linjc16/ctgov huggingface dataset:
Gestational Weight Gain and the Electronic Medical Record

Study Overview
=================
Brief Summary
-----------------
Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM) recommended weight gain. To date, there are no randomized controlled trials studying the use of the electronic medical record to alert providers to initiate the counseling of patients on the IOM gestational weight gain recommendations. In the investigator's planned study intervention, using the EPIC EMR system, an electronic alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This alert will remind providers to counsel patients on the recommendations for gestational weight gain. The control group will receive standard prenatal care, without electronic alerts generated regarding BMI and gestational weight gain. The investigators hypothesize that a higher percentage of patients who receive the intervention will meet the IOM guidelines for weight gain.

Official Title
-----------------
WATE Study - Gestational Weight Gain and the Electronic Medical Record

Conditions
-----------------
Pregnancy, Weight Gain

Intervention / Treatment
-----------------
* Other: EMR Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant with a single intrauterine gestation Present for new OB visit up to 13 weeks and 6 days gestation Exclusion Criteria: They have a multiple gestation pregnancy They are under the age of 18 They do not speak English

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMR intervention<br>Patients will have an electronic medical record popup/highlight in their chart, displaying the recommended guidelines for weight gain in pregnancy. | Other: EMR Intervention<br>* Electronic medical record flag/notification in the patient's chart<br>|
| No Intervention: Control<br>The patient's medical record will be displayed as usual, with no flag or highlight for weight gain recommendations | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain | Primary outcome will be measured as the percent of patients who achieve their recommended weight gain goal in pregnancy (IOM guidelines) | At delivery, average of 40 weeks from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perception | Survey to patients at the end of pregnancy regarding how patients perceive and are influenced by EMR notifications and counseling | At end of pregnancy, average of 40 weeks from enrollment |
Evaluation of N6 Sound Processor in Group of Freedom Users

Study Overview
=================
Brief Summary
-----------------
Study of freedom sound processor users that upgrade to N6 sound processor CP900 series. To test speech understanding in each device and usability of upgrade.

Official Title
-----------------
Evaluation of N6 Sound Processor in Group of Freedom Users

Conditions
-----------------
Sensory Hearing Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with sensorineural hearing loss 12 years of age and older Currently using Freedom Sound Processor Recipient of a Ci22M or CI24 series implant Minimum of 3 months experience with Freedom Sound Processor Prior documentation of sentence recognition in noise at a +10 SNR or better Native English speaker Willingness to participate and comply with requirements of protocol Exclusion Criteria: Unable to complete test metrics Unrealistic expectations regarding possible benefits Additional handicaps that would prevent or restrict participation in audiological evaluations ABI cochlear implant recipient

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Evaluation of N6 Sound Processor in Group of Freedom Users | Speech recognition measures in quiet & noise via word and sentence rest and SSiQ questionnaire to compare freedom to upgrade with N6 relative to speech, spatial and quality dimensions and N6 questionnaire. | 3 months of use |
A Study of LY2523355 in Patients With Solid Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to examine a recommended dose for subsequent phase trial(s), by the observation of the safety and toxicity profiles of LY2523355 in patients with advanced and/or metastatic cancer. The secondary objectives are to study the pharmacokinetics and antitumor effect.

Official Title
-----------------
A Phase 1 Study of LY2523355 in Patients With Solid Cancer

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: LY2523355


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological and/or cytological evidence of solid tumors A diagnosis of advanced and/or metastatic solid tumors Patients who are refractory to standard therapy or for which no proven effective therapy exists Written informed consent Appropriate bone marrow, hepatic and renal functions ECOG PS =< 1 Exclusion Criteria: Have serious preexisting complication Have active infection which requires intravenous antibiotics Have symptomatic central nervous system metastases Have current acute or chronic leukemia Have had an autologous or allogenic hematopoietic stem cell transplantation Have active multiple cancers

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2523355<br> | Drug: LY2523355<br>* Days 1, 2, and 3 in a cycle that consists of 21-days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity based on the Common Terminology Criteria for Adverse Events v4.0 |  |  | 
| Number of patients with adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Plasma concentration of LY2523355 and metabolite |  | 
| Antitumor effect | Response evaluation criteria in solid tumors |  |
Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery.

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Ondansetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing video-assisted thoracoscopic surgery Age 20-75 American Society of Anesthesiologists physical status classification I or II Exclusion Criteria: Antiemetic within 24 hrs Taking Steroids, Opioids within 1 week Active drug or alcohol abuse GI motility disorder, severe renal/ hepatic disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Dexamethasone<br> | Drug: Dexamethasone<br>* Experimental: Dexamethasone 8 mg IV after induction of anesthesia, Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.<br>|
| Active Comparator: Group Ondansetron<br> | Drug: Ondansetron<br>* Active comparator: Ondansetron 4 mg IV at the end of surgery and 12 mg mix to intravenous patient controlled analgesia device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting |  | within 48 hrs after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative nausea and vomiting after video-assisted thoracoscopic surgery
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy

Study Overview
=================
Brief Summary
-----------------
A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.

Detailed Description
-----------------
Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.

