linjc16/ctgov huggingface dataset:
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers

Study Overview
=================
Brief Summary
-----------------
This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).

Official Title
-----------------
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers

Conditions
-----------------
Leg Ulcer

Intervention / Treatment
-----------------
* Procedure: Collection of supernumerary biopsies during skin graft pellet procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with chronic leg ulcers evolving for more than 6 months Patient to receive skin pellet transplant Chronic wound area between 10 and 30 cm² Exclusion Criteria: Patient without health insurance, Pregnant womens, Smoking patient, Chronic wound area >30 cm²

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin graft pellet<br>This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies. | Procedure: Collection of supernumerary biopsies during skin graft pellet procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of skin substitute reconstructed with cells isolated from patient biopsies |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin Substitutes
A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery

Study Overview
=================
Brief Summary
-----------------
The purpose of this research project is to collect and store blood samples and clinical data. Researchers can then use the stored samples in future studies. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems.

Detailed Description
-----------------
Blood samples are collected in the comfort and safety of your home by a certified medical professional. We have mobile phlebotomists located in major metropolitan areas around the nation for your convenience.

Official Title
-----------------
A Multi-Center Longitudinal Biorepository Study to Provide Biospecimens & Clinical Data From Neurological Disease Patients To Approved Pre-Clinical And Clinical Investigators for Drug & Biomarker Studies

Conditions
-----------------
Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral Sclerosis (ALS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females >18 to 100 years old A diagnosis of neurological condition Proof of diagnosis can be provided Control group: Healthy donors, males and females, 18 to 100 years of age Exclusion Criteria Receipt of blood products within 30 days of study enrollment Receipt of an investigational (unapproved) drug within 30 days of study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Neurological Condition<br>Collect blood and other biospecimens like saliva, urine and CSF for research purposes. | |
| Control<br>Collect blood and other biospecimens like saliva, urine and CSF for research purposes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biospecimens & Clinical Data collection from patients with neurological diseases. | The purpose of this research project is to collect and store blood samples and clinical data. Researchers can then use the stored samples in future studies. Through such studies, they hope to find new ways to detect, treat, and maybe even prevent or cure health problems. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease, Huntington's Disease, Amyotrophic Lateral Sclerosis (ALS)
Sonographic Differences in Brain Measurements Between Normal and Intrauterine Growth Restriction (IUGR) Fetuses

Study Overview
=================
Brief Summary
-----------------
Intrauterine growth restriction is being suspected in cases where the fetal estimated weight is less then the 10 th percentile for its gestational age. Abdominal circumference is the most influenced measurement in this cases. Head circumference on the other hand can be or not be influenced. Previous studies have shown that transverse cerebellar diameter (TCD) is constant to gestational age and is not influenced by IUGR.Other showed lower TCD in IUGR fetuses. We would like to study the differences in cerebellar, vermian and corpus callosum growth between normal to IUGR fetuses and between symmetrical and asymmetrical IUGR. In this observational study we will include pregnant women between 28-37 gestational week with a singleton otherwise normal pregnancies. We will measure the fetal TCD, vermian distances and the CC, abdominal circumference, head circumference and femur length. we will compeer these measurements according to the following groups:normal fetuses, symmetrical and asymmetrical IUGR.

Conditions
-----------------
Intra-uterine Growth Restriction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton, 28-37 GA, well dated pregnancy. Exclusion Criteria: multifetal pregnancies, no first trimester dating, fetuses with known chromosomal or structural anomalies.

Ages Eligible for Study
-----------------
Minimum Age: 28 Weeks
Maximum Age: 37 Weeks

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 |
| --- | --- |
| AGA<br> | |
| symmetrical IUGR<br> | |
| asymmetrical IUGR<br> | |

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
-----------------
IUGR fetuses, symmetrical IUGR, asymmetrical IUGR
A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: Cefepime and Tazobactam combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that has been stable OR Healthy Subjects: Have normal renal function No evidence of any disease or condition that may affect pharmacokinetics of FEP-TAZ. Exclusion Criteria: Evidence of hepatorenal or nephritic syndrome Any clinically significant abnormal findings on medical history, physical examination,or clinical laboratory tests (other than those associated with controlled diabetes,hypertension, hypercholesterolemia, dyslipidemia, or renal impairment or related or causative diseases)

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FEP-TAZ<br>Cefepime and Tazobactam combination; IV infusion over a period of 90 minutes Healthy subjects, Mild and Moderate RI: 4 g (2 g FEP and 2 g TAZ) Severe RI and patients on HD: 2 g (1 g FEP and 1 g TAZ) | Drug: Cefepime and Tazobactam combination<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentrations (Cmax) |  | 48 hrs | 
| Tmax The elimination half-life (t1/2), |  | 48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abnormal Laboratory Values |  | 14 days | 
| Number of Participants With Adverse Events |  | 14 days |
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of tinnitus.

