linjc16/ctgov huggingface dataset:
Parecoxib In Post Surgery (Hemicolectomy) Pain

Study Overview
=================
Brief Summary
-----------------
This is a phase III, multicenter, open label, pilot to evaluate the analgesic efficacy and safety of parecoxib 40 mg IV in the treatment of the pain following hemicolectomy in an optimal management of the surgical patient

Detailed Description
-----------------
The study was terminated prematurely due to recruitment issues on 31 January 2006. Safety concerns did not lead to the decision to terminate this study.

Official Title
-----------------
A Multicenter, Open Label, Pilot Study To Evaluate Analgesic Activity And Safety Of Parecoxib 40 Mg IV In Patients Undergoing Hemicolectomy, In The Optimal Management Of Acute Post-Operative Pain Of Surgical Patients

Conditions
-----------------
Colectomy

Intervention / Treatment
-----------------
* Drug: Paracoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients hospitalised for resection of left/right colon; preoperative health graded as ASA <3. Exclusion Criteria: patients with any type of metastatic cancer, particularly metastatic colon cancer; patients with familial adenomatous polyps (sporadic adenomatous polyps are accepted);

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of efficacy assessments based on pain intensity (VAS) and on Pain relief (PR). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time between the first administration of parecoxib and the first request of morphine The total amount of morphine in the first 24 hours of treatment and the total amount of morphine given during the entire period of treatment with parecoxib |  |  |
BAX 855 Dose-Escalation Safety Study

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.

Official Title
-----------------
BAX 855 (PEGylated Recombinant Factor VIII): A Phase 1, Prospective, Open Label, Cross-Over, Dose-Escalation Study in Previously Treated Patients (PTPs) With Severe (FVIII < 1%) Hemophilia A

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
* Biological: PEGylated Recombinant Factor VIII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is male and is 18 to 65 years of age at the time of screening The subject has severe hemophilia A (factor VIII level < 1%) The subject was previously treated with plasma-derived factor VIII (FVIII) concentrates or recombinant FVIII for at least 150 exposure days (EDs) Exclusion Criteria: The subject has a detectable FVIII inhibitor at screening, with a titer >= 0.6 BU The subject has a documented history of FVIII inhibitors with a titer >= 0.4 BU at any time prior to screening The subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (PEG)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Low dose of ADVATE followed by low dose of BAX 855 | Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method<br>* 1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)<br>* Other names: ADVATE;Biological: PEGylated Recombinant Factor VIII<br>* 1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)<br>* Other names: BAX 855;|
| Experimental: Cohort 2<br>High dose of ADVATE followed by high dose of BAX 855 | Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method<br>* 1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)<br>* Other names: ADVATE;Biological: PEGylated Recombinant Factor VIII<br>* 1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)<br>* Other names: BAX 855;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious and non-serious AEs |  | 4 weeks after infusion with BAX 855 and ADVATE |
Evidence-Based Nutrition Practice Guidelines of Toolkit and Preliminary Outcomes

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to field test ADA's Type 2 Diabetes Evidence-Based nutrition Practice Guidelines (EBNPG) for Adults in 2008 as a tool for registered dietitians (RDs) for their patients with with type 2 diabetes who have no evidence of organ damage. A six month pilot study will be conducted to determine the feasibility of training RDs in documenting the outcomes of implementing Medical Nutrition Therapy (MNT) using ADA's evidence-based GL for T2D.

Official Title
-----------------
Pilot Study of Type 2 Diabetes Evidence-Based Nutrition Practice Guidelines--Field Test of Toolkit and Preliminary Outcomes

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 19 years no documented claims for the treatment of TD over the past 7 years no MNT claims submitted within the past 12 months not under RD care able to make visits to the clinic per guidelines Exclusion Criteria: not in end-stage renal disease or renal insufficiency; history of Cardiovascular Disease,Chronic Athrosclerotic Disease, or Myocardial Infection; Chronic Obstructive Pulmonary Disease, untreated depression, severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment; Congestive Heart Failure. pregnant or lactating at time of study presence of cognitive limitations that preclude making lifestyle or dietary changes as assessed by the RD during the initial interview

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 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 |
| --- | --- |
| practitioner interviews<br>phone interviews conducted | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation of new evidence-based nutrition practice guidelines | RDs and RDs with CDE credential, will have reached the target professional goals in successful implementation of new evidence-based nutrition practice guidelines in daily clinical practice. | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved health outcomes | Patients counseled by either an RD, or an RD with CDE credential, will exhibit improvements in critical health outcomes, relative to baseline levels. | six months |
SPC3649 Multiple Dose Study in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and tolerability of SPC3649 given in multiple doses to healthy volunteers.

