linjc16/ctgov huggingface dataset:
Laparoscopic Splenectomy in Children

Study Overview
=================
Brief Summary
-----------------
Laparoscopic splenectomy (LS) gained popularity since it has been described for the first-time during nineties of past century. It has become golden method for splenectomy in all ages including children

Detailed Description
-----------------
Background: laparoscopic splenectomy (LS) gained popularity during the last years in pediatric age group. Benign hematological diseases represent the main indications of that procedure. There are some score systems of difficulty of the technique but they are for adult patients. The aim is to develop a prognostic score system of LS in children with benign hematological diseases. Methods: LS was performed in all children with benign hematological diseases. LS was done by the same team. They operated children in lateral decubitus position. The control of pedicle was achieved using bipolar sealing devices, polymer clips or endoscopic linear staplers. Preoperative, operative, and postoperative data were recorded and analyzed. Children were divided into two groups A and B according to the development of complications.

Official Title
-----------------
Prognostic Scoring System of Laparoscopic Splenectomy in Children With Benign Hematological Diseases.

Conditions
-----------------
Benign Blood Diseases, Laparoscopic Splenectomy, Children

Intervention / Treatment
-----------------
* Other: laparoscopic splenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with benign hematological diseases Exclusion Criteria: malignant hematological diseases

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laparoscopic splenectomy|surgical|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prognosis of procedure | number of patients with peritoneal collections, number of patients having pancreatitis, number of patients staying more than two days postoperative | from day 0 to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic splenectomy,, children, prognostic score, benign hematological diseases
Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.

Official Title
-----------------
European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Already receiving NSAID treatment at enrolment visit Exclusion Criteria: Inability to complete the study related questionnaires Current participation in any interventional study

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 |
| --- | --- |
| 1<br>Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of selected GI events, classified as symptomatic or complicated GI events. Reported by the patients at the follow-up visits. |  | Time from NSAID treatment prescription to first diagnosis of the GI event for each patient will be registered. Each patient will be followed up for 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of health care visits and days of hospitalisation (health care consumption) related to arthritic disorder and/or GI events as reported by the patients at the follow-up visits. |  | Health care consumption accumulated over the 6 months study period will be registered. | 
| Quality of life assessed by EuroQol-5 Dimension (EQ-5D) at baseline and the follow-up visits. Measure how selected GI events impact the EQ-5D score. |  | Measurements at baseline, 3 months and 6 months | 
| Adherence with NSAIDs and proton pump inhibitors (PPI) measured by Morisky-Green-Levine Medication Assessment Scale (MMAS) at baseline and follow-up visits. |  | Measurements at baseline, 3 months and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSAID-treated patients, gastrointestinal events, Non-steroid anti-inflammatory drug (NSAID), Gastrointestinal events (GI events), Proton Pump Inhibitors (PPI)
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position

Study Overview
=================
Brief Summary
-----------------
Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

Detailed Description
-----------------
The purpose of this multi center, single arm study is to demonstrate the safety and performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the treatment of aneurismal and occlusive diseases of the abdominal aorta. The primary endpoint is the assessment of primary and secondary graft patency. The secondary endpoints were the assessment of adverse events and the assessment of triclosan and silver contents in the serum over the time.

Official Title
-----------------
Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position

Conditions
-----------------
Abdominal Aorta Aneurysm

Intervention / Treatment
-----------------
* Device: Intergard Synergy Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18-85 years Patient presenting with an aorto-iliac occlusion (obstruction of flow) or stenosis, or aorto-iliac aneurysm and eligible for a revascularization with a bifurcated graft Exclusion Criteria: Patient treated as an emergency Patient included in another investigation Patient pregnant or lactating or woman of childbearing potential Patient with a known allergy to the material device used (collagen, triclosan, silver) Patient with previous aorto-iliac bypass or replacement

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intergard Synergy Graft<br> | Device: Intergard Synergy Graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Graft Patency | Defined as uniterrupted flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoint - assessment of AEs | Follow-up timeframes - 1, 6, 12, 24, and 36 months | Up to 36 months |
Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

Study Overview
=================
Brief Summary
-----------------
Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria. The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.

Official Title
-----------------
A Single Arm Stuidy to Confirm Safety and Efficacy of Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

Conditions
-----------------
Vulvovaginal Candidiasis

Intervention / Treatment
-----------------
* Device: Multi-Gyn FloraFem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with Vulvovaginal Candidiasis confirmed by:itching, and/or burning, irritation, edema, redness, crumbly white discharge Aged >18 years Signed written informed consent form Willing to comply to the follow-up schedule Subject affiliated to a health social security system. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end. Exclusion Criteria: Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, bacterial vaginosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis) Current genital malignancies Chemotherapy for any reason in last 6 months Radiotherapy in the genitourinary system in the last 12 months Pregnancy or currently attempting to conceive Lactation Use of other treatment for vaginal conditions during the course of the clinical investigation Known allergies to ingredients of the product Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br> | Device: Multi-Gyn FloraFem<br>* Vaginal gel packed in 5 single use plastic tubes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of Multi-Gyn FloraFem in relieving itch during vaginal candidiasis (based on 0-10 point scale score improvement > 1 related to vulvovaginal candidiasis at Visit 2. | Women should have at least itch related to vaginal candidiasis. | 1 week |
Umbilical Cord Length Index for Prediction of Cord Abnormalities Before Delivery

Study Overview
=================
Brief Summary
-----------------
The umbilical cord plays an essential role in intrauterine life. It is the pathway between mother, placenta and fetus during pregnancy and delivery. Complete cord occlusion often leads to fetal demise, while intermittent occlusion has been associated with intrauterine brain damage. Compression and vasospasm in utero are important factors in fetal distress. Nuchal Umbilical Cord can be diagnosed antepartum using ultrasound, but the complications are unpredictable and unpreventable

Official Title
-----------------
Umbilical Cord Length Index as a New Ultrasonographic Method for Prediction of Cord Abnormalities Before Delivery

Conditions
-----------------
Umbilical Cord Problem

Intervention / Treatment
-----------------
* Diagnostic Test: ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy. Pregnant ≥ 37 weeks gestation. Women who will accept to participate in the study Exclusion Criteria: Preterm deliveries. Amniotic fluid abnormalities (oligohydramnios, polyhydramnios). Intrauterine growth retardation Early membrane rupture Women need urgent cesarean section. Multifetal gestation. Placenta previa. Fetuses with major congenital anomalies. Women with chronic maternal illness as hypertension
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>All pregnant women who will attend the labor unit during the study period will be invited to participate in the study. | Diagnostic Test: ultrasonography<br>* Ultrasound evaluation will be done with transducer abdominal probe. The amount of amniotic fluid and umbilical cord sections will be determined by evaluating the images obtained from the sagittal plane in the ultrasound evaluations in the 4 abdominal quadrants. When the anatomical structure of the umbilical cord is considered, it is folded in amniotic fluid. The folds appear as umbilical cord rings, side-by-side at the sagittal sections. Scoring of umbilical cord length index 1 point will be given for each quadrant where the umbilical cord was observed. 0.5 point will be given for each umbilical cord ring in one quadrant. Every quadrant will be evaluated in this manner, and the total score will be calculated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of Umbilical cord length index in diagnosis of long and short umbilical cords. | Ultrasonographic scoring of umbilical cord length | 15 minutes |
Treating Post-Lyme Disease Syndrome With Acetogenins

Study Overview
=================
Brief Summary
-----------------
To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).

Detailed Description
-----------------
To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS). After failure of antibiotic therapy to relive persistent symptoms of Lyme Disease, the use of Acetogenins to elevate Post-Lyme Disease Syndrome.

Official Title
-----------------
Using ReaLife+ to Treat Post-Lyme Disease Syndrome

Conditions
-----------------
Post-Lyme Disease Syndrome (PLDS)

Intervention / Treatment
-----------------
* Dietary Supplement: ReaLife+ (RLP)
* Other: Inert Brown powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment. Must be able to swallow and mixed powder drink. - Exclusion Criteria: Non Positive Western Blot test. Positive Western Blot test where the indivual has not been treated with antibiotics. -

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReaLife+ (RLP)<br>Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids | Dietary Supplement: ReaLife+ (RLP)<br>* RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.<br>|
| Placebo Comparator: Inert Brown Powder<br>Brown powder Inert brown powder to look similar to RLP | Other: Inert Brown powder<br>* Brown powder Inert brown powder to look similar to RLP<br>|
| No Intervention: Control<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood test | Western Blot showing negative | 3 months | 
| PROMIS Fatigue Scale | Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale. | 3 months |
The Chronic Pain Incidence After Elective and Urgent Cesarean Sections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain.

Detailed Description
-----------------
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain. Patients aged between 18 - 45 years whose underwent urgent or elective cesarean section will be invited to participate in the study. Preoperatively in operating theatre, patients will be asked to complete the pain catastrophizing scale (PCS) questionnaire. In postoperative 6 months after discharge, patients will be called by an investigator who is blind to the study to evaluate the presence of chronic pain. Patients will be asked to grade the pain that they suffer using a numeric rating scale for the intensity of pain.

Official Title
-----------------
The Chronic Pain Incidence After Elective and Urgent Cesarean Sections

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 18 - 45 years of age underwent elective or urgent cesarean section Exclusion Criteria: not willing to participate in the study can not reach by phone use of anti-psychotic or anti-depressant drugs

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale |  | One time when calling the patient, an avarage of three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain catastrophizing scale |  | one time in operating theatre, an avarage of three months | 
| presence of chronic pain using numeric rating scale |  | One time when calling the patient, an avarage of three months |
Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion. Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.

Official Title
-----------------
Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus

Conditions
-----------------
Liver Cirrhosis Due to Virus C Chronic Hepatitis

Intervention / Treatment
-----------------
* Genetic: Autologous bone marrow mononuclear cells infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic virus C hepatitis Liver cirrhosis Moderate liver disfunction Exclusion Criteria: Malignant disease Pregnancy Significant comorbidity Portal vein thrombosis

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

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 |
| --- |
|Genetic: Autologous bone marrow mononuclear cells infusion|At least 100.000.000 autologous BMMC will be infused in a peripheral vein once suspended in albumine during 10 minutes|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function worsening |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver related mortality |  | One year | 
| Hepatocellular carcinoma development accessed by ultrasound and CT scan |  | One year | 
| BMMC kinetics accessed by total body scintigraphy |  | 24 hours | 
| Liver tissue changes evaluated by histopathology analysis and molecular biology |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Cirrhosis, Stem cell
Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to evaluate the efficiency of the therapy with negative pression (TPN) and instillation in the debridement of chronic wound

Detailed Description
-----------------
it is an observation study with only the aim to evaluate the percentage of fibrin before and after the specific treatment of TPN

Official Title
-----------------
Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound

Conditions
-----------------
Wound

Intervention / Treatment
-----------------
* Device: therapy with negative pression and instillation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: wound with debridement Exclusion Criteria: -

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: therapy with negative pression and instillation|therapy with negative pression and instillation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of fibrine | percentage of fibrine | 1 day |