linjc16/ctgov huggingface dataset:
Registry and Fluid Banking of Pancreatic Cystic Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to follow patients, who have small mucinous cysts in the pancreas, prospectively over a 5-year period.

Detailed Description
-----------------
The patients will present to our endoscopy unit for EUS-FNA to work up pancreatic cystic lesion(s). At that time, we will recruit them to be in the patient registry and tissue repository. Their enrollment in the patient registry will allow us to contact them annually for survey purposes. Their enrollment in the tissue repository will allow us to store left-over pancreatic cyst fluid that was already aspirated for analysis (as part of the standard-of-care workup for pancreatic cysts).

Official Title
-----------------
Prospective Registry and Cystic Fluid Banking for Patients Undergoing EUS-FNA for the Evaluation of Pancreatic Cystic Lesions.

Conditions
-----------------
Pancreatic Cysts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consented patients between age 18 to 85 who are referred for EUS evaluation of pancreatic cysts. Exclusion Criteria: Patient unable to give informed consent age<18 or >85, patients with clinically suspected pseudocysts.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the Sendai criteria prospectively in patients with pancreatic cysts. |  | up to 1 year |
Prevalence and Predictors of Depression in COPD

Study Overview
=================
Brief Summary
-----------------
Depression adversely affects quality of life in COPD patients, associated with higher rate of exacerbations, admissions and mortality. However, local prevalence rate of depression in geriatric COPD patients remains unknown. Though BODE index is superior to FEV1 in prediction of depression in COPD, it is unclear which domain of BODE correlates best with depression. Furthermore, with multiple confounding factors, it's ambiguous that whether frequent exacerbation is an 'independent' predictor for depression among COPD patients. The objective of this study is i.) to study the local prevalence rate of depression in geriatric COPD patients, ii.) to identify risk factors for depression especially looking at the any independent relationship between frequent exacerbations, various domains of BODE index and depression.

Detailed Description
-----------------
This study is a multi-centers, cross-sectional study, conducted in Kwong Wah Hospital and Wong Tai Sin Hospital, Hong Kong SAR. Age and comorbidity-matched COPD and control subjects were recruited from clinics. Depressive symptoms were measured by a validated Chinese version of Geriatric Depression Scale short form (GDS - 15 items) with 2 cut-off points. A score of 8 or above was considered significant depressive symptoms while the cut off score of 5 or above was for patients with mild depressive symptoms. Prevalence rates of depressive symptoms were measured in both COPD and control groups. Predictors for depression (GDS = or> 8) were determined using univariate and multivariate analysis.

Official Title
-----------------
Prevalence and Independent Predictors of Depression in COPD

Conditions
-----------------
Depression, COPD

Intervention / Treatment
-----------------
* Other: Rate of depression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 60 or above, with stable COPD suggested clinically and post-bronchodilator spirometry FEV1/FVC ratio <0.7. Exclusion Criteria: Patients were excluded if they had co-existing pulmonary diseases like active pulmonary tuberculosis, interstitial lung diseases etc; if they were too demented or physically incapacitated to participate e.g wheelchair-bound for bedbound.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| COPD<br>Spirometry confirmed COPD patients | Other: Rate of depression<br> <br> |
| Control<br>normal geriatric patients without lung disease | Other: Rate of depression<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of depression (Prevalence rate) |  | 1 year |
Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.

Study Overview
=================
Brief Summary
-----------------
This study is aimed at evaluating the hypoglycemic effects of a dietary supplement that associates the properties of two inositols (myo-inositol and D-chiro-inositol) in the ratio 40:1 to Gymnema sylvestre, alpha-lactalbumin and zinc.

Official Title
-----------------
Hypoglycemic Effects of a Dietary Supplement That Combines the Properties of Myo-inositol and D-chiro-inositol With Gymnema Silvestre, Alpha-lactalbumin and Zinc.

