linjc16/ctgov huggingface dataset:
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL

Study Overview
=================
Brief Summary
-----------------
This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).

Detailed Description
-----------------
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in elderly patients with primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Official Title
-----------------
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma

Conditions
-----------------
Primary Central Nervous System Lymphoma

Intervention / Treatment
-----------------
* Drug: R-IDARAM plus intrathecal chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL). Exclusion Criteria: Involved sites other than the brain, meninges, CSF, or the eyes. Age less than 18 years or greater than 75 years. Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL). Known cause of immunosuppression (ie, HIV type I infection). Any previous malignancy. Creatinine clearance below 60 mL/min. Heart insufficiency (NYHA IIIB or IV). Uncontrolled infection. Noncompensated active pulmonary or liver disease. Previously treated for PCNSL, except by corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-IDARAM plus intrathecal chemotherapy<br>Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy | Drug: R-IDARAM plus intrathecal chemotherapy<br>* R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2); methotrexate 1.5 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 20mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.<br>* Other names: R-IDARAM plus intrathecal immuochemotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 3 year Overall survival | 3 year Overall survival |
Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

Study Overview
=================
Brief Summary
-----------------
to compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy.

Detailed Description
-----------------
To compare the analgesia and side effect of nalbuphine and morphine for elective Laparoscopic myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind clinical trial. Patients undergoing elective Laparoscopic myomectomy are randomly divided into two groups: nalbuphine and morphine groups. All patients are under general anesthesia with routine methods. The nalbuphine group receive postoperative patient controlled analgesia using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient controlled analgesia using morphine 60mg/120ml. Perioperative parameters are to be collected to compare the two groups.

Official Title
-----------------
Analgesia Comparison of Nalbuphine and Morphine for Laparoscopic Myomectomy

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Nalbuphine
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective Laparoscopic myomectomy patients 24hr post-operative patient controlled analgesia analgesia no mild or severe liver or renal disfunction Exclusion Criteria: can't understand patient controlled analgesia device refuse trial

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nalbuphine<br>using nalbuphine for patient controlled analgesia | Drug: Nalbuphine<br>* patient controlled analgesia with Nalbuphine<br>|
| Active Comparator: morphine<br>using morphine for patient controlled analgesia | Drug: Morphine<br>* patient controlled analgesia with Morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale | 1-10 | 24 hr post-operatively |
Cardiovascular Biorepository

Study Overview
=================
Brief Summary
-----------------
Use biospecimens procured from patients and organ donors to improve understanding of molecular, cellular, and tissue-level processes produced by cardiovascular disease and therapeutic interventions

Detailed Description
-----------------
This is a prospective evaluation of patients undergoing cardiovascular procedures at the University of Kentucky Medical Center.

Official Title
-----------------
Cardiovascular Biorepository

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing cardiovascular surgery/procedure at the University of Kentucky who are at least 18 years of age

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 |
| --- | --- |
| biological specimen<br>Biological specimen is taken from cardiovascular procedures that would have been discarded | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use biospecimens procured from patients and organ donors to improve understanding of molecular, cellular, and tissue-level processes produced by cardiovascular disease and therapeutic interventions. | This research aims to advance understanding of cardiovascular disease and to support the development of improved therapies. | 6/26/2008 - 6/9/2027 |
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.

Detailed Description
-----------------
Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.

Official Title
-----------------
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is aged 40 to 80 years old; Subject with AD diagnosed according to the criteria for probable AD as defined by the National Institute of Neurological Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); Subject have received the diagnosis of AD within the past 2 years; Subject have a CDR of 0.5 or 1.0; Score between 20 and 28 on the Mini Mental State Examination have been taking a stable dose of cholinesterase inhibitors for a minimum of 6 months. Exclusion Criteria: Patients with hearing impairment; Failures of important organs and in severe conditions Be reluctant or disabled to receive neuropsychological assessments; Participate in other clinical trial; Has a life expectancy of < 1 year. The investigator and/or enrollment review committee, would preclude participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep Brain Stimulation<br>DBS Implant and stimulation | Device: Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)<br>* PINS Stimulator System<br>* Other names: Deep Brain Stimulation Device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) | Change from Baseline | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Dementia Rating Scale | Change from Baseline | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease
Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis. The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking. Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.

Official Title
-----------------
Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Strength training and treadmill training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive Expanded Disability Status Scale (EDSS)score of ≤ 6 Reduced walking ability (subjectively experienced) Exclusion Criteria: persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training. spasticity requiring stretching og treatment with baclofen. Other, not MS-related, conditions affecting walking ability.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill group<br>Specific gait training on treadmill | Other: Strength training and treadmill training<br>* Eight weeks of intensive strength training or treadmill training<br>|
| Experimental: Strength training group<br>Eight weeks of intensive strength training | Other: Strength training and treadmill training<br>* Eight weeks of intensive strength training or treadmill training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking ability |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength |  | 8 weeks | 
| Work economy O2 |  | 8 weeks | 
| Balance |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Walking ability, Strength, Balance, Treadmill walking
Registry for Advanced Endoscopy

Study Overview
=================
Brief Summary
-----------------
Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract

Official Title
-----------------
Endoskopiskt Register för Diagnostik Och Behandling

Conditions
-----------------
Cholangiocarcinoma, Pancreatic Cancer, Sclerosing Cholangitis

Intervention / Treatment
-----------------
* Procedure: Endoscopic retrograde Cholangio- pancreatography
* Procedure: Endoscopic ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical indication for endoscopic intervention/procedure Exclusion Criteria: No 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic retrograde Cholangio- pancreatography|Endoscopic intervention in the biliary or pancreatic duct|
|Procedure: Endoscopic ultrasound|Endoscopic investigation/intervention with ultrasound|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events following endoscopic procedures | 30-days and 60-days post-procedure | 
| Diagnostic yield | Diagnostic yield after tissue sampling | 1-year follow up |
Ehealth: Second Life Impacts Diabetes Education & Self-Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to to develop and evaluate the feasibility, usability, and effect of participation in SLIDES (a virtual diabetes community in Second Life) for providing interactive diabetes education, support, and resources.

Official Title
-----------------
Ehealth: Second Life Impacts Diabetes Education & Self-Management

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

Intervention / Treatment
-----------------
* Behavioral: eHealth program in the Virtual Environment (VE) platform Second Life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current Duke Endocrinology patient are between 21 and 75 years old are able to speak and read English are computer literate (have used a computer for at least 6 months) understand how to use the Internet (have accessed the Internet on at least 6 occasions) have access to a computer with a non-dial-up Internet connection in a private location (home) are mentally capable of informed consent are reachable by telephone have no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (i.e., physical activity) or measures (e.g., renal failure, Stage III hypertension, severe orthopedic conditions or joint replacement scheduled within 6 months, paralysis, bleeding disorders, cancer, or receipt of pharmacologic doses of anti-coagulant medications [warfarin]) are able to travel to Duke University Medical Center (DUMC) for follow-up appointments. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: eHealth program in the Virtual Environment (VE) platform Second Life|determine the feasibility and acceptability of an eHealth program that provides diabetes education and self-management support.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Usefulness |  | 3 and 6 months | 
| Perceived Ease of Use |  | 3 and 6 months | 
| Process data |  | January 2011 through May 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics |  | baseline | 
| Metabolic Indicators |  | baseline, 3 months, 6 months | 
| Diabetes knowledge |  | baseline, 3 months, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Second Life, virtual community, diabetes education, diabetes support group
Cricoid Pressure vs. Paralaryngeal Pressure to Prevent Regurgitation

Study Overview
=================
Brief Summary
-----------------
Comparing the effects of ' Cricoid pressure' or 'Paralaryngeal pressure' during endotracheal intubation procedure.

Detailed Description
-----------------
Applying Cricoid pressure is widely used procedure to prevent gastric contents regurgitation during endotracheal intubation. To find out effectiveness external pressure is applied, the investigators will evaluate the relative position of esophagus and trachea. And also comparing the effects of Cricoid pressure and Paralaryngeal pressure during whole tracheal intubation procedures. Confirm the relative positions between esophagus and trachea in awake patients by using ultrasonography. Compare the effect of 'Cricoid pressure' and 'Paralaryngeal pressure' to esophageal opening during tracheal intubation procedure as below points. 1) Awake states. (Before sedation) 2) Anesthetized states. (After muscle relaxation) 3) During direct intubation procedure.

Official Title
-----------------
A Comparison of the Effects of Cricoid Pressure and Paralaryngeal Pressure to Prevent Regurgitation of Gastric Contents

Conditions
-----------------
Intubation Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Who would be scheduled any surgery under general anesthesia and agree with the purpose of the study Exclusion Criteria: Diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus, Aspiration tendency Known or predicted difficult airway.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion of esophagus | Occlusion of esophagus is checked under the application of cricoid and paralaryngeal pressures during direct laryngsocpy | for 1 minute during direct laryngosopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relative position of the upper esophageal end to the glottis | The position assessed by using ultrasonography and direct visualization | 1 minute before and after the induction of anesthesia, during direct laryngoscopy | 
| The outer anteroposterior diameter of the upper esophageal end | The outer anteroposterior diameter of the upper esophageal end is assessed before and durng the application of cricoid and paralaryngeal pressures. | During 1 minute in awake and anesthetized paralyzed states | 
| POGO score | POGO score under the application of cricoid and paralaryngeal pressures | during direct laryngoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cricoid pressure, Paralaryngeal pressure, Intubation
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Safety.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the safety in normal conditions of useof the product Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).

Official Title
-----------------
Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 10 and 20 years old; Integral skin test in the region; Use of cosmetic product of the same category; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time; Exclusion criteria: Lactation or gestational risk or gestation; Use of Anti-inflammatory, immunosuppression or antihistaminic drugs; Atopic antecedent or allergic to cosmetic product; Active cutaneous disease in the evaluation area; Diseases which cause immunology decrease, such as diabetes and HIV; Endocrinal pathologies; Intense solar exposure 15 days before the evaluation; Treatment until four months before the selection; The above information is not intended to contain all considerations relevant to a patient¿s potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix) | Drug: Lactic Acid<br>* Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. |  | From the treatment start to the end of the study |