linjc16/ctgov huggingface dataset:
Minimally Invasive Radioguided Parathyroidectomy

Study Overview
=================
Brief Summary
-----------------
The main purpose of this research study is to evaluate the effectiveness of a minimally invasive surgical approach to removing parathyroid gland(s). The researchers are also interested in analyzing abnormal parathyroid tissue for changes in genes and proteins that may contribute to overactive parathyroid gland(s).

Detailed Description
-----------------
The specific aims of this study are to determine the safety and efficacy of minimally invasive radioguided parathyroidectomy, to determine the positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas, and to differentiate adenomas from parathyroid hyperplasia. In addition, this study aims to determine the value of intraoperative parathyroid hormone assay to verify biochemical cure of primary hyperparathyroidism, to determine whether minimally invasive radioguided parathyroidectomy is cos-effective, and to collect abnormal parathyroid tissue at the time of surgery for tissue analysis.

Official Title
-----------------
Minimally Invasive Radioguided Parathyroidectomy

Conditions
-----------------
Primary Hyperparathyroidism

Intervention / Treatment
-----------------
* Procedure: Minimally invasive radioguided parathyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with biochemical evidence of primary hyperparathyroidism
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parathyroid surgery<br>Database of patients who have undergone minimally invasive radioguided parathyroidectomy | Procedure: Minimally invasive radioguided parathyroidectomy<br>* After the patient is prepared for surgery and under local anesthesia, the initial incision by the surgeon will be 2-3 cm. The surgeon will dissect in the designated quadrant until the parathyroid gland is identified.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The positive and negative predictive value of sestamibi scanning to detect parathyroid adenomas. |  | 2-3days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of intraoperative parathyroid hormone assay to verify biochemical cure or primary hyperparathyroidism |  | 2-3 days | 
| Collection of abnormal parathyroid tissue at the time of surgery for tissue analysis |  | day of surgery (1 day) |
Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.

Detailed Description
-----------------
The noble gas xenon is used for general anesthesia in clinical routine. Recent reports indicate that xenon is also used for increasing performance in high-performance sports. The purpose of this study is to establish a method for detecting xenon exposure in humans. In patients undergoing surgery with xenon anesthesia as part of routine hospital care, small blood samples (3ml) will be taken before anesthesia, during anaesthesia and at 1,2, 4, 8, 16, 24, 32, 40 and 48 hours after anesthesia. These blood samples will be analyzed for traces of xenon.

Official Title
-----------------
Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Anesthesia with inhalative application of xenon gas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years and older Xenon-based anesthesia as part of routine care Exclusion Criteria: Inability to give written informed consent Known pregnancy Hemoglobin concentration of less than 12g/dl

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 |
| --- | --- |
| Xenon<br>Patients undergoing surgery with xenon-based general anesthesia | Drug: Anesthesia with inhalative application of xenon gas<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of xenon in patient blood sample by mass spectrometry |  | Immediately before induction of anesthesia | 
| Detection of xenon in patient blood sample by mass spectrometry |  | During xenon anesthesia | 
| Detection of xenon in patient blood sample by mass spectrometry |  | 4 hours after extubation | 
| Detection of xenon in patient blood sample by mass spectrometry |  | 8 hours after extubation | 
| Detection of xenon in patient blood sample by mass spectrometry |  | 24 hours after xenon anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthesia, mass spectrometry, xenon, doping, surgery
Behavior of Children Related to Numbness After Dental Local Anesthesia

Study Overview
=================
Brief Summary
-----------------
In children, behavior management is critical to the success of pediatric dental procedures. Most of the studies on local anesthesia performed in children deal with the question how to avoid or minimize pain during injection. Due to the sensation of numbness children scratch the soft tissues and bite lips and tongue. In many cases, this may be kept in children's memory as a painful experience and may affect their behavior in the following visit. The purpose of this study is to evaluate children's reactions to the administration of local anesthetic injection in the mandible (mandibular block) and in the maxilla (supraperiosteal infiltration), and to assess their behavior in the following visit related to each type of injection.

Detailed Description
-----------------
Children between the ages of 4 to 7, undergoing dental treatment at the Department of Pediatric dentistry of the Hadassah School of Dental Medicine will participate in the study. All patients should be ASA Class I with no prior dental treatment who need at least two clinical sessions of similar operative procedures preceded by local anesthetic injection, one in each jaw, none of which due to emergency. Subjective and objective evaluation will be performed according to previously validated scales.

