linjc16/ctgov huggingface dataset:
Towards Improved Diagnostics for Suspected Platelet Function Disorders

Study Overview
=================
Brief Summary
-----------------
This study aims to improve platelet function testing during bleeding investigations. To this end, the study will evaluate the diagnostic accuracy of novel platelet function tests in patients with confirmed or suspected platelet function disorders. Study participants will be recruited from patients that are referred to or treated at the Coagulation Unit, Karolinska University Hospital, and Pediatric Coagulation Unit, Astrid Lingren Children's Hospital.

Official Title
-----------------
Towards Improved Diagnostics for Suspected Platelet Function Disorders

Conditions
-----------------
Platelet Function Disorder, Platelet Disorder, Thrombocytopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria, known defects: Known platelet function disorder under follow-up at Karolinska University Hospital (genetic or functional assay) High likelihood of platelet function disorder (aberrant screening test with inheritance) Family investigation for platelet disorder Exclusion Criteria, known defects:: Antiplatelet or anticoagulant drugs vWF:GPIb below 0.40 IU/mL Hematocrit below 0.35 or above 0.50 Other coagulation disorder Inclusion Criteria, suspected platelet function disorder: Bleeding investigation at Karolinska University Hospital Exclusion Criteria, suspected platelet function disorder:: Antiplatelet or anticoagulant drugs vWF:GPIb below 0.40 IU/mL Hematocrit below 0.35 or above 0.50 Other coagulation disorder

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

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 |
| --- | --- |
| Suspected<br>Suspected Platelet Function Disorder during bleeding investigation | |
| Confirmed<br>Confirmed Platelet Function Disorder by Functional or Genetic Assay, or confirmed negative by gold standard assay | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet-thrombus formation on collagen surface | Whole-blood platelet-thrombus formation on collagen surface measured in a semi-automatic microchip flow chamber by a pressure sensor. Coagulation activation is inhibited. | At study inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diagnostic accuracy
Comparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture

Study Overview
=================
Brief Summary
-----------------
To evaluate dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal mucosal graft as regard voiding and sexual outcomes.

Detailed Description
-----------------
At the Department of Urology, Sohag university Hospital, both techniques of dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal are used in repair of long stricture anterior urethra.Therefore, our data can be used as a source for the comparative analysis of these two Buccal mucosa graft urethroplasty techniques.This study aimed to compare these procedures to determine their advantages and disadvantages, as regard voiding ,sexual function and quality of life after the surgery.

Official Title
-----------------
Dorsolateral Versus Dorsal Approach Urethroplasty for Managing Long Anterior Urethral Stricture.

Conditions
-----------------
Urethral Stricture, Male

Intervention / Treatment
-----------------
* Procedure: Buccal mucosa substitution urethroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: long anterior urethral stricture Exclusion Criteria: children. Recurrent stricture

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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: Dorsolateral approach urethroplasty<br>Use of dorsolateral(Kulkarni technique) urethroplasty. | Procedure: Buccal mucosa substitution urethroplasty<br>* Use of buccal mucosa as a substitution for urethroplasty<br>|
| Active Comparator: Dorsal approach urethroplasty<br>Use of dorsal (Barbagli technique) urethroplasty | Procedure: Buccal mucosa substitution urethroplasty<br>* Use of buccal mucosa as a substitution for urethroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voiding function | Postoperative Q max | 2 months after catheter removal |
Real-World Outcomes in Relapsed/Refractory Multiple Myeloma Patients Treated, or Eligible for Treatment, With Idecabtagene Vicleucel

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. This study will use both prospective and retrospective data from the DESCAR-T registry database.

Official Title
-----------------
ABE-DESCART Study: Characterization and Outcomes of Patients With Relapsed and Refractory Multiple Myeloma Eligible for Treatment or Treated With Abecma© (Idecabtagene Vicleucel) in Real World Setting in France. A Database Analysis Based on the DESCAR-T Registry

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Idecabtagene vicleucel
* Other: Not treated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel Exclusion Criteria: Not registered with the social security in France
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated with idecabtagene vicleucel<br> | Drug: Idecabtagene vicleucel<br>* According to approved product label in France<br>|
| Eligible for idecabtagene vicleucel<br>Eligible for idecabtagene vicleucel treatment but not treated | Other: Not treated<br>* Eligible for idecabtagene vicleucel treatment but not treated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 15 years |
Open Technique Erector Spinae Plane Block in Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles.ESPB has been successfully applied as a part of multimodal analgesia in treating postoperative pain in spinal surgery. However, it may be difficult or impossible to perform lumbar ESPB in obese patients or cases of increased lumbar lordosis. This study aims to investigate the effectiveness of ESPB applied by the intraoperative surgeon.

