linjc16/ctgov huggingface dataset:
A Multiple Ascending Dose Study of the mTOR Inhibitor (RAD001) in Combination With R1507 in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This 2 part study will assess the safety, tolerability and efficacy of a combination of oral daily RAD001 and intravenous 3-weekly R1507 in patients with advanced solid tumors. In Part 1 of the study, patients will be enrolled sequentially to receive 5mg by mouth (po) RAD001 daily + 16mg/kg intravenous (iv) R1507 every 3 weeks (level 1) and if tolerated, 10mg po RAD001 daily + 16mg/kg iv R1507 every 3 weeks (level 2).In Part 2 of the study, patients with 1) advanced renal cell cancer and 2) advanced pancreatic neuroendocrine tumors will receive the maximum tolerated dose regimen from Part 1 (5mg or 10mg po RAD001 + 16mg/kg iv R1507). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Official Title
-----------------
Multiple Ascending Dose (MAD) Phase Ib/II Study of the mTOR Inhibitor (RAD001) in Combination With the IGF-1R Antagonist (R1507) for the Treatment of Patients With Advanced Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: RAD001
* Drug: RG1507


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; histologically confirmed recurrent or refractory advanced solid tumor (Part 1); advanced metastatic renal cell cancer OR advanced metastatic pancreatic neuroendocrine tumors, with evidence of progressive disease (Part 2); measurable disease (Part 2); ECOG performance status 0-2. Exclusion Criteria: prior treatment with agents acting via inhibition of IGF-IR pathway; prior treatment with agents acting via inhibition of mTOR (Part 2); untreated CNS metastases; current anti-cancer therapy, or radiotherapy or chemotherapy <=4 weeks prior to enrollment; other known malignancy requiring treatment.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RAD001<br>* 5mg or 10mg po daily<br>Drug: RG1507<br>* 16mg/kg iv every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of RAD001, in combination with R1507 (Part 1 |  | First 3 week cycle of treatment | 
| Progression-free survival (Part 2) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall objective response rate; duration of response; overall survival |  | Event driven; monitored throughout study |
Patient Experience of Interventional Pain Management. Qualitative Study

Study Overview
=================
Brief Summary
-----------------
There are quite a few qualitative studies done to find out patients experience of chronic pain. There are no studies on what the patients feel and what thoughts and feelings arise in the patients that are exposed to interventional pain management. This study aims to illuminate how it is to live through an interventional pain management program.

Detailed Description
-----------------
A qualitative interview is performed with patients that have passed through an interventional pain management program. The transcribed interviews are analyzed with qualitative content analysis according to Graneheim and Lundman in order to illuminate the experience, feelings and thoughts arisen among the patients.

Official Title
-----------------
Patient Experience of Interventional Pain Management. Qualitative Study

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Qualitative interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients passed through an interventional pain management program Exclusion Criteria: Purposeful sampling will be applied
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Interventional pain management patients<br>Patients passed through interventional pain management program | Other: Qualitative interview<br>* Qualitative interview to sample the patients feelings, experiences and thoughts risen by the treatments in the program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience of interventional pain management | Qualitative interview performed at one occasion where the patient describes the experience of the interventional pain management he/she has passed through | 1 year |
Association of CD49d and CD44 in CLL Patients and Their Role in Prognosis

Study Overview
=================
Brief Summary
-----------------
The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation

Detailed Description
-----------------
Chronic lymphocytic leukemia (CLL) is the most common type of chronic leukemia, accounting for approximately 40% of all leukemia's and mainly affecting older individuals. As it has a highly variable clinical course, identification of molecular and biological prognostic markers has provided new insights into the risk stratiﬁcation of patients with CLL . The interactions of chronic lymphocytic leukemia cells with the microenvironment in secondary lymphoid tissues and the bone marrow are known to promote CLL cell survival and proliferation . CD49d (one of biomarkers) is one of independent prognostic risk parameter in CLL with important roles in shaping these interactions. CD49d also is one of independent prognostic risk parameters in CLL that predict adverse outcome and linked to processes involved in interaction with the vascular endothelium and/or migration into the extravascular compartments . The cell-surface glycoprotein CD44 is involved in cell motility, cellular trafficking, and stem cell differentiation . It contributes to the phenotypic hallmarks of many cancers, such as invasiveness, self-renewal, and sustained survival. CD44 transmits both growth and apoptotic signals, a functional duality that is also observed in hematologic malignancies. CD44 expression in CLL is mediated by the tumor microenvironment. As a coreceptor, CD44 promotes leukemogenesis by regulating stimuli of MCL1 expression. Moreover, CD44 can be addressed therapeutically in CLL by specific antibodies.

