linjc16/ctgov huggingface dataset:
A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension

Official Title
-----------------
A Twenty Six-week, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, in Patients With Essential Hypertension

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

Intervention / Treatment
-----------------
* Drug: Aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential hypertension Exclusion Criteria: Severe hypertension History or evidence of a secondary form of hypertension History of myocardial infarction. Other protocol-defined inclusion exclusion criteria also apply.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic and diastolic blood pressure after 52 weeks |  |  | 
| Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks |  |  | 
| Achieve blood pressure control target of < 140/90 mmHg after 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, hydrochlorothiazide, amlodipine
Spontaneous Pneumothorax in Adolescents

Study Overview
=================
Brief Summary
-----------------
Pneumothorax is characterized by an abnormal presence of air in the pleural cavity, that is to say between the two layers of the pleura, the membrane that surrounds the lungs and lines the rib cage. The patient is usually seized with sudden chest pain and difficulty in breathing. In this retrospective research, the investigators wish to carry out an inventory of the management of spontaneous pneumothorax in adolescents within the University Hospitals of Strasbourg

Official Title
-----------------
Spontaneous Pneumothorax in Adolescents: Inventory and Management

Conditions
-----------------
Pneumothorax, Spontaneous

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (18-20 years old) Minor patient aged 14-17 years old Any gender Spontaneous pneumothorax without apparent cause, between 14 and 20 years old Patient operated on at the HUS between 2010 and 2021 Patient not objecting to the reuse of their data for scientific research purposes. Holders of parental authority who do not object to the reuse of their child's data for scientific research purposes. Exclusion criteria: Patient who has expressed his opposition to the reuse of his data for scientific research purposes. Holders of parental authority who have expressed their opposition to the reuse of their child's data for scientific research purposes. Secondary origin of the pathology: Cystic fibrosis, postoperative pneumothorax, post-traumatic, Subject having been treated initially in another structure without further information.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 20 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective description of the management of spontaneous pneumothorax in adolescents in the Strasbourg University Hospital | This study is retrospective, the analysis focuses on the medical records of patients treated at the Strasbourg University Hospital between between January 1, 2010 and December 31, 2021. | Files analysed retrospectively from January 1, 2010 and December 31, 2021 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumothorax, Spontaneous, Pleural cavity
ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).

Official Title
-----------------
Association of Lipid Core Plaque With Subsequent Clinical Outcomes: a Collaborative Near-infrared Spectroscopy Study

Conditions
-----------------
Coronary Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients who have undergone/ will be undergoing NIRS imaging at each of the participating centers. Exclusion Criteria: None

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 |
| --- | --- | --- |
| Incidence of major adverse cardiac events | The primary endpoint for both hypotheses is the incidence of major adverse cardiac events. Major adverse cardiac events include the following: cardiac death cardiac arrest acute coronary syndrome stent thrombosis, repeat coronary angiography coronary revascularization (either by percutaneous coronary intervention or coronary artery bypass graft surgery). rehospitalization for progressive angina, attributed to a non-culprit lesion secondary to significant fixed, non-reversible (not-spasm related) lesion progression of more than 20% from the baseline study (confirmed by either serial angiography or by necropsy). Events will be classified as events occurring at the site of stent implantation and events occurring at previously untreated lesions. Moreover, analyses will be performed on a per patient and per LCP basis. | 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipid Core Plaques (LCPs), Vulnerable Plaque, Near Infrared Spectroscopy
Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of transcutaneous electrical nerve stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion.

Official Title
-----------------
Effect of Transcutaneous Electrical Nerve Stimulation on Tissue Perfusion for the Critically Ill Patient

Conditions
-----------------
Renal Function Disorder, Critical Illness, Critical Illness Myopathy

Intervention / Treatment
-----------------
* Device: trans-cutaneous electrical nerve stimulation.
* Device: Sham TENS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recently intubated patient. Adult and both gender. Hemodynamic stability Exclusion Criteria: Vascular diseases Diabetic patients Patients who receive vasoactive drugs Patients with varicose vein Systemic scoliosis

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TENS<br> | Device: trans-cutaneous electrical nerve stimulation.<br>* • Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days.<br>|
| Sham Comparator: Control<br> | Device: Sham TENS<br>* Patients in the control group will receive sham TENS.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue perfusion of the lower limb. | capillary refill time | 5 ICU days | 
| Renal perfusion | quantitative assessment of neutrophil gelatinase-associated lipocalin | 5 ICU days |
CyberKnife for Unresectable Renal Tumors

Study Overview
=================
Brief Summary
-----------------
This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.

Detailed Description
-----------------
The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Official Title
-----------------
CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study

Conditions
-----------------
Renal Cancer

Intervention / Treatment
-----------------
* Radiation: Stereotactic radiation
* Device: CyberKnife Robotic Radiosurgery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tumor size 5 cm or less Radiographic evidence of malignancy or Histologically verified primary renal malignancy. If the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the CT/MRI is highly suspicious for cancer, you may participate Patients with highly suspicious lesions on CT or MRI One -three gold fiducials placed in or around tumor Contradiction or patient refusal to partial or complete nephrectomy Age 18 or greater KPS score 70 or greater Exclusion Criteria: Irreversible coagulopathies that preclude fiducial placement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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 |
| --- | --- |
| Experimental: 1<br>Phase I dose escalation | Radiation: Stereotactic radiation<br>* Dose escalation three consecutive treatments<br>Device: CyberKnife Robotic Radiosurgery System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose of CyberKnife radiation |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate local control, overall survival and late toxicity including preservation of renal function |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CyberKnife
A Research Study To Compare Two Kinds Of Daily Headache

Study Overview
=================
Brief Summary
-----------------
Chronic daily headache has been classified into several categories. One category is of sudden onset and is called New Daily Persistent Headache (NDPH). Another category of daily headache evolves gradually and is called Transformed Migraine (TM). This research study is being conducted to compare people with these two kinds of daily headache in order to improve our understanding of these conditions.

