linjc16/ctgov huggingface dataset:
Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

Study Overview
=================
Brief Summary
-----------------
The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.

Official Title
-----------------
A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

Conditions
-----------------
Lung Neuroendocrine Neoplasm

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed carcinoid tumors Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible Exclusion Criteria: Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible) Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus) Other protocol-defined inclusion/exclusion criteria may apply.

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

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: RAD001<br> | Drug: RAD001<br> <br> * Other names: Everolimus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis |  | every 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria |  | 6 weeks | 
| Date and reason of death, or discontinuation from the study. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phase Ib,, RAD001,, advanced pulmonary neuroendocrine tumor
Acute, Affective, Organic Disorders.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate whether patients with brief depressive periods together with other fluctuating psychiatric symptoms, have this condition due to epilepsy or an other organic brain disorder.

Detailed Description
-----------------
A limited number of patients admitted to psychiatric acute wards or Psychiatric Intensive Care Units are admitted with a fluctuating array of psychiatric symptoms including brief depressive episodes. These patients do not fit into the present diagnostic systems due to short duration of affective symptoms and the fluctuating arrays of other symptoms. Case histories indicate that these patients have psychiatric conditions due to epilepsy or organic brain dysfunctions. In the study acutely admitted patients filling criteria for two recent DSM-4 axis 1 diagnoses (one is a brief depressive period) during the last two weeks are compared to age- and sex-matched patients acutely admitted with a major depressive disorder. The patients are rated with a number of rating scales at admittance, day 5, after two weeks and three months. EEG and QEEG are taken three times the first week. MRI, drug screening and blood screening of medication-concentrations are taken.

Official Title
-----------------
Signs of Organic Brain Dysfunction in Psychiatric Patients With Fluctuating Psychiatric Symptoms Including Brief Depressions Compared to Patients With a Major Depressive Episode.

Conditions
-----------------
Depressive Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acutely admitted psychiatric patients who have at different times the last 2 weeks filled criteria for at least two new DSM-4 Axis 1 psychiatric diagnoses. One of them has to be a depressive episode (MADRS>20) Exclusion Criteria: Patients not speaking Norwegian or English. Patients not willing to participate. Patients with dementia or mental retardation to an extensive degree.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| brief depressive periods<br>brief depressive periods together with other fluctuating psychiatric symptoms | |
| major depressive disorder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epilepsy or an other organic brain disorder | EEG and QEEG are taken three times in the first week | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brief depressive episodes, affective disorders, EEG and QEEG, epilepsy, organic brain disorders, acute psychiatry
Changes in Doppler Signals From the Lung Due to Cardiac Resynchronization in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
Study Purpose and Rationale The purpose of this study is to evaluate the lung Doppler signals changes during cardiac resynchronization procedure. As the LDS represent the various mechanical events of cardiac origin it is assumed that they may reflect the relative timing between contraction of the ventricles and atria and thus serve for effective synchronization of these activities. Aim of the study: The aim of the study is to assess whether the changes in Lung Doppler Signal (LDS) waves' characteristics will mimic the changes in echocardiographic parameters designed to assess diastolic inflow and systolic flow in patients undergoing Echo-based CRT optimization.

Official Title
-----------------
Lung Doppler Signals Changes in Response to Cardiac Resynchronization in Heart Failure Patients

Conditions
-----------------
Change in LDS Signals Due to Cardiac Synchronization Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18 years or older, who met the indications for cardiac synchronization therapy (CRT) per the ACCF/AHA guidelines, underwent successful system implant for more than 3 months, and were referred to the CRT non-responder clinic at the Ohio State University for CRT- Echo optimization due to absence of clinical improvement in functional class or ejection fraction after the implant per the judgment of the referring physician. Exclusion Criteria: Chronic atrial fibrillation or new cardiac arrhythmias detected at the time of the visit that are known to affect the response to CRT (Atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or frequent premature ventricular contractions). CRT device malfunction Inadequate CRT programming that has contributed to lack of response to CRT Coronary sinus lead anatomical or electrical malfunctions at the time of the visit Acute systemic illness that can explain their lack of functional improvement (i.e., anemia, severe electrolyte imbalance, pneumothorax, pericardial effusion, pneumonia) Inability to sign 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Doppler signals before and after CRT |  | During procedure |
Portable Pves Study

Study Overview
=================
Brief Summary
-----------------
A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional urodynamics the two sources of Pves will be collected concurrently.

Official Title
-----------------
An Accuracy Study to Assess the Performance of the Peritron+ in Measuring Vesical Pressure in Patients in Comparison With Standard Urodynamic Measurements

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Device: Peritron+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients normally indicated for urodynamic evaluation Exclusion Criteria: Patients who suffer from bladder infections Patients who suffer from strictures in the urethra

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peritron+<br>Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter | Device: Peritron+<br>* Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accurate Vesical PRessure | To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position. | During a routine urodynamic study (1 hr approx) |
The Effect of Use of Dermal Fat Graft as a Barrier Membrane

Study Overview
=================
Brief Summary
-----------------
a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted bone

Detailed Description
-----------------
The study has two group in which the study will have in addition to the conventional bone grafting addition of dermal fat graft to protect the bone. The control will have just normal graft The results are assessed using computed tomography to assess the quality of the grafted bone. The Chisquare test was used to asses the results significance.

