linjc16/ctgov huggingface dataset:
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Study Overview
=================
Brief Summary
-----------------
This is a protocol to govern the prospective trial of facial nerve monitoring in patients undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor provides useful information to operating surgeons and if the information provided by the facial nerve monitor can predict degrees of postoperative facial nerve paresis. Additionally, the study will determine if performing daily facial rehabilitation exercises provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.

Official Title
-----------------
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

Conditions
-----------------
Parotid Neoplasms, Facial Paralysis

Intervention / Treatment
-----------------
* Behavioral: Facial exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Planned parotid gland surgery (superficial or total parotidectomy) Benign or malignant disease Exclusion Criteria: Pregnancy Preoperative facial nerve dysfunction Revision operation History of preoperative radiation to the surgical field Entire nerve not dissected Intentional nerve sacrifice Poor signal to noise ratio during surgery Lack of access to device compatible with video conferencing software, or lack of access to broadband internet connection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No facial exercises<br>This group will not receive any training in facial exercises. | |
| Experimental: Facial exercises<br>This group will receive instruction to perform a series of self-administered exercises of facial expression and movements. | Behavioral: Facial exercises<br>* A series of self-administered facial movements and expressions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative facial weakness | Measure degree of facial weakness on postop day 1 | postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of facial weakness | Monitor time to resolution of weakness in the facial exercises and control groups | 3 months |
A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review

Study Overview
=================
Brief Summary
-----------------
Myelofibrosis (MF) is a rare blood cancer, characterized by extensive fibrosis (scarring) of the bone marrow. It is one of a group of cancers known as myeloproliferative neoplasms (MPNs) in which bone marrow cells that produce blood cells develop and function abnormally. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with Myelofibrosis. Data from approximately 1000 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 156 weeks. There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 156 weeks.

Official Title
-----------------
A Multi-Country, Real-World Study to Explore Treatment Patterns, Effectiveness and Healthcare Resource Utilization for Patients Diagnosed With Myelofibrosis Through Chart Review

Conditions
-----------------
Myelofibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated for myelofibrosis (MF) [primary myelofibrosis (PMF) and secondary myelofibrosis (SMF)]. Must have initiated their first treatment on or after the first date when ruxolitinib was approved in their country of residence and no later than 31 December 2021. Exclusion Criteria: - Having received MF treatment in a clinical trial setting.

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 |
| --- | --- |
| Participants Undergoing Chart Review<br>Participants treated for myelofibrosis undergoing chart review. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from Diagnosis of Myelofibrosis (MF) to Initial Treatment | Time from diagnosis of MF to initial treatment. | Up to Week 156 | 
| Duration of Initial Treatment | Duration of initial treatment. | Up to Week 156 | 
| Duration of Second Treatment | Duration of second treatment. | Up to Week 156 | 
| Duration of Subsequent Treatments | Duration of subsequent treatments. | Up to Week 156 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myelofibrosis, Cancer
Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate

Study Overview
=================
Brief Summary
-----------------
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.

Detailed Description
-----------------
A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Glycopyrrolate
* Drug: Glycopyrrolate
* Drug: Glycopyrrolate
* Drug: Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value) Patients under Double Patients under triple therapy (for 1 Mo prior Screening) Exclusion Criteria: Pregnant or lactating women Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization concommitant diseases impacting feasibility or safety

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glyco 25<br>BDP/FF (400/24 daily)+ Glyco 25µg daily | Drug: Glycopyrrolate<br>* comparison of different dosages of drug<br>* Other names: Foster+GLyco 25;|
| Experimental: Glyco 50<br>BDP/FF (400/24 daily)+ Glyco 50 µg daily | Drug: Glycopyrrolate<br>* comparison of different dosages of drug<br>* Other names: Foster+GLyco 50;|
| Experimental: Glyco 100<br>BDP/FF (400/24 daily)+ Glyco 100µg daily | Drug: Glycopyrrolate<br>* comparison of different dosages of drug<br>* Other names: Foster+GLyco 100;|
| Active Comparator: BDP/FF 400/24<br>BDP/FF 400/24 | Drug: Comparator<br>* comparison of different dosages of drug versus comparator<br>* Other names: Foster;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aera under curve FEV1 AUC 0-12h |  | day 1 and 7 of treatment period |
Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure

Study Overview
=================
Brief Summary
-----------------
Evaluating the additional value of Macrophage Migration Inhibitory factor (MIF) in cardiovascular diseases when assessed in clinical routine.

Official Title
-----------------
Role of Macrophage Migration Inhibitory Factor (MIF) in Heart Failure

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: MIF ELISA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting with symptoms of heart failure to the West-German Heart and Vascular Center according to the definition of the ESC 2016. Patients fulfilling criteria for the diagnosis of HFrEF Patients fulfilling criteria for the diagnosis of HFpEF Patients fulfilling criteria for the diagnosis of HFmrEF Patients presenting with dyspnea according to the NYHA classification I-IV, elevated BNP/NT-proBNP levels and echocardiographic findings of heart failure. Exclusion Criteria: Age < 18 years Patients with symptoms of heart failure without fulfilling the criteria of the ESC guidelines 2016 Denial to participate

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: MIF ELISA|Blood sample|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 180 days mortality |  | 180 days |
COVID-19: Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children

Study Overview
=================
Brief Summary
-----------------
This study seeks to explore immunological mechanisms in patients with Multisystem Inflammatory Syndrome in Children (MIS-C) to improve the understanding of this pathogenesis of this disease. In a cohort of MIS-C patients diagnosed during the Wild type, Alpha, Delta and Omicron waves, research samples will be analyzed for whole-blood RNA expression, proteomics, inflammatory cytokines, cellular immune populations, autoantibodies, as well as host genetic markers.

