linjc16/ctgov huggingface dataset:
The Evicel Post-Authorization Surveillance Study

Study Overview
=================
Brief Summary
-----------------
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.

Official Title
-----------------
A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery

Conditions
-----------------
Hemorrhage, Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Biological: EVICEL ™ Fibrin Sealant (Human)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es Subjects must be willing to and capable of participating in the study, and provide written informed consent Exclusion Criteria: Subjects with known intolerance to blood products Subjects unwilling to receive blood products Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vascular Surgery Subjects Treated with EVICEL<br> | Biological: EVICEL ™ Fibrin Sealant (Human)<br>* Commercial Evicel<br>* Other names: Fibrin Sealant (Human);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Safety Parameters | Incidence of graft occlusion Incidence of adverse events potentially related to non-graft thrombotic events Incidence of bleeding events | Up to 4-weeks post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemostasis
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).

Detailed Description
-----------------
Healing percentages

Official Title
-----------------
A Multi-center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold, PriMatrix Ag Antimicrobial Dermal Repair Scaffold, and Standard of Care for the Treatment of Venous Leg Ulcers

Conditions
-----------------
Venous Stasis Ulcer

Intervention / Treatment
-----------------
* Device: PriMatrix
* Device: PriMatrix Ag
* Procedure: moist wound therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women ≥ 18 years of age Ankle-brachial index (ABI) > 0.80 Study wound 2-64 cm2 surface area Wound does not exhibit a greater than 50% reduction in surface area during the screening period Exclusion Criteria: Suspected or confirmed signs/symptoms of wound infection Hypersensitivity to bovine collagen Body Mass Index (BMI) ≥ 45

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PriMatrix<br>PriMatrix Dermal Repair Scaffold | Device: PriMatrix<br>* fetal bovine dermal scaffold<br>Procedure: moist wound therapy<br>* standard of care moist wound therapy<br>|
| Experimental: PriMatrix Ag<br>PriMatrix Ag Antimicrobial Dermal Repair Scaffold | Device: PriMatrix Ag<br>* fetal bovine dermal scaffold with Ag<br>Procedure: moist wound therapy<br>* standard of care moist wound therapy<br>|
| Active Comparator: Standard of Care<br>Standard of Care Moist Wound Therapy | Procedure: moist wound therapy<br>* standard of care moist wound therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of VLUs healed by week 12 post-randomization |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of treatment |  | 12 weeks |
Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Study Overview
=================
Brief Summary
-----------------
To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.

Detailed Description
-----------------
A randomized controlled study comparing: Tadalafil [20mg x1/day] and acetazolamide [125mg x2 day], versus Acetazolamide [125mg x2 day] alone, in trekkers to altitude > 3,000 m.

Official Title
-----------------
Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Conditions
-----------------
Pulmonary Edema, Cerebral Edema

Intervention / Treatment
-----------------
* Drug: Tadalafil and acetazolamide
* Drug: Acetazolamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in trekking to high altitude Agreement to sign the informed consent. Exclusion Criteria: No agreement to sign informed consent.

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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetazolamide<br>acetazolamide 125 mg BID | Drug: Acetazolamide<br>* Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude<br>|
| Experimental: Acetazolamide and Tadalafil<br>Intervention arm | Drug: Tadalafil and acetazolamide<br>* Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results will be evaluated by using the Lake Louise AMS scoring system |  | one month after travel | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Mountain Sickness, travellers, Acetazolamide, Tadalafil, Acute Mountain Sickness assessed by Lake Louise score, High altitude pulmonary edema, High altitude cerebral edema
Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

Detailed Description
-----------------
A prosepective case-control study ,the case were matched with 1:1according to gestational age,birth weight and admission diagnosis and divided into two groups according to the consensus definition of National Institute of Child Health and Human Development (NICHD). Platelet count, circulating megakaryocyte count, platelet activating markers (CD62P and CD63), thrombopoietin were recorded and compared in two groups, then, serial thrombopoietin levels and concomitant platelet counts were measured in infants with BPD.

