linjc16/ctgov huggingface dataset:
PAV Trial During SBT Trial

Study Overview
=================
Brief Summary
-----------------
Weaning from mechanical ventilation is milestone in intensive care unit. The prolongation of mechanical ventilatory support is associated with contractility disorders of the diaphragm muscle as well as an increase in the incidence of nosocomial pneumonia. On the other hand, an early interruption of mechanical ventilatory support could be associate with the onset of acute respiratory failure, pulmonary edema, hemodynamic instability and the increased risk of re-intubation. Therefore, careful analysis of surrogate clinical parameters is essential in understanding when the critically ill patient is really ready for a complete weaning from mechanical ventilatory support. To date, the physician is invited to examine various clinical parameters predicting the success of extubation, such as hemodynamic stability, metabolic structure and the patient's state of consciousness. In addition, various surrogate ventilatory parameters help the clinician to understand the patient's degree of autonomy in the spontaneous breathing process, such as alveolar exchange, as well as the degree of ventilatory performance through the analysis of ventilatory parameters that can be evaluated during assisted mechanical ventilation. To date, the use of proportional assisted ventilation methods such as Proportional Assisted Ventilation + (PAV +) allow us to continuously evaluate the mechanical characteristics of the respiratory system as well as the respiratory work that the patient sustains breath by breath. The objective of this study is to evaluate whether the ventilatory parameters derived from the PAV ventilatory algorithm are also predictors of extubation success.

Official Title
-----------------
Lung Mechanics Assessment During Extubation Trial in Critical Ill Patients

Conditions
-----------------
Mechanical Ventilation Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: start of mechanical ventilation 48 hours Exclusion Criteria: hemodynamic instability Neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| the aims of this study is assess all physiological variables that define the patient's breathing pattern in patients undergoing spontaneous breathing trial before extubation. | In this study will be assess the pulmonary characteristics of the respiratory system. The main outcome is the assessment of patient work of breathing (J/L) during SBT trial before extubation. The work of breathing will be recorded directly by the pulmonary ventilator. | 48 hours |
Paediatric Safety Study in Cat-PAD

Study Overview
=================
Brief Summary
-----------------
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects

Official Title
-----------------
A Multi-Centre, Single-Blind Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects

Conditions
-----------------
Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Cat-PAD
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or female, aged 5-12 years. Moderate to severe rhinoconjunctivitis on exposure to cats for at least 2 years. Subjects may optionally also have GINA Step 1 controlled asthma. Positive skin prick test to cat hair. Cat dander specific IgE ≥0.35 kU/L. Exclusion Criteria Asthma falling under the GINA definitions partly controlled and uncontrolled or Steps 2 to 5. FEV1 <80% of predicted. Clinically relevant abnormalities detected on physical examination. History of severe drug allergy, severe angioedema or anaphylactic reaction to food.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Cat-PAD and Placebo | Drug: Cat-PAD<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With AEs | To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years. | up to 36 weeks after start of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cat Allergy, Rhinoconjunctivitis
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

Official Title
-----------------
A Single Centre, Randomized, Balanced Double Blind, Cross-over Trial Investigating the Bioequivalence of Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant Fasting blood glucose below or equal to 6 mmol/L Body Mass Index (BMI) 22.0-27.0 kg/m^2 (both inclusive) Exclusion Criteria: Participated in another clinical study with an investigational drug within the last 4 weeks Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable Known or suspected allergy to the trial product or related products Family history of type 1 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NN729 manufacturing process<br> | Drug: human insulin<br>* Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)<br>|
| Active Comparator: Current manufacturing process<br> | Drug: human insulin<br>* Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the curve) 0-8h (human insulin) |  |  | 
| Cmax (maximum plasma concentration) |  |  | 
| Area under the curve (glucose infusion rate (GIR)), 0-8h |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax (time to reach maximum) |  |  | 
| t½ (terminal half-life) |  |  | 
| GIR (glucose infusion rate) max |  |  | 
| tGIR (glucose infusion rate) max |  |  | 
| Area under the curve (C-peptide, 0-8h) |  |  | 
| Physical examinations and vital signs |  |  |
Mitochondrial Diseases - Long-read Genome and Transcriptome Sequencing in Cases Unresolved After Short-read Genomics

Study Overview
=================
Brief Summary
-----------------
The MiDiSeq project will enroll 20 unresolved index patients with suspected mitochondrial disease prioritized for genomic analysis.

