linjc16/ctgov huggingface dataset:
ADPKD Patient Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the ADPKD Registry is to create an online patient network that includes at least 5,000 people with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who contribute data on their health and other topics. The ADPKD Patient Registry aims to support important scientific discoveries and support patient needs in the following ways: Connect ADPKD patients with opportunities to join clinical studies. Collect data for the research community to better describe the ADPKD disease experience and improve patient care. Engage with patients by measuring quality of life outcomes.

Detailed Description
-----------------
The ADPKD Registry will be a patient-powered network of people with ADPKD. This data will inform new research to improve ADPKD patient outcomes, learn more about the patient journey and discover unmet medical needs. We collect data most relevant to your ADPKD diagnosis, its major symptoms and management, as well as key demographic data (no personally identifiable information is shared). A Registry keeps information in one place making it easier for researchers to utilize Registry information while still protecting the privacy of those who take part. The Registry will be hosted on a secure, online platform that patients can access using their home computers, tablets or phones. The purpose of the ADPKD Registry is to allow PKD patients to: Connect with researchers and express interest in taking part in certain clinical studies for ADPKD, including studies of new medications and other treatments. Take confidential health-related surveys. These surveys are aimed at better understanding of the health of people with PKD across their lifespans.

Official Title
-----------------
Autosomal Dominant Polycystic Kidney Disease Patient Registry

Conditions
-----------------
Polycystic Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis or suspected diagnosis with autosomal dominant polycystic kidney disease (ADPKD) Exclusion Criteria: caretakers, family members or friends of individuals with ADPKD
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADPKD patients<br>Patients with a diagnosis, or suspected diagnosis, of ADPKD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of people with polycystic kidney disease who experience health-related quality-of-life changes | To be assessed with online modules, developed both internally and through validated partners | 1 year |
A Comparative Clinical Research on Single Roux-en-Y and Traditional Roux-en-Y of Pancreaticojejunostomy-choledochojejunostomy For Treatment of Obstruction of Pancreatic Duct and Bile Duct

Study Overview
=================
Brief Summary
-----------------
This study is being done to learn more about how different surgery procedures bring back the quality of life.After removing the small intestine at least 20cm in patients with pancreatic cancer, Some patients develop problems because they are disorder their digestive system, such as cramping, heartburn,vomiting.

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient 30 years of age or older Pathologically confirmed pancreatic cancer (biopsy may be performed at our institution) No evidence of metastases(a) decide performe Roux-en-Y(b) single Roux-en-Y reconstruction is technically feasible(c) Patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. If metastatic disease is identified at the time of operation, the patient will not be randomized. Patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a sngle Roux-en-Y at the time of operation. If a sngle Roux-en-Y is not performed, the patient will not be randomized. the surgeon feels that the single Roux-en-Y is not technically feasible at the time of operation,the patients will be excluded. This may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion. Exclusion Criteria: Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- |
| Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy<br> | |
| Pancreaticoduodenectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secretion function of the pancreas |  | Participants will be followed for overall 3 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The function of biliary tract |  | Participants will be followed for overall 3 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy
Continuous Hemoglobin Evaluation

Study Overview
=================
Brief Summary
-----------------
Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring.

Official Title
-----------------
Evaluation of the Masimo Continuous Hemoglobin Monitor With Polar Plot Methodology

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective surgery. Exclusion Criteria: 0

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 |
| --- | --- |
| Hemoglobin Measurement<br>Patients requiring intra-operative hemoglobin measurement. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Masimo Continuous Hemoglobin Monitor with Polar Plot Methodology | Determine the influence of initial calibration and intraoperative oxygenation variables on the correlation between SpHgb and clinical values | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemoglobin, Patient Monitoring
PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

Study Overview
=================
Brief Summary
-----------------
PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer. This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC). All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.

Official Title
-----------------
A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Biological: PROSTVAC®-VF/TRICOM™


Participation Criteria
=================
Eligibility Criteria
-----------------
Male patients > 18 years of age who have been vaccinated against smallpox; Histological confirmation of adenocarcinoma of the prostate with evidence of metastatic disease including either of the following: Lymph node metastasis measurable by CT and/or Bone metastasis evaluable by bone scan; Despite hormone therapy, there is evidence of two consecutive increases in PSA (Prostate Specific Antigen); Gleason Score of 7 or lower at initial diagnosis. Please note that there are additional eligibility criteria that you must meet to qualify. If you do qualify to participate, study personnel will explain the trial in detail and answer any questions you may have. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: PROSTVAC®-VF/TRICOM™|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial

Study Overview
=================
Brief Summary
-----------------
Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion. Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).

