linjc16/ctgov huggingface dataset:
Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant to intravenous narcotics).

Detailed Description
-----------------
It is often difficult to manage acute painful crisis in patients with sickle cell disease. The usual management of these crises relies on hydration, administration of oxygen and narcotics, like morphine. A select group of patients, for unknown reasons, does not respond to this management and these patients often require prolonged use (several days) of intravenous narcotics. Narcotics have proven to be ineffective in controlling this type of pain and can cause multiple side effects (sedation, vomiting, respiratory depression). We propose to administer intravenous ketamine in this group of patients who are resistant to intravenous narcotics. Ketamine has been proven to be effective in controlling pain in multiple clinical situations. However, there are no data in the literature describing its use in patients with sickle cell disease.

Official Title
-----------------
A Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 7 to <19 Acute vaso-occlusive crisis Persistent pain despite initial pain management with intravenous (IV) opioids Exclusion Criteria: Contraindications to the use of ketamine Mental retardation or psychological conditions that may affect the proper evaluation of pain and side effects Known allergy to ketamine

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients receiving ketamine are those patients, arm 1, that are sill experiencing pain after Morphine has been given. | Drug: Ketamine<br>* Ketamine. 0.2 mg/kg, intravenously<br>* Other names: Ketalar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility. |  | 48 hours |
Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief

Study Overview
=================
Brief Summary
-----------------
A comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

Detailed Description
-----------------
4 randomly assigned groups. Grop 1 will get sub cutaneous and intraperitoneal marcain. Grop 2 will get sub cutaneous marcaine and intraperitoneal saline. Grop 3 will get sub cutaneus saline and intraperitoneal marcaine. Grop 4 will get ub cutaneous and intraperitoneal saline

Official Title
-----------------
Local and Intraperitoneal Analgetics in Gynecologic Laparoscopy for Post Operative Pain Relief

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective laparoscopy Exclusion Criteria: Laparotomy Vaginal operations Oncologic operations Chronic use of analgetics due to pelvic pain Pregnancy Operations lasts more than 3 hours

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sub cutaneous+Intraperitoneal<br>Sub cutaneous Bupivacaine+ Intraperitoneal bupivacaine | Drug: Bupivacaine<br>* Sub cutaneous and/or Intraperitoneal Marcaine application<br>* Other names: Marcaine;|
| Active Comparator: Sub cutaneous+Placebo<br>Sub cutaneous Bupivacaine+ Intraperitoneal Nacl 0.9% | Drug: Bupivacaine<br>* Sub cutaneous and/or Intraperitoneal Marcaine application<br>* Other names: Marcaine;|
| Active Comparator: Placebo+Intraperitoneal<br>Sub cutaneous Nacl 0.9%+ Intraperitoneal bupivacaine | Drug: Bupivacaine<br>* Sub cutaneous and/or Intraperitoneal Marcaine application<br>* Other names: Marcaine;|
| Placebo Comparator: Placebo+Placebo<br>Sub cutaneous Nacl 0.9%+ Intraperitoneal Nacl 0.9% | Drug: Bupivacaine<br>* Sub cutaneous and/or Intraperitoneal Marcaine application<br>* Other names: Marcaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level during movement, 8 hours after laparoscopy |  | 8 hours |
Comparative Tolerability of Protease Inhibitors

Study Overview
=================
Brief Summary
-----------------
This study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV) patients treated with cART regimens including one of four different protease inhibitors [Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)] and the impact of these identifiable tolerability problems on PI persistence, healthcare utilization, and healthcare costs.

Official Title
-----------------
Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initiated treatment with a Protease inhibitor (PI)-based Combination antiretroviral therapy (cART) regimen Between 18-64 years of age on the index date At least 6 months of continuous enrollment and pharmacy benefits prior to the index date At least 6 months of continuous enrollment and pharmacy benefits following the index date At least 1 medical claim during the 6-month follow-up period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Atazanavir<br>HIV patients on antiretroviral therapy using Atazanavir | |
| Darunavir<br>HIV patients on antiretroviral therapy using Darunavir | |
| Fosamprenavir<br>HIV patients on antiretroviral therapy using Fosamprenavir | |
| Lopinavir<br>HIV patients on antiretroviral therapy using Lopinavir | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with new onset lipid abnormalities or new onset jaundice (separately) after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen |  | 6 months | 
| Healthcare utilization |  | 6 months | 
| Healthcare costs |  | 6 months |
The Impact of the Biopsy of 1-2 Cells in a PGD Program for Anueploidy Screening

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the impact of the biopsy of one or two cells in a preimplantatation genetic diagnosis program (PGD) for the screening of aneuploidies. This prospective and randomized study will be performed at the Instituto Valenciano de Infertilidad in Valencia (Spain) in those patientes included in our clinical program. Our purpose is to optimize the methodology employed in our laboratory in order to guarantee optimal implantation and pregnancy rates without a detrimental effect on the accuracy and efficiency of the cytogenetic analysis. Patients will undergo and IVF cycle, embryo biopsy will be performed on day 3 embryos in two fashions: in some patients only one cell per embryo will be retrieved whereas in others, 2 cells will be retrieved in good morphology embryos and only 1 in the slowl ones. In all cases aneuploidy screening will be performed by FISH for chromosomes 13, 16, 18, 21, 22, X and Y. Embryo developmente will be checked every 24 hours and chormosomally normal embryos will be replaced into the uterus on day 5 of development.

Official Title
-----------------
Prospective and Randomized Study of the Impact of the Biopsy of 1-2 Cells in a PGD Program for Aneuploidy Screening

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: Biopsy of Day 3 Embryo
* Procedure: · day embryo biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing PGD for aneuploidy screening with their own oocytes and for chromosomes 13, 16, 18, 21, 22, X & Y Exclusion Criteria: Patients undergoing PGD for monogenic diseases (PCR) Patients undergoing PGD for structural chromosomal abnormalities Ovum donation cycles Cryopreserved oocyte/embryos

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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 |
| --- | --- |
| Active Comparator: One cell biopsy<br> | Procedure: · day embryo biopsy<br> <br> |
| Other: Two cell biopsy<br> | Procedure: Biopsy of Day 3 Embryo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of biopsy |  | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy and implantation rates, Efficiency and accuracy of the genetic testing
Phase 4 Study - Mucinex D as Adjunct Therapy

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Mucinex D as Adjunct Therapy to Antibiotic Treatment of Acute Respiratory Infection

Conditions
-----------------
Acute Respiratory Infection, Bronchitis, Rhinosinusitis

Intervention / Treatment
-----------------
* Drug: Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages Eligible for Study: 18 to 75 years, Genders Eligible for Study: Both Adult patients presenting at the physician's office with symptoms diagnostic for acute respiratory infection, such as bronchitis or rhinosinusitis; with a clinical diagnosis of acute respiratory infection, meeting the physician's usual diagnostic criteria in practice for prescription of oral antibiotics. The investigator will evaluate patients on a total of seven criteria for inclusion. Exclusion Criteria: Have chronic, recurring respiratory signs and symptoms, such as allergic rhinitis or chronic bronchitis, which, in the investigator's opinion, would confound interpretation of symptoms ratings for the acute respiratory infection; The Investigator will evaluate patients on twelve additional criteria for exclusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mucinex D (600 mg guaifenesin and 60 mg pseudoephedrine HCl extended-release bi-layer tablets)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection. |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Respiratory Infection, Bronchitis, Rhinosinusitis
I-gel Versus Air-Q LMA for Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
This study targets to compare insertion facility, effect on hemodynamic parameters and effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing short-duration surgical procedures.

Detailed Description
-----------------
The patient were divided into 2 groups. I gel group and Air Q group according to LMA type used to maintain airway ventilation. The patients were compared according to insertion facility, effect on hemodynamic parameters and effective ventilation.

Official Title
-----------------
I-gel Versus Air-Q LMA for Pediatric Patients Undergoing Short-duration Surgical Procedures

Conditions
-----------------
Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA

Intervention / Treatment
-----------------
* Other: LMA i gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA grade I-II operative time of ≤60 minutes Exclusion Criteria: age >10 years ASA grade ≥II current or recently resolved upper respiratory tract infection presence of oropharynx or laryngeal pathologies or congenital anomalies pathologies inducing reflux or increasing the possibility of aspiration allergy to anaesthetic or drugs to be used, renal, cardiac or hepatic diseases, or bronchial asthma

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 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: i gel<br>I gel LMA was inserted for all patients | Other: LMA i gel<br>* insertion of LMA for maintaining airway during anesthesia<br>* Other names: LMA Air Q;|
| Active Comparator: Air Q LMA<br>Air Q LMA was inserted for all patients | Other: LMA i gel<br>* insertion of LMA for maintaining airway during anesthesia<br>* Other names: LMA Air Q;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supraglottic device success rate | Fitness of LMA for ventilation | 60 minutes |
Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation

Study Overview
=================
Brief Summary
-----------------
Completely or partially edentulous patients suffer from resorption of the alveolar bone, they always seek rehabilitation which becomes challenging. Alveolar ridge augmentation is widely done now to offer these patients functional and esthetic restoration. Many techniques have been proposed to obtain good results of ridge augmentation. Titanium Mesh (TiMe) is widely used, also digital and computer-guided surgery now plays an important role to improve the techniques and results in ridge augmentation procedures.

Official Title
-----------------
Mandibular Ridge Augmentation Using Three-Dimensional Printed Model for Customization of Titanium Mesh

Conditions
-----------------
Alveolar Bone Loss

Intervention / Treatment
-----------------
* Procedure: 3D customized Titanium Mesh (Study)
* Procedure: Conventional ridge augmentation (Control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will have a posterior mandibular atrophic ridge Distance between the crest of the ridge and the superior border of the inferior alveolar canal will be from 5 mm to 7 m Adequate inter-arch space Exclusion Criteria: Patients who have any uncontrolled systemic disease contraindicated to oral surgery ( Diabetes, hypertension, and patients under chemotherapy treatment ) Patients who have any relevant bone disease. Patients who are smokers

Ages Eligible for Study
-----------------
Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D mandibular ridge augmentation<br> | Procedure: 3D customized Titanium Mesh (Study)<br>* approach for planning and augmenting atrophic posterior mandibular ridge using a pre-customized TiMe on a 3D model. The 3D surgical model will be virtually created from a cone-beam computed tomography (CBCT) and printed using Fused deposition modeling (FDM) machine. The 3D model will be then used to contour the TiMe in accordance with the needed amount of augmentation then will be used to help pack and contour the graft material.<br>|
| Active Comparator: Conventional mandibular ridge augmentation<br> | Procedure: Conventional ridge augmentation (Control)<br>* the conventional technique of ridge augmentation using Titanium Mesh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone volume | Bone volume wa measured using CBCT | at baseline and 6 months | 
| Operation time | Time of operation for each group will be calculated | During the procedure |
Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >= 8mm in size

Detailed Description
-----------------
Observational study Structured endoscopic imaging protocol devised Applied prospectively to sequential SSP >= 8mm detected in a tertiary endoscopic resection cohort Review of specimens by blinded specialist pathologists Review of incongruent cases by endoscopists and pathologists

Official Title
-----------------
Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study

Conditions
-----------------
Sessile Serrated Adenoma

Intervention / Treatment
-----------------
* Diagnostic Test: Endoscopic imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) >= 8mm Exclusion Criteria: Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Patients referred to a tertiary endoscopic resection practice found to have an SSP >= 8mm. Endoscopic imaging applied to the sessile serrated polyp (SSP) to determine the presence or absence of dysplasia. | Diagnostic Test: Endoscopic imaging<br>* Analysis of the presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging (high definition white light +- narrow band imaging)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysplasia | Presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging and congruence with histopathology | at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sessile serrated polyp | Determination of a specific polyp as an sessile serrated polyp (SSP) | at the initial procedure compared with histopathology within 1 week. no ongoing determination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy, Endoscopic resection, Sessile serrated adenoma