linjc16/ctgov huggingface dataset:
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.

Detailed Description
-----------------
After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.

Official Title
-----------------
Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)

Conditions
-----------------
Dysbiosis, Microbial Colonization, Fertility Issues

Intervention / Treatment
-----------------
* Dietary Supplement: FertyBiotic Balance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged: 35-43 years old Vaginal pH > 4,5 and low Lactobacillus count or Nugent score of 4-6 With interest in getting pregnant and ideally in IVF waiting list History of recurrent genitourinary infections Exclusion Criteria: Any pathology that interferes with the study Current intake of food supplements or probiotics Current intake of contraceptives Use of oral or vaginal probiotics in the last 6 months Hypersensitivity to any of the components of the studied product Current vaginal infection Pregnant women Breastfeeding Use of intrauterine device Use of spermicide Use of cervical caps as hormonal therapy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 43 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 |
| --- | --- |
| Experimental: FertyBiotic Balance<br>Participants received FertyBiotic Balance one capsule a day | Dietary Supplement: FertyBiotic Balance<br>* Lactobacillus rhamnosus BPL 205, Lactobacillus plantarum BPL207 and Lactobacillus crispatus BPL209<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal and vaginal colonization | Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autoinmune capacity | Autoinmune capacity will be evaluated by measuring plasma levels of IL-10, TNF- alpha and IL-10 | 10 weeks | 
| Antioxidant effect | Antioxidant will be evaluated by measuring Total Antioxidant Capacity (TAC) and Malondialdehyde | 10 weeks |
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study

Study Overview
=================
Brief Summary
-----------------
The aim of this multicenter, cross-sectional, observational flash mob study is to investigate the prevalence of cognitive impairment in hospitalized elderly aged 65 years or older, and the recognition of cognitive impairment by healthcare professionals.

Official Title
-----------------
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study

Conditions
-----------------
Cognitive Impairment, Dementia, Alzheimer Disease, Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dutch-speaking Hospitalized Age ≥ 65 years old Exclusion Criteria: Unable to perform the Mini-Cog (e.g. due to visual impairment, severe hearing loss, being too ill, or otherwise unable to speak or write) Patients who require medical isolation Not willing to participate.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Percentage of hospitalized patients aged 65 years or older with cognitive impairment | Cognitive impairment is measured with the Mini-Cog | Baseline | 
| Percentage of hospitalized patients aged 65 years or older with cognitive impairment that has been recognized by nurses, physicians, both their nurse and physician, and either their nurse or physician | Cognitive impairment is measured with the Mini-Cog | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, Hospitalization
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases

Study Overview
=================
Brief Summary
-----------------
To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation. Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation. Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD

Official Title
-----------------
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases

Conditions
-----------------
Aortic Valve Regurgitation Acquired

Intervention / Treatment
-----------------
* Biological: blood samples
* Biological: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with long-term left-ventricular assistance awaiting transplant Patients with severe aortic surgical spring deficiency Major Patient Exclusion Criteria: Minor Patient Pregnant or nursing women Major under guardianship People in emergencies Persons not covered by the social security scheme

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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with aortic valve disease (AVD).<br> | Biological: blood samples<br>* blood samples<br>Biological: biopsy<br>* biopsy of aortic valve<br>|
| Experimental: patients with left ventricular assist device (LVAD<br> | Biological: blood samples<br>* blood samples<br>Biological: biopsy<br>* biopsy of aortic valve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood sample | RNA-sequencing analysis | 24 months |
Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments

Study Overview
=================
Brief Summary
-----------------
This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.

Conditions
-----------------
Maternal Anxiety, Maternal Depression, Infant Cognitive Development

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in their third trimester of pregnancy Who exhibited symptoms of anxiety and depression Exclusion Criteria: Women who express suicidality
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions | Behavioral: Cognitive Behavioral Therapy<br> <br> |
| No Intervention: Control Group<br>Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist |  | 10 months post-birth of their infant | 
| Infant Cognitive Development as measured by Mullen Scales of Early Learning |  | 10 months post-birth |
Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment

Study Overview
=================
Brief Summary
-----------------
Radio graphic and Intravascular (IVUS) Evaluation of Venous Morphology During Chronic Cerebral Spinal Venous Insufficiency Treatment

Detailed Description
-----------------
To determine the safety and validity of venous angioplasty and valvuloplasty in the treatment of CCSVI. In addition, it will allow researchers to sub-classify valve morphology in relation to treatment success. This will be evidenced by venous patency forty-eight hours by Doppler ultrasound as well as clinical symptom improvement.

Official Title
-----------------
Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment

Conditions
-----------------
To Determine the Safety and Validity of Venous Angioplasty and, Valvuloplasty in the Treatment of CCSVI. In Addition, it Will, Allow Researchers to Sub-classify Valve Morphology in Relation, to Treatment Success. This Will be Evidenced by Venous Patency, Forty-eight Hours by Doppler Ultrasound as Well as Clinical, Symptom Improvement.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to comprehend the nature of the study, including the risks and benefits and execute an informed consent Males or Females between the ages of 20 and 60 years of age. Voluntary agreement to participate in the study: Radiographic and Intravascular (IVUS) Evaluation of Venous Morphology During CCSVI Treatment. Exclusion Criteria: Any implantable/metallic objects that prevents subject from having a magnetic resonance imaging (MRI/MRV) study. History of uncontrolled hypertension Previous CCSVI treatment Presence of hypercoagulable state Special Populations. Special groups include, but are not limited to children, prisoners, pregnant women, fetuses, and cognitively impaired individuals who are unable to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVUS, CCSVI
Prospective Observational Study of Peri-implantation Serum hCG Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively define a set of data suitable for developing models of pregnancy viability. Those models will be based on serum hCG concentration measured during the peri-implantation period in patients that received fresh embryo transfer and those that received transfer of frozen-thawed embryos, and to compare and contrast these models. This may reveal insights into differences between these types of IVF cycles.

Detailed Description
-----------------
The current study seeks to examine the effect of the timing of implantation (as indicated by the first increase in serum hCG level) on the viability of pregnancies and to determine if such effect of timing differs between fresh embryo transfers and frozen-thawed embryos transfers. In this case, the timing of implantation will be measured through serum hCG analysis on days 3, 4, 5, and 7 after blastocyst transfer.

Official Title
-----------------
Prospective Observational Study of Peri-implantation Serum hCG Levels

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF patients (adults) who received blastocyst transfer Exclusion Criteria: Those patients using different laboratories

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Fresh embryo transfers<br>Patients who received fresh blastocyst transfer | |
| Thawed embryo transfers<br>Patients who received transfers of frozen/thawed embryos | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy | Fetal heart motion at 10 weeks gestation. | 10 weeks gestation |
The Development of Flat Foot After Ankle Fractures

Study Overview
=================
Brief Summary
-----------------
In this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. As compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle.

Detailed Description
-----------------
Pes planus may develop following ankle fractures due to additional injuries that are sustained at the time of ankle fracture. If this study can demonstrate an association, further research would investigate how to effectively treat the pes planus early to prevent it from becoming a symptomatic problem.

Official Title
-----------------
Pes Planus After Weber B and C Ankle Fractures

Conditions
-----------------
Pes Planus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be considered eligible if: They have sustained Weber type B or C ankle fractures and needed open reduction They are 18 years of age or older They are expected to be full weight bearing for at least 4 months to allow the potential of supporting structures to stretch and pes planus to develop Exclusion Criteria: Patients will be excluded if they already have flat foot in their non-fractured foot. Patients with bilateral ankle fractures Patients who are not competent to sign a consent form A second fracture to the ankle Pathological fractures Patients with underlying 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle fracture, pes planus
Inflammatory Myopathies in Primary Sjögren's Syndrome

Study Overview
=================
Brief Summary
-----------------
The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS).

