linjc16/ctgov huggingface dataset:
Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection

Study Overview
=================
Brief Summary
-----------------
Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection.

Detailed Description
-----------------
A questionnaire will be sent to every patient by mail. The questionnaire that will be used is the COREFO questionnaire (ColoRectal Functional Outcome). Depending on the amount of responses, we will try to make connections between peri-operative data and functional outcome after considerable period of follow-up. Peri-operative factors include grade of endometriosis, surgical technique and post-operative complications.

Official Title
-----------------
To Assess the Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infiltrating endometriosis<br>272 patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis, in the department of Abdominal Surgery, University Hospital Leuven, between the year 1997 and September 2011. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ColoRectal Functional Outcome | Operation: between 1997 and 2011 Questionnaire to assess the colorectal function sent once in 2012 | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep infiltrating endometriosis, Laparoscopic sigmoid resection, laparoscopic rectum resection, Colorectal surgery
Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia

Study Overview
=================
Brief Summary
-----------------
We propose to collect the data of vital signs and anesthesia medications administered in a subcategory of patients coming for anesthesia for upper GI endoscopy. This data will be analyzed to see any relation between the preoperative risk factors, procedure, type of anesthesia and the airway intervention. The adverse events that will be automatically recorded and later analyzed will be number of apnea episodes (described as no respiration for at least 30 seconds) duration of each apnea, number and duration of each desaturation event (oxygen saturation as measured by the pulse oximeter). A pulse oximeter saturation of less than 93 percent and lasting 30 seconds will be considered as a desaturation event. The airway interventions that will be recorded will be anything other than considered being routine. This includes LMA insertion, endotracheal intubation and the need to withdraw gastroscope to facilitate face mask ventilation. We also propose to monitor their awareness/depth of sedation/depth of anesthesia levels. This will be done using a monitor that analyses brain waves and gives an idea of sleep (anesthesia) depth. We can then see any correlation between any unwanted events and the sleep depth.

Official Title
-----------------
Incidence of Adverse Airway Events in High Risk Patients Undergoing Upper GI Endoscopy Under Anesthesia

Conditions
-----------------
SEDLine, Accoustic Respiratory Monitor RAD87, Adverse Events, Advanced Endoscopic Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients considered as high risk (see above) or undergoing an advanced upper GI procedure (see above) will be included. This is the prospective analysis of the data that is collected and stored in the monitors. We will be using the massimo Pulse oximeter ,masimo acoustic respiratory monitor and Masimo SED line Brain function monitors that allows electronic storage and retrieval of information. Postprocedure analysis of the data will not influence the patient care. Exclusion Criteria: Any patient who cannot give a valid consent will be excluded Children Pregnant women Fetuses and/or Neonates Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| incidence of adverse events |  | during the procedure |
Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the clinical impact of non-surgical and surgical treatment in atrial fibrillation induced tricuspid regurgitation (AFTR).

Official Title
-----------------
Tricuspid Regurgitation Due to Atrial Fibrillation - Impact of Rhythm Control and Early Surgery (TR-ES Study)

Conditions
-----------------
Severe Tricuspid Valve Regurgitation (Disorder)

Intervention / Treatment
-----------------
* Procedure: Inferior Vena Caval (IVC) Occlusion maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years. Moderate-severe or severe TR while in atrial fibrillation. Ambulatory (not wheelchair/scooter dependent). Exclusion Criteria: Systolic pulmonary artery pressure>70 mmHg with a fixed pulmonary vascular resistance >7 Wood units by catheterization. Ejection fraction <40%. Obstructive hypertrophic cardiomyopathy. Constrictive pericarditis or tamponade. Active myocarditis. Complex congenital heart disease. Other valve disease requiring surgical intervention. Terminal illness (other than HF) with expected survival of less than 1 year. Pregnancy or breastfeeding mothers.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Severe tricuspid regurgitation due to atrial fibrillation<br>Subjects will receive standard of care procedure right heart catheterization with a inferior vena caval (IVC) occlusion maneuver. | Procedure: Inferior Vena Caval (IVC) Occlusion maneuver<br>* During standard of care right heart catheterization (RHC), a second catheter will be inserted next to the catheter that was placed for the RHC in the jugular vein or femoral vein to assess the degree of pericardial restraint from the severe tricuspid regurgitation that may increase left sided filling pressures.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in KCCQ QOL scores | The KC Cardiomyopathy Questionnaire (0-100 scale) assess subject perception of heart failure limitation on their life; scale of extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, limited for other reasons or did not do the activity. | Baseline, 6 months |
A Follow-Up Study of Patients With HBeAg Positive Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML22265

Study Overview
=================
Brief Summary
-----------------
This multicenter, prospective, observational study will evaluate the one-year outcomes in HBeAg positive chronic hepatitis B patients who had received Pegasys (peginterferon alfa-2a) in Arm A of study ML22265. Data will be collected from each patient for up to one year post-therapy.

Official Title
-----------------
A Follow-up Study to Evaluate the One-year Post Treatment Effects of Peginterferon Alfa-2a (PEGASYS) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study ML 22265

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were randomized to study Arm A of ML22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point Exclusion Criteria: Patients unwilling to provide informed consent or abide by the requirements of the 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response (HBeAg seroconversion/HBV DNA reduction/HBsAg loss/seroconversion) after end of treatment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of duration of response with on-treatment response (HBeAg/HBV DNA/HBsAg/ALT) |  | 1 year |
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.

