linjc16/ctgov huggingface dataset:
Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.

Official Title
-----------------
the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial

Conditions
-----------------
Myomectomy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging Age ≥ 18 years and ≤ 50 years Pre-operative hemoglobin >8 g/dl Ability to understand and the willingness to sign a written informed consent. Admissible medical/surgical history Five or less symptomatic uterine myomas All myomas are subserous or intramural. Uterine size less than 24 weeks pregnancy Exclusion Criteria: • Patients who have had a prior abdominal myomectomy Post-menopausal women Patients with known bleeding/clotting disorders Patients with a history of gynecologic malignancy Hypertension. Cardiac and Pulmonary diseases. Obesity (body mass index > 30 kg/m2). History of allergic reactions attributed to misoprostol Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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>patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery | Drug: Dinoprostone 3 mg<br>* the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery<br>|
| Placebo Comparator: placebo<br>patients will take 1 tablet of placebo 1 hour before the surgery | Drug: placebo<br>* the patient will take one vaginal tablet of placebo 1 hour before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of intraoperative blood loss | Mean amount of intraoperative blood loss in ml | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of hemoglobin after surgery | Change of hemoglobin(g/dl) after surgery | 24 hours |
L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

Study Overview
=================
Brief Summary
-----------------
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corresponding tissues of eight normally nourished non-hepatic patients who died after an acute illness of a 1-3-day duration. In the recent years, it has been reported that sirtuin 3 (SIRT3) is protective against acute kidney injury (AKI) and suggest that enhancing SIRT3 to improve mitochondrial dynamics has potential as a strategy for improving outcomes of renal injury. In the current study, it is the first clinical interventional research whether L-carnitine corrects ammonia metabolism associated with liver injury in hepatectomized patients.

Official Title
-----------------
L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients

Conditions
-----------------
Ammonia Metabolism

Intervention / Treatment
-----------------
* Drug: L-carnitine
* Other: usual intake


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients were those surgically treated for hepato-biliary diseases Exclusion Criteria: Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
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 |
| --- | --- |
| Placebo Comparator: ordinary group<br>usual intake prior to liver surgery | Other: usual intake<br>* baseliner<br>* Other names: Usual group;|
| Active Comparator: carnitine group<br>treatment with oral L-carnitine, 1500 mg/body per day for 2 weeks prior to liver surgery | Drug: L-carnitine<br>* treatment with oral L-carnitine, 1500 mg/body per day<br>* Other names: Carnitine group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative ammonia levels | change from preoperative baseline at postoperative day 1 and day3 | 3 points; preoperative baseline, postoperative day 1, and day3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospitalization after liver resection | postoperative days | up to 24 weeks |
Perfusion Index and Labor Analgesia

Study Overview
=================
Brief Summary
-----------------
It can be suggested that sympathetic tonus increase and pain, caused by the removal of the effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose of this study is; To correlate the VAS value at the time of return of epidural analgesia with the PI values at that time and, to test the possibility of using PI variants as an objective tool for predicting pain initiation time and assessing pain.

Official Title
-----------------
Can the Perfusion Index be Used as an Objective Instrument for the Assessment of Pain in the Labor Analgesia?

Conditions
-----------------
perfüsion Index in Removal of the Epidural Analgesia

Intervention / Treatment
-----------------
* Diagnostic Test: perfüsion index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who will give normal spontaneous vaginal delivery Between the ages of 18-45 Exclusion Criteria: Patients who do not accept the procedure, those under 18 years of age - over 45 years, those with low platelet counts, those with infection at the puncture site, those with progressive neurological disease, Those with increased intracranial pressure, those with hypovolemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: perfüsion index|Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relationship between Visual analogue scale and Perfüsion index | Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia, | three month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relationship between heart rate and Perfüsion index | Determination of the relationship between heart rate and PI in patients with normal delivery who undergo epidural analgesia, | three month | 
| relationship between non-invazive blood pressure and Perfüsion index | Determination of the relationship between non-invazive blood pressure and PI in patients with normal delivery who undergo epidural analgesia, | three month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor, perfüsion index, epidural analgesia
COVID-19 and Lactating Mothers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there may be COVID-19 virus in various samples collected from mothers and infants.

Official Title
-----------------
COVID-19 and Lactating Mothers

Conditions
-----------------
Coronavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently lactating mother: English-speaking greater than or equal to 18 years of age Assigned female at birth (AFAB) Having a positive COVID-19 test within 14 days Child: Infants younger than or equal to 6 months of age, exclusively or partially human milk fed, sourced from mother. Infants who are fed both directly at the breast and exclusively fed mother's milk via bottle will be included Exclusion Criteria: Non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- | --- |
| mean change in SARS-Cov-2 viral load in breast milk | RNA will be extracted from all sample types and SARS-CoV-2 primers used to amplify any present viral RNA using real-time qPCR. Repeated measures analysis will be used to compare the changes in sample viral load over time between women with mild to severe symptoms. | baseline, days 3, 10, 19, 28 and 90 |
Assessing the Accuracy of the RevK Sensor

Study Overview
=================
Brief Summary
-----------------
Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.

Detailed Description
-----------------
Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.

