linjc16/ctgov huggingface dataset:
Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
We aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries.

Official Title
-----------------
Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery: a Randomized Double-blind Study

Conditions
-----------------
Abdominal Cancer Surgery

Intervention / Treatment
-----------------
* Procedure: Erector Spinae Plane block
* Procedure: Continuous Wound Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-II, weighing 50-90 Kg with Body Mass Index (BMI) 18.5- 29.9 kg/m2 Exclusion Criteria: ASA physical status ≥III, pregnancy, body mass index >30 kg/m2, preoperative opioid consumption, patient's refusal and contraindications of the use of spirometry or either of the truncal blocks under the study including; respiratory, cardiac, neurological, mental or coagulation disorders.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector spinae plane block<br> | Procedure: Erector Spinae Plane block<br>* An ultrasound linear probe is going to be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. . Local infiltration with 2% of lignocaine at the site of needle insertion is going to be administered. Using in plane approach an 18 G Tuohy needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 5 ml of normal saline.<br>|
| Active Comparator: Continuous wound infusion<br> | Procedure: Continuous Wound Infusion<br>* Towards the end of surgery, a multiholed 15-cm Anesthesia catheter will be placed in the preperitoneal space (the subfascial space between the peritoneum and posterior fascia) under direct vision and to be tunneled via the rectus sheath to the skin, rolled out and exiting laterally and stabilized with an adhesive tape on skin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Morphine consumption |  | 48 hours |
Facilitation of NGT Insertion

Study Overview
=================
Brief Summary
-----------------
Insertion of a nasogastric tube (NGT) in anesthetized patients can be a disappointing experience. Many techniques have been explained to improve success rate along with increasing safety, such as forward displacement of the larynx, tube rigidity improvement methods, pushing it down directly through pharynx or using a guide tube. Failure of insertion under general anesthesia reached 50% in some publications

Official Title
-----------------
Digital Facilitation of Nasogastric Tube Insertion Under General Anethesia

Conditions
-----------------
Nasogasrtic Tube Insertion

Intervention / Treatment
-----------------
* Procedure: Digital facilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all surgicl patients needing NGT insertion Exclusion Criteria: refusal coagulopathy ASA more than 2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Didgital group<br>After induction of anesthesia, and after ensuring muscle relaxation, NGT will be inserted through the selected nostril and advanced for 12 cm then the NGT was advanced according to study group advancing. In control group; NGT was inserted with patient head flexed. In D group, after feeling the NGT in pharynx, with the head in neutral position,the index finger was used to support the NGT with slight direction towards the left side. This will prevent tube kinking at this point in front of the resistance offered by the inflated tube cuff or arytenoids cartilage. Also, this digital support reinforces the tube at the area weakened by its openings | Procedure: Digital facilitation<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NGT insertion success rate |  | intraoperative |
Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery

Study Overview
=================
Brief Summary
-----------------
The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner

Official Title
-----------------
The Effect of Epidural, Combined and Dural Puncture Labor Epidural on Pain, Analgesics and Course of Vaginal Delivery: Randomised, Double Blind Study

Conditions
-----------------
Labor Pain, Analgesia

Intervention / Treatment
-----------------
* Procedure: regional analgesia for labor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parturients requiring regional labor analgesia dilation less than 5cm Exclusion Criteria: contraindication for regional technique refuse to participate language barriers obesity no pain

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 groups with different regional analgesic technique
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural<br> | Procedure: regional analgesia for labor<br>* three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia<br>|
| Active Comparator: combined<br> | Procedure: regional analgesia for labor<br>* three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia<br>|
| Active Comparator: dural puncture epidural<br> | Procedure: regional analgesia for labor<br>* three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | the amount of local anesthetic and opioid that required during labor | during the procedure/delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity on a numerical rating scale (minimum=0, maximum=10) | pain intensity | during the procedure/delivery | 
| duration of labor | duration of first stage | until delivery | 
| satisfaction on a numerical rating scale (minimum=0, maximum=10) | satisfaction of parturients | during the procedure/delivery |
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.

Detailed Description
-----------------
As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such nucleoside-sparing therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.

Official Title
-----------------
Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients

Conditions
-----------------
HIV Infections, Acquired Immunodeficiency Syndrome

Intervention / Treatment
-----------------
* Drug: lopinavir/ritonavir plus maraviroc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV viral load > 1,000 on current antiviral medications No resistance to study medications Over 18 years of age Exclusion Criteria: Hepatitis B co-infection Pregnancy Previous therapy with either of the study medications Ongoing substance abuse Significant history of other physical disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid<br>single arm | Drug: lopinavir/ritonavir plus maraviroc<br>* lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid<br>* Other names: Selzentry;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response defined as viral load reduction of >/= 1 log |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess proportion of patients with HIV-1 viral load < 48 copies |  | 48 weks | 
| Assess time to loss of virologic response |  | 48 weeks | 
| Assess development of resistance mutations in patients who develop rebound |  | 48 weeks | 
| Compare serum lipid profile changes |  | 48 weeks | 
| Assess safety and tolerability |  | 48 weeks | 
| Assess degree of immune reconstitution |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acquired Immunodeficiency Syndrome, HIV, AIDS, treatment experienced
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study to Evaluate the Efficacy, Safety and Toleration of Oral Sildenafil Citrate Administered in the Dose Range of 20 - 80 Mg TID for the Treatment of Pre-Eclampsia. (PET)