Official Title
-----------------
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV RNA positive. failed standard therapy Exclusion Criteria: Cirrhosis on biopsy Severe medical or psychiatric conditions that would make the evaluation difficult Tamoxifen is a pregnancy category D drug so pregnant women must be excluded. Patients with coumadin cannot be used from a drug interaction. Active use of alcohol or illegal substances -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tamoxifen<br>open label giving of tamoxifen | Drug: tamoxifen<br>* giving drug tamoxifen<br>* Other names: Nolvadex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No significant changes in ALT or total bilirubin |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA reduction |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C, tamoxifen
Effects of Psycho-education of Patients With Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose for this study is to determine whether psycho-education in groups is more effective than individual psycho-education for patients with bipolar disorder.

Detailed Description
-----------------
The main aim of the study is to compare the effects of psycho-education in groups with short individual psycho-education. It is a randomized controlled trial including Bipolar 1 and 2 patients in a stable euthymic phase. 42 or 43 patients will receive group education in 10 weekly sessions and then a session every third month for two years. 42 or 43 patients will receive three individual sessions of education. Symptoms, admittances to hospital and function will be followed for two years.

Official Title
-----------------
Effects of Psycho-education of Patients With Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: individual education
* Behavioral: Group education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar Disorder 1 or 2 Euthymic Exclusion Criteria: Active depression or mania/hypomania

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group education<br>Bipolar 1 and 2 patients in a stable euthymic phase will receive group education in 10 weekly sessions and then a session every third month for two years. Symptoms, admittances to hospital and function will be followed for two years. | Behavioral: Group education<br>* group psycho-education in 10 weekly sessions and then a session every third month for two years<br>|
| Active Comparator: individual education<br>Bipolar 1 and 2 patients in a stable euthymic phase will receive three individual sessions of education. | Behavioral: individual education<br>* individual sessions of psycho-education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on depression and mania rating scales |  | 12 months | 
| Admissions to hospital |  | 24 months | 
| Working activity |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms, function, use and change in medication, need for |  | 24 months | 
| consultations |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Psycho-education
The Safety and Effectiveness of r-HuEPO in Patients With AIDS and Anemia Caused by AIDS and Treatment With AZT

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of erythropoietin administered subcutaneously to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy. Efficacy will be assessed by correction of anemia and decrease in transfusion requirements.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Efficacy of Subcutaneous Doses of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

Conditions
-----------------
HIV Infections, Cytopenias

Intervention / Treatment
-----------------
* Drug: Epoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of any primary hematologic disease. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS. AIDS-related dementia. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). Presence of concomitant iron deficiency. Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy. Acute opportunistic infection. History of seizures. Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded. Patients who have previously participated in any other r-HuEPO clinical study are excluded. Prior Medication: Excluded within 30 days of study entry: Experimental drug or experimental device. Cytotoxic chemotherapy. Excluded within 2 months of study entry: Androgen therapy. Clinical diagnosis of AIDS related anemia. Clinical diagnosis of AIDS. Clinically stable for 1 month preceding study entry. Maintenance dose of zidovudine (AZT) of at least 400 mg daily. Substance abuse.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Epoetin alfa|nan|

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
-----------------
Recombinant Proteins, Injections, Subcutaneous, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, Zidovudine
Preoperative Nasal Swabs From Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
We intend to take a nasal swab from each pediatric pre-operative patient in our out-clinic with the intention of looking for a connection between positive operative incisions and a positive nasal swab. The patients will be in the out-patient clinic for a few hours, and will be examined post-operatively after one week. Those with positive nasal swabs will be advised to apply a nasal cream (Mupirocin)in their noses for one week. Our hypothesis is that there is a correlation between positive nasal swabs and positive incision infections.

Official Title
-----------------
Double-Blind Prospective Study Concerning the Connection Between Positive Nasal Culture for Staphyloccoci in Pediatric Patients Undergoing Any Elective Surgery in the Out-Patient Clinic in the Hillel Yaffe Medical Center, Over a Period of One Year

Conditions
-----------------
Staphylococcal Infections

Intervention / Treatment
-----------------
* Procedure: Nose swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients attending outpatient surgery clinic Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| 1<br>All pre-operative pediatric patients in our outpatient clinic | Procedure: Nose swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Open-Label Extension of Other SZ1839 (Iressa) Trials

Study Overview
=================
Brief Summary
-----------------
A trial to assess patients who have been treated with Iressa in a previous clinical trial and may benefit from continued treatment with Iressa.

Official Title
-----------------
Multi-Centre, Open-Label Extension Trial of Treatment With ZD1839 (Iressa) in Patients Who Have Been Treated in Other ZD1839 Clinical Trials and May Benefit From Continued Monotherapy ZD 1839.

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib (Iressa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received treatment in a previous Iressa clinical trial Provided Informed Consent to participate in the trial 30 days or less since completing the previous Iressa trial. Exclusion Criteria: Radiotherapy completed more than 14 days before starting treatment in this trial Incomplete healing from prior surgery Withdrawal from previous Iressa trial due to unacceptable toxicity to major organs

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

| Intervention/Treatment |
| --- |
|Drug: Gefitinib (Iressa)|Iressa|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Every 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Every 28 days | 
| Survival |  | Every 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iressa, Gefitinib, Cancer, Patients diagnosed with cancer who have previously received Iressa in an Iressa clinical trial