linjc16/ctgov huggingface dataset:
ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.

Official Title
-----------------
An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Neulasta
* Drug: Aranesp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer diagnosis node-positive or high risk node negative Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease. Exclusion Criteria: Metastatic breast cancer Clinically significant cardiac disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aranesp<br> | Drug: Aranesp<br>* If Hb drops below 110, 300mcg Aranesp will be administered.<br>|
| Experimental: Neulasta<br> | Drug: Neulasta<br>* 6mg Neulasta to be given approximately 24 hours afer each cycle of chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Febrile neutropenic events and adverse event profile will be assessed |  | 4 months | 
| To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities |  | 3 months | 
| Frequency of red blood cell (RBC) transfusions |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Doses dense chemotherapy, Growth factor support, Adjuvant Breast Cancer
Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.

Official Title
-----------------
An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Biological: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial Exclusion Criteria: Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| Observational immunotherapy follow-up<br> | Biological: Observational<br>* Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Long-term followup to week 48 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Long-term followup to week 48 | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, amyloid beta, vaccine
Effect of Lugol's Solution in the Patients With Graves' Disease

Study Overview
=================
Brief Summary
-----------------
Context: Although some of endocrine surgeons administer Lugol's solution to decrease thyroid gland vascularity, there is still no agreement on its effectiveness. Objective: The aims of this clinical trial are to evaluate thyroid blood flow and microvessel density in the patients with Graves' disease according to the Lugol's solution treatment preoperatively. Design: Retrospective clinical trial. Setting: A tertiary referral center. Method: Thirty-six patients were randomly assigned to preoperative medication with Lugol's solution. Patients in group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas patients in group 2 (n=19) didn't receive it. Main Outcome Measures: Blood flow through the thyroid arteries of patients with Graves' disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was assessed immunohistochemically and Western blot analysis using the level of expression of CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all patients.

Detailed Description
-----------------
Thirty-six patients were randomly assigned to preoperative medication with Lugol's solution. Patients in group 1 (n=17) received Lugol's solution for 10 days before surgical intervention, whereas patients in group 2 (n=19) didn't receive it. Blood flow through the thyroid arteries of patients with Graves' disease was measured by color flow Doppler ultrasonography. The microvessel density (MVD) was assessed immunohistochemically and Western blot analysis using the level of expression of CD-34 in thyroid tissue. The thyroid gland's weight and blood loss were measured in all patients.

Official Title
-----------------
Positive Effect of Lugol's Solution on the Blood Flow and Microvessel Density of Thyroid Gland in the Patients With Graves' Disease

Conditions
-----------------
Graves Disease

Intervention / Treatment
-----------------
* Drug: lugol's solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Graves disease Exclusion Criteria: Anticoagulant usage, Previous thyroid operation, Refused to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 61 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lugol's solution|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Graves' disease, Lugol's solution
Desmopressin in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring transfusions of blood products. Desmopressin (DDAVP), already used for patients with von Willebrand syndrome, could reduce bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in 20-30 minutes postoperatively.

Official Title
-----------------
Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery

Conditions
-----------------
Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage

Intervention / Treatment
-----------------
* Drug: Desmopressin (DDAVP)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing cardiac surgery excessive bleeding Exclusion Criteria: age<18 y not signing written consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desmopressin (DDAVP)<br> | Drug: Desmopressin (DDAVP)<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce transfusions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced bleeding |  |  | 
| Reduce time on mechanical ventilation |  |  | 
| Reduced ICU and Hospital stay |  |  | 
| Reduced mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Loss, Postoperative Blood loss
Clinical Trials to Assess the Efficacy and Safety of HLIM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of HLIM

Detailed Description
-----------------
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Official Title
-----------------
Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis

Conditions
-----------------
Acute Upper Respiratory Tract Infection, Acute Bronchitis

Intervention / Treatment
-----------------
* Drug: Test
* Drug: Active Comparator Control 1
* Drug: Active Comparator Control 2
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 2 and 75 Weight more than 11.5 kg Exclusion Criteria: Has a history of hypersensitivity to IP ingredients Hypertension or Diabetes Smoking more than 20 pack-years

Ages Eligible for Study
-----------------
Minimum Age: 2 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLIM<br>HLIM+SA160021 Placebo+SA160022 Placebo | Drug: Test<br>* three times a day for five days<br>* Other names: HLIM+SA160021 Placebo+SA160022 Placebo;|
| Active Comparator: SA160021<br>HLIM Placebo+SA160021+SA160022 Placebo | Drug: Active Comparator Control 1<br>* three times a day for five days<br>* Other names: HLIM Placebo+SA160021+SA160022 Placebo;|
| Active Comparator: SA160022<br>HLIM Placebo+SA160021 Placebo+SA160022 | Drug: Active Comparator Control 2<br>* three times a day for five days<br>* Other names: HLIM Placebo+SA160021 Placebo+SA160022;|
| Placebo Comparator: Placebo<br>HLIM Placebo+SA160021 Placebo+SA160022 Placebo | Drug: Placebo<br>* three times a day for five days<br>* Other names: HLIM Placebo+SA160021 Placebo+SA160022 Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo | 0(absent)   4(very severe), Total Score: 0 20 | 5 days | 
| Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group | 0(absent)   4(very severe), Total Score: 0 20 | 5 days |
Nonfunctional Pancreatic NET and PET Imaging

