linjc16/ctgov huggingface dataset:
Continued Access to RXDX-105

Study Overview
=================
Brief Summary
-----------------
This study is being done to see if people with Non-Small Cell Lung Cancer (NSCLC) or ovarian cancer benefit from continued treatment with the study drug, RXDX-105.

Official Title
-----------------
RXDX-105 for the Treatment of Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring a RET Gene Fusion and a Patient With Ovarian Cancer Harboring a BRAF Gene Mutation

Conditions
-----------------
Non Small Cell Lung Cancer, Ovarian Cancer, RET Gene Mutation, BRAF Gene Mutation

Intervention / Treatment
-----------------
* Drug: RXDX-105


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This individual patient protocol includes treatment for 3 patients previously enrolled on IRB #15-270 (phase1/1b clinical trial RXDX-105-01): Exclusion Criteria: Any patients other than those described above are excluded.

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: Participants previously enrolled on Study of RXDX-105<br>Participants were previously enrolled on Study of RXDX-105 | Drug: RXDX-105<br>* RXDX-105 capsules will be administered orally on a continuous daily dosing regimen. Patients will be continue to be treated at the dose level they were previously treated on during participation on Study of RXDX-105.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation during treatment/intervention | Safety assessments will be performed as standard of care and as clinically indicated. This will include monitoring of adverse events, including serious adverse events including CTCAE grading. | Through study completion, up to five years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RXDX-105, Memorial Sloan Kettering Cancer Center, 18-487
Effect of Vitamin B12 and n-3 Polyunsaturated Fatty Acids on Plasma Homocysteine

Study Overview
=================
Brief Summary
-----------------
Vitamin B12and n-3 polyunsaturated fatty acids (PUFA) decrease blood homocysteine (Hcy) concentration. However, the combined effect of these nutrients on Hcy and ferritin, and C-reactive protein is limited and inconclusive. The objective was to examine the synergistic effect of vitamin B12 in combination of n-3 PUFA on plasma Hcy, ferritin, and other biochemical markers. In a randomized controlled trial, thirty eligible subjects were randomly divided into three groups, and assigned to receive 1000 μg of vitamin B12, 2g fish oil, or 1000 μg vitamin B12 and 2g fish oil respectively for 8 weeks. Plasma phospholipid (PL) fatty acids and biochemical markers were determined. we hypothesize that combination of vitamin B12 and fish oil have synergistic effect on lowering plasma concentrations of Hcy and ferritin.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Fish oil
* Dietary Supplement: vitaminB12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reliability, regular eating habits, normal weight, nondrinking, and nonsmoking status Exclusion Criteria: None of the selected subjects used any vitamins or dietary supplements and was taking no medication for at least 8 weeks before the start of and during the entire experimental period

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 28 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: vitaminB12<br>VitB12 group (VitB12, n=10) receives 8 weeks of treatment with daily oral doses of 1000 μg of vitamin B12 (one capsule) | Dietary Supplement: vitaminB12<br> <br> |
| Experimental: Fish oil<br>Fish oil group (FO, n=10)receives 8 weeks of treatment with daily oral doses of 2g of fish oil in the form of two capsules of fish oil) . | Dietary Supplement: Fish oil<br> <br> |
| Experimental: Fish oil+vitaminB12<br>VitB12+Fish oil group (VitB12+FO, n=10) receives 8 weeks of treatment with daily oral doses of a combination of 1000 μg of vitamin B12 and 2g of fish oil | Dietary Supplement: Fish oil<br> <br> Dietary Supplement: vitaminB12<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| homocysteine,umol/L |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
homocysteine-vitamin B12-fish oil-ferritin
Study Evaluating Bifeprunox in Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bipolar disorder Experiencing a depressive episode

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bifeprunox|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of this study is to investigate if 8 weeks of treatment with flexible doses of bifeprunox (20 to 40 mg/day) is superior to treatment with placebo in depressed outpatients with bipolar disorder. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using the change from baseline to endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS), total score as the primary efficacy endpoint |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Bipolar Disorder
Clinical Study of Titrating PEEP of Different Methods on Right Heart Function

Study Overview
=================
Brief Summary
-----------------
To observe the influence of different methods titrating PEEP on right heart function and pulmonary artery pressure in ARDS patients .

Detailed Description
-----------------
30 patients who diagnosed as ARDS were included in this study.Then set PEEP with respectively ARDS net 、EIT and Esophageal Pressure in Breathing Machine . Recorded diameter of right and left ventricular TAM TAPSE pulmonary artery pressure.Objective to evaluate the correlation between the level of PEEP in three methods and the right heart function and pulmonary artery pressure in ARDS patients .

Official Title
-----------------
Clinical Study of Titrating PEEP of Different Methods on Right Heart Function and Pulmonary Artery Pressure in ARDS Patients

Conditions
-----------------
ARDS, Human

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to ICU diagnosed of modecate to severe ARDS (Berlin criteria) Patients age between 18 years old and 80 years Exclusion Criteria: Patients with chronic respiratory diseases such as COPD. Ventilated because of oesophageal surgery in the previous 12months. Patients who cannot obtain clear ultrasound images due to thoracic surgery ,massive pleural effusion. Oesophageal bleeding in previous 30 days history of oesophageal varices. Facial trauma and surgery.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the function of right heart and pulmonary artery pressure | Systolic Pulmonary Artery Pressure TAPSE or Tricuspid Annular Motion orTricuspid annular plane systolic excursion or right ventricular diameter or right left ventricular diameter ratio in diffrient PEEP | 2018.4-2019.3 |
Population-based Chronic Kidney Disease Cohort at Northern Taiwan

