linjc16/ctgov huggingface dataset:
Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.

Official Title
-----------------
A Study of the Effects of Sampling Rate on Cerebrospinal Fluid (CSF) Biomarker Levels in Healthy Subjects

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

Intervention / Treatment
-----------------
* Other: Sampling Rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age is between 18 and 50 years, inclusive Judged to be in general good health based on medical history, physical exam, neuro exam, vital signs, lab profile and ECG Exclusion Criteria: Positive urine drug screen for drugs of abuse History of bleeding disorder or deep vein thrombosis History of migraine or other types of headache more than twice/month, history of spinal disc disease or chronic significant low back pain Use of blood thinning compounds within 10 days of lumbar drain placement Finding on head CT that contraindicates lumbar puncture History of spinal surgery Use of tobacco/nicotine containing products within 6 month period prior to initial lumbar drain placement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| High Sampling Rate<br>Samples will be obtained at a high rate | Other: Sampling Rate<br>* Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.<br>|
| Low Sampling Rate<br>Samples will be obtained at a low rate | Other: Sampling Rate<br>* Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Exploratory Biomarkers |  | Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours) | 
| Multiple Exploratory Biomarkers |  | Day 1 (at 0, 1.2.3.4.5.6.7.8.9.10,12,14,16,18,20,22,and 24 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker
Protein Supplementation and Weight Loss

Study Overview
=================
Brief Summary
-----------------
This randomized control trial of diet with protein supplementation is being conducted to test the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss and improvement in cardio-metabolic profile.

Official Title
-----------------
Effect of Protein Supplementation on Weight Loss and Cardio Metabolic Profile of Overweight/Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: herbalife protein shake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged between 21 -65 years Subjects with BMI > 23 Kg/m2 Exclusion Criteria: Inclusion Criteria: Subjects aged between 21 -65 years Subjects with BMI > 23 Kg/m2 Exclusion Criteria: Diabetes (type 1 and type 2) Known or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication) Angina or other chest pain that may indicate CHD by history Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) by history Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, other investigational drugs within 30 days of study entry Pregnancy or planning pregnancy during the study period by history Uncontrolled hypertension Uncontrolled hypothyroidism Sensitivity or allergy to product by history Subjects who had undergone bypass procedure Any debilitating disease such as tuberculosis, HIV by history . Unwillingness to give written informed consent for participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treament<br>herbalife protein shake along with exercise | Dietary Supplement: herbalife protein shake<br> <br> |
| No Intervention: control<br>diet and exercise only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in lipid profile |  | baseline - 3 months |
Global Hemostatic Methods in Hemophilia and Von Willebrand's Disease

Study Overview
=================
Brief Summary
-----------------
Patients with hemophilia who have the same level of deficient factor(s) may express different severity of clinical presentation and bleeding tendency. Therefore a test which could determine overall hemostasis rather than simple concentration of a single deficient factor may correlate better with clinical phenotype in these patients. The investigators will therefore study the usefulness of global hemostatic methods (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot structure) and microparticles in the prediction of severity of bleeding and estimation of response to the treatment in patients with hemophilia. Since hemophilia patients on prophylactic treatment virtually do not bleed, additional patients who are treated on demand only will be included enabling to study possible modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will correlate both those factors and clinical severity with global hemostatic methods. The investigators expect to prove that individual tailoring of the treatment, which may enable lowering the prophylactic dose of factor concentrate without increasing the risk of bleeding, is justified in some hemophilia patients. This approach would reduce the amount of necessary factor concentrate in certain patients and decrease the cost (which represents extensive burden for health care systems) of treatment without potential risk for the patients.

Official Title
-----------------
GLOBAL HEMOSTATIC METHODS IN HEMOPHILIA AND VON WILLEBRAND'S DISEASE CORRELATION WITH PATIENTS' CLINICAL STATUS AND USEFULNESS FOR TREATMENT MONITORING

Conditions
-----------------
Hemophilia A, Hemophilia B, Von Willebrand's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with bleeding disorders Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of microparticles |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia A, Hemophilia B, Von Willebrand's Disease, Endogen thrombin potential, Overall hemostatic potential, Microparticles, Fibrin clot
Natural History Study of Pyruvate Dehydrogenase Deficiency

Study Overview
=================
Brief Summary
-----------------
Pyruvate dehydrogenase (PDH) deficiency is one of the most common mitochondrial disorders. Patients with this genetic condition have difficulty utilising carbohydrates to produce energy and develop a combination of problems including seizures, poor balance, developmental delay, disability and have a reduced life expectancy. As for most mitochondrial disorders there is a lack of effective treatments. It is essential to understand the mechanisms underlying the disease in order to identify new treatments, and to understand the natural history of disease in order to prepare for clinical trials. To date, a natural history study of PDH deficiency has not been undertaken in the UK. The researchers aim to undertake the first natural history study of PDH deficiency in the UK, to describe the spectrum of symptoms, genetics, management and outcomes in both children and adult patients.

