linjc16/ctgov huggingface dataset:
Diagnostic Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples

Study Overview
=================
Brief Summary
-----------------
Multicentre, diagnostic study evaluating the performance of an aspergillus-specific PCR in cerebrospinal fluid samples of immunocompromised patients for identification of central nervous system aspergillosis.

Official Title
-----------------
Diagnostic Study Evaluating the Performance of an Aspergillus-specific Nested PCR Assay in Cerebrospinal Fluid Samples of Immunocompromised Patients for Detection of Central Nervous System Aspergillosis

Conditions
-----------------
Focus: Immunocompromised Individuals at High Risk of Aqcuiring Invasive Aspergillosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Host factors Informed consent Exclusion Criteria: none
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 |
| --- | --- |
| Proven/probable CNS IA<br>Immunocompromised patients with proven/probable invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG | |
| Possible/No CNS IA<br>Immunocompromised patients with possible/NoIA invasive CNS Aspergillosis based on modified criteria by the EORTC/MSG | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test sensitivity |  | one year |
Gut Microbiota, Spark and Flame of COVID-19 Disease

Study Overview
=================
Brief Summary
-----------------
Elderly, hypertension, diabetes and cardiovascular diseases are risk factors for COVID-19 morbility and mortality. However, the real reason for this is not yet understood. It is well documented that gut microbiota has a critical role in health, particularly in the immune system and therefore, we propose that gut microbiota composition could affect vulnerability and disease outcomes of COVID-19.

Detailed Description
-----------------
In order to explore this hypothesis, we will analyse the gut microbiota of SARSCoV-2 infected patients categorized according to location: [1] ambulatory (self-isolation at home), [2] ward and [1] ICU; and severity.

Official Title
-----------------
Gut Microbiota, Spark and Flame of COVID-19 Disease

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults of 18 years and above. COVID-19 patients. Exclusion Criteria: None.

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 |
| --- | --- |
| Ambulatory<br>Patients that are self-isolated at home | Other: Exposure<br>* Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.<br>|
| Ward<br>Patients that are in an isolated room at the hospital | Other: Exposure<br>* Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.<br>|
| ICU<br>Patients that are in the ICU of the hospital | Other: Exposure<br>* Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in gut microbiota composition between COVID-19 patients with different degrees of disease severity. |  | Stool samples of COVID-19 patients will be collected after subject enrollment (single point collection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in gut microbiota composition between COVID-19 patients in relation to mortality. |  | Through study completion, an average of 3 months. | 
| Differences in gut microbiota composition between COVID-19 patients in relation to length of stay in hospitals. |  | Through study completion, an average of 3 months. | 
| Differences in gut microbiota composition between COVID-19 patients in relation to duration of mechanical ventilation. |  | Through study completion, an average of 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Gut microbiota
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease Study

Study Overview
=================
Brief Summary
-----------------
The associations between food nutrition and safety factors with the risk of chronic diseases are still unclear. This study is conducted in Jinhua, a city with a high prevalence of chronic diseases in China, to assess relations between food nutrition and safety factors and chronic diseases.

Detailed Description
-----------------
Investigations of associations of food nutrition and safety factors with the risk of chronic diseases are limited and studies in China are still lacking. The investigators aim to collect basic characteristics of participants at baseline, including sex, age, smoking, exercise, marriage, education level, dietary factors, and so on, to assess the association of food nutrition and safety factors including various food items, dietary fatty acids, and internal biomarkers of food contaminants such as acrylamide and 3-MCPD with various chronic diseases in a Chinese middle-aged and elderly population. We will use multi-omics technology to investigate the causal mechanisms. Results from this study will be valuable for chronic diseases prevention in China.

Official Title
-----------------
Precision Nutrition and Food Safety for Dietary Prevention of Chronic Disease (PNFS) Study

Conditions
-----------------
Chronic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject aged ≥45 and ≤74 years old Subject has complete data on diet and follow-up time Exclusion Criteria: had the major illness that had made personal life disabled

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Numbers of participants with metabolic syndrome | metabolic syndrome | From entry into the study (baseline:2018-2022) until 2022] | 
| Numbers of participants with obesity | Obesity | From entry into the study (baseline:2018-2022) until 2022] | 
| Numbers of participants with diabetes | Diabetes | From entry into the study (baseline:2018-2022) until 2022] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food safety, Food nutrition, Food contaminant, Mult-omics, Chronic diseases
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

Detailed Description
-----------------
The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.

