linjc16/ctgov huggingface dataset:
Pediatric Multicenter Study of REPEL-CV

Study Overview
=================
Brief Summary
-----------------
This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery.

Detailed Description
-----------------
- Efficacy at second sternotomy

Official Title
-----------------
Peds. Multicenter Study

Conditions
-----------------
Adhesions

Intervention / Treatment
-----------------
* Device: REPEL-CV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage sternotomies Exclusion Criteria: Delayed closure beyond 5 days

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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

| Intervention/Treatment |
| --- |
|Device: REPEL-CV|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
-----------------
post operative adhesions
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

Detailed Description
-----------------
This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.

Official Title
-----------------
A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: ferumoxytol or oral iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients ≥18 years. Chronic hemodialysis. Stable supplemental EPO therapy. Baseline hemoglobin of ≤ 11.5 g/dl. Exclusion Criteria: Women who are pregnant or who are breast feeding. Received another investigational drug or device within 30 days. Recent parenteral or oral iron therapy. Patients with active GI bleeding or acute bleeding within 4 weeks. Patients that have other causes of anemia. Major surgery within 30 days or anticipated or planned surgery during the study. Patients with active infections. Recent blood transfusions. Patients with known allergies to iron products.

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

| Intervention/Treatment |
| --- |
|Drug: ferumoxytol or oral iron|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in hemoglobin from baseline. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in iron indices. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, iron
Developing Violence Prevention Therapy for Substance Abusers

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to develop and pilot test a violence prevention intervention for men and women in treatment for substance use problems.

Official Title
-----------------
Development of Violence Therapy for Substance Abusers

Conditions
-----------------
Substance Use Disorders, Violence

Intervention / Treatment
-----------------
* Behavioral: IVPT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of substance use related problems Interpersonal Violence history in the year before recruitment Exclusion Criteria: Primary opiate dependence Presence of active psychotic disorder < 18 years of age

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: IVPT<br>Intervention based on Motivational Interviewing and CBT | Behavioral: IVPT<br>* Violence prevention intervention based on Motivational Interviewing and CBT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interpersonal Violence |  | 3 and 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alcohol and drug use |  | 3 and 6 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol, drugs, aggression, substance use disorder treatment
Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.

Conditions
-----------------
Sarcoma, Soft Tissue

Intervention / Treatment
-----------------
* Drug: Pegamotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease. Target tumors outside prior radiation field(s). Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count. Adequate renal function Adequate liver function No history of hemorrhagic cystitis or evidence of microscopic hematuria Capable of understanding the protocol requirements and risks and providing written informed consent. Either 0 or 1 prior chemotherapy regimens Exclusion Criteria: Subject has a diagnosis of gastrointestinal stromal tumors. Concurrent serious medical illness unrelated to tumor within the past 6 months. Known chronic infectious disease, such as AIDS or hepatitis. Positive screening pregnancy test or is breast-feeding. A female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study. Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks. History of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years. Known or clinically suspected brain metastases. Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma. Received any investigational drug within the last 30 days. Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy. Received a prior camptothecin analog (e.g., topotecan, irinotecan).

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

| Intervention/Treatment |
| --- |
|Drug: Pegamotecan|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
-----------------
soft, sarcoma, metastatic
Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

Study Overview
=================
Brief Summary
-----------------
Gastric banding has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. We have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.

Official Title
-----------------
Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Laparoscopic gastric banding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 40 ASA Class I or II Exclusion Criteria: Comorbid cardiac, pulmonary, renal, hepatic disease Bleeding disorder Previous gastric/esophageal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single incision laparoscopic gastric banding<br>Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision. | Procedure: Laparoscopic gastric banding<br>* Laparoscopic gastric banding for the treatment of morbid obesity.<br>|
| Active Comparator: Five port laparoscopic gastric banding<br>Patients in this group will undergo conventional laparoscopic gastric banding using 5 small incisions. | Procedure: Laparoscopic gastric banding<br>* Laparoscopic gastric banding for the treatment of morbid obesity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 1 month and 1 year post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 1 week and 3 months post-operative | 
| perioperative complication rate |  | 1 month |
Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the efficacy of recombinant human granulocyte colony-stimulating factor (G-CSF) in raising the absolute neutrophil count, platelet count, and hemoglobin level in patients with inherited bone marrow failure syndromes. II. Assess the efficacy of a reduced maintenance dose in patients who respond to daily G-CSF. III. Assess the toxic effects of G-CSF in these patients. IV. Measure bone marrow progenitor colonies before and after G-CSF. V. Measure CD34-positive cells in marrow and blood before and after G-CSF using flow cytometry and immunohistochemistry.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive granulocyte colony-stimulating factor (G-CSF) subcutaneously every day for 8 weeks; nonresponders receive an increased dose for an additional 8 weeks. Patients who respond at week 8 or 16 are then tapered to a lower maintenance dose of G-CSF administered every other day through week 40. The dose is adjusted to maintain an absolute neutrophil count above 1500. Patients are removed from study for failure to achieve a complete response by week 16, unacceptable nonhematologic toxicity, the identification of a clonal karyotype in marrow, or the onset of leukemia.

