cyrilzakka/clinical-trials huggingface dataset:
Effect of Renal Denervation on NO-mediated Sodium Excretion and Plasma Levels of Vasoactive Hormones

Catheter based renal denervation (CRD) in humans represents a promising new treatment of resistant hypertension. CRD is currently investigated as a treatment option in patients with resistant hypertension defined as at least 3 antihypertensive drugs (including a diuretic) in a randomized, sham-controlled, multicenter trial in Denmark (ReSet). In ReSet, patients are randomized to either CRD or a sham procedure with 6 months follow up. The mechanisms by which CRD reduce blood pressure are only partly understood and the interaction between renal sympathetic nerves and nitric oxide (NO) has not been investigated in humans.

To Study the interaction between NO and renal sympathetic nerves, we designed the present substudy, where the effects of NO-inhibition on renal, hemodynamic and hormonal variables are studied before and after CRD.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-70 years
* Stable antihypertensive treatment for 1-month with at least 3 antihypertensive drugs including a diuretic
* Day-time ambulatory blood pressure \> 145/75 mmHg

Exclusion Criteria:

* Non compliance
* Pregnancy/no-anticonception in fertile women
* Radiocontrast allergy
* Malignancy
* Congestive heart failure (EF \< 50)
* eGFR \< 45
* Unstable angina pectoris
* Recent myocardial infarction or PCI (\< 6 mdr)
* Secondary hypertension
* Renal artery stenosis or multiple renal arteries on CT
* Claudication
Systematic Ultrasound in the Initial Assessment of Ankle Sprain

Ankle sprains are the most frequently encountered trauma in emergency and general medicine. Lateral ankle sprain injuries have the highest relapse rate of all musculoskeletal injuries of the lower limbs. Optimal initial management is essential for a successful return to previous condition, with the aim of preventing chronic ankle instability, chronic pain, stiffness or recurrence. One of the 13 physicians at our facility routinely performs an ultrasound routinely scan during the second consultation to assess the severity of the sprain. We would therefore like to evaluate whether the performance of this examination at the time of clinical reassessment is associated with a better prognosis at 3 months post-trauma.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ankle sprain made during a preliminary prior consultation
* Patients undergoing re-evaluation of sprain severity, between D3 and D6 of trauma

Exclusion Criteria:

* Medial sprain
* Sprain recurrence \<6 months
* Age \< 15 years
* Radiographic fracture confirmed on an X-ray performed between initial diagnosis and re-evaluation visit
* History of hyperlaxity syndrome
Syph-Check Syphilis Antibody Point of Care (POC) Test

The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.

The overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (Syph-Check cassette format) for Treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (STD) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal RPR and a Treponemal ELISA or TPPA test.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women will be eligible who:

  1. are 18 years of age or older;
  2. Routine "presumed uninfected" for screening visit, or show symptomatic signs of infection or are asymptomatic but are suspected of infection, and either/or have other STD disease conditions and infections, will be identified.
  3. Pregnant women in the first and third trimester

Exclusion Criteria:

* are under 18 years of age
* unwillingness to give consent
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound

The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.

Antihypertensive therapy is reported to reduce cardiovascular events in patients with coronary artery disease. The goal of blood pressure in patients with coronary artery disease is recommended to control below 140/90mmHg. However, the effect of intensive blood pressure control compared to standard blood pressure control is still unknown. The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary atherosclerosis after 18 months. The goal of systolic blood pressure is under 120mmHg in intensive blood pressure control group and under 140mmHg in standard blood pressure control group. The design of this study is randomized control study.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery diseases which require coronary angiography or percutaneous coronary intervention
* primary hypertension (systolic blood pressure 140-180mmHg within one month)

Exclusion Criteria:

* severe hypertension
* secondary hypertension
* treated with more than three antihypertensive drugs
* left main trunk trunk coronary artery disease
* moderate heart failure
* severe valvular disease
* liver dysfunction renal dysfunction (Cr\>=2.0mg/dl) Pregnant or nursing women severe arrhythmia
BIOFLOW-SV Portugal Registry

Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm

Prospective, single-arm, multi-center, all-comers registry with clinical follow-up visits at the hospital or by phone at 6 and 12 months post-procedure. A minimum of 1000 patients will be enrolled in approximately 15 sites in Brazil, including at least 415 patients with reference vessel diameter ≤2.75 mm as assessed by online QCA.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥18 years of age
* Subject must sign a Patient Informed Consent (PIC) or a Patient Data Release Form (PDRF)
* Subject must agree to undergo all required follow-up visits

Exclusion Criteria:

* Pregnant and/or breast feeding females at the time of enrolment
* Known allergies to Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant

  /antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs, or the stent materials that cannot be adequately pre-medicated
* Currently participating in another study that has not yet reached the primary endpoint
The Impact of Sinopharm COVID-19 Vaccination on Male Fertility

The investigators shall study the effect of Sinopharm vaccination on semen parameters and serum testosterone

The investigators shall compare semen parameter (sperm density, sperm motility, and percentage of abnormal sperm form) as well as morning serum testosterone before vaccination, and 3 months after the second dose of the vaccine.

