linjc16/ctgov huggingface dataset:
The Effect of Oxytocin on the Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.

Detailed Description
-----------------
The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis. Oxytocin infusion will be compared with sodium chloride infusion.The gastric emptying is estimade by sitntigraphy during 70 minutes, and performed twicw. Once with saline and once with oxytocin.

Official Title
-----------------
The Effect of Oxytocin on Gastric Emptying in Patients With Gastro Paresis

Conditions
-----------------
Postprocedural Delayed Gastric Emptying

Intervention / Treatment
-----------------
* Drug: oxytocin
* Drug: oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroparesis in diabetics Exclusion Criteria: Treatment with other prokinetics, other severe organic or psychological diseases

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin, gastric emptying<br>Oxytocin is given to study the gastric emptying rate | Drug: oxytocin<br>* 80mIE/min as continuous infusion for 70 minutes<br>* Other names: syntocinon;Drug: oxytocin<br>* 80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy<br>* Other names: syntocinon;|
| Placebo Comparator: oxytocin<br>sodium chloride is given to study gastric emptying rate | Drug: oxytocin<br>* 80mIE/min as continuous infusion for 70 minutes<br>* Other names: syntocinon;Drug: oxytocin<br>* 80 mU/ min of oxytocin infusion for 70 min along with measuring the gastric emptying by ventricle scintigraphy<br>* Other names: syntocinon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine whether oxytocin improves gastric emptying in gastroparesis |  | dec 2008-dec 22009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, gastroparesis, diabetics, The effect of oxytocin on gastric emptying
ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox

Study Overview
=================
Brief Summary
-----------------
This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.

Official Title
-----------------
A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Deferasirox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of transfusion-dependent anemia. History of iron overload Exclusion Criteria: Patients with non-transfusional hemosiderosis. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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 |
| --- | --- |
| ICL670<br>ICL670 | Drug: Deferasirox<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - renal and hepatic function monitoring. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 5 years | 
| Longitudinal ferritin levels |  | 5 years | 
| Assessment of auditory and ophthalmologic status |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron overload, children, deferasirox, Transfusion-dependent anemia
IRF-PAI Functional Outcomes Data(With FIM Instrument Variables)

Study Overview
=================
Brief Summary
-----------------
IRF-PAI Functional Outcomes Data, including FIM instrument variables

Detailed Description
-----------------
United States IRF functional outcomes, medical and socio-demographic data for years 2002-2015

Official Title
-----------------
IRF-PAI Functional Outcomes Data(With FIM Instrument Variables)

Conditions
-----------------
Heart and Blood Disease, Muscle, Bone and Cartilage Disease, Nervous System Diseases, Skin and Connective Tissue Disease, Wounds and Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to an inpatient rehabilitation facility Exclusion Criteria: Admission to acute, SNF setting, etc.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 100 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 |
| --- | --- |
| Inpatient Rehabilitation Patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IRF-PAI Assessment Instrument(including the FIM instrument) |  | admission/discharge |
High Fat Diet II on Weight Loss

Study Overview
=================
Brief Summary
-----------------
To evaluate two different diets and their effects on weight loss and measurements of several risk factors for cardiovascular disease. One diet will be a high saturated fat diet (HSFD) and the other is a low saturated fat diet (LSFD) that limits fat but especially saturated fat as red meat. All participants in this study must eat both diets as this is a randomized cross-over design.

Official Title
-----------------
Effect of High Saturated Fat No Starch Diet vs. Low Saturated Fat, Low Trans Fat, High Fiber Diet on Weight Loss and Markers of Atherosclerotic Cardiovascular Disease

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

Intervention / Treatment
-----------------
* Other: high fat diet
* Other: low saturated fat diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In order to qualify, participants must have metabolic syndrome: triglycerides greater than 150 mg/dL blood pressure greater than 130 mmHg and/or diastolic blood pressure greater than 85 mmHg fasting glucose greater than 110 mg/dL waist circumference greater than 40 inches in men or 35 inches in women reduced HDL less than 40 mg/dL in men and less than 50 mg/dL in women. Participants must be capable of performing symptom-limited maximal exercise capacity study. Blood and urine samples collected at baseline will be analyzed for CBC, serum glucose and electrolytes, hepatic panel and TSH. Exclusion Criteria: Participants will be excluded for any significant blood dyscrasia, fasting glucose greater than 200 mg/dL, creatine greater than 2 mg/dL, any significant electrolyte disorder, hepatic functions greater than two times normal or abnormal TSH.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>high saturated fat diet | Other: high fat diet<br>* high saturated fat no starch diet<br>|
| Other: 2<br>low calorie low saturated fat low trans fat high fiber diet | Other: low saturated fat diet<br>* low calorie low saturated fat low trans fat high fiber diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial artery reactivity |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss, cardiovascular disease
Tomosynthesis in the Oslo Breast Cancer Screening Program

Study Overview
=================
Brief Summary
-----------------
The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP. Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.

