linjc16/ctgov huggingface dataset:
Active Drug Surveillance Program of Ferriprox Use

Study Overview
=================
Brief Summary
-----------------
Observational, open label, prospective, multi-center, post-marketing drug surveillance program.

Detailed Description
-----------------
A post-marketing, drug surveillance program evaluating the use, monitoring, benefits and adverse effects of Ferriprox under clinical conditions in newly treated patients.

Official Title
-----------------
Active Drug Surveillance Program of Ferriprox Use

Conditions
-----------------
Transfusional Iron Overload

Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Patients who started Ferriprox therapy less than one month or are to initiate Ferriprox therapy at the time of enrolment into the program. Main Exclusion Criteria: Patients treated with Ferriprox for more than one month prior to enrolment.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients on Ferriprox therapy <1 month<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of dose of Ferriprox, and if applicable concurrent chelator(s) in newly treated patients. | Evaluation of dose of Ferriprox includes the frequency of administration of chelator(s). | Baseline to 12 Months | 
| Evaluation of regimen of Ferriprox administration, and if applicable concurrent chelator(s) in newly treated patients. | Evaluation of how Ferriprox is prescribed/received by the patient: as monotherapy, simultaneous with deferoxamine, alternate with deferoxamine, simultaneous with deferasirox, alternate with deferasirox. | Baseline to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the beneficial effects of Ferriprox based on the characterization of its use in clinical practice. | Beneficial effects of Ferriprox will be assessed based on the changes in: serum ferritin and cardiac iron concentration as assessed by MRI T2*. | Baseline to 12 Months | 
| Assessment of the adverse effects of Ferriprox based on the characterization of its use in clinical practice. | Adverse effects of Ferriprox will be assessed based on: frequency of absolute neutrophil count (ANC) monitoring, occurrence of neutropenia or agranulocytosis and occurrence of other adverse events (AEs) or adverse drug reactions (ADRs). | Baseline to 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ferriprox, Deferiprone, DFP, L1
Popcorn Lung: the Discovery of a New Disease

Study Overview
=================
Brief Summary
-----------------
Recently, an epidemic of pulmonary disease has been recognized among workers in a popcorn factory in Jasper, Missouri. The exposure agent has not yet been identified, but suspects include butter flavoring and the powdered salt used in the mixing room. This disease resembles Bronchiolitis Obliterans Syndrome, an illness that makes it difficult to breathe. Of the 117 workers studied, one year later, 25 subjects whom were working in the mixing room or in the microwave packaging area have had decreases in lung function seven times the norm for their age. Industrial hygiene experts revealed that dust concentrations of salt and other flavorings were much higher in the mixing room compared to the office and outdoor work areas. Recently, rats were exposed to vapors created by heating the butter flavor compound obtained from this plant. Six-hour exposure to vapors at very high concentration resulted in significant damage to the breathing apparatus. Thus, there is clinical, epidemiological, and animal toxicity data that appears to implicate some constituent present during the mixing of the butter flavoring, salt, and oil causing a form of obstructive airway disease that has been rapidly progressive in a number of workers. It is not clear what the pathophysiologic nature of this entity is, though it resembles Bronchiolitis Obliterans Syndrome. It is not known what the long term consequence of this will be on the active workers, nor is it clear whether preventive measures taken to reduce exposures in the mixing room and elsewhere in the plant are going to be effective.

Official Title
-----------------
Popcorn Lung: the Discovery of a New Disease

Conditions
-----------------
Lung Diseases, Interstitial, Bronchiolitis Obliterans

Participation Criteria
=================
Eligibility Criteria
-----------------
Current employees who have a decline in FEV1 larger than 200cc within the past year will be eligible to participate. All index cases will be eligible to participate.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Quality of Life in Patients With Intermediate Uveitis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine if macular edema is associated with less visual function and quality of live in patients with intermediate uveitis

Official Title
-----------------
Influence of Macular Edema on Quality of Life in Patients With Non-infectious Intermediate Uveitis

Conditions
-----------------
Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pars planitis Exclusion Criteria: Patients with any other diseases Patients under age 18

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with intermediate uveitis<br> | |

