linjc16/ctgov huggingface dataset:
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women

Study Overview
=================
Brief Summary
-----------------
Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not yet been determined. The primary purpose of this study is to examine whether a pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in HIV infected women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.

Official Title
-----------------
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women

Conditions
-----------------
HIV Infected

Intervention / Treatment
-----------------
* Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV positive females between 21-40 years of age. Subjects must be receiving anti-HIV regimen consisting of tenofovir, emtricitabine, atazanavir, and ritonavir for a minimum of 4 weeks prior to the study. Subjects must have regular menstrual cycle (period), define at least 10 cycles a year, occurring approximately every 28 days+/- 4 days and cycle length varying by not more than 7 days. Exclusion Criteria: Subjects can not be breast feeding, pregnant, or taking oral contraceptives (birth control pills) for at least 3 months prior to the study. Subjects may not have the intrauterine device (IUD), Mirena, in place to prevent pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 40 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 |
| --- | --- |
| HIV+ Female<br>HIV infected women between 21-40 years of age, not receiving oral contraceptives. | Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir<br>* Women will be receiving Tenofovir 300mg, Emtricitabine 200mg, Atazanavir 300mg, Ritonavir 100mg, one dose on 2 separate visits. These medications will not be prescribed from the physician and not provided by the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters | The area under the concentration time curve and minimum concentration for tenofovir, emtricitabine, atazanavir and ritonavir | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Infected Women
Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.

Official Title
-----------------
Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: human insulin
* Drug: isophane human insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Treatment with insulin for at least 6 months prior to inclusion HbA1c below or equal to 11.0 % Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion Exclusion Criteria: The receipt of any investigational drug within one month prior to this trial Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator Total daily insulin doses at least 1.80 IU/kg Treatment with oral hypoglycaemic agents Known or suspected allergy to trial product or related products

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IAsp<br> | Drug: insulin aspart<br>* Injected s.c. (under the skin) three times a day<br>Drug: isophane human insulin<br>* May be administered s.c. (under the skin) in both treatment groups thrice daily<br>|
| Active Comparator: HI<br> | Drug: human insulin<br>* Injected s.c. (under the skin) 30 minutes before the meals<br>Drug: isophane human insulin<br>* May be administered s.c. (under the skin) in both treatment groups thrice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoglycaemic episodes during the treatment |  | Week 0; week 24 | 
| Change in HbA1c (glycosylated haemoglobin A1c) |  | Week 0; week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Week 0; week 24 |
Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies

Study Overview
=================
Brief Summary
-----------------
This study collects information about complications and clinical response in cancer patients treated with anti-VEGF-related therapies. This study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-VEGF related therapy. This may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To explore the incidence of clinical complications associated with anti-VEGF-related therapies in cancer patients treated at Emory University and the University of Texas M.D. Anderson Cancer Center (MDACC). SECONDARY OBJECTIVES: I. To explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-VEGF-related therapies. II. To explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-VEGF-related therapies. III. To investigate the validity of a novel multi-parameter-based blood pressure scoring system and to determine if the new scoring method is concordant with the current Common Terminology Criteria for Adverse Events (CTCAE) method. OUTLINE: Patients' medical records are reviewed.

Official Title
-----------------
A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies

Conditions
-----------------
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
-----------------
* Other: Electronic Health Record Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be able to understand and be willing to sign a written informed consent document Patients must be receiving any anti-VEGF-related regimen in monotherapy or combination therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (medical records review)<br>Patients' medical records are reviewed. | Other: Electronic Health Record Review<br>* Medical records are reviewed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately) | For each toxicity, will estimate the odds ratio, associated 95% confidence interval and p-value. | Up to 5 years |
A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children

Study Overview
=================
Brief Summary
-----------------
A cannot intubate, cannot oxygenate (CICO) situation is rare in paediatric anaesthesia, but can always occur in children under certain emergency situations. There is a paucity of literature on specific procedures for securing an emergency invasive airway in children under the age of 6 years. A modified emergency Front Of Neck Access (eFONA) technique using a rabbit cadaver model was developed to teach invasive airway protection in a CICO situation in children. After watching an instructional video of our eFONA technique (tracheotomy, initial intubation with Frova catheter over which an endotracheal tube is inserted), 29 anaesthesiologists will perform two separate attempts on rabbit cadavers. The primary outcome is the success rate and the performance time overall and in subgroups of trained and untrained participants.

Official Title
-----------------
A Modified Rabbit Training Model for Establishing an Emergency Front of Neck Airway in Children

Conditions
-----------------
Emergency Front of Neck Airway in Children

Intervention / Treatment
-----------------
* Procedure: eFONA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anesthesiologists working at the department of Anesthesia at University Children's Hospital Zurich Exclusion Criteria: n.a.
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 |
| --- | --- |
| Trained in eFONA<br>Trained participants completed our eFONA workshop within the last six month prior to participating in this study | Procedure: eFONA<br>* Surgical Tracheotomy<br>|
| Untrained in eFONA<br>Untrained participants had never taken part in our institutional eFONA workshop | Procedure: eFONA<br>* Surgical Tracheotomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sucess rate | Correct positioning of the endotracheal tube in to the trachea | during study period, approx 15min | 
| Performance time | Time needed to complete the surgical tracheotomy | during study period, max 240 sec | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary injuries | paratracheal placement of the ETT, perforation of the back wall or complete rupture of the trachea | during study period, approx 15min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannot intubate, cannot oxygenate in children, emergency front of neck airway, rabbit cadaver model, emergency tracheotomy
Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies

Study Overview
=================
Brief Summary
-----------------
The investigators aim to examine the impact of changes in plasma lipoproteins induced by nutritional and pharmacological interventions on glucose homeostasis

Official Title
-----------------
Effects on GLUcose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic STrategies Against Diabetes-Related Metabolic Diseases

Conditions
-----------------
Glucose Metabolism Disorders

Intervention / Treatment
-----------------
* Dietary Supplement: Intermittent Fasting
* Drug: Fibrates
* Dietary Supplement: Low-Carbohydrate/High-Protein diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-65 years both males and females Exclusion Criteria: acute or chronic conditions influencing glucose and lipid metabolism pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-Carbohydrate/High-Protein Diet<br> | Dietary Supplement: Low-Carbohydrate/High-Protein diet<br>* Low-calorie, low-carbohydrate, high-protein diet<br>|
| Experimental: Fibrate<br> | Drug: Fibrates<br>* Bezafibrate 400 mg/day<br>|
| Experimental: Intermittent Fasting<br> | Dietary Supplement: Intermittent Fasting<br>* Intermittent fasting meal pattern<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance | Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute 75g oral glucose tolerance test (OGTT) | 180 minutes |
High Frequency Stimulation of the GPi or Thalamus in Tourette's Syndrome

Study Overview
=================
Brief Summary
-----------------
Tourette's syndrome is a disabling neuropsychiatric disorder with major psychosocial consequences in some patients. The pathophysiology is still unknown. Some data suggest an dysfunction of limbic circuits in basal ganglia. The aim of this study is to evaluate the effect of high frequency stimulation of the internal part of the globus pallidus and/or parafascicular-median centre of the thalamus, two structures implicated in the limbic circuit, in patients with severe Tourette's syndrome.

Official Title
-----------------
Pilot Study of Internal Globus Pallidus or Median Centre of the Thalamus High Frequency Stimulation for the Treatment of Patients With Severe Tourette's Syndrome

Conditions
-----------------
Tourette's Syndrome

Intervention / Treatment
-----------------
* Device: high frequency stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tourette's syndrome (DSM IV) inducing a disability in the social and personal life No improvement with medical treatment Severe self suffering Exclusion Criteria: Cognitive impairment (MMS < 24) Depression

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: high frequency stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of tics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourette's syndrome, High frequency stimulation, Globus pallidus, Thalamus
Cone Beam CT for Daily Image Guidance - Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Conformal dose escalated radiation therapy (CRT) is standard treatment for patients with low and intermediate risk prostate cancer. CRT requires accurate daily localization of the prostate prior to treatment to correct for prostate motion and set-up errors. Cone beam computed tomography (CT) can accurately localize fiducial markers within the prostate. Cone Beam CT also provides important information on daily position of organs within the pelvis. This study aims to assess the feasibility of cone beam CT for daily localization of the prostate as well as document changes in size and location of pelvic organs during an entire course of CRT.

Official Title
-----------------
A Phase II Feasibility Study of Cone Beam Computed Tomography for Daily Image Guidance in Patients Receiving Dose Escalated Conformal Radiation Therapy for Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: daily Cone Beam CT for imaging guidance for radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of adenocarcinoma of the prostate Patient undergoing dose escalated conformal external beam radiation therapy Low or intermediate risk prognostic factors (PSA 20 or less, Gleason score <8, Clinical T category <T3, Clinical N category 0 or X, M category 0 or X Age 18 years or older ECOG performance status 0 or 1 Informed consent Exclusion Criteria: Inflammatory bowel disease or collagen vascular disease

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

| Intervention/Treatment |
| --- |
|Procedure: daily Cone Beam CT for imaging guidance for radiotherapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility of cone beam CT for daily on-line image guidance in patients receiving conformal radiation therapy for prostate cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the amount of interfraction movement of the prostate and seminal vesicles with current bowel regimen of daily milk of magnesia. |  |  | 
| To measure the amount of interfraction movement and deformity of the rectum and bladder with current bowel regimen of daily milk of magnesia. |  |  | 
| To develop a technique for delivery of radiation therapy that reduces normal tissue toxicity, based on rectal and bladder avoidance models. |  |  |
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder

Official Title
-----------------
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

Conditions
-----------------
Atrial Septal Defect

Intervention / Treatment
-----------------
* Device: AMPLATZER Septal Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she: is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure), is willing and able to complete the follow-up requirements of this study, and signs the informed consent (or a legal representative signs the informed consent).
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: AMPLATZER Septal Occluder<br>Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body). | Device: AMPLATZER Septal Occluder<br>* AMPLATZER Septal Occluder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With Two-year Device-related Hemodynamic Compromise | The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise. | 24 months | 
| Co-Primary Effectiveness Endpoint | The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair | 24 months | 
| Co-Primary Safety Endpoint | The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial, Septal, Defect