linjc16/ctgov huggingface dataset:
Protein Extrusion and Postprandial Amino Acid Handling

Study Overview
=================
Brief Summary
-----------------
The bulk of research that has investigated the effect of dietary protein on muscle tissue in humans has used isolated, minimally processed protein powders. However, the protein that we consume on a daily basis has typically undergone various processing methods, and evidence suggests these can change the way our bodies metabolise the protein. 'Extrusion' is a common processing method that uses high pressure to produce protein containing cereals and meat replacement foods. There is currently no research looking at how extrusion affects the way a protein source is digested and absorbed in humans. This study will compare the availability of ingested protein in the blood in the hours following consumption of an extruded versus a non-extruded source.

Official Title
-----------------
The Impact of the Extrusion Process During Dietary Protein Production on in Vivo Postprandial Amino Acid Availability

Conditions
-----------------
Postprandial Plasma Amino Acid Availability

Intervention / Treatment
-----------------
* Dietary Supplement: Dry protein blend ingestion
* Dietary Supplement: Extruded protein blend ingestion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18 and 30. Metabolically healthy Exclusion Criteria: Any metabolic impairments cardio/pulmonary diseases. Chronic use of the over the counter medicine A personal or family history of epilepsy, seizures or schizophrenia. Allergic to mycoprotein/Quorn/edible fungi/environmental mould products.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Blend<br>A dry blend of mycoprotein and pea protein. | Dietary Supplement: Dry protein blend ingestion<br>* Ingestion of protein blend powders mixed in water<br>|
| Experimental: Extrudate<br>An extruded blend of mycoprotein and pea protein | Dietary Supplement: Extruded protein blend ingestion<br>* Ingestion of protein blend powders mixed in water<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma amino acid concentrations | The rate of appearance of amino acids ingested in the drink | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | The concentrations of glucose in the blood | 5 hours | 
| Serum insulin | The concentration of insulin in the blood | 5 hours | 
| Resting metabolic rate | The amount of energy used to digest the protein | 5 hours |
Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet

Study Overview
=================
Brief Summary
-----------------
The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be analysed and statistical analysis will look at correlation between demographics, dietary habits and milk composition.

Official Title
-----------------
Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet

Conditions
-----------------
Breast Milk Collection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) Mothers who intend to breastfeed the infant at least 80% of the daily feeding Mothers who can comply with the study requirements Mothers who sign the informed consent form in writing and can read and write Hebrew. Exclusion Criteria: Participation in any other studies involving investigational or marketed products Is consuming alcoholic drinks and is a drug abuser. Is suffering from chronic disease Presence of psychosis and severe post-partum depression. Mothers who have given birth to twins or multiples Mothers who received chemotherapy or isotopes during pregnancy investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements. Infants: Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mothers for term infants<br>Lactating mothers | |
| Mothers for preterm infants<br>Lactating mothers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of natural lipids in human breast milk of Israeli's mothers | exploratory study | 30-60 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal diet survey | exsploratory study | 30-60 days after delivery |
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus Limbal Relaxing Incision (LRI) Patients

Study Overview
=================
Brief Summary
-----------------
A prospective evaluation of postoperative corneal aberrations and visual parameters in patients assigned to either an AcrySof IQ Toric intraocular lens (IOL) group or a group implanted with a SN60WF IOL and having concomitant limbal relaxing incision.

Official Title
-----------------
Comparison of Corneal Aberrations and Visual Outcomes in AcrySof IQ Toric Patients Versus LRI Patients

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: Toric
* Procedure: Limbal Relaxing Incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operable cataracts good ocular health 0.5 D to 2.0 D of corneal astigmatism Exclusion Criteria: > 2.0 D astigmatism irregular astigmatism prior or ongoing corneal disease or scarring history of ocular disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Toric IOL<br>AcrySof IQ Toric IOL | Device: Toric<br>* Unilateral implantation of the AcrySof IQ Toric IOL<br>|
| Active Comparator: Limbal Relaxing Incision<br>AcrySof IQ with Limbal Relaxing Incision | Procedure: Limbal Relaxing Incision<br>* Unilateral implantation of a AcrySof IQ (SN60WF) IOL with concomitant LRI at the time of surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal aberration |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Toric, IOL, AcrySof, LRI
The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear

Study Overview
=================
Brief Summary
-----------------
This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

Detailed Description
-----------------
A tear of the rotator cuff is one of the most common disorders of the shoulder. It is assumed that a large Critical Shoulder Angle (CSA) is associated with the occurrence of rotator cuff tears. This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

Official Title
-----------------
GTA-The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear - a Comparative Study.

