linjc16/ctgov huggingface dataset:
Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy

Study Overview
=================
Brief Summary
-----------------
Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, conformal radiation doses (>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the initiation of robust antitumoral immune responses.

Official Title
-----------------
Observational Study of Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy

Conditions
-----------------
Prostate Cancer, Breast Cancer, Lung Cancer, Melanoma

Intervention / Treatment
-----------------
* Radiation: SBRT
* Radiation: IMRT
* Radiation: Brachytherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer Exclusion Criteria: -Life expectancy of less than 3 months

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 |
| --- | --- |
| Prostate Cancer<br>Patients with prostate cancer will be treated with SBRT, IMRT or brachytherapy | Radiation: SBRT<br> <br> Radiation: IMRT<br> <br> Radiation: Brachytherapy<br> <br> |
| Breast Cancer<br>Patients with breast cancer will be treated with SBRT, IMRT or brachytherapy | Radiation: SBRT<br> <br> Radiation: IMRT<br> <br> Radiation: Brachytherapy<br> <br> |
| Lung Cancer<br>Patients with lung cancer will be treated with SBRT, IMRT or brachytherapy | Radiation: SBRT<br> <br> Radiation: IMRT<br> <br> Radiation: Brachytherapy<br> <br> |
| Melanoma Cancer<br>Patients with melanoma cancer will be treated with SBRT, IMRT or brachytherapy | Radiation: SBRT<br> <br> Radiation: IMRT<br> <br> Radiation: Brachytherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers. | Changes in baseline circulating tumor reactive immune markers after radiotherapy. | Before and after SBRT, IMRT, or brachytherapy |
Evaluation of Safety and Parameters of Application Technique

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.

Official Title
-----------------
Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Delivery Systems

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus (type 1 or type 2) Treated with insulin
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NovoPen® 4<br> | Other: No treatment given<br>* Collection of data about patients with type 1 diabetes or type 2 diabetes treated with insulin changing their insulin administration from syringe to a insulin delivery system based on completion of questionaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of insulin applications (punctures) |  |  | 
| Reasons leading to change of the therapy |  |  | 
| Patient satisfaction with NovoPen® 4 insulin delivery system |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions |  |  | 
| Hypoglycaemia |  |  |
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound

Study Overview
=================
Brief Summary
-----------------
to compare infection rate stoma reversal skin wound after primary or secondary closure

Detailed Description
-----------------
There will be two groups. In group A, skin will be stitched with prolene while in group B skin will be left open to follow up till 1 month and wound observed for infection according to CDC guidelines.

Official Title
-----------------
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound: Randomized Controlled Trial

Conditions
-----------------
Wound Infection

Intervention / Treatment
-----------------
* Procedure: primary skin closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . All patients who undergo ileostomy or colostomy reversal will be included Exclusion Criteria: included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc
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
Interventional Model Description: patients will be randomly distributed to two groups. Group A patients will have skin wounds stithed after stoma reversal while in secondary closure group B, wound will be allowed to heal by secondary intention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: primary skin closure<br>in this group, skin wound will be primarily closed | Procedure: primary skin closure<br>* skin will be stitched after stoma reversal to heal by primary intention<br>|
| No Intervention: secondary skin closure<br>skin will be left open to heal by secondary intention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection | skin wound infection at surgical site will be observed on CDC guidelines | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin closure, stoma reversal
Everolimus Modulation of Anti-tumor T CD4 Immune Responses

Study Overview
=================
Brief Summary
-----------------
Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with metastatic renal cell carcinoma. The objective of this study is to investigated the influence of everolimus immune modulation on antitumor efficacy .

