cyrilzakka/clinical-trials huggingface dataset:
Stress Reduction and Prevention of Hypertension in Blacks

To examine the role of Transcendental Meditation in stress reduction and prevention of hypertension in Blacks.

BACKGROUND:

African Americans suffer from disproportionate rates of hypertension and related cardiovascular morbidity and mortality due, at least in part, to excessive socioenvironmental and psychosocial stress. Furthermore, despite the substantial individual and population risk burden associated with high normal blood pressure (BP) in African Americans, there had been no controlled studies to evaluate stress reduction approaches in the primary prevention of hypertension targeted to this high risk group. Therefore, recent (mid 1990s) NIH and NIMH policy committees called for a new research focus on primary prevention of hypertension targeted to high risk populations-notably African Americans with high normal BP. In previous randomized controlled trials by the investigator, hypertension and psychosocial stress were significantly reduced in low SES African Americans who practiced stress reduction with the Transcendental Mediation (TM) program compared to relaxation or health education controls. In the most recent long-term trial, African Americans with borderline hypertension showed BP reductions that would be associated with a 17 percent decrease in prevalence of hypertension, a 15 percent reduction in stroke, and a 6 percent reduction in CHD in the population. These BP reductions compared favorably to decreases shown with sodium restriction and weight loss programs in other prevention trials. Also, pilot data from two clinical trials indicated that TM was associated with significantly lower cardiovascular morbidity and mortality in African Americans and in Caucasians with high BP over a 5-year and 15-year period, respectively.

DESIGN NARRATIVE:

A randomized controlled trial of stress reduction for the primary prevention of hypertension was conducted in African Americans with high normal BP. African American males and females (N-352, aged 21-75 years) with high normal BP (SBP 130-139 and/or DBP 85-89 mm Hg) were recruited from the African American Family Heart Health Plan at the Medical College of Wisconsin, Milwaukee, which housed the nation's largest registry of African Americans with known CVD risk factors. After baseline assessment, participants were randomized to either the TM program or to a matched health education control intervention. The primary outcome was change in clinic BP over a 12-month follow-up. Secondary outcomes included changes in ambulatory BP, hypertensive events, psychosocial stress and health behaviors. Also, a model of the pathways through which components of stressful experience affect high BP in African Americans was tested.

This study is described as a clinical trial. The summary statement states that it is not an NIH Phase III clinical trial.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent public health problem that has been neglected in HIV prevention research. In Zimbabwe , and across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. Pregnancy and the desire for children are common among HIV-infected individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy and risking HIV transmission to their partners. Recent surveys have found that 30-50% of HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant relationships, and HIV transmission within married, cohabitating HIV-discordant couples accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa. While knowledge of HIV discordance can lead to increased condom use, many discordant couples have unprotected intercourse often motivated by the desire to conceive. Currently, HIV discordant couples who attempt to conceive place themselves at considerable risk of transmission. This research study aims to help promote couples' rights to conceive while at the same time decreasing the risk of HIV transmission.

Eligibility Criteria:
Inclusion Criteria:

For all couples:

* Couple expresses a desire to conceive
* Sexually active (defined as having vaginal sex with one another at least 6 times in the past 3 months
* Willing to enter the study as a couple and intending to remain as a couple and have a sexual relationship for the next 12 months
* Willing to use at least one safer conception strategy
* For men, age ≥18 years. For women, age 18 - 35 years;
* Able and willing to provide written informed consent

For HIV-uninfected members of the couple

* HIV-negative based on parallel negative HIV rapid tests, both at study screening and enrollment visit
* Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min

For HIV-infected members of the couple

* HIV-positive based on parallel positive HIV rapid tests, based on national algorithm
* No current AIDS-defining illness

Exclusion Criteria:

* Amenorrheic
* Currently pregnant
* Active and serious infections, including active tuberculosis infection; active clinically significant medical problems including cardiac disease, pulmonary disease, and previously diagnosed malignancy expected to require further treatment.
* History of infertility defined as a year or more of regular unprotected intercourse with current partner without pregnancy, or otherwise medically diagnosed infertility
* Currently on any concomitant medication that requires the participant to avoid use of PrEP
Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room

Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?

Thermoregulation is a major problem for low birth weight infants. The EPICure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees Celsius. Hypothermia is associated with increased risk of morbidity and mortality. The HeLP trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. Forty-five centers are currently involved in this study. Infant enrollments began in December 2004.

Primary outcome: To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results in decreased mortality compared with the conventional method of drying. Because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation will be randomized as part of a separate Pilot Study and centers may choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcome will be axillary temperature taken on introduction into a warm environment in the NICU. We will also record clinically important variables including: acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results. Length of stay and cause of death at discharge will also be recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth.

Preterm infants meeting the eligibility criteria will be randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.

Eligibility Criteria:
Inclusion Criteria:Infants born at less than 28 weeks and who have prior to birth a firm decision to provide full resuscitative measures and intensive support.

