linjc16/ctgov huggingface dataset:
A Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

Study Overview
=================
Brief Summary
-----------------
PALV-08 is a multicenter, open-label treatment (OLT) study enrolling adults with Pachyonychia Congenita (PC) with genotyped keratin mutations KRT6A, KRT6B, KRT6C or KRT16 who were previously enrolled in the PALV-05 (VAPAUS) trial. The purpose of this OLT study is to investigate the safety of long term exposure and pharmacokinetics (PK) of QTORIN rapamycin 3.9% anhydrous gel or PTX-022.

Official Title
-----------------
A Multicenter Open-Label Treatment Study Evaluating the Safety and Pharmacokinetics of QTORIN Rapamycin 3.9% Anhydrous Gel in the Treatment of Adults With Pachyonychia Congenita

Conditions
-----------------
Pachyonychia Congenita

Intervention / Treatment
-----------------
* Drug: PTX-022


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completed the PALV-05 (VAPAUS) study Agree to contraceptive use Key Exclusion Criteria: Females who are pregnant or breastfeeding Concomitant use of sirolimus or any sirolimus-containing medications (systemic or topical) Any significant concurrent condition that could adversely affect participation and/or the assessment of the safety and efficacy in the study Prior or planned treatment, including surgery or other medically necessary intervention deemed by the investigator that could adversely affect participation and/or the assessment of the safety and efficacy in the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTX-022<br> | Drug: PTX-022<br>* QTORIN rapamycin 3.9% anhydrous gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters | AUC area under the sirolimus blood concentration-time profile | Prior to dose, 12 hours and 24 hours |
HepaStem Long-Term Safety Registry

Study Overview
=================
Brief Summary
-----------------
All patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HHALPC during a previous interventional clinical study conducted by Promethera Biosciences

Official Title
-----------------
HepaStem Long-Term Safety Registry - Registry for Patients Who Have Been Administered HepaStem

Conditions
-----------------
Urea Cycle Disorder, Crigler-Najjar Syndrome, Acute on Chronic Liver Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients having received at least one infusion of HepaStem during a previous interventional clinical study conducted by Promethera. Exclusion Criteria: Patients who received an OLT and completed 6-month FU documentation prior to the start of the PROLONGSTEM study. Patients who have received mature liver cells or stem cells other than HepaStem prior to the start of the PROLONGSTEM study.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Occurrence of Adverse Events of Specific Interest (AESI) | Adverse Events of Specific Interest (AESI): Event with fatal outcome (Death) Orthotopic Liver Transplantation (OLT) and Outcome. Development of Malignancy or unwanted tissue formation in different organs (tumor malignant or not). Disease linked to transmission of adventitious agents or reactivation of latent pathogens. Any AE which in the opinion of the Investigator has a plausible causal relationship to HepaStem. | 60 months |
A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum

Study Overview
=================
Brief Summary
-----------------
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent position, irrigated water and blood may prevent visual field of ESD. Generally, whole precutting around the lesion during the ESD is performed prior to dissection. However, it is expected that partial precutting method for the lesion located in the antrum of the lesser curvature may improve the visibility of ESD because it can help us the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time of ESD for the lesion located in the antrum of the lesser curvature according to the precutting methods (whole precutting vs. partial precutting).

Conditions
-----------------
Gastric Adenoma and Early Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Partial precutting
* Procedure: Whole precutting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 years old Patients with gastric adenoma or early gastric cancer Exclusion Criteria: Patients who has undergone subtotal gastrectomy Patients who has undergone gastrostomy Patients with local recurred gastric adenoma or early gastric cancer

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Whole precutting group<br> | Procedure: Whole precutting<br>* Whole precutting will be performed prior to dissection during the ESD.<br>|
| Active Comparator: Partial precutting group<br> | Procedure: Partial precutting<br>* Partial precutting will be performed prior to dissection during the ESD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods. | Within 5 mins after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En bloc resection rate | En bloc resection rate according to the precutting methods. | Within 7 days after the procedure |
QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

Study Overview
=================
Brief Summary
-----------------
Optimization and evolution of the patient will be evaluated over 6 months after the implant.

Detailed Description
-----------------
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.

Official Title
-----------------
Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle. Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured Patients who have granted their informed consent. Patients above 18 years. Exclusion Criteria: Patients that have been previously resynchronized. Patients with aortic stenosis or aortic valve prosthesis Patients who are or may potentially be pregnant. Patients with a life expectancy <12 months. Patients who cannot attend the monitoring visits established by the protocol.

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 Responder Patients (Structural Remodelling) | Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant. | 6 months after implant | 
| Safety Outcomes in CRT Responders and Non-Responders | Mortality rate, Rate of cardiovascular hospitalizations and for any cause or Combined endpoint (death and all-cause hospitalization) | 6 months after implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector | Response is defined as a reduction >15% in LVESV, measured 6 months after implant. Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads. | 6 months after implant | 
| Number of Responder Patients With Conventional Left Ventricular Pacing Vector | Response is defined as a reduction >15% in LVESV, measured 6 months after implant. Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads. | 6 months after implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT, Optimization, Responders
Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry for Off-Label Transplant Use of Plerixafor

Study Overview
=================
Brief Summary
-----------------
Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of plerixafor will be collected for data entered over a 5 year time span (i.e., data entered into the registry between the date of European Union (EU) marketing authorization [31 July 2009] and 31 July 2014). The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database. The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor shall provide information of a substantial number of patients who are representative of the patient population receiving plerixafor off-label.

