linjc16/ctgov huggingface dataset:
Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT

Study Overview
=================
Brief Summary
-----------------
Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.

Official Title
-----------------
Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT

Conditions
-----------------
Hepatocellular Carcinoma, Cholangiocarcinoma, Metastases, Stereotactic Body Radiotherapy

Intervention / Treatment
-----------------
* Other: Measuring liver function by PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver tumor referred for stereotactic radiation therapy age > 18 years Exclusion Criteria: Impaired kidney function Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Liver tumors<br>Patients where stereotactic body radiation therapy is planned for primary or metastatic liver tumors. | Other: Measuring liver function by PET/CT<br>* Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of FDGal | Volumetric uptake of FDGal can be measured is measured by PET/CT | Before, 1 month and 3 months after stereotactic radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver function, galactose, 18-F-deoxy-galactose, PET/CT, stereotactic body radiation therapy, SBRT
Hepatic Insulin Sensitivity and Very Low Density Lipoprotein Triglyceride (VLDL-TG) Kinetics

Study Overview
=================
Brief Summary
-----------------
Obesity is associated with dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in dyslipidemia. The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during acute hyperinsulinemia using VLDL-TG and glucose tracers.

Detailed Description
-----------------
Extensive description not included.

Official Title
-----------------
Basal and Insulin Mediated VLDL-triglyceride Kinetics in Obesity; Relationship With Hepatic Insulin Sensitivity

Conditions
-----------------
Obesity, Dyslipidemia

Intervention / Treatment
-----------------
* Other: Glucose clamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy BMI < 25 kg/m2 or > 30 kg/m2 Informed consent Exclusion Criteria: Alcohol misuse Smoking Use of prescription drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose clamp<br> | Other: Glucose clamp<br>* 450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min<br>* Other names: Human insulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL-TG kinetics | VLDL-TG secretion rates(umol/min) and clearance rates (ml/min)are determined during 30 min steady state periods postabsorptively and using acute hyperinsulinemia using primed-constant infusion of ex vivo-labelled 14C-VLDL-TG tracer and traditional tracer dilution technique. | VLDL-TG kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic insulin sensitivity | Hepatic glucose production (mg/min) is determined during 30 min steady state periods postabsorptively and during acute hyperinsulinemia using primed constant infusion og 3H-glucose tracer and traditional tracer dilution technique. | Glucose kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes) |
Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH

Official Title
-----------------
Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

Conditions
-----------------
Fatty Liver, Non-alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Procedure: liver biopsy
* Other: infrared spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank Men or Women aged of 18 years or more After giving their consent to participate in research Exclusion Criteria: Known Cancer Refusal of consent Inflammatory disease

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 |
| --- | --- |
| simple fatty liver<br>patients with fatty liver disease | Procedure: liver biopsy<br> <br> Other: infrared spectroscopy<br> <br> |
| NASH<br>patients with nonalcoholic steatohepatitis | Procedure: liver biopsy<br> <br> Other: infrared spectroscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Evaluation of the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH with liver biopsy as a gold standard | through study completion, an average of 1 year |
Fat Biology, Sleep Disorders, and Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to be a key process in the development of cardiovascular disease. Endothelial dysfunction appears to be caused by both sleep disordered breathing and obesity. As endothelial dysfunction is among the first clinical marker that predicts future cardiovascular events, understanding molecular mechanisms leading to impairment of endothelial function is very important. Endothelial function requires the proper functioning of endothelial nitric oxide synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal nitric oxide synthesis in endothelial cells as caveolin-1 helps to spatially organize eNOS in close proximity to signaling proteins that are important for eNOS activation. In certain diseases however, the balance of caveolin-1 and eNOS can be disrupted resulting in impaired nitric oxide synthesis and leading to endothelial dysfunction. The investigators therefore seek to characterize levels of caveolin-1, and correlate this with the presence or absence of sleep disordered breathing, obesity, and cardiovascular disease. The current IRB protocol covers the performance of fat biopsies on subjects who have recently completed a sleep study either in the Center for Sleep Medicine or in our sleep laboratory and were found to have sleep disordered breathing or no sleep disordered breathing, subject with sleep disordered breathing who have been treated successfully with continuous positive airway pressure for 3-6 months, and subjects undergoing other studies in our lab who are obese or non-obese and subjects who have known cardiovascular disease and subjects without known cardiovascular disease.

Official Title
-----------------
Fat Biology, Sleep Disorders, and Cardiovascular Disease

Conditions
-----------------
Sleep Disordered Breathing, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Lac of contraindication for fat biopsy, inability to provide informed consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Relationship Between Age and Carpal Tunnel Size

Study Overview
=================
Brief Summary
-----------------
Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.

Detailed Description
-----------------
Participants will be taken to a hand examination room where a portable ultrasound (US) machine is present. A previously determined wrist will be examined for each of the participants. The US will be used to obtain measurements of the subjects carpal tunnel and median nerve at multiple levels in order to define its size.

Official Title
-----------------
The Relationship Between Age and Carpal Tunnel Size

Conditions
-----------------
Carpal Tunnel

Intervention / Treatment
-----------------
* Procedure: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than age 18 having bilateral wrists amenable to ultrasound examination. Exclusion Criteria: Active carpal tunnel syndrome, history of carpal tunnel syndrome any prior arm or hand surgery (including previous carpal tunnel release for any reason or previous surgery on the volar wrist) distal radius fracture deformity rheumatoid arthritis open wounds or lesions of the hand or forearm known congenital deformities of the upper extremity.

