linjc16/ctgov huggingface dataset:
Use of Sucrose to Relieve Pain During Eye Exams in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12 hours following examination. Events include episodes when the infants temporarily stop breathing, have a drop in their heart rates, or have a drop in their oxygen levels.

Official Title
-----------------
Effectiveness of an Oral Sucrose Solution in Reducing Pain and Anxiety Associated With Neonatal Ophthalmologic Examination

Conditions
-----------------
Pain, Apnea of Prematurity, Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Dietary Supplement: sucrose solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All premature infants admitted to the Neonatal Intensive Care Unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. This includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen. Exclusion Criteria: Any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. This includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus. Any infant being maintained on narcotics for any reason will not be eligible for the study. All infants with major congenital anomalies will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 5 Weeks

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: sucrose solution|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
-----------------
pain control
Palliation of Dyspnea With Mouth Piece Ventilation

Study Overview
=================
Brief Summary
-----------------
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with incurable advanced disease. Subjects are recruited from a local Hospice and from oncology ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.

Official Title
-----------------
Palliation of Dyspnea With Mouth Piece Ventilation

Conditions
-----------------
Dyspnea

Intervention / Treatment
-----------------
* Device: Trilogy 100 ® (Philips Respironics)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4) incurable advanced disease able to understand the study and to give informed consent would not gain from intensive care or resuscitation according to the treating physician Exclusion Criteria: unable to participate and use MPV due to e.g. delirium or lack of co-operation the cause of the dyspnea can be succesfully treated unable to give informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MPV arm<br>Subjects use mouth piece ventilation (MPV) accoring to their will to alleviate dyspnea for 24 hours. | Device: Trilogy 100 ® (Philips Respironics)<br>* Trilogy 100 ® (Philips Respironics) on MPV mode.<br>* Other names: Mouth piece ventilation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dyspnea after initial use of MPV |  | 5 - 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dyspnea after 24 hours of using MPV |  | 24 hours | 
| Proportion of subjects having side-effects or not being compliant with MPV |  | 24 hours | 
| Proportion of subjects gaining from MPV |  | 24 hours | 
| Proportion of subjects willing to continue on MPV after the intervention |  | 24 hours |
Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.

Official Title
-----------------
Translational Diabetes Prevention in GDM

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland Pregnancy complicated by high glucose levels starting November 2011 Exclusion Criteria: Recognized DM prior to pregnancy Uncontrolled hypertension during pregnancy Severe active thyroid disease during pregnancy Severe diseases of the cardio-pulmonary system Diagnosis of a severe psychiatric disorder Diagnosis of cancer Conditions that lead to diet changes Addiction to alcohol or illegal drugs Current corticosteroid medicine use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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: Lifestyle Counseling<br> | Behavioral: Lifestyle Counseling<br>* The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postpartum body weight |  | through 24 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of women who reach body weight goals |  | through 24 months postpartum | 
| percent of calories from fat |  | through 24 months postpartum | 
| time spent in physical activity (PA) by intensity |  | through 24 months postpartum | 
| postpartum glycemia |  | through 24 months postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational Diabetes, Weight Loss, Physical Activity, Pregnancy, Postpartum, Intervention
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.

Official Title
-----------------
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

Conditions
-----------------
Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: IPI-145 (duvelisib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years of age; Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients; An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2. Exclusion Criteria: Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase); Patients with overt leptomeningeal leukemia or CNS lymphoma; Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x ULN; Inadequate renal function defined by serum creatinine > 1.5 x ULN

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 |
| --- | --- |
| Experimental: IPI-145<br>IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles. | Drug: IPI-145 (duvelisib)<br>* Oral Twice A Day (BID) Dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities. | At least 28 days (1 Cycle) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase 1
The Physical Effects of Pain Catastrophizing in Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. Other studies have shown that women who experience intense pain in the earliest stages of labor have a higher risk of complications. The investigators want to know if negative thoughts can predict this outcome.

