linjc16/ctgov huggingface dataset:
Phase 1 Safety Study of ALK-001 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact trials@alkeus.com for any questions.

Official Title
-----------------
A Phase 1, Open Label, Repeat Dose Study to Investigate the Safety and Pharmacokinetics of 4-week Daily Dosing of ALK-001 in Healthy Volunteers

Conditions
-----------------
Stargardt Disease, Age-related Macular Degeneration, Other Retinal Dystrophies

Intervention / Treatment
-----------------
* Drug: ALK-001 (No generic name)


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria Adult between 21 and 70 years old (inclusive) Healthy subject, as judged by investigator Subject is able and willing to comply with study requirements (study medication compliance, schedule of follow-up visits) Subject has provided informed consent to participate If female, subject uses a medically accepted birth control method and agrees to use such a method for entire clinical trial period Main Exclusion Criteria: Subject has taken disallowed items during the past 30 days Female with a positive urine pregnancy test at screening Lactating woman Subject has participated in any clinical study involving an investigational drug, biologic or device, during the past 30 days History or current evidence of gastrointestinal malabsorption Subject has any other medical condition, which in the opinion of the investigator, is likely to prevent compliance with protocol and/or interfere with successful collection of study Subject has, in the opinion of investigator, clinically significant laboratory result(s), positive drug or alcohol screening, or ECG, which makes subject unsuitable for participation.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALK-001 capsules<br> | Drug: ALK-001 (No generic name)<br>* Daily, oral administration of ALK-001 capsules.<br>* Other names: C20 Deuterated vitamin A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of 4-week daily dosing of ALK-001 in healthy adults. | Safety evaluations combine: adverse events (AE), laboratory testing (hematology and biochemistry panels), 12-lead electrocardiograms (ECGs), vital signs, physical examination, and visual function (visual acuity and a self-reported questionnaire). | 4 weeks |
Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to collect information on the safety, especially localized injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in patients with rheumatoid arthritis.

Official Title
-----------------
Outline of Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Orencia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are beginning to receive the treatment with ORENCIA Subcutaneous Injection 125mg Syringe 1mL under the approved indications, dosage, and administration

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 |
| --- | --- |
| Patients who are treated with ORENCIA<br>Patients who are treated with ORENCIA according to the approved indications, and dosage and administration | Drug: Orencia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events |  | 24 weeks |
Myth of Double Crush Syndrome in Median Nerve

Study Overview
=================
Brief Summary
-----------------
There is relation between the cervical radiculopathy and carpal tunnel syndrome and why the referred pain is fall at carpal tunnel not at elbow.

Detailed Description
-----------------
This is an observational cadaveric study which examined median nerve from shoulder to wrist by histological measurements to explain the difference at the median nerve.

Official Title
-----------------
Double Crush Syndrome in Median Nerve-cadaveric Observational Study

Conditions
-----------------
Cervical Radiculopathy, Median Nerve Disease

Intervention / Treatment
-----------------
* Other: Investigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intact Upper Limb Exclusion Criteria: Amputation at upper limb -

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Investigation|cadaveric dissection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological study | Studying the histological structure of the median nerve at shoulder, elbow and wrist | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wrist Pain
Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism (VTE) is an important cause of post-operative morbidity and mortality in women undergoing surgery for gynecologic malignancies. Although the benefit of thromboprophylaxis in reduction of post-operative VTE events after surgery for gynecologic cancers has been well documented around the world, the evidence for Chinese women is rare. The investigators designed this prospective and randomized study to assess the benefit of pharmacologic prophylaxis for patients received surgical treatment for gynecologic malignancies in China.

