxidative stress has been implicated in a large number of human diseases. To survive, the human body has developed a complex, efficient, and highly adaptive antioxidant defense system. The eye is also protected against oxidative stress by several mechanisms involving antioxidant enzymes such as catalase (CAT) and superoxide dismutase (SOD), as well as by low-molecular-weight antioxidants such as glutathion (GSH) and ascorbate. Primary open-angle glaucoma (POAG) is a chronic, slowly progressive optic neuropathy, characterized by excavation of the optic nerve head (ONH) and a distinctive pattern of visual field (VF) defects. The disease is multifactorial in origin, so that besides more extensively investigated factors oxidative stress has also been proposed as a contributing factor in the etiology of glaucomatous optic neuropathy. Oxidative stress represents a harmful state defined by the presence of pathologic levels of reactive oxygen species (ROS) relative to antioxidant defense. Therefore, it would be also important to determine whether there is a relationship between circulating levels of the defense parameters to oxidative stress like malondialdehyde, GSH and SOD, and the occurrence of POAG. Since there are only the limits of variation for these defense parameters available, mean values of the plasma levels of malondialdehyde, glutathion and superoxide dismutase will be determined in healthy subjects.

Official Title
-----------------
Determination of the Mean Values of Oxidative Stress Parameters in the Plasma of Healthy Subjects

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: German native speakers Age between 18-80 years Healthy without medication No ophthalmic disease Exclusion Criteria: Any history of ocular or systemic diseases or of drug or alcohol abuse Any mentally impaired patient

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

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

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

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
-----------------
oxidative stress parameters
Suicide Prevention by Lithium - the Lithium Intervention Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the proposed suicide preventive effects of lithium in a randomized controlled trial within a group of individuals with depressive disorders. The hypothesis being tested is that lithium treatment will significantly reduce the risk for another suicide attempt.

Detailed Description
-----------------
Several studies have shown that there is a significantly increased risk of suicide related mortality in patients with a positive history of suicide attempts. This study is the first prospective, randomized, double-blind, placebo controlled multi-center trial focussing on the proposed suicide preventive effects of lithium in patients with suicidal behavior but not suffering from bipolar disorder or recurrent major depressive disorder. Patients with a recent history of a suicide attempt are treated with lithium or placebo during a 12 month-period. The hypothesis is that lithium treatment will lead to a 50 % reduction of suicidal behavior.

Conditions
-----------------
Suicide, Depressive Disorders

Intervention / Treatment
-----------------
* Drug: lithium
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suicide attempt within 3 months prior to the first drug administration occurrence of suicide attempt within the context of an affective spectrum disorder minimum age of 18 years ability to complete screening and baseline assessment ability to understand and provide informed consent Exclusion Criteria: diagnosis of schizophrenia, borderline personality disorder, substance related disorders indication for long-term lithium treatment thyroid disease pregnancy and lactation

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Lithium treatment | Drug: lithium<br> <br> |
| Placebo Comparator: 2<br>Placebo treatment | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of attempted and completed suicides |  | follow-up period of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific aspects of the suicide attempt/completed suicide |  | follow-up period of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suicide, prevention, lithium, suicidality
Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela Power

Study Overview
=================
Brief Summary
-----------------
To prove the safety, in normal conditions, of the odontological use formulation of the product Cepacol Canela Power.

Official Title
-----------------
Uni Centric Study, Phase III, for Safety Oral Mucosa Evaluation: Basic Acceptability With Odontological Follow up - Cepacol Canela Power

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

Intervention / Treatment
-----------------
* Drug: Cetylpyridinium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral buccal mucous (without oral pathologies); Normal odontological exams; Exclusion Criteria: Lactation or gestational risk or gestation; Use of Anti-inflammatory or immunosuppression drugs 15 days before the study; Being in odontological treatment; Pathological or mucous disease which can interfere or active gynaecological disease which may interfere wtih study results; Personal history of allergic disease in the area to be treated; Allergic or atopic history;

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Cetylpyridinium chloride during 21 days. | Drug: Cetylpyridinium chloride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will be evaluated according to the adverse reactions and the intensity of them. The volunteers will also answer a questionnaire about the physical attributes of the product. |  | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral hygiene
Rehabilitation Glasses for the Treatment of Hemispatial Neglect

Study Overview
=================
Brief Summary
-----------------
This project is designed to test a lightweight, portable, computerized pair of glasses that will help reduce some of the cognitive deficits seen in patients who have suffered damage to their right cerebral hemisphere.

Detailed Description
-----------------
Hemispatial neglect is the inability or failure to attend and respond to the left side of space. Patients suffering right cerebral hemispheric damage from stroke or traumatic brain injury frequently suffer neglect and will ignore all information located in the left side of space. Currently there is no effective rehabilitation technique to treat neglect and many of these patients have severe long-term disability. The goal of this project is to determine whether a prototypical pair of rehabilitation glasses can reduce the symptoms of hemispatial neglect.