Official Title
-----------------
Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia

Conditions
-----------------
Preterm Infant, Bronchopulmonary Dysplasia, Thrombocytopenia

Intervention / Treatment
-----------------
* Other: BPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of clinical and radiologic signs of BPD, according to conventional criteria (Greenough, 1992); presence of peripheral arterial catheter; gestation <32 weeks; birth weight <1.5 kg; requiring mechanical ventilation for the treatment of respiratory distress syndrome for at least 3 days during the first weeks of life; ventilator and/or oxygen dependent at time of enrolment; Exclusion Criteria: congenital abnormalities; infection (bacteria infection confirmed by positive blood culture or viral infection confirmed by serological test or viral culture) evidence of complications of perinatal asphyxia including an apgar score <3 at one or five minute after birth, evidence of hypoxic-ischemic encephalopathy, acute tubular necrosis, or transient myocardial ischemia; identifiable hematologic disease;
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 |
| --- | --- |
| BPD group<br>premature infants diagnosed with BPD after postnatal day 28 | Other: BPD<br>* It is a observation research.we didn't intervene anything.<br>|
| control group<br>premature infants without BPD after postnatal day 28 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet counts and Circulating MK counts | Platelet counts and Circulating MK counts | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD62P and CD63 expression | CD62P and CD63 expression | up to 4 weeks | 
| TPO | Plasma TPO concentration | up to 4 weeks | 
| TPO and platelet | the relationship betweenTPO concentration and Platelet counts in BPD with thrombocytopenia | up to 6 weeks |
Taurolidine Lock in Long Term Parenteral Nutrition

Study Overview
=================
Brief Summary
-----------------
Taurolidine alone or in combination with citrate have been proposed for locking the catheter to reduce the number of catheter infections. As there is not enough evidence to give recommendations in this regard, the study tested the hipothesis that taurolidine improves the outcome of long term paretneral nutrition.

Official Title
-----------------
The Value of Taurolidine Lock in Long Term Parenteral Nutrition

Conditions
-----------------
Home Parenteral Nutrition, Central Venous Catheter

Intervention / Treatment
-----------------
* Drug: 2% Taurolidine Lock
* Drug: 1.35% Taurolidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: home parenteral nutrition for at least months before enrollment presence of central venous cathter Exclusion Criteria: home nutrition < 12 months catheter in peripheral vein

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Saline flush | Drug: 2% Taurolidine Lock<br>* Catheter lock with 2% Taurolidine<br>Drug: 1.35% Taurolidine<br>* Catheter lock with 1.35% Taurolidine + citrate<br>|
| Active Comparator: 2% Taurolidine lock<br>Catheter lock with 2% Taurolidine | Drug: 2% Taurolidine Lock<br>* Catheter lock with 2% Taurolidine<br>Drug: 1.35% Taurolidine<br>* Catheter lock with 1.35% Taurolidine + citrate<br>|
| Active Comparator: 1.35% Taurolidine with citrate<br>Catheter lock with 1.35% Taurolidine + citrate | Drug: 2% Taurolidine Lock<br>* Catheter lock with 2% Taurolidine<br>Drug: 1.35% Taurolidine<br>* Catheter lock with 1.35% Taurolidine + citrate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of CVC infections | Number of central venous catheter infections | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
home parenteral nutrition, central venous catheter
Coronary Anomalies in Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study. The investigators shall review the angiography data of 1200 consecutive cardiac catheterizations of children and babies with CHD (Congenital Heart Disease) since 1998 till now. Coronary artery origin and course will be evaluated in relation to the morphologic cardiac anomalies. Coronary artery anomalies will be described and statistical analysis will be performed.

Official Title
-----------------
Coronary Anomalies in Congenital Heart Disease

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cradiac catheterization with angiography with congenital heart disease. Exclusion Criteria: no congenital heart disease.

