linjc16/ctgov huggingface dataset:
A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites

Official Title
-----------------
A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites

Conditions
-----------------
Gastric Cancer, Stomach Neoplasms

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: Paclitaxel
* Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic malignant ascites(over pelvic cavity in CT scan and confirmed by cytology) an Eastern Cooperative Oncology Group performance status of 0 to 2 adequate renal, hepatic, and hematologic function Exclusion Criteria: previous chemotherapy or radiotherapy (unless in the adjuvant setting) uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer HER2 positive and willing to use trastuzumab

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: SOXP<br> | Drug: Oxaliplatin<br>* 130mg/m2, d1, q3w<br>Drug: Paclitaxel<br>* 40mg/m2 ip，d1、8 ,q3w<br>Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)<br>* 40mg/m2 Bid po，d1-14,q3w<br>|
| Active Comparator: SOX<br> | Drug: Oxaliplatin<br>* 130mg/m2, d1, q3w<br>Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)<br>* 40mg/m2 Bid po，d1-14,q3w<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the internal between the date of enrollment and the date of death or last follow-up. | 10 months |
Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups.

Detailed Description
-----------------
This study is a non-inferiority trial designed to determine whether placement of a continuous block within the adductor canal has a substantial impact on pain following total knee arthroplasty. Our primary outcome to determine this difference will be opioid consumption within the first day following surgery. Secondary outcomes will include: pain scores, quadriceps strength, and distance ambulated during physical therapy.

Official Title
-----------------
A Comparison of Proximal Versus Distal Continuous Adductor Canal Blocks After Total Knee Arthroplasty

Conditions
-----------------
Post-Operative Pain

Intervention / Treatment
-----------------
* Procedure: Proximal Adductor Canal Block
* Procedure: Distal Adductor Canal Block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral Total Knee Arthroplasty ASA physical status I-III >18 years old Non-pregnant Consent to participate in the study Exclusion Criteria: Refusal to participate <18 years old Chronic opioid use Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proximal<br>Proximal Adductor Canal Block | Procedure: Proximal Adductor Canal Block<br>* Continuous Nerve Block<br>|
| Active Comparator: Distal<br>Distal Adductor Canal Block | Procedure: Distal Adductor Canal Block<br>* Continuous Nerve Block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption (IV Morphine Equivalents) | Total opioid consumption | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption (IV Morphine Equivalents) | Total opioid consumption | 48 Hours | 
| Pain (Numeric Rating) | NRS Pain Scale | 48 Hours | 
| Quadriceps Strength (% of Baseline) | Maximum Isometric Voluntary Contraction | 48 Hours | 
| Distance Ambulated (Feet) | Total distance ambulated during physical therapy | 48 Hours |
Acitretin Plasma Levels Under Hemodialysis

Study Overview
=================
Brief Summary
-----------------
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.

Detailed Description
-----------------
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. Number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined. Trial with medicinal product

Official Title
-----------------
Acitretin Plasma Levels Under Hemodialysis

Conditions
-----------------
Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Drug: Chemopreventive application (Acitretin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin Exclusion criteria: Hepatopathy Pregnancy

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: a<br>single arm only. Only open label treatment anticipated | Drug: Chemopreventive application (Acitretin)<br>* Chemopreventive application (Acitretin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels acitretin |  | 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous cell carcinoma of the skin under hemodialysis
Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.

Official Title
-----------------
Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: Lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer Exclusion Criteria: Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed lamivudine tablet<br>Subjects with hepatitis B virus-induced liver cirrhosis prescribed lamivudine tablet during study period | Drug: Lamivudine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events in Japanese subjects with hepatitis B virus-induced liver cirrhosis treated with lamivudine tablet |  | 6 months or more |
Nutrient Nutritional Advise for Low Back Pain Patients Seeking Chiropractic Care

Study Overview
=================
Brief Summary
-----------------
The nutritional intervention will reduce LBP and cause 10% weight loss.

Detailed Description
-----------------
This feasibility study will assess a two-armed low-back pain (LBP) randomized, prospective clinical trial with nutritional offerings provided for one-arm.

Official Title
-----------------
Nutrition Plus Chiropractic Care for Low Back Pain: a Randomized Clinical Trial

Conditions
-----------------
Low Back Pain, Nutrition Poor

Intervention / Treatment
-----------------
* Dietary Supplement: Combination: Nutrition AND Chiropractic Adjustment
* Other: Chiropractic Adjustment: Spinal Manipulation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 25-40, Experiencing LBP (VAS>4, mechanical, chronic), not pregnant Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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
Interventional Model Description: Participants will be randomized into one of two arms: 1) nutrition+chiropractic or 2) chiropractic only
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition and Chiropractic<br>LBP chiropractic adjustment per protocol and 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings) | Dietary Supplement: Combination: Nutrition AND Chiropractic Adjustment<br>* LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)<br>|
| Active Comparator: Chiropractic Adjustment ONLY<br>LBP chiropractic adjustment per protocol | Other: Chiropractic Adjustment: Spinal Manipulation Therapy<br>* LBP chiropractic adjustment per protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain evaluation using NPRS | Reduces Low Back Pain | Maximum six weeks of care | 
| Weight loss being measured using scale in pounds | Promotes weight loss | Beginning of study and re-evaluation at the end of six weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chiropractic manipulation, spinal manipulation therapy, osteopathic manipulation
Early Bandage Removal Post-Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Women undergoing their first second or third cesarean section will be randomized into two groups. One group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. Staple removal will be at 5 - 7 days for both groups. The incision will be inspected at the time of staple removal. The 2 groups will be compared for incision disruption and infection. Also, the women will be asked about their satisfaction for time of bandage removal.

Official Title
-----------------
Early Bandage Removal Post-Cesarean Delivery

Conditions
-----------------
Wound Disruption, Wound Infection

Intervention / Treatment
-----------------
* Procedure: abdominal bandage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age of 18 to 44 elective cesarean section, primary or repeat low risk pregnancy Exclusion Criteria: under the age of 18 and above the age of 44 diabetes, preeclampsia or other pregnancy complications unable or unwilling to give informed consent chorioamnionitis BMI over 35 more than 3 cesareans

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 Hours<br>Removal of bandage after 6 hours | Procedure: abdominal bandage<br> <br> |
| Active Comparator: 24 hours<br>removal of bandage after 24 hours | Procedure: abdominal bandage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Disruption |  | 5 - 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Infection |  | 5 - 7 days | 
| Patient satisfaction |  | 5 - 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean, bandage removal, infection, disruption, satisfaction, patient satisfaction
Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA

Study Overview
=================
Brief Summary
-----------------
bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.

Detailed Description
-----------------
80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial. Divided into two groups ; Airtraq and ILMA . BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this study. patients demographic and airway variables were recoded. Patients were premedicated. After standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium was used for neuromuscular blockade. The device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.

Official Title
-----------------
Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA

Conditions
-----------------
Intubation; Difficult or Failed, Intubation Complication

Intervention / Treatment
-----------------
* Device: Airtraq
* Device: ILMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:18-65 years of age ASA I-III BMI>35 Exclusion Criteria:BMI<35 patients have airway tumor patients undergoing head and neck surgery upper respiratory infection less than 10 days prior the surgery

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intubation time<br>handling the device till the endotracheal tube passing through the glottis | Device: Airtraq<br>* video laryngoscope with a channel<br>Device: ILMA<br> <br> * Other names: intubating laryngeal mask airway;|
| Active Comparator: insertion time<br>handling of the device till the glottic visualization | Device: Airtraq<br>* video laryngoscope with a channel<br>Device: ILMA<br> <br> * Other names: intubating laryngeal mask airway;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time | handling of the device till the endotracheal tube entering the glottis | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Airtraq, Intubating laryngeal mask airway, BMI>35
Pulmonary Rehabilitation, Dyspnoea and Emotional Cognition in COPD

Study Overview
=================
Brief Summary
-----------------
To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).

Detailed Description
-----------------
The aim of the study will be to evaluate the effect of pulmonary rehabilitation on dyspnoea emotional component and on emotional cognition. It will add a better understanding of the mechanisms of pulmonary rehabilitation on dyspnoea. Patients with COPD will be included before starting a pulmonary rehabilitation and be evaluated with questionnaires (including the Multidimensional Dyspnea Profile, and quality of life questionnaires), emotional cognition (at rest and right after an endurance test, using some short movies sequences and pictures of faces expressing some well defined emotions) and smile production analysis. After having followed a pulmonary rehabilitation, the same evaluation will be realised and results will be compared before and after the intervention.

Official Title
-----------------
Effects of Pulmonary Rehabilitation on Dyspnoea Affective Dimension and Emotional Cognition in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD, Dyspnea, Rehabilitation; Tobacco Use, Emotional Disturbances

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients with pulmonary rehabilitation indication, hospitalized in Department of Pulmonary Diseases in La Pitié-Salpêtrière, Paris, France. Age of 40 at least. Exclusion Criteria: Facial paralysis Neuromuscular disease Contraindication for pulmonary rehabilitation Severe depression syndrom or psychiatric disease Drug use Impaired vision Higher functions disorders (Mini Mental Score Examination < 26) Severe obesity (BMI>40kg/m²)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| emotional cognition | Emotional cognition in patients with chronic dyspnoea using time to recognize some emotions on short movies and pictures of facial emotions. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between physical improvement, quality of life improvement and time to recognize facial emotions. | Correlations | 6 weeks | 
| Correlations between physical improvement and production of the smile. | Correlations | 6 weeks |
Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark

Study Overview
=================
Brief Summary
-----------------
This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.

Detailed Description
-----------------
This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD)implantation. Furthermore validation af the Danish Pacemaker and ICD Register will be conducted.

Official Title
-----------------
Complications Following Pacemaker or ICD Implantation in Denmark

Conditions
-----------------
Pacemaker, Defibrillators, Implantable

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving a cardiac device (pacemaker, cardiac resynchronization therapy (CRT) or implantable defibrillator cardioverter (ICD)), or undergoing a reoperation Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac device group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate | any complication that require treatment There is no 'Safety and Tolerability' or 'Pain' measurement. | 3 months |