linjc16/ctgov huggingface dataset:
To Survive After ICU Discharge

Study Overview
=================
Brief Summary
-----------------
Many factors before and after ICU stay determine the outcome of patients at ICU discharge, the type of illness, physical dependence and other sequelae can be a trigger for complications in hospital ward which can induce ICU readmission and worse outcome. The quality of medical assistance during all the hospitalisation should be guaranteed and many complications or fatal events could be avoidable. The objective of the present study is to demonstrate that collaboration between the intensivist and other medical teams in ward can reduce ICU readmission and hospital mortality after ICU discharge.

Detailed Description
-----------------
Material and Methods This observational multicenter study will be done in 21 medical-surgical ICUs. We will use Sabadell Score like prognostic scale at ICU discharge and the intensivist will collaborate with the medical team in medical assistance of patients at risk (Sabadell Score 1 and 2). Investigators will compare the hospital mortality and the readmission rate with a previous period when this collaboration didn't exist. Anticipate results The collaboration of attending intensivist might reduce ward mortality after ICU discharge by 3%.

Official Title
-----------------
Multicenter Prospective Study: To Survive After ICU Discharge

Conditions
-----------------
In-Hospital Mortality, Number of ICU Readmission, Number of Warnings On-duty

Intervention / Treatment
-----------------
* Other: None intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with Sabadell Score 1 (poor prognosis in long term) and 2 (poor prognosis in short term) at ICU discharge Exclusion Criteria: patients younger than 18 years old patients with Sabadell Score 0 (good prognosis) patients with Sabadell Score 3 (null expected survival) patients transferred to other hospitals

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None intervention|Investigators will study the usual medical assistance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decline in hospital mortality |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decline in number of warnings on-duty |  | 3 months |
A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®

Study Overview
=================
Brief Summary
-----------------
AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.

Official Title
-----------------
Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Menotrophin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged between [18-42] years. Both ovaries present. Regular menstrual cycles presumed to be ovulatory. Primary or secondary infertility of any origin for more than 12 months. Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion. Candidates eligible to a first IVF/ICSI cycle and for whom Menopur® HP-hMG 600 IU/mL has been prescribed. Having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written Informed Consent Form. Exclusion Criteria: Major uterine or ovarian morphological abnormalities or past ovarian surgery. Endometriosis stage III/IV. Polycystic ovarian syndrome. Major endocrine or metabolic abnormalities without treatment. Patient included in an interventional study assessing treatment for infertility.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 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 |
| --- | --- |
| Menopur® HP-hMG<br>Treatment according to routine clinical practice. | Drug: Menotrophin<br> <br> * Other names: Menopur® HP-hMG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels |  | At baseline (inclusion) |
An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral anticholinergic therapy.

Conditions
-----------------
Urinary Incontinence, Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No prior treatment with botulinum toxin Type A for treatment of iOAB Exclusion Criteria: Treatment with any botulinum toxin Type A within 18 months

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 |
| --- | --- |
| Patients With Urinary Incontinence Due to iOAB<br>Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice. | Biological: botulinum toxin Type A<br>* botulinum toxin Type A administered in accordance with physician standard practice.<br>* Other names: onabotulinumtoxinA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS) |  | Baseline, Week 12 | 
| Change From Baseline in Number of Urinary Incontinence Episodes |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Re-Injection of BOTOX® |  | 12 Months | 
| Number of Nocturia Episodes |  | 12 Months | 
| Usage of Incontinence Support Products |  | 12 Months | 
| Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence |  | Baseline, 12 Months |
Hemodialysis Frequency and the Calcification Propensity of Serum

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical research project is to test the hypothesis that daily dialysis has favorable effects on the calcification propensity of human serum, when determined by the investigators' newly developed in vitro serum test. The investigators' hypothesis is that shorter interdialytic intervals will result in an improved calcification propensity of serum. The determination of serum calcification has the potential to become a novel measure of dialysis quality in the future.

