linjc16/ctgov huggingface dataset:
Safety of Interferon Gamma-1b With Rituximab in Non-Hodgkin's Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of the dosing schedule of subcutaneous interferon gamma-1b (IFN g-1b) administered 3 times per week with Rituximab for 4 weeks, in patients with progressive or relapsed low-grade Non-Hodgkin's Lymphoma (NHL) International study with sites in the Czech Republic and Poland

Official Title
-----------------
Phase I/II Study of the Safety of Subcutaneous Interferon Gamma-1b Combined With Rituximab in Patients With Low Grade/Follicular Non-Hodgkin's Lymphoma

Conditions
-----------------
Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: Interferon Gamma-1b
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Relapsed or progressive low-grade/follicular NHL who are candidates for rituximab therapy Patients who were on other therapy including CHOP or radiation Previous therapy must have concluded 30 days prior to enrollment Demonstrable CD20-positive tumor population in lymph nodes or bone marrow

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon Gamma-1b|100 or 200 mcg, SQ, 3x per week|
|Drug: Rituximab|375 mg per square meters, IV, 1x per week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to complete response (disappearance of all detectable clinical and radiographic evidenc of disease, and regression of lymph nodes) |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lymphoma
Prescription and Persistence of Antithrombotic Agents in Acute Ischemic Stroke or Transient Ischemic Attack Patients With MCA(Middle Cerebral Artery) Disease

Study Overview
=================
Brief Summary
-----------------
Prescription and Persistence of Antithrombotic agents in Acute Ischemic Stroke or Transient Ischemic Attack Patients with MCA(Middle Cerebral Artery) Disease.

Conditions
-----------------
MCA - Middle Cerebral Artery Dissection

Intervention / Treatment
-----------------
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 years later, men and women Exclusion Criteria: Subject who is judged to be ineligible by investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription status of Antithrombotic Agents |  | at 12 months after baseline(onset) |
Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies

Study Overview
=================
Brief Summary
-----------------
This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.

Official Title
-----------------
ILUMINATE: An Open-Label, Non-Interventional Study of the Safety and Effect of Iluvien® (Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Applicator) in Patients With Chronic Diabetic Macular Edema (DME) Insufficiently Responsive to Available Therapies

Conditions
-----------------
Diabetic Macular Edema (DME)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT); Vision impairment associated with DME Prior treatment with available therapies for DME; and Patients considered by the physician insufficiently responsive to available therapies Exclusion Criteria: Patients with contraindications according to the current Summary of Product Characteristics (SPC) The presence of pre-existing glaucoma Active or suspected ocular or periocular infection The patient is hypersensitive to the active agent or to one of the excipients Elevated IOP Pregnancy or breastfeeding

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 |
| --- | --- |
| Chronic DME<br>Patients with vision impairment associated with chronic diabetic macular edema (DME) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics. | 24 Months | 
| Number of Patients With Ocular Adverse Events |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Center Subfield Thickness | Observed and change from baseline SD-OCT values will be summarized using descriptive statistics. | 24 months |
Endoscopy for Bleeding Situations in Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of surgical patients with relevant gastrointestinal bleeding situations and indication for endoscopy for bleeding

Detailed Description
-----------------
We performed an analysis of all adult, surgial patients with indication for emergency endoscopy because of relevant gastrointestinal bleeding situations. A retrospective analysisof the incidence, causes, endoscopic findings and therapy and the outcome of bleeding situations during a 24-mounths interval in the years 2017, 2018 and 2019 was performed at our tertiary centre. Informed consent was obtained from all participants. Patient records as well as database were analyzed for therapy-specific items.

Official Title
-----------------
Emergency Endoscopy for Gastrointestinal Bleeding Situations in Surgical Patients

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Procedure: emergency endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of the University Hospital of Tübingen Department of General, Visceral and Transplantation Surgery with gastrointestinal bleeding situations Exclusion Criteria: younger patients patients without indication for emergency endoscopy for bleeding situations

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 |
| --- |
|Procedure: emergency endoscopy|emergency endoscopy for gastrointestinal bleeding situation before or after surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate identification of bleeding sources | endoscopic reports with identification of bleeding sources | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical patients, gastrointestinal bleeding
Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).

