linjc16/ctgov huggingface dataset:
Determination of Metal Ion Serum Levels and Cytokines in Total Hip Replacement

Study Overview
=================
Brief Summary
-----------------
The goal of the study is the analysis of metal ion serum concentrations and of the cytokine production in the blood of patients with a conventional cementless total hip replacement. The rationale is that a) the bearing wear releases particles respectively metal ions into the joint and the blood which will differ in quantity and composition; b) the cytokine production of peripheral blood mononuclear cells (PBMC) might be influenced to a varying degree by the metal and the ceramic particles. The patients from whom the respective samples will be analyzed are randomized in one of the following three groups: metal-on-metal, ceramic-on-ceramic or ceramic-on-metal. A 36mm bearing is used in all patients. In this separate study, follow-up data of the clinical and radiographic examinations of the patients are available.

Official Title
-----------------
Determination of Metal Ion Levels in the Serum and Assessment of the Respective Cytokine Production of Peripheral Blood Cells in Patients With a Hard-on-hard Bearing Total Hip Replacement

Conditions
-----------------
Hip Replacement Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years, necessity of hip replacement, informed consent Exclusion Criteria: acute inflammatory disease, renal disease, other cobalt-chromium implant, ager over 75 years

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?
-----------------
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
-----------------
ion, metal, cytokine, hip arthroplasty, blood, Assessment, cytokine profile
Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the low-response prevalence of early antiplatelet therapy and to test the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Detailed Description
-----------------
Antiplatelet agents are important therapeutic options in treating patients with acute ischemic strokes to prevent recurrent ischemic events or death. The aim of this study was to evaluate the low-response prevalence of early antiplatelet therapy and the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Official Title
-----------------
Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke

Conditions
-----------------
Test the Efficacy of Antiplatelet Regimes in Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected acute cerebrovascular ischemic events and patients who were admitted to the stroke unit where antiplatelet therapy was initiated Exclusion Criteria: severe liver disorders, current gastrointestinal disorders, congestive heart failure, life-threatening malignancies and a personal or family history of bleeding disorders

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 |
| --- | --- |
| Responder<br>Responder versus Non-Responder as a result of platelet function test | |
| Non-Responder<br>According to the result of platelet function test | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of platelet function test | Aggregometry result of antiplatelet therapy |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspirin, Acute Cerebrovascular Ischemia, Platelet Function
Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).

Official Title
-----------------
A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Major Depressive Disorder (MDD)

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: GW679769


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Primary diagnosis of Major depressive Disorder as defined in DSM-IV. Capable of giving informed consent and willing to comply with the study requirements. Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control. Exclusion Criteria: Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder. Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type. Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months. Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine). Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

| Intervention/Treatment |
| --- |
|Drug: GW679769|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on a Depression rating scale following 8 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on a number of rating scales following 8 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, major depressive disorder, MDD
Prevention of Postoperative Delirium With Donepezil

Study Overview
=================
Brief Summary
-----------------
Patients undergoing hip or knee joint replacement at the age of 70 years or above who are cognitively unimpaired will receive donepezil or matching placebo before (over 5-7 days), during and after (over 7 days) surgery. The incidence of delirium will be monitored at 3 days, 7 days, and 49 days following surgery. We hypothesize that the incidence of delirium can be lowered from 20 per cent to 10 per cent by the intervention.

Conditions
-----------------
Cognitively Normal Elderly Individuals

Intervention / Treatment
-----------------
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitively healthy, elective hip or knee replacement Exclusion Criteria: Ongoing cholinergic treatment, dementia, delirium, acute physical illness

Ages Eligible for Study
-----------------
Minimum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Donepezil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive performance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium, Prevention, Donepezil
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.

Official Title
-----------------
Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Metastatic colorectal cancer Receiving Xeloda according to registered indication Exclusion Criteria: Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs. | Baseline up to end of study (up to 42 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Disease Progression | Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline. | Baseline to progressive disease or death (up to 42 months) | 
| Progression-Free Survival (PFS) | PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline. | Baseline to progressive disease or death (up to 42 months) | 
| Number of Participants With Hand-Foot Syndrome (HFS) | HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet. | Baseline up to end of study (up to 42 months) |
Quality Of Life After Eye Surgical Removal

Study Overview
=================
Brief Summary
-----------------
Studies have shown that health-related quality of life (HRQOL) was worse among patients who underwent surgical eye removal compared to the general population in Denmark. A third of eye amputated patients suffered from anxiety and depression. Most of the available evidence on the subject is based on retrospective studies that interviewed patients several years after surgery, which can potentially introduce biases. Moreover, in the literature, there are no data concerning postoperative psychological and visual impact.

