cyrilzakka/clinical-trials huggingface dataset:
VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test
Rivaroxaban - Percutaneous Coronary Intervention

We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.


Eligibility Criteria:
Inclusion Criteria:

* patients using the direct oral factor Xa inhibitor rivaroxaban
* Atrial fibrillation

Exclusion Criteria:

* malignancy,
* coagulopathy,
* heart valve disease,
* active infection,
* chronic systemic or inflammatory disease,
* recent ACS or elective PCI,
* uncontrolled hypertension and diabetes,
* cerebrovascular accident,
* thyroid disorder,
* left ventricular systolic dysfunction (ejection fraction \<50%),
* glomerular filtration rate \<50 mL/min/1.73 m2,
* underweight and overweight (\<60 kg and \>100 kg),
* age \>75 years,
* hyperbilirubinemia and hypertriglyceridemia (\>350 mg/dl).
Sleep TMS for Depression

The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.


Eligibility Criteria:
Inclusion Criteria:

* Current Major Depressive Disorder (MDD) diagnosis
* Failed \>= 1 antidepressant medication
* Moderate-to-severe depression

Exclusion Criteria:

* Intellectual disability
* Significant head injury/neurological disorder
* Pregnancy or postpartum
* TMS/MRI contraindications
* Active substance use/suicidal ideation
Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment

Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.

Primary objective: Efficacy of 4 weeks of liposomal amphotericin B (AmBisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose in initial zygomycosis treatment. Evaluation after 4 weeks of treatment or at end of treatment if it occurs before. Efficacy will be defined as objective responses; complete and partial response.

Secondary objectives: Efficacy, tolerance and survival after 15 days of treatment, cumulative dose of AmBisome® necessary to obtain objective response, efficacy in operated and non operated patients, tolerance after 4 and 12 weeks treatment, survival, and relapse rate at 6 months of 4 weeks of liposomal amphotericin B (AmBisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose.

Scheme : prospective, multicentric, non comparative therapeutic pilot study.

Inclusion criteria: Presence on a tissue biopsy of large non septated hyphae compatible with zygomycete or presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection.

Exclusion criteria: Life expectancy below 72 hours, pregnancy, breast feeding, polyene hypersensitivity, absence of histologic or mycologic zygomycosis documentation, absence of informed consent, previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion.

Treatment : AmBisome® 10 mg/kg/j monotherapy during at least 15 days, then AmBisome® at maximal tolerable dose during 15 days associated with early optimal surgical treatment. After the first treatment month, following treatment is decided by referent physician.

Eligibility Criteria:
Inclusion Criteria:

* Presence on a tissue biopsy of large non septated hyphae compatible with zygomycete
* Presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection.

Exclusion Criteria:

* Life expectancy below 72 hours,
* Pregnancy, breast feeding,
* Polyene hypersensitivity,
* Absence of histologic or mycologic zygomycosis documentation,
* Absence of informed consent,
* Previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion
Therapeutic Effect of Self-administered Auricular Acupressure on Insomnia Induced by Anxiety

This is a sham-controlled randomized trial to identify the effectiveness of treating insomnia induced by anxiety with self-administered auricular acupressure in Malaysia.

112 subjects with insomnia and anxiety who fit to the inclusion and exclusion criteria will be recruited into the trial. After initial screening, subjects will be randomly allocated to Vaccaria seed tapes (experimental arm) or non-Varracia seed plain tapes (sham comparator arm).

On the sixth day for the trial (after 5 days of daily auricular acupressure), the ISI and HAM-A score of subjects will be reassessed again. The subjects have to stop applying auricular acupressure for the next five days and reassess their ISI and HAM-A score again on the eleventh day.

Eligibility Criteria:
Inclusion Criteria:

* All Malaysian aged above 18 years old who are suffering from chronic insomnia based on International Classification of Sleep Disorders 3(ICSD-3) and with Insomnia Severity Index (ISI) of 18 and above and more than 3 months.
* Willing to comply with the recommended periodic acupressure stimulation every day during the 1 week period.