Study Overview
=================
Brief Summary
-----------------
Predicting aggressive behavior in the group of nonfunctional pancreatic neuroendocrine tumors (NF P-NET) remains a difficult problem in clinical practice. At present, the treatment planning in P-NET is significantly restricted by the limited results of conventional imaging. In addition, increasing use of multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) is increasing the number of NF P-NETs detected. Somatostatin receptor scintigraphy (SRS) combined with anatomical imaging are the conventional modalities in imaging of P-NET, but by these methods the diagnostic accuracy still remains compromised. Furthermore, recently encouraging results have been obtained in P-NET using 68Ga-labelled somatostatin analog, DOTA-1-NaI3-octreotide (68Ga-DOTANOC) positron emission tomography-computed tomography (PET-CT). The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using dual trace functional imaging 18F-labelled fluorodeoxyglucose (18F-FDG) and 68Ga-DOTANOC PET-CT imaging in patients with NF P-NET. The study consists of 20 patients with NF P-NET. The patients enrolled in the study will be imaged 68Ga-DOTANOC and 18F-FDG PET-CT followed by surgery or follow-up with endoscopic ultrasonography (EUS) biopsies. The data will be collected between autumn 2015 and spring 2018.

Official Title
-----------------
Dual Tracer Functional Imaging of Nonfunctional Pancreatic Neuroendocrine Tumors Using 68Ga-DOTA-NOC and 18F-FDG PET/CT

Conditions
-----------------
Diagnosis

Intervention / Treatment
-----------------
* Device: PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspicion of nonfunctional P-NET on primary CT (i.e hypervascularity) or MRI signed informed consent Exclusion Criteria: vulnerable study subjects such as described in Finnish law concerning clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative diagnosis<br>Preoperative diagnosis | Device: PET/CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The SUV of 68Ga-DOTANOC and 18F-FDG PET-CT predict the malignant potential of P-NETs |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroendocrine tumor, pancreas, diagnosis, positron emission tomography
Pre-study to Evaluate IENFD Induction in Patients With Taxane-induced CIPN

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects.

Detailed Description
-----------------
This is a non-interventional study examining IENFD levels in patients with CIPN after taxane chemotherapy and in age-matched healthy subjects. After the subjects sign the informed consent, the study physicians will judge the inclusion and exclusion criteria. Subjects meeting the inclusion requirements will register at the study center according to the requirements of the study physicians, and skin samples will be collected by specialized researchers.

Official Title
-----------------
A Clinical Study Examining Intraepidermal Nerve Fiber Density (IENFD) in Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN) Compared With Healthy Subjects

Conditions
-----------------
Peripheral Nervous System Diseases

Intervention / Treatment
-----------------
* Other: Non interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received taxane adjuvant chemotherapy for breast cancer for curative purposes and completed chemotherapy before entering the study; Persistent peripheral neuropathy of the lower extremities; CIPN Severity: The presence of at least one of the following symptoms on both lower extremities in a gloved and sock glove pattern: pain or burning, numbness, or tingling. Examination of the lower extremities showed needling loss of both legs; Neurological symptoms occur after exposure to taxane and cannot be attributed to any other neurological disease; NRS rating ≥ 4. Exclusion Criteria: Pregnant or lactating women. Presence of any neuropathy other than CIPN. According to the investigator's judgment, there are skin diseases in the affected skin area that may interfere with the evaluation of neuropathic pain symptoms, or diseases at the skin biopsy site that may affect the epidermal nerve morphology, or other factors. The presence of non-CIPN pain may interfere with study evaluation and/or peripheral neuropathic pain self-assessment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CIPN patient<br>Patient with CIPN symptom | Other: Non interventional<br>* Non interventional<br>|
| Healthy subject<br>Healthy subject | Other: Non interventional<br>* Non interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IENFD | IENFD change between CIPN patients and healthy subjects | 2021.10 2022.6 |
Peer-coaching to Teach Faculty Surgeons an Advanced Laparoscopic Skill

Study Overview
=================
Brief Summary
-----------------
This single-blinded randomized controlled trial assesses the efficacy of peer-coaching to teach novice surgical faculty an advanced laparoscopic skill.

Conditions
-----------------
Coaching, Technical Skill, Laparoscopy

Intervention / Treatment
-----------------
* Behavioral: conventional training
* Behavioral: peer-coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical faculty in the division of general surgery or obstetrics and gynaecology. novices in laparoscopic suturing (performed <20 intra-corporeal stiches and knots) Exclusion Criteria: n/a
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional training<br>Participants received access to a web-based tutorial for laparoscopic suturing and a box trainer for independent practice | Behavioral: conventional training<br>* After completing the initial assessment, faculty randomized to the conventional training group received a link to a web-based instructional video. In addition, they were given a laparoscopic box trainer, laparoscopic instruments and sutures that they could use to practice with at their leisure.<br>|
| Experimental: Intervention<br>Participants received access to a web-based tutorial for laparoscopic suturing and a box trainer for independent practice. In addition, they received two 1/2 hour peer-coaching sessions | Behavioral: peer-coaching<br>* Faculty randomized to the peer-coaching group received ½ hour of peer-coaching after completing the initial assessment on the simulator. Each faculty member sutured on the box trainer while being observed by his or her peer-coach. All study participants had the same peer-coach.After the coaching session, study participants received a link to the web-based video as well as the box trainer and supplies to independently practice laparoscopic suturing. Similar to individuals in the control group, no specific guidance regarding the amount of independent practice was given.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Skill | Technical skill as measured by the Objective Structured Assessment of Technical Skill (OSATS) global rating scale. Participants are scored on 4 domains from 0-5 (respect for tissue, precision of operative technique, economy of movements, confidence of movements). The maximum possible score is 20. | Two weeks post intervention |