cyrilzakka/clinical-trials huggingface dataset:
A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients

The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together.

Patients are randomized to one of the following three regimens:

Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3: 1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for 3 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Local treatment for Kaposi's sarcoma.
* Prophylactic treatment for opportunistic infections.

Patients must have:

* HIV-1 infection.
* CD4+ lymphocyte count \>= 200 cells/microliter within 14 days prior to study drug administration.
* No active diagnosis of AIDS (other than visceral Kaposi's sarcoma) according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.

Prior Medication:

Allowed:

Local treatment for Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption.

Concurrent Medication:

Excluded:

* Medications that cannot be withheld for 48 hours (24 hours for antiretrovirals) prior to study drug administration and until 12 hours after study drug administration on each dosing day.
* Immunomodulators, such as systemic corticosteroids, interleukins and interferons.
* Cytotoxic chemotherapeutic agents.
* Acute treatment for opportunistic infections.

Concurrent Treatment:

Excluded:

Radiation therapy.

Patients with the following prior conditions are excluded:

* Documented history of alcoholism.
* History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
* History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
* Participation in another research study within the past month.

Prior Medication:

Excluded:

* Cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
* Immunomodulating agents within six weeks prior to study drug administration.
* Treatment with the following within 2 weeks prior to study drug administration:
* acyclovir, carbamazepine, chloramphenicol, ganciclovir, phenytoin, rifampin, sodium valproate, or valacyclovir.

Prior Treatment:

Excluded:

Radiation therapy within 6 weeks prior to study drug administration.

1. Regular weekly alcohol intake of more than 21 units (a unit is equal to 1/2 pint beer or 1 glass of wine or 1 oz of liquor).

* Recent change in normal pattern of alcohol usage (e.g., prolonged use followed by \> one month abstinence).
* Total abstinence from alcohol use.
* Positive breath alcohol test upon arrival at the study center prior to any dosing day.
Osteoporosis Prevention in Preadolescent Girls

This study will test an osteoporosis prevention program aimed at preadolescent girls between the ages of 10 and 12 who have not yet started their menstrual periods. Girls in this age group are adding large amounts of new bone to their skeletons. Adding more bone at this time of life can reduce a person's chances of developing osteoporosis (thinning bones) in later years.

We will look at how this osteoporosis prevention program affects the amount of calcium in the girls' diets, the amount of weight-bearing exercise they do, and their bone mass measured using ultrasound testing of the heel.

The study's objective is to demonstrate the efficacy of a behavioral/educational intervention in increasing levels of dietary calcium intake and weight-bearing exercise within an at-risk population in a stage of rapid accrual of bone mass-specifically, premenarchal girls between the ages of 10 and 12. We will use cluster randomization to randomize girls to either the intervention or a program of education only. We will randomize eighteen groups of girls into each arm of the study.

The intervention consists of six interactive sessions using various media (i.e., overhead transparencies, graphics, and three-dimensional demonstrations) to present instructional material. Topics include an explanation of osteoporosis and its modifiable and nonmodifiable risk factors, prevention of osteoporosis via healthy food choices (i.e., high calcium, low fat foods), and prevention of osteoporosis via weight-bearing exercise. Each girl monitors her own progress toward the goal of 1350 to 1500 milligrams of calcium per day. A similar method allows simple self-monitoring of weight-bearing activity. The intervention program is reinforced via monthly self-monitoring for 18 months. The education-only program consists of six generic sessions on healthy eating, physical fitness, and healthy lifestyle choices.

The primary outcomes of interest are higher calcium intake and higher levels of weight-bearing exercise. A secondary outcome of interest is increased broadband ultrasound attenuation of the os calcis, assessed using quantitative ultrasound. In summary, the group of girls targeted is ideal for this intervention because they are at a stage of rapid accrual of bone mass.

Eligibility Criteria:
Inclusion Criteria:

* 9- and 10-year-old premenarchal girls (girls who have not started their periods).

