linjc16/ctgov huggingface dataset:
Olaratumab (LY3012207) Patient Access for Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (STS).

Official Title
-----------------
An Open-Label, Multi-Center Patient Access Program of Olaratumab for the Treatment of Soft Tissue Sarcoma

Conditions
-----------------
Soft Tissue Sarcoma

Intervention / Treatment
-----------------
* Drug: Olaratumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are currently receiving olaratumab and who, in consultation with their treating physician, want to continue their course of therapy. Have metastatic or locally advanced unresectable soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Have given written informed consent. Have an absolute neutrophil count (ANC) ≥1,000/microliter. Females of childbearing potential and males must agree to use highly effective contraceptive precautions during treatment with olaratumab and up to 3 months following the last dose of olaratumab. A highly effective method of birth control is defined as one that results in a low failure rate (that is, <1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner. Exclusion Criteria: Breastfeeding (patients who discontinue breastfeeding would be considered eligible).

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olaratumab|Administered intravenously (IV)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clonidine Versus Midazolam for Premedication

Study Overview
=================
Brief Summary
-----------------
alpha2-agonists like clonidine offer several useful effects that make these drugs an interesting alternative to benzodiazepines for pharmacological premedication. We therefore sought to determine the effect of pre-anesthetic medication with clonidine vs. midazolam in a randomized, double-blind, placebo controlled study. Effects of pre-anesthetic medication were assessed on (1) bispectral index (BIS),(2) sedation score and visual analog scales for anxiety and pain, (3) neuropsychologic tests to assess cognitive function and (4) circulating stress hormones.

Official Title
-----------------
Effects of Clonidine and Midazolam Premedication on Bispectral Index and Recovery After Elective Surgery

Conditions
-----------------
Anxiety, Pain

Intervention / Treatment
-----------------
* Drug: midazolam
* Drug: clonidine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery ASA physical status I and II informed consent weight 50 - 100 kg Exclusion Criteria: cardiovascular disease pregnancy problems of consent due to mentally handicap or language.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Midazolam<br>Pre-anesthetic medication with midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time | Drug: midazolam<br>* midazolam, 7.5 mg p.o., 60-90 min prior to estimated induction time<br>* Other names: Dormicum;|
| Active Comparator: Clonidine<br>pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time | Drug: clonidine<br>* pre-anesthetic medication with clonidine, 150 µg p.o., 60-90 min prior to estimated induction time<br>* Other names: Catapresan;|
| Placebo Comparator: Placebo<br>Pre-anesthetic medication with an inert tablet, p.o., 60-90 min prior to estimated induction time | Drug: placebo<br>* inert tablet p.o., 60-90 min prior to estimated induction time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of premedication on bispectral index |  | prior study medication until 2 h postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of premedication on postoperative recovery |  | prior to study medication until 2 h postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bispectral index, sedation, stress hormones, cognitive function
Comparison of Postprandial Inflammation in Lean and Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify the systemic inflammatory and metabolic response of lean subjects and obese subjects to the ingestion of three caloric doses of a high-fat meal.

Conditions
-----------------
Nutritional Intervention, Nutritional and Metabolic Diseases, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: High-fat meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for lean subjects: age 25-50 20<BMI<25 waist circumference <94cm Inclusion Criteria for obese subjects age-matched to healthy subjects 30<BMI<40 waist circumference >102cm Exclusion Criteria for lean and obese subjects: Physiological or psychological diseases Allergies to food or intolerance to high-fat meal Vegetarians Chronic intake of drugs Smokers Diabetes mellitus Type I and II Debilitating kidney diseases Debilitating liver diseases Clinically established coronary heart diseases Ingestion of vitamins or dietary supplements during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lean Subjects<br> | Dietary Supplement: High-fat meal<br>* Three caloric doses of high-fat meal (500, 1000, 1500 kcal)<br>|
| Experimental: Obese subjects<br> | Dietary Supplement: High-fat meal<br>* Three caloric doses of high-fat meal (500, 1000, 1500 kcal)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 (serum) | A statistically-significant increase in serum Interleukin-6 is expected at 4h compared to 0h | 4h vs 0h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose (serum) |  | 0h, 1h, 2h, 4h, 6h | 
| Triglyceride (serum) |  | 0h, 1h, 2h, 4h, 6h | 
| Insulin (serum) |  | 0h, 1h, 2h, 4h, 6h | 
| high sensitivity C-Reactive Protein |  | 0h, 1h, 2h, 4h, 6h | 
| HDL-cholesterol |  | 0h, 1h, 2h, 4h, 6h | 
| Total cholesterol |  | 0h, 1h, 2h, 4h, 6h | 
| Total cholesterol / HDL cholesterol |  | 0h, 1h, 2h, 4h, 6h | 
| Interleukin-6 (serum) |  | 0h, 1h, 2h, 4h, 6h | 
| Glucagon-like-protein-1 (serum) |  | 0h, 1h 2h, 4h, 6h | 
| Endotoxin (serum) |  | 0h, 1h, 2h, 4h, 6h |
Combined Antibody Screening for Celiac and Diabetes Evaluation

Study Overview
=================
Brief Summary
-----------------
The CASCADE Study (Combined Antibody Screening for Celiac and Diabetes Evaluation) is an observational study whose primary goal is to show that population-based screening for advanced prediction of type 1 diabetes (T1D) and celiac disease (CD) is feasible to prevent diabetic ketoacidosis (DKA), improve celiac disease diagnosis, and ultimately gain public health acceptance to facilitate future prevention. It has two arms, a Birth Cohort and a Kids (cross sectional) Cohort.