Detailed Description
-----------------
In the MiDiSeq (monocentric, prospective, open-label diagnostic) project, patients with suspected mitochondrial disease prioritized for i) high a priori probability for a genetic basis (e.g. positive family history) as well as availability of (ii) fibroblast cell lines with a biochemically defined phenotype, (iii) parental samples, (iv) short read whole genome and transcriptome datasets and (v) optional additional metabolomics and proteomics data. The following questions will be leading the project: i) to systematically benchmark different sequencing technologies to detect genetic and epigenetic variation and their impact on gene regulation. (ii) to further develop algorithms for integrative analyses of different 'omics datasets. (iii) to expand the analysis from coding Single-Nucleotide Variants (SNVs) and regulatory mutations to structural variants (SVs), repeat expansions and contractions, low complexity regions and epigenetic signatures. (iv) to identify novel alterations and disease mechanisms. (v) to gain fundamental new insights into disease mechanisms and cellular biology. (vi) to improve genetic diagnostics of future rare disease patients and to evaluate personalized therapeutic options.

Official Title
-----------------
Mitochondrial Diseases - Long-read Genome and Transcriptome Sequencing in Cases Unresolved After Short-read Genomics

Conditions
-----------------
Rare Diseases, Genetic Predisposition

Intervention / Treatment
-----------------
* Genetic: Next Generation Sequencing (NGS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unclear diagnosis Suspected genetic cause of the disease Exclusion Criteria: Missing informed consent of the patient/ legal guardian
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mitochondrial disease<br>Unresolved index patients with suspected mitochondrial disease | Genetic: Next Generation Sequencing (NGS)<br>* Determining the nucleic acid sequence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Epi)Genetic variation | Number of (Epi)Genetic variation | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rare Diseases, Genetic Predisposition, Epigenetic variation, Omics, Genetic variation, Mitochondrial disease, Next Generation Sequencing (NGS)
Forearm Tourniquet With Small Dose Intravenous Lidocaine

Study Overview
=================
Brief Summary
-----------------
The safety and effectiveness of the mini-dose Bier block, a technique of i.v. regional anesthesia using low-dose lidocaine (1.5 mg/kg) without routine premedication, was evaluated in the emergency department treatment of pediatric upper extremity fractures and dislocations.

Detailed Description
-----------------
this study aimed at comparing IVRA with small dose lidocaine and forearm tourniquet with conventional IVRA with arm tourniquet and usual lidocaine dose

Official Title
-----------------
Forearm Tourniquet With Small Dose Intravenous Lidocaine as a Substitute to Conventional Intravenous Regional Anaesthesia

Conditions
-----------------
Local Anaesthesia

Intervention / Treatment
-----------------
* Procedure: intravenous regional anaesthesia
* Procedure: forearm IVRA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA(American society of anesthesia) I, II , consent, forearm or arm surgery Exclusion Criteria: ASA(American society of anesthesia) III or more, allergy, refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: arm intravenous regional anesthesia<br>tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg | Procedure: intravenous regional anaesthesia<br>* tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg<br>|
| Experimental: forearm intravenous regional anesthesia<br>tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg | Procedure: forearm IVRA<br>* tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | visual analogue scale | 2 hours |
Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Official Title
-----------------
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: R89674 (generic name not yet established)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction Exclusion Criteria: narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis pterygium or diagnosis of dry eye ocular surgical intervention within 3 months history of refractive surgery within 6 months known history of retinal detachment, diabetic retinopathy, or progressive retinal disease presence of active ocular infection positive history of an ocular herpetic infection preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis

Ages Eligible for Study
-----------------
Minimum Age: 10 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: R89674 (generic name not yet established)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching and conjunctival redness post challenge |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ocular, allergic conjunctivitis, ophthalmic
aCGH Impacts Survival in Plasma Cell PTLD

Study Overview
=================
Brief Summary
-----------------
Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.

