linjc16/ctgov huggingface dataset:
Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy

Study Overview
=================
Brief Summary
-----------------
Granuloma annulare is a benign, usually self-limiting, cutaneous dermatosis, which typically presents as asymptomatic, flesh-colored or red papules, frequently arranged in an annular pattern on the distal extremities. Although localized granuloma annulare is most commonly observed, a generalized or disseminated form can occur. The etiology of granuloma annulare is unknown, however, multiple inciting factors have been proposed. The purpose of the investigators is to review the outcomes of treatment of granuloma annulare (GA) resistant to standard regimens that resolved after a 3-months treatment course of monthly rifampin, ofloxacin, and minocycline (ROM) therapy, successfully used to treat paucibacillary leprosy, a disease with clinical and histopathologic similarity to GA.

Detailed Description
-----------------
We will document the regimen treatment each patient has had and then review the following from the patient's chart to target our specific aims as outlined above. What previous treatment options have been or/are currently being used? How long did the patient take the treatment for? Was the patient able to discontinue or become less dependent on prior treatment? Was the disease process slowed by the treatment?; Were there any side effects that the patient experienced with treatment?

Official Title
-----------------
Granuloma Annulare Treated With Rifampin, Ofloxacin, and Minocycline Combination Therapy

Conditions
-----------------
Granuloma Annulare

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with granuloma annulare who are resistent to the standard treatment. Exclusion Criteria: Response to the standard treatment of granuloma annulare.
Sexes Eligible for Study
-----------------
All

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
granuloma annulare, ROM
Matrix Metalloproteinase (MMP) in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the production of MMP in failing hearts.

Detailed Description
-----------------
Myocardial fibrosis is observed in failing hearts and parallel to the progression of chronic heart failure (CHF) and myocardial remodeling. Matrix metalloproteinases (MMPs) are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with CHF. However, MMPs it is still unclear whether MMPs are produced in failing hearts. Thus, the purpose of this study is to evaluate the production of MMP in failing hearts.

Official Title
-----------------
MMP is Produced in Failing Hearts

Conditions
-----------------
Chronic Stable Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic stable heart failure
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMPs level of coronary sinus |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, MMP, coronary sinus
A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.

Official Title
-----------------
An Open Label,Crossover,Randomized Study Of Two Periods,Two Treatments,Two Sequences, And A Single Dose Of Two Oral Drug Products Of Alprazolam 2mg (Tafil (r), Product Of Pharmacia& Upjohn S.a De C.v Vs Xanax 2mg, Product Of Pfizer Pharmaceuticals Llc) In Healthy Volunteers In Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: Alprazolam
* Drug: Alprazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers (male or female) Age between 18-40 years body mass index (Quetelet´s index) between 18-27 Exclusion Criteria: Unhealthy subjects Volunteers who require any medication over the course of the study Volunteers who have received investigational drugs within 60 days prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tafil Tablets 2 mg Pharmacia Upjohn<br> | Drug: Alprazolam<br>* Single tablet<br>* Other names: Tafil Pharmacia Upjohn;|
| Active Comparator: Xanax Tablets 2 mg Pfizer LLC<br> | Drug: Alprazolam<br>* Single tablet<br>* Other names: Xanax Pfizer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish Cmax, Tmax, elimination half life, area below the curve from zero to t, and area below the curve from zero to infinity (ABC 0-∞) of the two formulations of Alprazolam. |  | 10 days | 
| Statistically compare the bioavailability of the pharmaceutical formulations of Alprazolam studied, to establish or rule out the existence of bioequivalence. |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the safety of both preparations based on the record of adverse events on completing both study periods. |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alprazolam, Tafil, Xanax, Bioequivalence, Drug Kinetics
Fetal Blood Flow Response to Partial Occlusion by External Compression

Study Overview
=================
Brief Summary
-----------------
Two earlier studies showed measurable fetal hemodynamics changes caused by external pressure induced by te abdominal ultrasound transducer. The investigators would like to study the response of flow in main fetal vessels to different, mild to moderate pressures induced by the abdominal transducer. The pressure induced by the transducer will be measured by a digital computed manometer. The flow chances in fetal vessels will be measured by ultrasound Doppler. Measurements will be taken on different pregnancy weeks, on one occasion in each pregnant woman. Ones without applying transducer pressure (control) and ones after applying mild pressure.

Conditions
-----------------
Gestational Age

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton Exclusion Criteria: multiple gestation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| pulsatility index in fetal vessels |  | at the time of pressure aplication |
Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
The gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements. Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. It is painless and does not have side effects. We believe that brain saturation will be more accurate then peripheral pulse oximeter and will be better correlated with the clinical presentation of OSA.

Detailed Description
-----------------
a prospective cohort study study group - pediatric population referred to PSG in Dana Duek Hospital. After informed consent received from the parents, the parents will fulfill Connors (age 6 +) & Brief (age 4-6) questionnaires. During the PSG, the brain saturation will be monitored by INVOS(TM) Medtronic device. They will be monitored & synchronized with the peripheral saturation documented performed as part of the PSG examination. The brain saturation & peripheral saturation levels will be compared and both will be correlated to the questionnaires & AHI.

Official Title
-----------------
Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea, Pediatric Sleep Apnea

Intervention / Treatment
-----------------
* Diagnostic Test: INVOS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4-16 y/o pediatric population referred for PSG in Dana Hospital Exclusion Criteria: down synd. craniofacial malformation PPD

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 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
Interventional Model Description: INVOS Medtronic device will be applied simultaneously with sleep lab monitoring
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: O2 brain (central) measurement<br>INVOS will be applied simultaneously for monitoring along with the regular polysomnography (sleep lab) workup | Diagnostic Test: INVOS<br>* INVOS monitoring brain o2 saturation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between brain o2 levels to peripheral measurements | correlation between brain o2 levels to peripheral measurements | procedure (during the examination PGS) |
Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.

