linjc16/ctgov huggingface dataset:
Feeding Tolerance Evaluation

Study Overview
=================
Brief Summary
-----------------
Crossover study of 2 infant formulas

Detailed Description
-----------------
Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.

Official Title
-----------------
Feeding Tolerance Evaluation

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

Intervention / Treatment
-----------------
* Other: infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy newborn infant Full-term (> 37 weeks gestation) 0-2 months (birth-56 days) of age on enrollment Infant exclusively formula-fed for at least 2 days prior to enrollment Having obtained his/her legal representative's informed consent Exclusion Criteria: Known or suspected cow-milk allergy Congenital illness or malformation Significant prenatal and/or postnatal disease Currently participating in another clinical study

Ages Eligible for Study
-----------------
Maximum Age: 2 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formula 1<br>infant formula | Other: infant formula<br>* infant formulas<br>|
| Active Comparator: Formula 2<br>infant formula | Other: infant formula<br>* infant formulas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool consistency | caregivers will document on diary records | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spit-up pattern | caregivers will document on diary records | 2 weeks | 
| formula intake | caregivers will document on diary records | 2 weeks | 
| adverse events | assessed throughout the study | 2 weeks | 
| stool pattern | caregivers will document on diary records | 2 weeks | 
| mood | caregivers will document on diary records | 2 weeks | 
| sleep pattern | caregivers will document on diary records | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
formula-fed, infants
Validity of Different Prognostic Models Assessing 1 Year Survival After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Validity of MELD vs MELD XI in assessing 1 year survival after living donor liver transplantation.

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Other: retrospecive observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplantation recipients Exclusion Criteria: Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: retrospecive observational|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year survival |  | 1 year |
Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation：Success Rate and Time in Untrained Medical Personnel

Study Overview
=================
Brief Summary
-----------------
Fiberoptic Intubation is the preferred technique to difficult airway. However, when performed by untrained anesthesiologists, bronchoscopic intubation has a high rate of failure. We want to know if the Transillumination-guided Fiberoptic Intubation technique can improves the success rate and time for tracheal intubation performed by inexperienced anesthesiologists; whether this technique improves the success rate and for normal intubations when performed by inexperienced anesthesiologists as well is unknown. Therefore, the authors compared the success rate and time of Fiberoptic Intubation versus the Transillumination-guided Fiberoptic Intubation performed by anesthesiologists inexperienced in Fiberoptic Intubation.

Official Title
-----------------
Fiberoptic Intubation and Transillumination-guided Fiberoptic Intubation：Time and Success Rate in Untrained Medical Personnel

Conditions
-----------------
Transillumination-guided Fiberoptic Intubation Intubation

Intervention / Treatment
-----------------
* Device: Transillumination-guided Fiberoptic Intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: general anesthesia ASA I II Mallampati Score grade I II thyromental distance ≥6cm mouth-open ≥3cm body mass index (BMI) ≤30kg/m2 Exclusion Criteria: neck and maxillofacial surgeries potential risks for regurgitation and pulmonary aspiration in pregnancy

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intubation<br>Transillumination-guided Fiberoptic Intubation | Device: Transillumination-guided Fiberoptic Intubation<br>* Light guided, Non-invasive<br>* Other names: Light guided Bronchoscopic Intubation Technique;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to intubation |  | Within 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate and postoperative side effect |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transillumination-guided, Fiberoptic Intubation, time, success rate, intubation
Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry.

Detailed Description
-----------------
Caffeine concentrations in the vitreous Body and exzised epiretinal membranes are measured by gas-chromatography/mass spectrometry. One hour before surgery patients in the caffeine Group will receive 180mg of caffeine. in all patients vitrectomy with Membrane Peeling will be performed, due to epiretinal membranes

Official Title
-----------------
Pharmakokinetik of Caffeine in Epiretinal Membranes After Oral Intake: a Pilot Study

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Procedure: vitrectomy with membrane peeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epiretinale membrane Exclusion Criteria: none

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: caffeine group<br>180mg of caffeine will be given orally one jour before vitrectomy with membrane peeling | Procedure: vitrectomy with membrane peeling<br>* during vitrectomy with membrane peeling a prob of the vitreous body and the excised epiretinal membrane will be harvested for gas-chromatography/mass spectrometry<br>|
| Active Comparator: control group<br>no caffeine will be given before vitrectomy with membrane peeling, patients are drinking no coffee in general | Procedure: vitrectomy with membrane peeling<br>* during vitrectomy with membrane peeling a prob of the vitreous body and the excised epiretinal membrane will be harvested for gas-chromatography/mass spectrometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of caffeine in vitreous probes and epiretinal membranes | concentration of caffeine in the probes will be measuread by gas-chromatography/mass spectrometry | one hour |
Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Lower respiratory tract infections are one of the main hospitalization or mortality cause in idiopathic Parkinson's disease. Because of akinesia and articular rigidity these patient develop restrictive syndrome by reduction in the thoraco-lung compliance.The consequence is a progressive loss of the aerobic physical abilities and infection. The myotensive technique of active muscular stretching seem to increase the range of motion in healthy subject but also in patient with chronic bronchiotisis . These technics also increase the vital respiratory capacity and re enforce the muscles.So adding these technics during the period when the Parkinson's disease patient is stable would be a way of improvement .