Study Overview
=================
Brief Summary
-----------------
Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD.

Detailed Description
-----------------
Pathological features of Autosomal Dominant Polycystic Kidney disease (ADPKD) include enlarged kidney volume, a higher frequency of digestive diverticulitis and abdominal wall hernias. Therefore, many nephrologists have concerns about the use of peritoneal dialysis (PD) in ADPKD patients. We aimed to analyze survival and technique failure in ADPKD patients treated with PD. We conducted two retrospective studies on patients starting dialysis between 2000 and 2010, and based on two French registries: The French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF).

Official Title
-----------------
Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).

Conditions
-----------------
Polycystic Kidney Diseases

Intervention / Treatment
-----------------
* Other: Dialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Iinclusion criteria : Patients starting dialysis Patients included from the French Renal Epidemiology and Information Network (REIN) and The French Language Peritoneal Dialysis Registry (RDPLF) exclusion criteria patients without diagnosis of nephropathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Dialysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the time from the start of dialysis to death | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technique survival | the time from the start of dialysis to change of dialysis technique (death and transplantation were considered as competing risk) | 15 years |
A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer

Official Title
-----------------
A Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects With Stable Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate
* Drug: Formoterol Fumarate
* Drug: Formoterol Fumarate
* Drug: Foradil Aerolizer
* Drug: Foradil Aerolizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to understand the requirements of the study and provide informed consent A Clinical diagnosis of COPD A current or prior history of at least 10-pack years of cigarette smoking women of child-bearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit and agree to avoid becoming pregnant for the duration of study Exclusion Criteria: A Clinical Diagnosis of Asthma Other significant disease than COPD Subjects who radiation or chemotherapy within the previous 12 months Subjects who had any lung resection QTcB greater than 0.460 seconds History of illegal drug abuse or alcohol abuse within the past 5 years

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Formoterol Fumarate<br>* Inhalation solution<br>|
| Experimental: 2<br> | Drug: Formoterol Fumarate<br>* Inhalation solution<br>|
| Experimental: 3<br> | Drug: Formoterol Fumarate<br>* Inhalation solution<br>|
| Experimental: 4<br> | Drug: Foradil Aerolizer<br>* Dry powder inhaler<br>|
| Experimental: 5<br> | Drug: Foradil Aerolizer<br>* Dry powder inhaler<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil |  | 12 hours on Day 1 and Day 7 of dosing during each treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD
Transmission of Mother-Infant Stress Communication

Study Overview
=================
Brief Summary
-----------------
The central aim of this study is to assess mother-infant communication via behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant.

Detailed Description
-----------------
This investigation examines a distal maternal stressor on the quality of interaction in mother-infant dyadic communication. Assessments include behavioral, physiological, and affective indices under conditions where distal stressors may not be directly detectable by the infant. The present research examines mother-infant interactions to test the hypothesis of whether maternal stress may be transduced to their infants via multiple pathways. The secondary aim is to explore effective emotion regulation strategies for the mother as potential buffers to stress and additionally reducing early life stress effects on the infant's regulatory development. While the emotion regulation literature posits that reappraisal may be associated with decreased in physiological and psychological stress, this type of regulation strategy may be ineffective when interfacing with discrimination. The regulation strategy needs to be titrated to the stressor in order to be effective. These findings will have notable social, clinical, and psychological significance,

Official Title
-----------------
Transmission of Discrimination-Related Stress Reactivity and Reduction From Mother to Infant

