linjc16/ctgov huggingface dataset:
Comparison of Cage Versus Plate in One Level Cervical Disc Disease

Study Overview
=================
Brief Summary
-----------------
There are largely 2 surgical methods for one-level cervical disc disease; cage only and plate/graft. Even there are many reports about the efficacy of either cage only or plate/graft, prospective comparative study is few. The object of the present study is to present design of prospective study and to demonstrate preliminary result.

Detailed Description
-----------------
Prospective study was started from April 2004 after permission by our Institutional Review Board. Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history. Operation method was randomized using the table of random sampling numbers. All operations were performed with standard anterior-medial approach. Two types of cages and 2 types of plates were used: cage, MC+ cage (LDR, Austin, Tx, USA) or Solis cage (Stryker, Kalamazoo, Michigan, USA); plate, Black stone (Orthofix, McKinney, Tx, USA) or Atlantis (Medtronic, Minneapolis, MN, USA). We checked neck disability index (NDI), neck visual analogue scale (VAS) and limb VAS before operation and 1/3/6/12/24/36 months after operation. Disc height ratio, cervical lordosis, bone fusion status and segmental lordosis at the index level were measured from X-rays and follow-up X-rays were obtained at before operation and 1/3/6/12/24/36 months after operation. The present prospective study was planned until 80 patients (cage n = 40, plate/graft n = 40) were enrolled.

Official Title
-----------------
Randomized Controlled Trial of Cage Versus Plate in One Level Cervical Disc Disease

Conditions
-----------------
Cervical Disc Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were single cervical disc disease with radiculopathy/myelopathy. Exclusion Criteria: We excluded patients with severe spondylosis, multiple disc disease, overt instability, osteoporosis or previous cervical operation history.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| cage<br>patient who underwent stand alone cage insertion after discectomy | |
| plate<br>patient who underwent plate fixation and autologous ilia bone graft after discectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disc height ratio, cervical lordosis, bone fusion and segmental lordosis at the index level |  | 1/3/6/12/24/36 months after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
difference
Correct Use of Sequential Formoterol and Budesonide Inhaler Capsule Treatment Via Aerolizer and Patient Satisfaction in Asthmatics

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the correct use of sequential formoterol and budesonide inhaler capsule treatment via Aerolizer and patient satisfaction in adult asthmatics.

Official Title
-----------------
A Single Arm, 12 Week, Multicentre, Open Label, Phase IV Study to Evaluate Correct Use of and Patient Satisfaction From Sequential Use of Formoterol and Budesonide Inhaler Capsules Via Aerolizer™ Device in Patients With Asthma.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Foradil Combi (Formoterol-budesonide)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate persistent asthmatic patients. No previous Aerolizer experience. Exclusion Criteria: Life-threatening asthma: A subject must not have life-threatening asthma as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s). Worsening of asthma: A subject must not have experienced a worsening of asthma which involved a hospitalization within 6 months of screening, or an emergency room visit three or more times in the past 6 months, or use of oral corticosteroids for worsening asthma within 3 months of screening. Unstable asthma: During screening period, a patient requires the use of >8 puffs/day of salbutamol 100 mcg per actuation pMDI on two consecutive days. A subject must not have had an upper respiratory tract infection within 4 weeks of screening. FEV1< 60% at screening. Other protocol-defined inclusion/exclusion criteria may apply.

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: Formoterol and Budesonide<br> | Drug: Foradil Combi (Formoterol-budesonide)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proper use of Foradil Combi |  | Day 0, Day 30, Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control test |  | Day 0, Day 30, Day 90 | 
| Ease of use: FSI-10 Questionnaire |  | Day 30, Day 90 | 
| Patient Satisfaction: PSAM and FSI-10 |  | Evaluations will be made at visit 2 (Day 30± 1) and 3 (Day 90± 3) | 
| Safety: Adverse events and severe adverse events |  | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aerolizer, formoterol, budesonide, asthma
Role of CX3CR1-expressing Cells in Hematologic Malignancy

Study Overview
=================
Brief Summary
-----------------
This study evaluates the clinical significance of CX3CR1-expressing myeloid and lymphoid cells in patients of hematologic malignancy. Tumor cells either express membrane molecules or release tumor-derived soluble factors able to alter myelopoiesis and lymphopoiesis. Myeloid cells expressing CD11b play a critical role in sustaining cancer progression. Also, the fractalkine (CX3CL1; Fkn)/CX3CR1 axis plays an important function in the pathophysiology of various forms of cancers. Fkn is the only known ligand for CX3CR1, and it triggers recruitment of CX3CR1-positive cells through its unique receptor, CX3CR1. Therefore, the investigators focused the prognostic significance of CD11b+ myelo-monocytic cells expressing CX3CR1 and CD3+ lymphoid cells expressing CX3CR1 in the clinical outcomes of newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) and Multiple myeloma (MM).