Conditions
-----------------
Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Scleroderma, Systemic

Intervention / Treatment
-----------------
* Drug: Ophthalmic Emulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Eighteen years or older Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria: Diagnosis of autoimmune disorder Female 65 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ophthalmic Emulsion|nan|

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
-----------------
dry eyes, rheumatoid arthritis, Lupus, Sjogren's syndrome, myositis, scleroderma, autoimmune disorder
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Study Overview
=================
Brief Summary
-----------------
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

Official Title
-----------------
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Conditions
-----------------
Cow Milk Allergy

Intervention / Treatment
-----------------
* Other: Test extensively hydrolyzed formula
* Other: Control extensively hydrolyzed formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born at term (>36 weeks gestation) 2 months to <4 years of age at enrollment Documented CMA within 6 months prior to enrollment Otherwise healthy Having obtained his/her legal representative's informed consent Exclusion Criteria: Children consuming mother's milk at the time of inclusion and during the trial Any chromosomal or major congenital anomalies Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)) Immunodeficiency Anaphylaxis to any food Receiving free amino acid formula Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol Currently participating in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 4 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test infant formula<br>Test non-commercial extensively hydrolyzed infant formula with HMOs | Other: Test extensively hydrolyzed formula<br>* extensively hydrolyzed formula with HMOs<br>|
| Active Comparator: Control infant formula<br>Control non-commercial extensively hydrolyzed infant formula without HMOs | Other: Control extensively hydrolyzed formula<br>* extensively hydrolyzed formula without HMOs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic reaction post DBPCFC | subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool characteristics | collected on daily diaries | 1 week | 
| formula intake | amount of formula ingested daily | 1 week | 
| adverse events | adverse events as reported by caregivers | 1 week |
Dextroamphetamine-Cocaine Behavioral Intervention - 5

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.

Official Title
-----------------
D-amphetamine-Cocaine Behavioral Intervention

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Dextroamphetamine
* Drug: D-amphetamine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks | Drug: Dextroamphetamine<br>* 15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks<br>|
| Experimental: 2<br>30 mg of d-amphetamine for first 8 weeks of study and 60 mg for the second 8 weeks | Drug: D-amphetamine<br>* 15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks<br>|
| Experimental: 3<br>placebo | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verifiable cocaine abstinence |  | 16 weeks of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
Efficacy of Topical Cyclosporine 0.05% in the Prevention of Ocular Surface Inflammation Secondary to Pterygia

Study Overview
=================
Brief Summary
-----------------
To Determine if topical cyclosporine 0.05% BID prevents recurrent inflammation and improves comfort in eyes with pterygia.

Conditions
-----------------
Pterygia

Intervention / Treatment
-----------------
* Drug: Topical Cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pts with symptomatic pterygia unresponsive to palliative treatment.
Sexes Eligible for Study
-----------------
All

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical Cyclosporine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)

Study Overview
=================
Brief Summary
-----------------
This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe and effective as an antigen used in the evaluation of primary and secondary immune responses. Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small blood specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14 days, and 28 days. Blood is collected at intervals following the administration of the bacteriophage and the number of phage/ml is determined by the agar overlay method using suspension of E. coli C and serially diluted patient's serum. Phage-specific IgG and IgM are measured by neutralization assay. Capacity of switch from IgM to IgG is determined.

Official Title
-----------------
To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency

Conditions
-----------------
Primary Immune Deficiency Diseases

Intervention / Treatment
-----------------
* Biological: Bacteriophage OX174


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject/parent or guardian willing to sign consent and adhere to study schedule known or suspected primary immune deficiency Exclusion Criteria: pregnancy breastfeeding unwilling to sign consent or adhere to study schedule < 2 yrs of age or > 85 yrs of age previous reaction to vaccine

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bacteriophage<br>Subjects receive bacteriophage vaccinations and blood draws | Biological: Bacteriophage OX174<br>* Give first dose of bacteriophage (2 x 109 PFU/kg body weight (0.02 ml/kg)) at visit one. Obtain labs prior to vaccine, 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. 6 weeks after 1st vaccine, obtain blood, give 2nd dose of bacteriophage, obtain labs 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. Selected patients may receive a tertiary vaccine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of capacity of switch from IgM to IgG. | Blood samples are obtained after each immunizition of Bacteriophage. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PID, PIDD, antibody deficiency, CVID, recurrent infections
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery

Study Overview
=================
Brief Summary
-----------------
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty. The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem.

Detailed Description
-----------------
The main object of the clinical investigation is the evaluation of Stem (SAPHIR) survival rate. The post market clinical follow up will also consider as further seconday endpoints: improvement of paient function, quality of life, safety of device (intended as possible adverse events related to the use of the prosthesis)

Official Title
-----------------
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery

Conditions
-----------------
Arthropathy of Hip

Intervention / Treatment
-----------------
* Device: hip arthroplasty with prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients>18 years Candidate for primary total hip replacement with femoral stem and acetabular cup if ostheoarthritis patients aged 18 to 85 years if femoral neck fracture patients aged 18 to 90 years patients with social security scheme patients understands the condition of the study and is willing to partecipate for the duration of the clinical investigation patients who gavee consent to partecipare in the clinical investigation Exclusion Criteria: <18 years if female, pregnant patient who has already had primary hip surgery on the same side local or disseminated neoplastic disease inability to understand the study and agree to partecipate patients cancelling partecipation before surgery patients under guardianship or curatorship patients without a social security scheme patients refusing to partecipate

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: hip arthroplasty with prosthesis|Use of femoral stem and acetabular cup for hip arthroplasty|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stem survival rate | Kaplan Meier survival analysis | 1 year, 3 years, 5 and 10 years |