linjc16/ctgov huggingface dataset:
Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

Study Overview
=================
Brief Summary
-----------------
Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for example to perform speech tests during brain tumor resection. With respect to anaesthesia, it is therefore required that the patient is asleep during the beginning and the end of the procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in the literature. The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.

Official Title
-----------------
Investigation on the Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

Conditions
-----------------
Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for awake craniotomy Exclusion Criteria: pregnancy

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 |
| --- | --- | --- |
| prediction error for propofol plasma concentrations | On the day of surgery, plasma samples will be drawn during induction, maintenance and recovery from anesthesia. Subsequently the actually measured propofol plasma concentration will be compared with the predicted propofol plasma concentration (according to Marsh et al. and Schnider et al.), and the prediction error will be calculated. | day of surgery (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, awake craniotomy, patients requiring an awake craniotomy for brain tumor/lesion resection
Cornell Translational Behavioral Science Research Consortium: Angioplasty Qualitative Study

Study Overview
=================
Brief Summary
-----------------
To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.

Detailed Description
-----------------
To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors. To use the responses obtained in the qualitative interviews to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in each of the populations under study. Specifically, this involves assessing what small gifts participants prefer to receive and what would be most effective in inducing positive affect.

Official Title
-----------------
Cornell Translational Behavioral Science Research Consortium: Angioplasty Qualitative Study

Conditions
-----------------
Angioplasty Patients

Intervention / Treatment
-----------------
* Behavioral: Semi-structured, open-ended interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-angioplasty patients who had previously participated in an RCT designed to motivate multi-behavior change. Exclusion Criteria: Patients who refuse to be interviewed, Patients who were not enrolled in the parent trial

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Semi-structured, open-ended interviews|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
-----------------
Angioplasty, Behavior change, Physical activity, Risk reduction
Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

Study Overview
=================
Brief Summary
-----------------
The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult French population presenting with pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.

Conditions
-----------------
Pulmonary Emphysema

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary emphysema highlighted by computed tomography Ratio Forced Expiratory Volume in 1 second (FEV1) / Vital Capacity (VC) < 70% measured by lung function test Exclusion Criteria: Hepatic transplant Patient under legal protection Patient not benefiting from the French Health Insurance

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: Pulmonary emphysema<br>Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies) | Other: Blood sampling<br>* Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with alpha-1 antitrypsin dysfunction | Alpha-1 antitrypsin protein will be measured either on serum or plasma by standardized immunoassay. The elastase-inhibitory capacity of plasma will be evaluated by a functional test. The anti-elastase dysfunction of alpha-1 antitrypsin will be evaluated using both measurements. | Samples for evaluation of alpha-1 antitrypsin dysfunction will be performed the day of the patient enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of alpha-1 antitrypsin protein phenotype | The determination of the alpha-1 antitrypsin protein phenotype may highlight genotype variants. The different known phenotypes are: Pi MM, Pi Z; Pi S, Pi SS, Pi SZ, Pi ZZ. | Samples for phenotype analysis will be performed the day of the patient enrollment | 
| Molecular genotyping of gene coding alpha-1 antitrypsin | For those patients who presented with either a functional or a quantitative dysfunction, we will look for genetic mutations in the gene coding the alpha-1 antitrypsin allowing the identification of specific genotype such as MM, MZ, MS, SS and SZ | Samples for molecular genotyping will be performed the day of the patient enrollment |
Acupuncture for Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.

