linjc16/ctgov huggingface dataset:
Clinical and Pathologic Studies in Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
This research involves the study of neuroendocrine tumors in order to better understand how the disease grows and spreads. This study requires will use tissue collected from from biopsies performed during your regular medical care (i.e. tissue leftover after your diagnosis has been made) and/or blood and urine samples. This study may lead to the development of special materials that could be used, in the future, to treat neuroendocrine tumors or to follow the response of neuroendocrine tumors to treatment

Official Title
-----------------
Clinical and Pathologic Studies in Neuroendocrine Tumors

Conditions
-----------------
Carcinoid Tumor, Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Procedure: blood sample draw
* Procedure: urine sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Patients are eligible if they have a histologically proven neuroendocrine tumor and are 18 years of age or older - Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:None

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

| Intervention/Treatment |
| --- |
|Procedure: blood sample draw|nan|
|Procedure: urine sample|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).

Detailed Description
-----------------
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.

Official Title
-----------------
Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria (AHP)

Conditions
-----------------
Acute Hepatic Porphyria

Intervention / Treatment
-----------------
* Drug: Givosiran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Coproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria) Have adequate venous access for program sample collections as judged by the Investigator for study sample collections Exclusion Criteria: Previously or currently participating in a givosiran clinical trial Has any of the following laboratory parameter assessments at Screening: Alanine aminotransferase (ALT) >2×ULN Total bilirubin >1.5×ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is <2×ULN Estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73 m2 On an active liver transplantation waiting list

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Givosiran|givosiran (ALN-AS1) administered as a subcutaneous (SC) injection|

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
-----------------
Givosiran, Expanded Access, EAP, Acute Hepatic Porphyria (AHP), Acute Intermittent Porphyria (AIP), Porphyria, Acute Intermittent, Acute Porphyria, Hereditary Coproporphyria (HCP), Variegate Porphyria (VP), ALA Dehydratase Deficient Porphyria (ADP)
ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis

Study Overview
=================
Brief Summary
-----------------
In patients with biliodigestive anastomosis direct cholangiography (ERC) is due to changed anatomy commonly not possible. The aim of the study is to test the feasibility to perform direct cholangiography in these patients via double-balloon enteroscopy and to compare it to MR cholangiography.

Official Title
-----------------
ERC Via Double-Balloon-Enteroscopy in Patients With Biliodigestive Anastomosis

Conditions
-----------------
Cholangiography

Intervention / Treatment
-----------------
* Procedure: cholangiography via double-balloon enteroscopy
* Procedure: MR cholangiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biliodigestive anastomosis; and Suspicion of biliary disorder Exclusion Criteria: Exclusion criteria of double-balloon enteroscopy and MR-cholangiography
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cholangiography via double-balloon enteroscopy|nan|
|Procedure: MR cholangiography|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
-----------------
Feasibilty of cholangiography via double-balloon enteroscopy
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination

Study Overview
=================
Brief Summary
-----------------
The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.

Official Title
-----------------
Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Device: Cytokine absorption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: septic shock acute renal failure with need for renal replacement therapy Exclusion Criteria: pregnancy nursing impossibility to do transcranial Doppler ultrasound

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Filter<br>Patients with CytoSorb absorber | Device: Cytokine absorption<br>* Use of CytoSorb absorber<br>|
| No Intervention: Control<br>Patients without CytoSorb absorber | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the index of cerebrovascular autoregulation (Mx) between both groups | Integrity of the cerebrovascular autoregulation will be measured using the index of cerebrovascular autoregulation Mx (moving correlation index). Outcome is the difference of the mean Mx between both groups and, therefore, the difference of integrity of the cerbrovascular autoregulation. A difference of 0.2 in Mx was set as clinically relevant. | days 1 to 4 after diagnosis of septic shock | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebrovascular Autoregulation, Septic Shock, Cytokine
Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants

Study Overview
=================
Brief Summary
-----------------
Our previous data demonstrated that premature infants treated with inhaled nitric oxide at birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to determine whether this benefit continues through school age.

Detailed Description
-----------------
Two questionnaires (truncated versions of previously validated surveys), one for parent and another for teacher, for which written consent was previously obtained are being sent to parents. The teacher questionnaires will be delivered via parents. A clinic visit will accompany age appropriate neurodevelopmental examination, administration of the Functional Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if appropriate).

Official Title
-----------------
Follow up at School-age of Children Participating in the Nitric Oxide Ventilatory Approach (NOVA) Study

Conditions
-----------------
Prematurity, Respiratory Distress Syndrome,Hypoxemia

Intervention / Treatment
-----------------
* Drug: Inhaled nitric oxide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who participated in NOVA study and are of school age Exclusion Criteria: Children who participated in NOVA study but deceased post discharge

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 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 |
| --- | --- |
| Experimental: Inhaled nitric oxide<br> | Drug: Inhaled nitric oxide<br>* 1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* No iNO given for days 1-7<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine school-readiness at school-age in premature infants treated with iNO or placebo in the first week of life |  | 4-7 years of age (between 2005-2006) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine health status at early school-age |  | 4-7 years of age (between 2005-2006) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhaled nitric oxide,, Lung recruitment,, Ventilatory approach,, Neurodevelopmental outcomes,, School age children
Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial

Study Overview
=================
Brief Summary
-----------------
The project consists of two studies where we want to throw light on the importance of physical activity/exercise to maintain physical function among cancer patients whose disease is not responsive to curative treatment. Study I is a randomised intervention study where we want to study the effect of adjusted physical exercise compared to usual care. In study II our main aim is to validate different subjective and objective methods to measure physical functioning

Official Title
-----------------
Phase 3 Physical Activity and Functioning in Palliative Cancer Patients - a Clinical Randomised Trial

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

Intervention / Treatment
-----------------
* Behavioral: Physical exercise
* Other: best supportive care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Palliative cancer patients, life expectancy between 3 and 12 months, Karnofsky status equally or above 60, pain score equal or below 3 on numerical rating scale (0-10), cognitive function intact
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br>Physical exercise twice a week for 8 weeks, and best supportive care | Behavioral: Physical exercise<br>* Physical exercise twice a week for 8 weeks, and best supportive care<br>Other: best supportive care<br> <br> |
| Other: No exercise<br>Best supportive care, no exercise | Other: best supportive care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  | immediately before and after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life and physical functioning |  | immediately before and after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative care, Physical exercise, Physical function
Measurement of Joint Attention Fluency

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study joint attention. Joint attention plays a critical role in social and language development in children with and without autism. Joint attention is the shared attention between a child and another person. This study seeks to set a standard benchmark of frequency scores for joint attention. Finding a rate of engaging in joint attention behavior would offer a benchmark for all researchers and practitioners working with learners with and without autism.

Official Title
-----------------
Measurement of Joint Attention Fluency

Conditions
-----------------
Autism Spectrum Disorders, Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: autism spectrum disorder Exclusion Criteria: hearing or vision problems behaviors that are a danger to self or others

Ages Eligible for Study
-----------------
Minimum Age: 8 Months
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Typically Developing<br>Typically developing toddler volunteers between the ages of 8 months and 3 years | |
| Autism<br>Children between the ages of 8 months and 6 years with a diagnosis of an autism spectrum disorder | |

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
-----------------
autism spectrum disorders, autism, joint attention, imitation, fluency
Kinesiotaping Therapy for Clavicular Fractures FRACTURES:

Study Overview
=================
Brief Summary
-----------------
This is a multicenter prospective randomized controlled study. Forty patients in whom conservative treatment for clavicle midshaft fractures was indicated between January 2018 and July 2019 were included. The investigators aimed to evaluate the effectiveness of the kinesiotaping technique for the conservative treatment of clavicle midshaft fractures. The investigators hypothesized that kinesiotaping reduces the disadvantages of conservative treatment, such as early-phase pain, high nonunion rates, and a prolonged time to return to work, and yields better clinical and functional outcomes by providing good mechanical support and neutralizing the deforming muscle forces around the fractured clavicle.

Detailed Description
-----------------
The investigators divided into 2 groups and followed one group of patients with clavicle fractures only with shoulder sling, while the other group were followed with kinesiotherapy treatment and shoulder arm sling. They investigated the effect of kinesiotherapy treatment on early pain and returning time to work.

Official Title
-----------------
An Alternative Conservative Treatment Method For Midshaft Clavicular Fractures: Kinesiotaping Therapy

Conditions
-----------------
Clavicle Fracture

Intervention / Treatment
-----------------
* Procedure: Kinesiotaping therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with midclavicle fracture within 24 hours Exclusion Criteria: Participants with open fractures,

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| No Intervention: Arm sling only group (group S)<br>Participants used only arm sling for clavicula fracture | |
| Active Comparator: Arm sling with kinesiotaping therapy group (group K).<br>Participants used arm sling and the investigators applied kinesiotheraphy for clavicula fracture | Procedure: Kinesiotaping therapy<br>* The investigators used kinesiotaping strips in formations such as the Y, I, X, fan, web, and donut formations ove fractured clavicula.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the two groups in terms of early return to work | The investigators aim is to examine the effect of kinesiotaping treatment on clavicle fracture union. | 6. months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kinesiotherapy, arm sling
EUS-CPN: A Retrospective Review

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study is to measure the safety of EUS-CPN in patients that have undergone this procedure in the last decade.

Official Title
-----------------
Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN): A Retrospective Review of Safety

Conditions
-----------------
Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any subject that has undergone EUS-CPN will be considered for this study. Exclusion Criteria: Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical) at an another institution.

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 |
| --- | --- | --- |
| Number of EUS-CPN procedures for each patient |  | over a ten year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related complications |  | over a ten year period |
Study of Hypercortisolism in Cushing's Syndrome and Stress-Induced Pseudo-Cushing's Syndrome

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether Cushing's syndrome and stress-induced pseudo-Cushing's syndrome can be differentiated by evaluating endogenous corticotropin-releasing hormone activity.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo a 30-hour infusion of deuterated cortisol with peripheral and petrosal vein measurements of adrenocorticotropin hormone (ACTH) and corticotropin-releasing hormone (CRH). Patients also have a 2-day, low-dose dexamethasone suppression test. Patients with ACTH tumors are referred for pituitary surgery as indicated. Patients without Cushing's syndrome are entered as controls. During scheduled radiologic procedures, these subjects undergo ACTH and CRH sampling from the petrosal vein or cavernous sinus following a deuterated cortisol infusion.

Conditions
-----------------
Cushing's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Suspected adrenocorticotropin hormone (ACTH)-dependent Cushing's syndrome No pregnant women Effective contraception required of fertile women

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rare disease, Cushing's syndrome, endocrine disorders