linjc16/ctgov huggingface dataset:
A Study of Respiratory Muscle Strength in Patients With Late-onset Pompe Disease (LOPD)

Study Overview
=================
Brief Summary
-----------------
Study 701-201 is a study in patients with late-onset Pompe disease (LOPD). The study will test respiratory muscle strength initially and again after 24 weeks in subjects treated or not treated with BMN 701 .

Official Title
-----------------
A Study of Respiratory Muscle Strength, Including Effort-Independent Measures, in Subjects With Late-Onset Pompe Disease

Conditions
-----------------
Late-onset Pompe Disease

Intervention / Treatment
-----------------
* Procedure: Respiratory muscle strength measurements by different techniques.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any study-related procedures Documented diagnosis with late-onset Pompe disease - At least 18 years of age at study entry Willing and able to comply with all study procedures Exclusion Criteria: Requires ventilatory support while awake and in the upright position Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise patient well-being, study completion, or data collection Allergy to tools or procedures used for respiratory muscle testing

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 |
| --- | --- |
| Measurement of Respiratory Muscle Strength<br> | Procedure: Respiratory muscle strength measurements by different techniques.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Inspiratory Pressure (MIP) | Pulmonary measure of change in maximal inspiratory pressure (MIP) | Baseline, Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Expiratory Pressure (MEP) | Pulmonary measure of change in maximal expiratory pressure (MEP) | Baseline, Week 28 |
Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).

Official Title
-----------------
A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia

Conditions
-----------------
Parkinson's Disease, Dyskinesia

Intervention / Treatment
-----------------
* Drug: Sarizotan HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female The subject is an out-patient Age 30 years or above Dyskinesias present during more than 25% of the waking day Dyskinesias at least moderately disabling Written informed consent Exclusion Criteria: Pregnancy and/or lactation Participation in another study within the last 30 days Dementia or other psychiatric illness that prevents provision of informed consent History of allergic disorders such as asthma Known hypersensitivity to the study treatment(s) Known hypersensitivity to ACTH

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Sarizotan HCl|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, Dyskinesia, L-dopa-induced dyskinesia
Berlin-Brandenburg Pregnancy Cohort

Study Overview
=================
Brief Summary
-----------------
This study will investigate the interplay of different immune cells and placental cells as well as their potential for the development of pregnancy complications. In particular, the translation of the uteroplacental syndrome into a maternal syndrome, considered in the multifactorial pregnancy disorder preeclampsia, will be investigated. Immune cell subtypes are causally involved in the formation and translation of preeclampsia by inducing an endothelial dysfunction which leads to cardiovascular damage.

Official Title
-----------------
Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders

Conditions
-----------------
Preeclampsia, Pregnancy Complications, Diabetes Mellitus in Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy pregnant women after giving informed consent pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes Exclusion Criteria: infections alcohol and drug abuse manifest and chronic diseases

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 |
| --- | --- | --- |
| T cell population content at the time of preeclampsia diagnosis compared to controls and verified by flow cytometry |  | at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy |
Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study the impact of dentinogenesis (DI) and amelogenesis (AI) imperfecta on oral quality of life, exposure to bullying and dental anxiety in a population of adolescents. WThe present study will use validated scales to evaluate the impact of bullying on the oral quality of live of youth aged 10 to 18 years, with non-syndromic DI or AI treated in seven national competence or reference centers in rare oral diseases.

