cyrilzakka/clinical-trials huggingface dataset:
Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh

The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.

In view of spreading antimalarial drug resistance there is an urgent need for new combination treatments for a disease that kills more than one million people every year. Azithromycin is a macrolide antibiotic that is particularly attractive due to its safety in children and experience with use in pregnancy. Recent trials suggest that azithromycin has a strong potential as an antimalarial. The purpose of this study is to investigate the efficacy of azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in Bangladesh.

Eligibility Criteria:
Inclusion Criteria:

1. Acute symptomatic falciparum malaria infection with a parasite density of 100 to 100,000 asexual parasites/uL as determined on the screening smear with fever (defined as ≥37.5ºC), or reported history of fever within the last 48 hours.
2. Age: 8-65 years old
3. Males or females. All females over the age of 12 are required to have a negative human chorionic gonadotropin (hCG) pregnancy test (urine). All females of childbearing potential (not surgically sterile, or less than two years menopausal) are required to use an acceptable method of contraception, such as implant, injectable, oral contraceptive(s) with additional barrier contraception, intrauterine device, sexual abstinence, or vasectomized partner, throughout the study
4. Written informed consent obtained
5. Willing to stay under close medical supervision for the study duration
6. Otherwise healthy outpatients

Exclusion Criteria:

1. Pregnant women, nursing mothers, or women of childbearing potential who do not use an acceptable method of contraception (as described in Inclusion Criteria, #3)
2. Mixed malaria infection on admission by malaria smear
3. A previous history of intolerance or hypersensitivity to the study drugs artesunate, azithromycin, or lumefantrine or to drugs with similar chemical structures
4. Malaria drug therapy administered in the past 30 days by history
5. Previous participation in this trial, or participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
6. History of significant cardiovascular, liver or renal functional abnormality or any other clinically significant illness, which in the opinion of the investigator would place them at increased risk.
7. Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
8. Signs or symptoms of severe malaria (as defined by WHO 2003)
9. Unable and/or unlikely to comprehend and/or follow the protocol
RATT Vs. VATT for Early-stage TETs

This study is a prospective, multicenter, phase II randomized controlled trial. We plan to screen 100 eligible thymoma patients for robotic-assisted thoracoscopic thymectomy (RATT) or video-assisted thoracoscopic thymectomy (VATT) at three medical centers in China. The trial was aimed to compare the perioperative outcomes between the two approaches.


Eligibility Criteria:
Inclusion Criteria:

* Thymoma was diagnosed by chest enhanced CT or MRI (clinical stage: Masaoka Koga I-II) with AJCC/UICC TNM grade system (9th edition).

The patients whose tumor diameter was not larger than 8 cm; The patients with the estimated survival time should be over 12 months; ASA grade：1-2; The patients should have no functional disorders in main organs; The patients should be able to understand our research and sign the informed consent.

Exclusion Criteria:

* Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis; Patients with myasthenia gravis; Patients had undergone a sternotomy; The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control; The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy; Female who is positive for serum pregnancy test or during lactation period; The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation; The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders; The patients attend other clinical trials.
Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status

The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men.

The aim of this study was to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.

Eligibility Criteria:
Inclusion Criteria:

* History of infertility of at least 12 months despite regular unprotected intercourse.
* Oligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm concentration (\<15 million/ml), progressive motility (\<32%), total motility (\<40%) and morphology (\<30% WHO criteria) as defined by WHO manual for semen analysis 2010

Exclusion Criteria:

* Azoospermia,
* Varicocele,
* Genital tract infection,
* Cryptorchidism,
* Testicular trauma or scrotal surgery,
* Endocrine disorder,
* Systemic illness,
* Smoking
* The presence of female factor
Peer-to-peer Tobacco and ENDS Prevention

In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers.

In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL media Plus on smoking and vaping.

In Phase I, participants will participate in pilot and usability tests of the curriculum prototype. For the pilot test, teachers and students will use the curriculum prototype and then be interviewed about it. For the usability test, students and teachers will use the revised curriculum and be interviewed/complete short survey. Teachers will provide consent and students will have parental consent and their own assent.

