linjc16/ctgov huggingface dataset:
Header Burden in Football (Soccer)

Study Overview
=================
Brief Summary
-----------------
To assess the realistic magnitude of the header burden in children's and youth' football in eight European countries. In a cross-sectional observational design, one match of 60 different teams in each of the eight European countries were monitored via video recording throughout the second half of the regular season 2017/18 and the first half of the regular season 2018/19. Clubs with (female, male, or mixed) Under-10, Under-12 and female and male Under-16 teams were invited to participate. Header frequencies and types were analysed using standardized heading registration forms. Additionally, head injuries were recorded using standardized head injury registration forms.

Official Title
-----------------
The Header Burden in Children's and Youth' Football (Soccer)

Conditions
-----------------
Header Frequencies, Head Injuries

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) officially registered in the football association 2) regular training participation 3) regular participation in official matches

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Under-10<br> | Other: No intervention<br>* observational study<br>|
| Under-12<br> | Other: No intervention<br>* observational study<br>|
| Under-16 female<br> | Other: No intervention<br>* observational study<br>|
| Under-16 male<br> | Other: No intervention<br>* observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Header frequency | Total number of headers and further observations during match play and training sessions | 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head injuries | Head injuries during match play and training sessions | 2018 |
Hepato-duodenal Ligament Occlusion and Classic Technique in Liver Transplant

Study Overview
=================
Brief Summary
-----------------
Liver transplantation was historically associated with massive blood loss. Many factors have contributed to the decline in bleeding and transfusion in the past two decades including refinement of surgical techniques, anesthetics management and the use of point of care guided goal-directed hemostatic therapies. Increasing awareness of the adverse associations of allogenic transfusion has driven the quest for transfusion-free transplantation. Pre-operative management of preoperative anemia and targeted correction of coagulopathy is done to decrease blood transfusion. Liver transplantation is associated with the potential for massive operative blood loss, which has been recognized as one of the main causes of morbidity and mortality after liver transplantation. Therefore, a fine surgical procedure to reduce intraoperative hemorrhage is necessary for favorable outcomes of liver transplantation.

Official Title
-----------------
Hepato-duodenal Ligament Occlusion Versus Classic Technique During Recipient Hepatectomy in Liver Transplantation

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Procedure: Surgical technique surgical occlusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing Living Donor Liver Transplantation accepted according to hospital protocol All patients with liver Cirrhosis who have Porto systemic collaterals based on ct angiography Exclusion Criteria: Acute fulminant liver failure

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early occlusion of hepatoduodenal ligament<br>Early occlusion of hepatoduodenal ligament during mobilization of the liver of the recipient by using portal vein clamp or occlusive temporary bands. | Procedure: Surgical technique surgical occlusion<br>* Occlusion of hepatoduodenal ligament by clamp or occlusive bands<br>|
| classical occlusion of hepatoduodenal ligament<br>classical occlusion of hepatoduodenal ligament after mobilization of the liver of the recipient immediately before explantation by suing of portal vein clamp | Procedure: Surgical technique surgical occlusion<br>* Occlusion of hepatoduodenal ligament by clamp or occlusive bands<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of intraoperative blood loss measure by Cubic Cm |  | 2 hours |
Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

Study Overview
=================
Brief Summary
-----------------
Fibromyalgia (FM) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. The evaluation of pain mechanisms in FM has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. Rheumatoid arthritis (RA) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. FM and RA patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.

Official Title
-----------------
Pain Processing in Inflammatory and Non-Inflammatory Chronic Pain Syndromes

Conditions
-----------------
Fibromyalgia, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-70 Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM Fulfills the 2010 ACR-EULAR classification criteria for RA Healthy volunteers: No significant pain/fatigue/depression/anxiety. Exclusion Criteria: Diabetes Cancer Advanced liver, kidney or cardiovascular disease Neuropathic pain

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fibromyalgia<br>Participants who fulfill the 1990 and 2011 American College of Rheumatology Criteria for FM. | |
| Rheumatoid Arthritis<br>Participants who fulfill the 2010 American College of Rheumatology (ACR)-European League against rheumatism (EULAR) classification criteria for RA. | |
| Healthy Volunteers<br>Participants who do not have significant pain/fatigue/anxiety/depression. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Pain Thresholds | Using an algometer pressure pain thresholds will be obtained several times at the upper and lower extremities | One hour |
Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate antiproliferative effects of Arimidex in ductal lavage fluids of Breast Cancer patients. Breast cancer is the leading cause of cancer incidence and the second leading cause of cancer mortality in women. Breast duct fluid provide biomarkers to aid in risk assessment of developing breast cancer.