Official Title
-----------------
The Influence of Acupuncture on Ovulation and Reproductive Hormones

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Procedure: Acupuncture
* Procedure: Sham Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18-43 confirmation of PCOS through the study signed informed consent able to receive study treatment at Virginia study sites agree not to use hormonal medications for the 5 months of the study Exclusion Criteria: pregnant use of hormonal drugs 30/60 days before the study entry acupuncture for ovulatory disorders 30 days prior to study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 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 |
| --- | --- |
| Experimental: 1<br>Active acupuncture treatment | Procedure: Acupuncture<br>* 12 treatments over 8 weeks<br>|
| Sham Comparator: 2<br>Sham acupuncture treatment | Procedure: Sham Acupuncture<br>* 12 treatments over 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation in 2 out of 5 months of study participation |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in follicle stimulating hormone and luteinizing hormone |  | baseline vs. 2 months vs. 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, ovulation, hormones, women
Surgery Versus Biologics for Stricturing CD--a RCT

Study Overview
=================
Brief Summary
-----------------
The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.

Official Title
-----------------
Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Group A
* Procedure: Group B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with intestinal obstructive symptoms; confirmed intestinal strictures; traditional drugs failed to induce remission; envidence of active bowel inflammation; inappropriate for EBD; acquirement of written informed consent of participant; Exclusion Criteria: unsuccessful medical treatment of intestinal obstruction; complete obstruction; contraindication for biologics; penetrating disease; short smaal bowel; suspicion of bowel tumor; no confirmed strictures; comitant severe disese of other system; obstructive symptoms under over 2 targets of biologics; successful treatment with traditional drugs; participate other clinical research.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biologic group<br>treat paticipants with up to 2 biologics | Drug: Group A<br>* treat participants with biologics<br>|
| Other: Surgery group<br>treat paticipants with surgery | Procedure: Group B<br>* treat participants with surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remmision rate within 1 year | Crohn's disease activity index < 150 | within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory bowel disease score | 32-224；the higher the better | within 1 and 5 year | 
| Crohn's disease obstructive score | 0-6； the higher the worse | within 1 and 5 year | 
| endoscopic recurrence | Rutgeert score >i2b (i0-i4); the higher the worse | within 1 and 5 year | 
| medical cost | cost for hospitalization | within 1 and 5 year | 
| sugical recurrence | disease recurrence that needs surgical resection | within 1 and 5 year | 
| clinical remmision rate within 5 year | CDAI>150 | within 5 year |
Acute Dyspnea After Use of Non-invasive Ventilation in COPD and Emphysema (Deventilation Syndrome)

Study Overview
=================
Brief Summary
-----------------
Acute dyspnea after use of non-invasive ventilation (NIV) is a common phenomenon in patients with COPD and emphysema. This trial aims to document incidence and severity of augmented dyspnea in patients with long term NIV therapy. These findings may help in understanding the pathomechanisms that lead to post-NIV dyspnea and thus give way to potential therapy schemes.

Detailed Description
-----------------
Non-invasive ventilation (NIV) is a widespread therapy option for patients with hypercapnic failure due to COPD and emphysema. Augmented dyspnea after use of NIV is commonly found and leads not only to high patient discomfort, but can also be associated with acute respiratory failure. This monocentric obervation trial includes patients with COPD III°-IV° (GOLD) and emphysema and an established long term NIV therapy. During their routine inpatient follow-up, we will extend the routine examinations, focussing on the vulnerable first hour after the nocturnal use of NIV. This includes monitoring of breath rate, heart rate, pulsoxymetry, trancutaneous CO2, blood pressure and capillary blood gas analysis. Sonographic measurement of diaphragm movement and thickness will be complemented. Subjective dyspnea will be documented by use of the BORG scale. By collecting this data, we hope to understand the pathomechanisms causing augmented dyspnea after NIV and thus provide information for therapeutical concepts to prevent it.

