linjc16/ctgov huggingface dataset:
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options by using vitamin D oral thin film (OTF) administration.

Detailed Description
-----------------
The purpose of this study is to investigate efficacy of oral thin film (OTF) cholecalciferol (vitamin D3) replacement in hematopoietic stem cell transplantation (HSCT) recipients who failed to achieve or sustain adequate vitamin D levels after vitamin D supplementation using current standard of care, or those unable to take/tolerate currently available enteral vitamin D formulations. With oral thin film (OTF) cholecalciferol, investigators hope to significantly improve the ease of administration, restoring compliance and facilitating therapeutic vitamin D levels without relying on the gut for absorption.

Official Title
-----------------
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Vitamin D Deficiency, Hematopoietic Stem Cell Transplantation (HSCT)

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF. Exclusion Criteria: Subjects with 25OHD level >60ng/mL. Subjects can be re-screened multiple times and enrolled later if they meet study criteria. Subjects with clinically significant and uncontrolled hypercalcemia as deemed by treating physician.
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 |
| --- | --- |
| Experimental: Vitamin D Oral Thin Film (OTF)<br>Study subjects will receive vitamin D OTF for a maximum of 12 weeks. | Dietary Supplement: Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)<br>* Study participants will receive vitamin D OTF weekly for a maximum of 12 weeks. The dose may be increased or decreased based on the dosing schema.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D Level | Number of participants who achieve 25OH vitamin D level >35ng/mL | 12 weeks from starting vitamin D supplementation |
Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether or not adding Raltegravir to a fully suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic inflammation and increase the t-lymphocyte memory cell pool.

Official Title
-----------------
A Pilot Study to Assess the Downregulation of HIV-1 Associated Chronic Inflammation in Patients With Limited Immunologic Responses When Raltegravir is Added to a Virologically Suppressed HAART Regimen

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

Intervention / Treatment
-----------------
* Drug: Raltegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age HIV-positive by Western blot or viral load Viral load < 400 copies/ml CD4+ T-lymphocyte count less than 350 cells/mm3 or change in CD4+ T-lymphocyte count < 100 cells/mm3 for at least one year on stable HAART with viral load < 400 copies/ml for the same period of time Exclusion Criteria: CD4+ T-lymphocyte count greater than or equal to 350 cells/mm3 or rise in CD4+ T-lymphocyte count greater than or equal to 100 cells/mm3 within one year of study entry Viral load > 400 copies/ml Allergy or resistance to raltegravir

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltegravir<br> | Drug: Raltegravir<br>* Raltegravir 400 mg PO BID for 12 months<br>* Other names: Brand name is Isentress;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the change in circulating CD4+ and CD8+ T-lymphocytes |  | 12 months | 
| Determine whether the circulating CD8+ T-lymphocyte count or the CD4+/CD8+ ratio can serve as a surrogate marker for suppression of chronic inflammation |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic inflammation, memory cells, activated t-lymphocytes
CoV-ICU Score, Intensive Care Unit, SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
In the course of COVID disease, some patients need intensive care treatment. We aim to find an answer to the question of whether the patient's CRP, ferritin, D-dimer, Oxygen Saturation, lymphocyte count, and body mass index can be used as a criterion for admitting patients with COVID to the intensive see unit.

Detailed Description
-----------------
It is aimed to determine the patients who are above the threshold value to be determined according to this scoring result. Identifying patients who may need intensive care and following them closely will positively affect patient prognosis.

Official Title
-----------------
CoV-ICU Score: Who Will Need Intensive Care in the Course of Corona Virus Disease?

Conditions
-----------------
Coronavirus as the Cause of Diseases Classified Elsewhere

Intervention / Treatment
-----------------
* Other: COVICU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the intensive care unit with the diagnosis of COVID Exclusion Criteria: <18 years patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| CoVID patients admitted to ICU<br>Patients admitted to the intensive care unit with the diagnosis of COVID | Other: COVICU<br>* COVICU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVICU score | With this scoring, identifying patients who may need intensive care early and following them closely will have a positive effect on patient prognosis. | 1 week | 
| Values | Minimum and maximum values will be determined at the end of the study. Higher scores mean a worse outcome | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-CoV-2, intensive care
Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.

