linjc16/ctgov huggingface dataset:
Effects of Ketamine On Precipitated Opioid Withdrawal Under General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether low-dose ketamine infusion is effective in suppressing the symptoms of opiate withdrawal during rapid opiate antagonist induction (RAI).

Conditions
-----------------
Opiate Dependence

Intervention / Treatment
-----------------
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed opiate dependence according to ICD 10 and/or DSM 4; Duration of substance abuse more than 1 year No or minor co-morbidities; Grade I-II according to physical status classification system of American Society of Anesthesiologists. Exclusion Criteria: Current history of long acting opiate or poly-substance abuse; Acute medical or surgical condition; Pregnancy; Breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Perceptions of Aesthetic Outcomes of Zigzag and Linear Scars

Study Overview
=================
Brief Summary
-----------------
Surgical wounds can be closed in several manners. Some physicians believe that closure in a straight line produces a scar that is more visible and slightly raised when compared to closure in a zigzagging fashion. The researchers of this study believe that there is no difference in the cosmetic appearance of one type of wound closure over the other. To evaluate this, they will provide a survey with visual aids to volunteers to rate the appearance of a straight line scar versus a zigzag scar.

Official Title
-----------------
Perceptions of Aesthetic Outcomes of Zigzag and Linear Scars

Conditions
-----------------
Zigzag Scar, Linear Scar

Intervention / Treatment
-----------------
* Behavioral: Visual Analog Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years or older Exclusion Criteria: Less than 18 years of age

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survey Group<br>Adult male or female volunteers. | Behavioral: Visual Analog Scale<br>* Subjects will review examples of both linear and zigzag scars and rate the aesthetic appearance of both configurations of scars on a scale of 1 through 10, with 1 being normal skin and 10 being the worst scar imaginable.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects will review examples of both linear and zigzag scars and rate the aesthetic appearance of both configurations of scars on a scale of 1 through 10, with 1 being normal skin and 10 being the worst scar imaginable. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cicatrix, Demonstrate, that there, is no perception of superiority
A Validation Study of a New System for Measuring the End Expiratory Lung Volume During Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim to evaluate a new system dedicated to estimate the end expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to the helium dilution technique and the computed tomography (CT) scan.

Detailed Description
-----------------
In this study we aimed to evaluate a new system dedicated to estimate the end expiratory lung volume, by measuring the VO2-VCO2, during mechanical ventilation compared to the Helium dilution technique and the CT scan. We will compare the data considering the CT scan data as the gold standard.

Official Title
-----------------
A Validation Study of a New System for Measuring the End Expiratory Lung Volume During Mechanical Ventilation Acute in Intubated Patients

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Procedure: Helium dilution technique, lung CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult intubated subjects Exclusion Criteria: Barotrauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| 1<br>ALI/ARDS patients | Procedure: Helium dilution technique, lung CT scan<br>* Helium dilution technique and lung CT scan<br>|

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
-----------------
Acute respiratory failure
Atrial Fibrillation in Beta-Thalassemia

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.

Detailed Description
-----------------
Observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the Cardiology Unit of the University Hospital of Ferrara. Patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation. The objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.

Official Title
-----------------
Atrial Fibrillation in Beta-Thalassemia

Conditions
-----------------
Atrial Fibrillation, Thalassemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transfusion-dependent Beta-thalassemia; Follow-Up at the Cardiology Unit of the University Hospital of Ferrara; Electrocardiogram performed; Echocardiogram performed. Exclusion Criteria: Age <18 years; State Of pregnancy; Inability to give informed consent.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Beta-thalassemia<br>Patients with Beta-thalassemia undergoing a cardiological evaluation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | New onset of Atrial Fibrillation documented at ECG | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolism | Stroke or peripheral embolization | 10 years | 
| Epicardial adipose tissue | Thickness of fat depot in epicardial region | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Thalassemia, Thalassaemia, Arrhythmia, Hemoglobinopathies
Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions

Study Overview
=================
Brief Summary
-----------------
To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.

