linjc16/ctgov huggingface dataset:
Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU. This is a monocentric interventional study (RIPH 2).

Official Title
-----------------
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU

Conditions
-----------------
Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Other: Doppler Echo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > or =18 years Hospitalization in intensive care PCR COVID 19+ or compatible clinical signs (fever, cough, myalgia, asthenia, loss of taste, anosmia) associated with compatible radiological signs Exclusion Criteria: Pregnancy in progress Patient <18 years Patients deprived of freedoms or under guardianship Patient or family opponent of protocol participation patient on curative anticoagulant for more than 48H00 impossible Venous Doppler Echo

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Doppler Echo<br>patients will have a Doppler Echo when they enter ICU (within 48 hours) and a second Doppler Echo 7 days later | Other: Doppler Echo<br>* 2 doppler echo will be done at patients hospitalized in ICU and with SARS-CoV-2 pneumopathy at 7 days apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU | Deep vein thrombosis at Doppler echo | Day 0 | 
| Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU | Deep vein thrombosis at Doppler echo | Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
doppler echo, Deep Vein Thrombosis, SARS-CoV-2, ICU
Once Daily vs Twice Daily Administration of Gonadotropins in Assisted Reproductive Technologies (ART)

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized study evaluating dosing frequency of gonadotropin administration in ART cycles.

Detailed Description
-----------------
Using once daily or bid dosing of gonadotropins in ART has been arbitrary with no studies showing whether splitting the medication dose improves ART parameters. This study was undertaken to provide an answer to this important question.

Official Title
-----------------
A Prospective Randomized Study of QD vs BID Dosing in ART

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women < 40 undergoing ART Exclusion Criteria: women > 40 endometriomas severe cervical stenosis testicular sperm

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| QD<br>Women who received their meds as QD administration | |
| BID<br>Women who received their gonadotropins as a BID dose | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak estradiol, number of follicles, number of oocytes, implantation rate, multiple pregnancy rate |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QD dose, BID dosing, peak estradiol, oocytes, implantation rate, pregnancy rate
Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Collection of thermal images of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device (RI3.0) capabilities , which will assist in early detection of breast cancer.

Official Title
-----------------
Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy. Exclusion Criteria: Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, prior to being imaged by RI3.0. Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study. Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study. Subjects who have undergone a mastectomy. Subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident). Subjects with prior breast reduction surgery or breast augmentation surgery. Subjects who have a fever on the day of their biopsy. Subjects who are pregnant. Subjects who are breast-feeding.

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

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 |
| --- | --- | --- |
A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment

Study Overview
=================
Brief Summary
-----------------
A post marketing surveillance, prospective study to collect safety information from 250 subjects with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type metastatic colorectal cancer treated with Erbitux as final evaluable cases.

Official Title
-----------------
A Post-Marketing Surveillance Study On Erbitux® (Cetuximab) In Patients With Metastatic Colorectal Cancer Refractory To Irinotecan Containing Treatment

Conditions
-----------------
Metastatic Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: EGFR expressing, KRAS wild-type subjects with metastatic colorectal cancer, who are indicated for Erbitux treatment according to the nationally authorized label (in combination with irinotecan, metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy) Exclusion Criteria: Subjects who are not eligible for Erbitux treatment according to the indication in national label; or with hypersensitivity reactions (grade 3 or 4) to Erbitux
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 |
| --- | --- | --- |
| Safety and toxicity of Erbitux in clinical practice | To obtain safety information on the use of Erbitux in subjects with metastatic colorectal cancer. | Till 28 days after last dose of Erbitux | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic colorectal cancer, mCRC, post marketing surveillance, Erbitux, Cetuximab, KRAS
Pharmacokinetic of Sevoflurane During a 48h Sedation in Intensive Care Unit With AnaConDa®

Study Overview
=================
Brief Summary
-----------------
This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.

Detailed Description
-----------------
Prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Official Title
-----------------
Pharmacokinetic of Sevoflurane During a 48h Sedation in ICU With AnaConDa®

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Other: sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line Exclusion Criteria: Acute kidney injury Obesity Sevoflurane anaphylaxia

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: Screening


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sevoflurane<br> | Other: sevoflurane<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of sévoflurane at different times of a 48h sedation of sévoflurane. |  | during 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of plasmatic concentrations of HFIP and fluoride at different times of a 48h sedation of sévoflurane. Determination of a pharmacokinetic model of sévoflurane. |  | during 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Sevoflurane, Fluorides, Sedation, Adult patients with a predicted sedation more than 48 h, Stable respiratory and hemodynamic conditions for SBT, Consent of patients, Arterial line
Per-procedural Concentration of Direct Oral Anticoagulants

Study Overview
=================
Brief Summary
-----------------
Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients. Objectives: To investigate the factors associated with per-procedural [DOAC]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural [DOAC], defined as [DOAC] < 30 ng/mL. Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. [DOAC], will be measured during invasive procedure.

