linjc16/ctgov huggingface dataset:
Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Detailed Description
-----------------
The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Official Title
-----------------
Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Knee Arthritis

Intervention / Treatment
-----------------
* Device: Simplex® Bone Cement
* Device: Cobalt™ Bone Cement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved Patients requiring correction of varus, valgus, or posttraumatic deformity Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure Exclusion Criteria: Infection, sepsis, and osteomyelitis

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 |
| --- | --- |
| 1<br> | Device: Simplex® Bone Cement<br>* This arm will utilize Simplex® Bone Cement in total knee replacement.<br>|
| 2<br> | Device: Cobalt™ Bone Cement<br>* This arm utilizes Cobalt™ Bone Cement in total knee replacement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic analysis and Knee Society Score |  | 10 years |
Ovarian Functions in Flight Attendants

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness, excessive hours spent on flight and UV radiation exposure over ovarian function in flight attendant women.

Detailed Description
-----------------
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness, excessive hours spent on flight and UV radiation exposure over ovarian function in flight attendant women. On the third day of the menstrual period, evaluate the number of antral follicle count will be examined and the level of hormones showing the ovarian functions will be measured in the blood sample given by the participant.

Official Title
-----------------
Evaluation of Antral Follicle Count and Amh Values in Women Working at Night and Flight Attendants

Conditions
-----------------
Ovarian Functions in Flight Attendants

Intervention / Treatment
-----------------
* Diagnostic Test: amh test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: day working women , 25-35 years old night working women , 25-35 years old flight attendant women, 25-35 years old Exclusion Criteria: those who cannot enter the groups above

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| flight attendant women<br>Assesment antral follicle count on day 3 5ml blood sample to be taken | Diagnostic Test: amh test<br>* Antral follicle count with ultrasound on the 3rd day of menstruation<br>* Other names: Day 3 antral follicle with transvaginal ultrasonography;|
| day working women<br>Assesment antral follicle count on day 3 5ml blood sample to be taken | Diagnostic Test: amh test<br>* Antral follicle count with ultrasound on the 3rd day of menstruation<br>* Other names: Day 3 antral follicle with transvaginal ultrasonography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of amh |  | one year |
Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate non-linear heart rate variability indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.

Official Title
-----------------
Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias

Conditions
-----------------
Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Device: Dataq Instruments DI-158


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who will have cardiac surgery The patient must be mentally able and willing to participate in the study Male or female patients over the age of 18 Exclusion Criteria: Patients with major renal, hepatic, respiratory, or cerebral dysfunction Patients with atrial fibrillation or other forms of sinus node dysfunction Patients requiring continuous artificial pacing Patients with significant congenital heart disease with or without arrhythmias Patients on Intra-Aortic Balloon Pump Patients experiencing cardiac emergencies or undergoing cardiac salvage operations

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>This is a prospective observational study. 100 patients in one arm scheduled for cardiac surgery will be enrolled. ECG tracings will be obtained when subject is at rest, in supine position, before induction of anesthesia (within 24 hours prior to induction), after induction of general anesthesia, right before emergence from anesthesia (or before transportation to the ICU if the subject remains intubated), and within 24 hours post-operatively; additional ECG readings may be obtained during the surgery if deemed necessary. | Device: Dataq Instruments DI-158<br>* Data Acquisition Device (connects to room instrumentation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate non-linear heart rate variability (HRV) indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery. |  | Sept 07 - Sept 08 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registration of HRV changes during cardiac surgery, and comparison HRV pre-operatively, post anesthesia induction, on emergence from anesthesia and postoperatively. |  | Sept 07 - Sept 08 |
Blood Sampling of Healthy Volunteers for Immunological Research

Study Overview
=================
Brief Summary
-----------------
This protocol will be used to collect crucial components of the immune system from healthy volunteers for the characterization of immune cells in fresh blood. A pipeline has been set up for comprehensive immune phenotyping of both lymphoid and myeloid cells within 24 hours after blood withdrawal.

Detailed Description
-----------------
In order to properly compare the immunobiology of healthy volunteers to (advanced) cancer patients, the investigators use age-matched controls with no history of cancer and no potentially interfering medication. Healthy volunteers will be asked to donate 5 tubes of blood

Official Title
-----------------
Blood Sampling of Healthy Volunteers for Immunological Research

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 35 years Written informed consent No history of cancer No use of systemic immunosuppressive medication (eg. corticosteroids). Local use of corticosteroids (eg. topical or inhalation) is allowed. Exclusion Criteria: Fever 14 days before blood withdrawal Donated blood for the same program within the last 2 years Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 36 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood sample<br>Blood sample | Other: Blood sample<br>* Blood sample<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of immune cells, both lymphoid and myeloid, present in the blood of healthy individuals, assessed by flow cytometry, as well as cytokine expression and transcriptome profiles of these cells | the number of lymphoid and myeloid immune cells present in the blood of healthy individuals using flow cytometry, assessing the cytokine expression of these cells in healthy individuals using ELISA cytokine assays, and assessing gene expression of these cells using single cell transcriptomics analyses using droplet-based single cell RNA sequencing. | assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunophenotyping of both myeloid and lymphoid cells in healthy individuals | Immunophenotyping of both myeloid and lymphoid cells in healthy controls to gain insights in immunological defects and immune evasion in cancer patients | assessed up to 12 months |
The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.