Official Title
-----------------
Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions

Conditions
-----------------
Gastrointestinal Neoplasms, Benign Neoplasm of Intestinal Tract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age >18 years that have been referred for endoscopic treatment of GI lesions. Exclusion Criteria: Patients for whom endoscopic treatment was 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 |
| --- | --- |
| Mucosal tumors of the colon<br>Patients who received endoscopic treatment for noninvasive mucosal tumors of the colon. | |
| Nonampullary tumors of the duodenum<br>Patients who received endoscopic treatment for noninvasive mucosal tumors of the duodenum. | |
| Ampullary tumors<br>Patients who received endoscopic treatment for noninvasive ampullary tumors. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success. | Technical success is defined as complete resection confirmed by the endoscopic absence of adenomatous tissue after inspection with high-definition white light and narrow-band imaging. | 1 day to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term recurrence rate | Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site | Less than 1 year | 
| Long term recurrence rate | Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site | Greater than 1 year | 
| Adverse event rate | Adverse events include infection, bleeding, perforation and death. | up to 1 month post procedure. | 
| Endoscopic en bloc resection rate | Resection in 1 piece without fragmentation, along or extrinsic to the diathermic markings placed around the perimeter of the lesion before resection, without remnant abnormal tissue visible on HD white-light imaging or NBI | Immediate |
dbGaP Protocol: Genetic Variants Associated With Pentalogy of Cantrell

Study Overview
=================
Brief Summary
-----------------
Background: Pentalogy of Cantrell (POC) is a syndrome that involves many heart abnormalities as well as large defects in the chest and abdominal wall. This often results in the heart and other organs being present outside the body at birth. Surgeons have learned to replace them and repair the heart. Researchers want to find possible gene changes that cause POC. To do this, they want to study data from the Pediatric Cardiovascular Genetics Consortium (PCGC) Cohort. The PCGC collects data and DNA samples from people with heart diseases and their families Objectives: - To find gene mutations in people with Pentalogy of Cantrell (POC) or other related syndromes. Eligibility: - PCGC data and DNA samples that are open to study by the public. Design: Researchers will study the data from the PCGC. The gene testing being done in this study was consented to in the original studies. No new consent or waiver request is required. The study will last 1 year.

Detailed Description
-----------------
The purpose of this protocol is to identify genetic mutations in patients with the diagnosis of Pentalogy of Cantrell (POC) or other related syndromes. We will be looking for any exomic/genomic mutations that could be associated with this syndrome. We have produced a mouse model with a mutation in the gene encoding nonmuscle myosin IIB which exhibit problems with ventral wall closure, including extrathoracic location of the heart (ectopia cordis) and defects in the abdominal wall with protrusion of the guts and liver. These mice have severe defects in both the heart and brain, and resemble humans born with POC, who manifest these same abnormalities, and so we take a special interest in mutations in nonmuscle myosin proteins.

Official Title
-----------------
dbGaP Protocol: Genetic Variants Associated With Pentalogy of Cantrell

Conditions
-----------------
Pentalogy of Cantrell

Participation Criteria
=================
Eligibility Criteria
-----------------
We will analyze data from subjects from congenital cardiovascular disease databases.
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 |
| --- | --- | --- |
| To identify novel genetic mutations associated with the disease Pentalogy of Cantrell |  | Ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify the molecular mechanisms underlying the congenital disease Pentalogy of Cantrell, to aid in the development of novel therapeutic strategies. |  | Ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Muscle Myosin
Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to understand how bazedoxifene is absorbed in the body when it is given in combination with 2 different formulations of conjugated estrogens. It is an open label study with no placebo control or comparator drugs. Subjects will take one dose of the investigation formulation daily for 14 days.