Official Title
-----------------
Monitoring of Plerixafor Off-Label Use in the European Group for Blood and Bone Marrow Transplantation (EBMT) Registry

Conditions
-----------------
Lymphoma, Acute Leukemia, Chronic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Solid Tumors, Plasma Cell Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with plerixafor who have 1 or more of the following: Background disease other than lymphoma or multiple myeloma (MM) Are younger than 18 years of age. Received transplant using ex vivo plerixafor-mobilised cells (umbilical cord cell, peripheral blood (PB), bone marrow (BM) cell collection) Received treatment with plerixafor alone (i.e., without granulocyte colony stimulating factor (G-CSF)) Contraindication for G-CSF Transplants using plerixafor-mobilised cells from allogeneic donor Received transplant using plerixafor-mobilised bone marrow cells Routes of plerixafor administration other than subcutaneous Patients whose cells do not mobilize poorly Other Exclusion Criteria: Adults diagnosed with lymphoma or multiple myeloma (MM) and have been treated with plerixafor according to the European Union (EU) label.

Ages Eligible for Study
-----------------
Maximum 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 patients who received plerixafor outside of the label indication in Europe and the reason for administration |  | 5 years |
Parameters of Lung Maturity During Late Pregnancy

Study Overview
=================
Brief Summary
-----------------
- Lung maturity is one of the most important factors in perinatal medicine

Detailed Description
-----------------
Fetal development passes in many stages till fetal maturation occurs We are trying to line out fetal maturation

Official Title
-----------------
The Different Factors Involved in Fetal Maturity in Late Pregnancy

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant ladies from 28 weeks till term Exclusion Criteria: pregnant ladies before 28 weeks

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ultrasonography|ultrasound to evaluate parameters of fetal maturity during pregnancy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of fetuses who will be mature postnatally | the neonates who willnot need incubators | within 2 weeks |
A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma

Study Overview
=================
Brief Summary
-----------------
This is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.

Official Title
-----------------
A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older, AND plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid. Exclusion Criteria: under 18 years of age, unable to give informed consent, OR not planned to go to operating room for sentinel node biopsy using technicium-99 labeled colloid.

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 |
| --- | --- | --- |
| Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity of the MGC for detection of sentinel nodes, compared to handheld gamma probe (secondary) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, imaging, sentinel node, biopsy
Chronic Kidney Disease in Pakistani Population

Study Overview
=================
Brief Summary
-----------------
The Indo-Asian developing countries are facing an epidemic of chronic diseases including hypertension, diabetes and chronic kidney disease (CKD). Diagnosis of early CKD is essential for institution of effective and timely prevention of its complications; costly late stage treatment for end stage renal disease is currently an unfeasible option in these populations. GFR estimates of kidney function provide a common reference standard for all people and are therefore readily applicable by physicians and understood by patients. However, the existing GFR equations yield widely discrepant results in the Indo Asian population, and none of the currently available estimating equations have been validated in this population. The main objective is to develop a tool which can be used for screening subjects at high risk for developing CKD (with hypertension and diabetes) as well as the general population.

Detailed Description
-----------------
The proposed study is being conducted at the Aga Khan University in collaboration with Tufts-New England Medical Center and Imperial College, UK. It is a population based cross-sectional study using a 2-stage cluster design. The study would be performed on 650 adult subjects from the general population in Karachi. A new GFR equation specific to a Pakistani population would be developed and validated using the gold standard of measured Insulin GFR. The performance of the new equation will be compared to the existing ones developed in other populations with respect to bias, precision, and accuracy. The project is likely to contribute significantly to moving the field to kidney disease forward, and its results are likely to have far reaching implications for understanding of CKD and, ultimately, its prevention in Indo-Pakistani populations worldwide.

Official Title
-----------------
Chronic Kidney Disease in the Pakistani Population

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals aged 40 years and above Exclusion Criteria: Shortness of breath on minimal to moderate exertion Acute fibril illness Doctor diagnosed liver disease Doctor diagnosed rheumatological disease Heart attack within past three months Pregnancy Mentally incompetent to give informed consent Too frail to travel to clinic Bed ridden subjects

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| GFR will be measured as the mean of at least two urinary clearance periods of Inulin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Renal insufficiency
Follow-up Study of ICUS and CCUS Patients

Study Overview
=================
Brief Summary
-----------------
The proposed minimal diagnostic criteria for myelodysplastic syndromes (MDS) and potential pre-MDS conditions has been released by an international consensus group. Based on the criteria, patients with persistent cytopenia could be diagnosed with MDS, CCUS and ICUS. However, the process and outcome of pre-MDS conditions (CCUS, ICUS) is still to be characterized in Chinese population. We design this prospective observational study to explore the disease process and outcome in ICUS and CCUS patients.

Official Title
-----------------
A Follow-up Observational Study of ICUS and CCUS Patients

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Other: Observation and necessary supportive care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cytopenia of any degree in one or more lineages: erythrocytes, neutrophils, or platelets. And the cytopenia has to be persistent (≥ 4 months) and lacking minimal diagnostic criteria of MDS. Exclusion Criteria: Patients with cytopenia which could be explained by any other hematologic or non-hematologic disease.

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 |
| --- | --- |
| Idiopathic cytopenia of undetermined significance (ICUS)<br> | Other: Observation and necessary supportive care<br>* For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated.<br>|
| Clonal cytopenia of unknown significance (CCUS)<br> | Other: Observation and necessary supportive care<br>* For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culumative transformation rate | Transformation is defined as progression from ICUS to CCUS, ICUS to MDS or CCUS to MDS. All patients are followed-up since entry into this trial and transformation events are recorded. Cumulative transformation rate is defined for all patients and estimated by competing risk methods. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | Defined for all patients entry into this trial; measured from the date of entry into this trial to the date of progression or death from any cause; patients not known to have any of these events are censored on the date they were last examined. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic cytopenia of undetermined significance (ICUS), Clonal cytopenia of unknown significance (CCUS)