linjc16/ctgov huggingface dataset:
The Prospective Segeberg TAVI Registry

Study Overview
=================
Brief Summary
-----------------
A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany

Detailed Description
-----------------
A prospective single center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 years to assess valve durability.

Official Title
-----------------
A Prospective Follow-up Assessment of Transcatheter Aortic Valve Implantation in Bad Segeberg

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: Transcatheter Aortic Valve Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated with TAVI Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter Aortic Valve Implantation|Interventional replacement of the aortic valve|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Cardiovascular and not cardiovascular death | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural valve deterioration | Transprosthetic mean pressure gradient ≥40 mmHg and/or ≥20 mmHg rise from baseline OR severe intraprosthetic aortic regurgitation | Up to 10 years |
Preemptive Analgesia for Postlaminectomy

Study Overview
=================
Brief Summary
-----------------
To relieve post laminectomy pain, we have tried intraoperative perineural injection of lidocaine right after the exposure in expecting that this would be preemptive analgesia by blocking the nerve transmission so that postoperative pain starts later and lighter.

Detailed Description
-----------------
A randomized double-blind 40 patients aged 18-50 of ASA I and II undergoing laminectomy were included in the study. All the patients were followed for their heart rate, arterial pressure , respiratory rate, oxygen saturation, end tidal CO2 and postoperative VAS scores. All the patients were premedicated with midazolam 0.1 mg/kg intramuscularly 40 minutes prior to surgery. The induction was made 2 mg/kg propofol, 1 ug/kg remifentanyl, 0.5mg/kg rocuronium. After the orotracheal intubation anesthesia was maintained with isoflurane (%0.5-2.0) and 0.1 mg/kg rocuronium.Just before the exposure of dorsal root, 0.5 cc %2 lidocaine was injected on the dorsal root.The patients postoperative analgesic period, VAS scores and additional analgesic need was recorded. For the postoperative analgesia tramadol 1 mg/kg tramadol was used.

Official Title
-----------------
Intraoperative Perineural Injection of Lidocaine for Postlaminectomy Pain

Conditions
-----------------
Laminectomy

Intervention / Treatment
-----------------
* Drug: Lidocaine, perineural injection, intraoperatively
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laminectomy 18-50 age ASA 1-2 both sex Exclusion Criteria: under 18 or older than 50 any disease other than back pain\ ASA 3-4

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A01L<br> | Drug: Lidocaine, perineural injection, intraoperatively<br>* 0.5 cc lidocaine, one single injection over the dorsal root.<br>* Other names: lidocaine;Drug: Lidocaine<br>* 0.5 cc %2 lidocaine,single injection<br>|
| No Intervention: B01C<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain. |  | postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia, postlaminectomy , lidocaine, dorsal root
B-line by Lung US in Patients With Acute Decompensated Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate that B-line detected by lung ultrasound before extubation in patients with acute decompensated heart failure can predict future risk of reintubation and clinical outcomes during admission in Korea.

Official Title
-----------------
Implication of B-line Estimated by Lung Ultrasound on Risk of Reintubation in Mechanically Ventilated Patients With Acute Decompensated Heart Failure

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

Intervention / Treatment
-----------------
* Diagnostic Test: Lung ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mechanical ventilation due to acute heart failure Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B-line positive<br> | Diagnostic Test: Lung ultrasound<br>* Lung ultrasound performed at the time of extubation to evaluate B-line in patients with mechanical ventilation due to acute decompensated heart failure<br>|
| B-line negative<br> | Diagnostic Test: Lung ultrasound<br>* Lung ultrasound performed at the time of extubation to evaluate B-line in patients with mechanical ventilation due to acute decompensated heart failure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intubation rate |  | within 72 hours from initial extubation |
The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

Detailed Description
-----------------
comparing the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

Official Title
-----------------
The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration: A 5-year Retro-prospective Clinical Study

Conditions
-----------------
Dental Caries, Caries; Dentin

Intervention / Treatment
-----------------
* Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged five to eight years at the time of dental treatment, patients attending follow-up appointments patients with compomer restoration and Hall restoration in their teeth patients with matching the extent of caries in the two groups Exclusion Criteria: patients not attending follow-up appointments patients without both treatment

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 8 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 |
| --- | --- |
| Preformed Metal Crowns using Hall Technique<br> | Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars<br>* Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.<br>|
| Compomer Restoration<br> | Other: Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars<br>* Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survival rate of Hall Technique and Compomer Restorations | Successful: restoration satisfactory, no additional treatment required, no clinical sign and symptoms of pulpal pathology or tooth exfoliated, Minor failure: restoration wear/fracture/loss (restorable) or crown perforation, secondary caries or new caries, reversible pulpitis treated without requiring extraction or pulpotomy, Major failure: the tooth is broken down (unrestorable), inter-radicular radiolucency or internal root resorption, signs or symptoms of irreversible pulpitis requiring extraction or pulpotomy. The survival analysis: the restorations are assessed as successful or failure. | 5 year |
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.