Detailed Description
-----------------
BACKGROUND Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. Thousands of children worldwide have been hospitalized with this new disease. Yet, the immunological mechanisms are sparsely described. AIM The project seeks to explore immunological mechanisms in patients with MIS-C. METHOD From a prospective nationwide cohort of patients with MIS-C from Denmark (May 2020-March 2022), research samples will be investigated for whole-blood RNA expression, proteomics, inflammatory cytokines, metabolomics, cellular immune populations, autoantibodies, as well as host genetic markers allowing for detailed mapping this disease. Samples from MIS-C patients will be compared to patients with bacterial and viral disease, and other inflammatory diseases. TIME FRAME Sample identification: February 1 2022 to April 1, 2022. Sample analysis: April 1, 2022 to December 31, 2022 PERSPECTIVES New molecular-based tools may lead to improved understanding of the pathogenesis of MIS-C. This could form basis for development of novel diagnostic markers, identification of severe phenotype and therapeutic interventions.

Official Title
-----------------
Immunological Mechanisms in Multisystem Inflammatory Syndrome in Children

Conditions
-----------------
Multisystem Inflammatory Syndrome in Children, COVID-19, SARS-CoV-2 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with MIS-C, according to the CDC criteria aged 0-17 years Exclusion Criteria: Patients from whom patient/parent/legal guardian signed consent is not received

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 17 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 |
| --- | --- | --- |
| Immunological mechanisms in MIS-C | Whole-blood RNA expression at admission and change during recovery | Day 0-3 and up to during 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multisystem Inflammatory Syndrome in Children
Comparison of Critical Flicker Fusion Versus Automated Visual Fields in the Detection of Early Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if critical flicker fusion is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease.

Detailed Description
-----------------
Our hypothesis is that critical flicker fusion (CFF) is a more reliable method for detection of early glaucoma compared to automated visual fields in comparison to subjects without evidence of glaucoma or optic nerve disease. We aim to evaluate the structure of the optic nerve and compare it to results of visual fields and CFF. The CFF will also be correlated with intraocular pressure (IOP) measurements to observe if it may be more closely related than visual fields. This may become an additional tool to detect glaucoma in those with unreliable visual fields or who are unable to perform a visual field from physical or mental limitations.

Official Title
-----------------
Comparison of Critical Flicker Fusion vs. Automated Visual Fields in the Detection of Early Glaucoma

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Glaucoma Suspects: Abnormal optic disc appearance with increased cup to disc ratio, or Increased intraocular pressure >21 in either eye Control Subjects: Normal appearing optic discs Normal intraocular pressure (<21) Exclusion: Other ocular pathology History of seizures or epilepsy

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 |
| --- | --- |
| Control<br>Patients with no evidence of glaucoma or as a suspect with normal intraocular pressure, normal cup to disc ratio with no other ocular pathology and a normal ophthalmic exam. | |
| Glaucoma Suspect<br>Patients with abnormal cup to disc ratio or increased intraocular pressure (>21mm/Hg) with an otherwise normal ophthalmic exam. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of mean deviation of glaucoma suspects from controls between critical flicker fusion and automated visual fields. |  | 1 visit (1 day) |
Responsible Side Effects Management in Oncology

Study Overview
=================
Brief Summary
-----------------
Study of pharmacovigilance in oncology. Monitoring and management of AEs during antineoplastic treatment.

Detailed Description
-----------------
Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's reported by patient with the ones recognised by the oncologist, and vice versa, during antineoplastic treatment.

Official Title
-----------------
Comprehensive Antineoplastic Therapy Adverse Events Monitoring and Report

Conditions
-----------------
Pharmacovigilance, Oncology, Antineoplastic Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cancer patients receiving systemic antineoplastic treatment, ECOG 0-2 Exclusion Criteria: age <18, >75; other active and severe comorbidities; no solid cancer; IUC patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| comparison of perspectives | comparison between patient's and oncologist's perspective on severity of AE's during antineoplastic treatment | may 2016 until october 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacovigilance in oncology, antineoplastic treatment, adverse events
A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on abdominal distension in IBS patients with constipation (IBS-C).

Conditions
-----------------
Women With IBS-C

Intervention / Treatment
-----------------
* Other: 1-fermented dairy product
* Other: 2- milk-based non-fermented dairy product (control product)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female Age: 18-70 Exclusion Criteria: NA

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 = Tested product<br> | Other: 1-fermented dairy product<br>* Arm 1 - Intervention 1 (probiotics)<br>|
| Active Comparator: 2 = Control product<br> | Other: 2- milk-based non-fermented dairy product (control product)<br>* Arm 2 - Intervention 2 (control)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean abdominal distension after a 4-week period of product consumption in IBS-C patients |  | 0-4 weeks |
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery

Study Overview
=================
Brief Summary
-----------------
In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.

Official Title
-----------------
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: Experimental Group
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5 to 12 year olds requiring scheduled surgery scheduled outpatient or weekly hospitalization. Anesthesia envisaged by inhalation induction Agreement of parents (and child according to age). Even parent (s) present at pre-anesthesia and on the day of surgery Exclusion Criteria: Child with previous surgery Parent (s) of a child who has already had surgery Parent (s) or child unable to follow the whole procedure (autism, blindness ...)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accompanying and information procedure<br>Preparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child. | Other: Experimental Group<br>* Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child<br>|
| Other: Usual care<br>Consultation of anesthesia and the care of the child without parental presence | Other: usual care<br>* Usual care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of anxiety | Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale | 10 minutes |