linjc16/ctgov huggingface dataset:
Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management

Study Overview
=================
Brief Summary
-----------------
This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.

Detailed Description
-----------------
Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, is directly affected by gynecologic malignancies and the surgical and medical management of those malignancies. Increased risk of injury to the urinary tract is a recognized complication of surgical and medical therapy of gynecologic malignancies. To date, only a few studies have looked at the incidence of lower urinary tract symptoms at the time of diagnosis of gynecologic malignancy and prior to treatment, and there have been no published studies describing the incidence of sexual dysfunction at the time of diagnosis and prior to therapy of gynecologic malignancies. However, sexual dysfunction has been described in patients with urinary incontinence and pelvic organ prolapse and following surgery for incontinence and pelvic organ prolapse.

Official Title
-----------------
Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management

Conditions
-----------------
Lower Urinary Tract Symptoms, Gynecologic Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a new diagnosis of gynecologic malignancy who plan to undergo surgical management, including cervical, endometrial, and ovarian cancer. Exclusion Criteria: Subjects less than 18 years of age Subjects unable to give informed consent

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 |
| --- | --- | --- |
| The outcome will be measured using validated general and condition-specific questionnaires. |  | 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower urinary tract symptoms, Gynecologic malignancy, Urinary incontinence, Fecal incontinence, Frequency, Voiding dysfunction, Sexual dysfunction
AZD7325 Multiple Ascending Dose Study

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.

Official Title
-----------------
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD7325


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects must be of non-child bearing potential. Exclusion Criteria: Clinically significant illness within 2 weeks before the study start. Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2 Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD7325<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs |  | Alssessments are made at each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses |  | Blood samples will be taken during the study. | 
| Evaluation of the pharmacodynamic effects of AZD7325 |  | Test batteries will be performed at specified times both before and following study drug administration. | 
| Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325. |  | A single blood sample will be obtained. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Pharmacokinetics
Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine removal of protein bound uremic substances by mFPSA in chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed for detoxification in acute liver failure by removal of protein bound as well as water soluble substances.

Detailed Description
-----------------
Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.

Official Title
-----------------
Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis

Conditions
-----------------
Uremia

Intervention / Treatment
-----------------
* Procedure: mFPSA treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over the age of 18 Anuria Chronic hemodialysis dependence Exclusion Criteria: No present history of bleeding episodes Cardiac diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: mFPSA treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  |  | 
| Safety serological parameters |  |  | 
| Concentrations of protein bound uremic toxins |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding episodes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mFPSA, Uremic toxins, Protein bound toxins, Uremia, Chronic hemodialysis
Prevention of Acute Radiation Enteritis With Glutamine

Study Overview
=================
Brief Summary
-----------------
Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with antioxidant effects that can protect tissues of damage dued to radiation. The investigators designed a randomized, double-blind trial phase III to study if glutamine prevents acute radiation enteritis.

Official Title
-----------------
Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.

Conditions
-----------------
Acute Radiation Enteritis

Intervention / Treatment
-----------------
* Dietary Supplement: Glutamine
* Dietary Supplement: Whole protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 yr Gynaecological,prostatic, rectal or other abdominal cancer Radiotherapy with/without chemotherapy Exclusion Criteria: life expectancy < 1 yr Age < 18 yr gut diseases: inflammatory bowel disease,sprue, irritable bowel disease... moderate to severe chronic renal failure hepatic cirrhosis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br> | Dietary Supplement: Glutamine<br>* Oral glutamine 30g/day<br>|
| Placebo Comparator: Whole protein<br> | Dietary Supplement: Whole protein<br>* Oral whole protein 30 g/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with acute radiation enteritis | RTOG criteria | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in inflammatory markers and oxydative stress |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Diarrhoea, Glutamine, Oxydative stress, Calprotectin, Citrulline
Biomarkers in Samples From Younger Patients With Wilms Tumor

Study Overview
=================
Brief Summary
-----------------
This research study is studying biomarkers in tissue samples from younger patients with Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine whether recruitment of tumor-associated macrophages is related to clinicopathological factors in Wilms tumor (tumor stage, presence of vascular invasion, tumor progression, and survival). OUTLINE: Paraffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival.

Official Title
-----------------
Observational - Relationships Between Tumor-Associated Macrophages and Clinicopathological Factors in Wilms Tumor

Conditions
-----------------
Wilms Tumor and Other Childhood Kidney Tumors

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wilms tissue microarray samples provided by the Children's Oncology Group
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic science (biomarker analysis)<br>Paraffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of tumor-associated macrophages and prognosis | Correlation of each type of macrophage score with tumor staging, presence of vascular invasion, and disease-free survival will be assessed. | 1 month |
Rosiglitazone and Insulin in T1DM Adolescents

Study Overview
=================
Brief Summary
-----------------
Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need insulin injections, blood sugar monitoring several times each day, and adhere to a strict diet. Adequate control of blood glucose is essential to prevent long term kidney and eye complications that result in kidney failure and blindness. Adolescence is a time when diabetes is difficult to control, due in part to high growth hormone levels causing insulin resistance ( a state where the body does not respond as strongly to insulin). This study will test whether treatment with rosiglitazone (an oral medication used frequently in type 2 diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1 diabetes during puberty.