Official Title
-----------------
Behavior of Children in the Following Appointment Related to Numbness Perception After Dental Local Anesthesia

Conditions
-----------------
Anesthesia, Local, Anesthesia, Dental

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 4-7 Behavior: Frankel 3-4 No sedation (premedication) ASA 1 No dental treatment before Need for similar treatment in the upper and lower jaw No emergency treatment Exclusion Criteria: Need of premedication Uneven treatment in each jaw

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 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
-----------------
behavior, local anesthesia, behavior after dental local anesthesia
Comparison of Different Gfr Measurements in Chronic Kidney Diseases

Study Overview
=================
Brief Summary
-----------------
Comparison of different Gfr measurements in Chronic Kidney Diseases

Detailed Description
-----------------
Comparison of gfr measured by different method as radionuclide method and creatinine clearance

Official Title
-----------------
Resident Doctor at Clinical Pathology Departement

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Device: Gamma counter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with proven or suspected CKD who will be referred to nuclear medicine departement of Assuit University hospital and will undergo dynamic renal imaging. Exclusion Criteria: Severely ill patients Disturbed conscious level Patients on dialysis patients have oedema or ascites

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Gamma counter|DTpA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is to Compare gfr measured by radionuclide method to gfr measured by creatinine clearance in patients with CKD | Gfr can be measured by quantification of plasma and standard volume sample using a quality controlled gamma_counter and Gamma camera these techniques the central assumption that the tracer is cleared solely by glomerular filtration. | 1year |
Activation of Polyamine Catabolism in Patients With Acute Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Background: Polyamines are essential compounds in all mammalian tissues. If tissue spermidine/spermine levels, however, dramatically decrease, the cellular survival is severely endangered. Transgenic animals, where the homeostasis of cellular polyamines can be disturbed and tissue spermidine/spermine levels are decreased, acute pancreatitis evolves, indicating pancreas to be one of the most vulnerable organs for tissue polyamine catabolism. On the other hand, our own data suggests that also in other models of acute experimental pancreatitis pancreatic polyamines are changed depending on the severity of pancreatitis in such a way that the more severe pancreatitis the lower are the pancreatic polyamine levels. Minor changes were observed also in rats undergoing sham operation only. In addition of pancreatic enzymes, inflammatory mediators are also involved in the pathophysiology of the disease. CRP, IL-6, IL-8, IL-10 and Procalcitonin are useful in predicting the severity of the disease, combination of IL-6 and IL-10 at admission can predict organ failure with sensitivity of 95 %, specificity of 88 %. Hypothesis: Similar to experimental pancreatitis, blood polyamine changes are associated with acute pancreatitis also in the man. These changes are dependent on the severity of pancreatitis, but not on the etiology of pancreatitis. The changes are specific to acute pancreatitis compared with other intra-abdominal emergencies. The changes observed return to baseline during recovery. Furthermore, we assume that blood polyamine negatively correlates with IL-6, IL-8, and procalcitonin, and positively with IL-10.

Conditions
-----------------
Pancreatitis, Polyamines

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are diagnosed as acute pancreatitis. Patients who are diagnosed as either of gallstone, duodenal ulcer or bleeding, gastric ulcer or bleeding, irritable bowel syndrome, hernia, diverticulitis, retrocecal appendicitis with non-pancreatic acute abdominal pain. Exclusion Criteria: Patients who underwent operation Patients who underwent recurrent acute pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
-----------------
pancreatitis, polyamine, cytokine
Multiple Dose Study of TRx0037

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.

Official Title
-----------------
A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: TRx0037


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 55 and over No clinically important abnormal physical finding No clinically significant lab results Normal ECG Normal BP and HR BMI between 19 and 32 Weight 50 to 100 kg Able to communicate Provide written informed consent Non smokers Males to use contraception Females to be surgically sterile or post menopausal Exclusion Criteria: Administration of any IMP other than study drug within 12 weeks before entry Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol Surgical or medical condition that might interfere with IMP History of drug or alcohol abuse Clinically significant allergy requiring treatment Loss of greater than 400ml of blood within 12 weeks. Serious adverse reaction or hypersensitivity to any drug Presence of Hep B, Hep c or HIV-1 or HIV-2 at screening Presence of G6PD at screening History of methaemoglobinaemia Partner who is pregnant of lactating Positive Pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRx0037<br>Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics | Drug: TRx0037<br>* 75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability | The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population. | 19 Days (7-10 day follow up) | 
| Pharmacokinetics | The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers. | 19 Days (7-10 day follow up) | 
| Safety and tolerability | Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037 | 19 Days (7-10 day follow up) |
Effect of Chlorhexidine Skin Cleansing on Skin Flora

Study Overview
=================
Brief Summary
-----------------
Given the potential of skin cleansing with chlorhexidine as a safe, feasible, and cost-effective intervention for reducing neonatal death in developing country settings, this study follows a trial already underway in Nepal to test the impact of a single cleansing of the skin with baby wipes cotaining chlorahexidine.

Detailed Description
-----------------
This study is designed to test the impact of a single cleansing of the skin with 0.25% or 4.0% Chlorhexidine wipes on qualitative and quantitative skin flora and skin condition in newborn infants. The study takes place in the Special Care Nursery at Dhaka Shishu Hospital in Dhaka, Bangladesh.

Official Title
-----------------
Effect of Chlorhexidine Skin Cleansing on Skin Flora of Newborn Infants in Bangladesh

Conditions
-----------------
Skin Diseases, Infectious

Intervention / Treatment
-----------------
* Drug: Chlorhexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant admitted to Special Care Nursery at Dhaka Shishu Hospital less than 48 hours chronological age parental consent must be obtained Exclusion Criteria: infants being admitted for major surgical procedure which is attended by high rate of infectious complications sepsis clinically-evident skin infection generalized skin disease structural defect of the skin involving greater than 5% of the body surface with a major congenital anomaly with a known immunodeficiency

Ages Eligible for Study
-----------------
Maximum Age: 48 Hours

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Chlorhexidine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wiping of newborn skin will be done immediatly upon enrollment in study, with follow up during hosptial stay and up to two weeks to determine skin condition and presence of any kind of skin infection. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin cleansing, Bangladesh, Skin Flora, Newborn, infectious disease, chlorhexidine
Identification Sepsis Related Single Nucleotide Polymorphism (SNP) by Whole Exome Sequencing

Study Overview
=================
Brief Summary
-----------------
Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was promising genetic biomarker for sepsis patients. The present study was designed to screen several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to be a new target for the treatment of sepsis.

Detailed Description
-----------------
The study is a non-intervention, prospective observational study. Purpose of this sudy is to screening several SNPs by whole exome sequencing which can be used as genetic marker for sepsis patients. We will collect whole blood samples from patients with sepsis inRespiratory Intensive Care Unit (RICU), the Emergency Intensive Care Unit (EICU), or the Department of Surgery's ICU 301 Hospital since January 2013, and then whole exome sequencing was used to Screen SNPs which were related to sepsis. Then another 500 sepsis patients and 500 normal controls were used to validated the sequencing results.

Official Title
-----------------
Identification Sepsis Related SNP by Whole Exome Sequencing: a Prospective Observational Study

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of sepsis Patients who agree with the study Exclusion Criteria: Aged <18 years; Into the group who died within 24 hours; Agranulocytosis (<0.5 × 109 / L); Combined HIV infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| normal control<br> | |
| Sepsis group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sepsis related SNP site |  | 28 days after admitted to ICU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, SNP, mortality
Pandemic Influenza Plasmid DNA Vaccines (Needle)

Study Overview
=================
Brief Summary
-----------------
The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.

Official Title
-----------------
A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: VCL-IPT1
* Biological: VCL-IPT1
* Biological: VCL-IPT1
* Biological: VCL-IPM1
* Biological: PBS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 45 years of age Able to provide informed consent and be followed for 6 months Exclusion Criteria: No immunomodulatory therapy within the past 6 months No evidence of immunodeficiency or pregnancy No laboratory or evidence of clinically significant medical disease No history of previous pDNA immunization No influenza immunization within the past 30 days No blood donations within 30 days of screening visit No history of bleeding disorder No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br> | Biological: VCL-IPT1<br>* IM, 0.5 mg/mL, 2 injections, 0 and 21 days<br>|
| Experimental: 3<br> | Biological: VCL-IPT1<br>* IM, 1 mg/mL, 2 injections, 0 and 21 days<br>|
| Experimental: 4<br> | Biological: VCL-IPM1<br>* IM, 1 mg/mL, 2 injections, 0 and 21 days<br>|
| Placebo Comparator: 5<br> | Biological: PBS<br>* IM, 1 mL, 2 injections, 0 and 21 days<br>* Other names: Phosphate Buffered Saline;|
| Experimental: 1<br> | Biological: VCL-IPT1<br>* IM, 0.1 mg/mL, 2 injections, 0 and 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pandemic Influenza, Avian Influenza, DNA Vaccines, Antibody, T Cells, HA/NP/M2