linjc16/ctgov huggingface dataset:
Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.

Study Overview
=================
Brief Summary
-----------------
To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.

Official Title
-----------------
Assessment of Local Retention and Duration of Activity of SPL7013 Following Vaginal Application of 3% SPL7013 Gel (VivaGel) in Healthy Volunteers

Conditions
-----------------
HIV Infections, HSV-2 Genital Herpes

Intervention / Treatment
-----------------
* Drug: 3% SPL7013 Gel (VivaGel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women aged 18-45 with regular menstrual cycles, free from sexually transmitted infections and using adequate contraception Exclusion Criteria: Any condition, including genital conditions, sexually transmitted infection, menopause, and/or allergies that would make the study participant unsuitable for the study. Pregnancy or breast-feeding

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label, only arm<br>3%w/w SPL7013 vaginal gel (VivaGel) | Drug: 3% SPL7013 Gel (VivaGel)<br>* A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup) | The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture. The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has. | at 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Experiences | Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product | Approximately 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

Detailed Description
-----------------
Labor induction for the preterm gestation is indicated for various maternal and fetal indications. The preterm cervix, however, is frequently not favorable for induction. Multiple methods have been evaluated in the term gestation. As these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

Official Title
-----------------
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

Conditions
-----------------
Premature Birth, Cervical Ripening

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Device: Foley bulb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton gestation, gestational age 23-35 weeks, indication for induction Exclusion Criteria: multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Misoprostol|nan|
|Device: Foley bulb|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to vaginal delivery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of chorioamnionitis |  |  | 
| Incidence of abnormal fetal heart rate tracings |  |  | 
| Rate of postpartum hemorrhage |  |  | 
| Incidence of NICU admissions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preterm gestation, Cervical ripening, Labor induction, Misoprostol, Foley bulb
Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate and compare the changes by two modalities: Imaging by Strain by Speckle Tracking and Magnetic Resonance versus soluble markers of cardiac dysfunction as early predictors of cardio-toxicity in cancer patients receiving low or high doses of radiotherapy.

Official Title
-----------------
Multimodal Assesment of Acute Cardiac Toxicity Induced by Thoracic Radiotherapy in Cancer Patients

Conditions
-----------------
Radiotherapy; Complications, Cardiotoxicity, Cancer, Lung Cancer, Breast Cancer, Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 year-old patients With histologically confirmed thoracic cancer (breast, esophagus or lung) Recommendation of thoracic radiotherapy (RT) with curative intent With or without chemotherapy All patients must be able to read and understand Spanish All patients must sign informed consent form. Exclusion Criteria: Patients with no medical records, Pregnant Previously diagnosed with severe left ventricular dysfunction or a cardiac insufficiency Patients with metastatic disease and indication of palliative RT Patients with significant comorbidities associated to a <5 year life expectancy. Patients previously treated with thoracic RT

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Global Longitudinal Strain (Left Ventricle) | >5 Absolute drop or 12% Relative reduction from baseline | Baseline, 1 and 12 weeks after Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Magnetic Resonance Cinema Imaging | Cinema imaging: Long axis balance, Balance 4 cameras, Short shaft full balance, Right ventricular balance | Baseline, 1 and 12 weeks after treatment | 
| Cardiac Magnetic Resonance Anatomical Image | Inversion recovery single shot balance 3D short axis covering the entire heart and aorta with free respiratory trigger | Baseline, 1 and 12 weeks after treatment | 
| Cardiac Magnetic Resonance Flow Image | 2D outflow tract of the aorta 2D pulmonary artery outflow tract | Baseline, 1 and 12 weeks after treatment | 
| Cardiac Magnetic Resonance Quantitative Image | T1 map short axis apical section T1 map short axis medial section T1 map short axis basal section T2 map short axis apical section T2 map short axis medial section T2 map short axis basal section | Baseline, 1 and 12 weeks after treatment |
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo (inactive substance) on pain.

Official Title
-----------------
A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

Conditions
-----------------
Pain, Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: AZD1386
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with painful symptoms due to neuropathic pain Provision of signed informed consent Non pregnant females Exclusion Criteria: Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator History, and/or presence of somatic disease, which may interfere with the objectives of the study as judged by the investigator

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD1386<br>* 90 mg, capsules, oral, during 3 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* capsules, oral, during 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in NRS pain (12 h-recall) |  | Morning and evening 12 hour recall | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, defined as any of the following:NRS (12 h recall) reduced by 30% compared to baseline and NRS (12 h recall) reduced by 50% compared to baseline |  | Morning and evening 12 hour recall | 
| Response rate, defined as any of the following: At least much improved on Patient Global Impression of Change global and at least much improved on PGIC pain |  | Day 8, 15 and 22 | 
| Response rate, defined as any of the following: Change from baseline in Brief Pain Inventory Short Form and Change from baseline in Pain Quality Assessment Scale |  | Day 1 and 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesic effect, Peripheral Neuropathic pain, Posttraumatic Neuralgia (PTN), Postherpetic Neuralgia (PHN)
IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing

Study Overview
=================
Brief Summary
-----------------
The chances to achieve pregnancy after retrieving >15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle. The purpose of this study is to compare the outcome of these two approaches.