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
-----------------
Quality of life in patients with macular edema compared to patients without macular edema.
An Observational Study of RoActemra/Actemra (Tocilizumab) in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

Official Title
-----------------
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe rheumatoid arthritis , according to the revised ACR criteria Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision Exclusion Criteria: RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra History of autoimmune disease or of any joint inflammatory disease other than RA

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 |
| --- | --- | --- |
| Proportion of patients on RoActemra/Actemra treatment at 6 months |  | approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of dose modifications/interruptions |  | approximately 2 years | 
| Clinical/demographic patient characteristics at initiation of treatment |  | approximately 2 years | 
| Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR |  | approximately 2 years | 
| Efficacy: Monotherapy versus combination therapy |  | approximately 2 years | 
| Use of disease-modifying anti-rheumatic drugs (DMARDs) |  | approximately 2 years |
Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.

Study Overview
=================
Brief Summary
-----------------
The investigators aim to study the pattern and frequency of pathogenic variants among ALL newly diagnosed cancer patients in a genetically distinct population. Additionally, the investigators will study the uptake rate of cascade family screening, frequency of pathogenic variants and barriers against testing.

Official Title
-----------------
Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.

Conditions
-----------------
Genetic Predisposition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient, age ≥ 18 years at time of cancer diagnosis Pathology proven diagnosis of cancer; any site, any stage (prior history of cancer is allowed) Jordanian nationality Willingness to participate Signed consent form Exclusion Criteria: Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications) Non-Jordanian Patients with Leukemia, Lymphoma and Myeloma

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing |  | 2021-2023 | 
| Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing |  | 2021-2023 | 
| To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients. |  | 2021-2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cascade of family member testing of the participants with positive pathogenic mutation | The family of tested patients with pathogenic mutations will be offered the genetic testing | 2021-2023 | 
| Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel |  | 2021-2023 | 
| Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing |  | 2021-2023 | 
| To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation |  | 2021-2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genetics
Cleft Palate Surgery and Speech Development

Study Overview
=================
Brief Summary
-----------------
Compare the outcome of two primary surgeries techniques (von Langenbeck and Furlow double z-plasty) performed on children with cleft lip/palate to determine if one results in significantly better velopharyngeal competency for speech.

Detailed Description
-----------------
This study is conducted with patients with complete unilateral cleft lip and palate. The subjects will have their palatal clefts surgically repaired by either the von Langenbeck or the Furlow double z-plasty palatoplasty. Patients will be randomly assigned to four groups, to have with the von Langenbeck palatoplasty with intravelar veloplasty or the Furlow double opposing z-plasty palatoplasty between 9 and 12 months of age or between 15 and 18 months of age. Lip repair will be randomized to either the Spina or Millard method and will be accomplished by six months prior to palatoplasty. The major emphasis will focus on assessment of the near and long term outcomes of the palatal surgeries on velopharyngeal function for speech.

Official Title
-----------------
Velopharyngeal Function for Speech After Palatal Surgery

Conditions
-----------------
Cleft Lip, Cleft Palate

Intervention / Treatment
-----------------
* Procedure: Furlow double z-plasty palatoplasty palate repair
* Procedure: Von Langenbeck palatoplasty palate repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unrepaired unilateral cleft lip and palate Lip repair surgery to be accomplished by 3-6 months of age Able to return to research site at least once a year for follow-up Exclusion Criteria: Patients with concomitant conditions (ie. mental retardation, deafness) Patients with Simonart Band of the cleft Patients who could not return to research site on a yearly basis
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

| Intervention/Treatment |
| --- |
|Procedure: Furlow double z-plasty palatoplasty palate repair|nan|
|Procedure: Von Langenbeck palatoplasty palate repair|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velopharyngeal function for speech was identified to be better for patients who received the Furlow double opposing z-palatoplasty procedure than patients who received the von Langenbeck procedure, as determined by the Cul-de-Sac Test of Hypernasality. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cleft lip and palate, children, speech, velopharyngeal function, congenital facial malformation, von Langenbeck procedure, Furlow procedure, cleft lip and palate repair, Unilateral cleft lip and palate
The Effect of Endurance Training in Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the effect of endurance on PSA doubling time in prostate cancer patients with an elevation in PSA following radical prostatectomy for localized cancer. Furthermore, underlying mechanisms such as reduction in inflammatory markers and improvement in insulin sensitivity and body composition are investigated.