Exclusion Criteria:

* Subject with insomnia score below 18 based on Insomnia Severity Index (ISI).
* Subject with stress and anxiety level below 18 in the Hamilton Anxiety Rating Scale (HAM-A).
* Subject with the history of skin sensitivity.
* Subject who just started on new medication to treat insomnia.
Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice

The purposes of this international post-marketing observational program is to investigate effectiveness of betahistine dihydrochloride (Betaserc®) tablets and assess the course of vestibular vertigo after treatment discontinuation in population of Russia and Ukraine outpatients suffering from vestibular vertigo in pragmatic clinical settings. Exploratory analyses of results from both participating countries may be expected to provide insights about the subjective circumstances of vestibular vertigo patients in a wider than usual range of gender, underlying ICD-10 diagnosis, national and cultural situations.

A prospective, multicentre, non-interventional, non-randomized, non-controlled, single arm, post-marketing observational program in patients whom betahistine dihydrochloride (Betaserc®) tablets were prescribed in the usual manner at the maximal recommended daily dose of 48 mg in accordance with the locally approved label. Over a program period physician is free to adjust betahistine dihydrochloride dose according to country approved label. Adult outpatients with vestibular vertigo who can be treated with betahistine dihydrochloride as per the locally approved label will be enrolled in the program. The program consists of an observational treatment period (up to 2 months) and a follow-up period (up to 2 months, for evaluation of the course of vestibular vertigo after treatment completion).

Eligibility Criteria:
Inclusion Criteria

* Male or female 18 years and older.
* Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe 48 mg of betahistine dihydrochloride (Betaserc®) in accordance with locally approved label.
* Patients who are willing and able to provide authorization to the investigator to use and/or disclose personal and/or health data.
* Patients who started betahistine dihydrochloride (Betaserc®) therapy not more than 5 days priory to sign Patient Authorization (Consent) for Use/Disclosure of Data.

Exclusion Criteria

* Patients with any condition which, in the opinion of the Investigator, makes the patient unsuitable for inclusion based on clinical judgment.
* Labeled contraindications of betahistine dihydrochloride (Betaserc®) treatment.
* Patients with middle or inner ear infection.
* Patient with psychiatric disorders, significant neurological disorder or spinal cord damage.
* Patients receiving any other agents for peripheral vestibular vertigo such as diuretics, transtympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking H1- histamine receptors.
Feasibility of Remote JVP Assessment

The JVPHome is a novel medical device that utilizes machine vision in order to facilitate assessment of jugular venous pressure (JVP) height relative to the sternal angle with the ultimate goal of enabling remote JVP monitoring. The current study aims to evaluate the ability of the JVPHome to enable remote identification of JVP height relative to ultrasound among congestive heart failure (CHF) patients when the device is applied by the study team in the clinic.

CHF is a common and devastating health problem estimated to affect upwards of 26 million individuals worldwide. Following an initial hospitalization for heart failure, approximately 25% of patients are readmitted within the first 30 days of discharge. Repeat heart failure hospitalizations are a major burden on both patients and healthcare systems. To date, there is an absence of non-invasive solutions proven to reduce the risk of re-hospitalization for CHF.

The key feature of the physical examination for assessing the volume status of CHF patients is the JVP, which manifests as a biphasic pulsation along the neck. The height of the JVP relative to the sternal angle is a reflection of right atrial pressure, which increases in response to higher pressures transmitted from the left side of the heart. Pathologic elevation of left sided heart pressures can result in fluid congestion in the lungs, which can cause patients to develop shortness of breath and reduced blood oxygen levels. Although a crucial marker of volume status, accurate identification of the JVP can be challenging for physicians due to its pulsations often being subtle.