Detailed Description
-----------------
The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.

Official Title
-----------------
Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the OZAKI Technique

Conditions
-----------------
Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aortic valve reconstruction using autologous Pericardium (OZAKI technique) Exclusion Criteria: missing informed consent
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 |
| --- | --- | --- |
| Change in aortic transvalvular gradient measured by transthoracic echocardiography | Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography | From Baseline (end of cardiac surgery) until 12 months after cardiac surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of death | Change in clinical Parameter: death | From Baseline (end of cardiac surgery) until 12 months after cardiac surgery | 
| occurence of cardiac re-surgery | Change in clinical parameter: cardiac re-surgery | From Baseline (end of cardiac surgery) until 12 months after cardiac surgery | 
| occurence of stroke | Change in clinical parameter: stroke | From Baseline (end of cardiac surgery) until 12 months after cardiac surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic valve reconstruction, OZAKI technique, autologous pericardium
GERAP's Epidemiological Survey on Perioperative Hypersensitivity Reactions

Study Overview
=================
Brief Summary
-----------------
Perioperative hypersensitivity reactions are still associated with significant morbidity and mortality despite early recognition and use of epinephrine. The epidemiology of these reactions evolves over time and changes with clinical practice. The main objective is to study the epidemiology of these reactions over a 10-year period, including patient phenotype, reaction phenotype and outcome of the allergic work-up.

Official Title
-----------------
Epidemiological Survey on Perioperative Hypersensitivity Reactions in France by the GERAP Network (Groupe d'étude Des réactions Anaphylactiques périopératoires)

Conditions
-----------------
Hypersensitivity, Drug

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minor and major subject Subject having experienced a perioperative hypersensitivity reaction between January the 1st 2017 and December the 31st 2027. Referred for an allegro-anesthetic workup Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion Criteria: Subject having expressed opposition to participating in the study Inability to provide the subject with research information Subject under guardianship or guardianship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- | --- |
| Retrospective analysis of incidence of all perioperative hypersensitivity reactions referred in an allegro-anesthetic |  | Outcome is analysed every 2 years over a 10 years period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anaphylaxis, perioperative, hypersensitivity reactions, neuromuscular blocking agents, hypnotics
3D Autotransplantation of Teeth

Study Overview
=================
Brief Summary
-----------------
The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.

Official Title
-----------------
3D Autotransplantation of Teeth

Conditions
-----------------
Tooth Loss

Intervention / Treatment
-----------------
* Device: 3D generated tooth replica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need for tooth transplantation Open apex tooth available for transplantation Exclusion Criteria: Facial syndrome Chronic facial pain Allergy to replica material

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 23 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Effect on surgery<br>Duration of surgery, degree of manipulation of the transplant | Device: 3D generated tooth replica<br>* 3D generated tooth replicas are compared to conventional procedure<br>|
| Active Comparator: Success of transplantation<br>Normal eruption and root development of the transplant | Device: 3D generated tooth replica<br>* 3D generated tooth replicas are compared to conventional procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with healthy transplanted teeth as assessed by clinical examination at one year. | The transplanted tooth is clinically healthy | One year postoperatively | 
| Number of patients with healthy transplanted teeth as assessed by radiological examination at one year. | The transplanted tooth is radiologically healthy | One year postoperatively |
Biomarker Analysis of Stress

Study Overview
=================
Brief Summary
-----------------
Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. The ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. It is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.

Detailed Description
-----------------
Blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. The blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. This will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. The ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.

Official Title
-----------------
Biomarker Signatures of Biological, Chemical, or Psychological Stress

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at Wadsworth Center with Sepsis
Sexes Eligible for Study
-----------------
All

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress
Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

Detailed Description
-----------------
A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of subjects currently using Exubera to treatment with TI Inhalation Powder

Official Title
-----------------
Patient Transfer Program for Transitioning From Exubera® (Insulin Human [rDNA Origin]) Inhalation Powder to Technosphere® Insulin (Insulin Human [rDNA Origin]) Inhalation Powder

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Technosphere Insulin Inhalation Powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or has been treated with Exubera. Subject has a severe phobia to sc injections of insulin (needle phobia) preventing conventional treatment OR has impaired sc insulin absorption Exclusion Criteria: Smoking in the previous 6 months History of asthma or chronic obstructive pulmonary disease (COPD) or any other significant pulmonary disease, or exposure to pulmonary toxins. Clinically significant pulmonary abnormalities on chest high-resolution computed tomography (HRCT). PFT results prior to transferring to TI Inhalation Powder showing any of the following: FEV1 < 70% of predicted, FVC < 70% of predicted, DLCO < 70% of predicted, TLC < 80% of predicted. Allergy to insulin
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Technosphere Insulin Inhalation Powder|Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe most characteristic association of signs and symptoms present at the time of acromegaly diagnosis.

Official Title
-----------------
Description of Sign-and-symptom Associations at Acromegaly Diagnosis.

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (greater than or equal to 18 years old) Patient with acromegaly, diagnosed for less than 5 years Exclusion Criteria: Patient who have objected to the collection of his/her data

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 |
| --- | --- |
| Acromegalic patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the most characteristic sign-and-symptom associations of acromegaly, collected by a patient questionnaire. |  | At the time of patient diagnosis, up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of demographic and clinical characteristics of patients with acromegaly, collected by a patient questionnaire. |  | At the time of patient diagnosis, up to 3 months |