Official Title
-----------------
Association of CD49d and CD44 in CLL Patients and Their Role in Prognosis

Conditions
-----------------
Cellular Diagnosis, Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients are newly diagnosed as CLL Exclusion Criteria: : patients with associated malignancies
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To what extent the identiﬁcation of molecular and biological prognostic markers has provided new insights into the risk stratiﬁcation of patients with CLL . | detecting membrane expression of CD49d and CD 44 and thier role in prognosis of CLL patients. | 1 YEAR |
Body Composition Analysis for Patient With Lung Cancer Using Computed Tomography Image Analysis

Study Overview
=================
Brief Summary
-----------------
Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, it has been mainly studied from several assessment methods which do not usually differentiate muscle from other tissues. Aim: To analyze body composition of patients with lung cancer at diagnosis using computed tomography (CT-Scan) image analysis. Methods: This is a retrospective study extending over a period of 3 years conducted at the Institut universitaire de cardiologie et de pneumologie de Québec (2009-2012). We listed patients newly diagnosed with lung cancer who had a thoraco-abdominal CT-scan performed in our institution. Following the collection of clinical data from patient records, we used SliceOmatic software to quantify muscle area, visceral fat area and subcutaneous fat area from a single abdominal cross-sectional image at the level of the third lumbar vertebra.

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women Between 40-80 years of age Primary lung cancer diagnosed between 2009 and 2012 CT-Scan done at the time of the diagnosis Exclusion Criteria: Chemotherapy, radiotherapy or surgery at the time of the first Ct-Scan image History of other cancer (during the last five years)

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Lung cancer patient at diagnosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of muscle area (cm2/m2) at the level of the third lumbar vertebra |  | at the time of the diagnosis of lung cancer and one year following it. | 
| Change of fat area (cm2/m2) at the level of the third lumbar vertebra |  | at the time of the diagnosis of lung cancer and one year following it. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of survival |  | From the time of the diagnosis of lung cancer until one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Body composition analysis, Ct-Scan, Muscle mass, Cachexia
Cardiopulmonary Bypass and Inflammatory Response

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a difference exists in the inflammatory response which occurs related to coronary artery bypass graft (CABG)surgery performed on cardiopulmonary bypass as compared to CABG surgery performed off bypass at the University of Pittsburgh Medical Center.

Detailed Description
-----------------
Acute inflammatory response occurring in cardiopulmonary bypass (CPB) patients has been clearly associated with deleterious clinical outcomes. Increasing understanding of the pathophysiology of systemic inflammatory response syndrome (SIRS) following CPB has facilitated the development of strategies to attenuate the damaging effects of cytokine-induced inflammation. For any strategy to be tested, one needs to clearly define and understand the inflammatory response occurring with CPB. Although this has been extensively studied, there is wide variation in the reported time course and magnitude of this response. This variation is, in part, due to the heterogeneous nature of the patient population studied (variable severity of illnesses, ejection fractions, co-morbidities, etc.). Hence, in our study, we propose to study the inflammatory response occurring in patients undergoing coronary artery bypass graft (CABG) with and without the use of CPB in our institution, and to determine whether the severity of inflammatory response seen in CABG patients is associated with impairment of any specific clinical parameter in the immediate post-operative period (i.e., ventricular dysfunction, lung injury, bleeding, renal failure, etc).

Official Title
-----------------
Cardiopulmonary Bypass and Inflammatory Response

Conditions
-----------------
Thoracic Surgery, Cardiopulmonary Bypass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing CABG and/or patients undergoing other procedures (i.e., valve surgery, myomectomy, etc.) in addition to coronary revascularization Age: 18 years up to and including 90 years Exclusion Criteria: Patient is not scheduled to undergo CABG surgery Ejection Fraction £ 30% Chronic renal failure requiring hemodialysis Long-term steroid use prior to surgery HIV positive patients (HIV testing will not be required to rule out HIV) Status post organ transplantation or on immune modulating drugs Presence of severe sepsis in the past month prior to surgery Prisoners

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, cardiopulmonary bypass, cytokines
Analysis of Risk Factors and Establishment of Early Warning Model for Pulmonary Complications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect perioperative diagnosis and treatment information for cardiac surgery patients, collect blood samples for laboratory testing when necessary, and analyze the data to clarify the risk factors of pulmonary complications in patients undergoing cardiac surgery during the perioperative period. On this basis, a clinical early warning model for pulmonary complications after cardiac surgery will be developed to reduce the risk of pulmonary complications and even death in clinical practice.