Eligibility Criteria:
Inclusion Criteria:

Receiving Sinopharm COVID-19 vaccines Male age 18-50 years old

Exclusion Criteria:

* Adults unable to consent
* Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year
* Men with a history of male infertility
* Men with a genetic or other medical condition known to be associated with decreased semen parameters Positive COVID-19 PCR test within the 3 months
Social and Monetary Incentives for Smoking Cessation at Large Employers

The investigators will conduct a cluster randomized controlled trial of several behavioral interventions for smoking cessation among a sample of employees at large workplaces in the Bangkok metropolitan area. The study aims to test the impacts of different incentive structures for smoking cessation on take-up, effectiveness, and cost-effectiveness. The interventions are designed to elucidate certain principles from the field of behavioral economics.


Eligibility Criteria:
Inclusion Criteria:

* Current full-time employee of a participating company
* Smoker of 100+ cigarettes during lifetime
* Smoker of 10+ cigarettes per week
* Individual is aged 18+ years old
* Smoker wants to quit within the next 6 months

Exclusion Criteria:

* Expects to leave company within the next 12 months
* Is currently pregnant
* Are unable to provide informed consent
Probiotc Lactobacillus Crispatus-M247 (Crispact®) Supplementation in the Sterilization of High-risk Human Papilloma (HPV-HR) Viruses

There is growing scientific interest in probiotic supplementation as a possible therapy for clearing the human papillomavirus (HPV) infection and reducing the risk of developement of cervical cancer.

This is a multicenter, randomized, longitudinal, prospective, parallel-group, single-blind study aimed to investigate the efficacy of probiotic Crispact® (which contains: 20 Bld CFU/Stick of Lactobacillus crispatus M247) in clearance of human papillomavirus (HPV) infection in healthy female who tested positive for human papillomavirus (HPV) infection.

Eligibility Criteria:
Inclusion Criteria:

* Women able to understand and agree to participation in the study and be able to provide written informed consent to the trial.
* Women aged 25-29 years who perform screening pap smears with the result: Low- grade squamous intraepithelial lesion (LSIL) or Atypical Squamous Cells of Undetermined Significanc (ASCUS) (for which, as per the recommendation of the Italian Society of Colposcopy and Cervico-Vaginal Pathology (SICPCV)/Italian Group of Cervical Cancer. Screening (GISCI), no treatment is indicated but only follow-up with Human papillomavirus (HPV) test at 12 months.
* Women aged 18-64 who independently perform a positive High risk sub-types of HPV (HR-HPV) test outside of screening even in the presence of a negative cytology (for whom, as per the recommendation of the SICPCV, no treatment is indicated but only follow-up with HPV test at 12 months).
* Women aged 30-64 years HPV HR positive with negative cytology or with positive cytology for ASCUS or LSIL but negative colposcopy (absence of colposcopic lesion or positive colposcopy but subsequent negative biopsy) who do not require treatment (therefore as per the recommendation of the SICPCV go to follow-up with HPV testing at 12 months).

Exclusion Criteria:

* Women who have been vaccinated for HPV.
* Patients who have undergone cervical treatments for preneoplastic pathology.
* Patients with High-Grade Squamous Intraepithelial Lesion (HSIL) cytological result who on histological examination after biopsy need treatment according to the SICPCV 2019 recommendations.
* Hypersensitivity to one or more components of the product.
* Patients being treated with antibiotic, immunomodulatory and immunosuppressive therapies.
* Patients with immune system or neoplastic pathologies being treated with chemotherapy
* Patients who are pregnant, breastfeeding, or planning to become pregnant in the next 6 months.
A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer

This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
* Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function.
* Life expectancy of 12 weeks or greater.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Able to swallow and retain oral medication.
* Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy.
* Non-childbearing potential.

Exclusion Criteria:

* History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
* Evidence of refractory ascites.
* Has clinically relevant or significant electrocardiogram abnormalities.
Serotonin 1A Agonists and Cognition in Schizophrenia

Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with antipsychotic medications. Patients will be assigned to take active medication (Buspar)or placebo along with their prescribed antipsychotic medication for six weeks. Patients' memory and problem-solving ability will be tested before and after medication.

Examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with olanzapine or risperidone for at least three months randomized to receive adjunctive treatment with a 5-HT1A agonist (buspirone, 15-30 mg/day)or placebo.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in the current research study.

1. Subjects will be males and females between 18-65 years of age;
2. Subjects will have a definite diagnosis by DSM-IV criteria for Schizophrenia or Schizoaffective Disorder;
3. The subjects or their legal guardian must sign the informed consent;
4. Subjects currently being treated with olanzapine or risperidone for a duration of at least 3 months

Exclusion Criteria:

1. Subjects who are pregnant or lactating
2. Subjects who have brain damage and/or neurological disorders
3. Subjects who have current substance dependence
4. Subjects unable to provide informed consent
Endothelial Function, Inflammatory Disease Activity, and Bone and Cartilage Markers in Rheumatic Patients: The Influence of Antirheumatic Treatment

The aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-80 years
* Able and willing to give written informed consent, and to comply with the requirements of the study protocol.
* Fulfilling the ACR 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis, or the diagnostic criteria by Moll and Wright for the diagnosis psoriatic arthritis, or the modified New York diagnostic criteria for ankylosing spondylitis.
* Clinical indication for starting treatment with methotrexate, TNFalpha- inhibitor or combination therapy.
* Use of reliable method of contraception for women with childbearing potential.

