linjc16/ctgov huggingface dataset:
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This study describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.

Official Title
-----------------
Effect of Partial Neuromuscular Blockade by Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea-before and After Three Month CPAP Treatment. A Non-randomized, Non-blinded Study.

Conditions
-----------------
OSA, CPAP, Rocuronium, Neuromuscular Blockade, Hypoxic Ventilatory Response

Intervention / Treatment
-----------------
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male with diagnosed moderate OSA (AHI 15-30), untreated, but planned for CPAP treatment. Healthy except for OSA and well controlled tablet treated hypertension where the treatment has not been changed during the last 3 month. None smokers. 18-70 years old. BMI <35. Exclusion Criteria: If they don´t fit the inclusion criteria

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rocuronium<br>Intravenous infusion of rocuronium with the goal of TOF 0.70 and >0.90 | Drug: Rocuronium<br>* Partial neuromuscular blockade with rocuronium with a TOF 0.70<br>* Other names: CPAP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxic ventilatory response |  | At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypercarbic ventilatory response |  | At baseline, with CPAP, at TOF 0.70 and at TOF >0.90. At diagnosis and after 3 month of CPAP treatment at home | 
| Hypoxic ventilatory response |  | At diagnosis and after 3 month of CPAP treatment at home | 
| Hypoxic ventilatory response during acute CPAP treatment |  | At diagnosis and after 3 month of CPAP treatment | 
| Hypercarbic ventilatory response |  | At diagnosis and after 3 month of CPAP treatment at home | 
| Hypercarbic ventilatory response during acute CPAP treatment |  | At diagnosis and after 3 month CPAP treatment at home | 
| Upper airway obstruction |  | At TOF 0.70 and TOF >0.90. At diagnosis and after 3 month CPAP treatment. |
Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.

Official Title
-----------------
Cross-over Study to Assess the Difference in Fasting Plasma Glucose (FPG) Between Vildagliptin (Galvus®/Eucreas®) and Sitagliptin (Januvia®/Janumet®) After Two Weeks

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

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: Sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes 18 to 85 years Metformin monotherapy > 4 weeks HbA1c 6.5 - 9.5% Exclusion Criteria: FPG > 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke…)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br>Experimental | Drug: Vildagliptin<br>* 50mg vildagliptin bid<br>|
| Active Comparator: Sitagliptin<br>Active comparator (drug) | Drug: Sitagliptin<br>* 100mg sitagliptin po qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin | Fasting Plasma Glucose measured on day 14. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin | Fasting Plasma Glucose on day 14 analyzed descriptively. | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus Type two, T2DM, vildagliptin, sitagliptin, FPG, DPP-4
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula

Study Overview
=================
Brief Summary
-----------------
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.

Official Title
-----------------
Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.

Conditions
-----------------
Growth

Intervention / Treatment
-----------------
* Other: Extensively hydrolyzed whey infant formula
* Other: Extensively hydrolyzed casein infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborn singleton infant Full-term (>= 37 weeks gestation) Birth weight between >= 2500 and < =4500 g 14 ± 3 days of age on enrollment Infant's mother has elected not to breastfeed baby has been exclusively formula fed a minimum of 3 days prior to enrollment Study explained and written information provided with Parent/Caregiver Informed consent signed (parent/legal representative) Exclusion Criteria: Congenital illness or malformation affecting infant feeding and/or growth Suspected or known allergy to cow's milk protein Significant pre-natal and/or post-natal disease Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements Infant has received probiotics in the seven days prior to enrollment Infant currently participating in another clinical study Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 11 Days
Maximum Age: 4 Months

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New hydrolyzed infant formula<br>New, extensively hydrolyzed infant formula | Other: Extensively hydrolyzed whey infant formula<br>* New hydrolyzed infant formula.<br>* Other names: Baby Formula;|
| Active Comparator: Commercially available infant formula<br>Commercially available, extensively hydrolyzed infant formula. | Other: Extensively hydrolyzed casein infant formula<br>* Commercially available infant formula.<br>* Other names: Baby Formula;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain | Mean weight gain (g/day) from enrollment to 4 months of age. | 4 Months |
Comparison of Two Regimens of Anesthesia for Children Undergoing Magnetic Resonance Imaging (MRI) in General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Comparison of two regimens (Sevorane/LMA ctr. Propofol/Remifentanil) for children undergoing MRI in general anesthesia.

Official Title
-----------------
Comparison of Two Regimens of Anesthesia for Children Undergoing MRI in General Anesthesia. Advantages, Disadvantages and Time Consumption Regarding the Two Regimens.

Conditions
-----------------
General Anesthesia, Children, MRI, Sevoflurane, Propofol/Remifentanil

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children aged 1 to 10 yrs. ASA 1-2 Exclusion Criteria: Allergy to soya (propofol) Allergy to Pentobarbital Allergy to Remifentanil Allergy to Sevoflurane Children undergoing blood tests or further examinations in conjunction with the MRI Children with unexplained fever Children which are evaluated not to be able to keep a open airway

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- | --- |
| anaesthesia using propofol<br>the children are anaesthetized using intravenous anaesthesia with propofol and remifentanil; a binasal catheter is used for administration of oxygen during the anaesthesia | |
| anaesthesia using sevoflurane<br>the patients are anaesthetized using sevoflurane 1 MAC; a laryngeal mask is used | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postanaesthetic recovery and behavioral score |  | 0-24 hours hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time span of the recovery process |  | 0-3 hours postoperatively |
Food Protein-induced Enterocolitis Syndrome (FPIES) in 14 Children

Study Overview
=================
Brief Summary
-----------------
Food protein-induced enterocolitis syndrome (FPIEES) is a particular non-Immunoglobulin E-mediated food allergy. A retrospective descriptive single-center study was conducted. Subjects included were children with acute FPIES who consulted the allergy department of the Nancy Regional University Hospital between November 2013 and June 2016.

Detailed Description
-----------------
As it is a descriptive study, the Primary Outcome is not a Measure. Therefore it is not possible to include the name of the measurement or measurement tool used to assess the measure in the primary outcome measure title.

Official Title
-----------------
Food Protein-induced Enterocolitis Syndrome (FPIES) in 14 Children

Conditions
-----------------
Allergy, Pediatric Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child from 0 to 17 years with acute FPIES Exclusion Criteria: -

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
| symptoms due to FPIES | description of symptoms due to acute FPIES and chronic FPIES | from november 2013 to june 2016 |
An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is aimed to evaluate response rate of the antihypertensive treatment with a calcium antagonist in real life practice, to evaluate patients' quality of life and to collect the following Serbia-specific epidemiology data on hypertension: demographic data, patents characteristics, and patients' management/treatment.

Official Title
-----------------
An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension and to Evaluate Patients' Quality of Life

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist

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 |
| --- | --- |
| 1<br>Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate proportion of patients on antihypertensive pharmacological treatment reaching SBP goals according to the ESC 2007 guidelines (<140 mmHg*). |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate proportion of patients on antihypertensive pharmacological treatment reaching DBP goals according to the ESC 2007 guidelines (<90 mmHg*). |  | 24 weeks | 
| To collect local epidemiological date on patients with hypertension (demographic data; hypertension management data: treatment, treatment changes and tolerability data). |  | 24 weeks | 
| To evaluate patients quality of life after 12 and 24 weeks by using patients quality of life questionnaire |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
essential arterial hypertension, calcium antagonist
3D Single Cell Analysis Using Cell Morphology and Organelle Scattering Texture

Study Overview
=================
Brief Summary
-----------------
The investigators will use an advanced high resolution 3D optical coherence tomography (OCT) technology to observe colon and skin images in ex vivo.

Detailed Description
-----------------
Achieved formalin-fixed paraffin embedded tissue specimens from colon cancers and/or other benign and pre-cancer colon lesions as well as melanoma and/or other benign pigmented skin lesions will be used. The achieved specimens were kept in Department of Pathology, National Taiwan University Hospital. Sections of achieved pathological specimens were put on glass slides and tissue image will be observed by 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution and suitable for single cell imaging. This study will not interfere with the normal medical practice and had no impact on patient's safety and health. All of the materials will be destroyed once the experiments are done. The enrollment criteria will be patients who underwent colon/skin surgery or examinations in NTUH with pathological specimens taken and stored at NTUH.

Official Title
-----------------
3D Single Cell Analysis Using Cell Morphology and Organelle Scattering Texture

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Participants are those who who received skin or colon surgery, with their surgical specimens preserved and stored at Department of Pathology, National Taiwan University Hospital. Exclusion Criteria: • Age younger than 20 years old.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Image of colon or skin tissue | Image of colon or skin tissue | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optical coherence tomography
Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

Study Overview
=================
Brief Summary
-----------------
Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an IP. There is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. In this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent IP.

Official Title
-----------------
Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

Conditions
-----------------
Inhalation Pneumonia, Risk Factor

Intervention / Treatment
-----------------
* Other: Risk factors and incidence of IP after inhalation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In intensive care: Any intubated patient who presented: It is a coma with GCS ≤ 12 without VAS protection, whatever the duration Either a proven inhalation, defined by the presence in the VAS of gastric fluid or food Either a suspected inhalation, defined by the extrahospital anamnesis In medicine : Any wrong way (defined by a reflex cough when taking food) Coma without intubation, regardless of duration or depth Exclusion Criteria: Patients with VAP
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inhalation pneumonia<br> | Other: Risk factors and incidence of IP after inhalation<br>* Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period.<br>|
| Proven inhalations<br> | Other: Risk factors and incidence of IP after inhalation<br>* Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period.<br>|
| Suspected inhalations (coma + anamnesis)<br> | Other: Risk factors and incidence of IP after inhalation<br>* Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period. |  | 1 day |
VPD-737 for Treatment of Chronic Pruritus

Study Overview
=================
Brief Summary
-----------------
A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments

Detailed Description
-----------------
The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 12 weeks

Official Title
-----------------
A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus

Conditions
-----------------
Chronic Pruritus

Intervention / Treatment
-----------------
* Drug: VPD-737
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic pruritus and unresponsive to current therapies Exclusion Criteria: Have chronic liver or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.25 mg VPD-737<br>0.25 mg of VPD-737 daily by mouth for 42 days | Drug: VPD-737<br>* NK1 Receptor Antagonist<br>* Other names: Serlopitant;|
| Experimental: 1 mg VPD-737<br>1 mg VPD-737 taken daily by mouth for 42 days | Drug: VPD-737<br>* NK1 Receptor Antagonist<br>* Other names: Serlopitant;|
| Experimental: 5 mg VPD-737<br>5 mg tablets of VPD-737 to be taken daily by mouth for 42 days | Drug: VPD-737<br>* NK1 Receptor Antagonist<br>* Other names: Serlopitant;|
| Placebo Comparator: Placebo<br>placebo tablets to be taken daily by mouth for 42 days | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Response Scale |  | 6 weeks |