linjc16/ctgov huggingface dataset:
The Pathophysiology of Bortezomib Induced Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
Since the pathophysiology of BIPN still remains unclear, in the present study we are going to assess the development of BIPN in newly diagnosed myeloma patients, based on clinical neurological examination and electrophysiological study (EMG) and trying to find out if there is any relationship between oxidative stress generation measured by serum malonyldialdehyde - (MDA) and urinary isoprostane, and the development of BIPN, which can explain important part of the BIPN pathophysiology and can suggest new ideas of treatment and prophylactic strategies of peripheral neuropathy.

Detailed Description
-----------------
The proteasome inhibitor bortezomib has shown impressive clinical activity alone and in combination with other novel agents for the treatment of multiple myeloma (MM). Peripheral neuropathy is a significant dose limiting toxicity of bortezomib, which typically occurs within the first treatment cycles with bortezomib, reaching plateau around cycle 5, and does not appear to increase thereafter. Although bortezomib is known to be selective proteasome inhibitor, the mechanisms of cytotoxicity are poorly understood. It has been theoretically hypothesized that bortezomib abrogates the degradation of I-kB, which blocks the transcriptional activity of NF-kB, however, recent studies demonstrated that bortezomib elicits activation of multiple pathways in cancer cells, such as reactive oxygen species (ROS) pathway. The involvement of oxidative stress is supported by emerging studies showing that ROS generation plays a critical role in the initiation of the bortezomib induced apoptotic cascade. Oxidative stress is a complex and dynamic situation characterized by an imbalance between the productions of ROS and the availability and action of antioxidants.

Official Title
-----------------
Is There a Role of Oxidative Stress in the Pathophysiology of Bortezomib Induced Peripheral Neuropathy (BIPN) in Multiple Myeloma Patients?

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A total of 30 newly diagnosed patients (age > 18 years) with multiple myeloma (stage3 Durie and Salmon, ECOG-performance status <2), who are candidates for bortezomib therapy will be enrolled in the study (duration of the study 6 months). Exclusion Criteria: Patients with relapsed or progressive multiple myeloma. Performance status > 2. Prior treatment with neuropathic agents such as Oncovin and thalidomide.

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 |
| --- | --- | --- |
A Study to Investigate The Effectiveness Of Atezolizumab In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the effectiveness of Atezolizumab with a primary focus on the overall survival (OS) rate at 2 years and secondary focuses on quality of life (QoL) and the sequence of treatment in mUC patients. Furthermore, this study aims at collecting data on safety of Atezolizumab and on the reason for cisplatin-ineligibility

Official Title
-----------------
Non-Interventional Study To Investigate The Effectiveness Of Atezolizumab Under Real-World Conditions In Patients With Inoperable Locally-Advanced Or Metastatic Urothelial Carcinoma Of The Urinary Tract (Announce)

Conditions
-----------------
Urothelial Carcinoma

Intervention / Treatment
-----------------
* Drug: Atezolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic UC (Urothelial Carcinoma) including cancers of the renal pelvis, ureters, urinary bladder, and urethra Will be receiving atezolizumab for the treatment of inoperable locally-advanced or metastatic UC, per the decision of the treating physician Have adequate hematologic and end-organ functions Have had no prior palliative chemotherapy for inoperable locally-advanced or metastatic UC and are clinically ineligible (unfit) for cisplatin-based chemotherapy Exclusion Criteria: Have received prior immune checkpoint therapy Are pregnant or breastfeeding Are included in any other trial

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

| Intervention/Treatment |
| --- |
|Drug: Atezolizumab|Atezolizumab is administered via IV 1200 mg every 3 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Rate (OS rate) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival (OS) |  | Initiation of study treatment until death or end of study, approximately 4 years | 
| Median Progression Free Survival (PFS) |  | Initiation of study treatment to first measured disease progression, through end of study (approximately 4 years) | 
| Percentage of participants with adverse events |  | Up to approximately 4 years |
A Study of Adjuvant Melanoma Stakeholder Treatment Preferences

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the trade-offs that participants with surgically treated melanoma would be willing to make among key features and outcomes of adjuvant anti-cancer treatments or no adjuvant treatment / observation.

