linjc16/ctgov huggingface dataset:
Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability.

Detailed Description
-----------------
A patient undergoing ophthalmic arterial chemosurgery may experience a sudden, profound decrease in lung compliance when the microcatheter is in the ICA or ophthalmic artery. However, underlying pathophysiology of the respiratory complication is unknown. In this study, the investigators are going to investigate the relation between underlying balance of parasympathetic and sympathetic tone and the respiratory complications by analyzing heart rate beat-to-beat variability. Also, the investigators are going to investigate whether baseline heart rate variability can predict respiratory complications during the procedures.

Official Title
-----------------
Relation Between Heart Rate Variability and Cardiorespiratory Complications During Ophthalmic Arterial Chemotherapy for Retinoblastoma

Conditions
-----------------
Parasympathetic Cardiovascular Function Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing ophthalmic arterial chemotherapy Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 20 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 |
| --- | --- | --- |
| Heart rate variability | Heart rate variability | 5 min after microcatheter enters ophthalmic artery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Heart rate variability | 5 min after anesthesia induction | 
| Heart rate variability | Heart rate variability | 5 min before end of anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart rate variability, intraarterial chemotherapy, ophthalmic arterial chemotherapy
Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about asthma in people who are not well-controlled with current asthma medication (refractory asthma). The investigators will compare data from refractory asthmatic patients here at National Jewish Health to mild asthmatics subjects and to people without asthma. Study experiments involve looking at samples from all 3 groups and comparing them at a molecular level. These laboratory experiments may help identify subtypes of refractory asthmatics that require different treatments.

Official Title
-----------------
Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to receive Informed Consent At least 18 years of age ICS < 880 mcg (FP equivalents) PC20<=16 mg/mL No more than 1 oral steroid bursts in previous 12 months Less that 3 urgent care visit in previous 12 months No deterioration with <=25% decrease in steroids No near fatal asthma event Exclusion Criteria: Pregnancy Current smoker, smoking within the past year or pack/year history >10 years Respiratory infection within past 6 weeks Antibiotics within the past 6 weeks Active lung disease other than asthma Cancer within past 5 years (excluding basal cell skin cancer) Active or chronic infection Hematological or autoimmune disease Unable to safely undergo bronchoscopy as determined by doctor or study doctor

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining phenotypes non-invasively | Comparing invasive phenotyping to non-invasive | October, 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma
A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

Detailed Description
-----------------
This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

Official Title
-----------------
A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: DSXS1411
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant, non-lactating females age 12 and older. Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening. Exclusion Criteria: Under 12 years of age. Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study. Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: DSXS1411<br>DSXS applied once a day for a total of 28 days. | Drug: DSXS1411<br>* DSXS (Taro Pharmaceuticals Inc.)<br>* Other names: Active;|
| Placebo Comparator: Placebo<br>Placebo (vehicle) applied once a day for a total of 28 days. | Drug: Placebo<br>* Placebo (vehicle) (Taro Pharmaceuticals Inc.)<br>* Other names: vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response of Success | The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1. | 28 Days |
Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to examine the efficacy and safety of transcranial magnetic stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological disorders. Subjects will be randomized into two groups: experimental (treated with pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and their clinicians will complete a battery of instruments that measure relevant symptoms, global functioning and quality of life. The first measurement will be done after the inclusion and before treatment. The second measurement will be made immediately after the end of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6 months.

Conditions
-----------------
Mood Disorders

Intervention / Treatment
-----------------
* Device: TMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed psychiatric or neurological disorder, duration of disorder for at least 5 years, inpatients or outpatients treated in Psychiatric hospital Sveti Ivan Exclusion Criteria: suicidality, psychosis, alcohol addiction, unable to complete the questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS<br>The experimental group will be treated with transcranial magnetic stimulation for 4 weeks. | Device: TMS<br>* Transcranial magnetic stimulation<br>|
| No Intervention: noTMS<br>The control (no intervention) group will be treated as usual (with pharmacotherapy). These patients will receive TMS treatment after data collection is ended. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of patients who experienced complete remission of the disease | Measurement points: immediately after the end of treatment, and follow-up after 3 and 6 months. | up to six months |
Chemotherapy Combined With Immunotherapy in HER 2 Insertion or Amplification Advanced NSCLC

Study Overview
=================
Brief Summary
-----------------
This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in HER 2 insertion or amplification.

Detailed Description
-----------------
Main enrolled criteria: Her2 insertion advanced NSCLC Her 2 amplification advanced NSCLC Failed with standard chemotherapy No history of PD-1/ PD-L1 antibody using

Official Title
-----------------
Chemotherapy or Chemotherapy Plus PD-1 Antibody in HER 2 Insertion or Amplification Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology HER 2 Insertion or Amplification First Diagnosis and Treatment Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody Exclusion Criteria: Patients received antitumor treatment before Patients with contraindication of chemotherapy Pregnant or breast feeding women

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | may 2020- may 2021 (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | may 2020- may 2021 (1 year) | 
| ORR | To measure the patients's overall response rate | may 2020- may 2021 (1 year) |
Tumour Registry Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.