In Phase II, a group randomized trial will be conducted during Spring semester 2020 among 9th grade student in 27 high schools in the Hillsborough County Public School system randomly assigned to treatment and control (14 treatment and 13 control). All students will complete a pretest survey. Students in two health classes in treatments schools will participate in the REAL media Plus curriculum and complete a short immediate posttest survey to rate their experience. All students will then complete two posttests. Students will have parental consent and provide their own assent.

Eligibility Criteria:
Inclusion Criteria:

Attendance at participating schools; 9th grade student status (for student participants, both phase 1 and 2); status as a teacher/counselor (for phase 1); written parental consent and assent from students (phase 1 and 2); written consent from counselors/teachers (phase 1); and all individuals must be willing to participate.

Exclusion Criteria:

Exclusion criteria include the inability to speak or read American English, use a computer, or navigate the Internet and, for youth, lack of parental consent.
The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer

The purpose of this study is to compare the effect of Bepreve® with an artificial-tear eye drop on the quality of your tears.

This is a single-center, randomized, parallel group, placebo-controlled study to evaluate the effect of BEPREVE compared to a placebo eye drop on the measurement of tear film osmolarity and tear film lipid layer in patients with allergic conjunctivitis.

Subjects will be screened for this study on day one of dosing with the test article. Subjects who sign the informed consent form and who meet all inclusion/exclusion criteria will be eligible for participation in this study. They will be assigned sequentially, according to a computer generated randomization list, in a ratio of 1:1 to receive either BEPREVE™ (bepotastine besilate ophthalmic solution) 1.5% or REFRESH TEARS® Lubricant Eye Drops (1:1). Subjects will instill one drop of test article either BEPREVE™ or REFRESH TEARS® into the study eyes twice daily for a maximum of 60 days. Subjects will be seen for evaluation on Days 0, 28±3, and 56±3 following randomization.

Eligibility Criteria:
Inclusion Criteria:

1. Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
2. Have documented positive skin prick puncture test to at least one (1) seasonal allergen (e.g., grasses, trees, weeds, or other allergens) within two (2) years of Visit 1.
3. Agree not to have any other ocular drops in study eyes within 2 days prior to the initiation of dosing with the test article or throughout the duration of the study.
4. Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
5. Are willing/able to follow instructions from the study investigator and his/her staff.
6. Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff.
7. Are able to self-administer test article (or have a caregiver available to instill all doses of test article).
8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

1. Have known hypersensitivity to either BEPREVE™ or REFRESH TEARS® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
2. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
3. Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
4. Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
5. Are pregnant or nursing/lactating.
6. Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
Keep bIfurcation Single Stenting Simple

KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

In the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of Percutaneous Coronary Intervention (PCI), when MB is treated according to the Murray law with a Proximal Optimization Technique (POT), remains unclear.

The KISS study will evaluate the non-inferiority of no side branch intervention versus side branch ballooning, in the setting of single stenting with systematic proximal optimization technique.

Eligibility Criteria:
Inclusion Criteria:

1. Coronary artery disease requiring revascularization that is amenable to percutaneous coronary intervention (PCI)
2. Any de novo Medina type bifurcation lesion with \>70% lesion in the main vessel by visual assessment except Medina 0,0,1 if the planned strategy does not include a main branch stenting
3. Side branch diameter compatible with a PCI with stent implantation (≥ 2.25mm)
4. Side branch requiring a protection wire according to operator evaluation
5. Anatomy compatible with a proximal optimization technique
6. Post main branch treatment (stenting then POT): Absence of side branch occlusion Or low flow associated with ongoing ischemia (either chest pain or ST changes)
7. Male or female patient \>18 years old

Exclusion Criteria:

1. Acute myocardial infarction with ongoing ST-elevation
2. Cardiogenic shock
3. Requirement for ongoing hemodialysis
4. Life-expectancy limited to \<12 months due to co-morbid condition
5. Lesion involves the left main coronary artery
6. Lesion requiring a double stenting
7. Plan to treat \>1 other coronary vessel at the time of the index procedure
8. Two lesions treated in the same session: unsuccessful PCI on the single non bifurcation lesion in a non-target vessel before the treatment of the target lesion.
9. Chronic total occlusion of any target vessel
10. Left ventricular ejection fraction \<20%
11. Side branch TIMI Flow \<3
12. Pre-dilatation of the Side Branch during the procedure prior to randomization
13. Known allergy to Aspirin
14. Known allergy to Clopidorel and Prasugrel and Ticagrelor
15. Known allergy to stent drug elutant
16. Known allergy to any other component of Onyx Resolute stent
17. Ongoing participation in another investigational device or drug study
18. Inability to provide informed consent
19. Patients under judicial protection, tutorship or curatorship
20. Pregnant and breast-feeding women or intention to become pregnant prior to completion of all follow-up procedures
Evaluation of the Improvement of Quality of Life of Patients Suffering From Hailey Hailey or Darier Disease After Injections of Botulism Toxin Into Large Folds.

Hailey Hailey and Darier disease are rare genetic dermatoses. Mutations of 2 genes (ATP2C1 or ATP2A2 respectively) are responsible for the diseases. These genes have a key role in calcium pump; their defect create abnormal link between keratinocytes' desmosomes and induce skin lesions. Clinically, patients present with inflammatory lesions located in the folds. Quality of life is impaired because of pain, pruritus and tendency to infections. Lesions are permanent but acute exacerbations occur in hot seasons because of increased sweating. Usual therapies are often not effective (local treatment, laser, phototherapy). Because sweating is a well established inducing or aggravating factor, botulism toxin could be an effective treatment for these diseases.

Botulism toxin is already used in clinical practice and acts via a decreased sweet secretion. Improvement of skin lesions in Hailey-Hailey or Darier diseases has been previously reported in a few cases but there is no study properly evaluating the benefit of such treatment.

The aim of the project is to study the improvement of quality of life for patients suffering from Hailey-Hailey or Darier diseases after a injections of botulism toxin in large skin folds. The principal objective is to estimate the distribution of the variation of quality of life at M1 vs. baseline.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis (clinical and histological features) of Hailey Hailey or Darier diseases.
* Moderate to very severe lesions located in large folds
* Patient aged 18 ans or more
* Patient with health coverage
* Patient who have signed the consent form
* Patient proficient into filling out the questionnaires.

Exclusion Criteria:

* Hypersensibility to toxin or excipients
* Myastheny
* Deglutition's problems
* Past medical history of dysphagia or aspiration pneumonia
* Pregnancy (positive B-HCG test performed a maxima 72h before) or breastfeeding
* Mental , physical incapacity to fill in the questionnaires
* Guardianship patients
* Skin infections at the inclusion visit
* Application in the last 7 days at the site of injection of local treatments (apart emollients or antiseptics) or injections of botulism toxin or dynamic phototherapy or laser in the last 6 months.
* Systemic treatment with aminosides in the last 15 days
* Inclusion in another study in the last 2 months.
A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
* Subjects must have the clinical diagnosis of Congestive Heart Failure (CHF) made at least three months prior to enrollment
* Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:

  * dyspnea and
  * clinical evidence of volume overload

Exclusion Criteria:

* Acute de-novo heart failure
* Acute myocardial infarction and/or myocardial infarction within 30 days
* Valvular heart disease requiring surgical intervention during the course of the study
* Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
* Primary hypertrophic cardiomyopathy
* Acute inflammatory heart disease, eg, acute myocarditis
* Unstable angina requiring angiography
Papillomavirus Load in Rheumatic Inflammatory Diseases

Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are the two most common chronic inflammatory rheumatism, with a prevalence in the French population of 0.3% and 0.4%, according to the criteria European League Against Rheumatism / American College of Rheumatology (EULAR / ACR) 2010 and Assessemnt of SpondyloArthritis International Society (ASAS) 2009 respectively. In patients whose pathology is resistant to first-line treatment, such as methotrexate for rheumatoid arthritis and peripheral spondyloarthritis, or non-steroidal anti-inflammatory drugs for axial spondyloarthritis, the treatment is based on biotherapies, such as anti-inflammatory drugs. -TNF, to obtain effective control of the disease and prevent joint damage.