Official Title
-----------------
Rehabilitation Glasses for the Treatment of Hemispatial Neglect

Conditions
-----------------
Hemispatial Neglect

Intervention / Treatment
-----------------
* Device: Computer rehabilitation glasses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of hemispatial neglect as defined by Behavioral Inattention Test score of 129 or worse (maximum score 146). Exclusion Criteria: Presence of aphasia at time of testing, Recent seizures Major psychiatric illness Prior unrelated neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 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
Interventional Model Description: 1/2 patients receive visual stimulation with rehabilitation glasses. 1/2 patients receive control stimulation with rehabilitation glasses.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic<br>Crossover study on the benefits of computer rehabilitation glasses on chronic sufferers of hemispatial neglect | Device: Computer rehabilitation glasses<br> <br> |
| Experimental: Acute<br>Randomized, controlled study on the benefits of computer rehabilitation glasses on acute sufferers of hemispatial neglect | Device: Computer rehabilitation glasses<br> <br> |
| Experimental: Optimization<br>Study to identify optimal operating parameters of computer rehabilitation glasses | Device: Computer rehabilitation glasses<br> <br> |
| Active Comparator: Duration<br>Study to determine duration of effect of computer rehabilitation glasses | Device: Computer rehabilitation glasses<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of patient's hemispatial neglect scores | Behavioral Inattention Test | 60 days |
Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study

Study Overview
=================
Brief Summary
-----------------
Acute coronary syndrome (ACS) is a lethal disease, reduced low-density lipoprotein (LDL) cholesterol due to inhibition of proprotein convertase subtilisin/kexin 9 (PCSK9) reduces cardiovascular events and improve cardiovascular prognosis. we assuming that PCSK9 inhibitor could bring metabolic change in serum, in order to investigate the metabolic modification, we conduct this clinical trial.

Official Title
-----------------
Acute Myocardial Infarction and Unstable Angina Patients With PCSK9 Inhibitor Usage Study

Conditions
-----------------
Lipid Metabolism, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: PCSK9 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosis ACS patient by serum biomarker and coronary arteriography. Exclusion Criteria: Severe renal dysfunction acute or chronic bacterial and viral infections sleep apnea cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pcsk9 inhibitor group<br>patients with severe coronary stenosis diagnosed ACS. The baseline blood and urine would be collected, thereafter, the PCSK9 inhibitor would be injected. 64-72 hours after, the blood and urine sample collection would be performed. | Drug: PCSK9 inhibitor<br>* For newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection.<br>|
| No Intervention: control group<br>Patients with comparable age, sex ratio, and BMI, but coronary arteries are relatively normal evaluated by coronary angiography. their blood and urine would be collected as the control group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular prognosis | composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina and heart failure. | 52 weeks |
Perceived Lactose Intolerance

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to examine the effects of self-perceived lactose intolerance (SPLI) as it relates to calcium intake and specific health problems that have been attributed to reduced intake of calcium and foods from the dairy group in a nationally representative multi-ethnic sample of adults.

Official Title
-----------------
Understanding Perceived Lactose Intolerance in White, Black, and Hispanic Adults

Conditions
-----------------
Lactose Intolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults between 18 and 50 years old Exclusion Criteria: pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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 |
| --- | --- |
| no treatment<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
-----------------
perceived lactose intolerance, calcium/dairy consumption, specific health outcomes
The Safety and Efficacy of Epidural Oxycodone

Study Overview
=================
Brief Summary
-----------------
There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone. In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.

Official Title
-----------------
The Safety and Efficacy of Epidural Oxycodone

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

Intervention / Treatment
-----------------
* Drug: Oxycodone intravenously
* Drug: Oxycodone epidurally


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned gynecological lower abdomen surgery with epidural pain treatment Informed consent obtained Exclusion Criteria: Planned surgery under regional anesthesia contraindication to the study drug contraindication to the lumbar puncture Contraindication to oxycodone Pregnancy or lactation no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone intravenously<br>Oxycodone 0,1 mg/kg IV | Drug: Oxycodone epidurally<br>* Oxycodone 0,1 mg epidurally<br>* Other names: oxycodoneEpid;|
| Experimental: Oxycodone epidurally<br>Oxycodone 0,1 mg/kg epidurally | Drug: Oxycodone intravenously<br>* Oxycodone intravenously 0,1mg/kg<br>* Other names: oxycodoneIV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of rescue medicine | The amount of rescue pain medication given after study drug administration up to four hours | from zero hours up to four hours |
Ezetimibe for Patients With Chronic Hepatitis D

Study Overview
=================
Brief Summary
-----------------
Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection

Official Title
-----------------
Ezetimibe for Patients With Chronic Hepatitis D

Conditions
-----------------
Chronic Hepatitis D

Intervention / Treatment
-----------------
* Drug: Ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy Age 18 years or above Presence of anti-HDV in serum Presence of quantifiable HDV RNA in serum Elevated ALT > ULN Exclusion Criteria: Decompensated liver disease Patients with ALT levels greater than 10 times ULN (400 U/L) Pregnancy or inability to practice adequate contraception. Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease. Systemic immunosuppressive therapy Evidence of another form of liver disease in addition to viral hepatitis Active substance abuse, such as alcohol or injection drugs Hepatocellular carcinoma Concurrent hepatitis C infection or HIV coinfection Diagnosis of malignancy in the five years Concurrent usage of statins Concurrent use of any other drug known to inhibit NTCP Inability to understand or sign informed consent Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe<br> | Drug: Ezetimibe<br>* Ezetimibe 20 mg oral daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Decline of HDV RNA quantitative measurements of >1 logs from baseline |  | 12 weeks of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis D, Ezetimibe, HDV RNA