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Exclusion Criteria:1. Infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele) 2. Infants born with blistering skin conditions that preclude the use of occlusive wrap

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Efficacy of Laser Doppler Flowmetry as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth

The aim of the study is to evaluate the efficacy of Laser Doppler flowmetry in determining the changes in the pulpal blood flow during the post-traumatic period of traumatised permanent teeth.

Traumatic injuries of permanent teeth in children and adolescents are very common. The conventional pulp vitality tests are inaccurate and unreliable techniques in assessing the pulp vitality during the post-traumatic period, as well as during the immature teeth examination. The aim is to evaluate the efficacy of Laser Doppler flowmetry in determining the changes in the pulpal blood flow during the post-traumatic period of traumatised permanent teeth. The study is designed as a randomized, split-mouth, controlled clinical trial. The measurement of the blood flow of the dental pulp of both, traumatised and non-traumatised teeth, will be performed, using a laser doppler flow monitor, emission wavelength 785nm±10nm, dual-channel laser Doppler monitoring option.

Eligibility Criteria:
Inclusion Criteria:

1. Fit and healthy subjects aged \< 18-year-old;
2. Subjects with maxillary permanent incisor subjected to a traumatic injury without any dentoalveolar trauma involvement and have a contralateral homologous tooth with no signs/symptoms of injury;
3. Subjects attended their first dental visit within 3 days of the dental trauma;
4. Sensitivity value of the electric pulp test over 200 μA;
5. Subjects with at least one vital and non-traumatised maxillary incisor acting as a control tooth;
6. Ability to obtain a verbal acceptance from all the subjects to comply with all the treatments and follow-up timepoints attendance;
7. Ability to obtain written informed consent by the patients' parents/guardians for treatment, participation in the study and publication

Exclusion Criteria:

1. Subjects who were undergoing therapy for neurological conditions or with mental or cognitive problems;
2. Subjects who were taking sedative, analgesic, and/or anti-inflammatory medication 7 days prior to the treatment commencement;
3. Subjects who have never had any first dental visit or treatment;
4. Subjects with systemic diseases or physiological development delay;
5. Subjects with active infectious diseases such as; influenza, scarlet fever, etc.
6. Subjects with restorations covered more than half the labial surface of the investigated teeth.
A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy

This is a prospective, observational, open-label, multi-center study, which will provide detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive patients requiring combination therapy. This will present a convenient treatment option for hypertension in Korean patients.

Study Design:

PMS Observational study

Eligibility Criteria:
Inclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.

Exclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.
PDE5 Inhibitor Use and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

The primary objective of this study is to determine whether the use of PDE5 inhibitors (vardenafil, sildenafil, or tadalafil) increases the risk for the development of NAION.

Collected data will be compared to historic data of the same participant in case-crossover design.

Eligibility Criteria:
Inclusion Criteria:

* NAION onset within 45 days before entry to the study
* NAION onset definable by the subject within a 2 calendar day window
* Men who have taken at least 1 dose of PDE5 inhibitor(s) at any time in the 1 year prior to enrollment in the study
* Age 40 years or older

Exclusion Criteria:

* History of multiple sclerosis or optic neuritis
* Evidence of temporal arteritis
* History of vasculitis or collagen vascular disease
* Previous history of NAION
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine

The objective of this trial is to evaluate the effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell health in comparison to a hypotonic saline solution in subjects with Dry Eye Disease (DED)

The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye disease (DED) in both eyes
* Be able and willing to follow instructions, including participation in all trial assessments and visits.

Exclusion Criteria:

* Be a woman who is pregnant, nursing, or planning a pregnancy;
* Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* Ocular/periocular malignancy
* History of herpetic keratitis
* Have any primary or secondary corneal endothelial disorder such as Fuchs dystrophy or other endothelial dystrophy, significant guttata
* Ongoing ocular or systemic infection at screening or baseline
* Presence of uncontrolled systemic diseases
* Presence of known allergy and/or sensitivity to the study drug or its components
* Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period;
* Have a known allergy or sensitivity to the IMP or its components
* Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the trial results, or may interfere with the subject's participation in the trial significantly.
* Randomized in a previous CyclASol trial
Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence

Priapism, a prolonged erection of the penis, is a medical issue that often affects men with sickle cell disease. The purpose of this study is to collect demographic and clinical information on priapism by interviewing men with sickle cell disease.

Priapism is a prolonged, painful erection of the penis that lasts for more than four hours and occurs without sexual stimulation. It occurs when blood in the penis becomes trapped and is unable to drain properly. If it is not treated immediately, it can lead to scarring and permanent erectile dysfunction. Many cases of priapism are the result of sickle cell disease; approximately 42% of all adults with sickle cell disease will eventually develop priapism. Current treatments include medication, ice packs, or surgery. More research is needed to better understand the demographic and clinical characteristics of priapism. The purpose of this study is to collect information and further characterize priapism by conducting interviews with men with sickle cell disease. In turn, these findings may guide future priapism clinical trials.

