linjc16/ctgov huggingface dataset:
Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Study Overview
=================
Brief Summary
-----------------
This study is to provide additional data to support the safety and efficacy of OP-1 Putty as a replacement for autograft in patients undergoing posterolateral spinal fusion.

Detailed Description
-----------------
Follow-up study 06-UPLF-01 was a prospective collection of longer-term data on the patient population from pivotal study S01-01US, and was conducted to expand the information regarding efficacy, particularly with regard to radiographic assessment of fusion, as well as the longer-term safety of OP-1 Putty in uninstrumented posterolateral fusion (PLF) as compared to autograft

Official Title
-----------------
Prospective Data Collection From the Stryker Biotech Pivotal IDE Study of OP-1 Putty in Uninstrumented Posterolateral Fusions

Conditions
-----------------
Degenerative Lumbar Spondylolisthesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient was treated in Stryker Biotech clinical protocol S01-01US (Pivotal IDE study) and not a retreatment failure at the time of completion. The patient or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent. The patient agrees to complete the necessary clinical and radiographic evaluations. Exclusion Criteria: 1. There are no exclusion criteria for participation in this protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| 1<br>Follow-up to S01-01US, conducted to expand information | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of bone by CT scan |  | 3+ years post-treatment from the Pivotal study S01-01US | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-assessments of all clinical parameters from S01-01US |  | 3+ years post-treatment from the Pivotal study S01-01US | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Degenerative disc disease
Coloplast DialogueStudy

Study Overview
=================
Brief Summary
-----------------
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.

Detailed Description
-----------------
It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.

Official Title
-----------------
An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life

Conditions
-----------------
Stoma

Intervention / Treatment
-----------------
* Device: SenSura


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Signed informed consent before any study related activities Subjects with a colostomy, ileostomy or urostomy Subjects must have had their ostomy for at least 6 months Subjects must have mental capacity to understand the study and questionnaires Subjects must be at least 18 years of age. Exclusion criteria Women who are pregnant or breast-feeding Subjects who have more than one ostomy Subjects with an ostomy who use plug Participation in other studies at the same time Previous participation in this study

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> | Device: SenSura<br>* Real life assessment of SenSura<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (Scale 0(Worst)-100(Best)) | The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening. | 6-8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stoma, Ostomy
Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy Study 2

Study Overview
=================
Brief Summary
-----------------
Single usage, open label study in up to 40 adult healthy males. Eligible subjects will receive a single usage of the investigational or commercial device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.

Official Title
-----------------
Retention of an Orally Administered Investigational Device vs Commerical Device in the Oral Cavity and Oropharynx of Healthy Human Male Volunteers

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: Polymer based lubricating liquid
* Device: Moi-Stir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test Are able to tolerate the procedure and Be generally healthy Exclusion Criteria: Have history of allergy or hypersensitivity to the study ingredients Major diseases Taking medication regularly Radiation exposure recently

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Polymer based lubricating liquid<br>* 5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane<br>|
| Active Comparator: 2<br> | Device: Moi-Stir<br>* 2 sprays (0.35 mL) of the radiolabeled commercial device. A blend of Water, sorbitol, carboxymethylcellulose, sodium, methylparaben, propylparaben, potassium chloride, dibasic sodium phosphate, calcium chloride, magnesium chloride, sodium chloride, flavor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve for volume of investigational device retained in the oral cavity. |  | 60 minutes |
Retrospective Study of MRI in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Collection of already existing data and images for patients < 2 years of age having MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during a prospectively designed blinded reading of the images.

Official Title
-----------------
The Safety and Efficacy of MULTIHANCE at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients Who Are Less Than 2 Years of Age

Conditions
-----------------
Central Nervous System Disease, Central Nervous System Neoplasms

Intervention / Treatment
-----------------
* Drug: Gadobenate Dimeglumine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female less than 2 years of age at the time of the MRI with MultiHance injection at a dose of 0.1 mmol/kg (± 25% in volume administered) Has available demographic and safety data Has documented known or highly suspected enhancing disease of the CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of MULTIHANCE contrast agent Has both pre and post dose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to sponsor or designee to be evaluated in a fully blinded read Has a documented dose of MultiHance administered for their MRI exam and/or volume (mL) and weight of the patient available to be used to calculate the dose of MultiHance that was administered Exclusion Criteria: Any patient who does not fulfill all of the inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gadobenate Dimeglumine|gadolinium contrast agent|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Border delineation of lesions | Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of lesion border delineation | Immediately post dose - Day 1 | 
| Visualization of internal morphology of lesions | Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of visualization of internal morphology of the lesion(s) | Immediately post dose - Day 1 | 
| Contrast enhancement of lesions | Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of contrast enhancement of lesions | Immediately post dose- Day 1 |
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

Study Overview
=================
Brief Summary
-----------------
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

Detailed Description
-----------------
This is a retrospective study aiming to explore the efficacy and safety of Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in patients with HER2-positive metastatic breast cancer.

