linjc16/ctgov huggingface dataset:
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen

Study Overview
=================
Brief Summary
-----------------
The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation. Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids.

Official Title
-----------------
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation

Conditions
-----------------
Bronchial Hyperreactivity, Hypersensitivity, Allergy, Bronchial Asthma

Intervention / Treatment
-----------------
* Other: inhalative specific bronchial provocation with grass-pollen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >12 and <45 years informed consent Known allergy on grass-pollen Exclusion Criteria: age <12 and >45 years Clinical asthma requiring regular inhalation vital capacity >80% FEV1 < 75% Chronic disease pregnancy Inhalative or systemic steroid use substance abuse incapability of understanding the study's purpose and performance

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: inhalative specific bronchial provocation with grass-pollen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO. |  | aug 2006 - feb 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
grass-pollen, allergy, bronchial hyperreactivity, asthma
Peripheral Parenteral Nutrition vs Conventional Fluid in Colorectal Resection in ERAS

Study Overview
=================
Brief Summary
-----------------
Assess if administration of early nutrition support with Perioperative Peripheral Nutrition (PeriOliclimonel) N4-E) in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery (ERAS) Protocol improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy.

Detailed Description
-----------------
The main objective is to determine if perioperative nutritional support with PeriOlimel N4-E, that reaches nutritional requirements of ERAS protocol for colorectal cancer surgery patients, can improve nutritional status so it decreases postoperative complications, hospital length of stay and costs, compared to conventional fluid therapy administration since patients receive oral nutrition at day 3-5.

Official Title
-----------------
A RANDOMIZED, CONTROLLED, CLINICAL TRIAL TO COMPARE PERIPHERAL PARENTERAL NUTRITION (PeriOlimel N4-E) VERSUS CONVENTIONAL FLUID THERAPY IN ENHANCED RECOVERY AFTER SURGERY (ERAS) PROTOCOL IN COLORECTAL CANCER SURGERY.

Conditions
-----------------
Fast-track, Colon Cancer, Parenteral Nutrition

Intervention / Treatment
-----------------
* Drug: Perioperative peripheral parenteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled colorectal cancer surgery ASA I-IV Exclusion Criteria: Emergency surgery Distant metastasis Patient´s refusal to participate Allergy or hypersensitivity to egg or soy protein Advanced kidney or hepatic impairment Severe bleeding disorders Congenital abnormalities of amino acid metabolism Hyperlipidemia and severe or difficult to control hyperglycemia

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: Perioperative peripheral parenteral nutrition<br>Perioperative peripheral parenteral nutrition during 4 days | Drug: Perioperative peripheral parenteral nutrition<br> <br> |
| No Intervention: Standard fluid therapy<br>Standard fluid therap | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbi-mortality | Early Peripheral Parenteral Nutrition in patients undergoing colon cancer resection in an Enhanced Recovery After Surgery Protocol to improve the results of morbi-mortality and hospitalization versus standard intravenous fluid therapy | 30 days |
Dietary Intake, Eating Behavior, Physical Activity Level and Their Relationships With Glycemic and Weight Control in Hong Kong Chinese Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to describe and examine the dietary intake, eating behavior and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association with weight and glycemic control at baseline and 1 year follow-up. The investigators hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern and low physical activity level are associated with poorer glycemic and weight control, and there will be no improvement with weight and glycemic control under usual care after 1 year.

Conditions
-----------------
Type 2 Diabetes Mellitus in Obese

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of Chinese ethnicity Diagnosis of T2DM Able to read Chinese and give informed written consents Exclusion Criteria: Type 1 diabetes mellitus End-stage renal failure requiring dialysis or chronic kidney disease (CKD) stage 4 or above Malignancy diagnosed within 3 years Pregnancy or lactation Any medical illness or condition as judged by the investigators as ineligible to participate the study

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>non-obese type 2 DM | |
| Group 2<br>obese type 2 DM | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c |  | 1 year | 
| Change of Weight |  | 1 year |
BPA Levels Relationship With IVF/ICSI Outcomes in Unexplained Infertility

Study Overview
=================
Brief Summary
-----------------
The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.

Official Title
-----------------
Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Unexplained Infertility

Conditions
-----------------
Infertility Unexplained, IVF, Infertility, Female

Intervention / Treatment
-----------------
* Other: BPA levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 23-33 years who underwent IVF due to unexplained infertility patients provided urine, blood, and follicle fluid (FF) samples on the oocyte retrieval day patients who did not smoke or use alcohol patients did not work in the plastic industry Exclusion Criteria: patients who underwent IVF due to low ovarian reserve or tubal factor or male factor indications patients diagnosed with endometriosis patients with freeze-all cycles women with metabolic disease (such as hypertension or diabetes mellitus) patients with a known genetic problem (male or female)

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 33 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BPA level<br>BPA (Bisfenol A) in urine, blood and follicle fluid samples | Other: BPA levels<br>* BPA (Bisfenol A) in urine, blood and follicle fluid samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to BPA | Concentrations of Bisphenol A (BPA) will be quantified in the ürine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with unexplained infertility | 6 month |
Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Purpose: To study the impact of endometriosis on subsequent pregnancy and delivery. Methods: retrospective analysis by questionnaire / interview of cases (endometriosis laparoscopically removed / child wish) vs. controls (endometriosis laparoscopically excluded / child wish) from the University Hospital Muenster, Germany, treated between 2009 and 2016; analysis of pregnancy rate, mode of delivery and complications using Clavien-Dindo-classification, role of deep infiltrating endometriosis using ENZIAN classification; data analysis using t-test with p < 0.050% being considered significant.

