linjc16/ctgov huggingface dataset:
Retrospective CT Imaging of BioComposite Interference Screw With BTB

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long-term appearance and resorption rate of biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).

Official Title
-----------------
Retrospective CT Imaging of BioComposite Interference Screw in Patients Undergoing Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Graft

Conditions
-----------------
ACL Tear

Intervention / Treatment
-----------------
* Procedure: Bioabsorbable screw fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-50 Patients who underwent primary ACL reconstruction performed by one of the study investigators at least 5 years ago Isolated ACL tear Type of graft used was bone-patellar tendon-bone autograft Type of screw used to attach graft to the tibia and/or femur was a BioComposite interference screws (Arthrex, Inc.) No degenerative joint disease on preoperative X-rays (> 50% joint space loss, presence of osteophytes) Exclusion Criteria: Revision ACL reconstructions Types of grafts other than bone-patellar tendon-bone autograft were used ACL tear with concomitant pathology Degenerative joint disease on preoperative X-ray (> 50% joint space loss, presence of osteophytes) Metal or other types of bioabsorbable screws other than BioComposite interference screws (Arthrex, Inc.) were used ACL reconstruction performed less than 5 years ago Pregnancy Greater than Grade 2 laxity of other ligaments No additional fixation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bioabsorbable screw fixation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screw resorption | Evaluated on X-ray and CT | 5 years |
Study of Energy Requirements in Critically Ill Newborns

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are assigned to one of three groups according to gestational age (24-28 weeks estimated gestational age (EGA) vs 29-34 weeks EGA vs 35 weeks EGA and over) and severity of respiratory illness (need for high frequency ventilation vs stable conventional ventilator settings or extubated within past 24 hours vs no need for mechanical ventilation). Patients receive water labeled with deuterium and oxygen O 18 by mouth or by gastrostomy tube on days 1 and 7. Urine samples are collected prior to the first dose, 4-6 hours after the first dose, and then every 24 hours until the second dose. All urine is collected for 4-6 hours after the second dose. Samples are analyzed by dual inlet isotope ratio mass spectrometry.

Official Title
-----------------
Study of Energy Requirements in Critically Ill Newborns

Conditions
-----------------
Respiratory Distress Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Infants with estimated gestational age (EGA) of at least 24 weeks with respiratory illness who are on high frequency ventilation (HFOV) and meet the following conditions: Appropriate size for gestational age (AGA) No congenital anomalies No medical complications, including seizures and necrotizing enterocolitis OR Control infants with EGA of at least 24 weeks Must meet 1 of the following conditions: Requirement for stable conventional ventilator settings with respiratory index score of less than 2.5 and/or extubated within past 24 hours No requirement for mechanical ventilation Must meet all of the following conditions: AGA No congenital anomalies No medical complications, including seizures and necrotizing enterocolitis No documented sepsis by positive blood culture No supplemental oxygen use (infants 35 weeks EGA and over only) --Prior/Concurrent Therapy-- HFOV group: Concurrent surfactant, theophylline, or inotrope (vasopressor) therapy allowed Control group: No concurrent inotrope (vasopressor) therapy

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 120 Hours

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
-----------------
rare disease, cardiovascular and respiratory diseases, neonatal disorders, respiratory distress syndrome
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the effect of the combination treatment on C-reactive protein and inflammatory markers as well as the safety and tolerability in a Spanish population

Official Title
-----------------
Efficacy and Safety Study of Fluvastatin and Ezetimibe Combined Versus Fluvastatin Alone

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: fluvastatin, ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-75 Primary hypercholesterolemia Signed informed consent Exclusion Criteria: Patients involved in clinical trials 3 months prior to inclusion Patients treated with drugs specified in protocol Fertile women not using contraceptive methods Other protocol defined in and exclusion criteria may apply

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluvastatin, ezetimibe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in low density lipoprotein cholesterol after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total triglyceride, high density lipoprotein cholesterol, and composition of low density lipoprotein cholesterol after 12 weeks |  |  | 
| Change from baseline in circulating marker of inflammation after 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyslipidemia, ezetimibe, inflammatory markers, fluvastatin
Engineering Gut Microbiome to Target Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. New studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. This study will investigate how probiotics will affect the subjects' immune system on breast cancer.

Official Title
-----------------
Engineering Gut Microbiome to Target Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal females ≥ 18 years of age Histologically confirmed adenocarcinoma of the breast ≥1.0 cm operable stage I-III Must have adequate organ function, Not receive systemic neoadjuvant therapy Be willing to provide tissue, blood, and stool samples for research study. Must not have taken any probiotics in the past 60 days prior to enrollment. Exclusion Criteria: Patients with autoimmune disease, immune deficiency such as HIV, irritable bowel, known diverticulosis, and other serious GI conditions at treating physician's discretion will be excluded.

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

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast Cancer Patients<br>All subjects will be given 2-4 weeks of probiotics prior to surgery in operable stage I-III breast adenocarcinoma tumors ≥1.0 cm. Subjects will take the probiotic three times a day. | Dietary Supplement: Probiotic<br>* Primal Defense Ultra® Probiotic Formula is an over-the-counter probiotic that provides 15 billion colony forming units of 13 species of beneficial bacteria, including Saccharomyces boulardii, Lactobacillus plantarum, Bacillus subtilis, Bifidobacterium lactis, Bifidobacterium bifidum, Lactobacillus rhamnosus, Bifidobacterium breve, lactobacillus casei, Lactobacillus salivarius, Lactobacillus acidophilus, Lactobacillus brevis, Bifidobacterium longum, and Lactobacillus paracasei.<br>* Other names: Primal Defense ULTRA Probiotic Formula;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of cytotoxic T lymphocytes (CD8+ cells) | CD8+ T cells (often called cytotoxic T lymphocytes) are very important for immune defence against intracellular pathogens, including viruses and bacteria, and for tumor surveillance. | Approximately 4 weeks after baseline |
Implantable Loop Recorder in Traumatic Syncope

Study Overview
=================
Brief Summary
-----------------
Prospective, observational registry enrolling consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation with the aim to evaluate the incidence of recurrence of traumatic syncope during follow-up.

