linjc16/ctgov huggingface dataset:
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.

Official Title
-----------------
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: soluble human insulin
* Drug: insulin aspart
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or 2 diabetes for at least 4 weeks Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks HbA1c: 7.5-13.5% Body Mass Index (BMI): 18-35 kg/m2 Exclusion Criteria: Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation History of drug abuse or alcohol dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: soluble human insulin|nan|
|Drug: insulin aspart|nan|
|Drug: insulin NPH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hours postprandial plasma glucose (PPPG) |  | after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving 2-hours PPPG treatment target |  |  | 
| Percentage of subjects achieving HbA1c treatment target |  |  | 
| HbA1c |  |  | 
| Fasting plasma glucose |  |  | 
| Hypoglycaemic episodes |  |  |
Research of the Correlation Between Metabolic Syndrome, Retinal Thickness and Visual Acuity

Study Overview
=================
Brief Summary
-----------------
Purpose: To investigate the relationship between retinal thickness (RT) and metabolic risks (MRs) in patients without retinal lesion. Methods: Fifty-two patients over 60 y/o were divided into four groups according to their MRs of hypertension, hyperlipidemia or hyperglyceremia. After complete ophthalmic examination, optical coherence tomography was performed to measure RT.

Official Title
-----------------
Research of the Correlation Between Metabolic Syndrome, Retinal Thickness and Visual Acuity

Conditions
-----------------
Visual Acuity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We enrolled the patients included age more than 60 years old, no positive finding during dilated fundus examination. Exclusion Criteria: The exclusion criteria were as followed: systemic disease that will affect visual acuity evaluation (for example: CVA), *opaque cornea and vitreous glaucoma uvietis and other clinically established ocular disease. According to the LOCS III11, those who had nuclear opalescence, nuclear color more than grade 3 or any grade of cortical cataract and posterior subcapsular cataract were also eliminated.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| control<br>0 metabloil risk | |
| 1<br>1 metabloil risk | |
| 2<br>2 metabloil risk | |
| 3<br>3 metabloil risk | |

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
-----------------
To investigate the relationship between retinal thickness (RT) and metabolic risks (MRs) in patients without retinal lesion
COVID-19 Registry Rhineland-Palatinate (Germany)

Study Overview
=================
Brief Summary
-----------------
Documentation of all patients undergoing inpatient treatment for SARS-CoV-2 infection with regard to clinical status at admission, medical history, inpatient treatment and course of disease. The aim is to create a risk stratification of the infection on the basis of clinical data as well as therapy and disease progression of the patients. This may also contribute to a better planning of resources.

Official Title
-----------------
COVID-19 Registry Rhineland-Palatinate (Germany) - COVID-19 Disease Registry a National, Multicentre, Non-interventional, Prospective Observational Study

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Other: Prospective oberservational registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In-patients fulfilling the following criteria: SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study Exclusion Criteria: No explicit medical exclusion criteria are stated to avoid selection bias.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-patients with SARS-CoV-2 infection<br>In-patients fulfilling the following criteria: SARS-CoV-2 infection In-patient treatment Written informed consent for participation in observational study No explicit medical exclusion criteria are stated to avoid selection bias. | Other: Prospective oberservational registry<br>* Non interventional study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest x-ray | presence of infiltrates | throughout study completion, in average 1.5 years | 
| Chest CT | presence of infiltrates | throughout study completion, in average 1.5 years | 
| Supportive care - ICU | number of patients with ICU treatment required | throughout study completion, in average 1.5 years | 
| Supportive care - oxygen therapy | number of patients with oxygen therapy required | throughout study completion, in average 1.5 years | 
| Supportive care - ventilation | number of patients with ventilation required | throughout study completion, in average 1.5 years | 
| Medication | number of patients with medication changes | throughout study completion, in average 1.5 years | 
| Therapeutic strategies | number of patients with ECMO required | throughout study completion, in average 1.5 years | 
| Lab parameters | number of patients with significant changes in lab parameters | throughout study completion, in average 1.5 years | 
| Intra-hospital complications | number of patients with complications during hospital stay | throughout study completion, in average 1.5 years | 
| Vital status at discharge | vital status at discharge: alive, dead | throughout study completion, in average 1.5 years |
Influence of Therapeutic Hypothermia on Resting Energy Expenditure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the evaluation of the influence of therapeutic hypothermia on resting energy expenditure (REE) in patients after cardiopulmonary resuscitation (CPR). We hypothesized that hypothermia would reduce resting energy expenditure in these patients.