Official Title
-----------------
Adjuvant Melanoma Stakeholder Treatment Preference Study

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-reported medical diagnosis of stage II or stage III melanoma Have been resected (had surgery) for their melanoma within 12 months prior to study participation Exclusion Criteria: Self-reported stage IIa Self-reported recurrence of melanoma after surgery Other protocol-defined inclusion/exclusion criteria apply

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 1<br>Participants diagnosed with stage II and stage III melanoma who have undergone surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference weights or utilities (a measure of relative preference; on a continuous variable scale) for each treatment attribute level based on responses to the Discrete Choice Experiment (DCE) choice tasks |  | At Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Discrete choice experiment, Resected melanoma, Adjuvant treatment, Patient preference
Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Study Overview
=================
Brief Summary
-----------------
A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.

Official Title
-----------------
Prevalence of Asymptomatic Rupture in SILIMED Breast Implants

Conditions
-----------------
Breast Implant Rupture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Subject implanted with the original Silimed gel-filled implant. Exclusion Criteria: MR imaging is not possible because of the following: Metal implant Battery activated stimulator Pregnancy Tattoos Body weight >300 pounds History of metal fragments in the eye Any other contraindication to MR exam.
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Magnetic Resonance Image | 390 Magnetic Resonance Images. | 1 year |
Survey of Knowledge and Attitude of Pain in Anesthesia Residents of Thailand

Study Overview
=================
Brief Summary
-----------------
This study is a prospective descriptive cross-sectional survey using the modified Knowledge and Attitudes Survey Regarding Pain (KASRP) in English via an online google form.

Detailed Description
-----------------
Setting of the study/Trial site This study will be conducted via google form survey. Target population (Provide a complete description of your target population in the study) Anesthesia residents of all levels throughout Thailand. Study population (Provide details of your population in the study) Anesthesia residents of all levels throughout Thailand. Inclusion criteria Anesthesia residents of all levels throughout Thailand. Exclusion criteria Anesthesia residents who do not want to participate in this study. Withdrawal criteria (e.g. research participant withdrawal, adverse outcome during participating the study) Anesthesia residents can stop answering the questionnaire survey at any time. Termination criteria (e.g. terminating investigational product treatment/trial treatment) Not relevant

Official Title
-----------------
Survey of Knowledge and Attitude of Pain in Anesthesia Residents of Thailand

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anesthesia residents of all levels throughout Thailand. Exclusion Criteria: Anesthesia residents who do not want to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain knowledge | To measure knowledge of pain management by using the Knowledge and Attitudes Survey Regarding Pain (KASRP) questionnaire which consists of 39 questions (the higher number of correct answers, the better) | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain attitude | To measure attitudes of pain management by using the Knowledge and Attitudes Survey Regarding Pain (KASRP) questionnaire which consists of 39 questions (the higher number of correct answers, the better) | Through study completion, an average of 1 year |
Post Covid-19 Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP

Study Overview
=================
Brief Summary
-----------------
A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.

Detailed Description
-----------------
The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021. The study assessed at 4 and 8 months after hospital discharge in the patient's home environment, quality of life, residual disability, anxiety and insomnia. Enrollment took place only after the approval of the Ethics Committee of each participating center.

Official Title
-----------------
Impact of COVID-19 on Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP: an Observational, Prospective Multicenter Study.

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Behavioral: administration of questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study Exclusion Criteria: Exclusion criteria were set in; patients admitted for COVID-19 pneumonia treated with NIV/CPAP and invasive ventilation and patients with pre-existing cognitive disorders at the hospital admission date.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| inclusion criteria<br>All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study. | Behavioral: administration of questionnaires<br>* administration of questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 qualità di vita | polmonite COVID-19 qualità di vita | 8 mesi |
Low-dose Radiotherapy in iNHL

Study Overview
=================
Brief Summary
-----------------
The current study is a phase II multi-center single arm trial to evaluate the efficacy and safety of low-dose radiotherapy (3 Gy*4f) in indolent lymphoma.