Detailed Description
-----------------
Bone marrow aspirates will be obtained from newly diagnosed MM and DLBCL patients at the time of diagnosis and relapse. Peripheral blood will be obtained at the time of diagnosis, finishing treatment, 3 months after treatment and relapse. The investigators will analyze the cell fractions of CD11b+ CX3CR1+ cells and CD3+CX3CR1+ cells in blood samples by flowcytometry. The investigators will find out the relationship between the tested cells and clinical outcome in MM and DLBCL.

Official Title
-----------------
Clinical Significance of CX3CR1 Adhesion Molecule-expressing Myeloid and Lymphoid Cells in Hematologic Malignancy

Conditions
-----------------
CX3CR1 Protein, Diffuse Large B Cell Lymphoma, Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject newly diagnosed multiple myeloma. Subject newly diagnosed diffuse large B cell lymphoma. Exclusion Criteria: History of other hematologic malignancy History of previous chemotherapy

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 |
| --- | --- | --- |
| progression free survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 
| Death |  | 3 years |
Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis

Study Overview
=================
Brief Summary
-----------------
Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries. Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations.

Detailed Description
-----------------
Brucellosis is a common zoonotic infection in many parts of the world including the Mediterranean and Middle Eastern countries. Neurobrucellosis may develop at any stage of disease and may have widely variable manifestations, including encephalitis, meningoencephalitis, radiculitis, myelitis, peripheral and cranial neuropathies, subarachnoid hemorrhage, and psychiatric manifestations. The aimed is to shed light to the obscure areas of diagnosis in neurobrucellosis and have detailed general and neurologic features

Official Title
-----------------
Cognitive Impairment and Neuropsychiatric Manifestations of Neurobrucellosis

Conditions
-----------------
Brucellosis

Intervention / Treatment
-----------------
* Diagnostic Test: MoCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years of age with laboratory-confirmed brucellosis Exclusion Criteria: Previous neuropsychiatric disease

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 |
| --- | --- |
| Neurobrucellosis<br>Brucellosis associated with neuropsychiatric manifestations | Diagnostic Test: MoCA<br>* Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26. Maximum score is 30.<br>|
| Non-neurobrucellosis<br>Brucellosis not associated with neuropsychiatric manifestations | Diagnostic Test: MoCA<br>* Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26. Maximum score is 30.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MoCA s | Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26 . | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brucellosis, neuropsychiatric manifestations, cognition
A Study of the Effects of Sodium Citrate on Olfactory Thresholds

Study Overview
=================
Brief Summary
-----------------
The study will be undertaken at the ENT department of the Leicester Royal Infirmary and in a research laboratory at the University of Leicester and also in the ENT department at the West Suffolk Hospital. One hundred subjects will be recruited. Subjects will be invited to undergo a series of smell tests using graded concentrations of 4 odours in 120ml bottles (1). This test has been described and validated by our previous work (2). The test will be fully explained to the subject beforehand by the researcher who will test the patient. The subject will be started with the smallest concentration of each odour and will ascend through the bottles until they detect 2 in a row, at which point the weaker concentration of the odour will be taken as their threshold. They will have a threshold levels determined for the odours phenethyl alcohol (roses), mercaptan (gas), acetic acid (vinegar) and eucalyptol (menthol). Then, the subject will undergo a sodium citrate nasal douche at a specific concentration or will douche with sterile water. There will be three concentrations used (3%, 6% and 9%) and a control solution (sterile water). Patients will be randomly allocated to one of the four groups using a coded bottle system. Both patient and tester will be blinded to the solution used as these will be made in the pharmacy and coded for anonymity - the code will be broken at the end of the trial. Subjects will then be retested with the bottles and threshold levels will be observed for the four odours at 15 minute intervals over 2 hours. The purpose of the repeated tests is to determine the length of the effect (if present) of the citrate on the olfactory ability of the patients. (N.B. Sodium citrate is a licensed product for use in body cavities (e.g. stomach, bladder) and can be found in the British National Formulary - the concentrations proposed do not exceed those used elsewhere.) Wudarski TJ, Doty RL. Comparison of detection threshold values determined using glass sniff bottles and plastic squeeze bottles.Percept Mot Skills. 2004 Feb;98(1):192-6 Gaskin J, Robinson A, Philpott CM, Goodenough P, Murty G. Are patients cross-sensitive to odours in parallel threshold tests? Chemical Senses 2006; in progress