Official Title
-----------------
Combined Antibody Screening for Celiac and Diabetes Evaluation

Conditions
-----------------
Type 1 Diabetes, Celiac Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Combined Risk Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child must be between 0 to 8 months in age or between 4 to 7 years in age. Child must be born in the state of Washington. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 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 |
| --- | --- |
| Birth Cohort<br>Newborns less than 8 months old and born in the state of Washington. | Diagnostic Test: Combined Risk Score<br>* Several factors will be analyzed to assign each subject combined risk score. This will assess the subject's risk of developing Type 1 Diabetes and/or Celiac Disease.<br>|
| Kids Cohort<br>Children ages 4-7 years and born in the state of Washington. | Diagnostic Test: Combined Risk Score<br>* Several factors will be analyzed to assign each subject combined risk score. This will assess the subject's risk of developing Type 1 Diabetes and/or Celiac Disease.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Type 1 Diabetes |  | 5 years | 
| Diagnosis of Celiac Disease |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of disease at diagnosis |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Celiac Disease, Diabetes, Celiac, Gluten, Autoantibodies
Effect of Intensive Nutritional Support in Subacute Stroke Patient

Study Overview
=================
Brief Summary
-----------------
Proper nutritional support during early rehabilitation may be beneficial for functional improvements in gaining functional independence and preventing complications in stroke patients. However, there was no consensus of proper amount of nutritional support in stroke patients. In this study, the investigators aimed to clarigy the effects of the intensive nutritional support during comprehensive rehabilitation during subacute phase to improve function in patients with first-ever strokes.

Official Title
-----------------
Effect of Intensive Nutritional Support on Functional Recovery in Subacute Stroke Patient

Conditions
-----------------
Stroke, Rehabilitation, Nutrition

Intervention / Treatment
-----------------
* Drug: Omapone Peri 724mL or Winuf Peri 654mL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute first-ever stroke patients less than 7 days after onset more than 19 years old at stroke onset ③ stroke confirmed by brain CT or MRI body mass index (BMI) <25 before the comprehensive rehabilitation ⑤ Mini Nutritional Assessment < 12 before the comprehensive rehabilitation ⑥ Fugl-Meyer assessment < 85 at 7 days after stroke onset Exclusion Criteria: Transient ischemic stroke Progressive or unstable stroke Pre-existing and active major neurological disease, e.g., spinal cord injury, Parkinson's disease, et al. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease or dementia ⑤ Advanced liver, kidney, cardiac, or pulmonary disease, e.g., advanced hepatocellular carcinoma, end-stage renal failure, et al.) A terminal medical diagnosis consistent with survival < 1 year Diabetes mellitus, Hyperlipidemia, Metabolic syndrome, Heart failure) ⑧ Pregnant or lactating women ⑨ Prohibited from taking medication (Omapone Peri 724mL or Winuf Peri 654mL)

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Intensive nutrition group<br>Standard nutritional support with additional intravenous nutrition of 500 kcal per day for 3 weeks | Drug: Omapone Peri 724mL or Winuf Peri 654mL<br>* Additional intravenous nutrition of 500 kcal per day for 3 weeks<br>* Other names: Comprehensive rehabilitation;|
| No Intervention: Control group<br>Standard nutritional support only per day for 3 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean modified Barthel Index (K-MBI) at 6 months after onset | Korean modified Barthel Index (0 100) | 6 months after onset |
Clinical Validation Study of Multi-EPI Mix

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the diagnostic validity of a new minute-MRI sequence for neuroradiological evaluation in comparison to conventional MRI.

Detailed Description
-----------------
The study aims to assess the imaging quality with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. The primary study aim is to define the AUC for diagnostic performance of minute MRI compared to conventional MRI. Included patients are those with suspiscion of cerebral pathology. Study participancts are investigated at 3T.

