linjc16/ctgov huggingface dataset:
Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure

Study Overview
=================
Brief Summary
-----------------
We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors.

Detailed Description
-----------------
At present, around 30% of women with stress urinary incontinence have overactive bladder syndrome after mid-urethral sling procedure. But its predictive factor is still unclear. We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors. In addition, we will explore the cure rate and predictors of cure of overactive bladder syndrome after the mid-urethral sling procedure for women with stress urinary incontinence. The above results will be used as a reference for preoperative and postoperative consultation.

Official Title
-----------------
Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: mid-urethral sling procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women with stress urinary incontinence who underwent mid-urethral sling procedure from January 01, 2008 to July 31, 2019 will be reviewed. Exclusion Criteria: Patients undergoing other gynecological operations at the same time, except for cystoscopy.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: mid-urethral sling procedure|mid-urethral sling procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting the presence of overactive bladder syndrome after mid-urethral sling procedure |  | 10 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting cure of overactive bladder syndrome after mid-urethral sling procedure |  | 10 years |
Korean Post-marketing Surveillance for Sprycel®

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Sprycel® so that the regulatory authority can manage the marketing approval properly.

Official Title
-----------------
Korean Post-marketing Surveillance for Sprycel®

Conditions
-----------------
Leukemia, Myelomonocytic, Chronic, Leukemia-Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including Imatinib Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy Exclusion Criteria: According to Warning/Caution in local label
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CML or Ph+ ALL<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurrence |  | 30 days after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in hematologic response | The number and percentage of subjects who satisfy each criterion of hematologic responses (Complete/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value | 4 weeks after registration | 
| Improvement in cytogenetic response | The number and percentage of subjects who satisfy each criterion of cytogenetic responses (Complete/Partial/Minor/Minimal/No response) will be presented as frequency distribution. McNemar test will be conducted to test the change from the baseline value | 12 weeks after registration | 
| Overall efficacy assessment by investigator's discretion | Based on demographic factors, treatment factors like medical history and concomitant medication | 4 weeks after registration |
The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008

Study Overview
=================
Brief Summary
-----------------
Evaluation of the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with Acute Lymphoblastic Leukemia treated in the NOPHO-ALL 2008 protocol.

Detailed Description
-----------------
Asparaginase treatment in acute lymphoblastic leukemia in children is jeopardized by a huge toxicity burden and the toxicities are often preventing further treatment. The most common asparaginase associated toxicities are hypersensitivity, pancreatitis, thromboembolism and osteonecrosis. In the NOPHO ALL2008 protocol asparaginase associated toxicities have been registered since the protocol opened in July 2008. In addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively. This study evaluate the association between risk and severity of asparaginase associated toxicities and asparaginase enzyme activity levels in children with ALL treated in the NOPHO-ALL 2008 protocol.

Official Title
-----------------
The Association Between Asparaginase Enzyme Activity Levels and Toxicities in Childhood Acute Lymphoblastic Leukaemia in NOPHOALL 2008

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: Asparaginase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALL, standard or intermediate risk Included in the NOPHO ALL2008 protocol (July 2016 - February 2016) Children (1-17,9 years at diagnosis) Exclusion Criteria: ALL: high risk disease, ph-, genetic predisposition, bilinear ALL < 2 samples for asparaginase enzyme activity measurements

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Asparaginase|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with hypersensitivity | Clinical allergy / silent inactivation. | July 2008 - February 2016 | 
| Number of participants with asparaginase associated pancreatitis |  | July 2008 - February 2016 | 
| Number of participants with tromboembolism |  | July 2008 - February 2016 | 
| Number of participants with osteonecrosis |  | July 2008 - February 2016 |
Amputee Residual Limb Volume Fluctuation

Study Overview
=================
Brief Summary
-----------------
The goal of this project is a useful clinical instrument for diagnosis and treatment of residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to be tested is that the instrument effectively measures short and long term volume fluctuations in individuals with trans-tibial amputation. Another hypothesis to be tested is that when subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they remove the sock or insert residual limb volume increases.