Official Title
-----------------
Everolimus Modulation of Anti-tumor T CD4 Immune Responses

Conditions
-----------------
Metastatic Renal Cancer

Intervention / Treatment
-----------------
* Other: Biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Performance status ECOG-WHO 0, 1 or 2 Metastatic renal cancer Patient candidate to everolimus treatment signed written informed consent fertile women with adequate contraception during the study and until 8 weeks after stopping treatment Exclusion Criteria: Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed) History of immune deficiency Hypersensitivity against rapamycin and derived Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years Active autoimmune diseases, HIV, hepatitis C or B virus Patients with any medical or psychiatric condition or disease, Patients under guardianship, curatorship or under the protection of justice.

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: Biological samples<br>Blood samples will be realized specifically to the study at inclusion (baseline before starting everolimus treatment), and then 3 months and 9 months (or at disease progression if occurs first) after initiation of everolimus treatment Peripheral blood mononuclear cell (PBMC) and serum will be collected. Available tumor tissues samples will be collected. | Other: Biological samples<br>* blood and tumor tissue samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in regulatory T cell counts during treatment with everolimus |  | 9 months after everolimus initiation |
A Prospective Clinical Outcomes Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective non-interventional 24 month post implant registry. Any patient that receives a St. Jude Medical FDA approved implantable neuromodulation system is eligible for enrollment. A minimum of 600 patients will be enrolled from a minimum of 30 sites. Patients will be enrolled post-implant and followed for 24 months. Data are collected at enrollment (within 30 days of device implant), and routine care follow-up visits at 3 months, 6 months, 12 months, 18 months and 24 months.

Official Title
-----------------
Partnership for Advancement In Neuromodulation (PAIN): A Prospective Clinical Outcomes Registry

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

Intervention / Treatment
-----------------
* Device: St. Jude Medical Spinal Cord Stimulation Systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has signed and received a copy of the Informed Consent form; Patient has been implanted with a St. Jude Medical Neuromodulation system, including battery and/or SCS leads; Patient is 18 years of age or older. Patient is not currently participating in another clinical trial. 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 |
| --- | --- |
| Spinal Cord Stimulation<br> | Device: St. Jude Medical Spinal Cord Stimulation Systems<br>* Spinal cord stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes over time | The primary objective of the registry is to create a prospective, outcome registry of patients implanted with neuromodulation devices. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCS, St. Jude Medical, Neuromodulation
Plasma Rich in Growth Factors (PRGF) Treatment for Muscle Tear

Study Overview
=================
Brief Summary
-----------------
the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF

Official Title
-----------------
PRP as a Treatment for Acute Muscle Tears - Randomized-double-blind-placebo Control Trail.

Conditions
-----------------
Muscle Tear

Intervention / Treatment
-----------------
* Biological: PRGF
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: US diagnosed muscle tear age 15-40 years old Exclusion Criteria: pregnancy mental or physical disabilities

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PRGF | Biological: PRGF<br>* 3-6mg IM (to area of muscle tear)<br>|
| Placebo Comparator: 2<br>physiological saline | Biological: Placebo<br>* 3cc IM of physiological saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of symptoms / disease progress |  | 1 year |
Evaluation of Different Interfaces for Noninvasive Positive Pressure Ventilation (NPPV)

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aimed to study the ventilatory performance of different interfaces during NPPV delivering.

Detailed Description
-----------------
We will test the ventilatory performance in term of ventilatory pattern, muscle effort and gas exchange of different interfaces for NPPV.

Official Title
-----------------
Evaluation of Different Interfaces for NPPV

Conditions
-----------------
Respiratory Failure, Healthy

Intervention / Treatment
-----------------
* Device: Helmet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy subjects Exclusion Criteria: Barotrauma

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

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>healthy subjects | Device: Helmet<br>* Evaluation of different interfaces for NPPV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Transpulmonary Pressure and Airway Pressure Release Ventilation (APRV).

Study Overview
=================
Brief Summary
-----------------
Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure. The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians

Official Title
-----------------
Incidence of High Levels of Transpulmonary Pressure During the Use of Airway Pressure Release Ventilation.