Detailed Description
-----------------
This observational, prospective registry enrolled consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation according to current clinical practice. The patients were evaluated every 6 months based on current clinical practice and the risk of recurrence of traumatic syncope was assessed during follow-up.

Official Title
-----------------
Safety and Effectiveness of Implantable Loop Recorder in Patients With Recurrent, Unexplained, Traumatic Syncope

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Other: outpatient follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with recurrent, unexplained, traumatic syncope patients underwent implantable loop recorder implantation Exclusion Criteria: patients unable to attend scheduled outpatient visits

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: outpatient follow-up|The patients were evaluated every six months in order to assess the incidence of traumatic syncope recurrence during follow-up after implantable loop recorder implantation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traumatic syncope recurrence | Incidence of traumatic syncope recurrence | through study completion, an average of 2 year |
Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: PEG-400
* Drug: Systane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females > 21 years old Scheduled to undergo bilateral LASIK Likely to complete all study visits and able to provide informed consent Exclusion Criteria: Prior or current use of topical cyclosporine within the last 1 year Known contraindications to any study medication or ingredients Ocular disorders Active ocular diseases or uncontrolled systemic disease Active ocular allergies Complications at the time of surgery

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Systane | Drug: Systane<br>* Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily<br>|
| Active Comparator: 1<br>PEG-400 | Drug: PEG-400<br>* Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of vision |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Vision
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression

Study Overview
=================
Brief Summary
-----------------
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis

Detailed Description
-----------------
To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis. To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.

Official Title
-----------------
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: DSXS topical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non pregnant, non lactating females Exclusion Criteria: Patients under 2 years of age

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSXS topical<br>administered twice daily for 28 days | Drug: DSXS topical<br>* topical treatment<br>* Other names: active;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients in the Study With HPA Axis Suppression | Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin | 28 Days |
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.

Official Title
-----------------
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure

Conditions
-----------------
HIV Infections, Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: A positive HIV antibody test (ELISA confirmed by Western blot). Chronic renal failure managed by a stable hemodialysis regimen. Acceptable hepatic function defined by specified lab values. Life expectancy > 6 months. Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Active, serious opportunistic infections at the time of study entry. Fever > 100 degrees F at study entry. Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss). Patients with the following are excluded: Active, serious opportunistic infections at the time of study entry. Fever > 100 degrees F at study entry. Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss). Prior Medication: Excluded within 2 weeks of study entry: - Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity. Excluded within 4 weeks of study entry: - Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2. Excluded within 8 weeks of study entry: - Other antiretroviral agents (e.g., zidovudine [AZT], suramin, ribavirin, HPA-23, foscarnet, dextran sulfate, disulfiram, ddA/ddC, or dideoxycytidine). Active drug or alcohol abuse.

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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
-----------------
Kidney Failure, Chronic, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Renal Dialysis
Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing

Study Overview
=================
Brief Summary
-----------------
The main objective is to improve genetic counseling in patients with Spina Bifida, by the characterization of variants in new genes using high throughput sequencing either on a panel of targeted genes or on exome in families.

Official Title
-----------------
Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing

Conditions
-----------------
Spina Bifida

Intervention / Treatment
-----------------
* Genetic: characterization of variants in new genes using high throughput sequencing either on a panel of targeted genes or on exome in families.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spina Bifida patients (without age restriction), attending the genetic consultation at the National Reference Centre for Spina Bifida. These patients gave their written agreement for studying genes which could be involved in Spina Bifida. Exclusion Criteria: Patients who refused to give their authorization to perform the sequencing of genes involved in Spina Bifida on their DNA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: characterization of variants in new genes using high throughput sequencing either on a panel of targeted genes or on exome in families.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absence or low frequency (<1%) in public databases (dbSNP, Hapmap, 1000Genome) |  | through study completion, an average of 1 year |
The Concussion or Brain Bleed Trial

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.

Official Title
-----------------
Shared Decision Making for Patients With Minor Head Injury: The Concussion or Brain Bleed Trial

Conditions
-----------------
Head Injury

Intervention / Treatment
-----------------
* Other: Concussion and Brain Bleed App (CBB)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old Present to the Emergency Department with a blunt head injury within the past 24 hours Determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider. Exclusion Criteria: Patients who are pregnant Non-English speaking In police custody Undergoing psychiatric evaluation Found to have drug or alcohol intoxication

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Head Injury Subject<br>Subjects that present to the Emergency Department with a blunt head injury within the past 24 hours, determined to be low risk by the Canadian CT Head Rules (CCHR), and are being considered for a head CT by the treating provider will use the shared decision making tool Concussion and Brain Bleed app (CBC) with their clinician | Other: Concussion and Brain Bleed App (CBB)<br>* Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of CT Scans | Number of CT scans performed when using the Concussion and Brain Bleed app | 6 months |