linjc16/ctgov huggingface dataset:
Sleep Quality Underwent Heart Transplant, an Observational Study

Study Overview
=================
Brief Summary
-----------------
The SQ_Heart has been designed as an observational study that evaluates the difference in sleep quality between 11 patients with VAD (Ventricular Assisted Device) and 98 Cardiotransplant patients.

Detailed Description
-----------------
The Primary objective of the SQ_Heart study is to evaluate the significant difference in sleep quality between patients with VAD (Ventricular Assisted Device) and cardiotransplant patients, using the Pittsburgh scale Sleep Quality Index (PSQI), with a cut-off of > 5 for poor sleepers. Patients, to be enrolled, must provide: Age ≥ 18 and < 90; Cardiotransplant patients, with VAD or non; patients with VAD. subjects able to sign informed consent. All the patients will have to complete some questionnaires: questionnaire about the diagnosis of pathology and lifestyle; questionnaire about the perceived quality of sleep through the use of Pittsburgh Sleep Quality (PSQI); questionnaire about the perceived quality of life (Euro Quality of Life 5D-5L). Questionnaires are necessary for the data collection for the study.

Official Title
-----------------
Sleep Quality: Comparison Between Patients With VAD and Patients That Underwent Heart Transplant, an Observational Study

Conditions
-----------------
Ventricular Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 and < 90; Cardiotransplant patients, with VAD (Ventricular Assisted Device) or non; patients with VAD ; subjects able to sign informed consent. Exclusion Criteria: Age < 18; subjects don't sign informed consent; hospitalization for more than 30 days before compilation in intensive care unit.

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 |
| --- | --- | --- |
| Sleep Quality Index | sleep quality | up 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiotransplant
Combined Versus Successive Macular Hole and Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.

Detailed Description
-----------------
Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of closure of MH by OCT (optical coherence tomography).

Official Title
-----------------
Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery

Conditions
-----------------
Macular Hole, Visual Acuity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular Hole Stage 2,3,and 4 Visual loss At least 18 years of age Exclusion Criteria: Stage of Macular Hole Stage 1 Macular hole post traumatism or associated with retinal detachment Diabetic retinopathy Glaucoma Age-related macular degeneration Myopia > 6 diopters Preoperative pseudophakia

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Combined surgery<br>Patient which underwent combined surgery of MH and cataract extraction | |
| Successive surgery<br>Patients which underwent the two successive procedures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post surgical procedure assessment of Visual acuity |  | 6 and 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of closure of macular hole by OCT |  | at 6 and 12 months post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Hole, Cataract surgery, Vitreoretinal surgery, Combined surgery, Idiopathic
Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD

Study Overview
=================
Brief Summary
-----------------
Aims: Prospective evaluation of patients with a suspicion or diagnosis of Inflammatory bowel disease (IBD) to evaluate osophageal motility before and during therapy Material and methods: The investigators prospectively perform manometry in patients with or with symptoms consistent with IBD. The investigators evaluate esophageal motility with high resolution manometry before, during and after IBD therapy. Clinical data are also collected to find possible correlations. The study do not modify the planned IBD therapy, but observe motility findings.

Detailed Description
-----------------
Oesophageal motility is measured with the high resolution manometry in order to detect pathologic peristaltic amplitude values among patient before and after therapy (mesalazine, steroids, biologicals) compared to the standard values detected among the normal population. Diagnosic intervention like oesophagoduodenoscopy, colonoscopy and stenosis ballon dilation are allowed as are part of the IBD therapy and follow up. No other interventions are administered to participants during this study.

Official Title
-----------------
Esophageal Motility Disease Screening in Patient With Suspicion or Diagnosis of IBD

Conditions
-----------------
Inflammatory Bowel Disease

Intervention / Treatment
-----------------
* Device: Manometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inflammatory bowel disease Suspicion of inflammatory bowel disease Exclusion Criteria: Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inflammatory bowel disease<br>Patients with Crohn's disease and ulcerative colitis undergoing manometry | Device: Manometry<br>* Flexible tube catheter pressure measurement of oesophageal contractions. Measurement without any sedation, transnasal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manometry finding (peristaltic amplitude values mmHG) compared to normal population findings |  | 1 year | 
| Correlation with gastrointestinal symptoms to manometry findings (peristaltic amplitude values) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manometry findings (peristaltic amplitude values, mmHG) during therapy |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory bowel disease, Manometry
Epidemiology and Clinical Features of Uveitis in a Tertiary Referral

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to report the pattern of uveitis in patients attending a tertiary referral center at the University hospital in Montpellier. The patients seen at the specialized consultation for uveitis between 2002 and first semester 2018 were included. Data about demography, clinical features and final diagnoses were collected and updated during the differenet visits. The medical records were restrospectively rewieved and analyzed.

Official Title
-----------------
Epidemiology and Clinical Features of Uveitis in a Tertiary Referral Center in Montpellier, France

Conditions
-----------------
Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seen at the specialized consultation for uveitis between 2002 and first semester 2018 Exclusion Criteria: Patients under 18

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Etiology of uveitis | Etiology of uveitis | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic description of patients with uveitis | Demographic description of patients with uveitis | 1 day | 
| Clinical description of patients with uveitis | Clinical description of patients with uveitis | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiology, Clinical features, Etiology, Tertiary center
Study of LV5FU2 Versus FOLFOX for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Oxaliplatin is a platinum analogue that has significant antitumor activity with better tolerability than cisplatin. The objective of the study is to evaluate the safety and activity of leucovorin and 5-fluorouracil and leucovorin and 5-fluorouracil plus oxaliplatin combination chemotherapy given as adjuvant therapy for curatively-resected, node-positive esophageal cancer.

