linjc16/ctgov huggingface dataset:
RFC and MTHFR SNPs & hENT1- dCK Expression as Prognostic Factors in ALL & hENT1- dCK Expression as Prognostic Factors in AML

Study Overview
=================
Brief Summary
-----------------
Results of actual treatment in ALL are not optimal. New prognostic factors, which may determine clinical & molecular response are required. Hyper-CVAD is an internationally accepted schema for such patients. The objective of this pilot study is to evaluate polymorphisms regarding RFC (reduced folate carrier) and MTHFR enzyme, which may affect the function of these proteins, and therefore the intracellular bioavailability of methotrexate. Also, the expression levels of hENT1 and dCK will be evaluated, since such genes codify for citarabine intracellular transport and activation, respectively. Clinical characteristics will be tabulated and analyzed for responders & non-responders patients. Uni- & multivariate analysis will be done to evaluate factors influencing on response and survival.

Official Title
-----------------
Evaluation of RFC Transporter & MTHFR SNP's, as Well as hEN1 and DCK Expression as Prognostic Factors in Patients With Acute Lymphoblastic Leukemia.

Conditions
-----------------
Acute Lymphoblastic Leukemia., Acute Myeloblastic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: older than 15 years. Male, female. Normal renal & liver functions. Without previous treatment. Candidate to be treated with hyperCVAD Schema (ALL patients). Candidate to receive induction remission with cytarabine (AML patients) Exclusion Criteria: Patients not candidate to receive methotrexate or cytarabine.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| one cohort<br>Adult patients with ALL attending at the Instituto Nacional de Cancerologia Mexico. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate clinical response | To evaluate clinical response after ending Hyper-CVAD schema for ALL patients. To evaluate clinical response & DFS in relation with hENT1 & dCK expression levels in AML patients. | December 2012 | 
| Clinical responses in relation with SNP's or gene expression |  | clinical response. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute lymphoblastic leukemia, prognostic factor, pharmacogenetics.
The Effects of Gum Chewing on Energy Intake and Expenditure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if chewing gum increases energy expenditure and decreases food intake.

Official Title
-----------------
The Effects of Gum Chewing on Energy Intake and Expenditure

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Chewing gum
* Other: Water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 27-37, between the ages of 18 and 38 Exclusion Criteria: History of chronic disease (e.g. liver, kidney, or heart disease, or diabetes) Medications that affect energy expenditure, appetite, or body composition (e.g. antidepressants, beta blockers, antipsychotic, or weight loss medications) A history of irregular menstrual cycles in women (indication of onset of menopause or other metabolic disturbances such as polycystic ovary syndrome) A history of phenylketonuria (PKU) Symptoms of depression A history of eating disorders Concurrent participation in a weight loss program Cigarette smoking or other tobacco use Jaw problems such as temporomandibular joint disorder (TMJ) Allergies to any of the common components in gum (sweeteners, mint flavors, etc) Heavy gum chewing prior to study ( > 3 times per week) Pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chewing gum<br> | Other: Chewing gum<br>* Subjects were instructed to chew gum at least 6 times a day in an effort to reduce snacking.<br>|
| Placebo Comparator: Water<br> | Other: Water<br>* Subjects were instructed to drink 8 oz of water at least 6 times a day in an effort to reduce snacking.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition |  | Baseline and end of study (6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity
Evaluation of OSSIX® Bone in Sinus Elevation

Study Overview
=================
Brief Summary
-----------------
A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure.