Detailed Description
-----------------
Muscle disease is associated with pSS, but this association is not well defined. The AMISS study, a retrospective observational multicentric study, will recruit patients with pSS and muscle involvement in order to characterize in details the features of this association (epidemiological aspects, clinical presentation, biological, radiological and histological findings, treatments and outcomes).

Official Title
-----------------
Characterization of Inflammatory Muscle Involvement in Patients With Primary Sjögren's Syndrome

Conditions
-----------------
Primary Sjögren Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Primary Sjögren's syndrome according to the ACR/EULAR classification criteria inflammatory muscle involvement, as diagnosed by the treating physician Exclusion Criteria: Diagnosis of inflammatory myopathy before the diagnosis of pSS

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Proportion of patients fulfilling classification criteria for inflammatory myopathies | Among the patients included in the AMISS study, we will assess the proportion of patients who fulfill the classification criteria for the different inflammatory myopathies. | At diagnosis |
Effect of Nutritional Supplementation on Pediatric Burn Patients

Study Overview
=================
Brief Summary
-----------------
This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.

Official Title
-----------------
Effect of Nutritional Supplementation on Pediatric Burn Patients

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Other: Nutritional Supplement
* Other: Hospital food


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-10 years of age Hospital admission within 24 hours post-burn At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher Capable of exclusive oral feeding within 3 days of hospitalization Expected to be hospitalized at least 14 days Exclusion Criteria: History diabetes or stress-induced hyperglycemia Artificial ventilation Requires parenteral or enteral feeding IV albumin Drug that affects metabolism Receiving Dialysis Acutely impacted or constipated Consumes non-study nutritional supplement Allergy or intolerance to any study product ingredient Participating in non-Abbott approved concomitant trial

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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: Hospital Feed<br>Standard hospital food | Other: Hospital food<br>* Typical hospital food given daily at meals<br>|
| Experimental: Hospital Feed plus nutritional supplement<br>Standard hospital food plus nutritional supplement | Other: Nutritional Supplement<br>* Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prealbumin |  | Change between Baseline and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preablumin |  | Change between Baseline and Day 7 | 
| C Reactive Protein (CRP) |  | Between baseline and Day 7 | 
| C Reactive Protein |  | Between baseline and Day 14 |
Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow

Study Overview
=================
Brief Summary
-----------------
The study is aimed at investigation of respiratory gases propagation in snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow.

Detailed Description
-----------------
The study is aimed at investigation of respiratory gases (oxygen and carbon dioxide) propagation in the simulated avalanche snow. The study involves volunteers breathing into the snow whereas concentrations of gases are measured at various positions in the snow. A special apparatus was created for sampling and measurement of gas concentrations and to assure stable geometry of the experiment required for data evaluation.

Official Title
-----------------
Evaluation of Gas Propagation in Snow During Breathing of Subjects Under Simulated Avalanche Snow

Conditions
-----------------
Accident Caused by Snow Avalanche

Intervention / Treatment
-----------------
* Other: extreme hypercapnia induced by ventilation insufficiency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy and fit volunteers, classified as The American Society of Anesthesiologists class I without a smoking history Exclusion Criteria: Tiffeneau Index less than 0.70 any cardiovascular or respiratory condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathing in the snow<br>Breathing in the snow using a specially designed apparatus and measuring the respiratory gases distribution in snow. | Other: extreme hypercapnia induced by ventilation insufficiency<br>* Re-breathing of gas by breathing into the simulated avalanche snow<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of breathing | Time to termination of the breathing experiment due to the decision of the tested subject, or determined by high end-tidal carbon dioxide value or by the order by the clinician assessing the health status of the subjects. | Continuously within up to 20 minute interval from the beginning of the breathing experiment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercapnia, diffusion, snow, avalanche