Ages Eligible for Study
-----------------
Maximum Age: 86 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
-----------------
CHD
Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments

Study Overview
=================
Brief Summary
-----------------
Prospective randomized comparison of two widely used in vitro culture system in human IVF treatments. In vitro fertilized oocytes and embryos are cultured in individual culture media droplets using conventional petridish or in group culture using WOW (well of the well) petridish. Primary outcome: implantation and pregnancy rates Secondary outcome: fertilization rate and embryo quality

Official Title
-----------------
Comparison of Individual Culture and Group Culture of Preimplantation Embryos in Human IVF Treatments

Conditions
-----------------
Other Complications Associated With Artificial Fertilization

Intervention / Treatment
-----------------
* Other: individual embryo culture or group culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile patients entering in vitro fertilization treatment at least 1 oocyte collected Exclusion Criteria: no oocytes collected

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group culture<br>Embryos cultured in groups of 2-10 | Other: individual embryo culture or group culture<br>* Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish<br>|
| Individual culture<br>Embryos cultured individually | Other: individual embryo culture or group culture<br>* Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Number of clinical pregnancies (/No. of embryo transfers) | 4 weeks after the embryo transfer | 
| Implantation rate | Number of embryos implanted (/number of embryos transferred) | 4 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Number of oocytes fertilized. (only in intracytoplasmic sperm injection cycles) | 18 hours after sperm injection | 
| Embryo quality | Number and quality of blastomeres, amount of fragmentation embryo grade | 36 and 72 hours after fertilization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In vitro fertilization, Embryo transfer, Embryo culture, individual culture, Group culture, embryo quality, Pregnancy rate, Implantation
Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy

Study Overview
=================
Brief Summary
-----------------
Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.

Official Title
-----------------
A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy

Conditions
-----------------
IgA Nephropathy

Intervention / Treatment
-----------------
* Drug: prednisone plus cyclophosphamide
* Drug: Prednisone alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-proven primary IgA nephropathy; 18-70 years old; elevated serum Creatinine and less than 3.0mg/dl; with a written consent from participants to receive prednisone and/or cyclophosphamide Exclusion Criteria: diabetes; contraindications for the treatment of prednisone and/or cyclophosphamide; any treatment with steroids or immunosuppressive drugs prior to this study; acute deterioration of renal function(including those of glomerular origin)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: prednisone plus cyclophosphamide<br>prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months) | Drug: prednisone plus cyclophosphamide<br>* prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months); supportive care,including ACE-I or ARBs and blood pressure control<br>|
| Experimental: prednisone alone<br>prednisone alone: prednisone(0.5mg/kg/day*6 months) | Drug: Prednisone alone<br>* prednisone alone: prednisone(0.5mg/kg/day*6 months); supportive care,including ACE-I or ARBs and blood pressure control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of kidney function or death | the changes of estimated glomerular filtration rate (eGFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine or death | 3,6 ,12, 24 and 36 months or more after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of proteinuria |  | 3,6 ,12, 24 and 36 months or more after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgA nephropathy, Cyclophosphamide, prednisone
Chromoendoscopy for Ulcerative Colitis Surveillance

Study Overview
=================
Brief Summary
-----------------
Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer targeted biopsies can replace standard colonoscopy with multiple random biopsies.

Detailed Description
-----------------
Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown. Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.

Official Title
-----------------
Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis, Crohn's Disease

Intervention / Treatment
-----------------
* Procedure: Chromoendoscopy with magnification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulcerative colitis, pancolitis > 8 years; left-sided > 15 years or history of PSC or history of previous dysplasia on colon biopsies or family history of colon cancer in first degree relative Exclusion Criteria: any condition that precludes colonoscopy expected survival less than 1 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IBD patients at risk for neoplasia<br>Patients with long-standing ulcerative colitis or Crohn's colitis at risk for neoplasia. | Procedure: Chromoendoscopy with magnification<br>* A blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dysplastic lesions by white light vs. chromoendoscopy |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia