linjc16/ctgov huggingface dataset:
Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period. The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.

Official Title
-----------------
Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin

Conditions
-----------------
Infection, Closed Fractures

Intervention / Treatment
-----------------
* Drug: Cefazolin
* Drug: Vancomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 years old and 85 years old Closed fracture Fracture treatment plan is for one operation on one day (one surgical setting) Likely to follow-up with surgeon until fracture is healed Ability to understand and agree to Informed Consent Exclusion Criteria: Under 18 years old or over 85 years old Open fracture(s) Fracture requires multiple operations Other injuries requiring operations Documented allergy to Cefazolin or Vancomycin Previous history of Methicillin-resistant Staphylococcus aureus infection Previous surgery on the injured extremity within 1 year Use of antibiotics within 2 weeks before or after injury Use of antibiotics within 2 weeks before surgery Unlikely to follow-up until fracture is healed Unable to understand and agree to Informed Consent

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cefazolin<br>intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively | Drug: Cefazolin<br> <br> |
| Active Comparator: Vancomycin<br>intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively | Drug: Vancomycin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of infection |  | one year |
How Fat Influences the Brain

Study Overview
=================
Brief Summary
-----------------
The aim of the current study was to investigate the effect of a high versus a low fat meal (operationalized by high and low fat yoghurt) on homeostatic and gustatory brain regions.

Official Title
-----------------
Fat Intake Modulates Cerebral Blood Flow in Homeostatic and Gustatory Brain Areas in Humans

Conditions
-----------------
Fat Processing in the Brain

Intervention / Treatment
-----------------
* Dietary Supplement: intake of high or low fat yoghurt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male healthy Exclusion Criteria: lactose intolerance fMRI contraindications (metal implants,...)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 32 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high fat yoghurt intake<br>500 ml of a high fat yoghurt | Dietary Supplement: intake of high or low fat yoghurt<br>* intake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day<br>|
| Experimental: low fat yoghurt intake<br> | Dietary Supplement: intake of high or low fat yoghurt<br>* intake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cerebral Blood Flow due to the high or low fat yoghurt intake after 30 minutes and 120 minutes compared to a baseline measurement 30 minutes before yoghurt intake. | We were interested in differential brain activations due to the high or low fat meal. To assess this, the mentioned time points are suitable. The Cerebral Blood Flow is measured using Arterial Spin Labeling sequences in a functional magnetic resonance tomography. | 30 minutes before as well as 30 minutes and 120 minutes after fat intake | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fat ingestion, hypothalamus, insula, fMRI, CBF
Egg Intake and Risk of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal study that will collect demographic, anthropometric and dietary data to determine the relationships between meat and egg intake and the incidence of Type 2 Diabetes.

Detailed Description
-----------------
Subjects of the Adventist Health Study who are non-diabetic will provide demographic, anthropometric and dietary data at baseline. Meat and egg intake will be assessed with a validated quantitative food frequency intake questionnaire. The relationship between meat and egg intake and the incidence of Type 2 Diabetes will be determined using multivariate-adjusted logistic regression.

Official Title
-----------------
Egg Intake and Risk of Type 2 Diabetes in a Low Meat Intake Population

Conditions
-----------------
Type 2 Diabetes, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AHS 2 Participants who filled out Hospital History Questionnaire version 3 or 5 Age > 30 years Exclusion Criteria: Subjects with missing values in dietary variables were excluded from the analytic sample, missing gender age < 30 years improbable questionnaire response patterns extremes of BMI (less than 16 or greater than 60) estimated energy intake (less than 500 or greater than 4,500 kcal/d) existing cases of type 1 or type 2 diabetes at baseline inconsistent reports of T2D between HHQ version 3 and 5

Ages Eligible for Study
-----------------
Minimum Age: 31 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 |
| --- | --- |
| Seventh day Adventist adults<br>Seventh day Adventist adults recruited from the USA and Canada. Approximately 65% female and 35% male. Composed of participants with different dietary patterns and a wide variation in egg and meat intake ranging from non-consumptive to daily consumption. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk for Type 2 Diabetes (T2D) in subjects who consume different frequencies/amounts of eggs and meat. | Validated quantitative food frequency questionnaire that compares risk of T2D in subjects who consume different frequencies /amounts of egg and meat and physician diagnosis of diabetes | Change between baseline and 5 Years of follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
egg, meat, western diet, type 2 diabetes, Adventist Health Study, Vegetarian cohort, Adventist
Information About HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the behavioral effects of learning information about male circumcision and HIV risk on sexual behavior and the demand for male circumcision.

Official Title
-----------------
A Study of the Effect of Information About the Relationship Between HIV Transmission and Circumcision on Subsequent Sexual Behavior, and the Demand for Circumcision Among Circumcised and Uncircumcised Men in Malawi, Africa.

Conditions
-----------------
Sexual Behavior, Dis-inhibition

Intervention / Treatment
-----------------
* Other: Information
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will involve men between the ages of 25 and 40 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Information<br>Information about male circumcision and HIV risk | Other: Information<br> <br> |
| Placebo Comparator: Control<br>Control | Other: Control<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condom use | frequency of reported condom use across all sexual acts (never, sometimes, always) | One year after baseline survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Male circumcision | Circumcision, willingness to circumcise, circumcision of son | One year after baseline survey | 
| Condom purchases | number of condoms purchased | one year after baseline survey | 
| number of sexual partners | number of partners over last year with which individual has engaged in vaginal, anal, oral intercourse | one year after baseline survey | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malawi, Risk Compensation, Male Circumcision, Demand
Could Colour Dopper Improve the Diagnosis of Retained Placental Fragments After Second Trimester Miscarriage ?

Study Overview
=================
Brief Summary
-----------------
Value of pelvi- abdominal ultrasound and Doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.

Detailed Description
-----------------
This is a study for diagnostic accuracy test where all patients will undergo US and Doppler examination after second trimester miscarriage. Then all patients with endometrial mass on US will undergo colour Doppler then surgical evacuation and results of histopathology will be recorded. Now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, PPV and NPV of US and Doppler are the primary outcome

Official Title
-----------------
Value of Pelvic Ultrasonography and Colour Doppler in Diagnosing Retained Placental Fragments After Mid Trimester Miscarriage

Conditions
-----------------
Miscarriage

Intervention / Treatment
-----------------
* Device: ultrasoungraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy duration: early mid-trimester from 14 to 20 weeks Endometrial mass upon ultrasound examination after second trimesteric miscarriage Exclusion Criteria: Uterine congenital anomaly Patients with signs of sepsis. Negative scan after second trimesteric miscarriage

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ultrasoungraphy|pelvic ultrasonography and Doppler|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, PPV and NPV of Doppler in diagnosis of retained placental fragments after second trimester miscarriage | All patients with endometrial mass after spontineous or medical miscarriage will undergo colour Doppler examination within 1 hour of miscarriage | 60 minutes after delivery |
Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.

Official Title
-----------------
Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores) At least two well documented head circumference values recorded within the first 2 years of life Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English Exclusion Criteria: Genetically identified ASD (syndromic form of autism, e.g. fragile X) Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 10 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 |
| --- | --- | --- |
| Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD) | A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autism spectrum disorder, endophenotyping, observational
COVID-19 Tests With Saliva Specimens

Study Overview
=================
Brief Summary
-----------------
Upper respiratory swabs, such as the nasopharyngeal (NP) swab, have so far been major specimen sources used for the SARS-COV-2 molecular test. However, due to the discomfort and invasiveness of NP collection, and the expense of personal protective equipment, alternative sampling sources such as saliva are desired. The purpose of this proposed study is: 1) to examine whether saliva can be used as an specimen for the SARS-COV-2 molecular test; 2) to test if gingival crevicular fluids is a reliable specimen for the SARS-COV-2 antibodies.

Official Title
-----------------
COVID-19 Tests With Saliva Specimens

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: Saliva collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons referred for COVID-19 testing including those with COVID-19 symptoms and/or a suspected SARS-COV-2 infection or undergoing surveillance testing and Is able to give informed consent Is able to understand oral or written instructions, and Is able to mentally and physically perform self-collection of saliva using the provided collection device. Exclusion Criteria: - Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Employees of Paradigm lab and the assisted living facilities involved in the study Members of other vulnerable populations

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saliva and NP paired specimen collection<br> | Other: Saliva collection<br>* Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical evaluation of saliva as specimen for COVID-19 molecular test | We will evaluate the positive and negative agreement of saliva with nasopharyngeal swab as specimens for COVID-19 molecular test. | 1 hour |
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge

Study Overview
=================
Brief Summary
-----------------
A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.

Official Title
-----------------
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Device: LifeSeal™ Kit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject, or authorized representative, signed a written Informed Consent Form Subject is 18 years or older Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge. If female - not be of child bearing potential, or be using acceptable contraception methods. Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor. Exclusion Criteria: Subject has a history of hypersensitivity to porcine derived gelatin or collagen Subject participating in any other study involving an investigational (unapproved) drug or device. Subject with a BMI higher than 40 Female Subject states that she is pregnant or breast feeding Subject with ASA status higher than 3 Avastin use within 30 days prior to surgery Subject who underwent a prior pelvic anastomosis Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm - Standard of Care<br>The anastomosis will be created using Standard of Care only | |
| Experimental: Device arm - Standard of Care + LifeSeal™ Kit<br>The anastomosis will be created using SOC + LifeSeal™ Kit | Device: LifeSeal™ Kit<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events. |  | Up to 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Rate of anastomotic leak (both radiological and clinical leaks) |  | Up to 15 weeks post procedure or at stoma closure, whichever comes first |
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349

Study Overview
=================
Brief Summary
-----------------
The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.

Official Title
-----------------
Phase-I Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 Under Fasting Conditions in Adult Healthy Human Volunteers

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: WCK 2349 Oral
* Other: Placebo Oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be healthy males or non-pregnant females Have a Body Mass Index (BMI) between 18 and 32 (both inclusive), calculated as weight in kg / height in m2 Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations and ECG recordings. Should test negative for drugs of abuse and urine alcohol test. Exclusion Criteria: Known hypersensitivity or idiosyncratic reaction to quinolones or any other related drugs. Any history or evidence of disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

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: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WCK 2349<br>WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days. Dosage form : Oral | Drug: WCK 2349 Oral<br>* 1 dose given orally twice daily at 12 hourly interval for five days.<br>|
| Placebo Comparator: Placebo<br>Matching Placebo administered as Oral | Other: Placebo Oral<br>* Subjects will receive matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety & tolerability of multiple doses of WCK 2349 | By monitoring the adverse events reported | 12 days | 
| To evaluate the pharmacokinetics of multiple doses of WCK 2349 | Measuring Cmax Maximum observed plasma concentration. | 5 days |