Official Title
-----------------
Comparison of the Effectiveness of Preoperative Ultrasound-Guided Erector Spine Plane Block and Erector Spine Plane Block Performed by the Intraoperative Surgeon in Postoperative Analgesia in Patients Undergoing Lumbar Disc Herniation Surgery

Conditions
-----------------
Postoperative Pain, Erector Spinae Plane Block in Spinal Surgery

Intervention / Treatment
-----------------
* Procedure: Erector spinae plane block
* Procedure: Erector spinae plane block performed by surgeon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III patients Agreed to participate in the study Exclusion Criteria: Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure Patients with heart disease Patients who have previously undergone surgery from the same area

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESPB performed by surgeon<br>The transverse process of the vertebra will be observed by the surgeon intraoperatively. Local anesthetic medication will be applied between the transverse process and the ESP muscle group. | Procedure: Erector spinae plane block performed by surgeon<br>* Erector spinae plane block performed by surgeon<br>|
| Active Comparator: Erector spinae plane block<br>The ultrasound-guided erector spinae plane block will be applied preoperatively. | Procedure: Erector spinae plane block<br>* ultrasound guided lumbar erector spinae plane block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump. | up to 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, postoperative analgesia, Erector spinae plane block, Spinal surgery, Open Technique
Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels

Study Overview
=================
Brief Summary
-----------------
Patients with hypovitaminosis D are randomized into three arms of treatment: Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment

Detailed Description
-----------------
Patients with hypovitaminosis D are randomized into three arms of treatment: Group A: Calcifediol 0,266mg each month Group B: Cholecalciferol 25000UI each 15 days Group C: Calcifediol 4 drops per day. Serum levels of vitamin D are dosed after one month of treatment to support the best dosage of Vitamin D intake.

Official Title
-----------------
Different Kinds of Vitamin D Intake and Its Metabolites: Blood Levels and Bone Mineral Density. A Randomized Clinical Trial.

Conditions
-----------------
Hypovitaminosis D

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypovitaminosis D (<20ng/mL) Exclusion Criteria: Osteoporosis (T score <-2.5SD) Renal or hepatic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcifediol each month<br>Calcifediol 0,266 mg each month | Dietary Supplement: Vitamin D<br>* Vitamin D<br>|
| Experimental: Cholecalciferol 25.000 UI<br>Cholecalciferol 25000UI each 15 days | Dietary Supplement: Vitamin D<br>* Vitamin D<br>|
| Experimental: Calcifediol 4 drops each day<br>Calcifediol 4 drops each day | Dietary Supplement: Vitamin D<br>* Vitamin D<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of Vitamin D | Blood dosage of Vitamin D | Between recruitment and 1 month | 
| level of Vitamin D | Blood dosage of vitamin D | Between recruitment and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEXA | DEXA is a radiographic measurement of Bone Mass | Between recruitment and 18 months |
Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate incidence of invasive antifungal infections among patients with acute lymphoblastic leukemia Ph negative during the first weeks of treatment

Official Title
-----------------
Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative

Conditions
-----------------
Acute Lymphoblastic Leukemia, Adult, Invasive Fungal Infections

Intervention / Treatment
-----------------
* Other: observation of invasive fungal infections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of acute lymphoblastic leukemia Ph negative age more than 18 yo Exclusion Criteria: diagnosis of acute lymphoblastic leukemia Ph positive acute lymphoblastic leukemia relapsed/refractory lymphoblastic lymphoma

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 |
| --- | --- |
| Acute lymphoblastic leukemia, no invasive fungal infection<br> | |
| Acute lymphoblastic leukemia, invasive fungal infection<br> | Other: observation of invasive fungal infections<br>* observation of invasive fungal infections during chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of invasive fungal infections during first week of chemotherapy |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate among patients with invasive fungal infections |  | 30 months |
A New Blood Score for Myelofibrosis Staging

Study Overview
=================
Brief Summary
-----------------
BCR:ABL1 negative myeloproliferative neoplasms (MPN) include three entities: polycythemia vera, essential thrombocythemia and primitive myelofibrosis. Myelofibrosis is a life-threatening complication in MPN with several therapeutic options including hematopoietic stem cell transplantation (HSCT) which remains the only curative treatment. Bone marrow biopsy with histological analysis allows myelofibrosis identification and staging. However, it is an invasive procedure that remains painful and provides potential haemorrhagic complications. Development of non-invasive biomarkers for myelofibrosis staging could help to better stratify this disease, better define patients' prognosis and lead to optimal cares. The main aim of this work is to develop a non-invasive blood score including several biomarkers for myelofibrosis staging in MPN using bone marrow biopsy as a gold standard.