Official Title
-----------------
Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab in HER2-Positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Pyrotinib Plus Trastuzumab
* Drug: Pertuzumab Plus Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HER2+ MBC patients scored +3 by immunohistochemical (IHC) analysis or scored +2 and the result of fluorescence in situ hybridization was positive. Patients received Pyrotinib(320-400 mg, po, qd) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or Pertuzumab(840mg q3w, and then 420 mg q3w) plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from Jan 2018 to Sep 2022. Patients had complete medical records. All data were retrospectively collected from medical records of individual institutions. Exclusion Criteria: Incomplete medical history

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PyroH<br>treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) | Drug: Pyrotinib Plus Trastuzumab<br>* treatment based on Pyrotinib(320-400 mg, po, qd) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)<br>|
| PertH<br>treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) | Drug: Pertuzumab Plus Trastuzumab<br>* treatment based on Pertuzumab(840mg q3w, and then 420 mg q3w) Plus Trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trastuzumab, Pyrotinib, Pertuzumab
Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study

Study Overview
=================
Brief Summary
-----------------
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions. This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.

Conditions
-----------------
Mammaplasty, Breast Neoplasms, Acellular Dermis

Intervention / Treatment
-----------------
* Procedure: breast capsule biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 20 and 70 planning 2-stage expander-implant breast reconstruction using acellular dermal matrix with no medical history such as diabetes, hypertension, or smoking no surgical history Exclusion Criteria: pregnant newly detected medical or surgical condition acellular dermal matrix loss due to allergic reaction or prosthetic infection breast cancer recurrence transfer to other institution reconstruction give-up due to patient's wish no biopsy score

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: breast capsule biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histology scoring | semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010) | immediate after biopsy |
In Vitro Models of Liver and Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective is to develop an in vitro model of cancer for laboratory study using liver, biliary and pancreatic cancer tissue. The secondary objective is to study the genetic and cellular biology of cancer of the liver, biliary tract and the pancreas. As well the investigators hope to compare molecular and cellular biology of cancer cells with normal cells as well as potentially test the efficacy of current and future anti-cancer therapies. Samples will be collected from tissue that has been resected as part of the treatment for a patient diagnosed with liver, bile duct or pancreas cancer.

Official Title
-----------------
A Study Designed to Develop in Vitro Models of Liver, Biliary and Pancreatic Cancer for the Investigation of Tumour Biology and Potential Therapies

Conditions
-----------------
Cholangiocarcinoma, Hepatocellular Carcinoma, Pancreatic Neoplasm

Intervention / Treatment
-----------------
* Genetic: Organoid in vitro culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients undergoing surgical resections for liver, biliary or pancreas cancers that are able to give informed consent. Exclusion Criteria: Patients aged <18 or those who are unable to give informed consent.

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

| Intervention/Treatment |
| --- |
|Genetic: Organoid in vitro culture|Generation of 'organoids' using in vitro culture techniques, genomic DNA and RNA sequencing, application of genome editing technology, investigation of anti-tumour drugs, investigation of biological and functional properties of tumour cells, transplantation of organoid lines into animal models.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of tumour-derived organoids successfully cultured in vitro for a minimum of 3 months. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of tumour-derived organoids that are genetically identical to the source tumour. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreas, stem cells, tumours, in vitro models, organoids, cancer,, bile duct, liver
Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate BNP in preterm infants < 28 weeks on the second day of life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the need of PDA intervention in the further course.

Detailed Description
-----------------
From the study infants blood samples (0.1ml) were collected in K-EDTA microtubes within 24 to 48 hours of age through umbilical artery catheter aspiration or routine venous puncture. The samples were spun at 7000 rpm for 3 minutes. Platelet-free plasma was stored at -20°C until BNP analysis of all collected samples was carried out. The BNP assay was performed using a fully automated immunoassay system ADVIA method for the Centaur System (Bayer Diagnostic Division). In preterm infants who were treated with indomethacin or surgical ligation we collected additional blood samples 2-4 hours before intervention and 24 hours after the completion of the ductus treatment.

Conditions
-----------------
Infant, Premature, Ductus Arteriosus, Patent, Natriuretic Peptide Brain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written parental informed consent Preterm infant < 28 weeks of gestation Admitted to our NICU within 48 hours after birth Exclusion Criteria: No written parental informed consent, Congenital heart disease, Death

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 48 Hours

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
-----------------
preterm infants < 28 weeks, B-type natriuretic peptide, prediction, ductus intervention
Copy Number Variation in CHRNA7 Gene in Migraine and Gene Expression

Study Overview
=================
Brief Summary
-----------------
Migraine is a common and possible hereditary disease. Copy number variation (CNV) is a phenomenon in which parts of the genome are repeated and the number of repeats in the genome varies between individuals in the human population.The CHRNA7 gene has a major role in the neuropsychiatric phenotypes observed in patients. The 15q13.3 gain/loss variation in this gene may be associated with migraine.

Detailed Description
-----------------
Migraine is a common neurological disorder. Although they have different genetic bases according to their types, cholinergic receptors after calcium channels play an important role in the clinic and genetics of the disease. Neuronal acetylcholine receptor subunit alpha-7, also known as nAChRα7, is a protein that in humans is encoded by the CHRNA7 gene.

Official Title
-----------------
Copy Number Variation in Migraine and Gene Expression

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Genetic: Migraine CNV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine Exclusion Criteria: Vascular problems
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Case-Control<br>Copy number variation | Genetic: Migraine CNV<br>* Copy number variation effect on migraine disease<br>|
| Experimental: Case-Control 1<br>Gene expression | Genetic: Migraine CNV<br>* Copy number variation effect on migraine disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNV number | CNV number effect on migraine | 1 year |