Official Title
-----------------
Effectiveness and Safety of Thromboprophylaxis After Surgery for Gynecologic Malignancy in China

Conditions
-----------------
Gynecologic Neoplasms, Venous Thromboembolism, Low Molecular Weight Heparin, Argatroban

Intervention / Treatment
-----------------
* Drug: s-LMWH
* Drug: LMWH
* Drug: Argatroban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of ovarian cancer, cervix cancer or endometrial cancer; Age ≤ 70 years; female, Chinese women; Initial treatment is surgery; Laboratory tests: WBC ≥ 4×10(9)/L, NEU ≥ 2×10(9)/L, PLT ≥ 100×10(9)/L, serum bilirubin ≤ 1.5 times the upper limit of normal, transaminase ≤ 1.5 times the upper limit of normal, BUN, Cr ≤ normal No prior pharmacologic prophylaxis; Provide written informed consent. Exclusion Criteria: PLT ≤ 75×10(9)/L Vascular injury History of thrombosis Liver and kidney dysfunction Concurrently participating in other clinical trials Unable or unwilling to sign informed consents; Unable or unwilling to abide by protocol.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: s-LMWH<br>2125 I.U. subcutaneous injection for 5-10 days | Drug: s-LMWH<br>* 2125KU, subcutaneous injection of 5-10 days<br>|
| Active Comparator: LMWH<br>4250 I.U. subcutaneous injection for 5-10 days | Drug: LMWH<br>* 4250KU, subcutaneous injection of 5-10 days<br>|
| Experimental: Argatroban<br>20mg, injection for 5-10 days | Drug: Argatroban<br>* 20mg, injection for 5-10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE rate |  | 30-days from the date of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding rate |  | 30-days from the date of operation | 
| Infection rate |  | 30-days from the date of operation |
Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.

Official Title
-----------------
A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

Conditions
-----------------
Myeloid Leukemia, Chronic, Chronic-Phase

Intervention / Treatment
-----------------
* Drug: Dasatinib in combination with imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females, 18 or older chronic phase Ph+ or BCR-ABL positive CML current complete hematologic response to imatinib lack of major molecular response on imatinib for at least one year on the same imatinib dose for at least 6 months adequate hepatic and renal function Exclusion Criteria: History of accelerated or blast phase CML Serious uncontrolled medical disorder or active infection Significant cardiovascular disease or bleeding disorder Concurrent use of medications at risk of causing Torsades de Pointe

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

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

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: Dasatinib in combination with imatinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess safety and tolerability of dasatinib and imatinib administered in combination throughout study |  |  | 
| identify dose limiting toxicities |  |  | 
| characterize plasma pharmacokinetics of dasatinib and imatinib in month 1 |  |  | 
| measure major molecular response rate |  |  | 
| measure the major cytogenetic response rate |  |  | 
| characterize mutations in the BCR-ABL gene |  |  | 
| evaluate progressive free survival and overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic phase chronic myelogenous leukemia (CML)
Muscle Pressure in the Flank Position

Study Overview
=================
Brief Summary
-----------------
Using healthy volunteers, participants will lay on an operating room table in various positions employed during kidney surgery. Using a pressure sensor mat, we hope to determine which areas of the body are subject to higher pressures. Using padding devices (foam, gel, water mattress)which are currently used in the operating room will be employed and measurements will be taken to determine which padding material and configurations is optimal to reduce the pressure to those body parts at risk for excessive pressure subject during laparoscopic surgery.

Official Title
-----------------
Muscle Pressure in the Flank Position

Conditions
-----------------
Tissue Breakdown

Intervention / Treatment
-----------------
* Device: surgical table pressure mat


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Subjects with musculoskeletal disabilities

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: surgical table pressure mat|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin).