Official Title
-----------------
Digital Breast Tomosynthesis in the Oslo Mammography Screening Program

Conditions
-----------------
Recall Rate, Cancer Detection Rate, False Positive Rate, Positive Predictive Value

Intervention / Treatment
-----------------
* Procedure: Digital breast tomosynthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 50 to 69 years who have signed the informed consent Exclusion Criteria: Women with pacemaker, implants, and severely disabled

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Digital mammography<br> | Procedure: Digital breast tomosynthesis<br>* The participants included in the trial will have an additional radiation exposure for breast tomosynthesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening performance indicators |  | From Nov. 22, 2010 to Dec. 31, 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interval cancer rate |  | From Nov. 23, 2010 to Dec. 31, 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Computer-aided detection, Mammography screening, Digital breast tomosynthesis
Nasal Specimen Collection Study in Patients With ILI and/or ARI in an Outpatient Setting

Study Overview
=================
Brief Summary
-----------------
This is a prospective specimen collection study targeting patients presenting with Influenza Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be used. These nasal swabs will be collected in different volumes of viral transport media (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected biological specimen. The collection of nasal swabs samples will support the optimization of point of care detection methods for respiratory viruses responsible for ILI and/or ARI.

Official Title
-----------------
Prospective, Nasal Specimen Collection Study in Patients Presenting With Influenza Like Illness and/or Acute Respiratory Infection in an Outpatient Setting

Conditions
-----------------
Influenza-like Illness, Influenzal Acute Respiratory Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female All Ages Valid Informed Consent and/or Assent, where applicable Onset of ILI and/or ARI within the last 3 days (≤ 72h) Patient presented with ILI and/or ARI Exclusion Criteria: Invalid Informed Consent and/or Assent Onset of ILI and/or ARI was > 3 days (> 72 h) Patient did not presented with neither ILI or ARI Patient received intranasal attenuated influenza virus in last 3 weeks (example FluMist®, Fluenz®) Patient received treatment with influenza direct antivirals in the last 7 days
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No interventions to be administered<br>Only a nasal swab is collected, no therapeutic interventions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal swab collection of left and right nostril | At the moment volunteer presents him/herself to the general practioner with influenza-like-illness | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of questionnaire | Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza-Like-Illness, nasal swabs, Detection of influenza, sensitivity of detection assays
Serum Autotaxin Levels in Cholestasis of Pregnancy

Study Overview
=================
Brief Summary
-----------------
Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.

Detailed Description
-----------------
Collected data will enable us to compare serum autotaxin levels in cholestasis of pregnancy and healthy control group.

Official Title
-----------------
Diagnostic Accuracy of Serum Autotaxin Levels in Cholestasis of Pregnancy

Conditions
-----------------
Intrahepatic Cholestasis of Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosed cholestasis of pregnancy patients Exclusion Criteria: acute or chronic liver disease acute or chronic gallbladder disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intrahepatic cholestasis of pregnancy<br>5 ml whole blood sample is going to collect from intrahepatic cholestasis of pregnancy group for the assessment of serum autotaxin levels | |
| healthy control group<br>5 ml of whole blood is going to taken from healthy control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum autotaxin levels in cholestasis of pregnancy |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intrahepatic Cholestasis of Pregnancy
Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.

Official Title
-----------------
Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair

Conditions
-----------------
Mitral Valve Regurgitation

Intervention / Treatment
-----------------
* Device: Implantation of the MEMO 3D Annuloplasty Ring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is 18 years old or older An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site. The subject is able to return for all follow-up evaluations of the study. Exclusion Criteria: The subject or subject's legal representative is unwilling to sign the informed consent. The subject is or will be participating in another medical device or drug clinical trial. The subject is a minor, prisoner, institutionalized, or is unable to give informed consent. The subject has a life expectance of less than 1 year.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MEMO 3D ring<br>All patients in the study will be implanted with the MEMO 3D ring | Device: Implantation of the MEMO 3D Annuloplasty Ring<br>* Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients with successful repair at 6 months. |  | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, mitral valve regurgitation, mitral valve disease, mitral valve repair, mitral valve dysfunction, heart valve, valve disease
Open-label Study With Bosentan in Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

Official Title
-----------------
Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330.

Conditions
-----------------
Interstitial Lung Disease, Scleroderma

Intervention / Treatment
-----------------
* Drug: bosentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To have completed the 12-month treatment period of the AC-052-330/BUILD 2. Women should not be pregnant Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception Signed informed consent prior to initiation of any study-mandated procedure Exclusion Criteria: Any major violation of the protocol AC-052-330.

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: bosentan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to all assessed time points in 6-minute walk test distance. |  |  | 
| Change from baseline to all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value). |  |  | 
| Transition Dyspnea Index at all assessed time points. |  |  | 
| Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 ≥ 4%), trough SpO2 and area under the curve during 6-minute walk test. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events; serious adverse events. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
interstitial lung disease, scleroderma, bosentan