linjc16/ctgov huggingface dataset:
Directly Observed Therapy in High Risk Populations in Newark, NJ

Study Overview
=================
Brief Summary
-----------------
30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center and be given Directly observed therapy.

Detailed Description
-----------------
30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center. Consent will be obtained, their regimens will be switched to QD based on previous therapies and resistance patterns if available. Patients will be placed on direct observed therapy.Each patient will be placed on Fortovase/Ritonavir (1600mg/100mg)QD plus two or three NRTIs based on a phenotypic baseline testing to a protease inhibitor. Patients will visit the office at baseline, weeks 1, 4, 8, 12, 16, 24, 32, 40, and 48. Patients will also be visited daily by the social worker (or designee) to observe patients taking their antiretroviral therapy for 6 months. After six months of direct observed therapy patients will be given a diary card to record administration of medications and the social worker ( or designee) will visit the home twice weekly. If the patient experiences a change in therapy secondary to virologic failure, the patient will return to baseline visit for the new once a day regimen. Virologic failure will be defined as < .5 log drop between each visit or > 400 copies/mL at week 24 on two separate occasions at least 14 days apart

Official Title
-----------------
Directly Observed Therapy in High Risk Populations in Newark, NJ

Conditions
-----------------
Directly Observed Therapy, HIV Infections

Intervention / Treatment
-----------------
* Drug: Invirase
* Drug: Norvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Men and Women > 18 years of age with a confirmed HIV-1 diagnosis 2. CD4 count <350 and or history of opportunistic infection 3. HIV PCR >55000 and >55,000 on one occasion in last 12 months 4. Patients with poor compliance (Poor compliance will de defined as taking less than 80 percent of prescribed medication 5. Patients with mental illness, HIV dementia, substance abuse or social factor prohibiting compliance 6. Willingness to sign informed consent or legal guardian - Exclusion Criteria: ALT/AST > 5X ULN CReatinine >2.0 -

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Invirase|nan|
|Drug: Norvir|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
-----------------
Invirase, HIV, DOT, Treatment Experienced
Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction

Study Overview
=================
Brief Summary
-----------------
The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group antegrade tibial tunnel unlike group retrograde tibial tunnel. To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.

Official Title
-----------------
Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain

Conditions
-----------------
Anterior Cruciate Ligament Reconstruction, Subchondral Microfractures of Tibia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear Exclusion Criteria: previous reconstruction of ACL associated lesions (meniscal tear, other ligament...) Refusal consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All-Inside TightRope technique<br> | |
| ACL reconstruction with TLS system<br> | |
| Hamstring Tendon Graft Reconstruction of the ACL<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subchondral microfracture of tibia on MRI |  | 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Visual Analogue Scale |  | During two days after surgery, twice a day |
Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese

Study Overview
=================
Brief Summary
-----------------
The investigators wish to determine if application of 2% lidocaine soaked gauze to the peritonsillar pillars will decrease the amount of gagging caused by awake videolaryngocope assisted tracheal intubation in the morbidly obese.

Official Title
-----------------
Glossopharyngeal Nerve Blockade for Awake Videolaryngoscope Assisted Endotracheal Intubation in the Morbidly Obese.

Conditions
-----------------
Gagging

Intervention / Treatment
-----------------
* Other: lidocaine
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbid obese patients scheduled for bariatric surgery, with a planned awake intubation. Exclusion Criteria: inability to communicate in English or french allergies to any study drugs any patient with an American society of anesthesiologists score of 4 or more

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>Patients in this arm will have gauze soaked with lidocaine applied to the peritonsillar pillars. | Other: lidocaine<br>* Application of lidocaine to the glossopharyngeal nerve.<br>|
| Placebo Comparator: Saline<br>Application of saline to the glossopharyngeal nerve. | Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gagging | We will assess the amount of gagging during the awake intubation. | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs | we will asses vital signs during intubation. | 2 minutes | 
| lidocaine levels |  | 40 minutes |
Risk Factors for Mortality for COVID-19 Admitted to an Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Studying clinical characterization of critically ill COVID-19 patients in a single center Studying Risk factors for Day 28 Mortality in COVID-19 patients admitted to intensive care unit

Detailed Description
-----------------
An observational study looking into clinical characterization of the novel Coronavirus Disease 2019 (COVID-19) in patients admitted, critically ill, into Intensive Care Unit of Hospital Queen Elizabeth between 1st October 2020 until 31st January 2021. Analysis also would be looking into the risk factors into Day 28 mortality of these patients

Official Title
-----------------
Clinical Characteristics & Risk Factors for Mortality of COVID-19 Patients Admitted Into Intensive Care Unit in Hospital Queen Elizabeth

Conditions
-----------------
Covid19, Critically Ill

Intervention / Treatment
-----------------
* Other: No intervention (Retrospective Cohort Observational)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the ICU in Hospital Queen Elizabeth, Kota Kinabalu between 1st October 2020 until 31st January 2021 Confirmed COVID-19 Positive using RT-PCR or RTK-Ag either before or during admission in ICU Exclusion Criteria: Patients that were admitted in ICU suspected to have COVID-19 and died in ICU which subsequently to be COVID-19 negative
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Survivors<br>Participants who had Critically-ill COVID-19 and admitted to the Intensive Care Unit which died before or on day 28 post ICU admission | Other: No intervention (Retrospective Cohort Observational)<br>* No intervention as this study is a Retrospective Cohort Observational<br>|
| Survivors<br>Participants who had Critically-ill COVID-19 and admitted to the Intensive Care Unit whom are still alive on day 28 post ICU admission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Died before or on Day 28 after ICU admission | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen supplementation requirement | Requirement of oxygen supplementation on day 28 after icu admission | day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Critically ill, Mortality Day 28
Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.

