linjc16/ctgov huggingface dataset:
Retrospective Natural History Study of Retinitis Pigmentosa

Study Overview
=================
Brief Summary
-----------------
This is natural history study of rods and cones degenerations in patients with Retinitis Pigmentosa (RP) caused by pathogenic mutations in RHO, PDE6A or PDE6B gene mutations.

Detailed Description
-----------------
This is a retrospective, longitudinal, observational case history study to determine the natural history of rods and cones degeneration in patients diagnosed with RP caused by pathogenic mutations in genes with selective expression in rods: rhodopsin (RHO), phosphodiesterase 6A (PDE6A) or phosphodiesterase 6B (PDE6B). 113 participants will be enrolled in this study at the single center: CHNO-CIC Quinze-Vingt Paris in France.

Official Title
-----------------
Natural History Study of Retinitis Pigmentosa in Patient Carrying Pathogenic Mutations in RHO, PDE6A or PDE6B.

Conditions
-----------------
Retinitis Pigmentosa (RP)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with RP caused by pathogenic mutations in RHO, PDE6A or PDE6B genes. Exclusion Criteria: Patients with a pathogenic mutation in any other gene known to be involved in RP. Patients with any ocular disorder other than RP, likely to impact the retinal function.
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 |
| --- | --- | --- |
| Visual acuity | Progression of disease over time as measured by best corrected visual acuity (BCVA) (ETDRS, Snellen) and refraction | 2 years | 
| Visual field | Progression of disease over time as measured by visual fields (kinetic and static) | 2 years | 
| Spectral Domain Optical Coherence tomography (SD-OCT) | Progression of disease over time as measured by SD-OCT (EZ length, ELM length, ONL thickness, macular volume). | 2 years | 
| Fundus Autofluorescence (FAF) | Progression of disease as measured by FAF (Hyperautofluorescent ring) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients characteristics | Age, gender, medical and surgical history, family history and concomitant treatments | 2 years | 
| Clinical diagnosis | Age and description at onset, clinical signs, relevant treatments and an ophthalmological anamnesis | baseline (At diagnosis) | 
| Genetic diagnosis | Mutated gene, identified pathogenic mutation | baseline (At diagnosis) | 
| Electroretinogram (ERG) | Photopic and scotopic full field | baseline (At diagnosis) | 
| Color vision | 15 Hue Desaturated Lanthony | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinitis Pigmentosa, RHO, PDE6A, PDE6B, Pathogenic mutation, Retrospective, Natural History, Retinal Disease, Eye Diseases, Blindness, Inherited Eye Diseases, Vision Disorders, Inherited Retinal Disorders, Rod-Cone Dystrophy
Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.

Official Title
-----------------
Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Device: Goal Directed Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Patients undergoing primary resection of esophageal cancer and resultant esophagectomy. Exclusion Criteria: Patients < 55kg or > 140 kg, based on literature regarding accuracy of FloTrac. Patients with sustained preoperative dysrhythmias, based on literature regarding accuracy of FloTrac (atrial flutter and/or atrial fibrillation). Patients with diagnosed NYHA class III-IV failure or documented EF < 30% Patients who are unable/unwilling to consent for study procedures

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Goal Directed Therapy<br>In this arm patient will have the FloTrac monitor and a Goal Directed Therapy algorithm will be used to manage blood pressures. | Device: Goal Directed Therapy<br>* Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures.<br>|
| No Intervention: Usual Care<br>Standard of care will be used to manage blood pressures. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cardiopulmonary Complications | Any documented cardiopulmonary complications present upon chart review. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic Leak Diagnosed Via Radiograph |  | 7 days | 
| Number of Participants With Renal Injury |  | 7 days | 
| Death |  | 30 days | 
| Length of Intensive Care Unit Stay |  | 30 days | 
| Hospital Length of Stay |  | 30 days |
Heparin Resistance: Predictors and Outcomes

Study Overview
=================
Brief Summary
-----------------
The investigators evaluated clinical impact of reduced heparin responsiveness (HRreduced) on the incidence of perioperative myocardial infarction (MI) and restenosis at 6 months after off-pump coronary artery bypass graft surgery (OPCAB) and identified its predictors.

Official Title
-----------------
Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication

Conditions
-----------------
Off Pump Coronary Artery Bypass Surgery

Intervention / Treatment
-----------------
* Drug: Heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008 Exclusion Criteria: presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Heparin|150 U/kg heparin was administered intravenously at the beginning of graft anastomosis and accepted a perioperative ACT value of around 300 s. Ten minutes after the loading dose, the ACT was measured. An ACT of 300 s or greater was considered as adequate. Then follow up ACT measurement was determined after 30 min from the previous ACT measurement. If ACT fell below the target value of 300 s, an additional dose of heparin was administered. If ACT was between 250 and 299 s, additional 2000 U of heparin was administered and if ACT was between 200 and 249 s then additional 3000 U of heparin was injected. Ten minutes after additional heparin injection, ACT was remeasured.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidences of postoperative MI and major morbidity |  | immediate postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidences of cardiac morbidities |  | 6 months following surgery | 
| restenosis of graft vessels |  | 6 months following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heparin responsiveness, Off-pump coronary artery bypass graft surgery, Risk factors, Myocardial infarction
Safety of ALK Ragweed Tablet

Study Overview
=================
Brief Summary
-----------------
This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults

Official Title
-----------------
A RANDOMIZED, MULTIPLE DOSE, DOSE-ESCALATION, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE I TRIAL INVESTIGATING THE OPTIMAL SAFE DOSE OF ALK RAGWEED TABLET AMBROSIA ARTEMISIIFOLIA IN ADULT SUBJECTS WITH SEASONAL RHINOCONJUNCTIVITIS CAUSED BY RAGWEED POLLEN ALLERGY

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: ALK Ragweed Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ragweed pollen induced rhinoconjunctivitis Adults of either sex (18-50 years of age) Positive skin prick test to ragweed Exclusion Criteria: Previous treatment with immunotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ALK Ragweed Tablet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety by recording of adverse events |  |  |
Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect Site Concentration for Loss of Consciousness

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to validate that an effect compartment concentration for loss of consciousness (LOC) was varied according to different Keo value.