Official Title
-----------------
The Effect of Use of Dermal Fat Graft as a Barrier Membrane in Unilateral Alveolar Cleft Grafting. (A Randomized Clinical Trial

Conditions
-----------------
Unilateral Cleft Lip

Intervention / Treatment
-----------------
* Procedure: Addition of dermal fat graft as protection over bone graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having age range of 8-14ys who performed for 2ry alveolar cleft grafting at the CCC using adipose fat graft in conjunction with ACBG Boys or girls. Unilateral or bilateral cleft alveolus. Accepts Healthy Volunteers has not been entered. Exclusion Criteria: Younger patients requiring 1ry grafting. Older patients requiring 3ry grafting.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Dermal fat graft is added over the grafted bone in the alveolar cleft to protect the bone from resorption | Procedure: Addition of dermal fat graft as protection over bone graft<br>* A barrier membrane<br>|
| No Intervention: control group<br>Conventional procedure of alveolar cleft grafting | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of oronasal fistula | assessment of incidence of recurrence of oronasal fistual after the surgical procedure clinically | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alveolar cleft grafting
Biomarker Research for Personalized Medicine

Study Overview
=================
Brief Summary
-----------------
The aim of this study : Through the study of genes of protein, transporter, translator and epigenome investigating the effect of anti-cancer treatment or the key factor of the MDR (Multidrug resistance) on the blood cancer patients who are under the anti-cancer sork treatment Giving a service of anticancer medicine therapeutic drug monitoring (TDM) and genotyping

Official Title
-----------------
Biomarker Research for Personalized Medicine in Blood Cancer Patient

Conditions
-----------------
Hematologic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean Clinical diagnosis of Hematologic neoplasms
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 |
| --- | --- | --- |
Extracellular Vesicles and Endothelial Function in Transgender Subjects

Study Overview
=================
Brief Summary
-----------------
Cardiovascular diseases are the leading cause of mortality. In women, the prevalence of cardiovascular diseases is lower and the presentation of coronary events often atypical. The lack of evidence is related in part to the methodology of studies not considering sex as an essential biological variable. Hormonal treatment is prescribed in transgender subjects to promote the development of sexual characteristics of the desired sex. Early cardiovascular effects of hormonal treatment have been reported in transgender men, while long-term mortality is higher in transgender women. The aim of this project is to study the effects of gender affirming hormonal treatment on arterial stiffness in young transgender subjects followed at the University Hospital of Nancy.

Official Title
-----------------
Effects of Plasma Extracellular Vesicles on Endothelial Function in Transgender Subjects

Conditions
-----------------
Transgenderism

Intervention / Treatment
-----------------
* Drug: gender affirming hormonal treatment in transgender men
* Drug: gender affirming hormonal treatment in transgender women


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Trasgender subject demanding gender affirming hormonal therapy Exclusion Criteria: Previous hormonal therapy Pregnancy Chronic disease Cancer Obesity Drug abuse Alcohol Tabac

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group: transgender men<br> | Drug: gender affirming hormonal treatment in transgender men<br>* testosterone enanthate<br>|
| No Intervention: Groupe: control cis-gender women<br> | |
| Experimental: Group: transgender women<br> | Drug: gender affirming hormonal treatment in transgender women<br>* GnRH agonists + estrogen<br>|
| No Intervention: Groupe: control cis-gender men<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulse wave velocity | measurement of arterial stiffness | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transgender persons, hormonal therapy
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

Study Overview
=================
Brief Summary
-----------------
The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.

Detailed Description
-----------------
Newly diagnosed non-Hodgkin lymphoma (NHL) patients will be recruited from each center participating in the LEO cohort. At time of consent, participants will be asked to completed several questionnaires collecting health history, current medical and quality of life questions. Patients will also provide a baseline blood sample that will processed locally and stored centrally for future research use. Additionally, consent is given for use of excess clinical tumor tissue for research use.

Official Title
-----------------
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

Conditions
-----------------
Non-Hodgkin Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed non-Hodgkin Lymphoma (NHL), within 183 days of enrollment Patients may have been treated as long as initial NHL diagnosis is within 6 months of enrollment 18 years of age or older Exclusion Criteria: Lymphoma diagnosis greater than 184 days from date of 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Time from date of diagnosis to date of death | Short (<5 years), medium (5-10 years), and long-term (>10 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event Free Survival (EFS) | Time from date of diagnosis to date of first defined event (disease progression, relapse or re-treatment for lymphoma, or death) | Short (<5 years), medium (5-10 years), and long-term (>10 years) | 
| Lymphoma Specific Survival (LSS) | Time from date of diagnosis to date of death due to lymphoma | Short (<5 years), medium (5-10 years), and long-term (>10 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cohort, non-Hodgkin, Lymphoma
Sutureless vs Sutured Gastroschisis Closure

Study Overview
=================
Brief Summary
-----------------
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

Detailed Description
-----------------
This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death. In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.

Official Title
-----------------
Sutureless vs Sutured Gastroschisis Closure

Conditions
-----------------
Gastroschisis

Intervention / Treatment
-----------------
* Procedure: Gastroschisis closure with suture
* Procedure: Gastroschisis closure without suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more. Exclusion Criteria:Exclusion criteria are infants with other major abnormalities or medical conditions, grade IV intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.
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 |
| --- | --- |
| Active Comparator: Sutured closure<br> | Procedure: Gastroschisis closure with suture<br> <br> |
| Active Comparator: Sutureless closure<br> | Procedure: Gastroschisis closure without suture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on ventilator |  | Up to 1 week | 
| Time to initiating enteral feeds |  | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmesis |  | 6 months after hospital discharge | 
| Length of hospital stay |  | Up to 6 weeks | 
| Complications including bowel resection, sepsis, and death. |  | Up to 45 days |