Exclusion Criteria:

* Comorbid conditions or medications that are associated with decreased bone density such as the following: corticosteroids; anticonvulsants; thiazide diuretics; history of cancer; Type I diabetes; thyrotoxicosis; hyperparathyroidism; Cushing's syndrome; juvenile rheumatoid arthritis; connective tissue disease or hemolytic anemia; asthma which may limit ability to participate in the exercise intervention; known history of dietary disorder, including anorexia, bulimia or lactose intolerance; postmenarchal.
Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response

Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT injection have suboptimal zinc concentration in their tissues, and will experience improved response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a double blind placebo controlled cross-over study, randomized order placebo and OZS, in patients at a neurology clinic on stable dose of BoNT.


Eligibility Criteria:
Inclusion Criteria:

* Patients of the PI
* Age 18-80
* Male or female
* With an approved indication for BoNT such as dystonia or hemifacial spasm
* Have received either two or three BoNT injection cycles within the prior 8 months
* Prior two injection cycles length differed by no more than 2 weeks
* Prior two injection cycles used same brand of BoNT and similar dose within 15%

Exclusion Criteria:

* Concommitant use of penicillamine or cisplatin
Cross Therapy Registry - Edema - US

The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.

The geko™ device has a wide range of clinical applications including the post-operative management of edema.

Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for edema management on patient outcomes during follow-up of up to twelve months.

As the manufacturer of the device, Firstkind Limited has an obligation to collect safety and performance data to comply with current regulations (MDR EU 2017/745 Annex XIV, Part B). Consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance.

The geko™ Cross Therapy Registry - Edema (gekoTM CTR - Edema) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. This study forms part of the overall Post-Market Clinical Follow-up strategy for the device and Post Market Surveillance (PMS) to support device and performance.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years and able to provide written informed consent.
* Intact healthy skin at the site of gekoTM device application.
* Subjects receiving gekoTM therapy as part of their standard care for edema reduction.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Use of any concurrent neuro-modulation device.
* Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
* No involuntary movement of the lower leg/foot at the maximum tolerable device setting.
* Bilateral lower limb surgical intervention.
* Unicondylar knee replacement surgical intervention.
Early Diagnosis in Glaucoma With GDxVcc

To compare the Retina Nerve Fiber Layer thickness, measured with Scanning Laser Polarimetry in subjects with exfoliation syndrome and normal controls and to evaluate the value of scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma

To compare the Scanning Laser Polarimetry findings in subjects with exfoliation syndrome and normal controls and to evaluate the value of scanning laser polarimetry in the early diagnosis and management of exfoliative glaucoma. Prospective study in progress. The investigators compare and analyze the scanning laser polarimetry parameters in consecutive subjects with exfoliation syndrome and normal intraocular pressure and compared them with consecutive normal controls. Randomly selected patients with exfoliation syndrome and normal controls undergo a comprehensive ophthalmic exam which includes 3 IOP measurements, corneal pachymetry, automated perimetry and assessment of the retina nerve fiber layer with scanning laser polarimetry. The investigators hypothesize that patients with exfoliation syndrome may show worse scanning laser polarimetry parameters than normal controls and this may prove to be an early sign of exfoliative glaucoma development. Evaluation of retina nerve fiber layer thickness may help us in identifying earlier those individuals with exfoliation syndrome that will develop exfoliative glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* Exfoliation material on pupil
* Intraocular pressure below 21 mm Hg without therapy
* No glaucomatous damage
* Age between 60-75
* Open angle

Exclusion Criteria:

* Other Ophthalmic diseases
* Dry eye
* Corneal disorders
* Diabetic Retinopathy
* Optic Neuropathy (other than glaucomatous neuropathy)
* Ocular surgery or laser
Evaluation of QTc Interval by Continuous Holter ECG Recording in Antipsychotic Drug-treated Patients With Schizophrenia

The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions


Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be males or females between 18 - 65 years of age.
2. Patient subjects will have a definite diagnosis by DSM-IV criteria, schizophrenia, schizoaffective disorder, or bipolar disorder.
3. Patient subjects are currently under treatment with any antipsychotic, any mood stabilizer, any antidepressant or any combination of the above at the therapeutic dose for at least 3 months.
4. Patients have a history of taking the medications listed in item 3 as prescribed.
5. The subjects must be able to provide written informed consent

Exclusion Criteria:

1. Subjects with a DSM-IV diagnosis of substance dependence as defined by DSMN within three months prior to selection.
2. Subjects who are currently taking other medications that have been shown to prolong the QTc, including tricyclic antidepressants (e.g. amitriptyline, imipramine, maprotiline), fluoroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol).