Official Title
-----------------
A Comparison Of Subjects With New Daily Persistent Headache (NDPH) And Subjects With Transformed Migraine (TM)

Conditions
-----------------
Migraine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients aged 14-65, inclusive Diagnosis of NDPH or TM according to the Silberstein-Lipton criteria. Ability to read and understand an informed consent form and study procedures Exclusion Criteria: Pregnancy Subjects with any disease or condition that would result in unreliable data or confound the data obtained for this study, as determined by the principal investigator.

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- | --- |
CMV Disease and IRIS in HIV-1 Infected Persons

Study Overview
=================
Brief Summary
-----------------
Various diagnostic methods are available for CMV infection. But none of them could be a standard and highly valuable. Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person. By using these tools, physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome (IRIS) to enroll this study. Furthermore, we will seek for a predict marker for CMV reactivation, CMV disease and IRIS. Finally, our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage.

Detailed Description
-----------------
At present, human cytomegalovirus (HCMV) remains a major health threat in immune compromised patients. Especially HCMV will cause blind and death in HIV-1 infected person. Currently, few antiviral drugs can be chosen for treatment of HCMV infection. Besides, more and more drug resistant virus strains were reported and led failure in antiviral therapy. Various diagnostic methods are available for CMV infection. Such as shell vial assay, CMV antigen test, pp65 antigen assay and polymerase chain reaction. But none of them could be a standard and highly valuable. Although CMV-PCR is very sensitive, it can't distinguish between active disease and asymptomatic infection or latency, can't predict symptomatic disease nor can't monitor the successful antiviral therapy. Our first goal is to setup a series of molecular diagnostic tools for HIV-1 infected person. By using these tools, physicians can easily select cases with CMV disease or immune restoration inflammatory syndrome (IRIS) to enroll this study. Furthermore, we will seek for a predict marker for CMV reactivation, CMV disease and IRIS. Finally, our research will focus on the mechanism of the IE gene alternative splicing between lytic and latent stage. We may find out new therapeutic concept and prevent virus reactivation from latency.

Official Title
-----------------
Molecular Diagnostics for CMV Disease and IRIS in HIV-1 Infected Persons, and the Mechanism Study for CMV Alternative Gene Splicing in Immediate Early Protein

Conditions
-----------------
HIV Infections, Cytomegalovirus

Intervention / Treatment
-----------------
* Genetic: IE gene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HIV-1 Disease Clinical diagnosis of CMV disease or immune restoration inflammatory syndrome (IRIS)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: IE gene|nan|

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
-----------------
CMV, IRIS
Study Evaluating the Safety and Tolerability of NSA-789

Study Overview
=================
Brief Summary
-----------------
This is the first time that NSA-789, a new compound being developed for schizophrenia, will be given to humans. Each healthy subject will receive a single dose, except for 8 subjects who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: NSA-789
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Healthy men and women between 18 and 50 years old. Women must be of non-child-bearing potential (not able to have children). Must be of normal body weight.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSA-789<br>active drug | Drug: NSA-789<br> <br> |
| Placebo Comparator: placebo<br>placebo | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability from reported adverse events, scheduled physical examinations, vital signs, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ascending single-dose study, healthy subjects
Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy and safety tamsulosin in reducing stent discomfort in the pediatric population in the peri-operative period. The secondary objective is to compare the efficacy of tamsulosin with that of oxybutynin in reducing stent discomfort.

Official Title
-----------------
Randomized Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Discomfort in the Pediatric Population

Conditions
-----------------
Disorder of Urinary Stent

Intervention / Treatment
-----------------
* Drug: Tamsulosin
* Drug: Oxybutynin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 4-18 years will be enrolled in this study. We will include all patients who will have a ureteral stent placement after their procedure. Exclusion Criteria: Patients with developmental delay or unable to verbalize their pain level will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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: Oxybutynin group<br>This group will be prescribed oxybutynin as well as standard narcotic pain medications. Oxybutynin will be prescribed based off of standard dosing. Patients who are unable to swallow pills will be given oxybutynin elixir (0.5mg/kg/day, divided TID). Patients who are able to swallow pills will be given oxybutynin 5mg either BID or TID. | Drug: Oxybutynin<br> <br> |
| Active Comparator: Tamsulosin group<br>This group will be prescribed tamsulosin and standard narcotic pain medication. Patients will be given tamsulosin 0.4mg at bedtime. This dosage has been used in other studies for children age ≥ 4. | Drug: Tamsulosin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of doses of pain in medication used | After surgery, each child will be prescribed the standard dosage of oxycodone/acetaminophen based on their weight. We will have the patient's family record the number of doses of narcotics used from post-operative day #1 to post-operative day #5 to assess their pain needs. | 5 days post-op | 
| Pain scale based on the faces pain score | We will have the family members record the child's pain score in the morning and evening using the faces pain scale and record the score. | 5 days post-op |