The JVPHome is a novel medical device designed to facilitate visualization of JVP height relative to the sternal angle through the use of machine vision. The current study aims to evaluate the JVPHome in a clinic setting when the device is applied to CHF patients by clinicians. Following its application, the JVPHome will be allowed to record a video of the JVP and images will subsequently be transmitted to a secure cloud and undergo analysis with machine vision software. JVP height of study participants will be concurrently assessed through the use of ultrasound (gold standard). Clinicians that are blinded to ultrasound determined JVP height values will assess JVP height values remotely based on the machine enhanced images generated by the JVPHome. Analyses will then assess the accuracy of the JVPHome relative to ultrasound and expert clinical assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 18 years
2. Congestive heart failure diagnosis receiving ongoing treatment
3. Able to provide informed consent

Exclusion Criteria:

1. Conditions which preclude visualization of the JVP, including neck deformity, scarring, and facial hair
Vitreous Inflammation in Standard and Heavy Silicone Oil

The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery has its apex in the development of PVR that occurs when retinal cells are exposed to the inflammatory milieu in the humor vitreous.

This situation is common in complicated retinal detachment, but is amplified after invasive surgery and by the use of intraocular tamponades that float over a subtle film of liquid where the inflammatory cytokines and growth factors reach the critical concentration over the inferior retina.

Many authors have noted that the heavy tamponade are more prone to cause intraocular inflammation compared to standard silicone oil, especially if they remain for several months in the eye.

The purpose of this study is to measure the vitreous concentration of some of the most important cytokines involved in the inflammatory vitreal response.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled for vitrectomy

Exclusion Criteria:

* diabetic retinopathy
* uveitis
Effect of Pregnancy on Androgenic Steroids in Different Genetic Panels

Androgens are important sex steroids in women. Androgens influence protein synthesis and muscle growth, are involved in maturation of the reproductive organs, have a fat reducing effect , have a negative effect on the serum lipid profile, and may also increase insulin resistance and coagulation activity. The role of androgens in women is not clear. This study is aimed at learning about the amount of androgen and its actions in pregnant women. This study is also looking to see if there are specific patient factors (such as genetics) that change the amount of androgen and its activity.

There is a lot of information about the main female sex hormones such as estrogens and progesterones (the main female sex hormones and the most important in menstrual , reproductive cycles and pregnancy) . However there is little information about androgens in pregnant women. It is known that certain illnesses, chemicals and dietary products might change the amount of androgen and its actions, which could affect the mother and her baby. It is also known that there are differences between the androgen levels in different people, and in different ethnic groups. These differences are mostly due to genetic factors. The goal of this study is to learn about the androgen levels in healthy pregnant women and if genetic or clinical factors (for example age, trimester of pregnancy, parity, ethnicity, etc.) play a role in changing the androgen amount and action, throughout pregnancy and after delivery.

Eligibility Criteria:
Inclusion Criteria:

* healthy women without drug treatment, in the age range of 18-40 years

Exclusion Criteria:

* Any chronic disease such as Hypertension or Diabetes Mellitus
* Positive for HIV, hepatitis, Syphilis
* Abnormal laboratory test results (e.g. abnormal TSH, glucose, creatinine, HIV, HBV, VDRL)
* PCOS
* Ongoing hormonal treatment-e.g. progesterone, estrogen or other
* Smoking cigarettes, alcohol, regular substance use
* Confirmed or suspected abuse of drugs
* Chronic prescription drugs
* Pre-existing diabetes or GDM in last pregnancy
Treatment of Obesity in Underserved Rural Settings (TOURS)

To test the effectiveness of interventions designed to promote long-term weight management of obese women in medically underserved rural counties.

BACKGROUND:

The recent dramatic rise in the prevalence of obesity has heightened awareness of the significant impact of overweight, physical inactivity, and unhealthy eating patterns on the development of chronic diseases and disability While there is little doubt that obesity and associated lifestyle factors (e.g., sedentary lifestyle) constitute serious threats to health, it is also clear that lifestyle interventions can produce body weight reductions of sufficient magnitude to improve health. The existing research is limited, however, with respect to two important factors, specifically, its generalizability to underserved populations, and the maintenance of treatment effects. Most weight-loss trials have consisted of efficacy studies conducted with middle-class participants and delivered in "optimal" (i.e., academic research) venues rather than in "real world" (i.e., community) settings. Furthermore, the existing literature shows that, in the absence of long-term care, a regaining of lost weight routinely follows the conclusion of treatment. Recent research has shown improved maintenance of lost weight when lifestyle interventions are supplemented with clinic-based follow-up programs. Thus, the next logical steps in this line of research are (a) to extend these studies to community settings with underserved populations and (b) to test promising alternative and potentially more efficient modes of treatment delivery, such as follow-up care via telephone-based contacts rather than via in-person clinic visits.