Study Overview
=================
Brief Summary
-----------------
CKD is a global endemic disease with increased comorbidities and mortality. The prevalence and the incidence of the end-stage renal disease (ESRD) are extremely high in Taiwan. The prevalence of CKD remains high; however, the awareness remains low. Screening of unique risk factor and early diagnosis of CKD can improve outcome. Furthermore, data of renal education deep into the community remains limited. The aims of this study are: Explore risk factors associated with CKD in the community Establish multidisciplinary care model in the community Investigate mechanistic mediators for CKD and multidisciplinary education approached in behavioral , physiological, immune and metabolomics aspects Provide bio-specimen repository for future study

Official Title
-----------------
Preventing Progression of Renal Disease by Multidisciplinary Education - A Cohort Study at Northern Taiwan.

Conditions
-----------------
Chronic Kidney Disease, Population, Community, Multidisciplinary, Education

Intervention / Treatment
-----------------
* Behavioral: multidisciplinary renal education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: residents of Northern Taiwan Exclusion Criteria: pregnancy women, unwilling to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: education arm<br>multidisciplinary education: multidisciplinary CKD education involving case management nurse, dietitian, social worker, pharmacists. | Behavioral: multidisciplinary renal education<br>* multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eGFR < 60 mL/min | change of renal function between groups | through study completion, every 1 year | 
| albuminuria/creatinine ratio >=30 | change of proteinuria between groups | through study completion, every 1 year | 
| proteinuria/creatine ratio >=150 | change of proteinuria between groups | through study completion, every 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | change of score between groups | through study completion, every 1 year |
A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of different parameters (voltage, pulse width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms in patients with Parkinson's disease (PD).

Detailed Description
-----------------
In this observational study, we will retrospectively analyze the one-year follow-up data of 27 PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University in the years 2008-2012. The data, including parameter settings and severity of motor symptoms indicated by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores, was collected during the patients' annual visit to the hospital for reprogramming. A correlation analysis will be conducted to investigate the relationship between change of a specific parameter and the subsequent change of motor scores.

Official Title
-----------------
A Retrospective Study of the Effects of Different Parameters on Motor Symptoms of PD in Bilateral STN Stimulation

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PD patients treated with bilateral STN DBS in the First Affiliated Hospital in the years 2008-2012 Exclusion Criteria: Simultaneous participation in another clinical trial Dementia (Mini Mental State Examination < 26) Removal of DBS electrodes Loss to follow-up

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Change of parameters (voltage, pulse width, frequency) during follow-up |  | at 12 months | 
| Change of UPDRS Part III score and the relation to parameters |  | at 12 months | 
| Changes of tremor, rigidity, bradykinesia and postural stability scores evaluated by UPDRS Part III and the relation to parameters |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of daily levodopa equivalent dosage (LED) during follow-up |  | at 12 months |
Hypothermia and the Effect of Ambient Temperature

Study Overview
=================
Brief Summary
-----------------
Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months.

Official Title
-----------------
The Impact of Ambient Operative Room Temperature on Neonatal and Maternal Hypothermia

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Other: change in temperature


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery West Unit (operating rooms 1, 2, 3, and 5) during the study period. Exclusion Criteria: Subjects will be excluded from the study if cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly, resuscitative efforts are not performed (comfort care only provided), or a neonatal temperature is not available.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Ambient Temperature of 67F<br>These patients will have an operating room temperature of 67F for cesarean delivery, the standard of care at our institution. | |
| Active Comparator: Ambient Temperature of 73F<br>These patient will have an operating room temperature of 73F for cesarean delivery, a temperature more consistent with WHO recommendations. | Other: change in temperature<br>* increase in ambient room temperature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal hypothermia | a core temperature of less than 36.5C | up to 2 hours following delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal hypothermia | an oral temperature of less than 36.5C | up to 10 hours following delivery |
Gender and Opioid Consumption

Study Overview
=================
Brief Summary
-----------------
Opioids are widely used for pain relief after major abdominal surgeries[1]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, Opioid related complications (respiratory depression, Nausea & vomiting, itching, over-sedation, delayed intestinal motility).

Conditions
-----------------
Postoperative; Parotitis

Intervention / Treatment
-----------------
* Drug: postoperative morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I and II Cases scheduled for elective intraabdominal surgeries Exclusion Criteria: diabetes, postmenopausal females, laparoscopic surgery, regional anesthesia emergency procedures, sepsis, hepatectomy, Renal impairment, and hepatic impairment, mental and psychiatric disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Male group<br>All male patients scheduled for upper abdominal surgeries | Drug: postoperative morphine<br>* Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.<br>|
| Active Comparator: Female group<br>All female patients scheduled for upper abdominal surgeries | Drug: postoperative morphine<br>* Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative morphine consumption |  | 24 hours after surgery |
The Role of Midkine in Diagnosis of Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of the role of serum midkine in differentiating malignant from benign thyroid nodule studying the level of serum midkine in relation to different thyroid cancer stages

Official Title
-----------------
The Role of Midkine in Diagnosis of Thyroid Cancer

Conditions
-----------------
Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with thyroid nodule Exclusion Criteria: Other known organ tumour Chemothyrapy Radiothyrapy c. Sample Size Calculation
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 |
| --- | --- | --- |
| serum midkine levels |  | Baseline |