Detailed Description
-----------------
Therapeutic hypothermia improves neurologic outcome in patients after cardiopulmonary resuscitation (CPR) because of cardiac arrest. In the present study patients will be cooled to 33 degree Celsius after CPR for 24h. To avoid shivering patients will be analgosedated and medically paralysed. Analgosedation and relaxation have already shown to reduce oxygen consumption up to 20 % in critically ill patients. In patients with brain injury, who were cooled to 33 degree Celsius using a cooling meadow REE could be significantly reduced. In critically ill patients with pyrexia cooling using a cooling meadow REE could be reduced. Oxygen consumption was reduced about 14,7% per degree Celsius. So far no studies evaluating influence of therapeutic hypothermia on REE in patients after CPR have been published. Therefore we plan to measure REE in 25 cooled patients after CPR using indirect Calorimetry (Deltatrac II Metabolic Monitor, Datex Instrumentarium, Helsinki, Finland).

Official Title
-----------------
Influence of Therapeutic Hypothermia on Resting Energy Expenditure in Patients After Cardiopulmonary Resuscitation

Conditions
-----------------
Cardiopulmonary Resuscitation

Intervention / Treatment
-----------------
* Procedure: Measurement of Resting Energy Expenditure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: St.p. CPR Indication for therapeutic hypothermia for 24h (33 degrees Celsius) Exclusion Criteria: Contraindication for therapeutic hypothermia

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 |
| --- | --- |
| 1<br>Patients successfully resuscitated after cardiac arrest undergoing therapeutic hypothermia | Procedure: Measurement of Resting Energy Expenditure<br>* Non-invasive measurement of Resting Energy Expenditure<br>* Other names: Deltatrac (Ohmeda);|

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
-----------------
Cardiopulmonary resuscitation, Therapeutic hypothermia, resting energy expenditure
Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

Study Overview
=================
Brief Summary
-----------------
The pathworks tissue of origin test is a microarray-based test with the goal of identifying the tissue of origin in patients with metastatic tumors of unknown primary site.

Official Title
-----------------
Evaluation of Pathwork Tissue of Origin (TOO) Test for Human Malignancies

Conditions
-----------------
Neoplasm Metastasis

Intervention / Treatment
-----------------
* Procedure: Pathwork TOO test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1 Subjects must be at least 18 years old. The TOO test is designed to determine the tissue of origin of common adult malignancies. There are no gender/ethnic restrictions. 2 Patients with a diagnosis of malignancy established by pathologic review of H&E staining of tumor biopsy or tumor resection without definitive determination of tissue of origin as assessed by the PI. Samples must have been obtained within three months of enrollment, or the patient must still be under active evaluation for tissue of origin at the time of enrollment. There are no limitations on prior therapy and time from last prior therapy. 3 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:1 Patients under the age of 18 are excluded. There are no exclusions based on gender/ethnicity. 2 There are no exclusion requirements due to co-morbid disease or incurrent illness, as needed. 3 Pregnancy or nursing participants will not be excluded from the study. 4 Patients with a diagnosis of leukemia including acute myelogenous leukemia, acute lymphocytic leukemia, hairy cell leukemia, chronic myelogenous leukemia and chronic lymphocytic leukemia are excluded from enrollment on this study. The TOO test does not cover these diagnoses.

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

| Intervention/Treatment |
| --- |
|Procedure: Pathwork TOO test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Epidural Magnesium Sulfate for Post-thoracotomy Pain Control

Study Overview
=================
Brief Summary
-----------------
Pain after thoracotomy is very severe and may cause pulmonary complications. Thoracic epidural analgesia has greatly decreased the pain experience and its consequences. However, new ways of decreasing post-operative opioid drugs consumption is an important issue of research. We aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled in a randomized double blind trial. Patients randomly will be allocated in two groups. Bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients at the end of operation. Patients in group I will be received epidural magnesium sulfate (50 mg) and patients in Group II will be received normal saline as an adjuvant. Visual analog scale (VAS) score and the amount of morphine consumption will be measured during 24 hours post-operation.

Official Title
-----------------
The Effect of Adjuvant Epidural Magnesium Sulfate to Bupivacaine and Morphine on Post-thoracotomy Pain Control: A Randomized Double Blind Clinical Trial Study

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: magnesium sulfate
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical statuses I-III Undergoing thoracotomy Exclusion Criteria: Known hypersensitivity to magnesium sulfate Renal failure Hepatic dysfunction Severe obesity Psychotic or neurologic diseases Currently taking opioid or calcium channel blocker AV block degree II or III Refused to participate in trial

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>magnesium group (Mg) | Drug: magnesium sulfate<br>* 2cc of magnesium sulfate ( 50%) will be administered epidurally<br>|
| Placebo Comparator: Group II<br>control group (C) | Drug: normal saline<br>* 2cc of normal saline will be administered epidurally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of post-thoracotomy pain | VAS (visual analog scale: 0-10 cm (0 cm = no pain and 10 cm = the worst pain)) score will be measured | 24 hours after thoracotomy |
Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
A Randomized, Open Label, Single dose, Cross-over, Phase I Trial to Investigate Safety and Pharmacokinetics of Apetrol ES and Megace® under Fed Conditions in Healthy Male Volunteers.

