linjc16/ctgov huggingface dataset:
Impact of Impaired Cerebral Autoregulation on Postoperative Delirium in Elderly Patients Undergoing Spine Surgery

Study Overview
=================
Brief Summary
-----------------
Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. There is very little information available about how often delirium occurs and the complications associated with it. Elderly patients are at high risk for delirium after surgery. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Detailed Description
-----------------
Delirium (confusion) after surgery is common and associated with a longer hospitl stay and increased hopsital cost. This research is being done to measure how often delirium after spine surgery occurs and to see if there are ways to predict if delirium will develop. We hypothesize that impaired cerebral autoregulation may be a possible mechanism for postoperative delirium. We will measure intraoperative cerebral autoregulation and assess the relationship with postoperative dleirium. The results from this study will provide important information on a possible mechanism and predictor of delirium.

Official Title
-----------------
The Impact of Impaired Cerebral Autoregulation on the Development of Postoperative Delirium in Elderly Patients Undergoing Spine Surgery

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 70 years old, Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery > 2 levels Exclusion Criteria: MMSE < 15 Delirium at baseline Inability to speak and understand English Severe hearing impairment, resulting in inability to converse. Planned use of intraoperative ketamine Planned use of intraoperative remifentanil, except for airway management pre-incision. Arterial catheter not planned to be inserted

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| Incidence of post-operative delirium in elderly patients undergoing spine surgery at Johns Hopkins Hospital |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of postoperative delirium, using Delirium Rating Scale-Revised-1998, in elderly patients undergoing spine surgery. |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delirium
Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes

Study Overview
=================
Brief Summary
-----------------
The present study aims to assess and compare the anti-plaque and anti-gingivitis effects of Moringa plant extract and Fluoride toothpastes among a group of Egyptian Children.

Detailed Description
-----------------
In the last few years, the use of plant extracts in alternative medicine has evolved widely. Various herbal products, including mouthwash and toothpaste, are now available and have been shown to possess a beneficial effect on oral health .Moringa plant is used to treat various diseases including the treatment of the oral cavity or dentistry .

Official Title
-----------------
Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Moringa Plant Extract and Fluoride Toothpastes Among a Group of Egyptian Children: A Randomized Clinical Trial

Conditions
-----------------
Oral Disease

Intervention / Treatment
-----------------
* Drug: Moringa oleifera leaf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of 12-14 years of age. Presence of gingivitis-calculus, and plaque (gingival index [GI]score ≥1/plaque index [PI] score ≥1). Children willing to participate. Children whose parents/caretakers gave informed consent. Exclusion criteria Children having fixed or removable orthodontic appliances or removable prostheses. Children suffering from any systemic illness. Children who were already using mouthwashes. History of oral prophylaxis within 6 months. Children using any other oral hygiene aids.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 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: moringa plant toothpaste<br> | Drug: Moringa oleifera leaf<br>* Moringa toothpaste<br>|
| Active Comparator: Fluoride toothpaste<br> | Drug: Moringa oleifera leaf<br>* Moringa toothpaste<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingival index (Loe and Sillness, 1963) | index | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plaque index (Sillness and Loe, 1964) | index | 6 weeks |
Gastric pH in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.

Detailed Description
-----------------
Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.

Official Title
-----------------
Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.

Conditions
-----------------
Critically Ill Patients, Indication for Stress Ulcer Prophylaxis

Intervention / Treatment
-----------------
* Drug: esomeprazole
* Drug: ranitidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critically ill patients indication for stress ulcer prophylaxis gastric pH < 4 Exclusion Criteria: gastrointestinal bleeding gastric pH > 4

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: 1<br>patients with indication for stress ulcer prophylaxis and gastric pH < 4 | Drug: esomeprazole<br>* 40mg once daily<br>|
| Active Comparator: 2<br>patients with indication for stress ulcer prophylaxis and gastric pH < 4 | Drug: ranitidine<br>* 50mg every h hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of time with gastric pH > 4 |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median gastric pH |  | 72 hours | 
| incidence of gastrointestinal bleeding |  | 72 hours | 
| incidence of ventilator associated pneumonia |  | ICU stay | 
| the percentage of time with an gastric pH > 5 |  | 72 hours |
Cognitive Behavioral vs. Interpersonal Therapy (IPT) Prevention of Depression in Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of a cognitive-behavioral vs. an interpersonal therapy program for preventing depressive symptoms in adolescents.

Detailed Description
-----------------
Hypothesis -- The cognitive-behavioral and interpersonal therapy prevention programs will be significantly better than the no-intervention control group in preventing depressive symptoms measured at post-intervention and at the 6-month follow-up. Gender differences also will be explored.

Official Title
-----------------
Promoting Well-being in Teens

Conditions
-----------------
Depressive Symptoms

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral
* Behavioral: Interpersonal Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All students in 9th grade Wellness classes who have parental consent Exclusion Criteria: Students without parental consent

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioral<br>Participants in this arm received a cognitive-behavioral program | Behavioral: Cognitive-behavioral<br>* Cognitive-behavioral approach<br>|
| Experimental: Interpersonal Therapy<br>Participants in this arm received a prevention program based on interpersonal therapy for depression | Behavioral: Interpersonal Therapy<br>* Interpersonal therapy approach<br>|
| No Intervention: No intervention<br>Participants in this arm did not receive an intervention, but complete assessments only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Depression Inventory | Change in depressive symptoms from baseline to post-intervention at 9 weeks | 9 weeks | 
| Center for Epidemiological Studies - Depression scale | Change in depressive symptoms from baseline to post-intervention at 9 weeks | 9 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schools, depression, adolescents, prevention
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain

Study Overview
=================
Brief Summary
-----------------
Excessive weight gain during pregnancy is associated with complications during delivery primarily due to macrosomia (large babies) but also with high levels of weight retention post pregnancy and thereby increased risk of future weight related health problems. The primary aim of this study is to evaluate the efficacy of an intervention consisting of; recurrent Motivational Interviewing (MI), prescription of physical activity and extended information on recommended weight gain during pregnancy in regards to preventing excessive gestational weight gain.