Official Title
-----------------
Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation

Conditions
-----------------
Maxillary Sinus Floor Augmentation

Intervention / Treatment
-----------------
* Device: OSSIX Bone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requiring vertical elevation of the maxillary sinus. Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of > 4-5mm. Males and females between 30-80 years old Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%) Patients that are willing to sign an informed consent and participate in a clinical study Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation. Exclusion Criteria: Patients who smoke over 5 cigarettes/day Pregnancy (confirmed by verbal inquiry) Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4. Patients taking bisphosphonates Any sites where an implant already failed sites Untreated Periodontitis Dental sites with acute infections Chronic inflammatory diseases of the oral cavity Autoimmune diseases (cortisone intake) Allergy declared to one or more medicaments to be used during treatment Alcoholics patients and/or drug addicts Patients with known collagen hypersensitivity. Patients with sensitivity to porcine-derived materials. History or malignant tumours of the maxillary sinus History of local radiation therapy

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- |
|Device: OSSIX Bone|subjects will be implanted with OSSIX Bone during sinus elevation surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Bone height from baseline |  | 1 year | 
| Difference in bone volume |  | 1 year |
Protective Effect in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery.

Official Title
-----------------
Study on the Protective Effect of Inhibiting Systemic Inflammatory Response in Patients Undergoing Cardiac Surgery.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: Ulinastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject needs to have valve surgery subject needs to have coronary artery bypass grafting surgery subject needs to have artificial blood vessel replacement surgery ASA(American Society of Anesthesiologists) score II III NYHA(New York Heart Association) II III Exclusion Criteria: LVEF(left ventricular ejection fraction) <40% measured by echocardiogram history of myocardial infarction within 1 month history of serious pulmonary infection or endocarditis within 3 months history of important surgery within 6 months

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: inhibiting systemic inflammatory response<br>Ulinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta | Drug: Ulinastatin<br>* Ulinastatin 5000U/Kg in 20 ml NS i.v. before occlusion of aorta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative delirium | the incidence of postoperative delirium | 7 days postoperatively or discharge, whichever came first | 
| postoperative renal insufficiency | the incidence of renal insufficiency | 7 days postoperatively or discharge, whichever came first |
Measurement of Substance P in Saliva of Low Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.

Official Title
-----------------
Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain

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

Intervention / Treatment
-----------------
* Other: The taking of a saliva sample from each subject.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible) Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results) For healthy subjects: Volunteers with no pain (anywhere) That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain. Exclusion Criteria: Subjects with pain that is additional to or different from chronic low back pain

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?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The taking of a saliva sample from each subject.|After taking the sample, the saliva will be transferred via a pipette to a clean tube which will be labeled with the subject's name, the date and the hour. Once a month the tubes will be sent to the collaborating laboratory for analysis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Substance P in the saliva |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, chronic, Substance P
UK Surveillance of Treated Retinopathy of Prematurity

Study Overview
=================
Brief Summary
-----------------
Currently, there is little recent data on regional variations in treatment methods, neonatal units that provide retinopathy (ROP) treatment, facilities for treatment available at each unit including anaesthetic support for such preterm babies, facilities to transfer babies to units that offer treatment etc. While some parts of the UK have established neonatal networks and agreements among units for ROP treatment, in other parts, such arrangements are illdefined. The number of babies needing ROP treatment may be higher since the introduction of revised guidelines in 2008 as earlier treatment has been shown to be beneficial. Collecting epidemiological data through the British Ophthalmic Surveillance Unit (BOSU) on the incidence of treatable ROP, the treatment methods used and facilities for treatment will provide the foundation for effective planning of resources and manpower to deal with the additional demand.

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Other: Surviellance card


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any baby with ROP who is treated or referred to another unit for treatment either in the form of laser therapy, cryotherapy, antiVEGF agent or vitrectomy/scleral buckling (or a combination of above treatments) Exclusion Criteria: None; we will monitor data to exclude duplication of cases which may arise from children being transferred between neonatal units or consultants

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retinopathy of prematurity<br>Any baby with ROP who is treated or referred to another unit for treatment either in the form of laser therapy, cryotherapy, antiVEGF agent or vitrectomy/scleral buckling (or a combination of above treatments) | Other: Surviellance card<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of babies requiring treatment for retinopathy of prematurity in the UK |  | 1 year |
Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD

Study Overview
=================
Brief Summary
-----------------
This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Procedure: Full-Thickness-Gastroplication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes >73. Exclusion Criteria: any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-Thickness-Gastroplication<br> | Procedure: Full-Thickness-Gastroplication<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  |  |
Bone to Skin Thickness Study: Obese Versus Normal Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the bone to skin depth for groups of lean, obese and morbidly obese patients. This information will be potentially helpful with implant design for obese and lean patients.

