linjc16/ctgov huggingface dataset:
Study of Hepatic Glucose Production and De Novo Lipogenesis in Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the amount of hepatic glucose production derived from gluconeogenesis and glycogenolysis in the post-absorptive state in patients with cystic fibrosis. II. Determine de novo lipogenesis in relationship to resting energy expenditure in this patient population.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo an oral glucose tolerance test (OGTT) in which blood is drawn from an IV in the arm 6 times over 3 hours. After the first blood draw, patients receive a beverage containing sugar and write down everything they ate and drank during the 24 hours before study entry. Patients also undergo a dual energy x-ray absorptiometry (DEXA) scan over 15 minutes. Within 2 weeks after the OGTT, patients keep a journal of everything they ate and drank over 3 days. Patients are fed a selected meal the following evening and receive saline fluids IV overnight. During the night, patients receive 2 doses of oral doubly labeled water. The next morning, patients receive [1,2-13C]acetate IV. A liquid mixed meal (Ensure Plus) is ingested hourly throughout the day. Patients also undergo hood indirect calorimetry over 30 minutes twice to measure resting energy expenditure. All urine is collected.

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of cystic fibrosis OR Normal healthy volunteer; not an endurance-trained athlete No colonization with Burkholderia cepacia --Prior/Concurrent Therapy-- Endocrine therapy: At least 2 months since prior oral or IV corticosteroids; low-dose inhaled corticosteroids allowed Other: Short-acting insulin therapy allowed; at least 24 hours since prior long-acting insulin (i.e., neutral protamine Hagedorn, or ultalente); at least 4 weeks since prior oral or IV antibiotics; no hospital admissions within the past 6 weeks --Patient Characteristics-- Hepatic: No elevation of SGOT or SGPT within the past 3 months Other: Must be medically stable; diabetes mellitus allowed; weight stable within the past 3 months; not pregnant; no prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
Trace Element During Anesthesia Insertion and Surgery-

Study Overview
=================
Brief Summary
-----------------
Trace elements are micronutrients that are of vital important importance to human health and are involved in the process of many key human functions including the immune response, antioxidant defense and wound healing. Deficiency in a single element can manifest with multiple systems and can have significant organ impact. Research has shown correlation between deficiencies in trace elements and increased risk for infections, sepsis, multi organ failure and mortality. However relatively few studies examined the impact of perioperative changes in trace elements and patients' postoperative outcomes. In this prospective observational cohort study, we aim to examine the impact of perioperative changes in trace elements on postoperative outcomes, morbidity and mortality. This study will include patients aged 18 and above undergoing elective surgeries under general anesthesia at Rabin Medical Center. In the operating room blood samples will be collected from all study participants in the beginning of surgery and at the end of surgery. Collected samples will be sent for analysis of periodic table elements to assess the perioperative period changes in trace elements measured in whole blood. Participants intraoperative and postoperative data will be collected. All postoperative complications will be documented. Perioperative changes will be correlated with participants' postoperative outcomes using computer analytical correlations.

Official Title
-----------------
Monitoring Trace Element During Anesthesia Insertion and Surgery- A Prospective, Observational, Cohort Trial

Conditions
-----------------
Trace Elements

Intervention / Treatment
-----------------
* Other: Collecting blood specimens


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients 18 and above Patients undergoing elective surgeries (as detailed above) under general anesthesia. Patients who can read and write Hebrew Exclusion Criteria: Emergency surgery Regional anesthesia only

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Cohort<br>Patients aged 18 and above undergoing elective surgeries (including general surgery, neurosurgery, ear nose and throat surgeries, cardiac surgery, orthopedic surgeries, vascular surgeries and urological surgeries) at Rabin Medical Center under general anesthesia | Other: Collecting blood specimens<br>* Blood samples will be collected from all study participants at different required timelines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periodic trace elements measured in whole blood before and after surgery under general anesthesia. |  | 24 hours from surgery |
Blood Mercury Levels Following Retrograde Amalgam Surgeries

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the blood's mercury level of patients who had amalgam root end filling surgeries. It is to be examined if the mercury concentration in blood is elevated by using amalgam retroseal.

Detailed Description
-----------------
A total of 14 patients who needs surgical root canal therapy (SRCT) participated in this clinical study. The Isfahan University Human Subjects Review Committee approved the protocol of the study. All patients filled in the consent form. Apicoectomy with retrograde amalgam filling performed for all participant. Blood samples were collected in three period of time immediately before and immediately after each surgery and also one week later. Each time 10 ml blood was drawn from each patient. Analysis of total mercury in blood samples was performed using cold-vapor atomic absorption spectrometry

Official Title
-----------------
Blood Mercury Levels Following Retrograde Amalgam Surgeries

Conditions
-----------------
Blood Mercury Concentration

Intervention / Treatment
-----------------
* Procedure: Amalgam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years without physician-diagnosed psychological, behavioral, neurological, immunosuppressive, or renal disorders having a tooth that required apical surgery Exclusion Criteria: using tobacco and alcohol one week before surgery and during the study dealing with mercury in their job like dentists, stonemason, mine workers

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

Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Amalgam|In all surgical intervention a zinc free amalgam (Tytin. Kerr Sybron Crop., Romulus, MI) was used in the root end prepared spaces as root end filling material. Blood samples were collected in three period of time immediately before and immediately after each surgery and also one week later.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood mercury concentration |  | within the 7 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amalgam, Mercury, Endodontics, Apicoectomy
Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program

Study Overview
=================
Brief Summary
-----------------
Subjects in this study have recently had or are scheduled for a (percutaneous coronary intervention) PCI as part of their normal, routine medical care. This procedure should restore the blood flow in the vessels of the heart. Recent studies have shown that stable patients who undergo PCI and are discharged home after 4 hours of observation do not suffer any more complications compared to patients who stay in the hospital overnight. In addition, studies suggest that patients express increased satisfaction at being discharged after 4 hours. The University of Chicago is one of the first US medical centers to institute a formal program of same-day discharge after PCI. This study will seek, through a analysis of medical information and satisfaction questionnaires, to assess whether this particular same-day discharge program can improve patient satisfaction and preserve patient safety.