Official Title
-----------------
A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)

Conditions
-----------------
Evisceration; Traumatic, Eye

Intervention / Treatment
-----------------
* Other: Quality of Life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration Exclusion Criteria: Patient who underwent bilateral eye removal surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Questionnaires<br>Questionnaires for global, psychological and visual Quality of Life (QoL) | Other: Quality of Life<br>* Questionnaire Perceived stress scale (PSS) + Questionnaire Short form 36 (SF-36) + Questionnaire Visual functioning questionnaire 25 (VFQ-25)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score VFQ 25 score up to 3 months after surgery | 100 = Best score, 0 = Worst possible score | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSS score up to 3 months after surgery | score from 0 to 13 = low stress score from 14 to 26 = moderate stress score from 27 to 40 = high perceived stress. | Month 3 | 
| SF-36 score up to 3 months after surgery | The SF-36, as described in the name, is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state | Month 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enucleation
Maturation Within Different Skeletal Growth Patterns Using Maturation Index in Males.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the difference between the maturation stages between different skeletal growth patterns

Detailed Description
-----------------
comparing the maturation of different vertical and horizontal growth patterns using CVMI

Official Title
-----------------
Skeletal Maturation Within Different Skeletal Growth Patterns Using Cervical Vertebrae Maturation Index in Males.

Conditions
-----------------
Skeletal Maturation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only male patients between 8-16 years old with clear sharp cephalometric radiograph, the radiographs which have all the cervical vertebrae will be included in this study. Exclusion Criteria: Previous orthodontic treatment. Radiographs of poor quality. Any hereditary diseases or syndromes such as Down's syndrome or cleidocranial dysostosis. Any disease, trauma or fracture of the jaw that might have affected the normal growth of permanent dentition.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Class I horizontal grower<br> | |
| Class I normal grower<br> | |
| Class I vertical grower<br> | |
| Class II horizontal grower<br> | |
| Class II normal grower<br> | |
| Class II vertical grower<br> | |
| Class III horizontal grower<br> | |
| Class III normal grower<br> | |
| Class III vertical grower<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the difference between the maturation stages (measured by CVMI index on lateral cephalograms) between different skeletal growth patterns | To evaluate the difference between the maturation stages (measured by CVMI index on lateral cephalograms) between different skeletal growth patterns | 8-16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to detect whether there were differences in the onsets of the pre-pubertal, pubertal and post-pubertal stages between the various antero-posterior and vertical skeletal patterns | to detect whether there were differences in the onsets of the pre-pubertal, pubertal and post-pubertal stages between the various antero-posterior and vertical skeletal patterns | 8-16 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical vertebrae maturation index
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Study Overview
=================
Brief Summary
-----------------
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury

Conditions
-----------------
Pruritus, Burns

Intervention / Treatment
-----------------
* Drug: Serlopitant
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Male or female, age 18-65 years at consent. History of serious burn injury Pruritus (itchiness) prior to the initial screening visit and during the screening period Judged to be in good health in the investigator's opinion. Key Exclusion Criteria: Prior treatment with study drug or similar drug Pruritus (itchiness) due to another reason besides burn injury/ healing. Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject. History of hypersensitivity to study drug or any of its components. Currently pregnant or male partner of pregnant female. Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Serlopitant<br>Dose of experimental drug Serlopitant | Drug: Serlopitant<br> <br> |
| Placebo Comparator: Placebo<br>Matching dose of Placebo | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Itch Intensity - Numeric Rating Scale |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Itch Intensity Responder Rate - Numeric Rating Scale |  | Week 6 |
Different Approaches for the Management of Post-dural Puncture Headache

Study Overview
=================
Brief Summary
-----------------
Detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache

Official Title
-----------------
Comparative Study Between Different Approaches for the Management of Post-dural Puncture Headache

Conditions
-----------------
Post-Dural Puncture Headache

Intervention / Treatment
-----------------
* Procedure: sphenopalatine ganglion block
* Drug: paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ASA physical condition І-П the patient underwent CS under spinal anesthesia The headache developed within 5 days after the dural puncture There is no different explanation for the headache Exclusion Criteria: coagulopathy history of nasal bleeding nasal polyp septal deviation local anesthetics reaction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine group<br> | Procedure: sphenopalatine ganglion block<br>* block of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache<br>|
| Active Comparator: bupivacaine group<br> | Procedure: sphenopalatine ganglion block<br>* block of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache<br>|
| Active Comparator: conservative group<br> | Drug: paracetamol<br>* intravenous paracetamol every 8 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postdural puncture headache | visual analog scale | within five days after the dural puncture |