linjc16/ctgov huggingface dataset:
(Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer

Conditions
-----------------
Non-Metastatic Prostate Cancer

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of non-metastatic cancer of the prostate gland Patient to be 18 years and above Exclusion Criteria: Previous systemic therapy for prostate cancer Previous history of another form of cancer (not prostate) within 5 years of study start.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Placebo<br> <br> |
| Active Comparator: B<br> | Drug: Bicalutamide<br>* 150mg p.o. daily<br>* Other names: Casodex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical progression |  | Throughout study period | 
| Tolerability in terms of adverse events and laboratory parameters |  | Throughout study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Throughout study period | 
| Time to treatment failure |  | Throughout study period | 
| Prostate-specific antigen |  | Initial study period up to 2005 amended protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
androgen antagonists, prostate neoplasms
REALL: A Retrospective Observational Study to Compare the Effectiveness and Cost-Effectiveness Between Different Step-3 Asthma Treatment Strategies

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational study utilising anonymised individual patient clinical and prescribing information routinely collected by UK General Practitioners (GPs). This information will be observed for two years, one year pre and one year post- Index Prescription Date (IPD). The IPD is the date when a patient was first switched to any option of the step-3 asthma treatment regimen. The one year before the IPD is the baseline period and will be reviewed for risk factors and confounding factors. The one year after the IPD is the outcome period and will be observed to see the outcomes of the new treatment.

Official Title
-----------------
REALL STUDY: A Retrospective Observational Study to Compare the Effectiveness and Cost-effectiveness Between Different Step-3 Asthma Treatment Strategies in Real Life Patients in Primary Care

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a physician diagnosis of asthma who have stepped-up to any option of step-3 asthma treatment (trial therapy), and; Patients with the trial therapy who have data in their records for at least one year for the baseline period and at least one year for the outcome period. Exclusion Criteria: Patients who were not prescribed with any option of step-3 treatment (the trial therapy) during the study period. Patients treated with the trial therapy, but do not have data in their records for at least one year for the baseline period and at least one year for the outcome period. Patients treated with long-acting anticholinergic drugs, either alone or in combination with other therapy. Patients with a physician diagnosis of COPD with or without asthma. Patients who have resolved from asthma; i.e. patients who were previously diagnosed as having asthma, have now been undiagnosed.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Asthma patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The achievement of asthma control. This will be assessed by evaluating the patient data for one year in the outcome period. On this basis patients will be divided into two groups |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The asthma control will be monitored, directly from patients' point of view, by Royal College of Physician (RCP) 3 questions at least after 6 months of IPD (British Thoracic Society (BTS) July, 2007). |  | 1 year |
A Multi-Center Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making

Study Overview
=================
Brief Summary
-----------------
The overall goal is to improve shared decision-making (SDM) about treatment options and thereby enhance disease outcomes and health-related quality of life (HRQOL) for patients with rheumatoid arthritis (RA). The objective of this study is to engage patients in using the ArthritisPower application on a weekly basis during the time between clinic appointments for collection of data on self-reported disease activity and patient-reported outcomes (PROs), and to display the data using an iPad to the patients and their rheumatology health care providers (HCPs) at the point of care for SDM.

Official Title
-----------------
A Multi-Center Cluster Randomized Controlled Clinical Trial to Determine the Impact of a Mobile Health Application on Rheumatoid Arthritis Shared Decision Making

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

Intervention / Treatment
-----------------
* Behavioral: Mobile Health App


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥ 18 years. Fulfillment of the ACR/EULAR 2010 classification criteria for RA [9]. Moderate or high disease activity, according to CDAI ≥ 10, at the baseline visit. Intent to modify DMARD therapy (i.e., adding a DMARD, switching to a new DMARD, or changing DMARD dosage) by the patient and HCP. Exclusion criteria: Current or previous use of ArthritisPower™ by the patient. Lack of access to an ArthritisPower™ compatible device (e.g., smartphone, tablet, or computer) Inability or unwillingness to participate with using the ArthritisPower™ app for this study

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Standard of care | |
| Experimental: Intervention Arm<br>Mobile Health App | Behavioral: Mobile Health App<br>* ArthritisPower App<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Determine the impact of ArthritisPower™ integration into the clinical evaluation of patients with RA on the primary endpoint of clinical improvement as defined by the continuous change in the Clinical Disease Activity Index (CDAI) (1). |  | 24 months |
Angiosome Perfusion After Tibial Bypass

Study Overview
=================
Brief Summary
-----------------
Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.

Detailed Description
-----------------
Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Drug: Indocyanine Green


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at CLI Rutherford stages IV to VI Patients with necessity of tibial Bypass surgery Exclusion Criteria: Allergy against indocyanine green Iodine allergy Contrast allergy Penicillin allergy Allergic diathesis Liver insufficiency Pregnancy Hyperthyreosis Pulmonary arterial hypertension

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: Diagnostic
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: foot perfusion<br>intravenous application of indocyanine green in patients receiving tibial Bypass surgery | Drug: Indocyanine Green<br>* Perioperative application of 0.1 mg ICG per kg Body weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingress) | Comparison of the fluorescence parameter Ingress in the direct and indirect revascularized angiosome before and after tibial bypass surgery | 12 months | 
| Comparison of the direct and indirect revascularized angiosomes of the foot on the Level of microcirculation (Parameter Ingressrate) | Comparison of the fluorescence parameter Ingressrate in the direct and indirect revascularized angiosome before and after tibial bypass surgery | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the wound healing rates with indirect and direct revascularization |  | 12 months |
Familial Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

Detailed Description
-----------------
The purpose of this study is to identify affected individuals in families with prostate cancer and to use this information to identify genetic markers closely-linked to the disease gene.

