linjc16/ctgov huggingface dataset:
Dose Escalation Study to Evaluate the Safety and Antiviral Activity of Val-mCyd in Adults With Chronic Hepatitis C

Study Overview
=================
Brief Summary
-----------------
This study was conducted to determine the safety, tolerance, pharmacokinetics and antiviral activity of val-mCyd at doses ranging from 50 mg to 800 mg per day.

Official Title
-----------------
A Phase I/II Double-Blind, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Val-mCyd (NM283) in Adults With Chronic Hepatitis C

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: val-mCyd


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history of chronic hepatitis C and compensated liver disease No antiviral treatment for hepatitis C in the 6 months prior to the Screening visit Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with HBV or HIV Other protocol-defined exclusion criteria may apply.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: val-mCyd|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Study Overview
=================
Brief Summary
-----------------
Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Official Title
-----------------
Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Aged of 18 and over Advanced hepatocellular carcinoma Exclusion Criteria: History of prior systemic chemotherapy Failure in vital organ

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib (Nexavar, BAY43-9006)<br>Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity. | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Multikinase Inhibitor; Sorafenib: 400mg bid of sorafenib<br>|
| Placebo Comparator: Placebo<br>Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily). | Drug: Placebo<br>* Placebo: matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP) | Time to progression (TTP) was defined as the time from date of randomization to radiological progression / recurrence. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. | From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at their last date of follow-up were censored at the time of analysis. | From randomization of the first subject until 39 months later. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, Cancer, Liver Cancer, TACE
Chromosomal and Morphological Structure of Mature and Immature Male Germ Cells and Recognition of IL-18 in Testicular Tissue of Azoospermic Men

Study Overview
=================
Brief Summary
-----------------
To develop a biotechnological assay which will be able to recognize germ cells of the spermatogenic lineand and to identify the chromosomal and morphological structure of mature and immature male germ cells, in cases of of sperm production disorders(azoospermic patients). To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it has been suggested that this cytokine may serve as a paracrine defense factor in the male gonad associated to spermatogenesis.

Detailed Description
-----------------
A new biotechnological assay was developed by adapting an existing computerized system which scans cell morphology and chromosomal ploidy in the same cell of hematologic line using digital technology, to recognize germ cells of the testis by their morphology and cytogenetics. Testicular tissues which obtained from 15 men were enzymatically digested and the cells received were fixed on slides. The cells were stained by Giemsa May Grinwald staining and scanned automatically in a bright field for cell morphology. Fluorescence in situ hybridization (FISH) using centromeric probes for chromosomes X, Y and 18 was performed on the same slide after destaining. The cells were automatically scanned and classified according to the ploidy of the chromosome signals. The presence of IL-18 in the same men's testis was examined parallelly, by immunohistochimical staining using specific antibody for human IL-18.

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-obstructive azoospermic patients Exclusion Criteria: Obstructive azoospermia

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 39 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
azoospermia FISH IL-18 TESTICULAR BIOPSY
Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

Study Overview
=================
Brief Summary
-----------------
This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.

Official Title
-----------------
A 24-week Prospective Open-label Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

Conditions
-----------------
Epilepsy, Partial Seizures

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females, 6 months - 17 years of age; diagnosis of epilepsy, partial seizures; ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy Exclusion Criteria: progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening; non-epileptic seizures; drug or alcohol dependence during a year prior to screening; Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 Years

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

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 |
| --- |
|Drug: Oxcarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epileptic activity at electroencephalography in rest |  |  | 
| Flash light and hyperventilation test with electroencephalography |  |  | 
| Frequency of epileptic episodes according to patient's diary |  |  | 
| Electrocardiogram analysis for rhythm and conduction |  |  | 
| Blood test for sodium, hepatic enzymes and blood cells |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures |  |  | 
| Rate of patients with total and partial control of epilepsy |  |  | 
| Rate of patients requiring additional antiepileptic drugs |  |  |
YAG Laser Versus Punch Biopsy for the Treatment of Tattoo Skin Markers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare patient satisfaction, clinical efficacy and adverse effects of Q-switched YAG laser versus punch biopsies for the treatment of tattoo dots that are applied as skin markers in relation to X-ray treatment of malignant disorders.

Conditions
-----------------
Tattoo Skin Markers

Intervention / Treatment
-----------------
* Device: Q-switched YAG laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older, Skin types I-IV, No previous laser treatment for the condition. Exclusion Criteria: Younger than 18 years, Skin types V-VI, Pregnant or lactating women, Previous laser treatment for the condition, Recent exposure to sun or sun-beds, Treatment with oral retinoids within 3 months, Tendency to produce hypertrophic scars or keloids, Immunosuppressive treatment or disorders

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Q-switched YAG laser|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Postpartum Sexual Function in Pregnant Women With COVID-19

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify women with postpartum sexual dysfunction and dyspareunia risk in the early period and to use the treatment and care services they need effectively. Our secondary aim is to reveal the difference in sexual life in the postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19.