Official Title
-----------------
Evaluation of Antiproliferative Effects of Arimidex in Ductal Lavage Fluid in Patients With Breast Cancer

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

Intervention / Treatment
-----------------
* Procedure: Ductal Lavage Fluid Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have a history of breast cancer. Patient must be scheduled to receive standard treatment with Arimidex for adjuvant hormonal management. Patient must be willing to undergo a duct lavage. Patient must sign an Informed Consent. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer Patients<br> | Procedure: Ductal Lavage Fluid Collection<br>* Procedure of inserting a small catheter into the ductal openings in the nipple and washing out cells from inside the duct.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Antiproliferative Effects of Arimidex | Biomarker modulation study on effects of Armimidex in ductal lavage fluid from evaluable epithelial cells specimen. | Study duration 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Arimidex
In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon

Study Overview
=================
Brief Summary
-----------------
During this project the amount of SCFA produced in the colon after consumption of 2 different 13C-labelled wheat fiber fractions will be quantified.

Official Title
-----------------
In Vivo Quantification of Short Chain Fatty Acids Production in the Human Colon After Consumption of Different Cereal Fractions.

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

Intervention / Treatment
-----------------
* Dietary Supplement: Arabinoxylan oligosaccharides
* Dietary Supplement: Dietary fiber enriched bran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular diet with 3 meals a day (minimal 5 times a week) BMI between 18.5 and 27 kg/m2 Exclusion Criteria: Calorie restricted diet or other special diet during the study or during the last month prior to the study Antibiotics in the month prior to the study Former surgeries on the gastrointestinal tract, with the exception of an appendectomy use of the following types of medications with effects on the gastrointestinal tract during the last 2 weeks prior to the study (spasmolytica, anti-diarrhea, anti-constipation, probiotics) Chronic disease of the gastrointestinal tract such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation, chronic frequent diarrhea, clinically relevant lactose intolerance Pregnancy, pregnancy desire or breastfeeding Diabetes (type 1 and 2) Blood donation in the past 3 months prior to the study Abnormal hemoglobin (Hb) levels in blood, men must have a Hb level between 14.0 and 18.0 g / dL and women between 12.0 and 16.0 g / dL Participation in studies in the past year in which radiation was used.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wheat derived fiber fraction 1<br>Arabinoxylan oligosaccharides | Dietary Supplement: Arabinoxylan oligosaccharides<br> <br> |
| Experimental: Wheat derived fiber fraction 2<br>Dietary fiber enriched bran | Dietary Supplement: Dietary fiber enriched bran<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of acetate, propionate and butyrate production in the colon after consumption of each wheat derived fiber fraction |  | 2 years |
Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
In the Intensive Care (IC)-unit moxifloxacin treatment is often started with intravenous administrations. As moxifloxacin is known to have a high oral bioavailability in healthy volunteers, patients are switched to oral or enteral therapy as soon as possible. However, no data on plasma levels for moxifloxacin during such a switch-therapy in IC-patients are available. Therefore, this study aims to evaluate the moxifloxacin-plasma levels and their inter-individual variability during IV to enteral switch therapy in IC-patients.

Official Title
-----------------
Pharmacokinetic Evaluation of Moxifloxacin IV to Enteral Switch Therapy in Intensive Care Patients

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: IV and enteral administration of moxifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IC patients treated with 400 mg moxifloxacin IV (once a day) that can be switched to enteral administration of 400 mg moxifloxacin. IV steady state Hemodynamic stability Normal enteral feeding without prokinetics Presence of arterial line Informed consent ≥ 18 jaar Exclusion Criteria: Dialysis patients Creatinine clearance < 30 ml/min Transaminase levels > 5x upper limit

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV and enteral administration of moxifloxacin<br>IV and enteral administration of moxifloxacin | Drug: IV and enteral administration of moxifloxacin<br>* IV and enteral administration of moxifloxacin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Pharmacokinetics will be followed. | 2 days |
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

Study Overview
=================
Brief Summary
-----------------
An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.