Official Title
-----------------
Phase I Study of Apetrol ES and Megace® in Healthy Male Volunteers

Conditions
-----------------
Healthy Male Volunteers

Intervention / Treatment
-----------------
* Drug: Apetrol ES


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is a healty male between 20 and 55 years old Has BMI result between 19 and 26 kg/m2 at screening Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Agrees to use an adequate means of contraception during clinical trials Exclusion Criteria: Has had a serious illness or medical condition(s) regarding liver, kidney, gastrointestines, pulmonary systems, etc. Has had a medical history of gastrointestinal diseases which might affect drug absorption (i.e. Crohn's disease, ulcer) or surgical history. Is allergic against Megestrol acetate or other drugs (Aspirin, NSAIDs, Antibiotics, etc.) or against foods, or has an clinically serious allergic history

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 : Megace 800mg - Apetrol ES 650mg - Apetrol ES 675mg<br> | Drug: Apetrol ES<br>* sequences of administered drugs<br>|
| Experimental: Group 2 : Apetrol ES 650mg - Apetrol ES 675mg -Megace 800mg<br> | Drug: Apetrol ES<br>* sequences of administered drugs<br>|
| Experimental: Group 4: Megace 800mg - Apetrol ES 675mg - Apetrol ES 650mg<br> | Drug: Apetrol ES<br>* sequences of administered drugs<br>|
| Experimental: Group 5: Apetrol ES 650mg - Megace 800mg - Apetrol ES 675mg<br> | Drug: Apetrol ES<br>* sequences of administered drugs<br>|
| Experimental: Group 3: Apetrol ES 675mg - Apetrol ES 650mg - Megace 800mg<br> | Drug: Apetrol ES<br>* sequences of administered drugs<br>|
| Experimental: Group 6 : Apetrol ES 675mg - Megace 800mg - Apetrol ES 650mg<br> | Drug: Apetrol ES<br>* sequences of administered drugs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, AUClast |  | Day 34 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, Tmax, t1/2(beta) |  | Day 34 |
Spinal for Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will study spinal anesthesia for laparoscopic cholecystectomy in comparison to general anesthesia (GA) regarding patient satisfaction as a primary variable, intraoperative complications, postoperative analgesic requirements, postoperative nausea and vomiting, patient hospital stay (secondary variables).

Conditions
-----------------
Laparoscopic Cholecystectomy

Intervention / Treatment
-----------------
* Drug: Bupivacaine with Fentanyl (Spinal Anesthesia)
* Drug: General anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for laparoscopic cholecystectomy Exclusion Criteria: coagulopathy Patient refusal previous spine surgery Obesity BMI more than 30

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia group<br>General anesthesia group: Standard anesthetic technique will be applied.Anesthesia will be induced by propofol 1% (1-2 mg/kg), Fentanyl 1-2 mic/kg, and Atracurium 0.5 mg/kg then according to train of four response. Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60.. | Drug: General anesthesia<br>* Induction by propofl 1.5-2 mg/kg, Fentanyl 1-2 mic/kg and atracrium 0.5 mg/kg Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60..<br>|
| Experimental: Spinal anesthesia group<br>While in sitting position; intrathecal injection using 25 G spinal needle using 3 mls of Bupivacaine 0.5% with 20 mic Fentanyl, at L 2-3 level the patient head will be lowered till sensory blockade of T6 obtained at least. | Drug: Bupivacaine with Fentanyl (Spinal Anesthesia)<br>* Intrathecal injection of 15 mg Bupivacaine 0.5% at L 2-3 level mixed with 20 µ Fentanyl. Patients head will be lowered till sensory level of T 6 is abstained.<br>* Other names: intrathecal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction (over a scale from 1 to 4) |  | 24 hours | 
| Postoperative analgesic consumption (mg morphine) |  | 24 hours |
Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous docetaxel in cancer patients with advanced solid tumors.

Official Title
-----------------
Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: Farnesyl Protein Transferase Inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Male or Female Measurable or evaluable disease No more than 2 prior chemotherapy regimens. Age greater than or equal to 18. Karnofsky Performance Status greater than or equal to 70%. Meets protocol requirements for specified laboratory values. No manifestations of a malabsorption syndrome. Written informed consent and cooperation of patient Appropriate use of effective contraception if of child-bearing potential. Exclusion: Acute or chronic leukemia or multiple myeloma. Evidence of 2 or more active malignancies, expect for in situ or adequately treated basal or squamous cell skin cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Farnesyl Protein Transferase Inhibitor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  |  | 
| Laboratory Tests |  |  | 
| ECG |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Exam |  |  | 
| Pharmacokinetics |  |  | 
| Tumor Response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer-Advanced Solid Tumors