Official Title
-----------------
An Open Label, Randomized, Multicenter Study To Compare Bazedoxifene Steady-State Exposures Obtained With 2 Bazedoxifene Acetate/Conjugated Estrogen Formulations In Postmenopausal Women

Conditions
-----------------
Postmenopause

Intervention / Treatment
-----------------
* Drug: Bazedoxifene/conjugated estrogens


Participation Criteria
=================
Eligibility Criteria
-----------------
Postmenopausal women, aged 40 to 65 years. Use of oral estrogen-, progestin-, or androgen-, or SERM-containing drug products within 8 weeks before screening. A history or active presence of clinically relevant important medical disease.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bazedoxifene/conjugated estrogens|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic analyses. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopause
European Non-interventional Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. For this purpose patients will be asked to answer a questionnaire over the phone

Official Title
-----------------
Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients with a diagnosis of COPD FEV1<50% and FEV1/FVC<0.7 according to lung function data in medical records. Smoker or ex-smoker > 10 pack-years Informed consent obtained Exclusion Criteria: Ongoing exacerbation of COPD or within the previous 3 months Any other significant respiratory disease (including asthma and allergic rhinitis)

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Patient's perception of the variability of symptoms due to severe stable state COPD throughout the day, the week and the year |  | Once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of symptoms (and variability of symptoms) on the patient's morning & daily living activities and sleep quality. |  | Once | 
| Describe how patient use their COPD treatment |  | Once | 
| Factors that may influence the patient's perception of symptom variability |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe COPD, COPD symptoms, variability of symptoms, patient's perception
The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis). Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis. Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.

Official Title
-----------------
An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.

Conditions
-----------------
Pulmonary Arterial Hypertension, Renal Dysfunction

Intervention / Treatment
-----------------
* Drug: UT-15C SR (treprostinil diethanolamine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female volunteers with ESRD (requiring dialysis), moderate (creatinine clearance; CrCL = 30-50 mL/min), mild (CrCL = 50-80 mL/min) and normal renal function (control group; (CrCL >80 mL/min)) may be enrolled. Eligible subject will be 18-79 years of age with a BMI between 18 - 40 kg/m2 and not taking chronic nonsteroidal antiinflammatory drugs (NSAIDs)

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

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

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

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: Treprostinil diethanolamine<br> | Drug: UT-15C SR (treprostinil diethanolamine)<br>* Single dose, 1 mg UT-15C SR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release. |  | 48hrs post dose (60 hours for ESRD) |
COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the pain experienced by patients undergoing orthodontic treatment with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment with conventional braces. Because the aligners are removable, nearly invisible and don't involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign Treatment and less affectation of the quality of life.

Detailed Description
-----------------
The aims of the study are to determine: the presence of pain, the magnitude of pain, the duration of pain, and the location of pain. The hypotheses of this study are: Treatment with Invisalign ® aligners result in less pain than the braces Treatment with Invisalign ® aligners result in less irritation to the soft tissues with braces Pain should increase each time the aligners are put in the mouse and decrease until disappearing on the third day. The quality of life will be most affected by treatment with braces than with Invisalign ®. Null Hypothesis: There is no difference at all points between the two treatments.

Official Title
-----------------
COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS

Conditions
-----------------
PAIN

Intervention / Treatment
-----------------
* Device: Invisalign


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In permanent dentition; Age less than 30 years; No medical contraindications or presence of systemic diseases (including nervous system disorders); No missing teeth except the third molars; Orthodontic treatment without extraction. Relationship skeletal cl. I (or slightly cl. II or cl. III) Speak and understand French without help. Exclusion Criteria: lack of compliance with appointments. -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 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 |
| --- | --- |
| INVISALIGN®<br>those with an Invisalign® Treatment for orthodontic correction | Device: Invisalign<br> <br> |
| braces<br>those with braces for orthodontic correction. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAIN DURING INVISALIGN TREATMENT | A questionnaire will be completed by the patient at different time points during treatment. This questionnaire includes questions on descriptive pain: location, duration, alteration in quality of life and a visual analog scale (VAS). | 6 MONTHS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAIN, ORTHODONTIC TREATMENT, INVISALIGN