Official Title
-----------------
Clinical Study to Investigate the Safety and Pharmacokinetics of Udenafil Tablet in Renal Impaired Male Patients

Conditions
-----------------
Renal Insufficiency, Kidney Diseases, Urologic Diseases

Intervention / Treatment
-----------------
* Drug: Udenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 19 to 64 years at screening. Subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9. Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. Exclusion Criteria: Subjects with the test results of QTc > 430 ms or non-sinus cardiac rhythm by ECG analysis. Subjects with hypotension or hypertension. Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study. Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br> | Drug: Udenafil<br>* 100mg Single Oral Dose of<br>|
| Experimental: Patients with mild renal impairment<br> | Drug: Udenafil<br>* 100mg Single Oral Dose of<br>|
| Experimental: Patients with moderate renal impairment<br> | Drug: Udenafil<br>* 100mg Single Oral Dose of<br>|
| Experimental: Patients with severe renal impairment<br> | Drug: Udenafil<br>* 100mg Single Oral Dose of<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUC and Cmax) |  | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Udenafil, DA-8159, renal impairment, healthy volunteers
Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.

Official Title
-----------------
Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer

Conditions
-----------------
Prostate Cancer, Prostate, Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: 68Gallium-PSMA-11
* Procedure: Positron Emission Tomography (PET)


Participation Criteria
=================
Eligibility Criteria
-----------------
Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria: Inclusion Criteria: Age ≥ 18 years Histopathologically confirmed or biopsy proven prostate adenocarcinoma. Concern for metastatic disease in one of the following settings: Initial staging with intermediate to high risk prostate cancer. Biochemical recurrence after initial therapy. Ability to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 68Gallium-PSMA-11|PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).|
|Procedure: Positron Emission Tomography (PET)|A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus

Study Overview
=================
Brief Summary
-----------------
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.

Official Title
-----------------
A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporin Dose Reduction With Cyclosporin Elimination in de Novo Renal Allograft Recipients Receiving Rapamune

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

Intervention / Treatment
-----------------
* Drug: Rapamune®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: = to ≥ 18 years. End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor. Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons). Exclusion Criteria: Evidence of active systemic or localised major infection prior to initial Rapamune® administration. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening. Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rapamune®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Function at 12 months after transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Disease
QUANTRA® References Range Protocol in Pregnancy and Postpartum

Study Overview
=================
Brief Summary
-----------------
Postpartum hemorrhage (PPH) remains the leading cause of maternal death. PPH associated coagulopathy varies and their treatments (tranexamic acid, fibrinogen concentrates,plasma, platelets need to be targeted and administrated early. Point of care hemostasis devices are helpful to develop this strategy. Quantra® (STAGO BIOCARE) use an innovative method to detect the clot formation. Pregnancy and non-hemorrhagic postpartum reference ranges are missing. The objective of this study is to establish these norms needed to elaborate thereafter the thresholds to be targeted in PPH conditions.

Official Title
-----------------
Normal Pregnancy and Postpartum Reference Ranges Intervals for QUANTRA® (STAGO BIOCARE) Hemostasis Point of Care Device

Conditions
-----------------
Pregnancy Postpartum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant woman (indemne of any chronic pathology neither obstetrical pathology) Delivering vaginally without postpartum hemorrhage for 60 patients Delivering through a programmed C-section for 20 patients Having given a non-opposition agreement to participate in the study. Major patient with social insurance Exclusion Criteria: Any acute or chronic hemostasis pathology before pregnancy or during pregnancy instrumental delivery or cesarean section Postpartum bleeding.

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

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 |
| --- | --- | --- |
| Description of the QUANTRA® parameters range intervals before and after vaginal delivery |  | At admission (= before delivery ) | 
| Description of the QUANTRA® parameters range intervals before and after vaginal delivery |  | At 30 minutes +/- 10 minutes after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the QUANTRA® parameters range intervals before and after vaginal delivery |  | At 30 up to 60 minutes after birth and placental removal. | 
| Comparison between end of pregnancy and immediate postpartum reference values (both vaginal and caesarean deliveries) |  | At 30 up to 60 minutes after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemostasis, pregnancy, postpartum, point of care, coagulopathy
High Dose Chemotherapy Followed By PBSC Rescue for HD

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation in the treatment of Hodgkin's Disease.

Detailed Description
-----------------
Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Official Title
-----------------
Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Conditions
-----------------
Hodgkin Disease

Intervention / Treatment
-----------------
* Procedure: high dose chemo then auto hematopoietic cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- adequate organ function recurrent HD Exclusion Criteria:- CNS disease no prior malignancy

Ages Eligible for Study
-----------------
Minimum Age: 4 Weeks
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: high dose chemo then auto hematopoietic cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| FFS |  |  | 
| Response rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity of high dose chemotherapy |  |  |