linjc16/ctgov huggingface dataset:
The Efficacy of Probe-based Confocal Laser Endomicroscopy in Staging OLGIM

Study Overview
=================
Brief Summary
-----------------
Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.

Conditions
-----------------
Probe-based Confocal Laser Endomicroscopy, the Operative Link on Gastric Intestinal Metaplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 40 years or older with Helicobacter pylori infection; Histologically verified GIM, atrophic gastritis or dysplasia. Exclusion Criteria: Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium; Pregnancy or breastfeeding; Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| the sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM). |  | 6 months | 
| the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the of sensitivity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM). |  | 6 months | 
| the of specificity of probe-based Confocal Laser Endomicroscopy (pCLE) in staging Gastric Intestinal Metaplasia (GIM). |  | 6 months |
Investigation on Medical Management of Dry Eye Patients

Study Overview
=================
Brief Summary
-----------------
Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. We conducted an perspective observational study to evaluate the medical management of dry eye patients.

Conditions
-----------------
Dry Eye Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given a written informed consent Clinical diagnosis of dry eye syndrome Have at least one Schirmer's test positive result (less than 10mm/5min) in at least one eye within one year Exclusion Criteria: Pregnancy Cognitive or psychiatric deficit that precludes informed consent Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Artificial tears utilization patterns |  | within 1 month before recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of dry eye symptoms, evaluated by clinicians | Measured by clinical global impression (CGI) | Baseline | 
| Changes of dry eye symptoms, evaluated by patients | Measured by subject global assessment (SGA) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye syndrome
Affective Responses in Neurological Rehabilitation

Study Overview
=================
Brief Summary
-----------------
Using a single blind within-subject design, 16 patients with neurological disorders were randomly exposed to two different treatments: physical therapy and robotic assisted gait training. Both before and after the treatments, a self-report Mood Survey Scale (MSS) was used to assess the effects on the treatment on distinct affective states. The subscales of the MSS were tested for pre-post changes and different effects between treatments with non-parametric tests.

Official Title
-----------------
A Preliminary Study on Acute Affective Responses Focussing on Differences Between Physical Therapy and Robotic Assisted Gait Training

Conditions
-----------------
Stroke, Neurological Incidents, Traumatic Brain Injury

Intervention / Treatment
-----------------
* Procedure: Physical therapy and robotic assisted gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntary participation neurological incident Exclusion Criteria: lack of communication ability interference of consciousness inability to speak German language

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| G<br>All participants were randomly exposed to two different treatments: Conventional physical therapy (no specific device used) Robotic assisted gait training (Lokomat, Hocoma AG, Switzerland) We consider the study as observational, since the both interventions of the study (physical therapy, robotic assisted gait training) did not change in the patients' usual therapy plan, as they received both interventions daily. We only added diagnostic interventions to assess the affective responses. | Procedure: Physical therapy and robotic assisted gait training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of subscales of mood survey scale from pre to post treatment |  | 30-60 minutes |
Predictability of Gestational Diabetes Mellitus in First and Second Trimester

Study Overview
=================
Brief Summary
-----------------
The objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).

Detailed Description
-----------------
It is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. For this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels. The primary outcome will be development of gestational diabetes mellitus in the second or third trimester. The secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs.

Official Title
-----------------
Predictability of Gestational Diabetes Mellitus in First and Second Trimester, Using Novel Biomarkers, and the Development of New Biomarkers by Quantitative Proteomic Analysis

Conditions
-----------------
Pregnancy, Gestational Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy singleton pregnancies Women at least 18 years old and not under guardianship Exclusion Criteria: Maternal diseases like hypertension, diabetes mellitus and chronic disease, known infection like hepatitis or human immunodeficiency virus Maternal history of hypertensive diseases in previous pregnancy and now under prophylactic acetylsalicylate treatment Foetal genetic, chromosomal or intervention-requiring morphologic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Women with/without gestational diabetes<br>Women with/without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Gestational Diabetes in second/third trimester | Development of gestational diabetes in 24-28 weeks of gestation by pathological values in oral glucose tolerance test 75g | 24-28 weeks of gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Glucose Tolerance Test, Fibronectin, Adiponectin, Copeptin, Cortisol
Association of Keratinised Mucosa Around Implants and Teeth With Peri-implant/Periodontal Disease and Soft Tissue Conditioning