Official Title
-----------------
Low-dose Radiotherapy in Indolent Lymphoma：A Multi-center Phase II Study

Conditions
-----------------
Indolent Lymphoma, Low-dose Radiotherapy

Intervention / Treatment
-----------------
* Radiation: Low-dose radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathology proved iNHL ECOG PS ≤3 Signed Informed consent Exclusion Criteria: History of radiotherapy at the same site Primary malignant lymphoma of the gastrointestinal tract CTV (Clinical Target Volume)>500ml Others that researchers consider inappropriate

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose Radiotherapy<br>Involved-site radiotherapy (3 Gy*4f) in one week | Radiation: Low-dose radiotherapy<br>* Electron Beam/3D-CRT/IMRT/VMAT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical complete response after radiotherapy | complete resolution of disease in imaging or biopsy after low-dose radiotherapy | 6-month after radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate after radiotherapy | complete or partial resolution of disease in imaging or biopsy after low-dose radiotherapy | 6-month after radiotherapy | 
| Progression-free survival rate at year 2 after enrollment, 2y-PFS | From enrollment to any disease progression or death | 2-year | 
| Local control rate at year 2 after enrollment, 2y-LCR | From enrollment to any local disease progression or death | 2-year | 
| Rate of acute toxicity (any and above grade 3) | toxicities according to CTCAE criteria | From enrollment to 3 months after treatment | 
| Rate of late toxicity (any and above grade 3) | toxicities according to CTCAE criteria | After 3 months of enrollment | 
| Quality of Life change, QoL | measurement basing on EORTC-QLQ-C30 tables | 1/3/6/12/24 months after radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
indolent lymphoma, low-dose radiotherapy
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.

Conditions
-----------------
Cataract, Inflammation

Intervention / Treatment
-----------------
* Drug: Indomethacin ophthalmic solution
* Drug: Ketorolac Ophthalmic Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia. Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively. Exclusion Criteria: Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents. Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study. Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration. Subjects with immunodepression. Subjects with a history of intolerance to the study drug or to any NSAI drug. Subjects who are monocular for any reason other than cataract. Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indomethacin<br>Indomethacin ophthalmic solution 0.1% for post-surgical inflammation | Drug: Indomethacin ophthalmic solution<br>* Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery<br>|
| Active Comparator: Ketorolac<br>Ketorolac ophthalmic solution 0.5% for post-surgical inflammation | Drug: Ketorolac Ophthalmic Solution<br>* Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous flare |  | Post-operative day 1 & day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous flare |  | Postoperative day 30 and day 90 | 
| Change from baseline of retinal thickness |  | Postoperative day 30 & day 90 |
A Controlled-Study on the Effect of a Combination of Fenofibrate and Metformin on Weight Loss and Weight Loss-Maintenance, in Obese Patients.

Study Overview
=================
Brief Summary
-----------------
To investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.

Official Title
-----------------
A Double-Blind, 3-Arm Study on Weight Loss With a Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Per Day Compared to Metformin 1,700 mg and to Placebo, at 6 Months, in Obese Patients, Followed by: A Double-Blind, 2-Arm Investigation of Weight-Loss Maintenance With the Same Combination of Micronised Fenofibrate 267 mg and Metformin 1,700 mg Compared to Placebo, at 6 Months, in the Responders.

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

Intervention / Treatment
-----------------
* Drug: Metformin and Metformin + Fenofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders, BMI ≥ 30 kg/m² and <40 kg/m². Exclusion Criteria: Known abnormal thyroid hormone levels, or high thyroid stimulating hormone (TSH) level.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 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: Metformin and Metformin + Fenofibrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist and hip circumference |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss and diet.