linjc16/ctgov huggingface dataset:
Monitoring Analgesia by ANI (Analgesia The Nociception Index)

Study Overview
=================
Brief Summary
-----------------
The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the NoStim period before surgical incision under general anesthesia and the period of hemodynamic reactivity ReactHemo peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).

Official Title
-----------------
Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel

Conditions
-----------------
Nociceptive Pain, Surgical Procedure, Unspecified

Intervention / Treatment
-----------------
* Device: ANI monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with IBD Scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion Exclusion Criteria: patient included in another current study or the previous month urgent surgery toxicomania or receiving opioids preoperatively pregnant woman psychosis betablocker treatment diabetic dysautonomia non-sinus heart rate pacemaker heart transplant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ANI monitor<br> | Device: ANI monitor<br>* experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ANI greater than 20 points | ANI decrease greater than 20 points between a NoStim period before surgical incision under general anesthesia and a period of intraoperative ReactHemo hemodynamic reactivity defined by a 20% increase in FC and / or PAS. | During the surgery, an average Three hours and a half |
Prostatic Cancer Versus Androgen Deficiency

Study Overview
=================
Brief Summary
-----------------
Open study to make a comparison between hypogonadism and euogonadism patients regarding the severity of prostate cancer. The purpose of this study is to determine the importance of the relationship between the hormonal status and the type of the tumor at the time of surgical intervention as well as follow up of the patients.

Official Title
-----------------
Localised Cancer of Prostate and Androgen Deficiency.

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

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients over than 18 years of age, with localized, stage I or II prostate cancer, not receiving local treatment (radiation, phototherapy, thermotherapy,…) or hormonal therapy, showing indication of radical prostatectomy. Exclusion Criteria: Absence of radical prostatectomy indication Patient received local or hormonal therapy prior to surgery Patients already enrolled in other clinical study incompatible with the study Patients on a treatment which can affect hormonal level (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Localised prostat cancer and androgen deficiency<br> | Other: Blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosteron Serum level |  | The day prior to surgery | 
| Gleason score |  | 5 years |
Measurement of Pulse Wave Velocity

Study Overview
=================
Brief Summary
-----------------
Optically-based data will be compared to tonometry to determine correlation of pulse wave velocity measurement.

Official Title
-----------------
Photoplethysmogram Measurement of Pulse Wave Velocity

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

Intervention / Treatment
-----------------
* Device: Pulse wave velocity measurement Photoplethysmogram
* Device: tonometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of18-25 and 65-90 will be studied. Normotensive and hypertensive subjects Willing to provide informed consent Exclusion Criteria: has finger deformities or amputations that will prohibit proper sensor placement pregnant or actively trying to get pregnant Cardiogreen or other intravascular/tissue dyes less than 5 hours prior to the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pulse wave velocity measurement Photoplethysmogram|Correlation of pulse wave velocity measurement.|
|Device: tonometer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optically based pulse wave velocity measurement correlation to the tonometry measure. |  | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Correlation, pulse wave velocity measurement, tonometry
Clinical Care of Autosomal Polycystic Kidney Disease: Retrospective Analysis and Prospective PKD Genotyping

Study Overview
=================
Brief Summary
-----------------
This is a retrospective analysis to include demographic, clinical, biochemical, and genetic data that will further explore the natural history of ADPKD and assess the factors that are likely to be associated with the progression of disease and the incidence of complications including progressive chronic kidney disease, cardiovascular disease, and cerebrovascular disease.

Detailed Description
-----------------
To explore questions regarding the natural history of PKD, as well as other, unforeseen issues, a comprehensive database of demographic, clinical, biochemical, and genetic data is required. This descriptive retrospective study can serve as a source of information regarding either the entire ADPKD population, or subsets of patients with specifically targeted characteristics. This will inform future prospective studies that will be designed to address issues regarding the natural history and complications of ADPKD. The goal of this project is to collect data from a large population of patients with PKD. Based upon the estimated prevalence of PKD (1:500 and 1:1000 live births), it is estimated that there may be 10,000 PKD patients in the New York City area. This sample size far exceeds any database established thus far. As many as 40% of affected PKD patients are reportedly unaware of a family history of this disease, in part because many patients may go undiagnosed until they present with a medical complication (e.g., hypertension, kidney failure). Furthermore, this initiative will provide an opportunity to compare data from racially diverse populations.

Official Title
-----------------
Chart Review/PKD Genotyping

Conditions
-----------------
ADPKD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects should have a confirmed ADPKD diagnosis. Exclusion Criteria: Unable to provide informed consent for PKD Genotyping.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of ADPKD | Retrospective review to determine clinical, genetic, and radiographic characteristics that may influence the incidence of renal and extrarenal complications of ADPKD and prospective PKD genotyping if not previously performed. | Up to 11 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADPKD, Chart Review, PKD Genotyping
Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years

Official Title
-----------------
A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol (Symbicort)
* Drug: budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6 and maximally 15 years of age Diagnosis of asthma and baseline lung function tests as determined by the protocol Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol Exclusion Criteria: Severe asthma Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>budesonide/formoterol | Drug: budesonide/formoterol (Symbicort)<br> <br> * Other names: Symbicort;|
| Active Comparator: 2<br>budesonide | Drug: budesonide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in evening PEF |  | Daily throughout the 12 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes |  | Daily throughout the 12 week treatment period | 
| Routine safety assessments described in the protocol |  | 2-4 assessments within 12 week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, children, adolescents, Symbicort, budesonide/ formoterol, budesonide
Citrate Pharmacokinetics and Regional Citrate Anticoagulation in CRRT

Study Overview
=================
Brief Summary
-----------------
To compare the differences of citrate pharmacokinetics in healthy individuals and critically ill patients as well as the influential factors. To validate a pharmacokinetic model which has been established in a formal paper. To create a safe and effective RCA-CRRT protocol.

