linjc16/ctgov huggingface dataset:
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma

Study Overview
=================
Brief Summary
-----------------
This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years. cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy) cohort B: patients with disease simple monitoring. The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.

Official Title
-----------------
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study

Conditions
-----------------
OMS Grade II Glioma

Intervention / Treatment
-----------------
* Behavioral: neurocognitive tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OMS grade II glioma signed informed consent age >=18 IK >=80% ability to read, write and undertand French Exclusion Criteria: glioma localized to brainstem other neurologic or psychiatric disease history of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization neuroleptic concomitant treatment pregnant or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OMS grade II glioma<br>neurocognitive tests | Behavioral: neurocognitive tests<br>* inclusion 1 year 3 years 5 years<br>* Other names: - QLQ-C30 and BN20;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MoCA test |  | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma, Neurocognitive functions
NAFLD in Diabetes Type 2 in Primary Care

Study Overview
=================
Brief Summary
-----------------
The EPSONIP (Evaluating Prevalence and Severity Of NAFLD In Primary care) trial is a longitudinal cohort study of patients with T2DM recruited from primary health care centers in Östergötland, Sweden. The latest MRI techniques will be used to quantify the amount of hepatic fat, inflammation, liver fibrosis and body composition. Each patient will be investigated twice with three years apart to determine patients with progressive disease.

Official Title
-----------------
Evaluating Prevalence and Severity of NAFLD In Primary Care

Conditions
-----------------
NAFLD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 2 Age 35-75 year Exclusion Criteria: Contraindication to MR Alcohol dependance Previously diagnosed liver cirrhosis Previously known liver disease (other than fatty liver)

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Prevalence of fatty liver | Number of patients with fatty liver measured with MR-PDFF | 2020 | 
| Prevalence of advanced liver disease | Number of patients with advanced liver disease (fibrosis stage > 2) | 2020 | 
| The association between physical activity and advanced liver disease (fibrosis >2) | Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with the international fitness scale (IFIS) | 2020 | 
| The association between physical activity and advanced liver disease (fibrosis >2) | Liver fibrosis measured with MRE and liver biopsy. Physical activity measured with Actigraph GT3X (accelerometer) | 2020 | 
| The association between fitness and advanced liver disease (fibrosis >2) | Liver fibrosis measured with MRE and liver biopsy. Fitness measured with the six minute walk test. | 2020 | 
| Genetic factors associated with advanced liver disease (fibrosis >2) | Liver fibrosis measured with MRE and liver biopsy. Genes to be analyzed: PNPLA3, TM6SF2, MBOAT | 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health economic model for disease management | Markow model | 2025 | 
| Number of patients that develop symptoms of end-stage liver disease | Symptoms of end-stage liver disease (ascites, encepahopathy, varices, HCC) or liver related Death will be recorded through chart review | 2030 |
Comparative Bioavailability Study of 600mg Azithromycin Monohydrate Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the bioequivalence of Azithromycin Monohydrate 600 mg Tablets.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva 600mg Azithromycin Monohydrate Tablets and Pfizer Inc. (Zithromax) 600mg Azithromycin Dihydrate Tablets in Healthy Adult Volunteers Under Fasting Conditions

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals
* Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results on screening Exclusion Criteria: Positive test results for HIV or hepatitis B or C Treatment for drug or alcohol dependence Female subjects who are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Azithromycin Monohydrate 600mg Tablets | Drug: Azithromycin Monohydrate 600mg Tablets Geneva Pharmaceuticals<br> <br> |
| Active Comparator: 2<br>Zithromax (Azithromycin Dihydrate) 600mg Tablets | Drug: Zithromax (Azithromycin Dihydrate) 600mg Tablets Pfizer Inc.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 32 days |
A Clinical Trial to Demonstrate the Efficacy and Safety of Cenestin 0.3 mg for the Treatment of Hot Flashes

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind study to compare the efficacy and safety of daily doses of Cenestin 0.3 mg tablets to placebo in reducing the frequency and severity of moderate to severe hot flashes in postmenopausal women.

