linjc16/ctgov huggingface dataset:
Pre Transplantation Melanoma

Study Overview
=================
Brief Summary
-----------------
Melanoma incidence is increase in global population and number of transplantation also. However immunosuppressor increase recurrence risk of melanoma. There are more and more cases of eligible patients to transplant with an antecedent of melanoma. There is no guideline yet. Main objective is survival time without melanoma recurrence in this population to do guideline of time limit or not between melanoma and transplantation by stage.

Official Title
-----------------
Pre Transplantation Melanoma : Retrospective and Prospective Multicenter Observational Study

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Other: patient with melanoma pre transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with an antecedent of melanoma before transplantation Not opposite to participate Exclusion Criteria: Under the age of 18 patient under Guardianship patient not affiliated with a health system

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 |
| --- |
|Other: patient with melanoma pre transplantation|survival time without melanoma recurrence|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival time without melanoma recurrence | Delay in recurrence-free survival since diagnosis and since transplantation | at enrollment |
Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)

Study Overview
=================
Brief Summary
-----------------
A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control, in Healthy Male and Female Volunteers.

Official Title
-----------------
A Crossover Study to Assess the Effects of FYU-981 on the QT/QTc Interval in Healthy Male and Female Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: FYU-981
* Drug: Placebo
* Drug: Moxifloxacin
* Drug: Moxifloxacin Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese adult subjects Body mass index: >=18.5 and <27.5 Exclusion Criteria: Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FYU-981 anticipated therapeutic dose<br>Drug: FYU-981, FYU-981 Placebo, Moxifloxacin Placebo (Oral) | Drug: FYU-981<br> <br> Drug: Placebo<br> <br> Drug: Moxifloxacin Placebo<br> <br> |
| Experimental: FYU-981 supratherapeutic dose<br>Drug: FYU-981, Moxifloxacin Placebo (Oral) | Drug: FYU-981<br> <br> Drug: Moxifloxacin Placebo<br> <br> |
| Placebo Comparator: Placebo<br>Drug: FYU-981 Placebo, Moxifloxacin Placebo (Oral) | Drug: Placebo<br> <br> Drug: Moxifloxacin Placebo<br> <br> |
| Active Comparator: Moxifloxacin<br>Drug: Moxifloxacin, FYU-981 Placebo (Oral) | Drug: Placebo<br> <br> Drug: Moxifloxacin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT/QTc Interval |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male and Female Volunteers
OASIS Wound Matrix (Oasis) Mechanism of Action

Study Overview
=================
Brief Summary
-----------------
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.

Detailed Description
-----------------
Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).

Official Title
-----------------
Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS

Conditions
-----------------
Diabetic Foot Ulcers (DFU), Venous Stasis Ulcers (VSU)

Intervention / Treatment
-----------------
* Device: OASIS Wound Matrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health Exclusion Criteria: Contraindications or hypersensitivity to the use of the study medications or their components

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OASIS Wound Matrix (Oasis)<br>This is a single arm study with only the test article Oasis used on all subjects | Device: OASIS Wound Matrix<br>* OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. | Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment. Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first) | Baseline and weekly up to 12 weeks | 
| Percent Wounds Closed | Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU). | baseline and 12 weeks |
Anastomotic Techniques in Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected. Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior

Official Title
-----------------
A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer

Conditions
-----------------
Pancreatic Cancer, Pancreatic Fistula

Intervention / Treatment
-----------------
* Procedure: type of anastomosis after pancreaticoduodenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head resectable tumour Exclusion Criteria: chronic pancreatitis/benign tumours- tumours extending into the body of the pancreas tumours with metastasis beyond regional lymph nodes requirement for sub total pancreatectomy prolonged hypotension - < 80 mm of hg for more than 30 min

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy | Procedure: type of anastomosis after pancreaticoduodenectomy<br>* pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy<br>|
| Active Comparator: 2<br>Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy | Procedure: type of anastomosis after pancreaticoduodenectomy<br>* pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pancreatic fistula rate |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 90 days | 
| Hospital stay |  | 90 days | 
| need for postoperative intervention |  | 90 days | 
| major complication |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreatic anastomosis, Whipple operation
A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.

Official Title
-----------------
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of Multiple Doses of SAGE-718 Using Ketamine Challenge to Evaluate the Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: SAGE-718
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator. Exclusion Criteria: Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAGE-718<br> | Drug: SAGE-718<br>* SAGE-718 in combination with Ketamine<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo in combination with Ketamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo |  | From Day 1 through Day 11 | 
| Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo |  | From Day 1 through Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. |  | Between Baseline and Day 26 |
Online Learning of Veterinary Anatomy During COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
This study aims to analyze the online learning of veterinary anatomy during COVID-19 pandemic lockdown.

Detailed Description
-----------------
Analysis of the online learning of veterinary anatomy during COVID-19 pandemic lockdown.

