linjc16/ctgov huggingface dataset:
Single-dose Vaginal Dinoprostone and Hysterectomy

Study Overview
=================
Brief Summary
-----------------
In this study, we will assess the efficacy of dinoprostone in minimizing blood loss during hysterectomy when used as a single preoperative dose via the vaginal route. The reduction of blood flow may be due to the combined effect of myometrial contraction and vasoconstrictive effect

Official Title
-----------------
Effect of a Single Preoperative Dose of Vaginal Dinoprostone on Intraoperative Blood Loss During Abdominal Hysterectomy:a Randomized Controlled Trial

Conditions
-----------------
Hysterectomy

Intervention / Treatment
-----------------
* Drug: Dinoprostone 3 mg
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients presenting for hysterectomy for any benign indication including uterine fibroids. Age ≥ 18 years Pre-operative hemoglobin >8 g/dl Willing to have dinoprostone or a placebo prior to hysterectomy Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: • Patients with known or suspected endometrial/ovarian/cervical cancer. Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia. Patients currently undergoing treatment for any type of cancer. Patients with known bleeding/clotting disorders or a history of thromboembolism (including deep venous thrombosis or pulmonary embolism) History of allergic reactions to dinoprostone.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dinoprostone 3 mg<br>60 minutes before the surgery 3 mg of dinoprostone inserted vaginally | Drug: Dinoprostone 3 mg<br>* 1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery<br>|
| Placebo Comparator: placebo<br>60 minutes before the surgery 1 tablet of placebo inserted vaginally | Drug: placebo<br>* 1 vaginal tablet of placebo 60 minutes before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease blood loss during hysterectomy | decrease blood loss during hysterectomy in ml | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hemoglobin level | postoperative hemoglobin level in gm/dl | 24 hours |
Blue Protocol Assessment

Study Overview
=================
Brief Summary
-----------------
Acute dyspnea is a common disease in emergency medicine. Mortality remains high is estimated at 15%. One third of initial diagnoses before paraclinical examination are estimated to be inaccurate. Lung ultrasound is a quick and immediate examination. Also, it is provided and performed at the bedside. The  Blue protocol  was designed by Daniel A. Lichtenstein as a diagnostic aid in dyspneic patients. It allows to obtain a diagnostic in more than 90% of acute dyspnea. However there is no validation in emergency medicine. The main purpose is to evaluate the interest of the  Blue protocol in the management and orientation of the dyspneic patient

Official Title
-----------------
Interest Assessment of the Blue Protocol in Improving Diagnosis of Dyspneic Patients in Pre- and Intra-hospital Emergency Medicine

Conditions
-----------------
Dyspnea, Emergencies

Intervention / Treatment
-----------------
* Procedure: lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years dyspneic patient requiring management by an emergency physician information given and no patient opposition. Exclusion Criteria: patient under a legal protection measure lack of social security

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

| Intervention/Treatment |
| --- |
|Procedure: lung ultrasound|The lung ultrasound will be performed by following the  Blue protocol |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance between the clinical diagnosis and the final diagnosis | comparison of the concordance between the clinical diagnosis and the final diagnosis | day of arrival in emergency | 
| concordance between the diagnosis establishes after the ultrasonography and the final diagnosis | concordance between the diagnosis establishes after the ultrasonography and the final diagnosis | day of arrival in emergency | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of proportion of examinations leading to a change in the therapeutic hypothesis | Change of proportion of examinations leading to a change in the therapeutic hypothesis | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyspnea, lung ultrasound, emergency medicine, blue protocol
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices. The study will gather this information from many patients to see if heart rate or rhythm data can predict the risk of a patient having a medical condition such as stroke.

Official Title
-----------------
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics

Conditions
-----------------
Atrial Fibrillation, Stroke, Heart Failure

Intervention / Treatment
-----------------
* Device: Diagnostic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides written informed consent and privacy/protection authorization. Subjects 65 years of age or older. OR Subjects with age >18 and < 65 years and one of the following stroke risk factors: Prior stroke or TIA Diagnosis of hypertension (HTN) Diagnosis of Diabetes Mellitus (DM) Diagnosis of Congestive Heart Failure (CHF) Subjects who meet the Class I/Class II indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device OR • Subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe CHF symptoms [NYHA Class III-IV] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a QRS duration ≥130 ms)13. Exclusion Criteria: Subjects who are to receive a replacement IPG, ICD or CRT device. Subjects with chronic (permanent) AT/AF. Subjects with a history of AV nodal dependent arrhythmias. Subjects with a terminal illness who are not expected to survive more than 6 months. Subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization. Subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial. Subjects who are or will be inaccessible for follow-up at a qualified study center.

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

| Intervention/Treatment |
| --- |
|Device: Diagnostic|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
-----------------
Stroke, Atrial fibrillation, Pacemaker, Implantable Cardiac Defibrillator, Resynchronization systems
Two Investigational Drugs in Patients With Mixed Hyperlipidemia (0653-036)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

Detailed Description
-----------------
The duration of treatment is 18 weeks.

Official Title
-----------------
Evaluation of the Efficacy and Safety of Fenofibrate and Ezetimibe Coadministration in Patients With Mixed Hyperlipidemia

Conditions
-----------------
Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: fenofibrate monotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High cholesterol and high triglycerides Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe|nan|
|Drug: Comparator: fenofibrate monotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL-C vs. fenofibrate for 12 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All plasma lipid parameters vs. ezetimibe; all non-LDL lipid parameters vs. fenofibrate; safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mixed hyperlipidemia, high cholesterol, high triglycerides
The Effects of Patient Features on Opioid Induced End-Tidal CO2

Study Overview
=================
Brief Summary
-----------------
Emergency department patients receiving opioid pain medicine such as morphine, fentanyl or Dilaudid are eligible. After medication exhaled carbon dioxide is measured. and recorded.