Official Title
-----------------
An Open-label, Randomized, Single-dose, 2X3X3 Partial Replicate, Crossover Study to Compare the Pharmacokinetics and Safety Between a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a Fixed Dose Combination of Fimasartan/Amlodipine and Rosuvastatin in Healthy Male Subjects

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subject, aged 19- 50 years Exclusion Criteria: History of clinically significant hypersensitivity to study drug, any other drug Hypotension or hypertension Active liver disease History of gastrointestinal disease History of excessive alcohol abuse Participation in any other study within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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: 1<br>A fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin | Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin<br> <br> |
| Active Comparator: 2<br>Co-administration of Fimasartan/Amlodipine combination drug and Rosuvastatin | Drug: Fimasartan/Amlodipine combination drug, Rosuvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum concentration of drug in plasma) of Fimasartan, Amlodipine and Rosuvastatin |  | 0 72 hour after medication | 
| AUCt (Area Under the Curve from the dosing time to the last measurable concentration) of Fimasartan, Amlodipine and Rosuvastatin |  | 0 72 hour after medication |
Reason Evaluation of Initial Treatment Failure in Patients With CAP

Study Overview
=================
Brief Summary
-----------------
This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for Injection) on the early deterioration or progression (<72 h of treatment) of community acquired pneumonia and to study the effect of the early deterioration or progression on the prognosis of community acquired pneumonia.

Official Title
-----------------
Reason Evaluation of Initial Treatment Failure in Patients With Community Acquired Pneumonia

Conditions
-----------------
Community-acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18y. Diagnosed with CAP. Need hospitalization. Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam antibiotics for injection +/- Azithromycin for Injection as initial treatment. Signed informed consent form. Exclusion Criteria: Patients who meet any of the following criteria will not be included in the study: Pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission. Start antibiotic treatment before admission. Gestational period or suckling period. Admitted to ICU. Immunocompromised patients. Pneumonia is the terminal event of a serious disease. Tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis. Allergic to the antibiotics of the study.

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 |
| --- | --- |
| Moxifloxacin group<br> | Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection<br>* Moxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and β-lactams group will be given β-lactam antibiotics for injection +/- Azithromycin for Injection.<br>|
| β-lactams group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early deterioration or progression rate |  | 3 days |
Phase I/II Safety Study of IPI-504 in Relapsed/Refractory Stage IIIb, or Stage IV Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability and maximum tolerated dose of IPI-504 in patients with non-small cell lung cancer (NSCLC). The study will examine how IPI-504 is absorbed, distributed, metabolized and eliminated by the body. The study will also evaluate the anti-tumor activity of IPI-504.

Detailed Description
-----------------
IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90), an emerging and recently identified target for cancer therapy. Hsp90 is a protein chaperone that plays a central role in maintaining the proper folding, function and viability of various client proteins. Many of the client proteins stabilized by Hsp90 are oncoproteins and cell-signaling proteins important in cancer cell proliferation and cancer cell survival. This clinical trial will study the effects of IPI-504 in a molecularly defined sub-group of patients who carry client proteins found in non-small cell lung cancer.

Official Title
-----------------
A Phase I/II Study to Investigate the Safety, Tolerability and Potential Activity of IPI-504 in Relapsed and / or Refractory Stage IIIb (With Malignant Pleural or Pericardial Effusion), or Stage IV NSCLC Patients

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: IPI-504


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed diagnosis of a Stage IIIb (with malignant pleural or pericardial effusion) or Stage IV NSCLC Measurable disease by RECIST criteria. Exclusion Criteria: Treatment for NSCLC with any approved or investigational product within 2 weeks of the start of IPI-504 treatment for any small molecule therapy; within 4 weeks of the start of IPI-504 treatment for any biologic or any conventional chemotherapy. Inadequate hematologic or renal or hepatic function Previous treatment with 17-AAG, DMAG or other known Hsp90 inhibitor.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IPI-504|IV Hsp90 inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine potential anti-tumor activity of IPI-504 in molecularly defined sub-groups of patients by RECIST criteria |  | Every 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer, Cancer of the lung, Non-small cell lung cancer