Study Overview
=================
Brief Summary
-----------------
Lack of keratinised mucosa around dental implants and teeth is associated with plaque accumulation and worse tissue conditions. However, there is lack of data on the influence of the presence/lack of keratinised mucosa on the periodontal condition. Hence, soft tissue conditioning by grafting with a gingival graft is aimed at improving the quality of the peri-implant conditions

Official Title
-----------------
Soft Tissue Conditioning to for the Treatment of Peri-implantitis in the Lack of Keratinised Mucosa

Conditions
-----------------
Peri-Implantitis, Soft Tissue, Bone Gain

Intervention / Treatment
-----------------
* Procedure: Free gingival graft obtained from the palate and debridement of the peri-implant lesion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partial edentulous patients with adjacent teeth Lack of keratinised mucosa Healthy patient Exclusion Criteria: Pregnancy Complete edentulous patients Patients taking any medication Smokers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-prospective one-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical treatment with free gingival graft<br>Free gingival graft harvested from the palate will be placed around the diseased implant | Procedure: Free gingival graft obtained from the palate and debridement of the peri-implant lesion<br>* granulation tissue debridement and grafting of a free gingival strip obtained from the palate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant conditions | Probing pocket depth measured in mm, bleeding on probing recorded as yes/no (I/0), suppuration as recorded as yes/no (I/0) | 12 months after implant loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of keratinised mucosa/gingiva with periodontal and peri-implant conditions | keratinised mucosa (mm) and keratinised gingiva (mm) | 12 months after implant loading |
Oxygenation Via Frova Bougie and Ambu Bag

Study Overview
=================
Brief Summary
-----------------
We will conduct this study to show that it is possible to deliver air through a Frova bougie and an Ambu® bag.

Detailed Description
-----------------
Participants will be invited to squeeze an Ambu® bag connected to a Frova bougie, and we will measure the volume of air delivered and peak pressure generated.

Official Title
-----------------
Comparison of Volumes of Air Delivered Through a Frova Intubation Bougie by a Maximal Bimanual Compression Versus a Normal Bimanual Compression of an Adult Ambu® Bag

Conditions
-----------------
Failed or Difficult Intubation

Intervention / Treatment
-----------------
* Other: Frova bougie


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: staff, fellows and resident anesthesiologists Exclusion Criteria: injury to hand
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Maximum bimanual compression<br>Squeeze through Frova bougie with maximum bimanual compression | Other: Frova bougie<br>* Squeezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated.<br>|
| Other: Normal bimanual compression<br>Squeeze through Frova bougie with normal bimanual compression | Other: Frova bougie<br>* Squeezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tidal Volume (ml) | volume of air delivered via Frova bougie (milliliters) | 15 minutes |
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status

Study Overview
=================
Brief Summary
-----------------
A 3 months randomized, placebo-controlled study on the effect of toothpaste fortified with vitamin B12 on vitamin B12 status markers and related metabolic markers. The primary outcome variable is the difference in the change of methylmalonic acid after 3 months between the two study arms.

Official Title
-----------------
Effect of Toothpaste Fortified With Cyanocobalamin on Vitamin B12 Status: A 3 Month Placebo Controlled Randomized Study