Conditions
-----------------
Patient Mechanically Ventilated With APRV Mode

Intervention / Treatment
-----------------
* Other: evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patient mechanically ventilated for more than 48 H for acute respiratory failure Decision to use of the APRV mode by clinicians in charge of the patient Exclusion Criteria: - Contraindication for the use of a nasogastric tube

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 |
| --- | --- |
| Other: Patient mechanically ventilated with APRV mode<br> | Other: evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transpulmonary pressure | Measurement of transpulmonary pressure needs the measurement of oesophageal pressure with a specific nasogastric tube. This measurement is now available in routine in few mechanical ventilators in intensive care units (eg: AVEA Ventilator. Vyasys HealthCare). Transpulmonary pressure is the difference between airway pressure and oesophageal pressure and it is now easy to obtain and monitor at the bedside with these ventilators. It is also possible to record the value furthermore than 24 hours. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal value of transpulmonary pressure | Value of tidal volume > 8 ml/kg | 24 hours |
Whole-Body Vibration for Functional Constipation

Study Overview
=================
Brief Summary
-----------------
Aim: The aim of this trial was to determine whether whole-body vibration (WBV) induced via a non-invasive oscillation platform could improve symptoms and health-related quality of life (HRQOL) in patients with chronic functional constipation. Methods: A single-blinded, randomized, control trial was performed in a single Hospital in Taiwan. Patients diagnosed with chronic functional constipation, as per the Rome III diagnostic criteria were included and randomized to either the WBV treatment or no treatment (control) group. The treatment group received six 15-minute sessions of WBV therapy over a two-week period. Patients received vibrations of 2 mm in amplitude at a frequency of 12 Hz. The primary outcome was assessed by the constipation severity instrument (CSI). The secondary outcome was improvements in HRQOL.

Official Title
-----------------
Whole-Body Vibration for Functional Constipation: A Single-Center, Single-Blinded, Randomized, Controlled Trial

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Procedure: whole body vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: met the Rome III criteria of constipation Exclusion Criteria: pregnant cardiovascular disease cerebrovascular disease recently undergone major surgery hypothyroidism depressive disorder.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vibration<br> | Procedure: whole body vibration<br>* to deliver mechanical oscillation to individuals at various frequencies, amplitudes, and accelerations for different durations. This technique has been applied for years to enhance strength, and improve bone mineral density and balance<br>|
| Placebo Comparator: placebo<br> | Procedure: whole body vibration<br>* to deliver mechanical oscillation to individuals at various frequencies, amplitudes, and accelerations for different durations. This technique has been applied for years to enhance strength, and improve bone mineral density and balance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in constipation severity instrument (CSI) at 2 weeks |  | baseline (day 1), the completion of the trial (day 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in health-related quality of life (HRQOL) at 2 weeks |  | baseline (day 1), the completion of the trial (day 14) |
Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).

Official Title
-----------------
Bipolar Depression Assessment Study on Tx Response

Conditions
-----------------
Depression, Bipolar

Intervention / Treatment
-----------------
* Drug: Olanzapine
* Drug: Fluoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders [Text Revision] (DSM-IV-TR) disease diagnostic criteria. Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR. Subjects must have an initial score at Visit 1 of at least 20 on the MADRS. Exclusion Criteria: Any patient currently meeting DSM-IV-TR criteria rapid-cycling course. A CGI-Severity - Mania score of at least 3.

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olanzapine|nan|
|Drug: Fluoxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS is a rating scale for severity of depressive mood symptoms. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Bipolar Version (CGI-BP) Severity - Depression is used by the clinician to record the severity of depression illness at the time of assessment |  |  | 
| CGI-BP Severity - Mania is used by the clinician to record the severity of mania illness at the time of assessment |  |  | 
| Short Form-12 (SF-12) Questionnaire was developed from the SF-36 Health Survey for use in monitoring outcomes for general and specific populations. |  |  |