Detailed Description
-----------------
This study will examine pelvic CT scans of injured patients to determine skin thickness in several distinct regions important in orthopedic surgery. All patients admitted to the University of Mississippi Medical Center with a pelvic ring injury or acetabular fracture obtain a pelvic CT scan as a standard part of patient evaluation. The CT scans attempt to encompass the entire soft tissue sleeve from the skin edge to the pelvic bones. Several landmarks described below have been described to measure important surgical sites where obesity is problematical. Therefore this study is an attempt to quantify the size of the soft tissue envelope in patients However, patients who are markedly obese may be too large for the entire soft tissue sleeve to be imaged with the CT scan. The second part of the study then is to validate the CT scan measurements obtained using clinical measurements. The clinical measurements will be obtained during operative management of displaced pelvic ring injuries and/or acetabular fractures. During surgical exposure, a measuring tape will be used to measure the soft tissue thickness in those areas corresponding to the CT scan measurements. These measures will be compared to validate the effectiveness of CT scan measurements to accurately document the soft tissue dimensions.

Official Title
-----------------
Bone to Skin Thickness Study: Obese Versus Normal Population

Conditions
-----------------
Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone admitted to the University of Mississippi Medical Center with a pelvic ring or acetabular injury Exclusion Criteria: Those not fitting the inclusion criteria

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
-----------------
acetabular fracture, pelvic ring injury
Comparative Study Between Different Approaches to CPA-petroclival Meningiomas

Study Overview
=================
Brief Summary
-----------------
• Give an effective treatment for CPA-petroclival meningiomas and can detect the best approach for these tumors. . Improve the outcome of these patients and decease rate of recurrence.

Detailed Description
-----------------
There are several lesions arising in the petroclival region. The most frequent tumor is the petroclival meningioma, followed by chondrosarcomas, chordomas, schwannomas of the cranial nerves V and VII, and other malignant tumors [1, 2, 3, 4, 5]. Petroclival meningiomas are tumors of the skull base that present a formidable challenge to surgical resection because of their deep location and relationship to vital neurovascular structures. In the majority of the cases they are benign tumors, but may involve or infiltrate the skull base bone, the dura mater, the brainstem, and all important neurovascular structures of this region. The petroclival region comprises the anatomical location of the body of the sphenoid bone, the anterior central portion of the occipital bone, and is bordered on the lateral aspect by the petrous apex. The roof of this space is formed by the petroclival ligaments and the tentorium. This space contains important neurovascular structures that are frequently involved or displaced by the tumor in a variable pattern. The basilar artery with its branches may be embedded or displaced by the meningioma. The petrosal vein is often displaced posteriorly by the tumor. Cranial nerves III and IV are usually displaced upwardly and the nerve VI is often surrounded by tumor. Petroclival meningiomas have their origin medial to cranial nerves V, VII, VIII, IX, X, and XI, and reach the tentorium . They frequently extend to the middle cranial fossa, cavernous sinus, prepontine space, and down to the foramen magnum. These tumors frequently compress the brainstem making total removal very difficult or impossible without neurologic deficits. cerebellopontine angle (CPA) and low clivus meningiomas may reach these areas. These lesions usually need different surgical approaches as transpetrosal approach ( anterior, modified and combined ) and retrosigmoid approach

Official Title
-----------------
Comparative Study Between Different Approaches to CPA -Petroclival Meningiomas

Conditions
-----------------
Brain Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a single lesion . Patient with a denovo lesion. Exclusion Criteria: Patient with recurrent lesions. Patient with lesions after adjuvant therapy.
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 |
| --- | --- | --- |
| The success rate of surgery | complete resection of the tumor | 1 year |