Official Title
-----------------
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

Conditions
-----------------
Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Radiomic, pathomic, and clinical markers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be men and women age 18+ Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-) Any state of disease as described by AJCC v7 criteria Participants must have received and completed neoadjuvant chemotherapy Exclusion Criteria: Participants who had other primary cancers prior to breast cancer

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: Radiomic, pathomic, and clinical markers|This is a non-interventional study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response (pCR) | Evaluating the degree of absence of residual cancer cells | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to local breast recurrence | Evaluating the time until a recurrence event has occurred in the breast | Up to 60 months | 
| Time to distant metastasis (months) | Evaluating onset of distant metastasis | Up to 60 months | 
| Time to death | Evaluating time to cancer-related death | Up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiomics, pathomics, breast cancer, machine learning, biomarkers
Tremor Monitoring Device

Study Overview
=================
Brief Summary
-----------------
Patients with tremor may have varying degrees of tremor at different times. The amplitude and frequency of tremor may change. The investigators observational study is intended to document this tremor.

Official Title
-----------------
Tremor Monitoring Device

Conditions
-----------------
Parkinson's Disease, Essential Tremor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with tremor due to Parkinson's disease or Essential tremor Exclusion Criteria: Severe dementia

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 |
| --- | --- |
| Patients with Parkinson's Disease<br>Patients with tremor due to Parkinson Disease | |
| Patients with Essential tremor<br>Patients with tremor due to Essential tremor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum linear acceleration of the forearm. | We will measure linear acceleration of the forearm in meter per second squared. | Linear acceleration of the forearm will be measured for 15-60 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum angular velocity of the forearm. | We will measure angular velocityof the forearm in degrees per second. | Maximum angular velocity of the forearm will be measured for 15-60 minutes. |
Helicobacter Pylori Empiric Treatment in Ulcer Bleeding

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to compare the effectiveness of empirical Helicobacter pylori treatment compared with treatment depending on diagnostic tests for Helicobacter pylori in patients with Upper gastrointestinal bleeding due to peptic ulcer. Main hypothesis is that empirical treatment will reduce the number of patients lost to follow-up thus improving the cure rates of Hp infection.

Official Title
-----------------
Phase IV Study Comparing Helicobacter Pylori Empiric Eradication With Test-Guided Treatment in Patients With Peptic Ulcer Bleeding

Conditions
-----------------
Peptic Ulcer Hemorrhage

Intervention / Treatment
-----------------
* Other: Empirical Hp eradication
* Other: Eradication treatment guided by a positive test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18. Informed Consent signed. Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer. Life expectancy longer than 6 months. Able to attend further clinical controls. Absence of the following exclusion criteria. Exclusion Criteria: Previous eradication treatment. Use of antibiotics 2 weeks prior to inclusion. Need for Antisecretor treatment that cannot be stopped to perform the breath test. Pregnancy or breastfeeding.

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 |
| --- | --- |
| Active Comparator: 1<br>Empirical eradication treatment | Other: Empirical Hp eradication<br>* Empirical Helicobacter pylori treatment initiated immediately after oral intake is resumed<br>* Other names: Standard Hp eradication treatment;|
| Active Comparator: 2<br>Eradication treatment according to a diagnostic test (URT, histological test, breath test or serology). | Other: Eradication treatment guided by a positive test<br>* Eradication treatment given if there is at least one positive diagnostic test (URT, histological test, breath test or serology) for Helicobacter pylori.<br>* Other names: Standard Hp treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economical evaluation through cost-effectivity study of the empiric erradicator Helicobacter pylori treatment. |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, Treatment, Upper gastrointestinal bleeding
Whole Milk Versus Whey Protein Supplement and Resistance Exercise

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the effects of consuming protein supplement (whey) compared to whole milk immediately after bouts of resistance training on muscular strength and body composition.