DESIGN NARRATIVE:

A randomized controlled clinical trial will examine the impact of two maintenance interventions designed to sustain weight lost in lifestyle treatment of obesity. The study sample will include 300 obese women, ages 50-75 years, from medically underserved rural areas in North Central Florida. All participants will receive a 6-month lifestyle intervention for weight loss (called Phase 1) followed by randomization to one of three 12-month follow-up (called Phase 2) programs: (A) a Face-to-Face Office-Based Maintenance Program, (B) a Telephone-Based Maintenance Program, or (C) an Education Comparison Condition. Participants will be stratified according to county and to BMI, and randomly assigned in groups of 11-12 to one of the two experimental programs or to the comparison condition. The experimental maintenance programs are designed to help participants sustain the eating and physical activity patterns needed to maintain lost weight. The primary difference between the two maintenance programs is their mode of delivery. One will be delivered via an office-based group counseling format; the other will be delivered via telephone counseling. The education comparison condition will involve a program of print materials on the maintenance of a healthy lifestyle delivered via biweekly newsletters.

Eligibility Criteria:
Inclusion criteria:

BMI between 30 and 45

Exclusion criteria:

presence of serious disease
The Application of Internet+ Home-based Cardiac Rehabilitation in Atrial Fibrillation Patients After RFCA

Epidemiological reports show that the incidence of atrial fibrillation continues to increase. AF is the most common arrhythmia with high mortality and disability rate. Radio frequency ablation has good therapeutic effect of AF symptoms. However, even after successful radio frequency ablation, there are still many discomforts that deserve medical attention. The benefits of cardiac rehabilitation for patients with heart disease have been recognized，but the adherence with cardiac rehabilitation is not satisfactory. Home-based rehabilitation has received increasing recognition because it has overcome many obstacles for patients to participate in cardiac rehabilitation. The application of Internet+ follow-up mode and intelligent wearable devices provide new ideas for home-based cardiac rehabilitation with the progress of information technology nowadays. This study used an experimental research design. The aim was to explore the application effects of Internet platform and wearable devices in home-based cardiac rehabilitation in patients with atrial fibrillation after radio frequency ablation. The final goal is to provide the basis for the development and application of this kind of home-based cardiac rehabilitation care in patients with atrial fibrillation after radio frequency ablation.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with atrial fibrillation and planned for treatment with radiofrequency catheter ablation (RFA) for AF;
* Patients with age from 18 to 75 years;
* Patients or primary caregiver are able to use smartphones;
* Providing oral and written informed consent.

Exclusion Criteria:

* Radiofrequency ablation was not performed for various reasons;
* patients who were unable to understand the study due to severe cognitive impairment;
* Patients with psychiatric disorders;
* Patients with serious and instable body or severe complications;
* Patients sufferring other exercise contraincations.
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects

The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
2. Be able to complete the study according to the trail protocol.
3. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
4. subjects and must be 18 to 45 years of age inclusive.
5. Body weight ≥ 45 kg(for female) or ≥ 50 kg(for male) and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive, at screening.
6. There was no clinically significant medical history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities at screening.
7. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. Use of \>5 cigarettes per day during the past 3 months.
2. Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
3. History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of \> 14 units/week).
4. Positive results from urine drug screen test.
5. Donation or loss of blood over 450 mL within 3 months prior to screening.
6. Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening.
7. Use of any prescription or non-prescription medications within 14 days prior to initial dosing
8. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
9. Subjects who participated in another clinical trial within 3 months prior to initial dosing.
10. Female subjects were lactating or had positive serum pregnancy results during the screening or testing period.
11. Subjects deemed unsuitable by the investigator for any other reason.