Conditions
-----------------
Shwachman Syndrome, Fanconi's Anemia, Dyskeratosis Congenita, Thrombocytopenia

Intervention / Treatment
-----------------
* Drug: filgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Inherited bone marrow failure syndrome, including: Fanconi's anemia Dyskeratosis congenita Shwachman syndrome Amegakaryocytic thrombocytopenia Decreased megakaryocytes in infancy No thrombocytopenia with absent radius syndrome (TAR) No trisomy 13 or 18 No clonal bone marrow karyotype --Prior/Concurrent Therapy-- At least 4 weeks since growth factors Concurrent therapy allowed if not altered for 30 days prior to entry through week 8 No concurrent investigational drugs --Patient Characteristics-- Hematopoietic: ANC <1000 No leukemia Other: No medical or psychiatric contraindication to protocol participation No pregnant or nursing women

Ages Eligible for Study
-----------------
Minimum Age: 0 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: filgrastim|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
-----------------
Fanconi's anemia, Shwachman syndrome, aplastic anemia, dermatologic disorders, dyskeratosis congenita, hematologic disorders, rare disease, thrombocytopenia
Renal Retention of Microbubbles

Study Overview
=================
Brief Summary
-----------------
Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study is to determine whether there is retention of ultrasound contrast agents in the renal microcirculation, which has been described in mice.

Detailed Description
-----------------
In this study patients undergoing clinically indicated contrast echocardiography will have renal ultrasound performed 10 minutes after completion of contrast infusion to determine the presence and location of renal retention of lipid microbubbles.

Official Title
-----------------
Study of Whether There is Renal Retention of Lipid Microbubble Ultrasound Contrast Agents

Conditions
-----------------
- Study Focus: Renal Retention of Lipid Microbubbles

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing clinically indicated contrast echo adequate renal ultrasound images Exclusion Criteria: chronic inflammatory disease known kidney disease immunomodulatory therapy

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 |
| --- | --- |
| Contrast administration<br>Patients undergoing contrast-enhanced echo. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Video Intensity Units | Video intensity units in the kidney 10 min after completion of a clinically indicated contrast echocardiography study. | 10 min |
Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)

Study Overview
=================
Brief Summary
-----------------
This study will try to understand the difference in brain structure between ALS patients and healthy people of similar age. ALS is a condition affecting the nervous system with disruption of the brain networks. This study aims to understand these disruptions and determine their significance in ALS.

Detailed Description
-----------------
Participants and healthy controls will be consented into the study. After consent, details including age, duration of disease, ALSFRS score, and grip strength will be collected. Participants will be trained to perform a grip and release task using a foam ball for 1 minute while inside an MRI scanner. Anatomical, functional and diffusion MRI sequences will be acquired during the scanning, and total scan time will be approximately 1 hour.

Official Title
-----------------
Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Intervention / Treatment
-----------------
* Other: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Based on El Escorial Criteria we will select Probable or Definite ALS. Healthy controls age matched to ALS patients Subjects should be able to lie down in a scanner and undergo an hour-long MRI study Subjects should be able to understand instructions, provide consent and perform a hand task while inside the scanner Exclusion Criteria: Unable to undergo MRI due to any reason Age <18 ALS patients having high aspiration risk Patients having cognitive limitations which prevents them from understanding the study requirements, providing consent or perform tasks inside the scanner.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| ALS patients<br>Patients with ALS | Other: fMRI<br>* fMRI scan for 1 hour<br>|
| Healthy controls<br>Age-matched healthy controls | Other: fMRI<br>* fMRI scan for 1 hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI | Brain network generation and analysis will be performed for anatomical and functional imaging | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyotrophic Lateral Sclerosis, Functional Magnetic Resonance Imaging, Connectivity, Diffusion Tensor Imaging, Dynamometer
Frailty in Older HIV-infected Individuals

Study Overview
=================
Brief Summary
-----------------
Frailty has been proposed as a measure of biological (as opposed to chronological) aging. In this study the investigators plan to: (1) measure frailty in a cohort of older HIV-infected individuals in Hong Kong, and its association with mortality and quality of life; (2) identify risk factors predictive of development of frailty in HIV-infected individuals in Hong Kong; and (3) determine the outcomes of HIV-infected individuals in Hong Kong with and without frailty. The following assessment will be done: Physical examination including measuring height, weight, hip and waist circumference. Grip strength, chair stand test, gait speed test, balance tests, and neurocognitive tests Geriatric syndromes, screening for depression, disability and quality of life. Blood tests during fasting state to measure metabolic parameters. This is a prospective longitudinal observational study that lasts for 10 years.

Official Title
-----------------
Frailty in Older HIV-infected Individuals in Hong Kong: Risk Factors and Association With Quality of Life and Mortality

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection with positive anti-HIV antibody Age ≥50 years Exclusion Criteria: Refuses to consent

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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 |
| --- | --- | --- |
| Frailty | Frailty defined by frailty phenotype measurement, according to Fried (Fried et al., 2011) definition. | 10 years |