This study will consist of two standardized questionnaires that will be administered to 1,650 men with sickle cell disease. Participants will complete an initial five-item questionnaire about priapism. If a participant indicates past experience with priapism on this initial questionnaire, he will be asked to complete a second questionnaire. This questionnaire will ask in-depth questions to further characterize the participant's episodes of priapism. If health issues such as drug use, harmful sexual behaviors, or impotence are identified upon reviewing the questionnaire, clinic staff will suggest care options and provide appropriate referrals to the participants. All participants will receive an educational brochure about priapism and compensation for completing the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sickle cell anemia or sickle beta zero thalassemia, if 5 years of age or over OR
* Diagnosis of sickle beta plus thalassemia or sickle hemoglobin C disease, if 15 years of age or over
* Participant and/or parent or guardian must be able to communicate adequately with the interviewer
* May participate if currently taking hydroxyurea, undergoing chronic transfusion, or participating in other research studies, including those involving treatments such as arginine, if all other inclusion criteria are met

Exclusion Criteria

Subjects who meet any of the following criteria are disqualified from enrollment in the study:

1. Patient or parent/guardian declines participation.
2. Female.
3. Subject or parent/guardian unable to communicate adequately with the interviewer.
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years

The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.

Patients will received Imatinib at a dose of 400mg daily. Tolerability and quality of life will be assessed Secondary objectives are : to evaluate the survival without progression, the survival without event, the overall survival, the hematologic, cytogenetic and molecular responses at various check points.

Duration of responses and failure to respond will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* CML Ph+ (assessed by cytogenetic or FISH)
* Chronic phase with less than 5% bone marrow blasts
* Diagnosis within 12 months
* Age ≥ 70 year at inclusion
* PS grade 0 to 2 (ECOG)
* Mini mental status more than 25
* Hydroxyurea optional before Imatinib
* Adequate end organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<3x uln, creatinine \<1.5x uln.

Exclusion Criteria:

* patients who cannot sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital
* Mini mental status ≤ 25
* patients who are not able to adequately take the study drug
* Age less than 70 y
* accelerated or blastic phase
* previous therapy with imatinib or interferon
* HIV positivity
Smartphone Application for Type 2 Diabetes

Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. In addition, this is regarded as the most effective method for prevention and treatment of diabetes. However, many diabetic patients are now reported to lack proper management in Korea with a low level of compliance with treatment instruction. In that sense, it is urgently necessary to develop a program in which diabetic patients are able to effectively manage their own blood glucose at home, and to grasp the real state of self-blood glucose measurement. Accordingly, a system to manage diabetes using electronic equipment such as mobile phone or the Internet is currently being developed and studied, for the effective management of diabetes with the help of highly evolving information technology. These investigators have developed a diabetes management program that provides an optimal solution based on a mobile device and software, so that individual patients can undergo a regular blood glucose test and achieve improvement and constant management of living habits by being properly informed of how to manage diabetes. This clinical study was designed to evaluate the effectiveness and efficacy of the application through the comparison between usual medical care and additional care using the smartphone application, targeting patients with type 2 diabetes who lack blood glucose control. This study is targeted at the subjects who are being treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the informed consent form (ICF). The subjects who pass the subject eligibility evaluation provide information regarding assessment items and demographic information using the smartphone application and questionnaire. Based on the information given by subjects, the medical team offers a management system that supports and improves the existing treatment process of diabetes using the application developed on its own. The feasibility and effectiveness of the management using the application are evaluated through the result values of the laboratory tests performed during the subject's usual medical care.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 19 years;
* android smartphone users;
* no changes in medication for diabetes for at least 6 months;
* HbA1c levels ≥6.5% within the last 3 months.

Exclusion Criteria:

* currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation;
* pregnant or had plans for pregnancy within 6 months;
* plans to participate in other clinical studies or illiteracy.
Telmisartan in Haemodialysis Patients With Chronic Heart Failure

Background: In haemodialysis patients, chronic heart failure (CHF) is responsible for a high mortality rate but, presently, very little data is available regarding this population.

Aim of the study: Aim of this study was to determine whether telmisartan decreases all-cause and cardiovascular mortality and morbidity in haemodialysis patients with CHF and impaired left ventricular ejection fraction (LVEF) when added to standard therapies with ACE inhibitors.

Methods: A 3-year randomized, double-blind, placebo-controlled, multicentre trial was performed involving 30 Italian clinics. Haemodialysis patients with CHF (NYHA class II and III; LVEF 40%) were randomized to telmisartan or placebo in addition to ACE inhibitor therapy. 332 patients were enrolled (165 telmisartan, 167 placebo), and drug dosage was titrated to a target dose of telmisartan of 80 mg or placebo. Mean follow-up period was 35±5 months. Primary outcomes were all-cause mortality, cardiovascular mortality and CHF hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Adult haemodialysis patients with CHF;
* New York Heart Association (NYHA) class II and III;
* Ejection fraction less or equal to 40% determined within 6 months; and
* Therapy with ACE inhibitors individually optimized and unchanged for 30 days before randomization

Exclusion Criteria:

* Hypotension during dialysis;
* Atrial fibrillation;
* Intolerant to low dose of telmisartan