Official Title
-----------------
Measuring and Controlling In-Socket Residual Limb Volume Fluctuation

Conditions
-----------------
Amputation

Intervention / Treatment
-----------------
* Other: Monitored for limb volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: trans-tibial amputees who have a regular prosthetist and who wear the prosthesis at least five hours per day. Exclusion Criteria: Inability to ambulate continuously with a prosthesis (with or without the use of an assistive device such as a cane or walker) for 10 minutes indoors on a level walkway. 2. Inability to shift from horizontal to vertical posture in 30 seconds.
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 |
| --- | --- |
| Lower-limb amputee<br>Subjects with at least one lower limb amputated at the trans-tibial level | Other: Monitored for limb volume<br>* Subjects are monitored for limb volume change using bioimpedance analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual limb fluid volume |  | 1 day |
Intraperitoneal Instillation of Levobupivacaine With Morphine Versus Levobupivacaine With Magnesium Sulfate for Postoperative Analgesia

Study Overview
=================
Brief Summary
-----------------
This is a prospective randomized study that included 60 patients and was divided into two equal groups of patients who were scheduled for LC, Ages 18 and 60 years, both sexes, ASA I-II and BMI 19 - 39. Group A received 30 ml levobupivacaine (0.25%) plus 3 mg morphine intraperitoneal at the site of surgery in the bed of the gallbladder via the navel port with the patient in a Trendelenburg position, Group B received 30 ml levobupivacaine (0.25%) plus 50 mg/kg magnesium sulfate in the same pattern as in the A group.

Official Title
-----------------
Comparison of Intra-Peritoneal Instillation of Levobupivacaine With Morphine Hydrochloride Versus Levobupivacaine With Magnesium Sulfate for Post-Operative Pain Relief After Laparoscopic Cholecystectomy

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: intraperitoneal levobupivacaine and morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were scheduled for L.C, Ages 18 and 60 years ASA I-II and BMI 19 - 39 Exclusion Criteria: Patients with hepatic or renal dysfunction use of opioids 24 hrs prior to the study treatment with steroids prior to surgery drug or alcohol abuse, allergy to any of the study drugs chronic pain syndrome as a result of neurological disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: levobupivacaine with morphine<br>30 patients will have intraperitoneal instillation of levobupivacaine with added morphine at the end of laparoscopic cholecystectomy operation | Drug: intraperitoneal levobupivacaine and morphine<br>* istillation of the peritoneum with levobupivacaine mixture with morphine<br>|
| Experimental: levobupivacaine with magnesium sulfate<br>30 patients will have intraperitoneal instillation of levobupivacaine with added magnesium sulfate at the end of laparoscopic cholecystectomy operation | Drug: intraperitoneal levobupivacaine and morphine<br>* istillation of the peritoneum with levobupivacaine mixture with morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of postoperative pain | reduction of post operative visual analogue score | 8 hours |
Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

Study Overview
=================
Brief Summary
-----------------
This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.

Official Title
-----------------
A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A

Intervention / Treatment
-----------------
* Drug: turoctocog alfa pegol
* Drug: turoctocog alfa pegol
* Drug: turoctocog alfa pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Haemophilia A Body Mass Index (BMI) below 35 kg/m2 History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand) Exclusion Criteria: Any history of FVIII inhibitors Surgery planned to occur during the trial Platelet count less than 50,000 platelets/microlitre (assessed by laboratory) Congenital or acquired coagulation disorders other than haemophilia A

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: turoctocog alfa pegol<br>* Single dose (low) administered intravenously (into the vein)<br>* Other names: NNC 0129-0000-1003;|
| Experimental: B<br> | Drug: turoctocog alfa pegol<br>* Single dose (medium) administered intravenously (into the vein)<br>* Other names: NNC 0129-0000-1003;|
| Experimental: C<br> | Drug: turoctocog alfa pegol<br>* Single dose (high) administered intravenously (into the vein)<br>* Other names: NNC 0129-0000-1003;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events (AEs) reported after administration of trial product |  | up to four weeks after trial product administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample) |  | from 0 to 168 hours after trial product administration | 
| Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments |  | up to four weeks after trial product administration |
Mifepristone Versus Laminaria for Cervical Ripening in Midtrimester Induction