Official Title
-----------------
Effects of Whole Milk Versus Whey Protein Supplementation With Resistance Exercise on Body Composition, Muscle Hypertrophy and Strength Changes in Healthy Individuals

Conditions
-----------------
Muscle Development

Intervention / Treatment
-----------------
* Dietary Supplement: Whey protein
* Dietary Supplement: Chocolate milk
* Dietary Supplement: Sugar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy currently working out at least 3 times per week Exclusion Criteria: taken any ergogenic aid/sport supplements in the last 2 months

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Milk<br>Chocolate milk compared to protein supplement | Dietary Supplement: Whey protein<br>* 18g protein, immediately after training, 9 weeks<br>* Other names: protein supplement;|
| Active Comparator: Whey protein<br>Whey protein compared to milk | Dietary Supplement: Chocolate milk<br>* 500ml chocolate milk, immediately after training, 9 weeks<br>* Other names: Milk;|
| Placebo Comparator: Sugar<br>Maltodextrin compared to treatments | Dietary Supplement: Sugar<br>* 55-65g maltodextrin solution, immediately after training, 9 weeks<br>* Other names: Maltodextrin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | DEXA for assessment of fat and lean tissue | 9 weeks | 
| Strength | 1RM tests to assess changes in strength on various sport resistant exercise equipment | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood amino acid | Assessment of plasma amino acid profile at baseline, mid and end of the study. | 9 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lean tissue, Strength condition, Protein, Amino Acid
Memory Study of Youngest Women Enrolled in the Women's Health Initiative Hormone Therapy (HT) Arm

Study Overview
=================
Brief Summary
-----------------
WHIMS-Y provides valuable information on the long-term effects on risk of cognitive impairment of hormone therapy in a subset of WHI participants in the WHI Hormone Trials. Following cessation of study-prescribed HT cognitive function and impairment were assessed.

Detailed Description
-----------------
The Women's Health Initiative Memory Study of Younger Women (WHIMS-Y) is proposed to assess the long-term impact of random assignment to postmenopausal hormone therapy (equine estrogen alone or in combination with medroxyprogesterone versus placebo) among women who were aged 50-54 at the time of randomization into the WHI hormone trials. Secondary objectives relate to the consistency of any treatment effects across unopposed or opposed therapy and whether there exists evidence of graded relationships between cognitive effects and age of administration, years from menopause, and baseline risk factors for cognitive impairment.

Official Title
-----------------
Women's Health Initiative Memory Study of Younger Women

Conditions
-----------------
Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be enrolled in the Women's Health Initiative Extension Exclusion Criteria: Not enrolled in the Women's Health Initiative Extension

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 54 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previous HT use and cognition<br>Women who were aged 50-54 at the time of randomization into the WHI hormone trials. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause dementia and Mild Cognitive Impairment | Participants will have a cognitive assessment administered over the telephone. | Measured once a year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global and domain specific cognitive function. | Participants will have a cognitive assessment administered over the telephone. | Measured once a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognition, memory, hormone therapy
Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients

Study Overview
=================
Brief Summary
-----------------
To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation. Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections. The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed

Official Title
-----------------
Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis

Conditions
-----------------
Sepsis, Candida

Intervention / Treatment
-----------------
* Drug: Amphotericine in liposome (Ambisome®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Supportive mechanical ventilation for more than 48 h LOD > 5 with with ailing body systems Candida colonisation of at least one site in addition to the digestive tract Suspected nosocomial infection with antibiotic treatment Informed consent Exclusion Criteria: Patients treated with oral or systemic antifungal agents within 15 days prior to inclusion Patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the EORTC criteria Patients with a SAPS score > 65 Patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy Blood creatinine > 220 µmol/L Hemodyalysis Pregnant 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amphotericine in liposome (Ambisome®)|2 IV infusions separated by one week 10 mg/kg per injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects |  | 28-day observation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of stay in the intensive care unit; occurrence of a systemic fungal infection |  | 28 days after first treatment administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FUNGAL INFECTION, SEPSIS, INTENSIVE CARE, AMBISOME, PREEMPTIVE TREATMENT, Sepsis with candida colonisation