cyrilzakka/clinical-trials huggingface dataset:
Finasteride 5 mg Tablets Under Fasting Conditions

The objective of this study is to compare the relative bioavailability of finasteride 5 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* All subjects selected for this study will be male non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.
* Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.

Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.

Clinical laboratory measurements will include the following:

* Hematology: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count (with differential).
* Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.
* Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
* HIV Screen: pre-study
* Hepatitis B, C Screen: pre-study
* Drugs of Abuse Screen: pre-study and at each check-in Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.

Exclusion Criteria:

* Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range on retesting, the subject will not be significant.
* Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each study period check-in. subjects found to have urin concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is require.
* Females will not be eligible to participate in the study.
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)

To evaluate the effect of Mucomyst nebulizer therapy on improvement in symptoms and quality of life in COPD patients with difficulty of expectoration.

In this non-interventional observational study, treatment for individual subjects is determined by the investigator according to the status of individual subjects in routine clinical practice. In this circumstance, doses for each drug product will not be specified in the protocol but will be determined as appropriate by the investigator with the product label and the subject's medical condition taken into consideration.

Primary objective To evaluate the effect of Mucomyst on improvement in difficulty of expectoration symptoms in COPD patients with difficulty of expectoration.

Secondary objective To evaluate the effect of Mucomyst on improvement in quality of life and safety in COPD patients with difficulty of expectoration.

Eligibility Criteria:
Inclusion Criteria:

1. man and woman at the age of ≥40 years old
2. Diagnosed with COPD within the past 1 year based on pulmonary function test (post bronchodilator FEV1/FVC\<0.7)
3. COPD Assessment Test (CAT) phlegm score ≥2
4. Smoking history ≥10 pack-years\* (\*Pack-year: number of packs of cigarettes smoked per day X number of years the individual has smoked)
5. Patient who is to be treated with Mucomyst nebulizer therapy to alleviate difficulty of expectoration symptoms
6. Voluntary written informed consent to study participation and to use of personal information for this study

Exclusion criteria

1. History of hypersensitivity reactions to any of the components of NAC or contraindicated to NAC therapy according to the product label
2. Treated with Mucomyst within the past 4 weeks
3. Newly treated with 'drugs for the alleviation of expectoration symptoms (antitussives/expectorants)' or dose changed for ongoing therapy within the past 4 weeks
4. Pregnant and lactating woman
5. Participating in another trial with investigational product treatment at the time of enrollment to the present study
6. Ineligible for study participation in the opinion of the investigator
Efficacy and Safety of Add-on Therapy With DLBS3233 in Patients With Type-2 Diabetes Mellitus

This is an open clinical study for 12 weeks of therapy to investigate clinical efficacy and safety of an add-on therapy with DLBS3233 in improving blood glucose control, lipid profile, and adiponectin in subjects with type-2 diabetes mellitus.

There will only be one group in this study who will receive study treatment as follows: anti-diabetic agents currently used by respective subjects for at least 3 months prior to Screening, treatment intensification (lifestyle modification), and DLBS3233 at a dose of 100 mg once daily for 12 weeks.

Clinical and laboratory examinations to evaluate the investigational drug's efficacy and safety will be performed at baseline and at interval of 6 weeks over the 12-week course of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects with age of 40 - 70 years; or female subjects with age of 55 - 70 years (post-menopause) at screening
* Diagnosed with type-2 diabetes mellitus
* Have been being treated with a combination of two OHA for at least 3 months prior to screening
* A1c level of \>= 7.0 %
* Hemoglobin level of \>= 10 g/dL
* Body Mass Index (BMI) \> 18.5 kg/m2
* Refuse insulin therapy
* Able to take oral medicine

Exclusion Criteria:

* Subjects with symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Uncontrolled hypertension defined as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg
* History of or current chronic treatment with insulin
* History of renal and/or liver disease
* Impaired liver function: serum ALT \> 2.5 times upper limit of normal and positive result of chronic or acute hepatitis B or C test
* Impaired renal function: serum creatinine \>= 1.5 times upper limit of normal
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* Any other disease state or uncontrolled illness, which judged by the investigator, could interfere with trial participation or trial evaluation
* Participation in any other clinical studies within 30 days prior to screening
Clinical Equivalency Validation Protocol Clinical Equivalency Eyenez Retina Camera v200 and Optomed Smartscope M5 EY3

This prospective equivalency study compares the performance of two Ophthalmic Cameras, the Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. The study includes healthy patients and patients with a spectrum of retinal diseases. The study requires that technicians take pictures of the retinas of adult patients between 18 and 80 years of age using both the OC and OP. The pictures will be reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is equivalent to the OP, based on the quality of the images

Subjects (patients) will be recruited via word of mouth.

The study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15 subjects per week. The images will be recorded within 15 minutes and will involve minimal disruption to the clinical workflow.

In the Study Environment setting (Foothill Medical Offices), the User Interface will be evaluated by comparing retinal pictures taken with subject device OC and predicate device OP.

Patient subjects will be given an Information and Consent Form to complete prior to the study

The technicians employed by Foothill Eye Clinic will operate the device on patient participants by taking a retinal picture using OC.

The technicians will use the predicate device OP to take retinal pictures.

The Ophthalmologist will compare the results with the pictures taken by OC and OP. The Ophthalmologist will be blinded to what picture was taken by which camera and record his assessment of the quality for each picture.

Patient subjects will receive a standard of care exam with or without dilation.

Eligibility Criteria:
Healthy subjects Inclusion Criteria:

* Written Informed Consent
* Male or female
* Age ≥ 18 years and ≤80 years
* Normal Retina

Healthy subjects Exclusion Criteria:

* Glaucoma
* Limited Ability for Agreement
* Spectrum of retinal diseases
* Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit

Diseased subjects Inclusion Criteria:

* Written Informed Consent
* Male or female
* Age ≥ 18 years and ≤80 years
* Spectrum of retinal diseases

Diseased subjects Exclusion Criteria:

* Normal Retina
* Limited Ability for Agreement
* Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit
Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population

Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot study performed at our department showed a correlation between weight and plasma concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old. Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary concentration testing will be evaluated


Eligibility Criteria:
Inclusion Criteria:

* Children with an uro- and/or nephropathy who need an urinary concentration test OR Children with monosymptomatic nocturnal enuresis (based on nocturnal polyuria) with treatment failure on desmopressin tablet
* Otherwise healthy children (on medical history and physical examination)
* Parents or legal guardian of the child signed the informed consent form
* Age: between 6 months and 8 years
* Minimum weight: 8 kg

Exclusion Criteria:

* Diabetes insipidus
* Renal failure (eGFR\<60ml/min/1,73m²)
* Current urinary tract infection
* Syndrome of inappropriate antidiuretic hormone secretion
* Heart failure
* Clinical significant medical conditions (renal, hepatic, gastro-intestinal, pulmonary, cardiac, endocrinologic) that might interfere with the clinical endpoints
* Sensitivity to desmopressin or excipients of the oral lyophilisate formulation
* Use of antibiotics, diuretics or other drugs that can influence diuresis (tricyclic antidepressants, chlorpropamide, oxcarbazepine, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine).
* Use of drugs that influence intestinal motility (such as loperamide)
* Anomalies of the mouth that might interfere with the intake / absorption of the medication
Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy

This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.

Eligibility Criteria:
Inclusion Criteria:

ACC patients who underwent early LC

Exclusion Criteria:

Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.
Effect of Prebiotic or Synbiotic on Inflammatory Response and Indicators of Nutritional Status in Obesity

The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. Study hypothesis: Supplementation of 12 g/day of fructooligosaccharides (prebiotic) or 12 g/day of fructooligosaccharides + strains of lactobacilli and bifidobacteria (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with BMI ≥ 40kg/m².

The purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. Adult individuals of both sexes with morbid obesity (body mass index ≥ 40 kg/m²) will be invited to participate in this randomized, placebo-controlled, triple-blind study. The participants will be divided into three groups: G1 - control group (placebo), G2 - prebiotic group and G3 - synbiotic group. The study will consist of four experimental time points: M0 - baseline and start of supplementation; M1 - after fifteen days of the first outpatient visit and fifteen days after the start of supplementation with prebiotic, synbiotic or placebo; M2 - after thirty days from the first outpatient visit and end of supplementation with prebiotic, synbiotic and placebo; and M3 - time after sixty days from the first outpatient visit. At all time points the inflammatory response will be assessed by determination of plasma cytokines (IL-1, IL-6, IL-10, TNF) and acute phase proteins (c-reactive protein and albumin), besides the evaluation of laboratory and anthropometric indicators of nutritional status. The primary endpoint will be the reduction in concentrations of inflammatory markers (cytokines and acute phase proteins).

Investigators expect to contribute with new information in this field of knowledge, which may facilitate the clinical application of these results.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years and less than 60 years
* Body mass index (BMI)≥40kg/m2

Exclusion Criteria:

* Previous gastrointestinal diseases (e.g. cancer and inflammatory bowel disease)
* Intolerances and/or food allergies (e.g. lactose intolerance and celiac disease)
* Current use of anti-inflammatory drugs and/or antibiotics and/or immunosuppressants
* Regular use of laxatives and/or appetite suppressants
* Current or previous use (up to one month) of prebiotics, probiotics, synbiotics or products enriched with these food compounds
* Intolerance to prebiotic and/or probiotic and/or synbiotic
* Following a diet for weight loss in the last three months
* Pregnant or breastfeeding
* Following unusual diets (e.g. vegetarian, macrobiotic)
* Alcohol dependence and/or illicit drugs dependence
* Smokers
Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation

The aim of this study is to evaluate whether Dabigatran itself reduces ADP induced platelet aggregation measured by MEA as compared to Phenprocoumon after a two-week treatment with either agent.

Oral anticoagulation with vitamin K antagonists (OAC) is the standard care for reducing stroke in patients with atrial fibrillation. Just recently the direct, competitive thrombin inhibitor dabigatran has been approved by the FDA for stroke prevention in patients with atrial fibrillation. In a large multicenter trial it was shown that dabigatran was at least as effective as Vitamin K antagonists in the prevention of stroke without an increase of major hemorrhage.

Approximately 6 % of patients who undergo coronary stenting and need DAT with aspirin and clopidogrel need in addition OAC for the reduction of cardiac, cerebral and systemic thromboembolic events. These patients will therefore need triple therapy, a therapy which is associated with increased bleeding complications. Although phenprocoumon given solely without clopidogrel has no impact on ADP induced platelet aggregation, it has been shown that phenprocoumon significantly attenuates the antiplatelet effects of clopidogrel.

ADP induced platelet aggregation measured with multiple electrode platelet aggregometry (MEA) is a marker for the efficacy of the clopidogrel therapy and (i) a low response (AUC ≥ 468) to clopidogrel has been associated with an increase of ischemic events such as stent thrombosis and (ii) patients with an enhanced response to clopidogrel (AUC ≤ 188) have higher bleeding rates.

It is therefore crucial to evaluate whether an additional antithrombotic therapy such as dabigatran alters ADP induced platelet aggregation in these patients. While it has been shown that intravenous administration of the direct thrombin inhibitor bivalirudin further reduces ADP induced platelet aggregation in patients on clopidogrel therapy, it is unknown whether dabigatran has also an impact on ADP induced platelet aggregation.

To evaluate the impact of dabigatran on ADP induced platelet aggregation we will randomize patients with atrial fibrillation and the need for oral anticoagulation for a two-week treatment with either dabigatran or phenprocoumon and we hypothesize that dabigatran is superior to phenprocoumon in the reduction of ADP induced platelet aggregation. Patients who are concomitantly treated with clopidogrel are being studied in a different trial with a similar study design (Dabi ADP-2).

