linjc16/ctgov huggingface dataset:
Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

Detailed Description
-----------------
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Official Title
-----------------
Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: pioglitazone
* Drug: inhaled human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Current treatment with oral antidiabetes drugs (OADs) for at least 2 months HbA1c between 7.0-11.0% if on OAD monotherapy HbA1c between 7.0-10.0% if on OAD combination therapy BMI less than or equal to 40 kg/m2 Exclusion Criteria: Current regular smoking or regular smoking within the last 6 months Current acute or chronic pulmonary disease (except for asthma) Proliferative retinopathy requiring treatment Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity Pregnancy

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 |
| --- | --- |
| Experimental: A<br> | Drug: pioglitazone<br>* Tablets, 45 mg/day.<br>Drug: inhaled human insulin<br>* Treat-to-target dose titration scheme, inhalation.<br>* Other names: NN1998;|
| Active Comparator: B<br> | Drug: pioglitazone<br>* Tablets, 45 mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change from baseline |  | After 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | after 26 weeks of treatment | 
| Lipid profiles |  | after 26 weeks of treatment | 
| Frequency of hypoglycaemic episodes |  | after 26 weeks of treatment | 
| Glucose profiles |  | at pre- and post meals, bedtime and 3:00 am | 
| Change in body weight |  | after 26 weeks of treatment |
Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

Study Overview
=================
Brief Summary
-----------------
Three arm study comparing three novel contact lens solutions.

Official Title
-----------------
Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

Conditions
-----------------
Contact Lens Solution

Intervention / Treatment
-----------------
* Device: Opti-Free contact lens solution
* Device: ReNu Multiplus contact lens solution
* Device: Clear Care contact lens solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl). Stable correction is defined as longer than six months. Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months Exclusion: Known sensitivity to the contact lens disinfecting solutions or fluorescein dye. Any systemic or ocular disease that could affect contact lens wear. Women who are pregnant or lactating.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Opti-Free contact lens solution | Device: Opti-Free contact lens solution<br>* Solution<br>|
| Active Comparator: 2<br>ReNu Multiplus contact lens solution | Device: ReNu Multiplus contact lens solution<br>* Solution<br>|
| Active Comparator: 3<br>Clear Care contact lens solution | Device: Clear Care contact lens solution<br>* Solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in corneal fluorescein staining as evaluated at Day 30 |  | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confocal evaluation variables as measured at Days 0, 14, and 30 |  | Day 0, 14, 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact lens, solution, confocal microscope
Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

Study Overview
=================
Brief Summary
-----------------
This study's primary objective is to determine the independent and combined effects of progressive resistance muscle strength training and testosterone on the development of sustainable improvements in physical function.

Official Title
-----------------
Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

Conditions
-----------------
Muscle Weakness, Muscular Atrophy

Intervention / Treatment
-----------------
* Procedure: exercise
* Drug: testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will be limited to those patients who are metabolically stable and free of metastatic cancer and limiting end organ disease. Their total serum testosterone must be less than 480 and PSA less than 10. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Procedure: exercise<br> <br> Drug: testosterone<br> <br> |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, Aging, rehabilitation
Differential Effects of Zolpidem Versus Ramelteon in Burned Children

Study Overview
=================
Brief Summary
-----------------
To examine sleep changes following therapeutic drug interventions designed to promote sleep.

Official Title
-----------------
Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings

Conditions
-----------------
Sleep, Burns

Intervention / Treatment
-----------------
* Drug: zolipidem
* Drug: ramelteon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn injury > 20% total body surface area Between 3 and 18 years of age < 7 days from acute injury Written informed consent and HIPPA release signed Exclusion Criteria: Suspected anoxic brain injury or head injury Hepatic or endocrine disease History of alcoholism or substance abuse Pre-existing neurological or primary psychiatric disorder Medical history of pre-existing sleep disorder or lactose deficiency Questionable survival (<72 hrs) as decided by PI Receipt of drugs with known effects on sleep within 24 hrs of study entry No informed consent/HIPPA release

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zolpidem<br>zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization | Drug: zolipidem<br>* zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization<br>* Other names: Ambien;|
| Active Comparator: ramelteon<br>ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization | Drug: ramelteon<br>* ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization<br>* Other names: rozerem;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography Data | Determine if intervention product elicits more total sleep time | 2 weeks postburn | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | evaluate the PK of zolpidem following standard dosing practices | 2 weeks postburn |
An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension (0954A-325)

Study Overview
=================
Brief Summary
-----------------
Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.

Official Title
-----------------
An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: MK0954, losartan potassium / Duration of Treatment - 12 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient treated with valsartan 80mg or irbesartan 150mg or vandesartan 8mg for at least 4 weeks prior to visit 1 Patient with systolic blood pressure between 140 to 159 mmhg and diastolic pressure between 90 to 99mmhg taken at visit 1 Exclusion Criteria: History of angina pectoris that has not been stabilized in the past 6 weeks History of clinically significant abnormal lab results or diseases Myocardial infarction within the past 6 months Stroke in the past 6 months

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0954, losartan potassium / Duration of Treatment - 12 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of diastolic blood pressure after 6 weeks of treatment with cozaar plus |  |  |
IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

Study Overview
=================
Brief Summary
-----------------
Objectives: Since 2007, natural orifice surgery evolved from theory and animal research to clinical applications, but is still limited in the literature to small casuistic reports. A preliminary prospective evaluation of postoperative results of the early casuistic of Natural orifice Surgery for many indications may show advantages and disadvantages of the methods. The IMTN Multicenter Trial for Clinical NOTES was and early results are described.

