linjc16/ctgov huggingface dataset:
Safety of an Early Discharge Protocol After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of an early discharge protocol (23 hours, overnight stay) after scheduled sleeve gastrectomy.

Detailed Description
-----------------
This study aims to demonstrate that a shorter hospital stay after sleeve gastrectomy is as safe and useful as conventional protocol with 48-36 hours of stay. We consider that an adequate patient information and support will facilitate this shorter stay

Official Title
-----------------
Safety of an Early Discharge Protocol After Sleeve Gastrectomy. Randomised Clinical Trial

Conditions
-----------------
Morbid Obesity, Sleeve Gastrectomy, Early Discharge, Safety Issues

Intervention / Treatment
-----------------
* Other: Early discharge
* Other: Conventional protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for Sleeve gastrectomy BMI 35 to 50 ASA I to III Conventional address close to our Hospital Laparoscopic surgery Accompanying person after discharge Availability for a smart phone Exclusion Criteria: ASA IV Revisional Surgery Conversion to laparotomy ICU Admission after surgery Insulin dependent Diabetes Mellitus Surgery finishing after 3 pm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early discharge group<br>Patients with a shorter hospital stay, 23 hours after surgery | Other: Early discharge<br>* Patients randomised to early discharge or not<br>|
| Active Comparator: Conventional discharge<br>Patients with conventional protocol and 48-72 hours of hospital stay | Other: Conventional protocol<br>* Discharge as usually done 48-72 hours after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmissions rate | No hospital admissions after surgery | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rate | Number of postoperative complications | 1 month | 
| Chronogram for complications after surgery | Detailed timing of appearance | 1 month | 
| Quality of life | BAROS questionnaire | 1 month | 
| Patients agreement to the protocol | Specific survey created ad hoc | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, sleeve gastrectomy, eras
Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

Study Overview
=================
Brief Summary
-----------------
Ex vivo lung perfusion (EVLP) is an established strategy to evaluate and optimize high-risk donor lungs that would otherwise be rejected for transplantation mainly due to the presence of edema or infection. Extracorporeal circuits may negatively affects pharmacokinetic (PK) of several drugs including antibiotics, thus exposing patients to risk of therapeutic failure or drug toxicity. The investigators set out to examine the concentration of imipenem in lung perfusate and in lung biopsy during EVLP, and its clinical impact.

Conditions
-----------------
Lung Transplantation

Intervention / Treatment
-----------------
* Procedure: normothermic ex vivo lung perfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best PaO2/FiO2 < 300 mmHg; Pulmonary edema on chest X-Ray; Poor inflation or deflation at visual inspection; Need for blood transfusion of more than 10U; Maastricht category III/IV Exclusion Criteria: Diagnosis of pneumonia; severe mechanical injury; gross gastric aspiration
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVLP group<br>All lungs from brain dead donors that were considered at high-risk for transplantation and underwent EVLP in the Turin lung transplantation program | Procedure: normothermic ex vivo lung perfusion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| imipenem concentration | concentration of imipenem in lung perfusate and in lung biopsy during EVLP | change from baseline in imipenem concentration at 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathogens isolated from donors |  | 48 hours before lung procurement | 
| pathogens isolated from recipients |  | 48 hours after lung transplantation | 
| Clinical Pulmonary Infection Score |  | at 72 hours after lung transplantation | 
| Primary graft dysfunction |  | at 72 hours after lung transplantation | 
| Days of mechanical ventilation |  | at 28 days | 
| Intensive Care Unit length of stay |  | at day 28 |
Amodiaquine+Artesunate for Uncomplicated Malaria Treatment

Study Overview
=================
Brief Summary
-----------------
This is a phase IV one-arm study aiming at recruiting 50 patients to assess the efficacy of AQ+AS in patients with a positive RDT diagnosis of malaria in Nanoro, Burkina Faso.

Official Title
-----------------
Amodiaquine+Artesunate for the Treatment of Uncomplicated Falciparum Malaria in Nanoro, Burkina Faso

Conditions
-----------------
Uncomplicated Malaria

Intervention / Treatment
-----------------
* Drug: Artesunate-Amodiaquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females aged 6 months and above. Body weight of 5 Kg and above. RDT positive test. Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours. Signed (or thumb-printed whenever patients are illiterate) informed consent. Patients' willingness and ability to comply with the study protocol for the duration of the study. Exclusion Criteria: Participation in any other investigational drug study (antimalarial or others) during the previous 30 days. Known hypersensitivity to the study drugs. Severe malaria. Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand. Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study. Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amodiaquine+Artesunate<br> | Drug: Artesunate-Amodiaquine<br>* Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008.It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure at day 28 |  | 28 days |
Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement

Study Overview
=================
Brief Summary
-----------------
Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time. A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.

Conditions
-----------------
Tooth Discoloration

Intervention / Treatment
-----------------
* Other: E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement
* Other: E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects are required to be: From 18-60 years old, and able to read and sign the informed consent document physically and psychologically able to tolerate conventional restorative procedures Have no active periodontal or pulpal diseases, have teeth with good restorations Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ….) Willing to return for follow-up examinations and evaluation Exclusion Criteria: Patients in the growth stage with partially erupted teeth Patient with fractured teeth of more than 50% enamel loss Patients with poor oral hygiene and motivation Pregnant women Psychiatric problems or unrealistic expectations Lack of opposite occluding dentition in the area intended for restoration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dual cure amine free adhesive resin cement<br>resin cement that get activated by both light and chemicals | Other: E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement<br> <br> |
| Active Comparator: light cured adhesive resin cement<br>resin cement that only get activated by light | Other: E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color stability assessed clinically using easy shade vita device | Color stability | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction assessed using a Questionnaire | Questionnaire for the patient satisfaction | 1 Year |
Kogenate FS Regulatory Post-Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications. The observation period for each patient is up to 6 months.