Detailed Description
-----------------
This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.

Official Title
-----------------
Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: emboli capturing guidewire device combined with stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unstable angina pectoris (Braunwald classification B & C, I-II-III, native vessels) or lesion located in the SVG; Single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft; The vessel diameter to place the AngioGuard™ device in must be > 3 and < 5.5 mm (6.5 when the 7mm AngioGuard™ is available); Target lesion stenosis is >50% and <100% (TIMI 1). Exclusion Criteria: A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal; More than one coronary artery is 100% occluded; Patient has unprotected left main coronary disease with > 50% stenosis; Patient has an ostial target lesion; Significant (>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff; Ejection fraction <30%; Totally occluded vessel (TIMI 0 Level).

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AngioGuard™ device and Bx Velocity™ stent | Device: emboli capturing guidewire device combined with stent<br>* AngioGuard™ device and Bx Velocity™ stent<br>* Other names: PTCA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful placement and retrieval without embolic occlusions of vessels distal to the position of the device |  | post-procedure | 
| overall survival rates |  | 1 month and 6 months | 
| device evaluation |  | post-procedure |
Treating Alzheimer's and Dementia With D-ribose

Study Overview
=================
Brief Summary
-----------------
To study the effectiveness of d-ribose in treating Alzheimer's and Dementia

Detailed Description
-----------------
Clinical experience and the pathophysiology of Alzheimer's, including neuronal insulin resistance, suggests that ribose improves clinical outcomes. This study will add ribose 5 gm 3 X day for 8 weeks to monitor outcomes in a pilot study.

Conditions
-----------------
Alzheimers, Dementia

Intervention / Treatment
-----------------
* Dietary Supplement: d-ribose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of Alzheimer's and/or dementia with a Mini Mental Status Exam ( MMSE) score over 12 or being ambulatory and able to travel outside the home with assistance. Must have a caregiver living with them. Exclusion Criteria: Overt and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness. Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months.
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
Interventional Model Description: Single arm pilot study using ribose for alzheimers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with d-ribose<br>Treatment with ribose 5 gm TID | Dietary Supplement: d-ribose<br>* giving ribose in those with a diagnosis of Alzheimer's and/or dementia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-ADL |  | 2 months |
Evaluation of Pharmaceutical Care in Depressed Outpatients

Study Overview
=================
Brief Summary
-----------------
The study examines whether pharmacotherapeutic follow-up improves outcomes of treatment of depressed outpatients.

Official Title
-----------------
EVALUATION OF THE EFFECTIVENESS OF PHARMACEUTICAL CARE (DÁDER PROGRAM) IN DEPRESSED OUTPATIENTS TREATED WITH PSYCHOTROPIC

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Procedure: pharmacotherapeutic follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women between 18 and 65 years, with diagnostic hypothesis of depression at the beginning of treatment or change in treatment unless 2 months (dosage or substance) Exclusion Criteria: record of dependence on psychoactive substances, diagnosed schizophrenia, low education (illiterate) or cognitive impairment evident that compromise the completion of research instruments

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>outpatients receiving usual care | |
| Experimental: intervention group<br>outpatients receiving pharmaceutical care or pharmacotherapeutic follow-up by 6 months | Procedure: pharmacotherapeutic follow-up<br>* health education adjustment of dose improve compliance replacement of medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression level | evaluation depression level by Beck scale | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety level | evaluation anxiety level by Beck scale. | 6 months | 
| compliance | evaluation antidepressive treatment compliance by Morisky scale | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmaceutical care, depression, compliance, pharmacist's intervention, Dáder
Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine what the long term survival is after in hospital use of total parenteral nutrition due to intestinal failure. Earlier studies only followed patients for a maximum of 6 months or included only very specific patients. We were interested in all patients in our hospital and followed them for up to 2 years.

Detailed Description
-----------------
Extensive description is not desired

Official Title
-----------------
Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition

Conditions
-----------------
Nutrition Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive patients on TPN Exclusion Criteria: patients from the Pediatric and Haematological Departments

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 |
| --- | --- |
| Total Parenteral Nutrition Use<br>The cohort investigated consisted of patients with intestinal failure requiring total parenteral nutrition use. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | Up to 1427 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mortality, Long term follow-up, Parenteral Nutrition, Total
Piperacillin as a Part of Antibiotic Streamlining in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The proposed endpoints of the study would be: comparative use of piperacillin versus broader spectrum agents (e.g., piperacillin/tazobactam, etc.) [measured as defined daily doses per 1000 patient days]; physician acceptance of piperacillin as part of a streamlining program [measured as successful occurrences of the use of piperacillin as streamlining therapy]; changes in susceptibility patterns of broad spectrum antibiotics [measured as % Gram negative bacilli susceptible to each of the commonly used broad spectrum antibiotics]; and outcome of patients treated with streamlined therapy.

Detailed Description
-----------------
The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, laboratory and radiographical data, antimicrobial usage, microbiological data and resistance patterns, choice of antibiotics once organism is identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome, gender, height, weight, ethnicity, and past medical history.

Official Title
-----------------
Piperacillin as a Part of Antibiotic Streamlining in the Intensive Care Unit

Conditions
-----------------
Gram-negative Bacterial Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Gram negative infections treated with piperacillin/tazobactam and/or piperacillin

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 |
| --- | --- | --- |
| dead or alive | health status | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pipercillin, gram negative bacteria infections