Official Title
-----------------
A Randomized Phase II Study of Leucovorin, 5-fluorouracil With or Without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma.

Conditions
-----------------
Curatively-resected, Node-positive Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 20 years or older Histologically confirmed squamous cell carcinoma of esophagus Curatively (R0) resected, lymph node positive ECOG performance status of 0 or 1 Restoration of oral intake >1500 kcal/d No prior chemotherapy except for neoadjuvant ones No prior radiotherapy within 1 month before registration Adequate marrow, hepatic, renal and cardiac functions Provision of a signed written informed consent Exclusion Criteria: Severe co-morbid illness and/or active infections Prior treatment with oxaliplatin Pregnant or lactating women Active CNS metastases not controllable with radiotherapy or corticosteroids Known history of hypersensitivity to study drugs

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LV5FU2<br>leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2 | Drug: oxaliplatin<br>* oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h<br>|
| Experimental: FOLFOX<br>leucovorin 200 mg/m2 and 5-fluorouracil 400 mg/m2 intravenously on day 1, followed by a 46-h protracted infusion of 5-fluorouracil 2,400 mg/m2 oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h | Drug: oxaliplatin<br>* oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 36 months |
Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Study Overview
=================
Brief Summary
-----------------
The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications). Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.

Detailed Description
-----------------
This is an investigator-driven, prospective multicenter trial which analyzes the impact of trainee participation on procedure-related outcome (technical success and procedure-related complications). All ERCPs in the participating centers will be documented using a standard report form which will require the attending endoscopist to provide data relating to the patient (age, gender, diagnosis, bilirubin levels) and the procedure (including but not limited to the indication, technical aspects including cannulation technique, time to cannulation, degree of trainee involvement - where appropriate, procedure-related adverse events and their outcome). Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large database, stemming from the experience of several teaching centers in order to identify the main patient and operator-related factors which might influence the outcome of the procedure.

Official Title
-----------------
Quality Assessment in ERCP: Risk Factors for Procedure-related Complications in Patients Undergoing ERCP in the Setting of an Endoscopy Training Program

Conditions
-----------------
Cholangiopancreatography, Endoscopic Retrograde, Common Bile Duct Lithiasis, Biliary Strictures, Bile Duct and Pancreatic Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing ERCP with attempted cannulation of either the major or minor papilla Exclusion Criteria: refusal to sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| procedure-related adverse events | the percentage of patients experiencing procedure-related adverse events (i.e post-ERCP pancreatitis; postERCP cholangitis; perforation; postERCP bleeding or death) occuring within 30 days of the procedure | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical failure of the procedure | percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting) | 30 days |
Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Official Title
-----------------
Comparison of Inhaled Ciclesonide (160 mcg b.i.d. or 320 mcg b.i.d.) and Fluticasone Propionate (250 mcg b.i.d. or 500 mcg b.i.d.) in Pretreated Patients With Mild to Moderate Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Patients who have had a history of bronchial asthma for at least 6 months FEV1 >60% of predicted for at least 24 h Patients who are hyperresponsive to methacholine and to AMP Patients who are in good health with the exception of asthma Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Patients suffering from COPD and/or other relevant lung diseases except asthma Current smokers and ex-smokers both with ≥10 pack years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-24h)/24 h of serum cortisol level |  |  | 
| 24 h urinary cortisol excretion adjusted for creatinine. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8 am measurement of bone formation markers |  |  | 
| PC20FEV1 to methacholine |  |  | 
| PC20FEV1 to AMP |  |  | 
| lung function (FEV1, FVC) |  |  | 
| pharmacokinetics |  |  | 
| safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Ciclesonide, Fluticasone propionate
Validation of the German Quality of Recovery-15 Questionnaire

Study Overview
=================
Brief Summary
-----------------
The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective. It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state. The aim of this study is to validate a German version of the QoR-15 scale (QoR-15Dt) to measure postoperative recovery in German-speaking patients.

Official Title
-----------------
Quality of Recovery After General Anesthesia for Elective Non-cardiac Surgery - Validation of the German Translation of the Quality of Recovery-15 Questionnaire

Conditions
-----------------
Postoperative Quality of Recovery

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective non-cardiac surgery fluency in German general anesthesia Exclusion Criteria: postoperative intensive care unit admission

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: Questionnaire|QoR-15Dt|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the German version of the QoR-15 questionnaire | Validity | first postoperative day |
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.

Official Title
-----------------
A Phase 1 Study of XmAb®5574 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Intervention / Treatment
-----------------
* Biological: XmAb5574


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: relapsed or refractory CLL/SLL at least 18 years of age able to receive outpatient treatment and follow-up at the treating institution completed all CLL therapies > 4 weeks prior to first study dose Exclusion Criteria: previously treated with an anti-CD19 antibody therapy undergone prior allogeneic stem cell transplantation within 6 months or having active graft versus host disease active Richter's syndrome designated Class III or IV by the New York Heart Association (NYHA) criteria history of myocardial infarction or stroke within the last 6 months active viral, bacterial, or systemic fungal infection requiring treatment HIV or Hepatitis C positive Hepatitis B 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>XmAb5574 | Biological: XmAb5574<br>* Intravenous infusion of XmAb5574 administered weekly during two 28-day cycles with an additional dose being administered during the first week of Cycle 1. (Cycle 1 on Days 1, 4, 8, 15, 22; Cycle 2 on Days 1, 8, 15, 22)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the dose limiting toxicities |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLL, SLL, CD19