Official Title
-----------------
Evaluation of the Online Learning of Veterinary Anatomy During COVID-19 Pandemic

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterinary Medical students who are studying anatomy online during the pandemic lockdown Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 35 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 |
| --- | --- |
| Veterinary Medical students<br>Veterinary Medical students who are studying anatomy during COVID-19 pandemic lockdown | Other: survey<br>* online survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the students' interest in studying anatomy on-line. | An online questionnaire (Statement: I'm interested in studying anatomy on-line. Response: Strongly agree/ agree/ neutral/ disagree/ strongly disagree | 05/06/2020-05/07/2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the easiness of using technology during studying anatomy online | An online questionnaire (Statement: I'm comfortable with technological skills during online studying of anatomy. (Using Computers, surfing the internet, downloading files, etc.....) Response: Strongly agree/ agree/ neutral/ disagree/ strongly disagree) | 05/06/2020-05/07/2020 | 
| Assess the student satisfaction regarding the provided study materials | 1- An online questionnaire (Statement: The anatomy study materials provided to me by the lecturers were enough. Response: Strongly agree/ agree/ neutral/ disagree/ strongly disagree) | 05/06/2020-05/07/2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Anatomy, online learning
Study to Evaluate Multiple Doses in Patients With Nasal Polyposis

Study Overview
=================
Brief Summary
-----------------
This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

Detailed Description
-----------------
AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis

Official Title
-----------------
A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis

Conditions
-----------------
Nasal Polyposis

Intervention / Treatment
-----------------
* Drug: AK001 low dose
* Drug: AK001 high dose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale History of sinusitis symptoms SNOT-22 ≥30 No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings Exclusion Criteria: Use of systemic corticosteroids within 6 weeks of screening Chronic use of antibiotic therapy within 3 months prior to Screening Nasal surgery (including polypectomy) within 6 months prior to Screening Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: 25 mg AK001<br>25 mg AK001 will be administered as multiple doses | Drug: AK001 low dose<br>* 25 mg AK001 will be administered as multiple doses<br>|
| Experimental: 250 mg AK001<br>250 mg AK001 will be administered as multiple doses | Drug: AK001 high dose<br>* 250 mg AK001 will be administered as multiple doses<br>|
| Placebo Comparator: Placebo<br>A placebo comparator consisting of inactive excipients will be administered as multiple doses | Drug: Placebo<br>* Placebo will be administered as multiple doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Polys Score (TPS) | NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Change in TPS from Baseline (prior to the first dose) to Week 12 (Day 84) was the primary outcome of the study. TPS ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps, a higher scores mean a worse outcome. | From Baseline (prior to the first dose) to Week 12 (Day 84) |
Organization in Acute Atrial Fibrillation Post Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem. It afflicts about 2 million Americans and is the single largest heart related cause of stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF are poorly understood. Acute AF is also the most common irregular heart rate after open-heart surgery in patients. This is seen in as many as 30% of such patients and often results in a longer hospital stay. In this study we would like to study the pattern of atrial fibrosis (scar tissue in the heart) and an associated blood marker (a protein called pro-collagen-1) in those patients concurrently having open heart surgery.

Official Title
-----------------
Organization in Acute Atrial Fibrillation Post Open Heart Surgery

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age, Male or Female Able to provide consent Cardiac surgery, CABG of Valve replacement or repair. Exclusion Criteria: If AF terminates within 1 hour of initiation. If the patient undergoes electrical cardioversion and/or receives digitalis within the first hour of inclusion. If the patients and/or their family or the primary caregiver choose to be excluded from the study anytime, even after the initial 24-hour period. If the patient expires within 1 hour of inclusion into the study. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation post open heart surgery
Social Media Use of Psoriasis Vulgaris Patients: Multicenter, Survey Work

Study Overview
=================
Brief Summary
-----------------
Psoriasis Vulgaris is a chronic, recurrent, inflammatory and hyperproliferative skin disease. Joint involvement is common along with skin involvement. However, metabolic diseases, such as cardiovascular diseases can be accompanied by many systemic diseases, chronic and repetitive due to the quality of life and psychological status of patients can affect. For this reason, patients carry out various research on their diseases on social media and follow programs on these issues in other media such as television and radio. However, there is no study on how much patients are interested in these publications, how much they trust them, and how they reach and organize information via social media. The aim of the study will be to clarify how and how patients with Psoriasis Vulgaris use social media to obtain information about the diagnosis and treatment of their disease, the interaction of patient groups with each other, and how often social media is used, especially in which group of patients.

Official Title
-----------------
Social Media Use of Psoriasis Vulgaris Patients: Multicenter, Survey Work

Conditions
-----------------
Psoriasis Vulgaris

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psoriasis vulgaris patients Exclusion Criteria: patients that don't want to answer questions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Social media use of psoriasis vulgaris patients, a questionnaire will be asked the patients and try to learn how they use social media for getting information about their disease. |  | July 2020 |