linjc16/ctgov huggingface dataset:
A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)

Study Overview
=================
Brief Summary
-----------------
A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after total knee joint replacement in patients with osteoarthritis of the knee.

Official Title
-----------------
A Study to Compare Pre-Operative Administration of Rofecoxib Vs Post-Operative Administration of Diclofenac or Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement in Patients With Osteoarthritis of the Knee.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: MK0966; rofecoxib
* Drug: Comparator: diclofenac 2x 75 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females at least 18 years of age who have osteoarthritis of the knee and have undergone total knee joint replacement.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0966; rofecoxib|nan|
|Drug: Comparator: diclofenac 2x 75 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of patient controlled |  |  | 
| Post-operative morphine administration |  |  |
Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.

Study Overview
=================
Brief Summary
-----------------
Non-interventional study. Data obtained by patient chart reviews. Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity assessed by Charlson Comorbidity Index. The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus, Aldesleukin, Interferon-alfa-2b.

Detailed Description
-----------------
No sampling. All eligible patients will be included.

Official Title
-----------------
Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic renal cell carcinoma Exclusion Criteria: None

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 |
| --- | --- |
| Non-Interventional Study<br>Outcomes Research Study | Other: Non-interventional<br>* Non-interventional (retrospective chart reviews)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival from initiation of first systemic anticancer therapy |  | 8 months | 
| Progression free survival from initiation of each systemic anticancer therapy separately |  | 8 months | 
| Time to treatment failure from initiation of each systemic anticancer therapy separately |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival |  | 8 months | 
| Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death. |  | 8 months | 
| Predictive factors |  | 8 months | 
| Co-morbidity assessed by Charlson Comorbidity Index |  | 8 months | 
| Combined PFS and OS on sequential treatment |  | 8 months | 
| Assessment of first line immunotherapy´s effect on second line targeted therapy |  | 8 months | 
| Assessment of prognostic factors and overall survival for patients not receiving systemic therapy |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic renal cell carcinoma
Effects of SIMEOX on Flow and Volume

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects

Detailed Description
-----------------
This is a pilot study assessing the effect of the SIMEOX device on flow and volume generated in healthy subjects. Assessment of flow and volume will be performed before and during the application of the SIMEOX. Vital capacity and expiratory flow will be assessed.

Official Title
-----------------
Evaluation of SIMEOX on Flow and Volume Elicited in Healthy Subjects

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

Intervention / Treatment
-----------------
* Device: SIMEOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand the instructions Exclusion Criteria: Obesity (BMI > 30kg/m²) Active smoker Severe scoliosis Cardiovascular ou neuromuscular disease

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

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

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

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: SIMEOX<br>Use of the device SIMEOX to exhale | Device: SIMEOX<br>* SIMEOX is a device generating a succession of gentle depression at the mouth.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in expiratory volume | Expiratory volume before and during the use of the SIMEOX will be compared | 5min | 
| Change in expiratory volume flow rate | Expiratory flow rate before and during the use of the SIMEOX will be compared | 5min |
Quality of Life in Children With HIV Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the quality of life (QOL) and longitudinal patterns of change in QOL outcomes in children and youth with HIV infection; to identify demographic, social, disease status, treatment, and health care utilization factors that predict longitudinal changes in outcomes; to develop a conceptual model that characterizes the effects of specific factors that predict longitudinal changes in QOL; and to characterize the influence of HIV symptoms on QOL outcomes in the domains of health perceptions, physical, psychological, and social role functioning.

Detailed Description
-----------------
This is a Phase III study. This study will use national data available through a prospective, observational, longitudinal study of children and youth (n=1,993) from birth to 25 with HIV infection (Pediatric AIDS Clinical Trials Group Protocol 219/219C) to develop knowledge about the quality of life (QOL) and the factors that affect it in order to be able to implement effective nursing interventions and clinical programs to support and improve QOL in this vulnerable population of children.

Official Title
-----------------
Quality of Life in Children With HIV Infection

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Children and youth with perinatally acquired HIV infection Enrolled in PACTG 219/219C Completed quality of life assessment Exclusion criteria --HIV exposed, not infected

Ages Eligible for Study
-----------------
Minimum Age: 10 Months
Maximum Age: 25 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 |
| --- | --- | --- |
| Quality of Life assessment |  | 1999 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADOLESCENCE, HIV INFECTION, PEDIATRIC AIDS, QUALITY OF LIFE, HIV
An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.

Official Title
-----------------
A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications Exclusion Criteria: History of autoimmune disease or of any joint inflammatory disease other than RA Pregnant or lactating women Patients who have started RoActemra treatment in a clinical trial or for compassionate use Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)

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 |
| --- | --- | --- |
| Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 12 months | 
| Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI) |  | 12 months | 
| Response rate according to EULAR (European League Against Rheumatism) criteria |  | 12 months | 
| Quality of life (Visual Analogue Scales, Health Assessment Questionnaire) |  | 12 months | 
| Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors |  | 12 months | 
| Effect on DMARD tolerance/dosage in combination therapy |  | 12 months | 
| Dosages used in clinical practice |  | 12 months |
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants. The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.

Official Title
-----------------
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Procedure: Pterygium excision followed by grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pterygium at least 1.5mm in extent Both male and female Age range 21-65 years Consenting to participate in study Unilateral and bilateral pterygium All grades of pterygium Exclusion Criteria: Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars Pseudopterygium or signs of malignancy on pterygium Recurrent pterygium Sufferers of collagen vascular disease, scleritis or diabetes -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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 |
| --- | --- |
| No Intervention: 1<br>Pterygium free participants | |
| Experimental: 2<br>Pterygium participants | Procedure: Pterygium excision followed by grafting<br>* Pterygium will be excised followed by either free conjunctival or limbal conjunctival graft obtained from the upper part of the globe. The graft will be kept in place by sutures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| None recurrence of pterygium |  | 6 months of follow up after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal scarring |  | 6 months of follow up | 
| tenon's granuloma |  | 6 months of follow up | 
| graft retraction |  | one month of follow up | 
| Graft haematoma |  | one week of follow up | 
| Graft hyperaemia |  | 3 months of follow up |
A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.

Official Title
-----------------
A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.

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

Intervention / Treatment
-----------------
* Procedure: Minilaparotomy vs laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by ultrasoud ASA physical status 1-3 Body mass index 18-30 AGE 18 - 75 years Exclusion Criteria: Pregnancy or lactating common bile-duct stones acute cholecystitis previous upper abdominal operation Chirrosis Renal disease Pancreatitis ASA 4-5 Participation of any other clinical trial within 30 days before the start of the screening period History of uncontrolled cardiovascular, epileptic disorder, psychosis.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minilaparotomy cholecystectomy with ultrasonic scissors<br>Minilaparotomy vs laparoscopy | Procedure: Minilaparotomy vs laparoscopy<br>* MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy<br>|
| Active Comparator: Laparoscopic cholecystectomy<br>Minilaparotomy vs laparoscopy | Procedure: Minilaparotomy vs laparoscopy<br>* MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early recovery | Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative outcome | Operative time, time at the operation theatre, bleeding, length of skin incision | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection
Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants

Study Overview
=================
Brief Summary
-----------------
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.

Detailed Description
-----------------
A cluster randomized controlled trial. Twenty health care service sites were randomly assigned to the intervention or control groups. Health care workers of the intervention health care service sites received training based on the programme Ten steps for healthy feeding for children from birth to two years old. Pregnant women, in their third term, were enrolled in the study. At 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.

Official Title
-----------------
Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants

Conditions
-----------------
Breast Feeding

Intervention / Treatment
-----------------
* Behavioral: Ten Steps for Healthy Feeding children programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All pregnant women in the last quarter of the gestation. Exclusion Criteria: HIV-positive mothers congenital malformation
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Study Withdrawn
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: I, Intervention<br> | Behavioral: Ten Steps for Healthy Feeding children programme<br>* Ten Steps for Healthy Feeding children<br>* Other names: Infant Nutrition Programme;|

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
-----------------
Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breast Feeding, Overweight, Child, Infant Nutrition Physiology, Public Health
Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This study aims to study the relationship between diet and cognitive function among 4-5-year-olds.

Detailed Description
-----------------
Children's ability for optimal cognitive function is critical for their long-term capacity to learn and achieve scholastic success. However, there is a gap in the knowledge pertaining to the selection of appropriate cognitive tasks for studying relationships between diet and cognitive control, particularly among young children. Accordingly, this study aims to study the relationship between diet and cognitive function using a standardized neuropsychological assessment and a modified cognitive task battery.

Official Title
-----------------
Diet Quality and Cognitive Control Function in Early Childhood: A Pilot Study

Conditions
-----------------
Diet Habit, Cognitive Function

Intervention / Treatment
-----------------
* Other: No Intervention/Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parental consent Child Assent 4 and 5 years of age Absence of neurological disorders Normal or corrected-to-normal vision Exclusion Criteria: Younger than 4 and older than 5 years of age Presence of neurological disorders Uncorrected vision

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 5 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention/Observational Study|No Intervention/Observational Study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Cognitive and Academic Development | Woodcock Johnson IV eCAD | Once at laboratory visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention | 2-stimulus Oddball task | Once at laboratory visit | 
| Cognitive Flexibility | Hearts and Flowers Task | Once at laboratory visit | 
| Diet Quality | Healthy Eating Index | 7-day average following first laboratory visit |