Conditions
-----------------
Rotator Cuff Tear

Intervention / Treatment
-----------------
* Other: data analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient after an arthroscopic rotator cuff repair 1 to 4 years postoperative Presence of pre-operative radiography of the shoulder Exclusion Criteria: Massive irreparable cuff tear Chronically retracted tendons and atrophic rotator cuff muscles Partial arthroscopic repair Absence of pre-operative radiography in neutral rotation

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 |
| --- | --- |
| rotator cuff lesion<br>patients treated for traumatic or degenerative rotator cuff lesion | Other: data analysis<br>* Data is extracted from the existing medical records and from the Rotator Cuff Repair Database (RCR_USB). The GTA (determined as the angle between a line parallel to the humerus diaphysis passing through the humeral head center of rotation and a line connecting the upper border of the humeral head to the most superolateral edge of the greater tuberosity) is determined.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Constant Score | This scoring system consists of four variables that are used to assess the function of the shoulder. The right and left shoulders are assessed separately. The subjective variables are pain and activity of daily life (ADL) (sleep, work, recreation / sport) which give a total of 35 points. The objective variables are range of motion and strength which give a total of 65 Points (the higher the score the better the shoulder function). | 1 year (before surgery and 1 year after surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Shoulder Angle (CSA), Greater Tuberosity Angle (GTA)
Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer

Official Title
-----------------
Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: beauty care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer with no metastasis receiving adjuvant chemotherapy Exclusion Criteria:

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br> | Other: beauty care<br>* beauty care performed before each chemo cycle<br>|
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life questionnaire | body image | up to 12 months |
Effect of Cherry Powder Supplementation on Vascular Function

Study Overview
=================
Brief Summary
-----------------
Examining the effect of four weeks of cherry powder supplementation on flow mediated dilatation

Official Title
-----------------
Effect of Cherry Powder Supplementation on Vascular Function

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

Intervention / Treatment
-----------------
* Dietary Supplement: Cherry powder
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physically inactive no prescription medications Exclusion Criteria: physically active taking prescription medication

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement<br> | Dietary Supplement: Cherry powder<br> <br> Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilatation |  | change from baseline to 4 weeks dietary supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma nitrite concentration |  | change from baseline to 4 weeks dietary supplementation | 
| Plasma nitrate concentration |  | change from baseline to 4 weeks dietary supplementation |
Incidence of Pancreatic Fistula After Radical Gastrectomy

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients.

Detailed Description
-----------------
Pancreatic fistula, which can lead to fatal end, is one of the most serious complications after radical gastrectomy. It is usually treated as a key factor to evaluate the quality of gastrectomy. The incidence of pancreatic fistula is far different between different areas, knowing the prevalence of pancreatic fistula and risk factors can help us to prevent pancreatic fistula and improve the short time outcome of gastric cancer surgery treatment. So, we designed this perspective, multi-center study to investigate the incidence of pancreatic fistula and its outcome in China.

Official Title
-----------------
Investigation of Incidence of Pancreatic Fistula After Radical Gastrectomy in Gastric Cancer Patients

Conditions
-----------------
Gastric Cancer, Pancreatic Fistula, Complication

Intervention / Treatment
-----------------
* Diagnostic Test: Amylase Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathological confirmed stomach adenocarcinoma preoperative curatively resectable tumor Exclusion Criteria: pancreas resection emergent surgery due to gastric cancer acute complications cancer of gastric remnant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Amylase Test<br>gastric cancer patients receiving radical gastrectomy | Diagnostic Test: Amylase Test<br>* body fluid amylase will be tested after radical gastrectomy in scheduled interval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Pancreatic Fistula | the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients | in 30 days following gastrectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Classification of Pancreatic Fistula | the percentage of different grades of pancreatic fistula, including Grade BL, Grade B and Grade C | in 30 days following gastrectomy | 
| The mortality of Grade B and C Pancreatic Fistula | the percentage of patients died of Grade B or C pancreatic fistula | in 30 days following gastrectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrectomy, Gastric Cancer, Pancreatic Fistula
A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.

Official Title
-----------------
A Single Arm Open Label Study to Evaluate the Pharmacodynamics and Safety of a 4 wk Treatment With BI 144807 in Patients With Newly Diagnosed Wet Age Related Macular Degeneration (wAMD)

Conditions
-----------------
Wet Macular Degeneration

Intervention / Treatment
-----------------
* Drug: BI 144807


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration Exclusion criteria: Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 144807<br>twice daily | Drug: BI 144807<br>* twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in CRT as Measured by SD-OCT on Day 29 | Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29. | Baseline (day 1) and day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29 | Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing. | Baseline and day 29 |
Use of Activated Recombinant Human Factor VII in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA). The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

Official Title
-----------------
A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

Conditions
-----------------
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-operative bleeding according to pre-defined criteria for critical bleeding

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: activated recombinant human factor VII|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of critical, serious adverse events |  | Within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical drainage volume |  | For the duration of the trial | 
| Amount of transfusions |  | For the duration of the trial |