Official Title
-----------------
Psycho-social Impact of Amelogenesis and Dentinogenesis Imperfecta in Young People

Conditions
-----------------
Dentinogenesis Imperfecta, Amelogenesis Imperfecta

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be between 10 and 18 years of age, consult for a care or follow-up consultation having a non-syndromic amelogenesis imperfecta or dentinogenesis imperfecta having access to a cell phone and/or tablet and/or personal or family computer covered by the social security of one of his parents understand French and one of whose parents (or legal representative) understands French have declared his or her non-opposition and one of whose parents (or legal representative) has declared his or her non-opposition to participate in the study. Exclusion Criteria: Child presenting for diagnostic consultation and child who cannot read or whose 2 parents (legal representatives) cannot read

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaires|For youth: self-reported questionnaires (on oral quality of life, bullying and cyberbullying, dental anxiety) and routine clinical examination for adolescents. For one parent: self-reported questionnaires (on perceived oral quality of life of their child and on their own dental anxiety).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Oral Health Impact Profile (COHIP) | Difference between the average total COHIP questionnaire score of bullied and non bullied patients at D0 (no follow up is planned). A youth is considered bullied if he or she answers three or more at least once on the Bullying and Cyberbullying scale for Adolescent questionnaire) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amelogenesis imperfecta, Dentinogenesis imperfecta, Bullying, Oral health related quality of life, Dental anxiety
The Impact of Food on Blood Sugar in People With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will record the impact of food on blood glucose levels using continuous glucose monitoring (CGM). The investigators think the impact will improve as medication doses are adjusted. The investigators also think that the impact will differ depending on the type of medication taken.

Official Title
-----------------
Evaluation of the Glycemic Impact of Food in Patients With Type 2 Diabetes Taking Glargine and/or Exenatide

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study participants who are consented for the primary study and have not yet done the baseline CGM data collection at week -2-0. Exclusion Criteria: Study participants who are unable to complete the baseline CGM data collection at week -2-0. Study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glargine Group<br>After baseline titration of metformin, this group will take glargine along with metformin. | |
| Exenatide Group<br>After baseline titration of metformin, this group will take exenatide along with metformin. | |
| Glargine and Exenatide Group<br>After baseline titration of metformin, this group will take glargine and exenatide along with metformin. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-hour glycemic response at 3 time points | The four-hour glycemic response includes: four-hour post-meal area under the median interstitial glucose curve, post-meal interstitial glucose peak, time to peak, time to return to pre-prandial level (to within 10% of baseline with a maximum of the 4-hour post-meal fast), difference between peak and baseline, average rate of change in interstitial glucose across the 4 hour post-meal period, and percent of the 4-hour post-meal glucose readings >180 mg/dL. | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, metformin, glargine, exenatide, glycemic impact of food, continuous glucose monitoring
Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

Study Overview
=================
Brief Summary
-----------------
Aims of the study were to find vascular markers of inflammation and endothelial damage during the course of severe sepsis in septic patients and the effects of treatment with anti-inflammatory medication (such as Drotregocin alfa (activated)). Another aim is to find new markers and gene polymorphisms for prognosis and mortality of patients with severe sepsis. The hypothesis is that higher plasma concentrations of certain markers in septic patients are associated with a higher mortality rate.

Detailed Description
-----------------
During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Human activated protein C (Drotrecogin alfa (activated)), an important coagulation inhibitor plays a major role in regulating microvascular coagulation, inflammation and immunology. Little is known about prognostic vascular biomarkers during the time course of patients with severe sepsis.

Official Title
-----------------
Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis

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

Intervention / Treatment
-----------------
* Procedure: vein puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SIRS-Criteria Proven Infection One sepsis-induced organ-failure Adults <18 years old Exclusion Criteria: Anemia Pregnancy Blood donor in the last 3 month

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: vein puncture|comparison of different inflammatory markers in the blood of septic patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New Prognostic markers for septic patients |  | until 300 Patients are included | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe sepsis, prognostic markers, polymorphisms, SIRS
Submandibular Gland Preservation in Neck Dissection

Study Overview
=================
Brief Summary
-----------------
Trial design: a randomized controlled trial. Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth. Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group. Primary Parameters: survival rate, mortality rate

Official Title
-----------------
Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma

Conditions
-----------------
Neck Dislocation, Oral Cancer

Intervention / Treatment
-----------------
* Procedure: modified neck dissection
* Procedure: traditional neck dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0). Exclusion Criteria: Cancer of the floor of the mouth.