Official Title
-----------------
A Placebo-controlled Double-blind, Randomised, Multiple Dose, Dose Escalating Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPC3649

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: SPC3649
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers: Males and postmenopausal females aged ≥ 18 to 60 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br> | Drug: saline<br>* 5 weekly doses<br>|
| Active Comparator: SPC3649<br> | Drug: SPC3649<br>* 5 weekly doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects experiencing adverse events |  | Up to 169 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of SPC3649 |  | Up to 169 Days | 
| Effect on total Cholesterol |  | Up to 169 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antisense, miR-122 antagonist, safety in healthy Volunteers, Hepatitis C
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results

Study Overview
=================
Brief Summary
-----------------
Investigators selected participants who operated by laparoscopic technique due to any gynecologic indication according to random number table. The ten mm trocar was inserted supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of patients. One month after we evaluated umbilical scar by used vancouver scar scale and compared results of vancouver scar scale.

Official Title
-----------------
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results

Conditions
-----------------
Cicatrix

Intervention / Treatment
-----------------
* Procedure: Ten mm trocar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant with eligible for laparoscopic surgery Exclusion Criteria: Participant with umbilical scar due to previous surgery, burn eg.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supraumbilical entry group<br>Umbilical port will be insert to supra umbilical area. | Procedure: Ten mm trocar<br> <br> |
| Experimental: Intraumbilical entry group<br>Umbilical port will be insert to intra umbilical area. | Procedure: Ten mm trocar<br> <br> |
| Experimental: Infraumbilical group<br>Umbilical port will be insert to infra umbilical area. | Procedure: Ten mm trocar<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The results of vancouver scar scale |  | One month |
Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population

Study Overview
=================
Brief Summary
-----------------
GlaxoSmithKline Korea has submitted a registration file for its hepatitis A vaccine. The present study will collect clinical data in the local target population as per the requirement of Korean Food and Drugs administration (FDA).

Detailed Description
-----------------
All subjects will be administered one dose of the hepatitis A vaccine.

Official Title
-----------------
A Multicentric, Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population.

Conditions
-----------------
Hepatitis A

Intervention / Treatment
-----------------
* Biological: Hepatitis A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g. be reachable over the phone) should be enrolled in the study. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Written informed consent is obtained from the subject/ subjects' parents or guardians. Exclusion criteria History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature < 37.5°C (99.5°F) / Axillary temperature < 37.5°C (99.5°F) / Rectal temperature < 38°C (100.4°F) / Tympanic temperature on oral setting < 37.5°C (99.5°F) / Tympanic temperature on rectal setting < 38°C (100.4°F).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hepatitis A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

Detailed Description
-----------------
Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.

Official Title
-----------------
Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage II or III multiple myeloma according to Durie and Salmon criteria. Patients between 65 and 75 years of age Previously untreated patients Exclusion Criteria: Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) Primary or associated amyloidosis World Health organisation performance index of at least 3 Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more Cardiac or hepatic dysfunction Cerebral circulatory insufficiency Absolute contraindication to corticosteroids Peripheral neuropathy HIV or hepatitis B or C positivity Patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Ages Eligible for Study
-----------------
Minimum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best response rate |  |  | 
| Progression-free survival |  |  | 
| Survival after progression |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple myeloma, Elderly patients, Thalidomide, Autologous transplantation
Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.

Detailed Description
-----------------
The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.

Official Title
-----------------
The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study

Conditions
-----------------
Other Acute Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Dipyrone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery Exclusion Criteria: increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br>15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose | Drug: Paracetamol<br>* 15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose<br>* Other names: Parol;|
| Active Comparator: Dipyrone<br>15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose | Drug: Dipyrone<br>* 15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose<br>* Other names: Metamizole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pain intensity until postoperative 6 hours | The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively. | Pain intensity recorded until postoperative 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric spinal anesthesia, paracetamol, dipyrone
Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2?

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to assess safety and efficacy of prone position ventilation beyond the usual 16 hrs in patients with SARS-COV-2

Official Title
-----------------
Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? A Randomized Clinical Trial

Conditions
-----------------
COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Procedure: prolonged prone position ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - American Society of Anesthesiologists (ASA) physical status II- III. Sex (male and females). Age 18 -80 years. Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of <150 mm Hg, with a fraction of inspired oxygen (FiO2) of ≥0.6, a positive end expiratory pressure (PEEP) of ≥5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight mechanical ventilation for less than 36 hours Exclusion Criteria: - Contraindication for prone positioning increased intracranial tension. face trauma or surgery. Recent Deep venous thrombosis Unstable spine, femur, or pelvic fractures Mean arterial pressure < 65 mm Hg Pregnant women Pneumothorax Prone positioning before inclusion Those returned to supine position before completing the session time

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: group(A) control group<br>pronation cycles each last for 16 hours every 24 hours | |
| Active Comparator: group(B)<br>pronation cycles each last for 24 hours followed by 6 hours supine position | Procedure: prolonged prone position ventilation<br>* patients mechanically ventilated with SARS COV 2 will be subjected to a longer than usual period of prone position ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of successful weaning | how many patients successfully extubated, hospital survival, ICU stay | 28 days | 
| Incidence of complications | Incidence of facial edema, pressure wounds, lines disconnections, hemodynamic instability | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of oxygenation | mean value of change in PaO2/FiO2 ratio and static lung compliance before and after 3 successive proning cycles | 28 days |