Official Title
-----------------
Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

Conditions
-----------------
Osteoporosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary elective total hip replacement Exclusion Criteria: Osteoporosis (BMD ≤-2.5) Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis Severe renal impairment Use of any medications affecting BMD Known sensitivity to bisphosphonates Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|
| Experimental: Zoledronic Acid<br> | Drug: Zoledronic acid<br>* Zoledronic acid per protocol<br>* Other names: Reclast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density (BMD) | Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem. | 2 years post-operative |
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas

Study Overview
=================
Brief Summary
-----------------
The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.

Official Title
-----------------
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas: Case Report and Literature Review

Conditions
-----------------
Solid Pseudopapillary Neoplasm of the Pancreas

Intervention / Treatment
-----------------
* Procedure: Enucleation of a tumor of the pancreas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with benign tumor of the pancreas Patients with a size tumor of less than 3 cm on the pancreas Exclusion Criteria: Patients with a size tumor greater than 3 cm on the pancreas Malignant tumors of the pancreas

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Enucleation of a tumor of the pancreas|Enucleation of a tumor in the pancreas is feasible and safe, as it offers a minimally invasive approach, and morbidities are fewer than open or conventional approach|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete enucleation of a tumor in the pancreas | Performance of a laparoscopic enucleation of a tumor in the pancreas, and compared it with a conventional approach | December 2020 |
Anterior Cruciate Ligament (ACL) Reconstruction- Bioabsorbable Screw

Study Overview
=================
Brief Summary
-----------------
To evaluate the knee functionality, screw integrity, graft integrity, cartilage effect, and bony ingrowth in patients treated with the CALAXO screw and MILAGRO screw two years after ACL reconstruction.

Detailed Description
-----------------
This study will combine the use of survey response, MRI, and x-rays of the knees in Dr. Spindler's ACL reconstructed patients in order to examine long term healing of two types of bioabsorbable screw. We will use a 2-4 yr time point to look at patient reported symptoms of pain and swelling from the surveys and use the x-rays and MRIs to look at absorption of the screw, healing of the graft, and body reactions to the screw.

Official Title
-----------------
ACL Reconstruction - Bioabsorbable Screws- 2 Year Follow-up

Conditions
-----------------
Rupture of Anterior Cruciate Ligament

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range: 12-35 years of age at the time of follow-up. Gender: Both. Minorities: All. Involved in sports at the time of injury. Participants must be at least two years past the date of ACL reconstruction surgery and not more than four years past the date of surgery Bioabsorbable Screws used during ACL reconstruction surgery Exclusion Criteria: Age: <12 or >35 years of age Non-active or unable to participate for health reasons Simultaneous bilateral ACL reconstruction surgeries. If any of the following conditions exist in the ipsilateral knee: Revision ACL reconstruction Complex knee injury If any of the following conditions exist in the contralateral knee: ACL deficient Prior ACL reconstruction Prior surgery of any type Insufficient initial documentation Cannot be contacted by phone Neither Calaxo nor Milagro screw used at the time of ACL reconstruction

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 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 |
| --- | --- |
| Calaxo<br>Received Calaxo screw | |
| Milagro<br>Received a Milagro screw | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screw integrity |  | 2-4 yrs | 
| Tunnel enlargement |  | 2-4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioabsorbable screw, acl reconstruction
Sevoflurane, Propofol, Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Sevoflurane and propofol will be compared.

Official Title
-----------------
Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial

Conditions
-----------------
Healthy Adults, Gynecological Disease

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-69 years Gender: female ASA status 1-3 Laparoscopic hysterectomy Exclusion Criteria: Body Mass Index over 35 Diabetes mellitus Liver disease Allergies to pharmaceuticals used in the Study Present use of opioids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sevoflurane|Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery|
|Drug: Propofol|Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative consumption of an opioid (oxycodone) | The consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump. | 20 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (numeral rating scale) of pain | NRS is evaluated frequently during the study period. | 20 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Postoperative, Anesthetics, intravenous, Anesthetics, inhalation, Otherwise healthy adults undergoing general anesthesia for gynecological disease.
Metformin as Added on Therapy in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is marked by increased intestinal motility and bloody diarrhea. The clinical value of existing therapeutic strategies of UC, including glucocorticoids, anti-tumor necrosis factor α (TNF-α), mesalamine, and thiopurines is still limited. Therefore, the discovery of new therapeutic approaches is essential to improve the effectiveness of the treatment.Adenosine monophosphate (AMP)-activated protein kinase (AMPK) is a conserved fuel-sensing enzyme that plays an important role in the regulation of cellular metabolism where it increases glucose and fatty acids uptake and activates the oxidation process to improve the cellular energy utilization

Official Title
-----------------
Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception Mild and moderate UC patients diagnosed and confirmed by the endoscope Exclusion Criteria: - Breastfeeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>This group will take mesalamine 1 g three times daily | |
| Active Comparator: Metformin group<br>This group will take mesalamine 1 g three times daily plus metformin 500 mg two times daily | Drug: Metformin<br>* Metformin is an antidiabetic biguanide drug that acts by promoting glucose uptake and utilization in the liver.Recent studies proved that metformin could reduce colonic inflammation by AMPK-mediated inhibition of p38 mitogen-activated protein kinase (MAPK)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores | The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224. | 6 months |