Official Title
-----------------
The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial

Conditions
-----------------
Type 1 Diabetes, Puberty: >Tanner 2 Breast Development or Testis >4ml

Intervention / Treatment
-----------------
* Drug: Rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1DM duration > 1year age 10-18years HbA1c > 8% puberty > Tanner stage 2 breast or testis >4ml Exclusion Criteria: known non-compliance hypo unaware

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin dose |  |  | 
| frequency of severe hypoglycaemia |  |  | 
| insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp |  |  | 
| weight |  |  | 
| BMI-SDS |  |  | 
| skin fold thickness |  |  | 
| cholesterol |  |  | 
| adiponectin |  |  |
Detection of Cytomegalovirus Virus in Neonates

Study Overview
=================
Brief Summary
-----------------
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs

Official Title
-----------------
Illumigene CMV Clinical Trial Protocol

Conditions
-----------------
CMV

Intervention / Treatment
-----------------
* Device: illumigene CMV assay, illumipro-10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Saliva swab specimens from neonates up to 21 days of age Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium. Flocked-nylon swabs Exclusion Criteria: Samples other than saliva swab from patients up to 21 days of age. Swabs other than flocked-nylon. Swabs in a viral transport media not defined in the Investigational Use Only package insert Multiple specimens from the same patient. Specimens received in the laboratory in unsatisfactory containers or condition.

Ages Eligible for Study
-----------------
Maximum Age: 20 Days

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 |
| --- | --- |
| Specimen collection<br> | Device: illumigene CMV assay, illumipro-10<br>* CMV assay for detection of CMV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative detection of CMV to aid in the diagnosis of CMV | Test each sample for CMV detection | within 30 days of sample collection |
Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Liver transplantation (LT) is a live-saving therapy for patients with complicated chronic liver diseases and acute liver failure .Even though many complications can occur after LT, biliary complications (BC) are both common and potentially severe . a prospective study and retrospective part from hospital records. Aim of the study: Detect frequency, risk factors for development of biliary complications post living donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone, cholangitis etc.…). Evaluate outcomes of different biliary complications

Official Title
-----------------
Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation in Al-Rajhy Liver Hospital in Upper Egypt.

Conditions
-----------------
Liver Transplant; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital , Assiut university,Egypt Exclusion Criteria: pediatric liver transplantation cadaveric liver transplantation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biliary complications | Biliary complications include biliary leak or stricture (anastomotic or non anastomotic), the investigator will record nature of complication , its time of presentation and number of hospital re-admissions due to biliary complications. | 1 year after liver transplantation | 
| Type of intervention done to each complication | Intervention is either non surgical (ERCP or PTD) or surgical revision with detailed description of each intervention and if the intervention is successful or not (biliary stricture resolved by MRCP, improvement of liver functions and symptoms) | 1 year after liver transplantation |
Ephedrine for the Treatment of Congenital Myasthenia

Study Overview
=================
Brief Summary
-----------------
Previous research has demonstrated possible efficacy of Ephedrine in the treatment of congenital myasthenia caused by end-plate acetylcholinesterase deficiency. The aim of the current study is to test the hypothesis that Ephedrine may be beneficial to these patients. To test this hypothesis we will perform a double blind, placebo-controlled, crossover study clinical efficacy and safety study. Drug naïve patients who agree to participate will be randomized to two groups. Each group will be treated in a blinded manner for 5 weeks with either placebo or Ephedrine HCl in an escalating dose up to 100 mg per day divided in two doses. After five weeks the groups will cross over and continue treatment or placebo for a further five weeks. Evaluations of strength and fatiguability will be done at baseline, at the end of each five week period and after a further two weeks. Safety will be assessed weekly by the investigators using interview and physical examination. Outcome measures will include Barthel index, Quality of life questionnaire, Timed up and go, spirometry, timed elevation of limbs, and force measurements. All patients will report to the clinic as per study schedule (See Appendix A). Specifically, the 12 clinic visits will include: baseline (1), safety and efficacy assessments(10) and closeout (1).

Conditions
-----------------
Myasthenic Syndromes, Congenital

Intervention / Treatment
-----------------
* Drug: Ephedrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients , with congenital myasthenia, belonging to a previously reported kindred diagnosed with COLQ deficiency. Exclusion Criteria: History of allergy to Ephedrine or any inactive component. Significant abnormalities in screening Cardiovascular parameters (blood pressure, pulse). Surgery within 6 weeks of screening. Concurrent use of any other medication except steroids. Pregnancy. Thyrotoxicosis. Co-morbid conditions or other neurological disorders that would confound assessment of clinical parameters. Participation in another clinical trial within 30 days of study start. Patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| strength and fatiguability: walking, straight arm raising, spirometry. |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
congenital myasthenia, ephedrine