linjc16/ctgov huggingface dataset:
Effects of Legumes on Glucose Regulation

Study Overview
=================
Brief Summary
-----------------
Dietary prevention strategies are increasingly recognized as essential to combat the current epidemic of obesity and related metabolic disorders. The purpose of the present study was to evaluate the potential effects of legumes in relation to cardiometabolic risk markers and appetite regulating hormones.

Official Title
-----------------
Over-night Metabolic Effects of Legumes

Conditions
-----------------
Dietary Prevention

Intervention / Treatment
-----------------
* Other: legume meal
* Other: white bread


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects between 20-35 years With normal BMI and No known metabolic- or gastro intestinal disease Exclusion Criteria: BMI > 25, Known metabolic disorder or Gastrointestinal problems or disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: white bread<br>White bread (based on 35 g available carbohydrates) | Other: white bread<br> <br> |
| Active Comparator: Legume meal<br>Legumes are consumed as a late evening meal(based on 35 g available carbohydrates) | Other: legume meal<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose | A portion of legumes or bread was consumed as a late evening meal, blood glucose was measured the next morning at breakfast. | 11 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satiety | legumes or bread was consumed as a late evening meal, satiety hormones (PYY, oxyntomodulin)and appetite sensations were determined at a following breakfast. | 11 hours |
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section

Study Overview
=================
Brief Summary
-----------------
Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.

Official Title
-----------------
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial

Conditions
-----------------
Paralytic Ileus

Intervention / Treatment
-----------------
* Behavioral: Gum chewing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women undergoing cesarean delivery Exclusion Criteria: Perioperative hyperalimentation Recent chemotherapy Concurrent bowel surgery Previous bowel surgery Concurrent bowel obstruction History of inflammatory bowel diseases Previous abdominal/pelvic radiation Postoperative placement of endotracheal tube/nasogastric tube Postoperative admission to intensive care unit

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gum chewing<br>Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule | Behavioral: Gum chewing<br>* Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule<br>|
| No Intervention: Conventional<br>Conventional postoperative feeding schedule | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative interval until the first flatus |  | Up to 7 days after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative interval until the first passage of stool |  | Up to 7 days after delivery | 
| Clinically significant postoperative ileus |  | Up to 7 days after delivery | 
| Postoperative hospital stay |  | Up to 7 days after delivery | 
| Related complications |  | Up to 7 days after delivery | 
| Patients' satisfaction |  | Up to 7 days after delivery |
L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase monotherapy as salvage treatment in patients with NK/T cell lymphoma

Detailed Description
-----------------
The prognosis of patients with progressive and recurrent NK/T cell lymphoma is poor partially due to lack of effective treatment. L-asparaginase was reported to be effective in this setting by several case reports. The investigators aim to evaluate the efficacy and toxicity of L-asparaginase monotherapy in a prospective phase II study.

Official Title
-----------------
Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: L-asparaginase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 18-75 years old Histological confirmed NK/T cell lymphoma with progressive or recurrent disease ECOG performance status 0-2 Life expectancy of more than 3 months Normal laboratory values: hemoglobin > 80 g/dl, neutrophil > 2×109/L, platelet > 100×109/L, serum creatine < 1.5×upper limitation of normal (ULN), serum bilirubin < 1.5×ULN, ALT and AST < 2.5×ULN Exclusion Criteria: Pregnant or lactating women Serious uncontrolled diseases and intercurrent infection The evidence of CNS metastasis History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Ages Eligible for Study
-----------------
Minimum Age: 18 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: L-asp<br> | Drug: L-asparaginase<br>* L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles<br>* Other names: L-asp;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival and overall survival |  | 2 years |
Safety and Feasibility of Fasting While Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.

Official Title
-----------------
Safety and Feasibility of Fasting While Receiving Chemotherapy

Conditions
-----------------
Fasting, Chemotherapy, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Established diagnosis of cancer Signed informed consent Adequate CBC and chemistry to receive chemotherapy Exclusion Criteria: Pregnancy

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 |
| --- | --- |
| I<br>Patients planning to observe fasting while receiving chemotherapy during the month of Ramadan | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of fasting while receiving chemotherapy |  | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of fasting on chemotherapy side effects |  | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fasting, Chemotherapy, Cancer
Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Detailed Description
-----------------
The current study aimed at prospectively assessing the performance of IUC as a predictive tool for residual tumor after primary TURBT of NMIBC, and possible future recurrence.

Official Title
-----------------
Diagnostic Performance and Predictive Capacity of Immediate Urine Cytology After Transurethral Resection of Non-Muscle Invasive Bladder Cancer; A Prospective Study

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: immediate urine cytology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -patients with primary or recurrent NMIBC for whom complete TURBT was done Exclusion Criteria: -Patients with concomitant CIS, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk NMIBC (single, primary, Ta, G1 tumor).