Official Title
-----------------
A Double Blinded Randomised Controlled Trial of the Effects of Sodium Citrate on Olfactory Thresholds

Conditions
-----------------
Anosmic and Hyposmic Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anosmia Hyposmia Exclusion Criteria: Under age of 18 years of age

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Info-AF Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to identify a variable that discerns patients who are interested in their disease (atrial fibrillation/atrial flutter) from patients who show no interest and furthermore test this theory in a questionnaire survey. This should help distinguish between patients who are interested in shared decision making and patients who are not (further projects planned).

Official Title
-----------------
Info-AF Information Preferences in Patients With Atrial Fibrillation/Flutter and the Association With Clinical Symptoms

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current atrial fibrillation/flutter >18 years of age sufficient knowledge of the german language to fill out the questionnaire Exclusion Criteria: < 18 years of age insufficient knowledge of the german language to fill out the questionnaire Hemodynamic instability

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaire including questions about Quality of life, symptoms and general informations|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferences for autonomy measured with questionnaire | Potential predictors of the outcome are clinical symptoms. Additional covariables will be patient characteristics including age and gender and disease characteristics. Regression analysis will be used as the main statistical method. Descriptive statistics and graphs and inferential statistics will be used as appropriate. | through study completion, an average of 1 year |
Accuracy of Pleth Variability Index (PVI) in Children

Study Overview
=================
Brief Summary
-----------------
Plethysmographic Variability index is a simple index accurate in predicting fluid responsiveness. The aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

Detailed Description
-----------------
The goal of the present study is to assess the validity of PVI in predicting the response to a fluid challenge during scoliosis surgery in children. During this observational non-interventional study, each fluid challenge will be monitored by esophageal Doppler and PVI (Massimo Radical 5). Anesthesia, surgery and intraoperative fluid administration id standardized according to our clinical protocol. An increase in indexed Stroke Volume (iSV) by more than 15 % will define the positive response to the fluid challenge. Fluid challenges will be performed in the supine position and in the prone position. Statistical analysis will performed using the Receiving Operator Characteristics (ROC) curve with determination of the gray-zone allowing an error tolerance of 10 %.

Official Title
-----------------
Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children

Conditions
-----------------
Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scoliosis surgery Age < 18 years Exclusion Criteria: Heart or vascular Diseases Rectal abnormalities Kidney Failure Neuromuscular scoliosis

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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 of children with scoliosis surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plethysmographic Variability before each fluid challenge and percentage of variation in Indexed Stroke Volume during each fluid challenge. | Data will be used to assess the accuracy of Plethysmographic Variability Index in predicting fluid challenge. | During the intraoperative period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indexed Stroke volume before each fluid challenge and percentage of variation in indexed Stroke volume during each fluid challenge. | Data will be used to assess the accuracy of indexed Stroke volume in predicting the response to fluid challenge. | During the intraoperative period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plethysmographic Variability Index, Esophageal Doppler, Scoliosis, Children, Age < 18 years, Scheduled for Scoliosis Surgery
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to determine whether calcium supplementation is effective to prevent preeclampsia in Sichuang Province of china and which dose is more suitable

Official Title
-----------------
Calcium Supplementation to Prevent Preeclampsia in Sichuan Province of China: a Multi-center, Prospective Random Trial

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Drug: calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparity;age ≥35 years;Previous pre-eclampsia;Family history of pre-eclampsia;Multiple pregnancy;Time between pregnancies ≥10years;Body mass index ≥25;diastolic pressure ≥ 80 mm Hg before 20 weeks' gestation;Proteinuria ≥+ on more than one occasion or ≥ 300 mg/24 h before 20 weeks' gestation;Underlying medical conditions(Pre-existing hypertension;Pre-existing renal disease;Pre-existing diabetes;Presence of antiphospholipid antibodies;Chronic autoimmune disease);male sex partner's predecessor wife has Previous pre-eclampsia Exclusion Criteria: first prenatal visit after 16 weeks' gestation;severe anemia;other Underlying medical conditions which need treatment first (such as uncontrolled hyperthyreosis )
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: calcium A<br>tablets, 600mg per day,till birth | Drug: calcium<br> <br> |
| Active Comparator: calcium B<br>tablets,1200mg per day,till birth | Drug: calcium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pre-eclampsia |  | postpartum forty-two days |