Official Title
-----------------
Acquisition and Evaluation of Augemented Dyspnea After Use of Non-invasive Ventilation in Patients With COPD and Empysema (Deventilation Syndrome)

Conditions
-----------------
Obstructive Chronic Bronchitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females with stabile COPD, last exacerbation over one month, GOLD III to IV Regular use of noninvasive ventilation, more than four hours per day for more than one year Signed declaration of consent Sufficient language capabilities, german Exclusion Criteria: Acute exacerbation in the past four weeks Acute pulmonary embolus Haemoptysis Severe neurological disease Severe cardiological disease Haemodynamic instability New hypoxia or worsening of hypercapnia more than twenty percent of usual rate Acute pneumothorax Other instable Situation, for example intraabdominal bleedings Drug or alcohol dependency Regular intake of morphium Adiposity BMI over 35

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of acute dyspnea after use of non-invasive Ventilation in COPD and emphysema |  | May 2018 |
Inter-Observer Reliability and Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected PE in the ED

Study Overview
=================
Brief Summary
-----------------
The purpose of this study will be to evaluate the measurement of tricuspid annular plane systolic excursion (TAPSE) by emergency physician performed echocardiogram on patients with suspected pulmonary embolism (PE) who are scheduled to get a computed tomography of the pulmonary arteries (CTPA)

Detailed Description
-----------------
This will be a prospective observational cohort study aimed at determining the utility and reproducibility of TAPSE, in patients who present to the emergency department with suspected pulmonary embolism (PE). The gold standard diagnostic test for PE is computed tomography of the pulmonary arteries (CTPA). Any patient for whom a CTPA is ordered because of suspected PE is eligible for study inclusion

Official Title
-----------------
The Inter-observer Reliability and Diagnostic Accuracy of Tricuspid Annular Plane Systolic Excursion in Patients With Suspected Pulmonary Embolus in the Emergency Department

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: Echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Concern for PE by attending physician and CTPA ordered Exclusion Criteria: If patient is under the age of 18, a prisoner, or a ward of the state CTPA ordered but not performed

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 |
| --- | --- |
| Suspected Pulmonary Embolus<br>Patients with suspected pulmonary embolus who are getting a CTPA | Other: Echocardiogram<br>* Tricuspid annular plane systolic excursion will by measured by emergency physician performed echocardiogram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of TAPSE (The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis) | The association of TAPSE measurements with a diagnosis of PE will be explored using multivariate analysis | 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-Observer Agreement (To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed.) | To assess the interobserver reproducibility of measuring TAPSE, intra-class correlation coefficients and Bland-Altman analysis will be performed. | 0 days |
IORT-Boost-Study, Prospective Observational Study for Intraoperative Radiotherapy of the Breast as a Boost

Study Overview
=================
Brief Summary
-----------------
In this study the investigators observe the investigation, whether the new method for Boost-Irradiation with the Intrabeam Device of Zeiss Germany influences local recurrence, acute and late effects of Radiotherapy, overall survival, quality of life and cosmesis.

Official Title
-----------------
Prospective Observational Study for Intraoperative Radiotherapy (IORT) of the Breast as a Boost

Conditions
-----------------
Adverse Effect of Radiation Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with histologically proven unifocal ductal-invasive or other histology of breast-cancer, size of tumor < or = 3.5 cm written informed consent ability to cooperate full legal capability Exclusion Criteria: missing written informed consent lack of compliance
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breast cancer<br>observation of intraoperative radiotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of Participants with local recurrence histologically proven | Recurrence of breast cancer proven by histology | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observation of acute and late effects of Radiotherapy | acute effects of Radiotherapy are assessed by Common Toxicity Criteria for Adverse Effects (CTCAE Version 4.0) and late effects of Radiotherapy are assessed by Late Effects Normal Tissue Subjective Objective Management Analysis (LENT-SOMA) | up to 10 years | 
| Overall survival | The number of Patients who died is assessed. | up to 10 years | 
| Quality of life | Quality of life is assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) cancer modul (C30) EORTC-QLQ-C30 version 3.0 and breast cancer modul (BR23) EORTC-QLQ-BR23 | up to 10 years | 
| Cosmesis | Cosmesis is assessed by Photographs and evaluated automatically. | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Observational Study, intraoperative Radiation of Breast Cancer, early and late effects of radiation, cosmesis and quality of life