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Gadolinium Contrast-enhanced Abbreviated MRI (AMRI) Vs. Standard Ultrasound for Hepatocellular Carcinoma (HCC) Surveillance in Patients with Cirrhosis

This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.

Ultrasound (US) is currently used for HCC surveillance. However, US has certain limitations, so physicians use contrast CT or MRI. However, these are expensive and time-consuming procedures. We introduced an abbreviated MRI (AMRI) exam, which works well in cirrhotic and obese patients (unlike US), involves no ionizing radiation (unlike CT), and is rapid (unlike multi-phasic MRI) with total scanner times of less than ten minutes, and can be performed at about the same cost as US. This study in adult patients with cirrhosis will compare the performance of AMRI vs. US for detection of early-stage disease, and will help to define and validate a novel, rapid, accurate, and potentially cost-effective imaging protocol for HCC screening in high-risk individuals.

Eligibility Criteria:
Inclusion Criteria:

* Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.
* Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology,
* Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images.

Exclusion Criteria:

* VA patient
* \< 18 years of age
* History of any liver cancer
* MRI contraindication(s)
* Subject knows that she is pregnant or states she trying to become pregnant
* Positive urine pregnancy test in woman of childbearing potential
* Nursing mother
* Subject has known allergy to any gadolinium agent
* Does not meet UC San Diego Intravenous Contrast Media Guidelines for administration of Eovist\*
* Clinical screening exam of the liver performed at UCSD within the prior 90 days to consent
Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)

This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not.

This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy, this preconditioning is administered through repeated insufflation of an arterial pressure cuff in one of the patient arms, which in theory liberates vasoactive mediators that prevents the ischemic damage to the kidneys secondary to contrast media. All of the patients will receive endovenous normal saline to prevent nephropathy, which is a common strategy in our institution. Half of the patients will receive remote ischemic preconditioning while the other half will only receive a dummy preconditioning intended to keep the double blind strategy of the trial.

The main endpoint will be to ascertain the incidence of contrast induced nephropathy in both arms of the study, as a way to evaluate the efficacy of this strategy.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in general wards, emergency room or ambulatory consult.
* 18 years or older.
* Requires computerized tomography with endovenous contrast.
* Glomerular filtration rate between 30 - 60 mL/minute/1,73 m2.
* Patient accepts and signs informed consent.

Exclusion Criteria:

* Allergic to contrast media.
* Unable to accept or sign informed consent.
* Did not received endovenous saline before and/or after the contrast procedure.
* Peripheral arterial disease.
* Bilateral upper extremities lymph node dissection or any situation impending arterial pressure taking.
* Morbid obesity (body mass index 40 or more).
* Arterial systolic pressure greater than 175 mmHg.
"Efesovir" (FS-1) for COVID-19, Phase 2

Study of the efficacy and safety of the new drug "Efesovir" in comparison with the drug "Remdesivir" in the treatment of patients hospitalized with COVID-19.

The hypothesis of clinical study is the clinical efficacy of new drug "Efesovir" is 10% to 30% higher than of "Remdesivir".


Eligibility Criteria:
Inclusion Criteria:

* polymerase chain reaction (PCR) confirmed coronavirus infection (COVID-19) in hospitalized patients with severe risk factors in age from 18 years to 59 years, of both sexes, irrespective of national or ethnic origin
* the duration of the COVID-19 disease is no more than 10 days
* informed concent to participate in clinical trials
* informed concent to to use reliable contraceptive methods while participating in a clinical trial

Exclusion Criteria:

* age less than 18 years old and over 59 years old
* pregnancy or breastfeeding
* hypersensitivity, allergy, intolerance to iodine, iodine-containing medicines
* hypersensitivity to Remdesivir or its components
* impaired consciousness, causing the impossibility of oral administration
* conditions or circumstances that, in the opinion of the investigator, may affect the patient's safety or the quality of the results obtained
* participation in another clinical trial, including in the period up to 2 months before this study
* signs of multiple organ failure
* alanine aminotransferase (ALT), aspartate aminotransferase (AST) is 5 or more times higher than normal
* thrombocytopenia below 100 \* 10\^9/ l
* decrease in glomerular filtration rate (GFR) less than 30 ml / min by 1.73 m2
* chronic heart failure with reduced ejection fraction
* liver failure
* coagulopathy
* mechanical ventilation for 48 hours or more
* extracorporeal membrane oxygenation (ECMO)
* disseminated intravascular coagulation
Dynamic Evolution of Pulmonary Nodules and Influence Factors of Its Clinical Decision-making

The researchers are aimed to investigate the dynamic evolution of indeterminate pulmonary nodules by a long-term follow-up of patients with different characteristics. Influence factors of clinical decision-making that might contribute to overtreatment or delayed treatment will also be studied.

This observatory study prospectively recruits patients with indeterminate pulmonary nodules identified in computed tomography (CT) scans from thoracic clinic. The radiological features and their chronological changes during follow-up period will be recorded in detail. Subgroup analyses will be performed based on the clinical and demographic characteristics of patients (including symptomatic information, comorbidities, family history, antibiotic usage, etc). Hospital Anxiety and Depression Scale (HADS) is collected from each patient at multiple time points to evaluate the patients' psychological status and its impact on clinical decision-making. The interaction analyses between individual characteristics (such as education level, occupation, disease cognitive level, etc) and Hospital Anxiety and Depression Scale will also be performed. The researchers aim to provide high-quality evidence for the formulation of a precise follow-up and management plan for patients with pulmonary nodules.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with pulmonary nodules ≤ 3cm
2. Patients who provide electronic, written or oral consent to be enrolled in the follow-up cohort

Exclusion Criteria:

1. Patients with a surgical history of pulmonary nodules;
2. Patients who have obtained pathological diagnosis through surgery or non-surgical methods such as puncture;
3. Patients with pulmonary nodules that are likely metastatic from other sites;
4. Refuse to participate in this study.
Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1

The goal of this study is to assess the health literacy level of patients enrolled in the HOPE program, identify any gaps in their knowledge of hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.

The study will compare the effectiveness of providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.

Eligibility Criteria:
Inclusion Criteria

* The study will include patients with and without Hepatitis C diagnosis.
* Patients will be recruited at their routine prenatal and post-partum visits.
* Patients who speak and understand English

Exclusion Criteria:

* Patients under the age of the 18 years
ACTUAL: Efficacy and Safety of Irbesartan/Hydrochlorothiazide Combination

To compare the antihypertensive efficacy of the combination irbesartan/hydrochlorothiazide (HCTZ) using either a usual or an active elective titration regimen. The main efficacy criteria will be the change in mean Systolic Blood Pressure (SBP), measured at doctor's office with an automatic device, after a 10-week treatment period in hypertensive patients insufficiently controlled by monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Established essential hypertension treated for at least 4 weeks by one antihypertensive drug alone
* With uncontrolled Blood Pressure (BP) defined as:
* SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg in non diabetic patients
* SBP ≥ 150 mmHg and/or DBP ≥ 90 mmHg in diabetic patients

Exclusion Criteria:

* SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at V1
* Known or suspected causes of secondary hypertension
* Patient with bilateral renal artery stenosis, renal artery stenosis in a solitary kidney; history of renal transplant or only has one functioning kidney
* Associated cardiovascular conditions that prevent the patient from stopping the current antihypertensive drug (e.g.: Beta-blocker for angina, ACE-inhibitors for heart failure, etc...).
* Known hypersensitivity to diuretics or sulphonamides or history of angioedema or cough related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
* Known contraindications to the study drugs:
* Severe renal dysfunction (creatinine clearance \<30ml/min)
* Known hypokaliemia (\< 3 mmol/L) , known hypercalcemia
* Severe hepatic impairment, biliary cirrhosis, cholestasis
* Inability to obtain a valid automatic BP measurement recording
* Administration of any other investigational drug within 30 days prior to study entry and during the course of the study
* Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of the subject.
* Presence of any other conditions (e.g. geographic, social, etc) that would restrict or limit the subject participation for the duration of the study.
* Pregnant or breast-feeding women
* Women of childbearing potential not protected by effective contraceptive method of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.