Official Title
-----------------
IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

Conditions
-----------------
Gastrointestinal Surgery, Natural Orifice Surgery

Intervention / Treatment
-----------------
* Procedure: Cholecystectomy
* Procedure: Appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients submitted to elective surgery Exclusion Criteria: emergency surgery High ASA risk patients

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transgastric<br>Patients submitted to Transgastric NOTES surgery | Procedure: Cholecystectomy<br>* Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.<br>Procedure: Appendectomy<br>* Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.<br>|
| Transvaginal<br>Patients submitted to Transvaginal surgery | Procedure: Cholecystectomy<br>* Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.<br>Procedure: Appendectomy<br>* Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.<br>|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NOTES, Natural Orifice Translumenal Endoscopic surgery, Cholecystectomy, Appendectomy, Endoscopy, Laparoscopy, Minimally invasive surgery, clinical trials
Whole Blood-plasma-oral Fluid Ratios of Psychoactive Drugs and Medicines

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to get new information on the whole blood-plasma-oral fluid ratios of psychoactive drugs which are encountered in traffic. Samples are taken from drivers suspected of being under the influence of drugs or medicines. The samples are analysed with immunological methods and GC-MS. Observations from Police and a physician on impairment are combined with the results of the different bodily fluids. Observational evaluations and substance concentrations are compared.

Official Title
-----------------
DRUID Sub-study: Substance Concentration Ratio/Impairment

Conditions
-----------------
Driving Under the Influence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older driver of a motorised vehicle Exclusion Criteria: 17 years or younger not the driver of a motorised vehicle

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>drivers of motorised vehicles suspected of being under the influence of psychoactive drugs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of psychoactive substances in the general driving population |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
driving under the influence, psychoactive substances, oral fluid, whole blood, plasma, Ratio of psychoactive substances in whole blood-plasma-oral fluid, Prevalence of psychoactive substances in road traffic
First Line Metastatic Breast Cancer Treatment (ESMERALDA)

Study Overview
=================
Brief Summary
-----------------
The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra toxicities. It could be interesting to explore the combination of bev + eribulin in first line metastatic breast cancer.

Official Title
-----------------
A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Eribulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 ans Patient with metastatic mammary adenocarcinoma Hormone receptors ER and PR positive or negative for HER 2 negative Exclusion Criteria: Prior chemotherapy for metastatic disease Previous treatment with eribulin or bevacizumab Presence of symptomatic brain metastases or meningeal

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

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

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: Association eribulin and bevacizumab<br>Drug: eribulin 1,23mg/m²; d1 and d8 in IV, all 3 weeks until 6 cycles or progression Drug: bevacizumab 15m/kg ; d1 in IV, all 3 weeks until 6 cycles or progression or toxicity | Drug: Eribulin<br>* Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV<br>* Other names: Drug: Bevacizumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with non progressive disease | The principal endpoint is to determine the disease control rate (or rate of non-progression) at one year in patients with metastatic breast cancer treated in the first line setting by a combination of eribulin/bevacizumab. In this open-label trial, the sample size is calculated based on Simon's two-stage design, used to test whether the disease control rate at one year will be at least 50%, a clinically promising rate, versus a rate of 33%, a rate that is not clinically promising. Considering a type I risk (alpha) error of 5%, with 54 patients, this study has an 80% power to detect a disease control rate at one year of 50%. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity based on the CTCAE v4.03 criteria |  | 12 months |
A Novel Nomogram to Predict Severity of COVID-19

Study Overview
=================
Brief Summary
-----------------
Investigators use clinical data from a large sample of COVID-19 disease patients to screen out biomarkers associated with disease severity. Then, a novel nomogram model will be established to predict covid-19 disease severity, which could provide important assistance and supplement for clinical work. In the case of extremely shortage of front-line medical resources, patients with potential severe diseases will be timely treated with the help of the novel nomogram model.

Official Title
-----------------
A Novel Nomogram to Predict Severity of COVID-19

Conditions
-----------------
COVID-19 Disease, Nomogram Model

Intervention / Treatment
-----------------
* Other: other


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 disease patients confirmed by virus nucleic acid RT-PCR and CT Exclusion Criteria: unconfirmed suspected cases Patients during pregnancy and lactation incomplete clinical data investigators considered patients ineligible for the trial Child patients

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 |
| --- | --- |
| Observed group<br>COVID-19 disease patients who were detected by RT-PCR and CT imaging. | Other: other<br>* clinical diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the consistency of predicted severe rate and observed severe rate of COVID-19 patients | We aim to use the clinical data of COVID-19 patients to construct a nomogram model to predict the severe rate of each patient, then the the consistency of predicted severe rate and observed severe rate will be evaluated by calibration plot. | up to 3 months | 
| Duration of severe illness | the duration of severe illness of each patient will evaluated | up to 3 months |
A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of a new allergy medication

Detailed Description
-----------------
Study withdrawn prior to determining study details

Official Title
-----------------
Study Withdrawn Prior to Determining Official Title

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Ketotifen/vasoconstrictor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 6 years of age, of any race, or either gender. Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months. Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart. Positive bilateral CAC reaction at Visit 1 & 2. Exclusion Criteria: Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components. Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketotifen/vasoconstrictor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of a new allergy medication | STUDY WITHDRAWN PRIOR TO OUTCOME DETERMINATION | 0 |