Official Title
-----------------
A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkins Lymphoma

Intervention / Treatment
-----------------
* Drug: hLL2 (epratuzumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Disease Characteristics: Patients with a documented histologic or cytologic diagnosis of B-cell NHL. Patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority. Patients with at least one measurable tumor site > 1.5 cm in at least one dimension. Prior/Concurrent Therapy: Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. Biologic Therapy: Patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hLL2 IgG (i.e., HAHA). Radiotherapy: No prior radiation therapy to >25% of the bone marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cGy for the lungs and kidneys). Patients who have had whole pelvic irradiation are not eligible. Patient Characteristics/Inclusion Criteria: Age Range: Male or Female at least 18 years of age Performance Status: Patients with a Karnofsky performance status > 60% (or equivalent, ECOG 0-2) and expected survival of at least 12 weeks. Hematopoietic: Hemoglobin > 10 g/dL; ANC > 1.5x10^9/L; Platelets > 100x10^9/L; Hepatic: Serum bilirubin < 2.0 mg/dL; AST and ALT < 2 x ULN w/o liver metastases or <5 x ULN w/liver metastases Renal: Creatinine < 2.0 mg/dL Cardiovascular: Patients with LVEF >/= 50% by MUGA or 2D-ECHO. Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests. Other: Patients agreeing to use a medically effective method of contraception while enrolled in the study. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hLL2 (epratuzumab)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Methodist Health System COVID-19 Patient Registry

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort observational registry study that will include data on all patients who are treated at MHS facilities for COVID-19.

Detailed Description
-----------------
This is a prospective cohort observational registry study that will include data on all patients who are treated at MHS facilities for COVID-19. Data including, but not limited to demographics, comorbidities, medications, treatment, and clinical outcomes will be collected from February 2020 to December 2025. Subjects will undergo no additional tests or procedures as part of this registry study. All patient data will be obtained from the patient's electronic health records (EHR) of the hospital or clinic in a retrospective manner. The process for gathering the data will not influence treatment decisions. There will be no direct patient contact associated with inclusion in this registry study.

Official Title
-----------------
Methodist Health System COVID-19 Patient Registry

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Treatment for COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient tested positive for COVID-19 (SARS-CoV-2) Patient sought care for COVID-19 at a MHS facility Aged 18 years or older Exclusion Criteria: Patient that do not have COVID-19 Non-confirmed COVID-19 patients Aged 17 years or younger

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Cohort<br>Patients treated at MHS facilites for COVID-19 | Other: Treatment for COVID-19<br>* Patients treated for COVID-19<br>|
| Synopsis for COVID Bariatric, Hepato-Biliary and Colorectal surgery study<br>30 Day Mortality after surgery in patients with COVID19 infection who undergo elective bariatric, hepato-biliary and colorectal surgery. Patients diagnosed with COVID-19 at the time of surgery up to seven days before surgery Patients diagnosed with COVID-19 within 30 days after surgery | Other: Treatment for COVID-19<br>* Patients treated for COVID-19<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Characteristics | Patient characteristics | June 2020 - Dec 2025 | 
| Treatment Measures and Intervention strategies | Treatment measures and intervention strategies | June 2020 - Dec 2025 | 
| Clinical and survival outcomes | Clinical and survival outcomes | June 2020 - Dec 2025 |
Optimization of the Core Number and Location for Targeted Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

Detailed Description
-----------------
This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.