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

Intervention / Treatment
-----------------
* Drug: Teneligliptin 20mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A signed and dated informed consent form has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place. The subject is aged ≥18 years at signature of the informed consent form. Hospitalization status: outpatient. The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28). The subject is undergoing diet and exercise therapy, and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria. The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day -14. Exclusion Criteria: The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes. The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (< 2 weeks' duration). The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teneligliptin 20mg<br>Teneligliptin (20mg once daily) for 24 weeks | Drug: Teneligliptin 20mg<br> <br> |
| Placebo Comparator: Placebo<br>Placebo for 24 weeks | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c From Baseline to Week 24 | The change in HbA1c from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS. | at Day 1(baseline) and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Changes in Fasting Plasma Glucose (FPG) at Week 24 | The change in FPG from baseline to Week 24 in Teneligliptin compared to Placebo was performed on FAS. | at Day 1(baseline) and Week 24 |
Bloodstram Infections in ICU. Single Centre Observational Study.

Study Overview
=================
Brief Summary
-----------------
Hospital-acquired bloodstream infection (BSI) is serious care problem worldwide associated with significant morbidity and mortality. However, only few nationwide studies have focused on the incidence of BSI, and its results were often inconsistent. The objective of this study was to analyze bloodstream infections in patients hospitalized in the intensive care unit of the tertiary, university hospital. Special attention was put on the etiology of the infections, the antimicrobial susceptibility/resistance of the isolated pathogens, as well as the incidence of central vein catheters infections in the analyzed population. Data were collected in the intensive care unit of the Military Institute of Medicine, Warsaw, Poland, between January, 1, 2007 and December, 31, 2019.

Official Title
-----------------
Bloodstram Infections in Intensive Care Unit. A Single Centre Bacteriological Analysis Between 2007-2019.

Conditions
-----------------
Bloodstream Infection, Antibiotic Resistant Strain, Intensive Care Unit

Intervention / Treatment
-----------------
* Diagnostic Test: Microbiological analysis of blood samples.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients hospitalized in the ICU with clinically suspected infection. Exclusion Criteria: none.

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 |
| --- | --- |
| Patients hospitalized in the ICU during the study period.<br>Patients hospitalized in the ICU during the study period with clinically suspected infection. | Diagnostic Test: Microbiological analysis of blood samples.<br>* Microbiological analysis of blood samples collected from the patients with clinically suspected infection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of microbiological analysis. | Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period. | After completion of the microbiological analysis, up to 72 hours. | 
| Isolated pathogens' susceptibility for antimicrobial agents. . | Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period. | After completion of the microbiological analysis, up to 72 hours. | 
| Isolated pathogens' resistance for antimicrobial agents. . | Results of the microbiological analysis of the blood samples collected from patients with clinically suspected infections hospitalized in the ICU during the study period. | After completion of the microbiological analysis, up to 72 hours. |
Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: umbilical cord drainage of fetal blood after delivery of the infant would reduce the incidence of feto-maternal transfusion. Patients were randomized to placental drainage or no drainage at the time of cesarean section. The incidence of fetal to maternal transfusion was noted postoperatively.

Detailed Description
-----------------
86 patients were randomized to placental drainage vs. no drainage of fetal blood at the time of cesarean section. Kleihauer-Betke testing was performed within 12 hours postoperatively to assess the incidence of feto-maternal transfusion. A significant difference was found between the two groups.

Official Title
-----------------
Effect of Placental Drainage of Fetal Blood at Cesarean Section on the Incidence of Feto-Maternal Transfusion: A Randomized Controlled Trial

Conditions
-----------------
Fetomaternal Transfusion

Intervention / Treatment
-----------------
* Procedure: drainage of placenta of fetal blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women undergoing cesarean section Exclusion Criteria: Preoperative Kleihauer-Betke, known antepartum erythrocyte sensitization, overt vaginal bleeding, history of a previous delivery by low vertical cesarean section, prolonged rupture of membranes, twin gestation, failure to obtain both preoperative and postoperative Kleihauer-Betke tests.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: placental drainage<br> | Procedure: drainage of placenta of fetal blood<br> <br> |
| No Intervention: no drainage of fetal blood<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of fetal blood in maternal circulation |  | within 12 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no secondary outcome measures |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Feto-maternal transfusion, Kleihauer-Betke