Official Title
-----------------
Influence of Equilibration Rate Constant (ke0) of Propofol on the Effect-site Concentration for Loss of Consciousness

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Device: Diprifusor (Target-controlled infusion)
* Device: Orchestra (Target-controlled infusion)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing general anesthesia Exclusion Criteria: Hepatic or renal disease Drug addiction

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diprifusor group<br>Propofol was infused via Diprifusor TCI (Target-controlled infusion) | Device: Diprifusor (Target-controlled infusion)<br>* Two TCI devices with different Teo and same Marsh PK model<br>* Other names: Diprifusor(Grasby Medical Limited, United Kingdom);|
| Experimental: Orchestra group<br>Propofol was infused via Orchestra TCI | Device: Orchestra (Target-controlled infusion)<br>* Two TCI devices with different Teo and same Marsh PK model<br>* Other names: OrchestraTM (Fresenius Vial, Brezins, France);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated effect-site propofol concentration at loss of consciousness |  | after propofol infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to loss of consciousness |  | after propofol infusion |
MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms

Study Overview
=================
Brief Summary
-----------------
The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec TAAA spinal loop graft custom made CE equivalent branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.

Official Title
-----------------
DediCated MuLtibranchEd DacrOn Graft for OPen RepAir of ThoRacoabdominal Aneurysms - CLEOPATRA Study

Conditions
-----------------
Aneurysm Abdominal, Aneurysm Thoracic

Intervention / Treatment
-----------------
* Device: branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged ≥ 18 years; patients candidates for surgical treatment of thoraco-abdominal aorta of the II and III type sec. Crawford using TAAA spinal loop graft custom made CE equivalent prosthesis Exclusion Criteria: • patients aged ≤ 18 years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAAA spinal loop graft<br> | Device: branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms<br>* Jotec TAAA spinal loop graft custom made CE equivalent branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants who obtain technical success | number of surviving participants | 12 month | 
| incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries | freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries | 12 month | 
| incidence of aneurysmal dilatation of visceral and replanted intercostal arteries | freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries | 12 month |
Efficacy and Safety of Ivabradine in Severe Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects on heart function of ivabradine administered to patients with severe chronic heart failure

Official Title
-----------------
Evaluation of the Effects on Peripheral and Central Haemodynamics Parameters, Safety, and Tolerance of Three-hour Intravenous Perfusion (0.1 mg/kg) of Ivabradine Given to Severe Congestive Heart Failure Patients

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: Ivabradine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: systolic congestive heart failure sinus rhythm, HR >= 80bpm Exclusion Criteria: unstable cardiovascular condition

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic parameters |  |  | 
| Twelve-lead ECG |  |  | 
| Systolic and diastolic blood pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography |  |  | 
| Neurohormones |  |  |
Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
Prospective Randomized Controlled Multicenter Clinical Trial for Comparison of Safety Between Totally Laparoscopic Distal Gastrectomy(TLDG) and Laparoscopy-Assisted Distal Gastrectomy(LADG) With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer

Conditions
-----------------
Total Laparoscopic Distal Gastrectomy, Locally Advanced Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: TLDG or LADG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of gastric cancer was confirmed by pathological examination Preoperative staging as cT2-4aN0-3M0 according to AJCC-7th No accompany with another cancer ECOG 0-1 ASA I-III Agreement Exclusion Criteria: Pregnant or suckling period Patients with a history of preoperative chemoradiotherapy Patients with unable to finish D2 lymphadenectomy or R0 resection Laparoscopic surgery contraindications Serious organ disfunction Accompany with serious mental disease Continuous treatment with steroid in 1 month Disagreement

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TLDG or LADG<br>To complete the distal gastrectomy with Billroth-II reconstruction and D2 lymphadenectomy for locally advanced gastric cancer with TLDG or LADG | Procedure: TLDG or LADG<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative early anastomotic morbidity |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flatus time |  | 7 days | 
| Quality of life | estimated with EORTC QLQ-C30V3、EORTC QLQ-STO22 | 30 days | 
| Postoperative hospital stay |  | 30 days | 
| Pain score |  | 10 days | 
| Postoperative inflammation response | using C-reactive protein、IL-6、WBC and so on postoperative 1,3,5,7 days | 10 days | 
| Nutrition | NRS-2002 and PG-SGA in 30 days | 30 days |
Diet and Physical Activity Interactions in Obesity

Study Overview
=================
Brief Summary
-----------------
The projects funded by this grant, primarily focus on environmental factors that promote weight-gain in the general human population, and how to modify these factors, to prevent further weight-gain in the future. In the coming years, the researchers at the University of Colorado-HSC hope to gain an understanding as to how small changes in diet and physical activity can be achieved and sustained to prevent weight-gain.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: small changes in physical activity and diet


Participation Criteria
=================
Eligibility Criteria
-----------------
BMI: 21-26 < 5lb. weight change in 6 mo. usual fat intake 25-35% regularly eats 3 meals/day no chronic health problems known to affect appetite either active or inactive (specific criteria do exist) no smoking women must be on bcps no evidence of depression, eating disorder, or restrained eater (determined from validated questionnaires).

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: small changes in physical activity and diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |