linjc16/ctgov huggingface dataset:
The Undernourished Patient: Prevention and Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a nutrition intervention during a rehabilitation stay followed by nutritional advice after discharge, can improve the nutritional status of the patients after 3 months.

Official Title
-----------------
The Undernourished Patient: Prevention and Treatment

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Dietary Supplement: Nutritional support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In risk of undernutrition or undernourished according to the screening tool NRS-2002, score 3 or above. Living in Oslo, Bærum or Asker municipality. Must be able to cooperate. Exclusion Criteria: Unwilling to participate Less than 12 months life expectancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional counseling<br>Dietary supplement | Dietary Supplement: Nutritional support<br>* Nutritional support and counseling<br>|
| No Intervention: No nutritional counceling<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight change |  | Baseline and 3 months |
Pharmacokinetics of Oral Thiamine

Study Overview
=================
Brief Summary
-----------------
Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine. The aims of this study are to: Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers; Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.

Official Title
-----------------
Pharmacokinetics of High Dose Oral Thiamine

Conditions
-----------------
Pharmacokinetics in Healthy Subjects

Intervention / Treatment
-----------------
* Dietary Supplement: Thiamine
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 55 Exclusion Criteria: Non dietary thiamine supplement within two weeks of the start of the study or during the study History of thiamine deficiency Anemia (Hgb<10) History of gastrointestinal absorption disorders Taking prescription or over-the-counter medication Pregnant or breast feeding a child Alcohol and or drug abuse Smoker

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 mg Thiamine<br> | Dietary Supplement: Placebo<br>* Placebo<br>|
| Experimental: 100 mg Thiamine<br> | Dietary Supplement: Thiamine<br>* Vitamin B1<br>|
| Experimental: 500 mg Thiamine<br> | Dietary Supplement: Thiamine<br>* Vitamin B1<br>|
| Experimental: 1500 mg Thiamine<br> | Dietary Supplement: Thiamine<br>* Vitamin B1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) for whole blood |  | predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose | 
| Area Under the Curve (AUC) for plasma |  | predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose |
The Role of Progesterone and PIF for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy. The second part of the project will determine the value of Preimplantation Factor (PIF) measurement in embryo culture medium as a possible tool for improved embryo selection and the use of PIF as an early pregnancy serum marker for healthy implantation and embryo development. IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.

Official Title
-----------------
The Role of Luteal Progesterone and Preimplantation Factor (PIF) for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: IVF/ICSI treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -All women undergoing IVF/ICSI treatment at the participating clinics in either antagonist protocol or long agonist protocol will be offered participation. Exclusion Criteria: -Prior participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Standard IVF/ICSI treatment<br> | Other: IVF/ICSI treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-going pregnancy rate |  | 10th week of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 7th week of gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, IVF/ICSI, Progesterone, Preimplantation Factor (PIF)
Oral Acetyl-L-Carnitine Therapy Reduces Fatigue In Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effect of exogenous ALC on the both physical and mental fatigue in mild and moderate encephalopatic patients.

Official Title
-----------------
ORAL ACETYL-L-CARNITINE THERAPY REDUCES FATIGUE IN HEPATIC ENCEPHALOPATHY

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Dietary Supplement: ACETYL-L-CARNITINE
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Chronic hepatitis with spontaneous manifest HE (mental state grade 1 or 2 according to the West Haven criteria) and an NCT-A performance time >30 seconds; 2) Hyperammonemia (venous ammonia concentration >50 mmol/L); 3) Cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage II and III observed by endoscopy. Exclusion Criteria: 1) Major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; 2) Acute superimposed liver injury; 3) Patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; 4) Alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of HE; 5) Severe HE; 6) Administration of anti-HE medications such as neomycin, branched-chain amino acids; 7) Any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics; 8) Patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature; 9) Illiteracy.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACETYL-L-CARNITINE<br> | Dietary Supplement: ACETYL-L-CARNITINE<br>* 2 g acetylcarnitine taken orally twice a day.<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo twice per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A). Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.

Official Title
-----------------
An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients With Generalized Anxiety Disorder With an Optional Twenty-Four Week Extension

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: SR58611A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module Exclusion Criteria: Minimum total score of less than 22 on the 14-item HAM-A scale Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS) Mini-Mental State Examination (MMSE) score of 22 or less The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 60 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: SR58611A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI) Severity of Illness Score |  |  | 
| Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety, Anti-Anxiety Agents
Venous Occlusion and Limb Swelling

Study Overview
=================
Brief Summary
-----------------
Problems affecting the veins in the legs can cause discomfort and swelling. We want to see how artificially and reversibly blocking the leg veins affects swelling in the lower limb.