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NMIBC patients<br>Patients with primary or recurrent NMIBC for whom complete TURBT was done. | Diagnostic Test: immediate urine cytology<br>* Forty-eight hours after primary TURBT, IUC was retrieved and patients were scheduled for repeat TURBT 2 to 6 weeks later according to the predetermined protocol. The primary outcome was to determine the role of positive IUC to predict positive biopsy findings on repeat TURBT.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of IUC | The primary outcome included assessment of the performance of IUC as a predictive tool for possible residual malignancy after primary TURBT. Thereafter, sensitivity (Sn), specificity (Sp), positive and negative predictive values (PPV, NPV) and overall accuracy of IUC as a preliminary step before repeat TURBT will be determined. | It was assessed 48 hours after primary TURBT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants. | The secondary outcome included the evaluation of predictive capacity of IUC for tumor recurrence in the study participants. | Within duration of follow up (4 years ) |
Differin® Gel x12 Wks vs Tazorac® Cream x12 Wks vs Differin® x6 Wks Switched to Tazorac® x6 Wks for Treatment of Acne

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of 12 weeks of treatment with Differin Gel, 0.1% compared to 12 weeks of treatment with Tazorac Cream, 0.1% and compared to 6 weeks treatment with Differin Gel, 0.1% followed by 6 weeks of treatment with Tazorac Cream

Detailed Description
-----------------
Same as above.

Official Title
-----------------
A Comparison of Differin® Gel, 0.1% vs. Tazorac® Cream, 0.1% vs. Differin® Gel, 0.1% 6-week Treatment Switched to Tazorac® Cream, 0.1% 6-week Treatment in Patients With Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Adapalene Gel, 0.1%
* Drug: Tazarotene Cream, 0.1%
* Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose Exclusion Criteria: Subjects with more than 3 nodulo-cystic lesions

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Differin® Gel, 0.1% for 12 weeks | Drug: Adapalene Gel, 0.1%<br>* Apply once daily in the evening for 12 weeks<br>* Other names: Differin® Gel, 0.1%;|
| Active Comparator: 2<br>Tazorac® Cream, 0.1% for 12 weeks | Drug: Tazarotene Cream, 0.1%<br>* Apply once daily in the evening for 12 weeks<br>* Other names: Tazorac® Cream, 0.1%;|
| Active Comparator: 3<br>Differin® Gel, 0.1% for 6 weeks switched to Tazorac® Cream, 0.1% for 6 weeks | Drug: Adapalene Gel, 0.1% + Tazarotene Cream, 0.1%<br>* Apply adapalene Gel, 0.1% once daily in the evening for 6 weeks and Tazarotene Cream, 0.1% once daily in the evening for 6 weeks<br>* Other names: Differin® Gel, 0.1% and Tazorac® Cream, 0.1%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - total lesion counts |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - tolerability assessments and adverse event reporting |  | 12 weeks |
Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized, double-blind, active-controlled, phase III clinical trial to evaluate the efficacy and safety of Dp-R206 and Bonviva for 16 weeks once a month on the improvement of vitamin D in postmenopausal women with osteoporosis.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R206 and Bonviva for the Improvement of Vitamin D in Postmenopausal Women With Osteoporosis

Conditions
-----------------
Postmenopausal Women With Osteoporosis

Intervention / Treatment
-----------------
* Drug: Test group
* Drug: Reference group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female more than 40 years old in postmenopausal Exclusion Criteria: Subject who has a history of malignant cancer

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DP-R206<br> | Drug: Test group<br>* Once a month, administration of DP-R206 & placebo for 16 weeks<br>* Other names: <Ibandronate 150mg + cholecalciferol(Vitamin D3) 24,000IU>;|
| Active Comparator: Bonviva<br> | Drug: Reference group<br>* Once a month, administration of Bonviva & placebo for 16 weeks<br>* Other names: (Ibandronate 150mg);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A ratio of subject whose 25 OHD concentration is less than 15ng/mL | A ratio of subject whose 25 OHD concentration is less than 15ng/mL after 16weeks | 16weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A ratio of subject whose 25 OHD concentration is less than 9ng/mL | A ratio of subject whose 25 OHD concentration is less than 9ng/mL after 16weeks | 16 weeks | 
| Safety evaluation (AE, Lab test, Vital sign etc) |  | 16weeks |
Accuracy Of Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The aim of this work to evaluate the accuracy of contrast enhanced spectral mamography in predicting the response to NAC and assessment of residual disease in breast cancer patients

Detailed Description
-----------------
This a prospective series ,will be performed for 50 patients diagnosed by biopsy as breast cancer who will be scheduled for surgery after completing the full coarse of neoadjuvant chemotherapy

Official Title
-----------------
Contrast Enhanced Mamography in Predicting Response of Breast Cancer Post Neoadjuvant Chemotherapy

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient confirmed diagnosed by early breast cancer decided to received neoadjuvant treatment locally advanced breast cancer operable metastatic breast cancer Exclusion Criteria: patient not candidate for NAC contrast allergy renal impairment pregnancy
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Stable | |
| 2<br>Partial response | |
| 3<br>Moderate response | |
| 4<br>Excellent response | |
| 5<br>Complete response | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of contrast enhanced spectral mamography in the predicting of pathological response to NAC and assessment residual disease in breast cancer patients |  | Basline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess best imaging modalities in pedict post neoadjuvant response |  | Baseline |
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.

Official Title
-----------------
An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)

Conditions
-----------------
Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency

Intervention / Treatment
-----------------
* Drug: Immunoglobulins Intravenous (Human)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Patients with primary immunodeficiency Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10 Key Exclusion Criteria: Allergic reactions to immunoglobulins or other blood products Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day History of cardiac insufficiency Epilepsia

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Immunoglobulins Intravenous (Human)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute serious bacterial infections |  |  | 
| Number of days out of work/school due to underlying PID |  |  | 
| Number of infections |  |  | 
| Rate, severity and relationship of all adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunoglobulin intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children