Official Title
-----------------
The Effect of Endurance Training on PSA Doubling Time, Body Composition, Insulin Sensitivity and Inflammation in Patients With Prostate Cancer

Conditions
-----------------
Prostate Cancer, Insulin Sensitivity, Body Composition, Beneficial

Intervention / Treatment
-----------------
* Behavioral: endurance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer patients with an increase in PSA following radical prostatectomy Exclusion Criteria: severe cardiovascular disease severe arthritis severe neuropathy severe hypertension therapy with antidiabetic agents other treatment for prostate cancer than radical prostatectomy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate cancer, endurance training<br>Prostate cancer patients doing 2 years of home-based endurance training Cross over design with a control group with no intervention | Behavioral: endurance training<br>* 2 years of home-based endurance training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA doubling time |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity, body composition and inflammation status |  | 0 months, 6 months and 24 months of training |
Quality of Life After Liver Resection

Study Overview
=================
Brief Summary
-----------------
Patients with malignant diseases are increasingly receiving more extensive hepatic resections, with im-proved preoperative and postoperative care leading to a reduced postoperative morbidity and mortality. In this setting, postoperative quality of life may become as important as overall patient survival. In this study we will be investigating the effect of the initial disease for which hepatic resection was carried out on short- and long-term quality of life.

Detailed Description
-----------------
Background: Due to advances in operative methods and perioperative care, mortality and morbidity following major hepatic resection have decreased substantially, making long-term quality of life (QoL) an increasingly prominent issue. Objectives: We plan on evaluating whether postoperative diagnosis is associated with long-term QoL and health in patients who require hepatic surgery for benign or malignant diseases and how QoL evolves with time. Method: QoL will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and the liver-specific QLQ-LMC21 module. All patients requiring hepatic surgery aged >18 years will be included in the study. QoL evaluation is carried out preoperatively and at set intervals postoperatively.

Official Title
-----------------
Long-term Evaluation of the Quality of Life After Major Hepatic Resection for Malignant and Benign Diseases.

Conditions
-----------------
Liver Diseases, Liver Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with planned liver resection Exclusion Criteria Patients with biopsy of the liver only Inability of understanding the questionnaire

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 |
| --- | --- |
| malignant<br>eg. hepatocellular carcinoma, colorectal liver metastases | |
| benign<br>eg. liver cysts, traumatic liver injuries, adenoma etc | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | preoperatively, 1-,3-,6-,12 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Liver Neoplasms, Surgical procedures, Operative
Cervical Cancer Detection Using Optical Spectroscopy

Study Overview
=================
Brief Summary
-----------------
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Official Title
-----------------
Cervical Cancer Detection Using Optical Spectroscopy

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Device: Optical Spectroscopy Bench-Top System
* Device: Portable Optical Spectrometer
* Device: Transvaginal colposcope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing colposcopy for the diagnosis of cervical cancer LEEP for the treatment of cervical cancer in early stages. Follow-up Pap smear in surveillance Exclusion Criteria: Women under the age of 18 (minors) will be excluded from this study. patients will be excluded if she has had a recent episode of bleeding or preterm labor. Subjects who are not competent to give consent will excluded

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

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

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 |
| --- | --- |
| Experimental: Colposcope<br>Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope or LEEP. The intervention for this arm is the use of the bench-top, miniature optical spectrometer or trans-vaginal colposcope | Device: Optical Spectroscopy Bench-Top System<br>* This device is a bench-top optical spectrometer<br>Device: Portable Optical Spectrometer<br>* This device is a portable optical spectrometer<br>Device: Transvaginal colposcope<br> <br> * Other names: Transvaginal digital colposcope, Pocket colposcope, callascope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of optical signatures of cervical tissue | The primary outcome of this study is the identification of the optical signatures of cervical tissue. | Day of procedure (less than 10 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical cancer, LEEP, colposcopy, Pap smear