Study Overview
=================
Brief Summary
-----------------
Data from other countries have suggested that oral mifepristone used as a cervical ripening agent may decrease induction to delivery time in midtrimester inductions. To our knowledge, there are no trials comparing mifepristone to laminaria in a standard clinical setting with standardized misoprostol induction protocol to examine the issue of induction to delivery time. We hypothesize that mifepristone will work at least as well as laminaria for midtrimester cervical ripening prior to induction of labor with misoprostol.

Official Title
-----------------
Randomized Controlled Trial of Mifepristone Versus Laminaria for Cervical Ripening In Midtrimester Induction

Conditions
-----------------
Abortion, Induced

Intervention / Treatment
-----------------
* Drug: mifepristone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women with fetal anomalies, aneuploidy, or demise at 15-22 weeks gestation age greater than 16 able to speak English Exclusion Criteria: prior uterine scar or allergy or history of bad reaction to any of the study drugs or history of chronic adrenal failure or porphyria or concurrent long-term corticosteroid treatment

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mifepristone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction to delivery time |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 
| delivery within 24 hours |  |  | 
| need for post-partum D&C |  |  | 
| adverse events |  |  |
Diagnosis and Treatment of Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

Detailed Description
-----------------
This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

Official Title
-----------------
Diagnosis and Treatment of Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis, Liver Disease or Abnormalities, Diabetes, Pancreatic Insufficiency (Exocrine and Endocrine)

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Patients with known or suspected CF and family members of patients with CF. >=4 years of age EXCLUSION CRITERIA -Concomitant medical, psychiatric or other problems which might complicate interpretation of studies of CF, or for which we are unable to provide adequate care.

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- |
| CF Patients<br>cystic fibrosis patients | |
| CF Relatives<br>relatives of cystic fibrosis patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop a database and collection of samples obtained from patients with CF during their clinical care to allow for future research | To develop a collection of samples and a database from patients with cystic fibrosis to be used in future research. | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis, Pancreatic Insufficiency, Bronchiectasis, Liver Disease, Natural History
Cervix:Hypoxia, Interstitial Fluid Pressure and GSH Levels

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure the oxygen content and interstitial fluid pressure in cervix cancer patients. Tumour oxygen content and internal pressure of tumours may be an important factor that influences the effectiveness of radiotherapy and other treatments.

Official Title
-----------------
Predictive Assays in Cervix Cancer: Assessment of Hypoxia, Interstitial Fluid Pressure, and GSH Levels

Conditions
-----------------
Cervix Neoplasms

Intervention / Treatment
-----------------
* Procedure: Pre-treatment tumour oxygen measurements (under anesthesia)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed patients with carcinoma of the cervix ( 3 cm in size or larger) where an examination under anesthesia is to be performed for staging purposes Informed consent Exclusion Criteria: Patients with clinically occult cervix carcinoma

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-treatment tumour oxygen measurements (under anesthesia)<br> | Procedure: Pre-treatment tumour oxygen measurements (under anesthesia)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if tumour oxygen tension prior to and during radiation therapy is an independent prognostic factor for primary tumour response and control in patients with cervix cancer. |  | tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter | 
| To correlate tumour IFP measured before and during radiation therapy with oxygen tension as measured by the Eppendorf probe and to assess IFP as a prognostic factor for pelvic control. |  | tumour measurement will be done 2-3 months following completion of treatment; follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if whole cell or nuclear GSH levels are correlated with tumour oxygen tension and with tumour response and control. |  | follow-up every 3 months for 2 years; every 4-6 months during year 3 to 5; and annually thereafter |