Official Title
-----------------
Repetitive Transcranial Magnetic Stimulation (rTMS) Effect on Tinnitus

Conditions
-----------------
Patients With Subjective Tinnitus

Intervention / Treatment
-----------------
* Device: real repetitive Transcranial Magnetic Stimulation
* Device: sham repetitive Transcranial Magnetic Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjective tinnitus Age 18 years and older Exclusion Criteria: Meniere, conductive hearing loss, objective tinnitus History of seizure disorder or epilepsy Clinically relevant psychiatric comorbidity Previous symptomatic stroke Surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real rTMS<br>Real rTMS is real continuous theta burst stimulation. | Device: real repetitive Transcranial Magnetic Stimulation<br> <br> |
| Sham Comparator: Sham rTMS<br>Sham rTMS is sham continuous theta burst stimulation. | Device: sham repetitive Transcranial Magnetic Stimulation<br>* This sham stimulation is not true stimulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus handicap inventory score | Primary outcomes will be measured twice. One is before, and the other is after 5-day rTMS interventions. Baseline primary outcome will be acceptable if it is done within the prior 6 months of 1st rTMS. Follow-up primary outcome will be done within the five days after 5th rTMS. | Before (- six months) and after (+ 5 days) rTMS interventions |
Study of Biological Determinants of Bleeding Postpartum

Study Overview
=================
Brief Summary
-----------------
At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices. The percentage of the immature platelets is a an additional parameter on the hemogram. The clinical assessments (recorded in medical records) and biological values will be used to determine if there is a correlation between these data and the occurrence of postpartum hemorrhage.

Official Title
-----------------
Study of Biological Determinants of Bleeding Postpartum : Predictive Role in the Number of Immature Platelets

Conditions
-----------------
Postpartum Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman giving birth in a maternity of Finistère Exclusion Criteria: Refuse to participate in the study
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Postpartum Hemorrhage |  | Volume of blood loss up to 24 hours after delivery and / or weight compresses collected at delivery, and / or diagnosis of the clinician | 
| Percentage of immature platelets |  | Percentage of immature platelets just before the entry in the birth room | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum Hemorrhage, Immature platelet
Single Subject Neratinib in Bladder Cancer (NRR)

Study Overview
=================
Brief Summary
-----------------
This study will be a single subject study to evaluate the efficacy of the HER2 kinase inhibitor, neratinib, in a patient with metastatic bladder cancer harboring a HER2-GRB7 gene fusion.

Official Title
-----------------
Single Subject Neratinib in Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: Neratinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * none Exclusion Criteria: * none We have received FDA approval for a single subject Investigational New Drug (IND) Application to treat a specific patient with the HER2 kinase inhibitor neratinib. Therefore there is no inclusion / exclusion criteria.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Neratinib|240 mg orally once daily|

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
-----------------
13-2526, Bladder Cancer, Neratinib
Neural Mechanism Underlying Social Cognition in Depressive Patients

Study Overview
=================
Brief Summary
-----------------
In the project, investigators plan to test difference of social cognition between depressive patients and healthy individuals and the brain activation underlying the difference to further understand the neural mechanism of depressive disorder.

Official Title
-----------------
Neural Mechanism Underlying Social Cognition in Depressive Patients

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range between 18 and 60 Education experience above high school Score for Hamilton's Depression Scale >=17 Diagnosis of depression through Scid Exclusion Criteria: Undergoing electric shock treatment in 3 months Excluding those who with bipolar disorder Excluding those who with postpartum depression Excluding those who with hysteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| emotion recognition | After viewing a video, participants will be asked to judge the person's attitude in the video. Through this paradigm, investigators could test emotional bias in social interaction in depressive patients. | Baseline | 
| resting state | In this part, investigators basically want to test the automatic neural activity for depressive patients while they are resting. | Baseline | 
| self-reflection | Participants will be asked to judge the discrepancy between actual self and ideal self. | Baseline | 
| response to negative stimuli | investigators used face-matching task to measure their response to negative stimuli. The participants will be asked to detect the identical face with same emotion. | Baseline | 
| structure | Investigators scanned structural images to detect the difference between clinical population and healthy population. | Baseline | 
| white matter | Investigators scanned DTI to detect the difference between clinical population and healthy population. | Baseline |
Study in Polish Acromegalic Patients Treated With Somatuline Autogel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.

Official Title
-----------------
A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval

Conditions
-----------------
Acromegaly

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available Exclusion Criteria: Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria

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 |
| --- | --- | --- |
| Percentage variation of Insulin-like growth factor-1 (IGF-1) levels |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean growth hormone (GH) levels |  | 24 months | 
| Proportion of patients with GH levels below 1.0 microgram/liter |  | 24 months |
Steroid Aromatase Inhibitors Versus Progestogens for nSAID-resistanced Late Stage Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.

Detailed Description
-----------------
A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Official Title
-----------------
A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer

Conditions
-----------------
Carcinoma Breast Stage IV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be the postmenopausal women Patients must be diagnosed with advanced breast cancer by imageology，cytology or histopathology Immunohistochemistry shows ER and/or PR positive Patients ECOG score must be 0-2 Drug resistant about Non-Steroid Aromatase Inhibitors Exclusion Criteria: Not suitable for endocrine therapy Have receive the standard Steroid Aromatase Inhibitors treatment Severe hepatic dysfunction
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation group<br>Steroid Aromatase Inhibitors | |
| Control group<br>Non-Steroid Aromatase Inhibitor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RECIST 1.1 |  | -7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAID, Progestogens, nSAID-resistanced, LSBC