Official Title
-----------------
Development of a Blood Score for Myelofibrosis Staging in BCR:ABL1 Negative Myeloproliferative Neoplasms Using Bone Marrow Biopsy as a Gold Standard

Conditions
-----------------
Myeloproliferative Neoplasm

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Diagnosis of BCR::ABL1 negative MPN according to WHO criteria classification Indication for bone marrow biopsy Non opposition Social security affiliation Exclusion Criteria: Non-contributory biopsy AML transformation Organ fibrosis (liver, lung, kidney…) HSCT Chronic inflammatory disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Adults with MPN who need a bone marrow biopsy during the management of the disease<br> | Diagnostic Test: Blood sampling<br>* Blood samples will be collected at diagnosis, in the same time as BOM is performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve | Area under the receiver operating characteristic (AUROC) curve of the blood score to discriminate absence or mild fibrosis from advanced fibrosis, using histological analysis as a gold standard. | At diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients | Number of patients initially classify as essential thrombocythemia and refile with primitive myelofibosis diagnosis. | Up to 2 years |
Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain

Study Overview
=================
Brief Summary
-----------------
Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.

Official Title
-----------------
Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Bupivacaine + Magnesium
* Drug: Bupivacaine + Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18 to 65 years. Male and female sexes. ASA I-II.,III Cancer patients undergoing thoracotomy incisions Body mass index (BMI) from 18.5 to 30 kg/m2 Exclusion Criteria: Patient refusal Known allergy to any of the used drugs Low platelet count, any coagulation defect

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Erector spinae plane block with 0.25% bupivacaine<br>Patients will receive ultrasound guided ESPB with 0.25% bupivacaine | Drug: Bupivacaine<br>* Bupivacaine 0.25%<br>|
| Experimental: Erector spinae plane block with 0.25% bupivacaine and Magnesium<br>Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium | Drug: Bupivacaine + Magnesium<br>* Bupivacaine 0.25% + Magnesium<br>|
| Experimental: Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine<br>Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine | Drug: Bupivacaine + Dexmedetomidine<br>* Bupivacaine 0.25% + Dexmedetomidine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative morphine consumption | Total dose of morphine needed postoperatively in the first 24 h | First 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first postoperative rescue analgesia. | Time to first postoperative rescue analgesia. | First 24 hours postoperatively |
Reliability and Validity of the Turkish Version of the Object Permanence Scale

Study Overview
=================
Brief Summary
-----------------
The aim of the study is the cultural adaptation of the Object Permanence Scale to Turkish and to examine its validity and reliability. The sample of the study will be 7-16 months old babies with motor developmental delay. Inclusion criteria: 7-16 months of age, sitting for at least 3 seconds but not being able to switch independently between sitting and other positions, and showing at least one developmental delay in the motor development subscale of the Bayley III Developmental Assessment. Evaluations will be done at baseline and after 1 week (retest). Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder.

Official Title
-----------------
Reliability and Validity of the Turkish Version of the Object Permanence Scale

Conditions
-----------------
Developmental Delay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7-16 months, Sitting for at least 3 seconds but unable to independently switch between sitting and other positions To show at least one retardation in motor subscale of Bayley III. Exclusion Criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder

Ages Eligible for Study
-----------------
Minimum Age: 7 Months
Maximum Age: 16 Months

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 |
| --- | --- | --- |
| Object Permanence Scale | The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome. | Baseline | 
| Object Permanence Scale | The minimum score of the Object Permanence Scale is 0, and the maximum score is 10. Higher scores indicate better outcome. | After 1 week (retest) | 
| The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) motor and cognitive subscales | Cognitive subscale consists of 91 items and Motor subscale consists of 138 items. Items are scored as 1 (done) and 0 (not able to). Higher scores indicate better outcome. | Baseline | 
| Gross motor function measure sitting subscale | The sitting subscale consists of 20 items. Each item is scored on a 4-point ordinal scale (0-3). Higher scores indicate better outcome. | Baseline |