Official Title
-----------------
Impact of Endometriosis on Pregnancy and Delivery - a Retrospective Cohort Study

Conditions
-----------------
Endometriosis, Pregnancy Complications, Delivery Complication, Complication, Miscarriage

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases: Operation because of endometriosis at the endometriosis Center, University Hospital Muenster, child wish, wants to participate, correct age group controls: Operation because of sterility, exclusion of endometriosis during this Operation, child wish, wants to participate, correct age group Exclusion Criteria: cases / controls: declines participation, incorrect age Group, no child wish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| endometriosis cases<br>endometriosis laparoscopically removed / child wish | Other: questionnaire<br>* if no Reply to questionnaire, telephone interview<br>* Other names: interview;|
| controls<br>endometriosis laparoscopically excluded / child wish | Other: questionnaire<br>* if no Reply to questionnaire, telephone interview<br>* Other names: interview;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | pregnancy rate | through study completion, an average of 1 year | 
| complications | complications during pregnancy, delivery, puerperium | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometriosis, pregnancy, delivery, miscarriage, cesarian section
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019. The safety of McGhan breast implants (textured and smooth) will be evaluated based on occurrence of local complications including capsular contracture, malposition of implant, seroma/late seroma and anaplastic large cell lymphoma (ALCL).

Official Title
-----------------
A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China

Conditions
-----------------
Breast Augmentation, Breast Reconstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019 Exclusion Criteria: -

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experienced adverse events |  | up to 4 years |
Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.

Official Title
-----------------
Evaluation of Satisfaction in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C

Conditions
-----------------
Hepatitis C, Chronic, Hepatitis C

Intervention / Treatment
-----------------
* Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen
* Drug: Rebetol (ribavirin; SCH 18908)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania. Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Treated Patients<br>All patients participating in the study. | Biological: PegIntron (peginterferon alfa-2b; SCH 54031) pen<br>* PegIntron pen administered in accordance with approved labeling<br>* Other names: SCH 54031;Drug: Rebetol (ribavirin; SCH 18908)<br>* Rebetol administered in accordance with approved labeling.<br>* Other names: SCH 18908;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of Patients Receiving PegIntron Pen Plus Rebetol Therapy, Assessed by a Survey. | The scale used in the patient questionnaire ranged from 0 (dissatisfied) to 8 (very satisfied). Patients evaluated the training received from the medical staff, ease of the preparation and administration of the medication, and the personal experience when using the PegIntron pen. | The survey was administered during a follow-up visit in the clinic, at any point during the 48-week treatment. |
The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.

Official Title
-----------------
The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial

Conditions
-----------------
Congenital Heart Diseases

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients (body weight < 10 kg) diagnosed with congenital heart diseases scheduled for repair operation with CPB in the Department of Cardiovascular Surgery, Xijing Hospital Exclusion Criteria: systemic infections other systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 24 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>Patients will receive 2% sevoflurane via oxygenator during CPB | Drug: Sevoflurane<br>* Sevoflurane will be given at a concentration of 2% through oxygenator during CPB<br>|
| No Intervention: Control<br>Patients will receive only oxygen and air through oxygenator | Other: Control<br>* Patients will receive only oxygen and air through oxygenator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality | All cause mortality after the cardaic surgery, patients will be followed up for 30 days | within the first 30 days (plus or minus 3 days) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum cTnI concentrations | serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation. | 48 h after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, congenital heart diseases, cardiopulmonary bypass, sevoflurane
Pulmicort Asthma Prevention (Post-PAC)

Study Overview
=================
Brief Summary
-----------------
This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.

Official Title
-----------------
A Study to Evaluate the Feasibility of a Treatment Algorithm in Newly Diagnosed Asthmatic Children. An Open Follow-up to Asthma Prevention in Infants/Young Children (PAC)

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Procedure: Pulmicort (budesonide) pMDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms. Exclusion Criteria: Differential diagnoses including at least a chest x-ray and sweat test.

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- |
|Procedure: Pulmicort (budesonide) pMDI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps. |  |  | 
| Efficacy - development of lung function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the treatment algorithm by the parents. |  |  | 
| Growth rate and BMD. |  |  | 
| Exhaled nitrogen Oxide, bronchohyperresponsiveness. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children of asthmatic mothers
Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Olmesartan medoxomil
* Drug: Amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 18 years of age or older (20% equal to or older than 65 years) With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication Exclusion Criteria: Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

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

| Intervention/Treatment |
| --- |
|Drug: Olmesartan medoxomil|nan|
|Drug: Amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the number (%) of patients achieving BP goal. |  |  | 
| To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of high blood pressure in mild to severe hypertensive patients