Detailed Description
-----------------
To validate if these techniques really improve the the vital respiratory capacity, investigators randomize patient in 2 groups; one will have the standard protocol of stretching + self stretching of the same muscles (experimental group) and the other one (control group) will have the standard protocol and self stretching of forearm . Self stretching of forearm is selected to avoid bias .

Official Title
-----------------
Impact of Myotensives Techniques, With and Without Auto-reeducation, on the Vital Capacity Forced by the Patient Affected by a Honeymoon Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Procedure: with self stretching same muscle
* Procedure: with self stretching of forearm muscles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 with Parkinson's disease stable stade of pathology without any treatment modification. Exclusion Criteria: rehabilitation support or osteopathic support active smoking respiratory disease cognitives trouble any other neurologic pathology

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with self stretching same muscle<br> | Procedure: with self stretching same muscle<br>* with self stretching<br>|
| Sham Comparator: with self stretching forearm muscle<br> | Procedure: with self stretching of forearm muscles<br>* without self stretching<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage vital respiratory capacity |  | 4 weeks |
Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Study Overview
=================
Brief Summary
-----------------
Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds

Detailed Description
-----------------
Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.

Official Title
-----------------
Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Conditions
-----------------
Pressure Ulcers

Intervention / Treatment
-----------------
* Device: TheraHoney HD
* Device: SkinTegrity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects of any age Sacral wounds with necrotic tissue Exclusion Criteria: 3rd degree burns know hypersensitivity to products
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
Interventional Model Description: A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TheraHoney HD<br>Honey product | Device: TheraHoney HD<br>* Honey<br>|
| Active Comparator: SkinTegrity<br>Skin moisturizer | Device: SkinTegrity<br>* Hydrogel<br>* Other names: Hydrogel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Wounds Healed | Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Adverse events related to the presence or absence of wound infections and worsening in ulcer staging. | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin ulcers
Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Evaluate the Effect of APL180 on Endothelial Function in Patients With Familial Hypercholesterolemia

Conditions
-----------------
Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: APL180
* Drug: APL180
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed presence of familial hypercholesterolemia Women must be sterilized or post-menopausal Exclusion Criteria: Smoking an average of greater than 10 cigarettes per day History of cardiac events Very low or high body weight Treatment with fibrates or niacin High blood triglyceride levels Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: APL180<br> <br> |
| Active Comparator: 2<br> | Drug: APL180<br> <br> |
| Placebo Comparator: 3<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in forearm blood flow during each treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation
Acute Hamstring Strains in Danish Elite Soccer - Diagnosis and Biomechanical Tests

Study Overview
=================
Brief Summary
-----------------
A common soft tissue injury in sports involving sprinting and jumping is the hamstring strain. In addition to the frequency of injury, hamstring injuries are also the most recurrent soft tissue injury occurring in sport. There is a need for further research concerning diagnosis and different prognostic parameters for the rehabilitating process. The aims for this study are: A longitudinal comparison of sonographic and MRI assessments of acute and healing hamstring injuries. A study investigating different biomechanical parameters in the process of determining whether a former hamstring injured soccer player is fully rehabilitated. We hypothesize that it is possible to use electromyography, muscle strength measurements and different tests on a force platform to help determine this issue.

Official Title
-----------------
Acute Hamstring Strains in Danish Elite Soccer - Diagnosis and Biomechanical Tests

Conditions
-----------------
Strains

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute hamstring strain caused during soccer activities (match or training) Exclusion Criteria: A hamstring strain at the time for inclusion

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hamstring, Strain, Rehabilitation, muscles
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Study Overview
=================
Brief Summary
-----------------
Controversies still exists concerning the overall clinical effects of blood-based vs. crystalloid- based cardioplegic solution for myocardial protection during cardiac arrest. Both techniques are used world-wide. No larger prospectively randomized studies comparing the two methods have been reported. The aim of this study is to collect a large number of clinical data to create a proper basis for evaluation of the two techniques.

Detailed Description
-----------------
All patients admitted for aortic valve replacement with or without concomitant CABG and operated by E.Ø. or G.T. are included in the study. All preoperative, operative and postoperative data are prospectively recorded, focusing on clinical outcome parameters

Official Title
-----------------
Intermittent Cold Blood vs Crystalloid Cardioplegia in Aortic Valve Surgery

Conditions
-----------------
Aortic Valve Disease, Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Myocardial protection techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Aortic valve replacement
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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Myocardial protection techniques|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial function, |  |  | 
| postoperative ventilatory support, postoperative arrhythmia, |  |  | 
| blood transfusions, |  |  | 
| physical recovery, |  |  | 
| mortality. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs |  |  |
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease

Official Title
-----------------
A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: sumanirole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease < 7 years duration Modified Hoehn and Yahr Scale Stages I through III Age greater than or equal to 30 years old Patients or their partners must use adequate contraceptive methods Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study Exclusion Criteria: Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases. Levodopa received for 1-year accumulated interval in the last two years. Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline. Unstable dose regimes of hypnotics, anxiolytics or antidepressants Dementia History of stereotaxic brain surgery, psychosis or active epilepsy within past year. Participation in clinical trial within the previous 30 days. Malignant melanoma or history of melanoma Significant medical or pshychiatric condition

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: sumanirole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo |  |  |