Official Title
-----------------
An Exploratory Study of Optimizing the Core Number and Location for MRI/Ultrasound Fusion Targeted Prostate Biopsy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: MRI/Ultrasound Fusion Saturation Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men more than 18 years old with clinical suspicion of prostate cancer; Serum PSA ≤ 20 ng/ml within the previous 3 months; No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm； Able to provide written informed consent. Exclusion Criteria: Prior prostate biopsy or prostate surgery; Prior treatment for prostate cancer; Contraindication to MRI (e.g. claustrophobia, pacemaker); Contraindication to prostate biopsy; Men in whom artifact would reduce the quality of the MRI.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI/Ultrasound Fusion Saturation Biopsy<br> | Procedure: MRI/Ultrasound Fusion Saturation Biopsy<br>* MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area |  | When histology results available, at an expected average of 3 days post-biopsy |
Functional Study of Metabolites in Patients With Aortic Dissection

Study Overview
=================
Brief Summary
-----------------
Research on metabolites in patients with aortic dissection, with a view to finding products with high or low metabolism in patients with aortic dissection, looking for metabolic factors related to the onset of aortic dissection, and further verifying the role of metabolic factors in disease through functional verification The role of formation, and ultimately explore the early screening of potential aortic dissection patients

Official Title
-----------------
Functional Study of Metabolites in Patients With Aortic Dissection

Conditions
-----------------
Aortic Dissection

Intervention / Treatment
-----------------
* Diagnostic Test: aortic dissection and healthy people


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Aortic dissection Exclusion Criteria: Sepsis

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Baseline table of patients<br> | Diagnostic Test: aortic dissection and healthy people<br>* Differential expression of metabolites in patients with aortic dissection and healthy people<br>|
| Differential metabolites of two groups of control patients<br> | Diagnostic Test: aortic dissection and healthy people<br>* Differential expression of metabolites in patients with aortic dissection and healthy people<br>|
| Functional verification of differential metabolites<br> | Diagnostic Test: aortic dissection and healthy people<br>* Differential expression of metabolites in patients with aortic dissection and healthy people<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential expression of metabolites in two groups of patients | Differential expression of metabolites in the two groups of patients, looking for metabolic factors related to the incidence of aortic dissection, and further verifying the function of metabolites through functional methods, with a view to finding high-risk metabolic factors for patients with aortic dissection | 2019-11----2021.01 |
Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX)

Study Overview
=================
Brief Summary
-----------------
The investigators aim to determine the effect of the correction of vitamin D in vitamin D deficient patients (<15ng/ml) in oxidative stress and insulin resistance in patients with impaired glucose tolerance. Vitamin D deficiency has been associated with chronic low-grade inflammation, diabetes mellitus type 2, cardiovascular risk and increased prevalence of coronary heart disease, cerebrovascular disease and myocardial infarction.

Official Title
-----------------
Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Impaired Glucose Tolerance: A Randomized, Double-blind, Placebo-controlled Trial

Conditions
-----------------
Vitamin D Deficiency, Glucose Intolerance, Oxidative Stress, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, 18 to 70 years, glucose intolerance (post-2 hour 75-grams glucose load > or equal 140 mg/dl), 25-hydroxy vitamin D concentration < or equal 15 ng/ml Exclusion Criteria: Diabetes, systemic inflammatory disorders, treatment with statins, metformin or fibrates, renal insufficiency, intestinal malabsorption

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units) | Drug: Vitamin D<br>* Vitamin D supplementation<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo<br>Identical placebo capsules, 20 capsules per week during four weeks | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anti-oxidant capacity measured in serum | Change in serum anti-oxidant capacity after one month | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in homeostasis model assessment (HOMA) index measured in serum | Change in homeostasis model assessment (HOMA) index after one month | One month |
Transcutaneous Measurement of Carbon Dioxide Versus Current Sedation Practices in Sedated Patients

Study Overview
=================
Brief Summary
-----------------
Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?

Official Title
-----------------
Does Transcutaneous Carbon Dioxide Partial Pressure (TcCO2) Monitoring Detect Hypoventilation Prior to Current Sedation Monitoring Practices?

Conditions
-----------------
Colonoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring sedation for colonoscopy Exclusion Criteria: Patient refusal

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 |
| --- | --- |
| elective colonoscopy and requiring sedation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies? |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To verify if there is an association with the following variables: age, gender, weight, length, ASA-classification, sedation depth (BIS), co-morbidity, diagnostic or therapeutic colonoscopy. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carbon dioxide, TcC02, Hypoventilation, endoscopic, elective colonoscopy and requiring sedation