Conditions
-----------------
Cobalamin Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Cyanocobalamin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults: men and women Stable diet for at least 24 months (omnivorous or a vegan diet). Exclusion Criteria: Pregnancy and lactation Malabsorption disorders (Crohn disease, chronic gastritis, pernicious anemia, gastric or intestinal resection) Renal diseases Liver diseases Patients with cancer (or cancer history) Pre-study treatment with vitamin B12 or folate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A toothpaste, with the same matrix, all components, and appearance like the active arm but not containing vitamin B12. | Dietary Supplement: Placebo<br>* Toothpaste not containing the vitamin.<br>|
| Active Comparator: Cyanocobalamin<br>A toothpaste with cyanocobalamin 100 µg cyanocobalamin per 1 g. | Dietary Supplement: Cyanocobalamin<br>* Toothpaste containing100 µg cyanocobalamin/g.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in plasma concentrations of methylmalonic acid | Lowering methylmalonic acid in the B12 arm compared with the placebo arm | Baseline, 3 months | 
| The change in plasma concentrations of holotranscobalamin | The effect on increasing holotranscobalamin in the B12 arm compared with the placebo arm | Baseline, 3 months | 
| The change in plasma concentrations of homocysteine | Lowering homocysteine in the B12 arm compared with the placebo arm | Baseline, 3 months | 
| The change in plasma concentrations of vitamin B12 | The effect on increasing plasma vitamin B12 in the B12 arm compared with the placebo arm | Baseline, 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cobalamin biomarkers, Anemia, Vegan diet, Subclinical, Metabolic functional markers, Holotranscobalamin, Methylmalonic acid
Follow-up Study of Autologous Cultured Adipose-derived Stem Cells for the Crohn's Fistula

Study Overview
=================
Brief Summary
-----------------
This is an open follow-up clinical trials to evaluate a sustained efficacy and safety of Adipoplus inj. for 10 months (12 months after final dose injection)after Phase II clinical trial.

Official Title
-----------------
Follow-up Study to Evaluate the Sustained Efficacy and Safety for the Patients With Adipoplus Injected in Phase II Clinical Trials(ANTG-ASC-202)

Conditions
-----------------
Crohn's Disease, Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients who have participated in ANTG-ASC-202 clinical trial the patients who have experienced with Adipoplus in ANTG-ASC-202 trials the patients who submit written consents and is able to obey requirements of trials Exclusion Criteria: pregnant or breast feeding autoimmune disease other than Crohn's disease infectious diseases including HBV, HCV or HIV who is not willing to use effective contraceptive methods during the study. active tuberculosis moderate to severe active or worsened Crohn's disease who have received Infliximab during or after ANTG-ASC-202 trial

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 |
| --- | --- | --- |
| Number of patients with Sustained efficacy of complete closure of fistula | Proportion of patients whose fistula has been completely closed. | Month 4, 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with sustained efficacy of closure of fistula | Proportion of patients with more than 50% closed of fistula (Month 2, 4, 10) | Month 2, 4, 10 | 
| Number of patients with any adverse event | number of patients with any adverse event (Month 2, 4, 10) | Month 2, 4, 10 | 
| Grade of Investigator's satisfaction | Grade of Investigator's satisfaction (Month 2, 4, 10) very satisfaction satisfacttion somewhat satisfaction unsatisfaction very unsatisfaction | Month 2, 4, 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's fistula, Autologous adipose derived stem cell
Multi-centre Observational Registry on Patients With Implantable Devices Remotely Monitored

Study Overview
=================
Brief Summary
-----------------
Multicentric, observational, retrospective registry including patients underwent implantable device implantation (pacemaker or ICD) for any indication in the period from 2009 to 2016, followed by remote monitoring. The aims of the registry are to evaluate the occurrence of atrial arrhythmias, of hospitalizations, and the mortality during a long-term follow-up.

Official Title
-----------------
Italian Multi-centre Observational Registry on Patients With impLANTable Devices Remotely monitorED

Conditions
-----------------
Arrythmia, Defibrillators, Implantable, Heart Failure With Reduced Ejection Fraction, Pacemaker

Intervention / Treatment
-----------------
* Device: Assesment of outcome of implantable device patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD of pacemaker implantation fo any indication Followed by remote monitoring Age >18 years Exclusion Criteria: life expectancy of less than one year

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 |
| --- |
|Device: Assesment of outcome of implantable device patients|Evaluation during follow-up of the occurrence of atrial arrhythmias, hospitalizations, and of death.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death for any cause |  | an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial arrhythmias |  | an average of 2 years | 
| Hospitalizations for any cause |  | an average of 2 years |