Official Title
-----------------
Evaluation of Pregnant Women Diagnosed With COVID-19 Using Carol Postpartum Sexual Function and Dyspareunia Scale

Conditions
-----------------
COVID-19, Dyspareunia, Postpartum Period

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Patient with COVID-19 Exclusion Criteria: Those with known sexual dysfunction disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Pregnant women with COVID-19 who have given birth | |
| Control<br>Healthy pregnant women who have given birth | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale | In the study planned to be carried out, it is aimed to identify women at risk of postpartum sexual dysfunction and dyspareunia early and benefit from the treatment and care services they need effectively. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pregnant women diagnosed with COVID-19 using Carol Postpartum Sexual Function and Dyspareunia Scale | To reveal the difference in sexual life in postpartum period between healthy pregnant women and pregnant women diagnosed with COVID-19. | 3 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum Period, Dyspareunia, COVID-19
Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Null hypothesis: No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM). Alternative hypothesis: There is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM.

Official Title
-----------------
Phase 1 Study of Randomized Clinical Trial Comparing Vitamin C Supplementation Plus Oral Hypoglycemic Drugs Versus Hypoglycemic Drugs Alone on Serum Selenium, Zinc, Copper and Malondialdehyde Levels in Type 2 Diabetes Mellitus and Its Microvascular Complications

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin C
* Drug: glyburide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of type 2DM patients in good health receiving oral hypoglycemic drugs Exclusion Criteria: Insulin dependent diabetes receiving vitamin complex smoking renal disease liver disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin C supplementation plus oral hypoglycemic agents arm<br>This group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients. | Dietary Supplement: Vitamin C<br>* Vitamin C supplementation 500mg<br>|
| Active Comparator: Type 2DM patients receiving oral hypoglycemic agents alone<br>this group is the control group who receive oral hypoglycemic agents alone | Drug: glyburide<br>* this group receiving glyburide 5 mg alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving the renal function | vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function. | the renal function will be measure at day 1 and after one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin C can improve the visual fields | the damage of the eye can be prevented by decreasing the oxidative stress in the eye, this can be accomplished by vitamin C. | the visual field will be assesed at day 1 and after one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin C, Oxidative stress, Type 2DM
Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty

Study Overview
=================
Brief Summary
-----------------
The study aims at detecting possible differences between an open (Lichtenstein) and a video-assisted (TEP) technique in treating recurrent inguinal hernia. The differences monitored are further recurrence and chronic pain as well as primary complications.

Official Title
-----------------
Lichtenstein Hernioplasty Versus Totally Extraperitoneal Laparoscopic Hernioplasty in Treatment of Recurrent Inguinal Hernia - A Prospective Randomized Trial

Conditions
-----------------
Recurrent Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Lichtenstein hernioplasty
* Procedure: Laparoscopic TEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent inguinal hernia willing to participate Exclusion Criteria: unwilling to participate bilateral hernia preference towards either treatment arm

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients receive Lichtenstein hernioplasty as a treatment for recurrent inguinal hernia. | Procedure: Lichtenstein hernioplasty<br> <br> |
| Active Comparator: 2<br>Patients receive laparoscopic TEP as a treatment for recurrent inguinal hernia. | Procedure: Laparoscopic TEP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| further recurrence |  | 3 weeks, 1 year, 2 years, 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pain or discomfort |  | 3 weeks, 1 year, 2 years, 3 years |
Validation of Quantitative Ventricular Function Imaging Single Photon Emission Tomography (Spect)Using the D-SPECT Cardiac Camera

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the use of DSPECT camera for the performance of quantitative spect ventricular function imaging by comparison to a validated procedure performed on standard nuclear cameras.

Official Title
-----------------
Validation of Quantitative Ventricular Function Imaging

Conditions
-----------------
Quantitative Validation for Ventricular SPECT Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have been referred by their physician to the nuclear medicine department for the quantitative SPECT ventricular function study voluntarily participate in the study Exclusion Criteria: voluntarily to the study without being referred to the nuclear medicine department for the quantitative SPECT ventricular function study
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Vaginal Microbiota Among Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
It is known that vaginal bacteria have an impact upon the health status of the host, in some cases protecting against infection and in other cases causing infection, depending on the bacterial types present. This study will compare the composition of vaginal bacteria to symptoms of vaginal dryness in order to try and identify if certain bacteria might cause some of the problems associated with vaginal dryness among post-menopausal women.

Official Title
-----------------
The Role of Vaginal Microbiota in Symptoms of Vaginal Dryness in Postmenopausal Women

Conditions
-----------------
Vulvovaginal Atrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 30 and 80 years old. Postmenopausal = 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. Prepared not to take hormone replacement therapy during 8 weeks follow-up and not taking estrogen alone or estrogen/progestin containing drug products at the time of screening.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaginal Dryness<br> | |
| Non-vaginal dryness<br> | |

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

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