Detailed Description
-----------------
Background The serum calcification test has been established and validated by A. Pasch and coworkers, the expertise to perform the necessary statistical analyses is present in the investigator's department, all patient-related procedures necessary for this project are routinely performed in the investigator's department. Objective Does short daily hemodialysis strengthen the calcification-inhibitory forces inherent in hemodialysis patient sera, when compared to conventional three-times weekly hemodialysis? Methods Serum calcification test

Official Title
-----------------
Hemodialysis Frequency and the Calcification Propensity of Serum

Conditions
-----------------
Hemodialysis, Anuria

Intervention / Treatment
-----------------
* Procedure: Short daily dialysis for 2 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hemodialysis >3 months Anuria (<100ml urine per day) Written informed consent Exclusion Criteria Citrate dialysis Significant fistula recirculation (>15%) Infection

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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All study participants<br>Short daily dialysis for 2 weeks | Procedure: Short daily dialysis for 2 weeks<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline calcification propensity of serum |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of sodium, potassium, calcium, phosphate, magnesium, albumin, protein, hematocrit and their correlation with calcification propensity of serum |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Dialysis
Study on the Role of FDG-PET in Patients With FL at Time of Relapse/Progression

Study Overview
=================
Brief Summary
-----------------
The study is designed as a retrospective analysis of patients with relapsed/refractory FL identified by the hematological centers of Italy.

Detailed Description
-----------------
The study does not require any intervention on the patient, but it involves the simple collection of data that are already present in the medical record. Since this is a retrospective study, it will not require further analysis or diagnostic investigations than those already made.

Official Title
-----------------
Study on the Role of FDG-PET in Patients With Follicular Lymphoma at Time of Relapse/Progression

Conditions
-----------------
Follicular Lymphoma

Intervention / Treatment
-----------------
* Other: Metabolic activity measured by FDG-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with initial diagnosis of follicular lymphoma since 2001 Histological confirmation of follicular lymphoma, grade I, II, III according to WHO 2008 classification, at the time of initial diagnosis Systemic first-line treatment with immuno-chemotherapy PET availability at the time of response after first-line treatment (optional) Clinical and radiological evidence of FL relapse or progression Histological confirmation of relapse (strongly recommended) PET availability of at the time of relapse/progression and images available for central assessment Availability of clinical, laboratory and therapeutic treatment data at the time of initial diagnosis and relapse/progression Follow up of at least 12 months after relapse/progression Exclusion Criteria: None

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 |
| --- |
|Other: Metabolic activity measured by FDG-PET|To evaluate whether metabolic activity measured by FDG-PET (SUV max) at time of relapse is predictive of patient's outcome.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival from time of relapse/progression | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Follicular lymphoma, FDG-PET, Relapse/progression
Study Evaluating the Clinical and Therapeutic Management of Rheumatoid Arthritis in Spain

Study Overview
=================
Brief Summary
-----------------
This is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the early RA group) and individuals who have had RA for more than 2 years and who currently meet the ACR criteria for RA (the established RA group).

Official Title
-----------------
Clinical and Therapeutic Management of the Rheumatoid Arthritis in Spain

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Group 1: early RA : patients with disease lasting 2 years or less, considered by the investigator as an early RA Group 2: established RA: patients with disease lasting more than 2 years who meet the ACR criteria for RA Exclusion criteria: Patients with any rheumatic disease different from RA Participation in any clinical trial or study in the last 12 months

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>Patients with early RA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic management of the RA (actual and 12 month follow-up) in a real-world setting. Descriptive analysis of sociodemographics and clinical variables for patients and sorted by group (early and established RA) for the last 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements of diagnostic and outcomes used in the common clinical practice. Degree of follow-up of the actual Spanish consensus on clinical and therapeutic management of patients with RA |  | 12 months |
Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
MedlinePlus related topics: Blood Sugar Primary Outcome Measures: Fast glucose and HbA1c change between the baseline and end of study [ Time Frame: From baseline to 30 and 100 days] [ Designated as safety issue: No ] Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) [ Time Frame: From baseline to 30 days and 100 days] [ Designated as safety issue: No ] Secondary Outcome Measures: • To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36 [ Time Frame: From baseline to month 1 ] [ Designated as safety issue: No ]

Detailed Description
-----------------
This study is aimed to evaluate the safety and efficacy of Sangrow Decotion, diet and exercise for the treatment of type 2 diabetes. Previous study has shown that this therapeutic regimen is safe and effective.

Official Title
-----------------
SanGrow Decoction in Patients With Diabetes- Single Center, Open, and Non-randomized Study

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: SanGrow Decoction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes mellitus patients who have received medical treatment for more than 3 months Patients willing to sign written informed consent form Exclusion Criteria: Patients unable or unwilling to comply with the requirements of the protocol Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study Life expectancy < 6 months due to concomitant illnesses.

