linjc16/ctgov huggingface dataset:
Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.

Detailed Description
-----------------
CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). These subspecies of probiotics bacteria have been shown to be effective in improving the immunity. Several trials are currently underway, in order to evaluate the effects of probiotics as potential novel therapies in addition to traditional therapeutic approaches. Although probiotics do not play an anti-tumor action per se, these agents may significantly contribute to decrease the typical side effects due to traditional anti-tumor treatments, such as gastrointestinal symptoms, immunity deficit, as well as the alterations in the gut lymphoid tissue. It is therefore expected that CITOGENEX may have several significant beneficial effects in patients under anti-tumor treatments. In order to test this hypothesis, we will perform a randomized, single-blind, two-arms, prospective study in patients with colon-rectal cancer.

Official Title
-----------------
Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Conditions
-----------------
Colonic Neoplasms

Intervention / Treatment
-----------------
* Dietary Supplement: citogenex
* Other: conventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage IIIa-IIIc (AJCC/TNM)

Ages Eligible for Study
-----------------
Minimum Age: 40 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: citogenex<br>citogenex + conventional therapy | Dietary Supplement: citogenex<br>* CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type).<br>Other: conventional therapy<br>* conventional therapy for colon-rectal cancer<br>|
| Active Comparator: conventional therapy<br>conventional therapy | Other: conventional therapy<br>* conventional therapy for colon-rectal cancer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 2 years |
Effect of Head Position During Thyroidectomy on Postoperative Cognitive Functions

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to observe the effect of head-neck position of patients scheduled for thyroidectomy, on carotid artery blood flow, regional cerebral oxygen saturation measured using near-infrared spectroscopy technology, and postoperative cognitive dysfunction.

Official Title
-----------------
The Effect of Head Position During Thyroidectomy on Cerebral Oxygenation and Postoperative Cognitive Functions

Conditions
-----------------
Thyroid, Carotid Doppler, Cerebral Perfusion

Intervention / Treatment
-----------------
* Procedure: Carotis Doppler Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergo a total thyroidectomy operation ASA I-II euthyroid patients in the preoperative period Exclusion Criteria: Hemoglobin< 8 g / dl Hypertension Hyperlipidemia Pregnancy Patients diagnosed with diabetes mellitus Cerebrovascular insufficiency Known carotid artery lesion Metabolic diseases Any intracranial pathology present Surgeries exceeding 180 minutes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Carotis Doppler Ultrasound|Neck was rotated about 30-45 ° to the opposite side of the image. The common carotid artery and internal jugular vein were viewed transversely on the B Mode USG image. Then, the probe was rotated approximately 90 ° and the carotid artery was visualized in the longitudinal plane. The probe and guide line were adjusted so that the Doppler angle was 60 °. The image was created with the guiding line parallel to the blood flow. After imaging of the carotid artery bifurcation, measurements were made 1 cm distal to this level.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cognitive functions | determine cognitive dysfunction using mini mental state examination | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cerebral Perfusion | Changes in main carotid artery blood flow and cerebral oxygenation by using carotid doppler | during surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head position, Cerebral Oxygenation, Postoperative Cognitive Dysfunction
Lumax 740 Master Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.

Official Title
-----------------
PME/Master Study of the Lumax 740 ICD Family

Conditions
-----------------
Safety and Efficacy of the Lumax 740 ICD Family

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD. Legal capacity and ability to consent Signed patient informed consent In addition for HF-T devices: Bipolar LV-lead with a min. distance of 15 mm between tip and ring True bipolar RV lead Exclusion Criteria: Standard contraindication for single, dual, or triple chamber ICD. Age < 18 years Pregnant or breast-feeding woman Cardiac surgery planned within the next 6 months Life expectancy of less than 6 months Participating in any other clinical study of an investigational cardiac drug or device

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the automatic Capture Control feature |  | PHD, 1-, 3- and 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD therapy, RV/LV Capture Control, Safety and Efficacy
Long Term Follow-Up Study for rAAV-GAD Treated Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is the long term follow-up of Parkinson's patients who participated in a clinical trial in which they received AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and provide long term safety information.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Biological: rAAV-GAD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in a clinical trial where they received AAV-GAD Able to give informed consent to participate in the study Exclusion Criteria: Received Deep Brain Stimulation after receiving AAV-GAD Received any experimental device in the brain after receiving AAV-GAD Had any type of brain surgery after receiving AAV-GAD Received any experimental therapy (drug or biologic) for Parkinson's disease or any other indication after receiving AAV-GAD

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 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 |
| --- | --- |
| rAAV-GAD Treated Subjects<br>rAAV-GAD treated subjects who are being observed for long-term effects of the gene therapy product which they received from participating in a previous clinical study. | Biological: rAAV-GAD<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

Study Overview
=================
Brief Summary
-----------------
To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.

Official Title
-----------------
A Double-Blind, Randomized Controlled Trial of Voriconazole (VFEND®) Plus Micafungin (MYCAMINE™) Versus Voriconazole Plus Placebo in the Treatment of Patients With Proven or Probable Invasive Aspergillosis

Conditions
-----------------
Aspergillosis/Blood, Aspergillosis/Invasive

Intervention / Treatment
-----------------
* Drug: micafungin
* Drug: voriconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proven, probable or possible invasive aspergillosis Patient is 2 years of age or older Exclusion Criteria: The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for >7 days immediately prior to randomization for treatment of the Possible, Probable, or Proven invasive aspergillosis for which the patient is being enrolled. The patient has been treated with voriconazole for > 7 days immediately prior to randomization

Ages Eligible for Study
-----------------
Minimum Age: 2 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: micafungin|nan|
|Drug: voriconazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Success (GS) at Wk 12, Favorable response (FR) & survival at Wks 6 & 12. GS and FR by infection site, overall frequency of emergent & recurrent fungal infections at Wks 6 & 12, duration of FR, and relationship of galactomannan to clinical outcome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspergillosis/blood, micafungin, voriconazole, Aspergillus
Personality Profile of Patients With Apical Ballooning Syndrome

Study Overview
=================
Brief Summary
-----------------
The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status.