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

Intervention / Treatment
-----------------
* Procedure: oocyte vitrification
* Procedure: embryo freezing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF patients ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or >15 oocytes. Normal uterus Exclusion Criteria: <20% fertilization rate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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 |
| --- | --- |
| Experimental: oocyte vitrification<br>All retrieved mature oocytes will be vitrified. | Procedure: oocyte vitrification<br> <br> |
| Active Comparator: embryo freezing<br>All retrieved oocytes will be fertilized, and resulting embryos will be frozen. | Procedure: embryo freezing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal Heart Activity 1 Month Post Embryo Transfer | Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer | 1 month after embryo transfer |
Post-marketing Study to Supplement Data on Safety, Tolerability and Efficacy of Micardis® With Special Emphasis on the Control of Blood Pressure

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study is designed to supplement under conditions of normal clinical practice data on safety, tolerability and efficacy of Micardis® collected in clinical studies with special emphasis on the control of blood pressure in the morning before intake of the next antihypertensive drug

Official Title
-----------------
Risk of Morning Hypertension

Conditions
-----------------
Hypertension

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential hypertension At least 18 years of age Exclusion Criteria: NA

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 |
| --- | --- |
| essential hypertension patients<br> | Drug: Micardis®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood pressure | with special emphasis on the morning blood pressure, before intake of the next antihypertensive treatment | Baseline, after 3 months | 
| Number of patients with adverse events |  | up to 3 months | 
| Changes from baseline in pulse rate |  | Baseline, after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on 5- point scale |  | after 3 months | 
| Assessment of tolerability by investigator on a 5-point scale |  | after 3 months |
Cohort of Peripheral T Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Prospective, observational cohort study of peripheral T cell lymphoma. Purpose is to investigate the complication including febrile neutropenia in the era of pegylated G-CSF prophylaxis.

Detailed Description
-----------------
Prospective evaluation of frequencies of febrile neutropenia or infectious complications in a homogeneous population of patients with peripheral T cell lymphoma

Official Title
-----------------
Multicenter Prospective Cohort Study of Peripheral T Cell Lymphoma

Conditions
-----------------
Lymphoma, T-Cell, Peripheral, Febrile Neutropenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naive peripheral T cell lymphoma Subtypes are as followings: Anaplastic large cell lymphoma angioimmunoblastic T cell lymphoma Peripheral T cell lymphoma-NOS Enteropathy-associated T cell lymphoma Hepatosplenic T-cell lymphoma Subcutaneous panniculitis-like T-cell lymphoma Primary cutaneous gamma-delta T-cell lymphoma Primary cutaneous CD8+ aggressive epidermotropic lymphoma Scheduled to receive chemotherapy of curative intent 19 years old or over Expected survival is more than 6 months Informed consent Exclusion Criteria: Other histology than those described above Extranodal NK/T cell lymphoma Other than peripheral T cell lymphoma Other combined malignancy Previous history of chemotherapy or radiation therapy No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Febrile neutropenia | Incidence and severity of febrile neutropenia | 2 years after the last enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complication | incidence, severity, microbiology of infection | 2 years after the last enrollment |
Heart Rate Variability in Pneumothorax

Study Overview
=================
Brief Summary
-----------------
Changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy

Official Title
-----------------
Changes in Heart Rate Variability in Ventilated Patients Undergoing Tension Pneumothorax for Thoracoscopic Cervical Sympathectomy

Conditions
-----------------
Pneumothorax

Intervention / Treatment
-----------------
* Procedure: for thoracoscopic ablation of cervical sympathetic chain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 15 - 50 years body mass index 25 - 45 Exclusion Criteria: heart rate other than sinus cardiac pacemaker status heart transplant

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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 |
| --- | --- |
| Tension pneumothorax group<br>Patients undergoing intentional pneumothorax for thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis | Procedure: for thoracoscopic ablation of cervical sympathetic chain<br>* bilateral thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in heart rate variability | Non linear changes in R-R intervals extracted from ECG | From immediately after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumothorax |
Relationships Between Anterior and Condylar Guidance - Comparison by CBCT and Electronic Axiography

Study Overview
=================
Brief Summary
-----------------
The aim of the following study was to investigate the existence of a statistically significant correlation between the incisal features (incisal guidance angle, interincisal angle, overbite, overjet), temporomandibular joint (TMJ) morphology and its function. The hypothesis was: I. The protrusive movement of the mandible does correlate with the TMJ anatomy. II. The protrusive movement of the mandible does not correlate with the incisal features. III. The position and relationship of upper and lower permanent incisors do not have a direct and significant effect on the TMJ morphology in young adults.

Detailed Description
-----------------
The study was based on anatomical and functional measurements of the parameters within the masticatory system. The study group was composed in a way that all the participants (age 20-24) had the temporomandibular joints fully developed and at the same time not yet modified by adaptive processes.

Official Title
-----------------
Complicated Relationships Between Anterior and Condylar Guidance and Their Clinical Implications- Comparison by Cone Beam Computed Tomography and Electronic Axiography - an Observational Cohort Cross-sectional Study.

Conditions
-----------------
Temporomandibular Joint Disorders, Occlusion

Intervention / Treatment
-----------------
* Radiation: CBCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-24 years old Exclusion Criteria: history of trauma, orthodontic treatment or temporomandibular disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 24 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Patients without any disorders and diseases in age range ensuring full temporomandibular joint development. | Radiation: CBCT<br>* CBCT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sagittal condylar guidance angle during protrusion | recorded with axiograph | evaluated within 24h from baseline visit | 
| Vertical height of the temporomandibular joint fossa | measured on Cone Beam Computed Tomography | evaluated within 24h from baseline visit | 
| Sagittal condylar guidance angle on Cone Beam Computed Tomography | conducted in 4 variants of measurements | evaluated within 24h from baseline visit | 
| Features of the incisors | incisal guidance angle, interincisal angle, overjet, overbite measured on Cone Beam Computed Tomography | evaluated within 24h from baseline visit |