Official Title
-----------------
Citrate Pharmacokinetics in Healthy Individuals and Critically Ill Patients and the Application of Regional Citrate Anticoagulation in Continuous Renal Replacement Therapy(RCA-CRRT).

Conditions
-----------------
MODS, Acute Kidney Failure With or Without:, Sepsis, Hepatic Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals, none-pregnant diagnosed with acute renal failure according to RIFLE criteria ARF with hepatic insufficiency ARF with MODS or sepsis within informed consent Exclusion Criteria: used drugs with citrate within one week infused with blood,plasma or platelet or undergone plasma exchange therapy within 48 hours serious alkalosis with PH>7.55 serious lactic acidosis not in resuscitation state

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

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

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
citrate anticoagulation, pharmacokinetic, critically ill, acute kidney failure
Investigation of Desmoplastic Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to verify wether it is possible to have a more sensitive diagnostic tool using pancytokeratin immunohistochemistry for desmoplastic squamous cell carcinoma compared to regular H&E staining. The investigators therefore plan to include 73 participants with a confirmed diagnosis of desmoplastic squamous cell carcinoma and do regular follow up.

Official Title
-----------------
Prospektive Therapie-Studie Zur Behandlung Des Desmoplastischen Plattenepithelkarzinoms

Conditions
-----------------
Squamous Cell Carcinoma of the Skin

Intervention / Treatment
-----------------
* Procedure: Immunohistochemistry using Pancytokeratin Staining


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: desmoplastic squamous cell carcinoma (SCC) of the skin Exclusion Criteria: tumor recurrence collision tumors other skin malignancies progeria Rothmund-Thomson-Syndrome lacking of the capacity for informed consent

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

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

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

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 |
| --- | --- |
| Other: Immunohistochemistry<br>Patients are investigated using immunohistochemistry with Pancytokeratin | Procedure: Immunohistochemistry using Pancytokeratin Staining<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival of patients with desmoplastic squamous cell carcinoma (SCC) diagnosed with immunohistochemistry . |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of local recurrence with immunohistochemistry |  | 4 years | 
| Histological pattern of tumour growth (continuous versus discontinuous) |  | 4 years | 
| Dimension of the tumor spreading according to histological work-up (measured in mm) |  | 4 years | 
| Presence of perineurial and perivascular tumor invasion according to histological work-up |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
squamous cell carcinoma, dermatosurgery, immunohistochemistry
Profile of HIV Seropositive Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to delineate the epidemiological profile of HIV seropositive patients on antiretroviral therapy at the Clinical Hospital of the Federal University of Goiás.

Detailed Description
-----------------
Objective: To delineate the epidemiological profile of HIV seropositive patients on antiretroviral therapy at the Clinical Hospital of the Federal University of Goiás. Methods: The present study is documental and analitical descriptive and it was conducted at the Clinical Hospital of the Federal University of Goiás, trough data collection of 222 records of individuals in drug therapy. Data were collected regarding the personal aspects, aspects related to the infection and information about the most used therapeutic.

Official Title
-----------------
Profile of HIV Seropositive Patients on Antiretroviral Therapy at the Clinical Hospital of the Federal University of Goiás

Conditions
-----------------
HIV Infection, HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of the patients that had data in the hospital All with the diagnose of HIV Using antiretroviral drugs Exclusion Criteria: Incompleted records Patients who didn't take their medicines regularly.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV seroposite patients<br>Seroposite HIV patients that take their treatment at the Clinical Hospital of The Federal University of Goias, and have their records in the hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data regarding the personal aspects, aspects related to the infection and information about the most used therapeutic. |  | Since the start of the drug therapy ( means of 36 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Profile, AIDS, Health Promotion, HIV, treatment experienced
Pre-Approval Access to Pimodivir for the Treatment of Patients With H7N9 Influenza A Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this program is to provide pre-approval access to pimodivir for the treatment of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision for therapeutic use of an investigational product prior to its marketing authorization. Such access may be considered for eligible patients with serious/life-threatening diseases or conditions, where alternative treatments do not exist or have been exhausted.

Official Title
-----------------
Pimodivir (JNJ-63623872) Pre Approval Access_Single Patient Access (SPR) for Patients Diagnosed With H7N9 Influenza A Infection

Conditions
-----------------
H7N9 Subtype of Influenza A Virus

Intervention / Treatment
-----------------
* Drug: Pimodivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has an H7N9 Influenza A infection The patient has no known severe hepatic impairment Exclusion Criteria: - Any other Influenza A sub-strains other than H7N9

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pimodivir|Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis. The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm. The aim is also to study the rate of complications, cosmetic results and quality of life.

Official Title
-----------------
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction

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

Intervention / Treatment
-----------------
* Procedure: Mastectomy
* Device: Da Vinci Robot Xi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 .Patients with an indication of mastectomy with areola conservation 2. In case of carcinologic surgery: Disease located more than 2cm of the areola on the clinical and paraclinical evaluation Patients with indication of total mastectomy Patients looking for immediate reconstruction 3. In case of prophylactic surgery Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....) 4. Cup A, B or C maximum 5. Aged between 18 and 70 years old 6. OMS 0, 1 7. Signed informed consent 8. Patients affiliated to a social security system Exclusion Criteria: Patients with a high risk of skin necrosis Planned post operative radiotherapy Patients with an historic of breast surgery on the side that needs to be operated Pregnant or breastfeeding women Persons deprived of liberty Persons not able to undergo medical follow up due to geographical, social or psychic reasons

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

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

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: Patients with breast cancer<br> | Procedure: Mastectomy<br> <br> Device: Da Vinci Robot Xi<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of necrosis |  | Assessed up to 1 year |