Official Title
-----------------
Familial Prostate Cancer

Conditions
-----------------
Neoplastic Syndromes, Hereditary, Prostatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Families will be identified with two or more first degree relatives affected with prostate cancer or with one male with prostate cancer that developed before age 55. Must have clinical evidence of prostate cancer in the family.
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
-----------------
Familial, Inherited Prostate Cancer, Linkage, Prostate Cancer
Clinical Outcomes About Heparin Surface Modified Aspheric Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.

Detailed Description
-----------------
Heparin surface treatment lens can reduce inflammatory reaction. Modified aspheric lens are more in line with human optical properties than the traditional aspheric lens. To obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation. After one day, one week, one month, three month follow-up，Key observation on the flare, the optical quality, contrast sensitivity and other parameters.Study the postoperative inflammatory reaction with test group lens，and the impact on the visual quality.

Official Title
-----------------
Clinical Outcomes About Heparin Surface Modified Aspheric Lens

Conditions
-----------------
Inflammatory Reaction

Intervention / Treatment
-----------------
* Device: traditional lens
* Device: heparin surface modified aspheric lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract patients Exclusion Criteria: Eyed patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Heparin Surface Modified Aspheric Lens<br>Heparin Surface Modified Aspheric Lens | Device: heparin surface modified aspheric lens<br>* the other eye implant heparin surface modified aspheric lens<br>|
| Other: traditional lens<br>traditional Aspheric lens | Device: traditional lens<br>* A random eyes with traditional lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flare value in the anterior chamber after surgery | use Laser Flare Meter to measure the flare in the anterior chamber to evaluate postoperative ocular inflammatory reaction | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the ocular and the anterior corneal aberration after surgery | use wavefront aberrometer to measure the ocular and the anterior corneal aberration to evaluate postoperative ocular optical quality | six months |
Myocardial Perfusion Assessment With Multidetector Computed Tomography

Study Overview
=================
Brief Summary
-----------------
Demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable one-stop shop of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any blockages visualized.

Official Title
-----------------
Myocardial Perfusion Assessment With Multidetector Computed Tomography

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

Intervention / Treatment
-----------------
* Device: Regadenoson (Lexiscan) [muti-detector computed tomography]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18 years of age Adults undergoing myocardial perfusion SPECT imaging Adults with suspected coronary artery disease Exclusion Criteria: Age <18 Known or suspected renal insufficiency (Creatinine <1.7 mg/dl) Allergy to contrast Inability or contraindication to lexiscan or beta blocker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Regadenoson (Lexiscan) [muti-detector computed tomography]|Regadenason, typical dosing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy (Sensitivity/Specificity/Positive Predictive Value/Negative Predictive Value) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dosimetry |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, stress testing
Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. Therefore the investigators will conduct a prospective randomized controlled, single blind trial.

Detailed Description
-----------------
Two groups: A cholecystectomy at a low pressure pneumoperitoneum (8-10 mmHg) A cholecystectomy at a lowpressure pneumoperitoneum (8-10mmhg) and at the end a pulmonary recruitment manoeuvre (5 sec at max 40 cmH2O).

Official Title
-----------------
The Effect of Low Pressure Pneumoperitoneum and Pulmonary Recruitment Manoeuvre on Postoperative Pain After Laparoscopic Cholecystectomy

Conditions
-----------------
Pneumoperitoneum, Recruitment, Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Pulmonary recruitment
* Procedure: No pulmonary recruitment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II Exclusion Criteria: refusal to give consent cholecystitis BMI above 35 intolerance to one of the pain medication pregnancy

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low pressure pneumoperitoneum<br>Surgery on low pressure pneumoperitoneum (8 - 10 mmHg). | Procedure: No pulmonary recruitment<br>* At the end of surgery no intervention was completed<br>|
| Active Comparator: low pressure peritoneum and pulmonary recruitment<br>Surgery on low pressure pneumoperitoneum (8 - 10 mmHg) and at the end of surgery a manual pulmonary recruitment manoeuver (2 x 5sec max 40cmH2O) will be done | Procedure: Pulmonary recruitment<br>* At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief during the first 24 hours | VAS (0-10) | 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total analgesic use during the first 24 hours |  | 24hours | 
| Length of hospital stay |  | 2 days | 
| Recovery after 48 hours | quality of recovery scale | 48 hours |
Gonadal Toxicity in Women With Hodgkin Lymphoma

Study Overview
=================
Brief Summary
-----------------
The Gruppo Italiano Studio Linfomi has been collecting data on patients with Hodgkin Lymphoma (HL) since 1988. This archive represents a homogeneous series of consecutive patients with HL. The very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for HL.

Official Title
-----------------
Observational Retrospective Study to Evaluate the Incidence of the Gonadal Toxicity in Women of Reproductive Age With Hodgkin Lymphoma

Conditions
-----------------
Hodgkin Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients in complete remission after chemotherapy for Hodgkin lymphoma Age ≥ 18 e < 40 years Previous regular menstrual cycle No previous or concomitant gynecological diseases affecting reproducing function No other chemo-radiotherapy for other neoplasm Written informed consent Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women with hodgkin lymphoma treated with chemotherapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of gonadal toxicity in terms of irreversible amenorrhea and infertility, in women of reproductive age with Hodgkin lymphoma treated with chemotherapy. |  | from end of treatment until date of last contact/visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| role of a prophylactic treatment with oral contraceptives and GnRH analogs in preventing gonadal damage |  | from end of treatment until date of last contact/visit |