linjc16/ctgov huggingface dataset:
Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided Percutaneous Coronary Intervention in coronary tandem lesions.

Official Title
-----------------
A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions

Conditions
-----------------
Percutaneous Transluminal Coronary Angioplasty

Intervention / Treatment
-----------------
* Other: 5 year Follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tandem lesion evaluated by FFR Written consent Exclusion Criteria: TIMI flow < 3 Grafted vessel Left ventricular ejection fraction < 30% Severe calcification and/or severe tortuosity Uncontrolled coronary spasm Life expectancy < 2 years Planned high risk surgery Pregnancy or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Tandem lesion evaluated by FFR<br> | Other: 5 year Follow-up<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure | defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death |  | 5 years | 
| cardiac death |  | 5 years | 
| myocardial infarction |  | 5 years | 
| target vessel revascularization |  | 5 years | 
| target lesion revascularization |  | 5 years | 
| Cardiac rehospitalization |  | 5 years | 
| Cardiac death and myocardial infarction |  | 5 years | 
| death, myocardial lnfarction, revascularization | related with stented lesion | 5 years | 
| stroke |  | 5 years | 
| stent thrombosis |  | 5 years | 
| angina |  | 5 years | 
| number of antianginal medications |  | 5 years | 
| complications with FFR |  | 5 years | 
| clinical predictors of events |  | 5 years | 
| functional index | IMR(index of microcirculatory resistance), CFR(CFRthermo) | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Fractional flow reserve, Tandem, Percutaneous Coronary Intervention
Combined Hormonal Versus Progestin Only Contraception During Lactation

Study Overview
=================
Brief Summary
-----------------
Objective: To determine and compare the effect of low dose estrogen combined hormonal contraceptives and progestin-only contraceptives on lactation. The subjects will be drawn from a healthy obstetric population in each center, where possible preliminary contact during antenatal period. At the postpartum visit, subjects that express their wish for a hormonal contraceptive method will be offered enrollment. After obtaining an informed consent the participants will be allocated according to their free wish to either receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg desogestrel (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel (Cerazette, Organon). Demographic, habits and perinatal data will be collected and stored to analysis. Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12 weeks post - partum. Instruction will be given as to recording information on intercurrent disease, frequency of nursing and use of complementary formula supplements. Maternal BMI calculation ( weight/height2) will be obtained at first visit. The objective is to compare the capacity of the breast to secrete milk under standard conditions and evaluate the influence of different hormonal contraception means. Thus samples will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell pump will be used for a maximum of 20 minutes form from both breasts, simulating a regular breast feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest will be offered to the infant. The milk volume/feeding will be estimated and expressed in ml/feeding and multiplied by the number of feedings reported. Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk analysis : lipid, casein and carbohydrate content

Conditions
-----------------
Lactation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: mothers to infants that their weight will be below the 10th percentile mothers to infants sensitive to milk

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| combined contraceptives<br>combined contraceptives | |
| pregesterone only contraceptives<br>pregesterone only contraceptives | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of a video shown using an iPad, compared to a standard treatment, to reduce preoperative anxiety in children who have to undergo to elective surgery procedure

Official Title
-----------------
Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

Conditions
-----------------
Preoperative Anxiety

Intervention / Treatment
-----------------
* Procedure: Video
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 6 and 11 No cerebral impairment or cognitive impairment Child and his/her family native speaker of Italian admission to the hospital at list one day before the sugery procedure presence of written consent of the parents to the study Exclusion Criteria: age lower than 6 or upper than 11 presence of cerebral impairment or cognitive impairment Child and his/her family are not native speaker of Italian absence of written consent of the parents to the study

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procedure<br> | Procedure: Video<br>* The afternoon before the surgery session, a researcher will show to the child a video of the length of 6 minutes, using an I-pad. The video shows two clown doctors working constantly at Meyer Children's Hospital, which, through skits and gags, will tell the child how is an operating room and some devices and procedures used during the induction of anesthesia.<br>|
| Active Comparator: Standard Care<br> | Other: Standard care<br>* In this arm orally information will be given by the nurse of the ward only to the parents of the child. Any additional information or explanation will be given to the child<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety | Preoperative anxiety is measured using the Modified Yale Preoperative Anxiety Scale (m-YPAS) | perhaps 24 hours from child admission to surgery procedure |
Risk Factors of Perforated HSCR in Neonates

Study Overview
=================
Brief Summary
-----------------
Hirschsprung's disease (HSCR) is a common digestive malformation with radiographic evidence of distal bowel obstruction and clinical signs of abdominal distension, vomiting, constipation, and failure to pass meconium. Bowel perforation (perforated HSCR) is a very serious complication of HSCR, but if this occurs it is most often in the neonatal period. The current study collected information on all cases diagnosed with perforated HSCR from multi-centers in China over 10 years, the aim was to evaluate the clinical features of perforated HSCR, and investigate possible risk factors for perforated HSCR in neonates.

Official Title
-----------------
The Risk Factors for Bowel Perforation in Neonates With Hirschsprung Disease

Conditions
-----------------
Hirschsprung Disease, Bowel; Perforation, Fetus or Newborn

Intervention / Treatment
-----------------
* Procedure: Emergency surgical enterostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates (≤1 month age) Diagnosed with HSCR Suffered with bowel perforation Exclusion Criteria: Patients complicated with suspected necrotizing enterocolitis (NEC), imperforate anus (IA), intestinal atresia, and meconium plug syndrome Neonates who transferred from outside participating hospitals.

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 30 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Perforated group<br> | Procedure: Emergency surgical enterostomy<br>* Emergency surgical enterostomy<br>|
| Controlled group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bowel perforation in neonatal Hirschsprung disease (perforated HSCR) | Cases with bowel perforation in neonatal Hirschsprung disease/ total neonatal Hirschsprung disease | 14 years |
Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. We plan to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Detailed Description
-----------------
Ultrasound measurement of optic nerve sheath diameter (ONSD) had been considered as a non-invasive way to distinguish the presence of elevated intracranial pressure (ICP). Besides detecting elevated ICP in various neurological diseases, ONSD can also be applied to cardiac arrest survivors as one of the prognostic factors. It is a simple, quick, repeatable technique without the need of contrast medians. In order to make precise interpretations, the database of the normal distribution of ONSD and its associated factors in healthy volunteers is necessary. The majority of previous reports are from Western countries, and limited reports of ONSD in the Asian population have high variability. Therefore, collecting local data of ONSD in Taiwan is important. In this study, the investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. The investigators planed to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Official Title
-----------------
Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers and Its Associating Factors

Conditions
-----------------
Normal Diameter of Optic Nerve

Intervention / Treatment
-----------------
* Other: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult volunteer aged more than 20 years Exclusion Criteria: aged less than 20 years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: ultrasound|ultrasound measurement for optic nerve outer diameter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optic nerve outer diameter | optic nerve outer diameter | 60 days |
OCS Heart EXPAND + CAP Continued Follow-Up

Study Overview
=================
Brief Summary
-----------------
Post-approval observational study of subjects that were enrolled and transplanted in the OCS Heart EXPAND and OCS Heart EXPAND CAP studies.

Official Title
-----------------
OCS Heart EXPAND + CAP Continued Follow-Up Post-Approval Study

Conditions
-----------------
Heart Transplant

Intervention / Treatment
-----------------
* Device: OCS Heart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients transplanted in the OCS Heart EXPAND and EXPAND CAP trials

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OCS Heart|Transplanted with OCS preserved heart.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival | Patient survival through 5 years post-transplant | 5 years post transplant |
Glulisine + Lantus in Type I Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus

Official Title
-----------------
26-week, International Multicenter, Open, Non-randomized Phase III Clinical Trial for Evaluation of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Subjects With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Insuline glulisine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type I diabetes mellitus (onset of diabetes under the age of 40), an HbA1c range of >6.5 - <11%, and on multiple injection regimen (more than 1 year of continuous insulin treatment), body mass index <35. Exclusion Criteria: Active proliferative diabetic retinopathy, Diabetes other than type I diabetes mellitus, Pancreatectomised subjects, Subjects who have undergone pancreas and or islet cell transplants, Requiring treatment with not permited drugs during the study, Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine, Hypersensitivity to insulin, Major systemic diseases, Impaired hepatic or renal function The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insuline glulisine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c |  | from baseline to endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c |  | from baseline to week 26 | 
| Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins |  | from baseline to endpoint |
Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families

Study Overview
=================
Brief Summary
-----------------
Negative symptoms in cancer in palliative care, such as pain, can lead to a withdrawal that can lead to a form of social exclusion. Maintaining pre-illness relationships is often difficult for the patient, especially since he is often not available to relationships. Art therapy defined as the exploitation of artistic potential in a therapeutic and humanitarian aim can contribute to the reduction of symptoms, to adaptation and to well-being. A recent review shows that positive affective states and meaningful social connections are important factors contributing to more effective adaptation to pain. Study hypothesis is that art therapy could play on these two factors. The objective of the qualitative study is to measure, using a questionnaire, the indirect impact of art therapy sessions on parents, during support and after death, from a relational and emotional point of view.

Official Title
-----------------
Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families

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

Intervention / Treatment
-----------------
* Other: satisfaction questionnaire after art therapy session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any major person who has accompanied a patient to the palliative care unit of the Lyon-Sud hospital Man or woman ; 18 years old or older; Death of the accompanied patient> 1 month; Number of art therapy session of the accompanied patient > 1; Having agreed to participate in the study; Not subject to a legal protection measure. Exclusion Criteria: Nobody without the physical or mental abilities to respond to the questionnaire ; No one reading or speaking French.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Family of patient<br> | Other: satisfaction questionnaire after art therapy session<br>* After the administration of art therapy sessions (>1) and the death of patients (> 1 month), the intervention consists in submitting to families of patients a satisfaction questionnaire intended to evaluate the impact of art therapy session and in particular about their relationships.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with art therapy | The primary endpoint is the item of overall satisfaction with art therapy session in 3 groups (VAS scale between 0 and 3, between 3 and 7 and between 7 and 10) | 6 month |
To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)

Study Overview
=================
Brief Summary
-----------------
To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo

Official Title
-----------------
A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Biological: Human rotavirus liquid vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of > 2000 grams. Written informed consent obtained from the parent or guardian of the subject. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs since birth. Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 10 Weeks

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Human rotavirus liquid vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis against gastroenteritis caused by Rotavirus