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: ultrasound carpal tunnel size on subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasound<br>Ultrasound wrists to determine carpal tunnel size | Procedure: Ultrasound<br>* This ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of carpal tunnel | using ultrasound imaging to determine size of carpal tunnel | Baseline |
Gut Microbiota Pilot Study

Study Overview
=================
Brief Summary
-----------------
Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.

Detailed Description
-----------------
Microbiota is known to effect metabolism. Patients in specific conditions like hypovolemic shock, sepsis might have changes in status of microbiota. This is pilot study to get status of microbiota from normal control. Stable patient who are admitted to ICU for observation will be gathered. Samples will be collected via rectal swab at time of admission and analyzed via Next generation sequencing.

Official Title
-----------------
Anaylsis of Gut Microbiota in ICU

Conditions
-----------------
Microbiota, Metabolism

Intervention / Treatment
-----------------
* Biological: Gut microbiota


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 17 years old Every patients who are admitted to ICU Exclusion Criteria: With history of disease such as cancer, Crohn's disease, ulcerative colitis, irritable bowel syndrome With history of immunosuppressive agents. Initial systolic blood pressure <100 Initial pulse rate > 100 Need emergent operation at brain or torso Need vasopressor, transfusion

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 |
| --- | --- |
| Stable patient<br>Stable patients who admitted to ICU for observation. | Biological: Gut microbiota<br>* Status of microbiota<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal microbiota | Status of microbiota of stable patient in ICU | 1day |
Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9

Study Overview
=================
Brief Summary
-----------------
The genetic factors associated with variability in CYP2C9 induction have not been elucidated. The hypothesis underlying this study is that following 7 days treatment with rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9 expression will be associated with the magnitude of change in INR response to warfarin and in CYP2C9-mediated warfarin metabolism.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Rifampicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Consumption of any medication during 30 days Smoking Alcohol consumption

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifampicin<br>Consecutive treatments with rifampicin and placebo | Drug: Rifampicin<br>* oral, 450 mg/day , 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Normalized Ratio (INR) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warfarin concentration |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
induction, CYP2C9, Genetic variability, Expression
Use of Saline-Washed Platelet and Red Cell Transfusions in Adult Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.

Detailed Description
-----------------
The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature. Key outcomes will be treatment related mortality (deaths at 30, 60 and 100 days) and three year survival.

Official Title
-----------------
Impact of Washed Transfusions in Adult Patients With Acute Myeloid or Lymphoid Leukemia

Conditions
-----------------
Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: previously untreated patients with a diagnosis of acute leukemia between the ages of 0 and 50 (AML) and 18 and 50 (ALL) Exclusion Criteria: all other patients

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survial Rate at 30 Days | The percentage of patients who were alive at 30 days after transfusion. | 30 days | 
| Survial Rate at 60 Days | The percentage of patients who were alive at 60 days after transfusion. | 60 days | 
| Survial Rate at 100 Days | The percentage of patients who were alive at 100 days after transfusion. | 100 days | 
| Survial Rate at 5 Years | The percentage of patients who were alive at 5 years after transfusion. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, Transfusion
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis

Study Overview
=================
Brief Summary
-----------------
Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women living with HIV.

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti
* Dietary Supplement: Yogurt not supplemented with a probiotic strain.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Confirmed HIV infection; Being treated with anti-retroviral medication for > 6 months. Exclusion criteria: Pregnancy; Hypersensitive to fermented milk; Intolerant for lactose; Complaints of bacterial vaginosis requiring treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic yogurt<br> | Dietary Supplement: Yogurt supplemented with L. rhamnosus fiti<br>* 200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.<br>|
| Placebo Comparator: Placebo yogurt.<br> | Dietary Supplement: Yogurt not supplemented with a probiotic strain.<br>* 200 ml yoghurt without L. rhamnosus fiti daily for 30 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal microbiota of HIV patients. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial vaginosis. |  | 30 days |
Treatment Adherence of Tuberculosis Medicines

Study Overview
=================
Brief Summary
-----------------
It was hypothesized that tuberculosis patients receiving multiple interventions like educations, counseling and default tracing along with DOTS were more likely to adhere to tuberculosis treatment as compared to few interventions or DOTS only.

Official Title
-----------------
Interventions to Promote Adherence to Tuberculosis Treatment Among Patients Attending Basic Medical Unit of Taluka Gambat, Pakistan

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Other: education,counseling, default tracers,quality of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient > 18years either sex diagnosed to have tuberculosis through chest x ray or sputum microscopy eligible to participate in the study Exclusion Criteria:

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: education, counselling, default tracer<br> | Other: education,counseling, default tracers,quality of care<br>* these interventions were administered along with standard treatment i.e. DOTS at the time of standard follow up of patients at clinic<br>* Other names: default tracer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients cured | Cured: If the patient was sputum smear positive (ss+ve) at the time of enrollment, completed treatment, Had negative smear on 2 occasions during follow-up | 8 months | 
| Proportion of patients completed treatment | Treatment completed: SS+ve, or SS-ve or extra-pulmonary, had a negative smear result at the end of intensive phase but no smear result at the end of treatment completed 8 month treatment | 8 months | 
| Proportion of patients died | died during the course of treatment | 8 months | 
| proportion of patients defaulted | not collected drugs for more than 2 consecutive months either sputum smear positive or negative | 8 months | 
| proportion of patients with treatment failure | Treatment failure: SS+ve, found to be smear positive at 5th month or later or SS-ve found to be smear positive at 2nd month | 8 months | 
| proportion of patients transferred out | Transferred to another TB register | 8 months |