Conditions
-----------------
Per-procedural Concentrations of Oral Anticoagulants

Intervention / Treatment
-----------------
* Other: DOAC concentration measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient over 18 years-old undergoing invasive procedure treated with DOAC Exclusion Criteria: none

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: DOAC concentration measurement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOAC concentration |  | beginning of invasive procedure |
Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Detailed Description
-----------------
Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Official Title
-----------------
Effects of Positive End-Expiratory Pressure Ventilation on Optic Nerve Sheath Diameter in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy

Conditions
-----------------
Other Surgical Procedures

Intervention / Treatment
-----------------
* Other: PEEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy Exclusion Criteria: Patients who have cerebrovascular disease or history of cerebrovascular disease Patients who are younger than 20 years

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEP group<br>Mechanical ventilation with PEEP 8 cmH2O | Other: PEEP<br>* Mechanical ventilation with PEEP 8 cmH2O<br>|
| No Intervention: No PEEP group<br>Mechanical ventilation with no PEEP | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic nerve sheath diameter |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak airway pressure |  | intraoperative | 
| Arterial blood pressure |  | intraoperative | 
| Heart rate |  | intraoperative | 
| Arterial carbon dioxide tension |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positive end-expiratory pressure ventilation, Optic nerve sheath diameter
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.

Official Title
-----------------
A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety of KRN321 in Adult Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndrome

Conditions
-----------------
MDS

Intervention / Treatment
-----------------
* Drug: KRN321


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IPSS low- or intermediate-1-risk MDS diagnosed at enrollment Serum EPO concentration ≤ 500 mIU/mL Hemoglobin concentration ≤ 9.0 g/dL at the screening examinations Exclusion Criteria: Previous bone marrow or hematopoietic stem cell transplantation History of pure red cell aplasia Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension Those who have increased risk of thrombosis during the study Uncontrolled diabetes mellitus Concurrent active infection or chronic inflammatory disease Other causes of anemia Previous or concurrent active malignancies other than MDS

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: KRN321|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects achieving a erythroid response |  |  | 
| Adverse Events as a Measure of Safety |  |  |
Stroke Education Intervention Trial - Pilot

Study Overview
=================
Brief Summary
-----------------
The objectives of the trial of a medication-coach program for patients with stroke or transient ischemic attack are to pilot test the study design, the intervention components and the data collection forms and refine them for a larger trial whose goal will be to improve long-term adherence to stroke prevention medications.

Official Title
-----------------
AVAIL interVention Trial (Adherence Evaluation After Ischemic Stroke - Longitudinal): Pilot Protocol

Conditions
-----------------
Ischemic Stroke, Intracranial Hemorrhage, Transient Ischemic Attack

Intervention / Treatment
-----------------
* Behavioral: stroke education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at Wake Forest University Baptist Medical Center (WFUBMC) over age 18 Diagnosed with acute ischemic stroke, transient ischemic attack or intracranial hemorrhage provide consent to participate Exclusion Criteria: discharged to nursing home, acute rehabilitation center, inpatient hospice, or other acute hospital homeless non-English speakers patient and proxy unable to participate in telephone conversation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stroke education<br>Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen. | Behavioral: stroke education<br>* call by medication coach 2 weeks after hospital discharge<br>|
| No Intervention: control arm<br>Subjects in this arm received instruction at hospital discharge and a 3-month follow-up call to collect study data. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention (Ability to Reach Patients at 3 Months) | Number of patients contacted at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow up Appointment With MD | Follow up appointment with primary care provider since stroke | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, patient education, medication adherence
Incubation of Alcohol Craving During Abstinence

Study Overview
=================
Brief Summary
-----------------
In order to determine whether the 'incubation of craving' phenomenon also occurred in alcoholics, investigators employed an experimental approach to investigate the time course of cue-induced craving in alcoholism. Eighty male participants were randomly divided into Four groups, and they were assessed at 7, 14, 30, and 60 days of abstinence for cue-induced alcohol craving . Another group including 19 patients was repeatedly tested for the cue-induced alcohol craving at the above abstinence days. Other psychological and physiological measures were administered at the four abstinence time points.

Detailed Description
-----------------
All subjects provided written informed consent after a full explanation of the protocol design.

Official Title
-----------------
The Neural Mechanisms of the Incubation of Cue-induced Craving in Alcohol Dependence

Conditions
-----------------
Alcohol Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: met the criteria of DSM-IV for alcohol dependence aged 18-60 years,male Exclusion Criteria: current or past history of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) axis I disorders with other serious physical diseases (respiratory disorders, cardiovascular disease and so on) other drug abuse except for nicotine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| changes of alcohol craving measured with visual analogue scales |  | abstained from alcohol for 7 days, 14 days, 30 days and 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate changes |  | 7, 14, 30 and 60 days after abstained | 
| blood pressure changes in different abstinence days |  | 7, 14, 30 and 60 days after abstained | 
| skin conductance changes in different abstinence days |  | 7, 14, 30 and 60 days after abstained | 
| changes of Alcohol Urge Questionnaire |  | 7, 14, 30 and 60 days after abstained | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incubation, Craving, alcohol dependence