Official Title
-----------------
Weight Gain During Pregnancy - a Randomized Controlled Trial of Intervention to Prevent Excessive Gestational Weight Gain.

Conditions
-----------------
Weight Gain

Intervention / Treatment
-----------------
* Behavioral: motivational intervention in pregnancy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years, Adequate language skills (swedish), BMI>19.9, Pregnancy estimated <16 weeks (LMP), Planned for basic pregnancy surveillance (healthy mother). Exclusion Criteria: History of eating disorder, History of having a growth restricted child.

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>standard maternity care | Behavioral: motivational intervention in pregnancy<br>* Motivational program including individualized counseling on diet and physical activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women with a weight gain during pregnancy within IOM´s recommendation is compared between study groups. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight retention(kg) up until one year after delivery is compared between study groups. |  | one year after delivery | 
| Number of fetal and maternal complications in pregnancy is compared between study groups |  | 9 months | 
| Number of fetal and maternal complications during delivery is compared between study groups |  | during delivery | 
| Child birth weight and weight development of the child up to one year of age is compared between study groups. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, weight gain, obesity, macrosomia
Correlation of Arterial Blood Gas (ABG) and Venous Blood Gas (VBG) in the Undifferentiated Critically Ill Patient

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to identify a correlation between the pH and pCO2 in arterial and venous blood. The secondary objectives include a correlation of pulse oximetry and arterial pO2 along with subgroup analyses of specific patient populations such as congestive heart failure, chronic obstructive pulmonary disease, diabetic ketoacidosis, pneumonia, overdose, and trauma.

Official Title
-----------------
Correlation of Arterial Blood Gas (ABG) and Venous Blood Gas (VBG) in the Undifferentiated Critically Ill Patient

Conditions
-----------------
Patients Needing Blood Gases

Intervention / Treatment
-----------------
* Other: Venous Blood Gas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Signed consent Patient in the ED or ICU Have a disease state that necessitates obtaining an ABG Have a disease state that necessitates pulse oximetry monitoring Exclusion Criteria: Any contraindication to arterial or venous blood draw Prior enrollment in the study during the current hospitalization Pregnancy Prisoners

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Venous Blood Gas<br>All subjects have an ABG and VBG drawn. No intervention. | Other: Venous Blood Gas<br>* patients who have been identified by the treating physician as needing an ABG will receive an VBG is they consent to take part in the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree to which pH and pCO2 correlate between ABG and VBG | ABG and VBG will be obtained 5 minutes apart and compared | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ABG, VBG, pH, pCO2
Claustrophobia and Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to determine the ability of open magnetic resonance imaging (MRI) scanners to reduce claustrophobic reactions, thereby enabling more examinations of severely anxious patients. The investigators hypothesize that anxiety-based claustrophobia that prevents MR examinations without sedation can be reduced using an open MR scanner design thereby improving clinical management of those patients.

Official Title
-----------------
Reduction of Claustrophobia During Magnetic Resonance Imaging: Randomized, Controlled Trial

Conditions
-----------------
Claustrophobia

Intervention / Treatment
-----------------
* Device: Open MRI scanner.
* Device: Closed MRI scanner.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severely anxious patients with reported claustrophobia during MRI or with the inability to undergo MR examinations on conventional scanners Clinical indication for MR imaging of the head, spine, or shoulder. Exclusion Criteria: Contraindication to MR imaging (shrapnells, pacemakers, certain unsafe implants) Age below 18 years

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Open MRI scanner.<br>* Imaging in an Open MRI scanner.<br>|
| Active Comparator: 2<br> | Device: Closed MRI scanner.<br>* Imaging in a short-bore closed MRI scanner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability of an open MRI scanner to reduce claustrophobic reactions that prevent MR examinations. |  | Before or During MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of MR imaging results on subsequent measurement. |  | 6 months after MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
claustrophobia, magnetic resonance imaging, MRI, anxiety, open design, severely anxious patients
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry

Study Overview
=================
Brief Summary
-----------------
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device

Detailed Description
-----------------
The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System. The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device. The secondary objective is to evaluate adverse events and device performance of the newly marketed device.

Official Title
-----------------
Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry

Conditions
-----------------
Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry The subject and treating physician agree the subject will return for all required post-procedure follow-up visits Exclusion Criteria: 1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.

Ages Eligible for Study
-----------------
Minimum Age: 75 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 all-cause mortality |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transfemoral access, TAVI
Free Radical Level in SCC of Tongue Patients Tumor, Serum and Saliva

Study Overview
=================
Brief Summary
-----------------
Study comparing level of free radicals in tumor tissue, blood serum and saliva in patients with Squamous Cell Carcinoma of tongue and mouth floor. Patients with benign fibroma of oral cavity and normal gingiva around extracted lower wisdom tooth are used for control

Conditions
-----------------
Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years of age. Mentally healthy SCC of Tongue or Mouth Floor Benign Fibroma of Oral Cavity Lower wisdom tooth extraction - Exclusion Criteria: Younger than 18 years of age Mentally incapacitated

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

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

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
-----------------
Squamous Cell Carcinoma of Tongue and mouth floor