Official Title
-----------------
Array-CGH in Plasma Cell Post-transplantation Lymphoproliferative Disorders

Conditions
-----------------
Post-transplantation Lymphoproliferative Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WHO classification 2008 as monomorphic PCM (plasma cell myeloma) or PLL (plasmacytoma like lesion) / PTLD (post transplantation lymphoproliferative disorders). Exclusion Criteria: Other than PCM or PLL PTLD at diagnosis
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 |
| --- | --- | --- |
| Genome wide array-based comparative genomic hybridization (aCGH) |  | At diagnosis of PTLD, Day 0. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival according to aCGH complexity |  | Overall survival (OS) was calculated from date of diagnosis to date of death from any cause, up to 130 months. |
Ventricular Remodeling and Heart Failure After Myocardial Infarction: A Community Study

Study Overview
=================
Brief Summary
-----------------
To comprehensively characterize Left Ventricular (LV) remodeling after Myocardial Infarction (MI) in the community, study the association between patterns of remodeling and biological pathways and examine the association between the predictors of remodeling and heart failure after Myocardial Infarction.

Official Title
-----------------
Ventricular Remodeling and Heart Failure After Myocardial Infarction: A Community Study

Conditions
-----------------
Heart Failure, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients with a clinical diagnosis of Myocardial Infarction. Residents of Olmsted, Dodge, Goodhue, Wabasha, Winona, Fillmore and Mower Counties. Able to provide informed consent. Exclusion Criteria: Previous clinical diagnosis of Myocardial Infarction Previous diagnosis of Heart Failure and/or Cardiomyopathy Diagnosis of Apical Ballooning Syndrome Planned Coronary Artery Bypass Graft (CABG) during index hospitalization Unable to provide informed consent

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 |
| --- | --- |
| Myocardial Infarction subjects<br>Subjects with first Myocardial Infarction presenting to one of the Mayo Clinic Hospitals in Rochester, Minnesota. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure | Development of Heart Failure post Myocardial Infarction | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All cause mortality post Myocardial Infarction | 5 years |
Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the relationship between smartphone addiction and trunk position sense, insomnia and fatigue in adolescents. Sample size will be determined after a pilot study conducted on a small sample of adolescents. Digital goniometer will be used to evaluate trunk position sense, insomnia severity index will be used to evaluate insomnia severity and fatigue will be measured by fatigue severity scale.

Official Title
-----------------
Smartphone Addiction in Relation to Trunk Position Sense, Fatigue and Insomnia in Adolescences

Conditions
-----------------
Adolescent Behavior, Smartphone Addiction

Intervention / Treatment
-----------------
* Device: Smartphone use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents with age between 17 and 18 years old. BMI between 16.4 and 24.8 kg/m2 Smartphone addiction scale (short version) higher than 33 Smartphone users of 4-5 inches screen size smartphones, weighing 140-160 grams and dimensions less than 159*79*9 mm. Exclusion Criteria: Visual or hearing defects. Congenital abnormalities. Neurological abnormalities Musculoskeletal abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smartphone addiction group<br> | Device: Smartphone use<br>* Smartphone addiction scale (short version) higher than 33 Smartphone users of 4-5 inches screen size smartphones, weighing 140-160 grams and dimensions less than 159*79*9 mm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk position sense | Digital goniometer will be used to determine trunk position sense. Procedure will be performed with open-closed eye positions with a trunk flexion and trunk lateral bending right/left without any verbal feedback from the examiner. It will be measured in terms of repositioning error angle (the difference between reached and targeted angles). | Single measurement (instant measure) | 
| Insomnia severity index | Insomnia severity will be assessed by insomnia severity index. It contains 7 items and each participant will read each statement and check a number from 0 to 4. respondents use five point LIKERT scale to rate each item (example: 0= no problem, 4= very severe problems). | Single measurement (instant measure) | 
| Fatigue severity scale | Arabic version of fatigue severity scale will be used to determine fatigue level. It contains 9 items as each participant will be asked to read each statement and circle a number from 1(completely disagree) to 7 completely agree/ | Single measurement (instant measure) |