Official Title
-----------------
Assessing the Accuracy of the RevK Sensor for Non-Invasive Hemoglobin Monitoring

Conditions
-----------------
Patients Undergoing Spine Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female American Society of Anesthesiology Classification 1, 2 or 3 Scheduled to undergo spine or hip surgery Exclusion Criteria: Pregnant or nursing Patients who in the study investigators clinical judgement would not be suitable for research

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient undergoing spine surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the accuracy of the RevK sensor for measuring blood hemoglobin compared to a laboratory-derived hemoglobin value. | Primary outcome is based on the difference between a value from the SpHb (Masimo SpHb™ continuous hemoglobin reading) minus tHb (laboratory hemoglobin determination). | Intermittently during spine surgery |
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Official Title
-----------------
A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate
* Drug: Comparator: metformin hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
General Inclusion Criteria: Patient has type 2 diabetes mellitus (T2DM) Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy General Exclusion Criteria: Patient has a history of type 1 diabetes mellitus or history of ketoacidosis Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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: 1<br>Drug | Drug: sitagliptin phosphate<br>* (1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period<br>* Other names: MK0431;|
| Active Comparator: 2<br>Active comparator | Drug: Comparator: metformin hydrochloride<br>* (4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 | HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea |  | Baseline to Week 24 | 
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea |  | Baseline to Week 24 | 
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain |  | Baseline to Week 24 | 
| Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting |  | Baseline to Week 24 |
Ulnar Nerve Deep Branch Compression by a Ganglion

Study Overview
=================
Brief Summary
-----------------
Ulnar nerve compression is common at the elbow, but less common at the wrist. The purposes of this study are to report a series of 9 patients with pure ulnar nerve deep branch compression by a ganglion and to evaluate the outcome following a surgical treatment. According modified Bishop's scoring system, the investigators would evaluate postoperative results of this uncommon nerve lesion.

Detailed Description
-----------------
Pre- and post-operative physical examination include assessment of tenderness and strength (grip and pinch). Grip strength and tip pinch strength between the thumb and index finger are measured using the E-LINK system. According Bishop's scoring system, the investigators redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion.

Conditions
-----------------
Guyon's Canal, Nerve Compression

Intervention / Treatment
-----------------
* Procedure: Decompression of the ulnar nerve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulnar nerve deep branch compression by a ganglion - Exclusion Criteria: Ulnar nerve deep branch compression caused by other reasons -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Decompression of the ulnar nerve<br>Surgical decompression of the Guyon's canal and ganglion excision | Procedure: Decompression of the ulnar nerve<br>* Surgical decompression of the Guyon's canal and ganglion excision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Grip strength is measured using the E-LINK system. | 18-24 months | 
| Tip pinch strength | Tip pinch strength between the thumb and index finger is measured using the E-LINK system. | 18-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Bishop's scoring system | According Bishop's scoring system, we redesign a questionnaire for comprehensive assessment of this uncommon nerve lesion. | 18-24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep branch of the ulnar nerve, Distal ulnar nerve compression
Automated Visual Monitoring for Improving Patient Safety (VIPSafe)

Study Overview
=================
Brief Summary
-----------------
After an operation many patients are in a confused mental status at the intensive care unit. In this status they possibly fall out of their bed or pull out endotracheal tubes or central venous catheters accidentally. For this, they need permanently monitoring and control through intensive care personnel. The goal of the VIPSafe project is to develop robust techniques for automated patient monitoring, that rely on data from a small number of untethered sensors, which are nonetheless flexible enough to cope with a large variety of demands.

Official Title
-----------------
Automatisierte Optische Überwachung Mittels Videosensorik Zur Verbesserung Der Patientensicherheit Auf Intensivstation (Automated Visual Monitoring for Improving Patient Safety (VIPSafe))

Conditions
-----------------
Postoperative Confusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with planned postoperative stay at intensive care unit after previous written consent to the study patients with not-planned postoperative stay at intensive care unit with written consent after admission to intensive care unit patients unfit to plead with admission to intensive care unit with written consent of the officially appointed agent Exclusion Criteria: absent written consent age < 18 years old

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative delirium
Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.

Study Overview
=================
Brief Summary
-----------------
To date, there has been no head to head comparison of Upper Airway Stimulation (UAS) and Continuous Positive Airway Pressure (CPAP) utilizing a full night polysomnographic evaluation. With this study we aim to evaluate a pilot cohort of patients with OSA treated with CPAP or UAS using the WatchPAT polysomnography system.

Official Title
-----------------
Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 22 years old History of moderate to severe OSA (AHI 15-65) UAS implantation with postoperative titration and demonstrated successful use of therapy or has demonstrated the ability to tolerate CPAP for greater than 4 hours per night 5 days per week. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Upper airway stimulation<br> | |
| Continuous positive airway pressure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in polysomnography (PSG) data between UAS and CPAP groups |  | 2 years | 
| Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups |  | 2 years | 
| Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea, Continuous Positive Airway Pressure
Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.

Official Title
-----------------
Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Drug: Ethyol (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed squamous cell cancer of the head and neck Eligible sites: oral cavity, oropharynx, hypopharynx, larynx. Patients requiring postoperative IMRT. KPS > 70%. Patient has signed specific protocol consent prior to registration. Calcium test within normal limits. No previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years. Labs completed with 30 days of registration (CBC & platelet, Ca++, Alk phos, SGOT, Bili, albumin) CXR and CT simulation. Liver CT if alk phos, SGOT, or bili elevated. Bone scan if elevated alk phos Exclusion Criteria: Metastatic disease. Patient using Salagen or concurrent chemotherapy. Previous XRT for head and neck tumors. Active untreated infection.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ethyol (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary function at 6 months and yearly compared to pre-treatment salivary function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and regional tumor control |  |  |