Official Title
-----------------
Natural History Study of Pyruvate Dehydrogenase Deficiency

Conditions
-----------------
Pyruvate Dehydrogenase Complex Deficiency, Pyruvate Dehydrogenase E1 Alpha Deficiency, Pyruvate Dehydrogenase E1-Beta Deficiency, Pyruvate Dehydrogenase E2 Deficiency, Pyruvate Dehydrogenase Phosphatase Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Compatible clinical history AND 2a Enzymatic confirmation demonstrating reduced PDH activity in patient cells or muscle tissue OR 2b Confirmed pathogenic mutation in a gene associated with primary PDH deficiency (PDHA1, PDHB, PDHX, PDP1, DLAT) OR 2c First degree relative with a confirmed pathogenic mutation causing primary PDH deficiency Exclusion Criteria: Patients with 'secondary PDH deficiency' that is patients who meet criteria 1 and 2a but who have received a genetic diagnosis which confirms pathogenic variants in a gene not associated with primary PDH deficiency.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient cohort<br>Non interventional study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newcastle Mitochondrial Disease Scale | Newcastle Paediatric and Adult Mitochondrial Disease Scale This is a validated scoring system for mitochondrial disease patients and measures severity of disease using multiple different clinical outcome measures and questionnaires. A higher score indicates greater disease severity. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PDH deficiency, Natural History, Outcomes, Prognosis, Genotype-phenotype correlation, Quality of life, Outcome measures
Fluid ORiented Therapy for yoUNg Asa 1patients

Study Overview
=================
Brief Summary
-----------------
In this retrospective analysis investigators will study the effects of using a minimally invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants will compare a control group to a case group; in both groups ASA 1 patients suffering from advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic was managed by using the FloTrac system; in the control group a standard hemodynamic monitoring was used.

Official Title
-----------------
Effects of the Goal-directed Fluid Therapy on ASA 1 Patients Scheduled for Intensive Debulking Surgery

Conditions
-----------------
Hemodynamics

Intervention / Treatment
-----------------
* Device: FloTrac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 Exclusion Criteria: cardiac diseases pulmonary diseases renal diseases metabolic disorders

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>patients in which standard fluid administration was applied | |
| Active Comparator: case group<br>patients in which fluids were administered according to FloTrac parameters | Device: FloTrac<br>* For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of complications |  | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of hospitalization |  | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Goal Directed Fluid Therapy
Enhancing Complex Care Through an Integrated Care Coordination Information System

Study Overview
=================
Brief Summary
-----------------
Cluster randomized controlled trial comparing care coordination incentives to pay for performance (quality measure) incentives in clinics on utilization, cost, quality, and patient experience.

Official Title
-----------------
Ambulatory Safety and Quality Program: Improving Management of Individuals With Complex Healthcare Needs Through Health It

Conditions
-----------------
Nurse Based Care Management, Health Information Technology

Intervention / Treatment
-----------------
* Other: Data collection
* Other: Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Six Clinics participating whom Care Management Plus team has worked with before Patients belonging to one of these six clinics Picked based on an algorithm designed to identify high risk patients. Clinic will review potential patients list and issue a survey with consent form Exclusion Criteria: Younger than 18 Older than 90

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care Coordination Arm<br> | Other: Data collection<br>* Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).<br>|
| Active Comparator: Quality Measure Improvement<br> | Other: Data Collection<br>* Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Utilization | Utilization includes Emergency Department visits and hospitalizations for this high risk group. | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction/Experience | Patient Assessment of Care for Chronic Conditions (PACIC; Consumer Assessment of Healthcare Providers and Systems | 0, 18 months | 
| Reduce Costs | Costs will be aggregated and compared across groups | 0, 12, 18 months | 
| Improve quality of care | 5 pre-validated quality measures will be aggregated and compared across groups. | 0,3,6,9,12,15,18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Care coordination, primary care, nurse care management, practice facilitation
Primovist Regulatory Post Marketing Surveillance (PMS)

Study Overview
=================
Brief Summary
-----------------
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice

Official Title
-----------------
Primovist Regulatory Post Marketing Surveillance

Conditions
-----------------
Liver

Intervention / Treatment
-----------------
* Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who take Primovist for liver MRI Exclusion Criteria: Patients who belong to the contraindication on the product label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)<br>* Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation in real practice (SAE/AE/ADR collection) |  | After administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of contrast effect by imaging after administration |  | Before administration | 
| Overall contrast effects by combining individual assessment |  | Before administration | 
| Assessment of contrast enhancement effect |  | After administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver MRI
The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

Study Overview
=================
Brief Summary
-----------------
To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.

Official Title
-----------------
The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: Radical resection of colon cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-100 years old; Postoperative pathology confirmed colon adenocarcinoma; The tumor is located from the cecum to the sigmoid colon; No distant organ metastasis; Exclusion Criteria: Simultaneous or metachronous multiple primary colorectal cancer; History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer) local excision procedure; palliative resection (R2 resection); pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Radical resection of colon cancer|The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year Disease-free Survival | The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis. | Within 3 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year Over-all Survival | The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis. | Within 3 years after surgery | 
| Postoperative complication rate |  | Within 30 days after surgery | 
| Postoperative mortality rate |  | Within 30 days after surgery | 
| Local recurrence rate |  | Within 3 years after surgery | 
| Distant organ metastasis rate |  | Within 3 years after surgery |
Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials

Study Overview
=================
Brief Summary
-----------------
A study in patients with depression

Official Title
-----------------
Open-Label Duloxetine Extension Phase in Patients Who Have Completed the HMDG Clinical Trial

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Duloxetine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients at least 18 years of age who have previously completed satisfactorily the Lilly sponsored previous clinical trial, and who are clinically controlled with Duloxetine, as judge by the investigator All females must test negative for a urine pregnancy test at Visit 1. Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study. Women who are pregnant or breast-feeding may not participate in the study. Must sign the informed consent document (ICD). Exclusion Criteria: Have received treatment within the last 30 days with a drug ( not including study drug) that has not received regulatory approval for any indication at the time of study entry. Patients who have entered the optional tapering period of the previous study. In the opinion of the investigator, patients judged to be at serious suicidal risk. Treatment with a MAOI within 14 days prior to Visit 1 or potential need to use MAOI during the study or within 5 days of discontinuation of the study drug. Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital signs |  |  |