Conditions
-----------------
Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Exclusion Criteria: No presence of heart murmur or wear a pacemaker No medication for hypertensive or cardiovascular disease Not using beta blockers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol | Salivary cortisol is a measure that indicates hypothalamus-pituitary-adrenal axis activity. The study obtains 4 assessments with 20 minutes between each assessment. Participants chew on a cotton role for 2-minutes which is placed in a cortisol salivette tube (Sarstedt) | One lab appointment for approximately 80 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Amylase | Salivary amylase is an indicator of sympathetic nervous system activity. The same salivary salivette is used to later extract the amylase. | One lab appointment for approximately 80 minutes. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mother-infant dyadic regulation, stress, psychophysiology, emotion regulation
Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is a comparison of efficacy and side effects of Q-switched Ruby laser treatment for solar lentigines in two different skin types II and IV.

Detailed Description
-----------------
It has been widely accepted that dark colored individuals are prone to develop laser induced side effects especially post inflammatory hyperpigmentation(PIH) and it could be a limiting issue in selecting dark colored individuals. We designed this study to evaluate the difference of efficacy and side effects in light and dark skinned individuals.

Official Title
-----------------
Efficacy and Side Effects of Q-Switched Ruby Laser Treatment of Solar Lentigines in Two Different Fitzpatrick Skin Types II and IV

Conditions
-----------------
Solar Lentigines

Intervention / Treatment
-----------------
* Device: Q-switched Ruby Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solar Lentigines Fitzpatrick skin type II and IV Exclusion Criteria: Pregnancy Age above 80 Photosensitivity Concern for malignancy Active Infection

Ages Eligible for Study
-----------------
Maximum Age: 80 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Q-switched Ruby Laser|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Clearance |  |  | 
| Side Effects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Q-switched Ruby laser
Biomime Stent in All-comers PCI Patients Registry

Study Overview
=================
Brief Summary
-----------------
Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an all-comers patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive all-comers employ of this novel stent.

Official Title
-----------------
Biomime Biosorbable Polymer Sirolimus-ELuting Stent in alL-comers patIeNts Treated With Percutaneous Coronary Interventions: the BELLINI Registry

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: percutaneous coronary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent Exclusion Criteria: patients <18 years old

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 |
| --- | --- |
| Study cohort<br>All comers patients with coronary artery disease treated with percutaneous coronary intervention and at least one Biomime stent | Device: percutaneous coronary intervention<br>* percutaneous coronary angioplasty with implantation of at least one Biomime stent<br>* Other names: Biomime stent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target vessel revascularization | rate of target vessel percutaneous or surgical reintervention for recurrent symptoms or inducible ischemia at follow up testes | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death from any cause | death from any cause after the procedure | 1 year | 
| cardiac death | death form cardiac causes (reinfarction, sudden cardiac death, death during coronary reintervention, heart failure, arrhythmias) | 1 year | 
| reinfarction | reinfarction in the myocardial region supplied by the treated coronary artery | 1 year | 
| target lesion revascularization | rate of target lesion percutaneous reintervention for recurrent symptoms or inducible ischemia at follow up testes | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-Eluting Stents, Coronary Artery Disease, Sirolimus, Absorbable Implants
Acute Lung Injury After Aortic Valve Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, randomized clinical trial is to understand and measure lung injuries caused by CPB in aortic valve surgery. Study questions: Is there any correlation between the release of pro-inflammatory biomarkers and lung injury degree? Is there any correlation between oxyhaemodynamic parameters and lung injury degree? Is there any correlation between oxyhaemodynamic parameters and the release of pro-inflammatory biomarkers? Are budesonide, erdostein and acetylcystein effective in the prevention of lung injuries?

Official Title
-----------------
Acute Lung Injury After Aortic Valve Surgery

Conditions
-----------------
Lung Injury

Intervention / Treatment
-----------------
* Procedure: aortic valve surgery with CPB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective aortic valve surgery patient written consent Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aortic valve surgery<br> | Procedure: aortic valve surgery with CPB<br>* elective aortic valve surgery with CPB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung injury |  | within the first 3 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic valve surgery, CPB, lung injury