Official Title
-----------------
KOGENATE® FS , Local Post Authorization Safety Study

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of hemophilia A Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS Signed the informed consent form to participate in this study. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician. Exclusion Criteria: Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)<br>* Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables will be summarized using descriptive statistics based on adverse events collection |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of the treatment (prophylaxis, on demand, surgery) |  | Initial visit and 6 month f/u or at the end of the observation visit | 
| Total consumption of FVIII |  | Initial visit and 6 month f/u or at the end of the observation visit | 
| Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively) |  | Initial visit, 6 month follow-up visit and 12 month follow-up visit | 
| General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient |  | 6 month f/u or at the end of observation visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kogenate FS, Hemophilia A
Statistical Analysis of Pediatric Task Force Data Base

Study Overview
=================
Brief Summary
-----------------
To define pediatric sex-specific blood pressure percentiles that were a function of both age and height. Also, to define the precise age at which blood pressure distributions for different racial groups diverged.

Detailed Description
-----------------
BACKGROUND: Hypertension is a well-recognized risk factor for cardiovascular disease in adults. Furthermore, many studies have shown that there is tracking among longitudinal pediatric blood pressure determinations. An important unresolved goal in pediatric hypertension research is to define at what level of pediatric blood pressure is a child at increased risk for adult hypertension. When the grant was awarded in February 1991, there had been two NHLBI Task Forces in Blood Pressure Control in Children which had published reports in 1977 and 1987. One of the goals of each task force was to define appropriate percentiles for blood pressure in children. In the Second Task Force Report, results from nine large epidemiologic studies were combined into a data base with more than 70,000 readings from which blood pressure percentiles were derived as a function of age and sex. However, many research workers stated that height is more strongly related to blood pressure than age and have urged that Normative data for pediatric blood pressure be demarcated by height rather than age. DESIGN NARRATIVE: Blood pressure percentiles were constructed that were a function of age, sex, race, and height, thus providing a more comprehensive profile of pediatric blood pressure distributions than any previously published work. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the bioequivalence of Roxane Laboratories' Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose, 2-treatment, 2-period, crossover design, under fasting conditions

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Calcitriol Tablets, 0.25 mg, Under Fasting Conditions

Conditions
-----------------
Secondary Hyperparathyroidism, Hypocalcemia

Intervention / Treatment
-----------------
* Drug: Calcitriol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Calcitriol or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calcitriol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Fourteen day washout |
Fosrenol Post-marketing Surveillance for Continuous Cyclic Peritoneal Dialysis in Japan

Study Overview
=================
Brief Summary
-----------------
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

Official Title
-----------------
Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Ambulatory Peritoneal Dialysis)

Conditions
-----------------
Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing continuous ambulatory peritoneal dialysis who received Fosrenol for hyperphosphatemia Exclusion Criteria: Patients who are contraindicated based on the product label

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Group 1<br>Drug (incl. Placebo) | Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet<br>* Patients in CAPD who have received Fosrenol for hyperphosphatemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subjects who received Fosrenol |  | After Fosrenol administration, up to 1 year | 
| Incidence of serious adverse events in subjects who received Fosrenol |  | After Fosrenol administration, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol |  | After Fosrenol administration, up to 1 year | 
| Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] |  | After Fosrenol administration, up to 1 year | 
| Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL] |  | After Fosrenol administration, up to 1 year | 
| Clinical test value collections [calciotropic hormones, bone turnover markers] |  | After Fosrenol administration, up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fosrenol, Hyperphosphatemia, Continuous Cyclic Peritoneal Dialysis
Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate urinary function before and one year after single incision sling placement at the time of robotic sacrocolpopexy. The thought is that the more minimally-invasive, single incision sling would provide a similar subjective success rates as those of retropubic and trans-obturator slings.

Official Title
-----------------
Single Incision Suburethral Sling at Time of Robotic Sacrocolpopexy

Conditions
-----------------
Stress Urinary Incontinence (SUI)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing single incision sling placement at the time of robotic sacrocolpopexy during the study period Exclusion Criteria: previous surgical treatment for stress urinary incontinence (SUI)
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single incision sling<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough Stress Test | Subjects will undergo a cough stress test to evaluate for stress urinary incontinence. | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mesh related complications | possible mesh related complications such as: exposure/erosion, urinary retention, voiding dysfunction, chronic pain and dyspareunia will be collected throughout the study period | 12 months post procedure | 
| Urinary Distress Inventory 6 (UDI-6) | This validated questionnaires will be given to subject to collect subjective data | baseline and 12 months postoperatively | 
| Urinary Impact Questionnaire (UIQ-7) | this validated questionnaire will be completed by subject to collect subjective data | baseline and 12 months postoperatively | 
| Sandvick Severity Index Questionnaire | This validated questionnaire will be given to subjects to collect subjective data regarding urinary incontinence | baseline and 12 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
single incision sling, cough stress test, MiniArc, UDI-6, UIQ-7, Sandvick Severity Index (SSI)