linjc16/ctgov huggingface dataset:
Cross-cultural Adaptation and Validity of Mini Bestest in Balance Disorders in the Autonomous City of Buenos Aires: Validation Study Protocol

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to carry out the cross-cultural adaptation of the Mini BESTest (a balance assessment scale) into Argentine Spanish, as well as to study its validation in patients with peripheral vestibular disorders in the autonomous city of Buenos Aires.

Official Title
-----------------
Cross-cultural Adaptation, Reliability, Validity and Viability of the Mini Bestest in Balance Disorders Upon Admission or Readmission to Vestibular Rehabilitation in the Autonomous City of Buenos Aires: Validation Study Protocol

Conditions
-----------------
Vestibular Disease, Peripheral Vestibular Disorder

Intervention / Treatment
-----------------
* Other: Assessment scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects >18 years of age, With vestibular alterations of peripheral etiology, within the second year of evolution Time of evolution of symptoms ≤ 2 years Independent walking with or without walking assistance device Who are at the beginning of a VR program No diagnoses of psychiatric disorders or cognitive impairment, Sign the informed consent Exclusion Criteria: Who have suffered amputation in one of their lower limbs, History of neurological pathologies (stroke, multiple sclerosis, 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Assessment scale|Evaluation scale to carry out its cross-cultural adaptation and study its validity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini BESTest | Assessment scale of postural balance | 1 hour |
Market Research - Acceptability Study for a New PKU Protein Substitute

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.

Official Title
-----------------
Market Research - Acceptability Study for a New PKU Glycomacropeptide Based Protein Substitute (Dr Schär- Mevalia Amino Acids) Mevalia PKU GMPower - Vanilla

Conditions
-----------------
PKU, Phenylketonurias, Inborn Errors of Metabolism, Metabolic Disease

Intervention / Treatment
-----------------
* Dietary Supplement: GMPOWER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PKU or PKU variant requiring a protein substitute. Subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days. Patients aged 3 years of age to adulthood. Written informed consent obtained from participant or parental caregiver (as appropriate). Exclusion Criteria: Presence of serious concurrent illness Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. Any patients having taken antibiotics over the previous 2 weeks leading up to the study. Patients less than 3 years of age.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PKU GMPOWER<br>(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years | Dietary Supplement: GMPOWER<br>* (casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance | Questionnaire detailing any GI symptoms, severity and change from usual • The collection of daily data about the gastro-intestinal tolerance of the protein substitute. | 7 days | 
| Product compliance | Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. | 7 days | 
| Product palatability | Questionnaire data captured to evaluate taste | 7 days | 
| Product acceptability | Brief tick-box questionnaire on overall liking and acceptability of product | 7 days |
To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability, parallel study Of Leflunomide 20 mg tablets under fasting conditions.

Official Title
-----------------
A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

Conditions
-----------------
Rheumatoid Arthritis, Psoriatic Arthritis

Intervention / Treatment
-----------------
* Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)
* Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Leflunomide 20 mg Tablets (Geneva Pharmaceutical) | Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical)<br> <br> |
| Active Comparator: 2<br>Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.) | Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 11 days |
Two Handed Jaw-thrust on Postoperative Sore Throat After Double-lumen Endotracheal Tube Insertion

Study Overview
=================
Brief Summary
-----------------
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of two-handed jaw thrust maneuver in patients undergoing double-lumen endotracheal intubation.

Official Title
-----------------
Influence of Two-handed Jaw Thrust on Postoperative Sore Throat in Patients Undergoing Double-lumen Endobronchial Tube Insertion

Conditions
-----------------
Lung Surgery

Intervention / Treatment
-----------------
* Procedure: Two-handed jaw thrust
* Procedure: Conventional intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Patients scheduled for double-lumen endotracheal intubation Exclusion Criteria: Difficult airway Mallampatti scores greater than 3 Recent sore throat Cervical spine disease History of head and neck surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Procedure: Conventional intubation<br>* The attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust.<br>|
| Experimental: Two-hand<br> | Procedure: Two-handed jaw thrust<br>* The assistant applied two-handed jaw thrust when intubating with double-lumen tube endotracheal tube.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative sore throat for postoperative 24 h |  | At 24 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative sore throat |  | At 1, 6, and 24 hr | 
| Postoperative sore throat scores | Visual anlogue scales will be used (10: most imaginable pain, 0: no pain). | At 1, 6, and 24 hr | 
| Number of participants with postoperative hoarseness |  | At 1, 6, and 24 hr | 
| Number of participants with postoperative shivering |  | At 1, 6, and 24 hr | 
| Wound pain scores | Visual anlogue scales will be used (10: most imaginable pain, 0: no pain). | At 1, 6, and 24 hr | 
| Jaw discomfort scores | Visual anlogue scales will be used (10: most imaginable pain, 0: no pain). | At 1, 6, and 24 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, pharyngitis
A Multiple Ascending Dose Study of CSL112 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CSL112 in healthy volunteers after multiple infusions.

Official Title
-----------------
An Adaptive, Phase I, Randomised, Placebo-controlled, Sponsor-unblinded, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous CSL112 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Biological: CSL112
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and females aged 18 years to less than 55 years Body weight 50kg or greater Body mass index (BMI) between 18 and 42.0 kg/m2 Exclusion Criteria: Evidence of a clinically significant medical condition, disorder or disease Evidence of hepatobiliary disease Any clinically relevant abnormal laboratory test result Evidence or history of alcohol or substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSL112<br>Multiple ascending intravenous doses of CSL112 | Biological: CSL112<br>* reconstituted high density lipoprotein<br>|
| Placebo Comparator: Placebo<br>Multiple intravenous infusions of placebo | Biological: Placebo<br>* Normal saline (0.9%)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of drug-related adverse events |  | Up to 6 days after each infusion | 
| The frequency of redness and swelling at the infusion site |  | up to 24 hours after each infusion | 
| Clinically important elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) |  | up to 6 days after each infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile of apoA-I after multiple intravenous infusions |  | up to 7 days after each infusion |
Detection of Gut Metabolites in Mother's Milk Following Juice Intake

Study Overview
=================
Brief Summary
-----------------
The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.

Official Title
-----------------
Prospective Human Specimen Collection for Medical Research

Conditions
-----------------
Healthy Diet

Intervention / Treatment
-----------------
* Other: Pomegranate Juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-40 yrs. female subjects with no lactation problems Healthy and term delivery Healthy dietary intake (vegetarian or omnivore) Agree to donate breast milk (not colostrum) First 6 months of lactation Subjects agree to consumer 8oz. of pomegranate juice for a week prior to 2nd collection Exclusion Criteria: <20 yrs or >40 yrs. of age Subjects with lactation problems Preterm delivery Colostrum samples Lactation>6 months Subjects fail to drink juice for at least a week

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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: Juice Intake<br> | Other: Pomegranate Juice<br>* Collection of Mother's milk before and after juice consumption<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels of gut metabolites in breast milk following juice intake | Collection before and after juice intake | 7 days |
HeartStart FRx Defibrillator Event Registry

Study Overview
=================
Brief Summary
-----------------
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant/child key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.

Official Title
-----------------
HeartStart FRx Defibrillator Event Registry

Conditions
-----------------
Sudden Cardiac Arrest

Intervention / Treatment
-----------------
* Device: HeartStart FRX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered Exclusion Criteria: AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II AED used for training purposes.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected Sudden Cardiac Arrest<br>All subject with suspected of a circulatory arrest for any cause. | Device: HeartStart FRX<br>* Automated External Defibrillator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algorithm accuracy | Algorithm performance as determined by adjudication of the wave form data as aligned with the device advisement. | Up to 15 minutes after device placement | 
| Shock Delivery | Percentage of events where a shock was delivered when indicated. | 1 day | 
| Unexpected adverse events. | Frequency and severity of unexpected adverse events. | 1 day | 
| Unanticipated adverse device effects (UADE) | Unanticipated adverse device effects (UADE) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Intervals | Measurements of device performance time intervals. | 1 day | 
| Device Preparation | Percentage of events where the device prepared to shock. | 1 day | 
| Shock Energy Delivered | The amount of shock energy delivered as measured in joules with each shock. | 1 day | 
| Pad Replacement | Frequency of pad replacement. | 1 day | 
| User | Frequency of user pressing the shock button. | 1 day |
Factors Influencing Inclusion in Digestive Cancer Clinical Trials

Study Overview
=================
Brief Summary
-----------------
Since the early 1990s, evidence-based medicine has played an increasingly important role in decision-making for the treatment of patients with cancer. The highest level of evidence is attributed to the results of randomized comparative studies, and the public health authorities require proof from randomized therapeutic trials before authorizing the use of new treatments. Patients included in therapeutic trials benefit either from the best current treatment (control group) or from a treatment supposed to present a better or similar efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize the fight against cancer, French public health policies have led to the progressive implementation of successive nationwide Cancer Plans since 2003. One of the objectives is to increase the proportion of patients included in clinical research trials. Thus, the fraction enrolled in France has progressively increased but remained low at around 8% in 2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a context of socio-economic inequalities that concern resources, residence and access to services, identifying factors that determine inclusion in trials will in turn highlight the reasons for non-inclusion. The aim of this study was to determine, at a population level, the influence of demographic characteristics and socio-economic status of patients with digestive cancer on inclusion in a clinical trial. Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.

Official Title
-----------------
Factors Influencing Inclusion in Digestive Cancer Clinical Trials: A Population-based Study

Conditions
-----------------
Digestive Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with digestive cancer residing in Burgundy, France Exclusion Criteria: associated cancer
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| included in a clinical trial<br> | |
| not included in a clinical trial<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants included in a clinical trial |  | within a year after cancer diagnosis |
Influence of Priming on Goal-directed and Cue-dependent Behavior

Study Overview
=================
Brief Summary
-----------------
The current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Detailed Description
-----------------
Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. Since a change in eating-behavior and long-lasting weight loss is most problematic to achieve, the current proposal aims to investigate implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Official Title
-----------------
Influence of Priming on Goal-directed and Cue-dependent Behavior

Conditions
-----------------
Habits, Eating Behavior

Intervention / Treatment
-----------------
* Behavioral: health mindest
* Behavioral: palatability mindset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: currently dieting intolerance to provided food cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: health prime<br> | Behavioral: health mindest<br>* groups be confronted with health aspects of food items<br>|
| Experimental: palatability prime<br> | Behavioral: palatability mindset<br>* groups be confronted with palatability aspects of food items<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| behavior | change in food choice within a Pavlovian-to-instrumental transfer task (duration of complete protocol about 45 minutes, including priming (5 minutes) and pre and post measurements) | pre and post priming (directly before and directly after a 5 minutes priming paradigm) |