Detailed Description
-----------------
The TKK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of colorectal cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. The impact of nutrition (CoNut) and physical activity (CoNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (CoTox) and the final phase of the palliative process (CoLife). Based on the available data a prognostic score will be developed.

Official Title
-----------------
Prospective and Retrospective Observation of the Adjuvant and Palliative Treatment Strategies in the Therapy of Colorectal Cancer in Germany

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colorectal cancer 18 years and older Antineoplastic treatment Exclusion Criteria: No colorectal cancer Below 18 years No antineoplastic treatment

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 |
| --- | --- | --- |
| Course of Antineoplastic Treatment |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer, Advanced Colorectal Cancer, Epidemiology, Health Services Research, Germany, Registry, Palliative Care, Palliative Treatment, Adjuvant Drug Therapy, Nutrition Assessment, Physical Activity
Therapeutic Alliances in Alcoholism Treatment

Study Overview
=================
Brief Summary
-----------------
This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders.

Detailed Description
-----------------
This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders. Alliances are assessed over the course of treatment and will be reviewed in the context of posttreatment functioning.

Conditions
-----------------
Alcohol Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral treatment
* Behavioral: Cognitive-behavioral treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current Alcohol Dependence diagnosis Live within commuting distance of treatment program Minimum 6th grade reading level Provide consent Exclusion Criteria: Presence of current organic mental disorder, schizophrenia, or another psychotic disorder Treatment for an alcohol use disorder in past 12 months

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alliance Feedback to Therapist<br>Alliance feedback provided to therapist | Behavioral: Cognitive-behavioral treatment<br>* Cognitive-behavioral treatment of alcohol use disorders<br>Behavioral: Cognitive-behavioral treatment<br>* Cognitive-behavioral treatment for alcohol use disorders<br>|
| Placebo Comparator: No alliance feedback to therapist<br>No alliance feedback provided to therapist | Behavioral: Cognitive-behavioral treatment<br>* Cognitive-behavioral treatment of alcohol use disorders<br>Behavioral: Cognitive-behavioral treatment<br>* Cognitive-behavioral treatment for alcohol use disorders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days abstinent |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinks per Drinking Day |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol use disorders, Treatment, Outpatient, Therapeutic alliance
Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome

Study Overview
=================
Brief Summary
-----------------
a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.

Detailed Description
-----------------
The first-line treatment of severe Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) is nocturnal ventilation with Continuous Positive Airway Pressure (CPAP). and The second-line treatment is the mandibular advancement orthosis (MAO)]. CPAP is the most effective treatment to reduce the apnea-hypopnea index (AHI). However, its tolerance is sometimes difficult, causing many discontinuations. The purpose of this review is to evaluate a vascular morbimortality criteria: Cardiovascular: myocardial infarction, heart failure, rhythm disorder Neurological: transient or non transient stroke ophthalmologic: anterior ischemic optic neuropathy, occlusion of the central artery or central retinal vein occlusion

Official Title
-----------------
Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) With Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis

Conditions
-----------------
Obstructive Sleep Apnea/Hypopnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis Age ≥ 18 years old Read, write and understand the French language Exclusion Criteria: Patient under guardianship, deprived of liberty, safeguard of justice Refusal to participate in research

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Continuous Positive Airway Pressure (CPAP)<br>Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP | |
| Mandibular Advancement Orthosis<br>Obstructive Sleep Apnea/Hypopnea Syndrome treated with Mandibular Advancement Orthosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbimortality vascular criteria | Presence or absence of cardiovascular event | up to 6 months | 
| morbimortality vascular criteria | Presence or absence of neurologic event | up to 6 months | 
| morbimortality vascular criteria | Presence or absence of ophthalmologic event | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular risk
A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.

Detailed Description
-----------------
Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Official Title
-----------------
Long-term Study of ASP1941 - A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: ipragliflozin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients for at least 12 weeks HbA1c value between 6.5 and 9.5% Body Mass Index ( BMI )20.0 - 45.0kg/m2 Exclusion Criteria: Type 1 diabetes mellitus patients Serum creatinine > upper limit of normal Proteinuria (albumin/creatinine ratio > 300mg/g) Dysuria and/or urinary tract infection, genital infection Significant renal, hepatic or cardiovascular diseases Severe gastrointestinal diseases Proliferative diabetic retinopathy

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 |
| --- | --- |
| Experimental: before meal group<br>ASP1941 will be administered before meal | Drug: ipragliflozin<br>* oral<br>* Other names: ASP1941;|
| Experimental: after meal group<br>ASP1941 will be administered after meal | Drug: ipragliflozin<br>* oral<br>* Other names: ASP1941;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | For 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | For 52 weeks | 
| Fasting serum insulin |  | For 52 weeks | 
| Plasma levels of ASP1941 for population PK analysis |  | For 52 weeks | 
| Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs |  | For 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood glucose, ASP1941, Food effect, Diabetes mellitus