Eligibility Criteria:
Key Inclusion Criteria:

* Patients with atrial fibrillation and an indication for oral anticoagulation (CHA2DS2-VASc score≥ 1).
* Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

Key Exclusion Criteria:

* Age ≤18 years
* Cardiogenic shock
* Current therapy with dabigatran
* Current, recent (2 weeks) or expected (1 week) clopidogrel therapy
* Contraindication for oral anticoagulation
* Active bleeding
* Known allergy or intolerance to the study medications: dabigatran, phenprocoumon
89Zr-DFO-girentuximab Expanded Access Program (EAP)

The purpose of this Expanded Access Program (EAP) is to enable the use of 89Zr-DFO-girentuximab with positron emission tomography/computed tomography (PET/CT) imaging to non-invasively detect carbonic anhydrase 9 (CAIX)-expressing clear cell renal cell carcinoma (ccRCC) in patients with renal masses as determined by conventional imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Written and voluntarily given informed consent.
2. Male or female ≥ 18 years of age.
3. Imaging evidence of renal mass(es) obtained from conventional diagnostic imaging with CT or MRI (without and with contrast enhancement) based on national standards that is not older than 90 days on Day 0, and that was performed before any screening procedure.
4. Negative urine/serum pregnancy tests in female patients of childbearing potential.
5. Consent to practice highly effective contraception until a minimum of 42 days after IV 89Zr-DFO-girentuximab administration.

Exclusion Criteria:

1. Renal mass known to be a metastasis of another primary tumor.
2. Active non-renal malignancy requiring therapy during and up to EOT visit.
3. Radiotherapy or immunotherapy within 4 weeks (28 days) prior to the planned administration of 89Zr-DFO-girentuximab or continuing adverse effects (\> grade 1 using Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) from such therapy.
4. Planned antineoplastic therapies (for the period between IV administration of 89Zr-DFO-girentuximab and imaging).
5. Previous administration of any radionuclide within 10 of its half-lives before Day 0.
6. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator.
7. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
8. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-DFO-girentuximab.
9. Women who are pregnant or breastfeeding.
10. Known hypersensitivity to girentuximab or DFO (desferoxamine).
Cardboard Cot in Neonatal Thermoregulation: A Randomized Cross Over Trial

This study will determine whether the efficacy of Mylar-lined cardboard cots is equivalent to traditional incubators in their ability to prevent hypothermia (axillary temperature \< 36° C) in preterm neonates \<36 6/7 weeks gestational age in a randomized cross-over designed trial. Infants will be randomized to receive care in the cardboard cot or incubator and then cross over to the other device for 24 hour periods, rotating for a total of 96 hours total trial time.

The aim of the trial is to determine whether a corrugated cardboard cot will assist in maintaining infant axillary temperatures comparing it to the temperatures of the same infant being nursed in low heat incubators. The study will be done in the context of standard medical care, including the WHO thermoregulation protocol (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling).

The cardboard cot is approximately 24 inches long to accommodate the length of the infant and about 12 inches wide to accommodate term infants, even beyond the first months after birth. The cots are fully lined with a reflective metallized film sheet of Mylar. The cot will be covered with a cardboard piece also lined in reflective film up to about the infant's shoulders so that the infant's face is visible. Attached to the lid is a 5 inch cardboard flap lined with reflective film which folds down into the body of the cot to reduce heat loss.

Infants ≤ 36 6/7 weeks gestation will be randomized to receive care in a cardboard cot or an incubator. Infants will begin care in one device and after 24 hours will cross over to the other device for another 24 hours. The process will be repeated once more for a total of 96 hours of study duration. The infants will be normothermic and stable when they are enrolled in the trial. Axillary temperatures will be measured at 1 hr, 6 hours and 24 hours after being placed in the cost or incubator. Infants with observed hypothermia (\<36° C) will have measures taken to increase temperature (i.e. adding blankets, hat).

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age \< 36 6/7 weeks
* Hospitalized in the NICU at University Teaching Hospital in Zambia
* Requiring incubator/radiant warmer for at least 1 week

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
* Suspected Sepsis
* Requiring ongoing respiratory support