Exclusion Criteria:

* Lack of cooperativity
* Positive serology for hepatitis B or C
* History of positive HIV status.
* History of tuberculosis or untreated tuberculosis.
* PPD more than 15 mm in previously BCG immunized subjects. PPD 6 mm or more if not previously BCG immunized.
* Histoplasmosis or Listeriosis
* Persistent or recurrent infections
* Any inflammatory disease of permanence not related to RA, PSA or AS.
* Pregnancy or breast-feeding.
* Use of prednisolone more than 10 mg daily for 2 weeks at inclusion.
* Use of TNFalpha-inhibitor the last 4 weeks.
* History of cancer.
* Uncontrolled diabetes.
* Congestive heart failure (Nyha 3-4)
* Recent stroke (within 3 months)
* Previous diagnosis or signs of central nervous system demyelinating disease.
* Previously diagnosed immunodeficiency.
Optimizing the Evaluation of Awareness in Disorders of Consciousness

The purpose of this study is to evaluate whether personalized stimulations can improve the detection of electrophysiological signs of awareness in patients with disorders of consciousness.


Eligibility Criteria:
Inclusion Criteria:

* patients in a vegetative state or a minimally conscious state
* agreement from families

Exclusion Criteria:

* patients with akinetic mutism or locked-in syndrome
* patients in a coma
* patients with damages in the inner or middle ear
* contraindication to a high-density electroencephalography exam
Cellulose Sulfate (CS) Gel and HIV in Nigeria

This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.

This is a Phase 3, multi-center, randomized, placebo-controlled trial to assess the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV among HIV sero-negative women at high risk for HIV infection. Eligible participants who are HIV negative, at risk for becoming infected, and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in Port Harcourt and Lagos, Nigeria. The enrollment phase will last until 2,160 women have enrolled. It is anticipated that the enrollment will be completed within 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent
* At least 18 years old and not more than 35 years old
* Average of three vaginal coital acts per week with a male partner
* More than one male sexual partner in the last 3 months
* Willing to use study product as directed
* Willing to adhere to follow-up schedule
* Willing to participate in the study for 12 months
* Willing to report self-medication during study participation
* Willing to give urine for pregnancy testing; self-administered vaginal swabs for GC/CT testing; OMT for HIV monthly; finger prick for HIV confirmation if required; and blood draw for syphilis and HIV at baseline, and for HIV at the final visit
* Willing to not use a spermicide, other vaginal contraceptive, or vaginal lubricant during the study
* At least 3 months since end of the last pregnancy

Exclusion Criteria:

* History of adverse reactions to the study products, including latex
* Pregnant or desire a pregnancy during the 12 months of participation
* Injection drug user
* Gynecological abnormality that may have an impact on the safety and/or response to the study gel according to the investigator
* HIV positive as diagnosed by OraQuick® rapid test
* Participation in any other microbicide research
* Discontinued from the CS study previously
* Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe or complicate data interpretation
Defocus Induced Changes on Choroidal Thickness

The goals of this study are to assess the short-term (10-60 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-60 minutes of monocular exposure to -5 diopters to +5 diopters of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.

The purpose of this study is to determine modifying factors inducing or protecting against the development or progression of myopia, or nearsightedness. Myopia has reached epidemic levels in urbanized countries, reaching up to 90% of the teenage and young adult population in urban Asia. Myopia represents a significant socioeconomic burden and poses a risk for associated ocular diseases such as retinal detachment, choroidal neovascularization, and glaucoma. The economic and public health burden of myopia are growing disproportionately to the population, spurring interest in the development of therapies to prevent occurrence or progression. Myopia generally occurs because the eye grows too long, with onset and progression occurring from about ages 6 to 20. Though much is known about factors that influence eye growth, the exact mechanisms by which they do so have not been elucidated.

The goals of this study are to assess the short-term (10-50 minutes) effects of different magnitudes of myopic and hyperopic optical defocus on the transient thickness of the choroid in children and adults, as well as to assess the recovery period. Choroidal thickness will be measured non-invasively following 10-50 minutes of monocular exposure to -5D to +5D of optical defocus induced by spectacle lenses. The hypothesis is that choroidal thickness will increase with increasing myopic defocus and decrease with increasing hyperopic defocus. The relationship between the magnitude of defocus and the magnitude and direction of choroidal thickness change will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 45 years of age (preliminary studies indicate that children under 6 cannot sit for imaging, and subjects over 45 do not respond to the optical defocus with expected choroidal thickness changes)
* Best corrected visual acuity of 20/25 or better in better-seeing eye

Exclusion Criteria:

* Age younger than 6 years or older than 45
* Best corrected visual acuity worse than 20/25 in better-seeing eye
* Ocular pathology or prior ocular injury
* Heavily-pigmented choroid that precludes accurate measurement of choroidal thickness