Detailed Description
-----------------
Emergency department patients receiving opioid pain medicine such as morphine, fentanyl, or Dilaudid are eligible. After receiving the pain medication, a small soft plastic tube will be placed between the upper lip and nose. This tube is used to measure the amount of carbon dioxide the patient is breathing out. It can also be used to deliver oxygen if the provider feels the patient needs it. The carbon dioxide breathed out is measured and collected. Other information collected are height, weight, and vital signs. Patient participation time is approximately 2 hours during the emergency department visit.

Official Title
-----------------
The Effect of Patient Features on Opioid Induced End-Tidal CO2

Conditions
-----------------
Opioid Use During Medical Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non intubated patients receiving intravenous opioid medications Exclusion Criteria: mechanically ventilated patients patients with physiologic shock

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end tidal carbon dioxide | measured through small nasal cannula (plastic tube at base of nares) | study start, 30 minutes, 60 minutes, 90 minutes, 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fentanyl, morphine, dilaudid, capnography, opioid
Limited Access Protocol for the Use of Oral Cisapride

Study Overview
=================
Brief Summary
-----------------
Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the compassionate use of cisapride to treat patients who had no other effective therapy. For this observational study, 3 patients who had already been prescribed cisapride by outside physicians, were followed to determine the effectiveness of cisapride on their gastric emtpying.

Official Title
-----------------
Limited Access, Open-label, Compassionate Use of Cisapride in the Treatment of Gastroparesis

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gastroparesis. Exclusion Criteria: No diagnosis of gastroparesis.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in gastric emptying via self-report | Patients were asked at clinical appointments about problems and improvement with gastric emptying. | ten years |
Cataract Surgery With Intracameral Triamcinolone in Infants

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone. This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.

Official Title
-----------------
The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Triamcinolone acetonide
* Drug: Prednisolone syrup


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients younger than 2 years of age Unilateral or bilateral congenital cataracts compromising the red reflex Exclusion Criteria: Corneal opacity Glaucoma Aniridia Subluxated cataract Traumatic cataract Complex microphthalmia Persistant hyperplastic primary vitreous Retinal detachment Patients with intraoperative complications, such as IOL implanted in the sulcus

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 2 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 |
| --- | --- |
| Active Comparator: Triamcinolone acetonide<br>The study group will receive an intraoperative intracameral injection of triamcinolone acetonide | Drug: Triamcinolone acetonide<br> <br> * Other names: Triancinolona Ophthalmos;|
| Active Comparator: Prednisolone syrup<br>The control group will receive prednisolone syrup postoperatively | Drug: Prednisolone syrup<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual axis obscuration | Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex. | 1 year after surgery | 
| Intraocular pressure |  | 1 year after surgery |
Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to find appropriate biomarkers such as serum neurofilament light chain in reflecting disease severity in hereditary ataxia from a large cohort during long-term follow-up. The disease severity is indicated by clinical scales and brain MRI tests.

Official Title
-----------------
Genotype-phenotype Correlation and Pathogenic Mechanism in Hereditary Ataxia

Conditions
-----------------
Hereditary Ataxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: genetically diagnosed as Spinocerebellar ataxia Exclusion Criteria: deny follow-yp

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum neurofilament light chain | Serum neurofilament light chain levels were collected among patients in preclinical or mild stage of Spinocerebellar ataxia, especially type 3. | from 2021 to 2025 |
Effect of Video Monitor Size on Adenoma Detection Rate

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the adenoma detection rate achieved while using either a 24 video monitor or a 32 video monitor.

Detailed Description
-----------------
Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26) used at this facility while the other room will have a larger video monitor (NDS 32). The ADR achieved by each physician in each room will be compared.

Official Title
-----------------
Effect of Video Monitor Size on Adenoma Detection Rate

Conditions
-----------------
Colon Adenoma

Intervention / Treatment
-----------------
* Device: Monitor size


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit Exclusion Criteria: Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard monitor (24)<br>Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24). | |
| Active Comparator: Large monitor (32)<br>Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32). | Device: Monitor size<br>* Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32) video monitor or the standard (24) video monitor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate (All Indications) | Number of patients with adenoma detected | within 2 weeks (range of 1 day-14 days) of the endoscopy | 
| Adenoma Detection Rate (Screening Exams Only) | Number of patients with adenoma detected | within 2 weeks (range of 1 day-14 days) of the endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp Detection Rate (All Indications) | Number of patients with polyps detected | recorded during endoscopy (immediate) | 
| Polyp Detection Rate (Screening Exams Only) | Number of patients with polyps detected | recorded during endoscopy (immediate) |
Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Study Overview
=================
Brief Summary
-----------------
This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Official Title
-----------------
A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety

Conditions
-----------------
Bone Neoplasms

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Documented bone metastases from breast cancer, prostate cancer or multiple myeloma Prior treatment with zoledronic acid for 1-2 yrs Life expectancy of at least 6 months Exclusion criteria: Prior treatment with bisphosphonates other than zoledronic acid Abnormal kidney function Current or previous dental problems or planned dental surgery Pregnant or likely to become pregnant during the study Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic Acid<br>ZOL446 | Drug: Zoledronic acid<br> <br> * Other names: ZOL446;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs). |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Breast Cancer, Multiple Myeloma, Zoledronic acid, Bone metastases, Skeletal Related Events (SREs), Renal Impairment, Osteonecrosis of the Jaw (ONJ), Bone involvement, Multiple Myeloma (MM)