Official Title
-----------------
Analysis of Risk Factors and Establishment and Application of a Clinical Early Warning Model for Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Postoperative Pulmonary Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients aged 18 years or older; Elective cardiac surgery under general anesthesia Exclusion Criteria: Patients and their family members refused to be enrolled; Patients unable to communicate due to language barriers such as dementia; Patients admitted to ICU 24h before surgery; Estimated duration of surgery less than 2 hours; Patients died or discharged within 24 hours after surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients with pulmonary complications following cardiac surgery<br> | |
| Patients without pulmonary complications following cardiac surgery<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of postoperative pulmonary complications |  | 1 week after surgery |
Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

Detailed Description
-----------------
40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Official Title
-----------------
Milrinone Versus Sildenafil in Treatment of PPHN in Neonates

Conditions
-----------------
Persistent Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Milrinone
* Drug: Sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age >34 weeks postnatal age <10 days Exclusion Criteria: neonates with congenital heart disease neonates with congenital diaphragmatic hernia

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 10 Days

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 |
| --- | --- |
| Active Comparator: milrinone<br>Milrinone is a phosphodiesterase inhibitor typ3 used in treatment of PPHN. used in dose (0.25 to 0.75 mg/kg/min) intravenous infusion compared with nasogastric sildenafil. | Drug: Milrinone<br>* milrinone lactate, 1mg/ml, for intra venous use only<br>* Other names: primacor;|
| Active Comparator: sildenafil<br>Sildenafil is a phosphodiesterase inhibitor typ 5 used in treatment of PPHN. used in dose (0.2 to 0.5 mg/kg/6h) by nasogastric tube compared with intravenous milrinone infusion. | Drug: Sildenafil<br>* 50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube<br>* Other names: Viagra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of milrinone versus sildenafil in treatment of PPHN | effect on oxygenation index | 6 - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| final outcome | Mortality | 6 - 12 months | 
| Bleeding | Bleeding (e.g pulmonary hemorrhage) that is believed to be attributed to medication | 6-12 months | 
| Ventilation | total duration of mechanical ventilation | 6-12 months | 
| Ventilatory settings | highest ventilator settings | 6-12 months |
Mental Health in Veterans and Families After Group Therapies

Study Overview
=================
Brief Summary
-----------------
PTSD (posttraumatic stress disorder) and associated mental health conditions affect both veterans and their family members. This study investigates whether group therapy using EFT (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in PTSD and comorbid symptoms.

Official Title
-----------------
Mental Health in Veterans and Families After Group Therapies

Conditions
-----------------
Post-Traumatic Stress Disorders

Intervention / Treatment
-----------------
* Behavioral: CBT (Cognitive Behavior Therapy)
* Behavioral: EFT (Emotional Freedom Techniques)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ability to follow instructions, complete written forms, and provide informed consent. Subjects are required to be literate and understand English. Physically healthy. Active duty military service, veterans, and their family members. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait List<br>Wait Period corresponding in length to treatment period | |
| Experimental: EFT (Emotional Freedom Techniques)<br>EFT group therapy sessions. | Behavioral: EFT (Emotional Freedom Techniques)<br>* Group therapy sessions using EFT<br>|
| Active Comparator: CBT (Cognitive Behavior Therapy)<br>CBT group therapy sessions | Behavioral: CBT (Cognitive Behavior Therapy)<br>* CBT group therapy sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline PTSD (posttraumatic stress disorder) Symptom Levels | Symptoms are measured before the first group therapy session. Symptom levels are also recorded immediately after the last group session, and at follow-up points: one, three, six, and twelve months later. | Pre-Intervention, Post-Intervention, with one, three, six, and twelve month follow-ups |
A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.

Detailed Description
-----------------
Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen. The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.

Official Title
-----------------
A Non Randomized Stratified Phase II Trial Evaluating Efficacy and Safety of Oxaliplatin in Combination With 5-Fluorouracil in Patients With Platinum-sensitive and Platinum-resistant Recurrent Ovarian Carcinoma

Conditions
-----------------
Ovarian Carcinoma, Relapse

Intervention / Treatment
-----------------
* Drug: Oxaliplatin
* Drug: oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ovarian carcinoma relapse Exclusion Criteria: neurotoxicity grade III renal clearance < 60 ml/min

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: intravenous chemotherapy<br>treatment of ovarian carcinoma in relapse | Drug: Oxaliplatin<br>* 85 mg/m² / 14days<br>* Other names: No other intervention;Drug: oxaliplatin<br>* oxaliplatin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | at 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian carcinoma, Bordet, relapse