Official Title
-----------------
Clinical Validation Study of a Novel Minute MRI Sequence

Conditions
-----------------
Brain Diseases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Neuroradiological MRI Exclusion Criteria: - Aborted exam
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: MRI|MRI sequence without intravenous contrast|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic potential | Diagnostic performance of lesion conspicuity of new MR sequence compared to conventional sequences | At MRI scan. Diagnostic accuracy to categorize scan as normal or abnormal on a five point Likert scale compared to abnormal/normal conventional MRI. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion location determination | Anatomical localization of abnormality | At MRI scan | 
| Lesion classification | Classification into disease categories | At MRI scan | 
| Imaging quality | Artefacts | At MRI scan | 
| Diagnostic imaging quality | Diagnostic imaging quality | At MRI scan | 
| Anatomical conspicuity | Specified anatomical structures | At MRI scan | 
| Multifocality | Determine multifocal lesion | At MRI scan | 
| Ability to rule out diseases | A list of diseases | At MRI scan | 
| Lesion description | For example effect on brain parenchyma and size | At MRI scan | 
| Diagnostic confidence | Scale | At MRI scan | 
| Brain coverage | Full or lower | At MRI scan | 
| Clinical diagnostic summay report | Text | At MRI scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Neuroradiology, minute-MRI, multi EPI-mix, Clinical Validation
Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
Primary objective: Determination of safety and tolerability of GV1001 administration combined with Temozolomide (based on blood samples and adverse events). Feasibility of combining active immunisation with Temozolomide treatment. Determination of immunological response after administration of GV1001 and Temozolomide as measured by presence of DTH skin test reaction and specific T-cell responses. Secondary: Evaluation of objective tumour response The trial is an exploratory study which main objective is to estimate safety and feasibility of combining active immunisation with chemotherapy. However, the trial may also indicate the efficacy of the combination.

Official Title
-----------------
Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: GV1001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosis of malignant melanoma. Previously untreated and non-resectable disease Measurable or evaluable tumour. Age ≥ 18 and ≤ 75 years. Performance status ECOG-WHO 0, 1 and 2 (Appendix III) Written informed consent (Appendix II) Adequate bone marrow liver, heart and renal function: WBC count >3.0 x 109/L and platelets count >100 x 109/L. ASAT, ALAT <2 x upper normal laboratory value. Serum creatinine <2 x upper normal laboratory value. Exclusion Criteria: Previous treatment with chemotherapy. Clinical signs of brain metastases. Severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable cardiac or coronary artery disease. Severe active infections such as HIV or hepatitis B or Hepatitis C. Medication for severe intercurrent disease which might affect immunocompetence (e.g. immunosuppressants, systemic corticosteroids). Pregnancy, breast-feeding or absence of adequate contraception for fertile patients. Simultaneously participation in other clinical studies. Any reason why, in the opinion of the investigator, the patient should not participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: GV1001|nan|

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
-----------------
Non-resectable, advanced malignant melanoma.
The Effect of Patient Position on Postdural Puncture Headache

Study Overview
=================
Brief Summary
-----------------
We aimed to investigate the association between the position in which spinal anesthesia was performed and postdural puncture headache occurrence.

Detailed Description
-----------------
Records of patients who underwent caesarean section between January, 2013 and November, 2013 with spinal anesthesia will be retrospectively examined. Demographic data of patients, comorbid diseases, position of patient while performing spinal anesthesia, the number of spinal puncture attempts will be recorded.

Official Title
-----------------
Phase IV Study of Application Position During Spinal Anesthesia

Conditions
-----------------
Pregnancy, Headache

Intervention / Treatment
-----------------
* Other: lateral
* Other: sitting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years were included Exclusion Criteria: Conversion to general anesthesia was the exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lateral<br>spinal anesthesia performed during lateral position | Other: lateral<br>* spinal anesthesia performed during lateral position<br>|
| sitting<br>spinal anesthesia performed during sitting position | Other: sitting<br>* spinal anesthesia performed during sitting position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postdural puncture headache | patient records will be evaluated regarding post dural puncture headache | postoperative first day |
Study of the Hemispheric Specialization for Language in Subjects With Neuropsychiatric Disorders Compared to Control Subjects

Study Overview
=================
Brief Summary
-----------------
Recently, we have shown functional resonance imaging (fMRI) that variations in signal induced by a language task were significantly lower in a semantic region of the left hemisphere (comprised of that part pars triangularis of the inferior frontal gyrus and the temporal gyri medium and angular) in schizophrenic patients compared with controls matched for age, sex, level of education and handedness. Investigators wish to test the hypothesis that functional modification of the hemispherical specialization is specific language and also specific for schizophrenia.

Conditions
-----------------
Neuropsychiatric Disorders

Intervention / Treatment
-----------------
* Device: IMRf
* Other: language task and a reference task (rest and Tamil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients under 65 years Schizophrenics, bipolar or schizoaffective (DSM IV) Patients who signed informed consent Exclusion Criteria: Women with childbearing potential without effective contraception or positive pregnancy test. Contra-indications to fMRI

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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Neuropsychiatric Disorders<br>Neuropsychiatric Disorders patients | Device: IMRf<br> <br> Other: language task and a reference task (rest and Tamil)<br> <br> |
| Other: Healthy volunteers<br>control subjects matched to patients by age, sex, socio-cultural level and laterality | Device: IMRf<br> <br> Other: language task and a reference task (rest and Tamil)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation in signal (SPM99) during a language task compared to a reference task (rest or Tamil) in fMRI in anatomical regions of interest |  | baseline |