Official Title
-----------------
Patient Satisfaction and Safety Outcomes After Enrollment in a Same-Day (SD) Percutaneous Coronary Intervention Program

Conditions
-----------------
To Evaluate Clinical Outcomes, Safety, and Satisfaction of Patients Who Have Participated in a Same Day Outpatient Percutaneous Coronary Artery Intervention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 and up undergoes coronary angiography in the Cardiac Catheterization Laboratory Exclusion Criteria: if the subject declines participation

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 |
| --- | --- |
| Subjects who are designated to receive same-day PCI<br> | |
| Subjects who had been admitted to the hospital after their PCI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate clinical outcomes, safety, and satisfaction of patients who have participated in a same-day outpatient percutaneous coronary artery intervention program |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
percutaneous coronary artery intervention, coronary disease
Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines

Official Title
-----------------
A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines

Conditions
-----------------
Glabellar Frown Lines

Intervention / Treatment
-----------------
* Biological: QM1114-DP
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 18 years or older Moderate to severe GL at maximum frown as assessed by the Investigator Moderate to severe GL at maximum frown as assessed by the subject Exclusion Criteria: Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment Female who is pregnant, breast feeding or intends to conceive a child during the study.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active arm - QM1114-DP<br>a Botulinum Toxin Type A (BoNT-A) | Biological: QM1114-DP<br>* QM1114-DP<br>|
| Placebo Comparator: Inactive arm - Placebo<br> | Biological: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1 | Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum frown | 1 month |
Fungemia in Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the risk factors for fungemia in a population of patients diagnosed with hematologic malignancies and eligible for chemotherapy.

Detailed Description
-----------------
The coordinating center provides all participating centers with an epidemiologic form, in order to collect data in a comparable way. The requested informations include type of malignancy and its treatment, environmental expositions, laboratory work up, antifungal prophylaxis, clinical signs of infection, microbiological findings, antifungal therapy and outcome of infection at 30 days. The planned sample size is about 300 patients to be recruited in 35 participating center over 5 years, in a retrospective-prospective fashion. Data check will be performed at the coordinating center. Missing data will be managed to minimize incomplete reports. Statistical analysis will be performed by an independent reviewer, in order to assess risk factors predictive of fungal infection and outcome.

Official Title
-----------------
SEIFEM 2015: Fungemia in Hematologic Malignancies

Conditions
-----------------
Acute Leukemia, Chronic Leukemia, Multiple Myeloma, Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with hematologic malignancies and eligible to chemotherapy Exclusion Criteria: Patients not eligible to chemotherapy

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- | --- |
| Rate of fungemia outbreak during antifungal prophylaxis |  | Since 30 days average before fungemia onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality from fungemia |  | After 30 days from fungemia onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fungemia, Hematologic malignancies
Magnetic Resonance Imaging (MRI) Using Liverspecific Oral Contrast Agent in Metastatic Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether MRI with manganese containing contrast agent detects more livermetastasis compared to CT scan

Official Title
-----------------
MR Skanning Med Leverspecifikt Oralt Kontraststof Sammenlignet Med CT Skanning Hos Colorectalcancer Patienter Med Levermetastaser

Conditions
-----------------
Neoplasm Metastasis, Liver, Colorectal Neoplasms, Magnetic Resonance Imaging, Contrast Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proved liver metastasis Exclusion Criteria: pacemaker, metal in the body, claustrophobia, pregnancy, age below 18 years, psychiatry patients

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, liverspecific, contrast, colorectal, metastases
Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Study Overview
=================
Brief Summary
-----------------
This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.

Detailed Description
-----------------
In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) . To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.

Official Title
-----------------
Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures

Conditions
-----------------
Tibial Fracture

Intervention / Treatment
-----------------
* Biological: Mesenchymal stem cell injection
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 years The presence of tibial fracture based on X ray tibial fracture is limited to diaphysial Exclusion Criteria: Addiction Pregnancy liver or kidney disease or uncontrolled diabetes or heart and lung disease immune deficiency

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell receipients<br>Transplantation of allogenic adipose derived mesenchymal stem cells in patients with tibial fracture. | Biological: Mesenchymal stem cell injection<br>* Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .<br>* Other names: stem cell transplantation;|
| Placebo Comparator: Placebo<br>Placebo injection in the site of fracture in patients with tibia fracture. | Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allogenic adipose derived mesenchymal stem cell tibial fracture
BTT-1023 in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.

Official Title
-----------------
A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group Trial

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: BTT-1023
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult-onset rheumatoid arthritis Exclusion Criteria: -

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTT1023<br> | Drug: BTT-1023<br>* intravenous<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and intensity of adverse events |  | 17 wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of the verum |  | 17 wk | 
| Disease activity |  | 17 wk | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, safety