Ages Eligible for Study
-----------------
Maximum Age: 90 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 |
| --- | --- |
| Experimental: Experimental group<br> | Procedure: modified neck dissection<br>* Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.<br>|
| Active Comparator: Control group<br> | Procedure: traditional neck dissection<br>* traditional neck dissection without preservation of submandibular gland<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year survival rate | disease free survival rate | 5-year after operation | 
| 3-year survival rate | disease free survival rate | 3-year after operation | 
| 5-year regional recurrence rate | rate of participants with tumor recurrence in the neck | 5-year after operation | 
| 3-year regional recurrence rate | rate of participants with tumor recurrence in the neck | 3-year after operation | 
| 1-year regional recurrence rate | rate of participants with tumor recurrence in the neck | 1-year after operation |
Neural Correlates of Lower Extremity Motor Recovery in Stroke Patients: Longitudinal Diffusion Spectrum Imaging Studies

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship between the integrity of the white matter, including the corticospinal tracts and the corpus callosum, with the recovery of lower extremity function in patients with cerebral stroke at the subacute and chronic stages.

Detailed Description
-----------------
Recent studies have provided strong evidence that motor recovery after adult ischemic stroke is a function of neural plasticity. Up to date, it remains largely unknown as to the relationship between the integrity of the subcortical white matter with the lower extremity function recovery. Given the fact that the white matter is more resistant to ischemia after acute stroke than the gray matter (Falcao et al., 2004) and that the intensity of white matter in stroke has been found to be much greater in many brain areas in stroke than in healthy controls (Wen et al., 2004), it is of interest to study how the integrity of the subcortical white matter, primarily the corticospinal tracts and the corpus callosum, contributes to the recovery of lower extremity function in subacute and chronic stroke with lesions involving different areas of the brain.

Official Title
-----------------
Neural Correlates of Lower Extremity Motor Recovery in Stroke Patients: Longitudinal Diffusion Spectrum Imaging Studies

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 30 to 80 years old diagnosis of the first-time onset of stroke as confirmed by imaging studies within 30 days post onset University Hospital brain lesions mainly involving either the cortical primary motor cortex (M1) area or confined to the subcortical (M1 spared) No neurological or orthopedic problems which would affect their lower extremity function no contraindications for MRI studies Exclusion Criteria: medically unstable unable to communicate with the experimenters

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| clinical assessments, included balance, motor, walking,ADL, will be obtained for tests performed on D7, D30 and D90 |  | D30, D90 and D180 post stroke onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Diffusion spectrum tractography, Functional MRI (fMRI), Lower extremity
Point of Care Ultrasound to Confirm Endotracheal Tube Cuff Position in Relationship to the Cricoid in Pediatric Population.

Study Overview
=================
Brief Summary
-----------------
Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the cricoid in children. Previously, no clinical or imaging method has been used in real time at the bedside to determine the exact location of the ETT cuff after endotracheal intubation. Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby allowing ideal ETT positioning.

Detailed Description
-----------------
Airway below vocal cords until the distal end of the cricoid referred to as subglottis or infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are routinely used to verify the position and the tip of the ETT in the airway, however verification of the cuff position remains obscure.

Official Title
-----------------
Senior Atending Anesthesiologist

Conditions
-----------------
Endotracheal Tube, Cricoid Cartilage, Ultrasound

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound of the airway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing general anesthesia requiring endotracheal intubation Exclusion Criteria: Patients with any anatomical airway deformity or mass

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 71 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Microcuff ETT<br>Patients intubated with microcuff ETT | Diagnostic Test: Ultrasound of the airway<br>* Placing ultrasound on the neck after intubation<br>|
| Non-microcuff ett<br>Patients intubated with regular ETT | Diagnostic Test: Ultrasound of the airway<br>* Placing ultrasound on the neck after intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualize the saline-filled cuff of the endotracheal tube | The primary objective was to visualize the saline-filled cuff of the endotracheal tube in relation to the cricoid and tracheal rings | 3 months |