Conditions
-----------------
Pain Score

Intervention / Treatment
-----------------
* Drug: Paracervical block
* Drug: Lidocaine spray
* Drug: Paracervical block + lidocaine spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Single Pregnancy <7 weeks of gestation Exclusion Criteria: Incomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: Placebo group<br> | |
| Active Comparator: Paracervical block plus lidocaine spray<br>Lidocaine injection+Lidocaine spray received PCB with 2 ampoules of lidocaine solution plus 2 pumps (20 mg=2 pumps) of 10% lidocaine spray | Drug: Paracervical block + lidocaine spray<br> <br> |
| Active Comparator: paracervical block plus isotonic saline spray<br>2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray | Drug: Paracervical block<br> <br> |
| Active Comparator: only lidocaine spray<br>paracervical block with saline solution plus 10% lidocaine spray | Drug: Lidocaine spray<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abortion, analgesia, paracervical block, lidocaine spray
1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study

Study Overview
=================
Brief Summary
-----------------
This is observational study to assess the prognosis of patients hospitalized with COVID-19 confirmed by RT-PCR and exposed to trimethylxanthine (TMX). Trimethylxanthine is the active molecule present in coffee. Due to the lack of etiologic treatments and considering interest about old treatments as an avenue for research, we conducted a comparative study aiming to evaluate the effect of 1,3,7-trimethylxanthine on COVID-19 infected patients. This is actually a study about methodology. The objective of this study is therefore not to demonstrate the effect of the substance on the disease but the importance of a rigorous methodology in scientific research. This project is called Method and Teaching of Scientific Studies.

Official Title
-----------------
1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study

Conditions
-----------------
Coronavirus Disease 2019

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18, No Trimethylxanthine contraindications (defined as allergy, previous reported secondary effects), Infectious Disease Unit admission. Exclusion Criteria: Secondary effects about Trimethylxanthine, Refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coffee:1,3,7-trimethylxanthine<br> | Other: Data collection<br>* Only data collection<br>|
| Tea and hot chocolate with milk<br> | Other: Data collection<br>* Only data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of vital status | the patient clinical status at day 6 after hospital admission, defined as alive, or dead. | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparaison of duration of hospital stay |  | 6 days | 
| Comparaison of severity | Evaluated by National Early Warning Score from 0 to 20, 20 being the worst score, with a high risk of death. | 6 days | 
| Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee). | with | 6 days | 
| Comparaison of use of antibiotics |  | 14 days after hospital admission. |
High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.

Official Title
-----------------
A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed stage IIIB/IV NSCLC Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment Patients whose tumors: are EGFR mutation-positive or T790M mutation-negative Performance status: WHO 0-2 Measurable disease according to RECIST 1.1 at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm ANC ≥ 1.5*109/L, Platelets ≥ 75*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures Patient must be able to comply with the protocol Exclusion Criteria: Patient with symptomatic central nervous system metastases Patient has known active hepatitis B or C, or HIV infection Pregnant or breastfeeding. Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icotinib<br>250mg, tid until disease progression or unacceptable toxicities occurred | Drug: Icotinib<br>* Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free survival |  | 2 years |
A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.

Official Title
-----------------
A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Parallel Group Exploratory Study to Investigate the Efficacy, Safety and Tolerability of AD 337 in the Treatment of Fibromyalgia in Female Subjects.

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: AD 337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18-65 Meet ACR 1990 criteria for classification of Fibromyalgia Able and willing to discontinue CNS active therapies Exclusion Criteria: If pain is NOT primarily due to Fibromyalgia Current or prior history of serious psychiatric disorder Pregnant/breastfeeding QTc > 470ms Failure to respond to 2 or more adequate regimes of different classes of antidepressants.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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: AD 337|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| These will be |  |  | 
| FIQ Total score at weeks 1, 2, 3, at end of study and overall |  |  | 
| FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall |  |  | 
| Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall |  |  | 
| Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall |  |  | 
| Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall |  |  | 
| Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACR 1990 Fibromyalgia, Fibromyalgia Impact Questionnaire
A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry enrolment. These participants will be prospectively followed for at least 5 years after study enrolment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.

Conditions
-----------------
Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrolment, although they can have received anti-cancer treatment during that time Exclusion Criteria: There are no exclusion criteria for entry into 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with unresectable LA/mBC<br> | Other: No intervention<br>* No intervention was administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen |  | Up to approximately 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to approximately 8 years | 
| Objective Response Rate (ORR) For Each Anti-Cancer Treatment Regimen |  | Up to approximately 8 years | 
| Number and Percentage of Participants Receiving Each Unique Treatment Regimen Overall and as First-Line Therapy Versus Second-Line Therapy Versus Subsequent-Line Therapy |  | Up to approximately 8 years |