linjc16/ctgov huggingface dataset:
Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.

Detailed Description
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Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option. In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter. For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System. There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.

Official Title
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Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension

Conditions
-----------------
Hypertension, Resistant to Conventional Therapy

Intervention / Treatment
-----------------
* Procedure: Renal Denervation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual is ≥18 years old Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention. Systolic Office based blood pressure ≥140mmHg Individual receives 3 or more antihypertensive drugs including one diuretic Individual is willing to provide written informed consent to participate in this study Exclusion Criteria: Individual has hypertension secondary to an identifiable and treatable cause Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation. Individual is pregnant, nursing or planning to be pregnant Renal artery abnormalities which may affect the procedure

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

| Intervention/Treatment |
| --- |
|Procedure: Renal Denervation|Sympathetic nerve ablation via transcatheter renal denervation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office Blood pressure measurement |  | up to1 year |
Long Study - Longitudinal Thrombosis in End Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
The primary focus of this study is to collect information through diagnostic testing, blood sample analysis and patient data collection on patients starting hemodialysis to determine risk and preventative factors of bleeding and clotting events.

Detailed Description
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Hemodialysis patients have a very high rate of heart attacks, strokes and amputation. These problems are caused by a blood vessel problem called atherosclerosis (hardening of the arteries), and by clotting. Clotting is also a problem in the access, which is their lifeline for hemodialysis. We have early results which show that some risk factors for clotting in the general population are common in dialysis patients. Bleeding is another significant problem within this population. In this pilot study we will measure bleeding/clotting factors in the blood of consenting patients who are just starting dialysis. We will also do special tests to show how much calcium build up and atherosclerotic build up has happened in the arteries and whether the arteries are becoming stiff. We will then follow patients for up to four years and record any health problems that might reflect bleeding, clotting or a blood vessel problem. At the end of the study, we will compare people who have had bleeding, clotting or blood vessel problem with those who have not, and learn which of the measurements predicted problems. We will go on to study potential treatments, such as anti-clotting drugs, which might prevent or delay the occurrence of such problems. This would improve the health of dialysis patients.

Official Title
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Canadian Longitudinal Thrombosis in End Stage Renal Disease Pilot Study

Conditions
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End Stage Renal Disease, Thrombosis, Bleeding, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Adult patient (aged > 18 years) Patient on hemodialysis between 30 and 90 days Exclusion Criteria: Anticipated recovery of renal function (on dialysis < 90 days) Critical illness at time of recruitment (patients who are critically ill [ICU] when first screened, who survive to 80 days, will be rescreened and will be able to participate at that point if no longer critically ill) Planned live-donor renal transplant within 6 months Patient cannot consent due to language barrier Patient cannot consent due to cognitive difficulties Patient cannot consent due to hearing impairment Patient cannot consent due to speech impairment Patient or decision maker declines consent Patient is unable to give consent and no substitute decision maker is available Patient on dialysis longer than 90 days

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 |
| --- | --- | --- |
Short-term Effect of COVID-19 Vaccine on Blood Pressure

Study Overview
=================
Brief Summary
-----------------
To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM

Detailed Description
-----------------
Safety of coronavirus disease 19 (COVID-19) vaccines has been a concern. Despite safety profile of different vaccines demonstrated in phase 2/3 trials, there has been evolving evidence on adverse effects of some particular COVID-19 vaccines. One of the mostly known example is vaccine-induced thrombotic thrombocytopenia (VITT). Apart from the thrombotic risk of ChAdOx1 nCoV-19 vaccine, there has been studies providing the preliminary data on effect of mRNA-based COVID-19 vaccine on blood pressure. A case series report was published on Hypertension in June 2021 on documented stage III hypertension within minutes of vaccination (mRNA vaccines) in a vaccination centre located in Switzerland. The study reported 9 subjects experienced a surge in blood pressure to stage III hypertension after vaccination. Yet the study had a few shortcomings. There was not baseline measurement of blood pressure. Surge of blood pressure shortly after vaccination could be due to nervousness or white coat effect. Thus surge of blood pressure within minutes of vaccination could be not due to vaccination. There was not long-term follow-up on blood pressure measurement after vaccination. Further to the case series report, another prospective study in Italy investigated effect of mRNA vaccine on blood pressure and heart rate. The study was conducted as a survey. There was 5.3% of respondents (6/113) reported rise of home blood pressure of at least 10mmHg after 1st dose vaccination, compared with home blood pressure prior to vaccination. Among these subjects, 4 of them required anti-hypertensive medication intensification. Yet there remains lack of evidence and detailed description on effect of COVID-19 vaccines and blood pressure before and after vaccination. Use of ambulatory blood pressure monitoring (ABPM) before and after vaccination helps to understand the details on short-term blood pressure changes.

Official Title
-----------------
Short-term Effect of COVID-19 Vaccine on Blood Pressure

Conditions
-----------------
Covid19, Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who will be receiving COVID-19 vaccination Subjects who understand Chinese to make an informed consent Exclusion Criteria: Skin condition around the cuff not suitable for long term cuff wearing (e.g. severe dermatitis, wound)

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

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 |
| --- | --- | --- |
| To investigate short-term effect of COVID-19 vaccination on blood pressure by conducting 24-hour ABPM |  | 1 day |
Flucelvax Pregnancy Registry

Study Overview
=================
Brief Summary
-----------------
The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy

Official Title
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Flucelvax Pregnancy Registry: an Observational Study on the Safety of Flucelvax Exposure in Pregnant Women and Their Offspring

Conditions
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Pregnant Women, Influenza

Intervention / Treatment
-----------------
* Biological: Flucelvax (cTIV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes. Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry) Date the pregnancy exposure is registered Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation) Exclusion Criteria: Invalid registry reports and pregnancies deemed lost to follow-up will be excluded from the primary analysis. Retrospective reports will not be included, although retrospective cases with MCMs will be reviewed and reported separately.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 1, Flucelvax<br>Flucelvax exposure in pregnancy | Biological: Flucelvax (cTIV)<br>* vaccine exposure in routine care (no vaccination per protocol)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major congenital malformation |  | From time of enrollment during pregnancy to time of delivery or pregnancy termination | 
| preterm birth |  | From time of enrollment during pregnancy to time of delivery or pregnancy termination | 
| low birth weight |  | From time of enrollment during pregnancy to time of delivery or pregnancy termination |
A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome

Study Overview
=================
Brief Summary
-----------------
The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: STX107


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects 18 to 50 years of age, inclusive. Molecular documentation of the full fragile X mutation. Exclusion Criteria: Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled. Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics). Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. Subjects who, in the Investigator's opinion, might not be suitable for the study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: STX107 10 mg<br> | Drug: STX107<br>* STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule<br>|
| Placebo Comparator: Placebo<br> | Drug: STX107<br>* STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule<br>|
| Active Comparator: STX107 30 mg<br> | Drug: STX107<br>* STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events will be monitored for tolerability | physical exam, laboratories, collection of adverse events | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of STX107 will be measured to define pharmacokinetics |  | 1 day |
Procedural Advantages of a Novel Drug-Eluting Coronary Stent

Study Overview
=================
Brief Summary
-----------------
This study sought to compare procedural performance of a new coronary stent generation, that is already available in Germany, with hitherto established current drug-eluting stents.

Official Title
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Procedural Advantages of a Novel Drug-Eluting Coronary Stent With Ultra-Thin Struts and Bioabsorbable Abluminal Polymer Coating in an All-Comers Registry

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Synergy Stent
* Device: Currently common drug-eluting stent (DES)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CAD for PCI, consecutive patients Exclusion Criteria: Age under 18 Bare Metal Stents or Scaffolds

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Common DES<br>Group of Patients with narrowed coronary artery disease, who were treated with an implantation of currently established drug-eluting stents (Xience Prime, Promus Element plus, Resolute Integrity). | Device: Currently common drug-eluting stent (DES)<br>* Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)<br>* Other names: DES including Xience Prime, Resolute Integrity, Promus Element Plus.;|
| Other: Synergy Stent<br>Group of Patients with narrowed coronary artery disease, who were treated with Synergy stent implantation | Device: Synergy Stent<br>* Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.<br>* Other names: Synergy Coronary Stent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital major cardiac adverse events | In-hospital major cardiac adverse events were collected up to one week after procedure throughout the in-patients stay | One week post-procedure |
Preventing Substance Use and Risky Behavior Among Rural African American Youth

Study Overview
=================
Brief Summary
-----------------
The Rural African American Families Health (RAAFH) Project is a federally funded research study designed to evaluate the effectiveness two prevention programs designed for rural African American families. One program, FUEL, helps teens develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The sessions deal with goal setting, peer pressure, and staying in school.

Official Title
-----------------
Preventing Substance Use and Risky Behavior Among Rural African American Youth

Conditions
-----------------
Risky Sexual Behavior

Intervention / Treatment
-----------------
* Behavioral: Strong African American Families-Teen Program
* Behavioral: FUEL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American student in 10th grade Agree to randomization and assessment Resides in targeted county Target and parent speak English Exclusion Criteria: Active psychoses

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 17 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>The Strong AFrican American FAmilies-Teen program is a five part educational program has been designed to help teens and their parents create successful futures and avoid the risky behaviors that sometimes keep teens from reaching their goals. | Behavioral: Strong African American Families-Teen Program<br>* 5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours.<br>|
| Other: 2<br>The FUEL program is a family-based adaptation of a curriculum designed to assist teens to develop lifestyles that prevent health problems such as heart disease, diabetes, and being overweight. This program deals with diet and exercise, the influence of TV and magazines on eating habits, and handling stress. | Behavioral: FUEL<br>* 5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual behavior |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use |  | 3 months |
Cedar Honey in Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).

Official Title
-----------------
Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial

Conditions
-----------------
Erosive and Atrophic Oral Lichen Planus

Intervention / Treatment
-----------------
* Drug: orally administered cedar honey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation Severity of pain≥2 (VAS score) Severity of lesions≥2 (tong prasom criteria) absence of any treatment in the last month absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups) Exclusion Criteria: evidence of lichenoid reaction in clinical or histopathologic assessment loss of follow up pregnant patients diabetic patients any other mucosal disease any severe systemic disease patients who refuse doctor's advice any unexpected adverse effect of honey

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cedar honey<br>The two study groups were provided with standard treatment(dexamethasone and Fluconazole).The Case group(A) received cedar honey, 20 ml 3 times daily by swish and swallow technique, in addition to the standard treatment . | Drug: orally administered cedar honey<br> <br> |
| No Intervention: control group<br>the control group (B) only received standard treatment(Dexametazone and Fluconazole). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of lesions | severity of lesions due to thong prasom criteria | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of lesions | A sterile caulis was used to measure the maximum diameter of erosive and atrophic lesions and the maximum width perpendicular to the maximum diameter was recorded. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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oral lichen planus, cedar honey, atrophic, erosive, pain, treatment, clinical trial