Human papillomavirus (HPV) infection, the leading risk factor for cervical carcinoma, is the most common sexually transmitted infection (STI) with a particularly high prevalence among young women.

In addition, anti-TNF, used in the treatment of RA and SpA, and anti-IL6 receptor, used in that of RA, could have opposite effects on HPV-dependent oncogenesis.

Thus, patients with RA or SpA may have a higher risk than the general population of progression to cervical cytological abnormalities. Evaluation of the chronic carriage of HPV would then be a useful tool in the management of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Woman between 18 and 65 years old
* Patient with rheumatoid arthritis as defined in 2010 ACR/EULAR criteria or with spondyloarthritis as defined in 2009 ASAS criteria
* Patient able to understand the objectives of the study and give documented informed consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant or breastfeeding patient
* Patient with a history of cervical cancer
* Patient under juridical protection
* Patient unable to provide informed consent due to linguistic or psychic impairment
Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects

The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD signals in ROIs in resting fMRI in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female subjects between 18 and 55 years of age inclusive (at the time of initial informed consent)
* Body weight ≥ 45 and ≤ 87 kg
* Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

* Female subjects who are pregnant, intend to become pregnant, or are breastfeeding
* History or presence of psychiatric or neurologic disease or condition
* History of first-degree relative with schizophrenia or mood disorder with psychosis
* History of alcohol or drug abuse
* History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine
* History of violence
* Presence or positive history of significant medical illness, including high blood pressure, low blood pressure or orthostatic hypotension
* Any subjects who show subthreshold ketamine BOLD response
* Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
* Claustrophobia
* Subject with any history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator
The Prospective Segeberg TAVI Registry

A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany

A prospective single center registry including all patients treated with transcatheter aortic valve implantation (TAVI) at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical and echocardiographic follow-up schedule, including a long-term follow-up plan beyond 5 years to assess valve durability.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with TAVI

Exclusion Criteria:

* None
Safety, Skin and Plasma Concentration of Azithromycin Dermal Formulation

IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.

In this study two consecutive cohorts will be treated:

* Cohort 1: 8 volunteers
* Cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each

The study will be conducted in the following three phases:

1. Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a local treatment with azithromycin dermal formulation.

   1. Treatment of cohort 1 with azithromycin dermal formulation and follow up
   2. Assessment of local safety within the 7 days following the first treatment
   3. The maximal tolerated dose (MTD) will be determined
2. Treatment of cohort 2: The aim is to confirm the local tolerance of the selected doses and to evaluate the local skin and plasma concentration of azithromycin after application of SHB001 dermal formulation.

   1. Treatment of cohort 2 with azithromycin dermal formulation at maximal tolerated dose (MTD), with a dose one or more concentrations lower than maximal tolerated dose (MTD) and with placebo
   2. Skin biopsies of treated skin areas will be taken for the PK assessment
3. Study completion examination

Eligibility Criteria:
Main inclusion criteria:

* Male or female healthy volunteers, age 18 - 70 years

Main exclusion criteria:

* A known hypersensitivity against azithromycin, erythromycin or any of the macrolide antibiotics
* A known hypersensitivity against lidocaine
* Treatment by any route with any macrolide antibiotic within the last 2 month
Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor in Lung Cancer Patients

Massive blood loss occurs in metastatic spinal tumor resection and may cause severe complications. The objective of this study is to investigate whether the use of tranexamic acid will reduce perioperative and postoperative bleeding when compared to those without use of tranexamic acid.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as metastatic carcinoma of the thoracolumbar spine
* solitary neoplasm involve only one segment of spine
* patients underwent separation surgery

Exclusion Criteria:

* coagulation function was abnormal preoperatively
* patients are allergic to tranexamic acid
* neoplasm involve more than one segment of spine
* patients with rich blood supply who need embolization