Official Title
-----------------
Personality Profile of Patients With Apical Ballooning Syndrome (ABS)

Conditions
-----------------
Apical Ballooning Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who have suffered with ABS Adults (18 years or older) Able to read English at a 6th grade level (questionnaires are self-administered and written in English) Exclusion criteria: Have withdrawn from the registry Have died

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of personality traits as assessed by the NEO-PI-3 | The NEO PI-3 measures the five major domains of personality, which are: Neuroticism Extraversion Openness Agreeableness Conscientiousness | Baseline: the traits will be assessed once upon enrollment into the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Apical Ballooning syndrome, Personality
Proton and Carbon Ion Radiotherapy for Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for cervical cancer.

Detailed Description
-----------------
To retrospectively analyze cervical cancer patients received radical proton and carbon radiotherapy in our center. The acute and late toxicities, overall survival (OS), local control rate (LC), progression-free survival (PFS) and distant metastasis-free survival (DMFS) were analyzed.

Official Title
-----------------
Proton and Carbon Ion Radiotherapy for Cervical Cancer : A Retrospective Analysis

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

Intervention / Treatment
-----------------
* Radiation: proton and carbon ion radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . histologically diagnosis of squamous cell carcinoma of the cervix; . International Federation of Gynecology and Obstetrics (FIGO) stage (2014) IB2 - IIIB, without rectum invasion; or FIGO stage IA - IB1, who refused surgery or were contraindication for surgery due to comorbidity diseases; . received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention; . Follow-up data available. Exclusion Criteria: a previous history of other malignancy; squamous cell carcinoma of the cervix patients who had received surgery; rectum was invaded.

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

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

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

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: proton and carbon ion radiotherapy<br>proton and carbon ion radiotherapy | Radiation: proton and carbon ion radiotherapy<br>* proton and carbon ion radiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate | overall survival rate | 3 years | 
| local control rate | local control rate | 3 years | 
| progression-free survival | progression-free survival | 3 years | 
| distant metastasis-free survival | distant metastasis-free survival | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proton and carbon ion radiotherapy
The Effects of Trunk Impairment on Fatigue and Balance

Study Overview
=================
Brief Summary
-----------------
Fatigue is a common symptom associated with cerebral palsy (CP); it has been estimated that up to 40% of adolescents with CP experience fatigue that impacts their quality of life and daily activities. Although fatigue was stated as the primary symptom, a limited number of studies were found on secondary motor and nonmotor symptoms related to trunk control in children when the literature was examined.

Official Title
-----------------
The Effects of Trunk Impairment on Fatigue and Balance in Children With CP

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Diagnostic Test: Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 2-18 years old; (2) had a form of CP; (3) had the cognitive competence to participate to the all assessments. Exclusion Criteria: The sufferers who had an additional neurological or musculoskeletal disability, unstable medical conditions, any recent medical intervention (such as tendon lengthening surgery or botulinum toxin injection…) were excluded

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Diagnostic Test: Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)<br>* control/study group<br>|
| Active Comparator: Study<br> | Diagnostic Test: Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)<br>* control/study group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk Impairment Scale (TIS) |  | 1 month | 
| PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS) |  | 1 month | 
| Pediatric Balance Scale (PBS) |  | 1 month |
Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

Detailed Description
-----------------
The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.

Official Title
-----------------
A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma

Conditions
-----------------
Hodgkin Disease

Intervention / Treatment
-----------------
* Drug: Bortezomib
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hodgkin's lymphoma Second or higher relapse (first relapse if high-dose chemotherapy not possible) Age >/= 18 years No major organ dysfunction or intercurrent disorder Written informed consent Exclusion Criteria: Pregnant or nursing

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bortezomib|nan|
|Drug: Dexamethasone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (complete and partial responses) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Event free survival |  |  | 
| Overall survival |  |  | 
| Duration of response |  |  | 
| Treatment administration (dose-intensity, total dose) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin disease, Bortezomib, Relapse, Lymphoma
Small Changes a One Year Protocol for Weight Management

Study Overview
=================
Brief Summary
-----------------
A trial comparing Treatment as usual with Motivational Interviewing focussed treatment in the 'Small Changes' programme.

Detailed Description
-----------------
A quasi-experimental design. With one arm focussed on 'treatment as usual' and the other on Motivational Interviewing. Subjects were not randomly assigned but treated as two separate cohorts one Running October 2011-October 2012 using the Treatment as usual and a separate cohort running from October 2012 to October -2013 using motivational interviewing as the approach for treatment.

Official Title
-----------------
Study Protocol: Small Changes, a One-year Weight Management Intervention for Adults Who Are Overweight or Obese

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Group motivational interviewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass index equal to or greater than 30 kgm2

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as Usual<br>A Treatment as Usual (TAU) group received a psycho-educational programme for weight management over one year | Behavioral: Group motivational interviewing<br>* Monthly group meetings were held for two hour sessions each month and verifiable (treatment fidelity checked) motivational interviewing employed in helping clients make health behaviour changes.<br>|
| Experimental: Group Motivational Intervieiwng<br>A Motivational interviewing group received one year of programme using motivational interviewing as the approach for treatment. | Behavioral: Group motivational interviewing<br>* Monthly group meetings were held for two hour sessions each month and verifiable (treatment fidelity checked) motivational interviewing employed in helping clients make health behaviour changes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | Bodyweight in Kilograms | 1 year |