Conditions
-----------------
Pre-eclampsia

Intervention / Treatment
-----------------
* Drug: Sildenafil citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with pre-eclampsia defined as new hypertension with a diastolic BP of > or = 90 mmHg on two occasions separated by at least 4 hrs arising after 20 weeks of pregnancy, associated with >500 mg/24 hr proteinuria. Subjects with pre-existing hypertension (on treatment) need only fulfill proteinuria requirement. Gestational age 24-34 w Singleton pregnancy Exclusion Criteria: Where urgent delivery is indicated Where the fetus is suspected to have a structural or chromosomal abnormality

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sildenafil citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint is the time from randomization to delivery. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individualised birth-weight ratio at delivery, Placental weight, Umbilical artery pulsatility index, Other indices of PET (incl. uric acid and maternal BP), Safety and toleration, Population PK, Fetal exposure (PK) |  |  |
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection

Official Title
-----------------
Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: BMS-650032 or Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronically infected with HCV genotype 1 Treatment naive or treatment non-responders or treatment intolerant HCV RNA viral load of ≥10*5 IU/mL BMI 18 to 35kg/m² Exclusion Criteria: Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug Co-infection with HIV or HBV Women of childbearing potential

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: or Placebo - Dose Panel 1<br>Oral Suspension, 10 mg | Drug: BMS-650032 or Placebo<br>* Oral, Once daily, Single Dose<br>|
| Experimental: or Placebo - Dose Panel 2<br>Oral Suspension 50 mg | Drug: BMS-650032 or Placebo<br>* Oral, Once daily, Single Dose<br>|
| Experimental: or Placebo - Dose Panel 3<br>Oral Suspension, 200 mg | Drug: BMS-650032 or Placebo<br>* Oral, Once daily, Single Dose<br>|
| Experimental: or Placebo - Dose Panel 4<br>Oral Suspension or Solution, 2.5 to 600 mg | Drug: BMS-650032 or Placebo<br>* Oral, Once daily, Single Dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Outcome Measures |  | Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Measures |  | Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose | 
| Pharmacodynamic Measures |  | Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing |
Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

Detailed Description
-----------------
Purpose: In this study, authors describe a new surgical technique for the treatment of refractory DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab. Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.

Official Title
-----------------
Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Procedure: Sub-macular injection of Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: refractory diffuse non tractional DME. Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy. Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5. Exclusion Criteria: Previous vitrectomy, recent cataract surgery less than 6 months, evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT, glaucoma and one eyed patients.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Persistent Diabetic macular edema<br>Authors defined refractory DME as eyes with persistent DME despite receiving at least 6 monthly Ranibizumab injections of anti VEGF, and then switched to Aflibercept, receiving at least three monthly injections. | Procedure: Sub-macular injection of Ranibizumab<br>* In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint for this study was the change in CMT at the final visit. | Central macular thickness | at the 6 month follow up visit |
Natural History of Oro-pharyngeal Cancer Precursors

Study Overview
=================
Brief Summary
-----------------
Oro-pharyngeal cancers can develop from squamous dysplastic precursor lesions, which occur in a subset of common white (leukoplakia), red (erythroplasia), or mixed oro-pharyngeal plaques. Known risk factors for oro-pharyngeal cancer include tobacco smoke, alcohol consumption, diet and, in a subset of tumors, human papillomavirus (HPV). Along the oro-pharyngeal disease continuum, there may be variations in gene expression precursor lesions as a result of exposure to smoking, alcohol and HPV. However, the components of gene expression that are most likely associated with tumorigenesis in these tissues are poorly understood. This study will focus upon early gene expression profiles in the oral cavity and oropharynx in subjects who have precursor lesions and have been exposed to the common risk factors for carcinoma development including smoking and HPV infection. This application is to conduct pilot testing and establish appropriate procedures for an international prospective cohort study of the natural history of oro-pharyngeal cancer precursors among men and women at high risk of oro-pharyngeal cancer at Montefiore Medical Center, Bronx-NY. Brush biopsy specimens will be used to collect a transepithelial sample of cells from oro-pharyngeal plaques, as well as normal tissue from defined regions of the oral and pharyngeal mucosa. Measurement of gene expression will employ novel high-throughput cDNA microarray analysis and PCR-based HPV DNA testing. Oro-pharyngeal dysplasia will be diagnosed using cytopathology. Under this application, we will assess our planned instruments and procedures on an initial sample of 40 subjects. This planning period will allow for precise identification of methodologies, standardization of instruments and assays to be utilized by additional participating centers in a subsequent application.

Official Title
-----------------
Natural History of Oral Cancer Precursors

Conditions
-----------------
Leukoplakia, Precancerous Conditions, Erythroplasia, Oral Papillomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established residence in the greater Metropolitan area of New York City, including Westchester, Long Island, Southern Connecticut and Northern New Jersey Exclusion Criteria: No history of therapy for oral cancer in the previous 6 months

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