Detailed Description
-----------------
Subjects will complete questionnaires at three timepoints: during the prenatal period, within 24-48 hours of giving birth, and 4-8 weeks postpartum. The questionnaires will measure pain catastrophizing, depression, maternal support, support and control in birth, and childbirth satisfaction. Chart review following delivery will record data such as length of labor, medication used, need for augmentation or surgical delivery, complications.

Official Title
-----------------
The Physical Effects of Pain Catastrophizing on Normal Labor

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 20 weeks of pregnancy Nulliparous Singleton pregnancy Low risk pregnancy Exclusion Criteria: Primiparous and multiparous women Women who request cesarean delivery Women who are pregnant with twins Women who plan induction Women who deliver before 37 weeks Women enrolled in the Centering Pregnancy program at the Family Birth Center High risk pregnancies Severe mental illness that impairs cognition or function Suicidal ideation Women who do not speak English or Spanish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms) |  | Immediate postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between pain catastrophizing and reported pain in labor |  | 1 day postpartum and 4-8 weeks postpartum | 
| Relationship between pain catastrophizing and satisfaction with birth experience and care |  | 1 day postpartum and 4-8 weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, birth, labor, labor pain, catastrophizing
Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy

Study Overview
=================
Brief Summary
-----------------
A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.

Official Title
-----------------
A Phase IV, Open-label, Multi-center Trial to Evaluate the Safety and Efficacy of Keppra® After Conversion to Mono-therapy in Adult Subjects With Partial Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Drug: Levetiracetam (Keppra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of epilepsy with partial seizures; having completed the trial N01031 of Keppra as adjunctive therapy (SKATE); seizure-free over the last 3 months prior to protocol Visit 1; 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031; on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted. Exclusion Criteria: History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years; presence of known pseudoseizures within the last year; presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives; felbamate with less than 18 months exposure; vigabatrin, without visual field assessment as per recommendation of the manufacturer, i.e., every 6 months; uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Levetiracetam (Keppra)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate seizure freedom with Keppra flexible dose. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and safety. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levetiracetam, Keppra
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

Study Overview
=================
Brief Summary
-----------------
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.

Detailed Description
-----------------
Patients are randomized to 1 of 2 arms: Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).

Official Title
-----------------
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Lamivudine
* Drug: Stavudine
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV-1 seropositive status. CD4 count greater than 100 cells/mm3. Viral RNA above 10,000 copies/mL. Consent from parent or guardian if less than 18 years of age. Exclusion Criteria Prior Medication: Excluded: Prior therapy with protease inhibitors. Prior therapy with 3TC.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|
|Drug: Zidovudine|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
-----------------
HIV-1, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors
Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The investigators examined the efficacy of nefopam in patients undergoing kidney transplantation.

Detailed Description
-----------------
Drug combination are frequently used to relieve postoperative pain. Nefopam can inhibit serotonin, dopamine, and norepinephrine reuptake through central mechanisms. Several studies have demonstrated analgesic efficacy of nefopam in the postoperative period. The purpose of this study is to ascertain the analgesic effect and tolerance of intravenous nefopam in combination with fentanyl based patient-controlled analgesia after kidney transplantation.

Official Title
-----------------
Analgesic Efficacy of Nefopam in Patients Undergoing Kidney Transplantation : Randomized Controlled Study

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Normal saline
* Drug: Nefopam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective living donor kidney transplantation Exclusion Criteria: pre-operative tachycardia (> 100bpm) liver dysfunction severe cardiac disease body mass index ≥ 30 kg/m2 drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nefopam<br> | Drug: Nefopam<br>* Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours<br>|
| Placebo Comparator: Control<br> | Drug: Normal saline<br>* Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl consumption by patient-controlled analgesia |  | 48 hours | 
| Numerical rating score of pain |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients who had side effects (e.g. nausea, vomiting, dizziness, headache, confusion, tachycardia) |  | 48 hours | 
| Early postoperative graft function | serum creatinine, estimated glomerular filtration rate, delayed graft function defined as the need for dialysis within 1 week after surgery, acute rejection episodes included both biopsy-proven and clinically suspected acute rejection | until discharge |