Ages Eligible for Study
-----------------
Minimum Age: 10 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SanGrow<br>Patients will be given SanGrow Decoction 150 ml per day for 3 months. | Dietary Supplement: SanGrow Decoction<br>* SanGrow Decoction is perpared according to the principle of Chinese medicine to treat thirsty and maransis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Sugar level | Fast glucose change between the baseline and end of study | From baseline to 30 and 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Chinese medicine, exercise, diet
Safety and Efficacy of Galvus as add-on Therapy to Metformin Plus Glimepiride

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid as add-on therapy to metformin plus glimepiride in patients with Type 2 Diabetes (T2D).

Official Title
-----------------
A Multi-center, Randomized, Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin 50 mg Bid as add-on Therapy to Metformin Plus Glimepiride in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Confirmed diagnosis of T2DM by standard criteria. Treatment with oral anti-diabetic therapy, on stable dose for at least 12 weeks prior to the screening visit. Acceptable background anti-diabetic therapy includes: metformin (≥ 1500 mg) as monotherapy or in combination with SU, TZDs, or glinides Age: ≥18 to ≤ 80 years HbA1c of ≥ 7.5 and ≤ 11.0% Body Mass Index (BMI) ≥22 to ≤45 kg/m2 Exclusion criteria: FPG ≥ 270 mg/dL (≥ 15.0 mmol/L) Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months Any of following within past 6 months: Myocardial infarction, TIA or stroke, coronary artery bypass surgery or percutaneous coronary intervention History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes Acute infections which may affect blood glucose control within 4 weeks prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Vildagliptin (metformin + glimepiride)<br> | Drug: Vildagliptin<br> <br> |
| Placebo Comparator: Placebo (metformin + glimepiride)<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Reduction |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG reduction |  | 24 weeks | 
| Safety and tolerability-frequency of treatment emergent adverse events (incl. overall Aes, SAEs, death, Aes leading ot study discontinuation or study drug interruption, pre-specified potential AEs) |  | 24 weeks | 
| Responder Rate |  | 24 weeks |
Surgical Treatment of Marfan Syndrome With Subluxation Lens

Study Overview
=================
Brief Summary
-----------------
To analyze the postoperative visual effects, and to compare the safety and efficacy of different surgical treatment with of Marfan Syndrome with subluxation lens.

Official Title
-----------------
Effect of Different Surgical Treatment of Marfan Syndrome With Subluxation Lens

Conditions
-----------------
Marfan Syndrome, Lens Subluxation or Dislocation

Intervention / Treatment
-----------------
* Procedure: surgical treatment of Marfan Syndrome with subluxation lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with MFS according to the revised Ghent etiology. refractive errors difficult to correct. pupillary block glaucoma caused by severe dislocation of the lens Exclusion Criteria: Keratoconus, late glaucoma, uveitis, history of traumatic lens dislocation, and preoperative retinal rupture with or without retinal detachment (RD)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 55 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 |
| --- | --- |
| posterior chamber intraocular lens(IOL) implantation with a Cionni capsular tension ring (CTR)<br> | Procedure: surgical treatment of Marfan Syndrome with subluxation lens<br>* different surgical treatment of Marfan Syndrome with subluxation lens<br>|
| sutured scleral fixation of posterior chamber IOL/ posterior chamber IOL and CTR<br> | Procedure: surgical treatment of Marfan Syndrome with subluxation lens<br>* different surgical treatment of Marfan Syndrome with subluxation lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected distance visual acuity |  | 1 month postoperatively | 
| Uncorrected distance visual acuity |  | 3 month postoperatively | 
| Corrected distance visual acuity |  | 1 month postoperatively | 
| Corrected distance visual acuity |  | 3 month postoperatively | 
| intraocular pressure |  | 1 month postoperatively | 
| intraocular pressure |  | 3 month postoperatively | 
| postoperative complication |  | Early and late stages | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative astigmatism and astigmatism axial of cornea |  | 1 month postoperatively | 
| Postoperative astigmatism and astigmatism axial of cornea |  | 3 month postoperatively | 
| endothelial cell count |  | 1 month postoperatively | 
| endothelial cell count |  | 3 month postoperatively |