Detailed Description
-----------------
The overall study duration will be approximately 16 weeks. After a screening/baseline period of up to 4 weeks patients will be randomized to receive either placebo tablets or Cenestin 0.3mg tablets

Official Title
-----------------
A Randomized, Multicenter, Double-blind, Placebo-controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens, A (Cenestin) for the Treatment of Vasomotor Symptoms in Postmenopausal Women

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Drug: Cenestin 0.3 mg Tablets
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Naturally or surgically postmenopausal At least 12 months since last menses or 6 weeks past surgery Minimum of 7 daily or 50 weekly moderate to severe hot flashes Exclusion Criteria: Any contraindication to natural or synthetic estrogens

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Cenestin 0.3 mg Tablets<br>* 1 tablet daily<br>* Other names: Synthetic conjugated estrogens, A;|
| Placebo Comparator: 2<br> | Other: Placebo<br>* 1 tablet daily<br>* Other names: Placebo tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in average frequency of moderate to severe hot flashes |  | Baseline to Day 28 and to Day 84 | 
| Mean change in severity of moderate to severe hot flashes |  | Baseline to Day 28 and to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of Cenestin 0.3mg |  | Throughout study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menopause, vasomotor symptoms
Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

Study Overview
=================
Brief Summary
-----------------
The use of forced coughing during cervical punch biopsy may reduce pain & discomfort associated with the procedure.

Detailed Description
-----------------
Pain and anxiety are associated with many medical procedures performed in ambulatory setting. Colposcopically guided punch biopsies are a standard procedure performed in women with abnormal cervical cytology, as a part of the diagnosis and treatment selection. Coughing is thought to provide a distraction and to cause a momentarily increase in blood pressure, reducing pain perception. Therefore, the present study is designed to compare pain associated with cervical punch biopsy and the effect of forced coughing on pain and pain perception.

Official Title
-----------------
Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy

Conditions
-----------------
Pain, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Forced coughing during cervical punch biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Women undergoing cervical punch biopsy Exclusion Criteria: Women under 18 years old Women currently taking prescription pain medications Women who consumed pain medication up to 2 hours prior to the scheduled biopsy. Women who refuse to take part in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No coughing<br>Cervical punch biopsy without forced coughing intervention | |
| Experimental: coughing<br>Forced coughing during cervical punch biopsy | Behavioral: Forced coughing during cervical punch biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain associated with cervical biopsy | Evaluating pain during cervical punch biopsy using VAS 0-10 scale. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of cervical punch biopsy with and without cough intervention | Measurement of procedure length in minutes | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervical biopsy, forced cough, pain, VAS scale
How do Patients, Nurses and Physicians Perceive Negative Postoperative Events?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess how patients, nurses and physicians perceive negative events following surgical procedures.

Official Title
-----------------
Perception of Surgical Complications - Agreements Among Patients, Nurses and Physicians

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 18 years Capacity to act and no legal guardian Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery German language as daily language. Exclusion Criteria: Patients with cognitive difficulties and diseases, which may yield unreliable answers Patients unable to read and write

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients who admit for a minor or major surgical intervention | Other: Questionnaire<br>* Questionnaire, complications, grading severity, visual analog scale<br>|
| Nurses<br>Medical staff of the University Hospital of Zurich | Other: Questionnaire<br>* Questionnaire, complications, grading severity, visual analog scale<br>|
| Physicians<br>Medical staff of the University Hospital of Zurich and other institutions | Other: Questionnaire<br>* Questionnaire, complications, grading severity, visual analog scale<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess how patients, nurses and physicians perceive negative events following surgical procedures |  | August 2008- December 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association to the Clavien Dindo Classification |  | August 2008 - December 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perception, surgical complications, patients, nurses and physicians
Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

Study Overview
=================
Brief Summary
-----------------
Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly

Official Title
-----------------
Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Diagnostic Test: Flow cytometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who have been orally informed, and given a short written information notice about the study Adult patient>18 years For whom a blood sample analysis is routinely prescribed Presenting cytopenia on at least one lineage according to the 2016 WHO classification (Hemoglobin level<100 g/L and/or platelets <150 G/L and/or Neutrophils<1G/L). For whom a bone marrow analysis for morphology assessment and cytogenetics have to be performed, because of suspicion of MDS.t The results of this bone marrow evaluation will classify the patients in Group 1 (MDS diagnosis) and Group 2 (no MDS according to the 2016 WHO criteria), defining the two populations of this validation cohort for whom the FC score will be calculated. Exclusion Criteria: 1. Transfused patients (less than 3 months) in RBC or platelets units

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 |
| --- |
|Diagnostic Test: Flow cytometry|Flow cytometry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of the most relevant combination of FC markers | The main objective is to identify the most relevant combination of FC markers to discriminate between already diagnosed MDS patients and non-MDS patients. | 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prospective validation of a diagnostic score using pre-identified markers | The secondary objective is to build prospectively a diagnostic score using markers identified | 0 days |
Multicenter National Trial of Clinical Results of Surgical Elderly Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to study clinical results including mrobidity and mortality of elderly patients (age > 75 years) in Spain during a 3-month period.

Detailed Description
-----------------
The aim of the study it is to analyze the morbidity and mortality of patients older tha 70 admitted on hospital and who needs surgical operation. The results will be analysed in relationship with surgical risk calculator in order to know if it would be posssible to predict morbi-mortality of these cohort of patirents.

Official Title
-----------------
An Observational Multicenter National Trial of Clinical Results and Morbimortality of Surgical Elderly Patients

Conditions
-----------------
Surgery--Complications, Age Problem

Intervention / Treatment
-----------------
* Procedure: Elderly surgical patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an age of 70 years old or older Admitted on hospital (minimum 1 day of hospital length) Needing surgery Exclusion Criteria: Day case -surgery

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 100 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 |
| --- | --- |
| Elderly patients<br>Patients age 70 or older, who are admitted in hospital for surgical operation (elective or emergency surgery) | Procedure: Elderly surgical patients<br>* Patients who needs elective or emergency surgery for any reason<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Patients death during hospitalization or first 30 days after surgery | 30 day | 
| Complications | Any complication during admission or 30 day after | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASA score | Assessment of surgical risk | preoperative | 
| ACS NSQIP surgical risk score | Assessment of surgical risk | preoperative |
The Natural History of Wheat Hypersensitivity in Thai Children

Study Overview
=================
Brief Summary
-----------------
Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance is exceedingly difficult and imposes major dietary restriction. The purpose of this study were to determine the rate of oral tolerance and identify clinical and laboratory predictors of tolerance development in Thai children who allergic to wheat.

Detailed Description
-----------------
All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by both a detailed medical examination and collection of medical history. Blood sample was taken for baseline determination of ImmunoglobulinE antibodies to wheat and to omega-5-gliadin. The oral wheat challenge were performed in all study subjects to identify a case of wheat outgrowing. The primary outcome was the development of oral tolerance to wheat. Oral wheat challenge were generally performed at least every 1 years if the child did not have an interval history of symptoms with unintentional exposure.

Official Title
-----------------
The Natural History of Wheat Hypersensitivity in Thai Children

Conditions
-----------------
Wheat Allergy, Child

Intervention / Treatment
-----------------
* Dietary Supplement: oral wheat challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children 1 to 15 years History of IgE-mediated wheat allergy Exclusion Criteria: Parents refused to sign the consent Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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 |
| --- | --- |
| Experimental: oral wheat challenge<br> | Dietary Supplement: oral wheat challenge<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants who outgrow from wheat allergy |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wheat allergy, wheat outgrowing, wheat hypersensitivity, omega-5-gliadin, natural history of wheat hypersensitivity