Official Title
-----------------
Venous Occlusion and Limb Swelling

Conditions
-----------------
Venous Occlusion

Intervention / Treatment
-----------------
* Device: Venous occlusion (leg tourniquet, made in-house)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old, able to consent Exclusion Criteria: History of cardiovascular/renal disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Trial cohort<br>Measurements taken before and after venous occlusion applied | Device: Venous occlusion (leg tourniquet, made in-house)<br>* Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg Swelling | Perometer measured leg volume from footplate to middle of knee joint (in standing position; ml) | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous Diameter | Great saphenous vein diameter at the knee, taken with duplex ultrasound (cm) | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous occlusion
Acupuncture for Post-stroke Shoulder-hand Syndrome

Study Overview
=================
Brief Summary
-----------------
Shoulder-hand syndrome，a common complication of stroke patient，which is an important factor of limb function recovery.This research aims to observe the effect and safety of Acupuncture and Traditional Chinese medicine Combined with Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome.Furthermore, the investigators will promote the treatment in community hospital.

Official Title
-----------------
Acupuncture and Traditional Chinese Medicine Combined With Rehabilitation Therapy for Post-stroke Shoulder-hand Syndrome in Community Hospital: a Multicenter，Randomized，Controlled Trial

Conditions
-----------------
Shoulder-hand Syndrome

Intervention / Treatment
-----------------
* Device: rehabilitation
* Device: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Ischemic stroke and shoulder hand syndrome,conscious,For 2 weeks to 6 months,Patients with I or Ⅱ period. Exclusion Criteria: - Disturbance of consciousness,With shoulder joint disease or muscle disease,Patients with shoulder hand syndrome Ⅲ period,Serious primary diseases such as heart,liver and kidney,Mental illness.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture with rehabilitation<br>Electric acupuncture,Chinese medicine,Chinese medicine cupping,rehabilitation,To treat five times a week,Total course is eight weeks | Device: rehabilitation<br>* rehabilitation,To treat five times a week,Total course is eight weeks<br>Device: Acupuncture<br> <br> |
| Other: rehabilitation<br>rehabilitation,To treat five times a week,Total course is eight weeks | Device: rehabilitation<br>* rehabilitation,To treat five times a week,Total course is eight weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) method Visual analogue scale (VAS) method Visual analogue scale (VAS) | To evaluate the pain in shoulder joint | 4 weeks and 8 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer scale | To evaluate the limb movement function | 4 weeks and 8 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture，rehabilitation,Shoulder-hand Syndrome
Blunt Thoracic Trauma: Definition of a Standard Operating Procedure

Study Overview
=================
Brief Summary
-----------------
Rib fractures are the most frequent injury after blunt thoracic trauma. It is very important to choose the most appropriate interventions to prevent complications. But who will benefit most of those interventions remains a challenge. This study analyses the correlation between chest X-Ray and CT scan. We also analyse different scores to predict respiratory failure.

Official Title
-----------------
Blunt Thoracic Trauma: Definition of a Standard Operating Procedure

Conditions
-----------------
Rib Fractures, Polytrauma, Thoracic Injury, Respiratory Failure

Intervention / Treatment
-----------------
* Diagnostic Test: CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polytrauma patients admitted to de ICU with a thoracic CT scan in the first 24h of arrival Exclusion Criteria: Penetrating trauma Patients referred from other hospitals

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: CT scan|Polytrauma patients with thoracic CT-scan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best predictor of respiratory complications | Compare different items to identify the best predictor of respiratory complications: resipratory failure and pneumonia. | 01/02/2021 - 18/08/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare XRay and CT | Compare findings in x-ray (read by surgeon), x-ray (read by radiologist) and CT scan | 01/02/2021 - 18/08/2022 | 
| Number of fractures to predict complications | Analyse if there is a number of rib fracture that can predict respiratory complications | 01/02/2021 - 18/08/2022 | 
| Compare scores | Compare different scores: OIS, CTS, Ribscore, Rib Fracture Score | 01/02/2021 - 18/08/2022 |
Platelets Antiaggregation Control Enhancement (PACE) Study

Study Overview
=================
Brief Summary
-----------------
Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.

Official Title
-----------------
Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study

Conditions
-----------------
Bleeding, Blood Transfusion

Intervention / Treatment
-----------------
* Device: Aggregometry+Thromboelastography
* Device: Thromboelastography Alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing surgical myocardial revascularization. Exclusion Criteria: none.
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thromboelastography alone<br>Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances. | Device: Thromboelastography Alone<br>* Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.<br>|
| Experimental: Aggregometry+Tromboelastography<br>Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin. | Device: Aggregometry+Thromboelastography<br>* Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Volume | Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir. | 12 hours after end of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of allogenic blood transfusions. | Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation. | In hospital stay (usually 5 to 8 days after operation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, blood sparing procedure, desmopressin, aggregometry, thromboelastography