Conditions
-----------------
Metabolism Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: EUDIAMET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 30 and 35 Basal Glycemia between 100 and 125 mg/dl Exclusion Criteria: Diabetes diagnosis Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc Intolerance to inositols, gymnema, alpha-lactalbumin and zinc
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Hypocaloric diet | |
| Experimental: EUDIAMET<br>Hypocaloric diet plus a supplementation with myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc | Dietary Supplement: EUDIAMET<br>* A combination of myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulinemia | Reduction of systemic insulin levels | Three time points: change in insulin levels from the baseline to three and six months |
Knowledge, Perception, Attitude and Responsibility of Dentists Regarding to Physical Child Abuse in Some Governorates of Upper Egypt

Study Overview
=================
Brief Summary
-----------------
Child abuse and neglect (CAN), child maltreatment, and child victimization are interchangeable terms that refer to a major public health problem confronting children and families. . This study Investigated dentists' level of knowledge, perception, attitude & responsibility regarding child physical abuse in some of Upper Egypt governorates

Official Title
-----------------
Knowledge, Perception, Attitude and Responsibility of Dentists Regarding Child Physical Abuse in Some Governorates of Upper Egypt

Conditions
-----------------
Child Abuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dentists who working in Egyptian Ministry of health &/ or private dental clinics &/ or centres in three governorates of Upper Egypt (Minia, Assuit & Sohag). Dentists with all dental academic degrees (Bachelor, diploma, master, doctoral & other post graduate degree). Exclusion Criteria: Dentists who are working in any other governorates except (minia, Assuit & Sohag). Under graduated dental students

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge | questionnaire used to assess dentists' knowledge level to high and low knowledge levels | 1 year | 
| perception | questionnaire used to assess dentists' perception level into high, moderate and low perception | 1 year | 
| attitude | questionnaire used to assess dentists' attitude level into positive and negative attitude | 1 year |
The Length of Uteroovarian Ligament and the Risk of Ovarian Torsion

Study Overview
=================
Brief Summary
-----------------
Ovarian torsion is one of the gynecological emergency. This complication requires high clinical suspicion and early detection, to prevent permanent loss of ovarian function. The long uterine ovarian ligament could be a risk factor for ovarian torsion. We want to measure the uterine ovarian ligament length during routine laparoscopy/laparotomy and to compare the length between the torsion group and other non torsion patients

Detailed Description
-----------------
Female patient who are going to undergo laparoscopy/laparotomy for any gynecological reason will ask to participate. During the operation the uteroovarian ligament length will be measure by sterile ruler (calibrated plastic device 1 mm in diameter). The length of uteroovarian ligament will compared between the patient who will diagnose with ovarian torsion (study group) and the other women (control group)

Conditions
-----------------
Ovarian Torsion

Intervention / Treatment
-----------------
* Procedure: Measure of uteroovarian ligament length during gynecological surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for gynecological operation hemodynamically stable Exclusion Criteria: Ovarian torsion in the past History of pelvic inflammatory disease (PID)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: female undergoing gynecological surgery<br> | Procedure: Measure of uteroovarian ligament length during gynecological surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uteroovarian ligament length |  | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
the length of uterine ovarian ligament
To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women

Study Overview
=================
Brief Summary
-----------------
Zoledronic acid is a medicine being studied in people with low bone mass. Side effects such as headache, fever, muscle aches, and pains, may occur following the infusion. This study will investigate the use of over-the-counter medicines to improve these symptoms.

Official Title
-----------------
To Assess the Efficacy of Over-the-counter Analgesics in the Prevention/Treatment of Transient Post-dose Symptoms Following Zoledronate Infusion in Post-menopausal Women

Conditions
-----------------
Osteopenia

Intervention / Treatment
-----------------
* Drug: zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women greater than or equal to 45 years and less than or equal to 75 years of age inclusive Low bone mineral density Exclusion Criteria: Certain prior treatments for low bone mass/osteopenia Current use of medicines (prescription or non-prescription) for pain, fever, or inflammation Impaired kidney function Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: zoledronic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature increase |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires |  |  | 
| VAS (visual analog scale) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zoledronic acid, bisphosphonate, Low bone mass
Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the supracrestal tissue attachment.

Official Title
-----------------
Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment. A Longitudinal Study

Conditions
-----------------
Gingivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: an age range 18-70 years a good general health the ability to understand the phases of the trial and to stick to them for the whole length of the study the ability of will to release a written informed consent presence of a marginal cavity or a 2mm subgingival cavity presence of a cavity subgingival > 2mm Exclusion Criteria: PPD>4mm patients affected by active periodontal disease patients smoking more than 10 cigarettes/pipes per day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on Probing | bleeding from the gingival sulcus when probing | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographic distance from the caries/margin of the restoration to the bone crest | LInear measurement between the most apical level of the restoration to the bone crest | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subgingival restorations, proximal restorations, cytokine, biomarkers, GCF sampling
Safety and Efficacy Study of Eculizumab in Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Study Overview
=================
Brief Summary
-----------------
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.

Official Title
-----------------
An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)

Conditions
-----------------
Shiga-like Toxin-producing Escherichia Coli

Intervention / Treatment
-----------------
* Drug: Eculizumab (Soliris®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be willing and able to give written informed consent/Assent. Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS) Exclusion Criteria: Known complement regulatory mutation or family history of complement regulatory mutation Unresolved systemic meningococcal disease 3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients

Ages Eligible for Study
-----------------
Minimum Age: 2 Months

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

| Intervention/Treatment |
| --- |
|Drug: Eculizumab (Soliris®)|Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis | Analysis of primary endpoint will occur after all patients have reached 8 weeks of treatment. The response rate will be summarized as patients who are either a complete or partial responder. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEC-HUS, Shiga-like toxin-producing Escherichia Coli Hemolytic-Uremic Syndrome, uncontrolled complement activation
Monitoring in Congestive Heart Failure Study

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, non-randomized study designed to develop an external monitor for CHF patients.

Detailed Description
-----------------
Heart failure patients will be externally monitored. The collected information will be used to assess patient status.

Official Title
-----------------
Multi-Sensor Monitoring in Congestive Heart Failure Study

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: MUSE clinical system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older

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: MUSE clinical system|non-invasive external monitoring device|

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
-----------------
Congestive Heart Failure
DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)

Study Overview
=================
Brief Summary
-----------------
Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.

Official Title
-----------------
Long-term Outcomes Following Drug Eluting Balloon Versus Thin Struts Drug Eluting Stents for Treating In-stent Restenosis: Propensity Score-matched Analysis(DEB-Dragon Registry).

Conditions
-----------------
In Stent Restenosis

Intervention / Treatment
-----------------
* Device: percutaneous coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES. Exclusion Criteria: PCI with DES struts thickness >100μm PCI with DEB and thin-DES in the same procedure PCI of other vascular territories during the same procedure PCI in saphenous vain graft or internal mammary artery

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ISR PCI with thin-DES<br> | Device: percutaneous coronary intervention<br>* Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)<br>|
| ISR PCI with DEB<br> | Device: percutaneous coronary intervention<br>* Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLR | target lesion revascularisation | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DOCE | composite of cardiac death, TLR, and target vessel MI | 3 years | 
| TVR | target vessel revascularization | 3 years | 
| TV-MI | target vessel myocardial infarction | 3 years | 
| cardiac death |  | 3 years | 
| myocardial infarction |  | 3 years |
Pre-approval Access for Janssen's COVID Vaccine VAC31518 for Treating Physician Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this Pre-approval access (PAA) program is to provide VAC31518 (Ad26.CoV2.S) vaccine for the prevention of coronavirus disease-2019 (COVID-19) infection. This PAA program may be considered to protect participants against a serious/life-threatening diseases or conditions, where there are no alternative treatments available.

Official Title
-----------------
COVID Vaccine VAC31518 Pre-approval Access Study

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

Intervention / Treatment
-----------------
* Biological: Ad26.COV2.S


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Ad26.COV2.S|Participants will be administered 0.5 milliliter suspension of Ad26.COV2.S 1*10^11 virus particles per milliliter (vp/ml) as intramuscular injection.|

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

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