cyrilzakka/clinical-trials huggingface dataset:
Finasteride 5 mg Tablets, Non-fasting

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 non-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 urine 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.
Rest/Stress Quantification Of Left Ventricular Dyssynchrony By 3D Gated Blood Pool D-SPECT

Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not clinically improve with CRT. New LVD markers other than QRS duration are needed.

Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) to quantify LVD.

Sequential 5 min Gated blood pool D-SPECT acquisition at rest and during last stage of dobutamine and atropin infusion (\>85% PHR).

Rest and stress left ventricular ejection fraction, phase standard deviation and entropy will be determined using a fully automatic commercial software (QBS, Cedars-Sinai, Los Angeles, CA).

Eligibility Criteria:
Inclusion Criteria:

Chronic heart failure with LVEF \< 35 %, QRS \> 120 ms, NYHA III/IV, optimal medical therapy for more than one month.

* Patient with stable hemodynamic for more than one month,
* More than 18-year old man or woman,
* Patient having given his free, inform and signed consent,
* Patient place setting by the social security system,

Exclusion Criteria:

* Psychiatric disorder
* Any contra-indication to Technetium,
* Any contra-indication to dobutamin or atropin
* Personal or family history of sudden death
* Previous severe ventricular arrhythmia
* Obstructive cardiomyopathy, severe aortic stenosis,
* Pulmonary hypertension,
* History of renal, lung, hepatic, cardiac transplantation,
* Pregnant or breast-feeding Woman,
* Patient who can not conform to the requirements of the protocol,
* Patient included in another medical study,
PRIMM Trial (Phone Reminder for IMMunization)

The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a customized automated telephone and email immunization reminder system will be feasible, acceptable, and significantly improve immunization utilization rates.

Background: Worldwide, vaccine preventable diseases account for 29% of all deaths between 1 month and 5 years, underscoring the importance of immunizations. In Nigeria, routine childhood immunization rates are unacceptably inconsistent and low, ranging from 35-85% at 14 weeks and 10-37% for all routine immunizations at 12-24 months.

GAP: The feasibility, acceptability and utility of an automated phone immunization reminder system have never been explored in this rural setting of Nigeria.

HYPOTHESIS: Given \~90% of the adult population in Nigeria uses a mobile phone, a customized mHealth immunization reminder system will be feasible and acceptable; and will significantly improve immunization rates in this rural setting of Ondo State, Nigeria.

METHODS: A prospective randomized controlled trial study design will be utilized. This study will recruit parents of healthy newborn infants delivered at Mother and Child Hospital Ondo, who live in Akure or Ondo Town and plan to receive their immunizations at Mother and Child Hospital Ondo.

DATA ANALYSIS: The proportion of immunization visits between intervention and control groups will be compared using a two-sided, two sample test of proportions with p \<0.05 being significant. Secondary analysis will focus on the predictive value of social demographic variables on immunization rates.

Eligibility Criteria:
Inclusion Criteria:

1. Parents of healthy infants who have a cellular phone
2. Born at Mother and Child Hospital Ondo (Akure or Ondo Town)
3. Plans to receive immunizations at Mother and Child Hospital Ondo

Exclusion Criteria:

1. Parents of infants requiring hospital admission due to illness or prematurity.
2. Parents without a cellular phone
The Effect of Snack Consumption on Energy Intake in Preschoolers

The purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee.

Providing snacks to children is widely recommended for appetite regulation and assisting with meeting nutritional guidelines.1 Currently, snacks contribute a larger portion of dietary intake in children than in previous years.2,3 Additionally, observational research has found that self-reported, low-nutrient-dense snack consumption, has increased among preschoolers (ages 2-to-6 years) over the past 20 years, leading to an increase of total daily energy intake.3 However, no experimental studies examining the influence of snack intake on energy consumption in children have been conducted.2 Therefore, at this time it is not clear how snacks impact appetite regulation or energy intake, especially in young children.

Thus, the purpose of this pilot study will be to examine the influence of providing snacks on consumption of overall energy intake in children aged 2-5 years in the Early Learning Center (ELC) at the University of Tennessee. Children will be provided with 3-to-5 ad libitum eating occasions over the course of a day for three sessions. To test the effects of providing snacks to preschoolers on consumption of food throughout the day, the food will be provided in three ways in the three different sessions: 1) children will be provided three meals (TM); 2) children will be provided three meals and two snacks, with total amount of food provided in the day the same as TM (M+S); and 3) children will be provided three meals and two snacks with total amount provided in the meals equal to TM and total amount provided in the snacks equal to M+S (TM+S).

Primary Hypothesis:

1) Energy consumed from food and beverages will be greatest during the TM+S session, followed by M+S, and then TM.

Eligibility Criteria:
Inclusion Criteria:

* 3 -to- 5 years of age
* enrolled at the Early Learning Center for the full day program
* have guardian consent to participate
* like the foods served

Exclusion Criteria:

* have allergies or intolerances to the foods being served
* not able to use a spoon
* did not attend all feeding sessions
Effects of tDCS on Quadriceps Strength After Stroke

Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.

We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.


Eligibility Criteria:
Inclusion Criteria:

* written consent
* hemiparetic patient after stroke in chronic phase (\> 6 months)
* capacity to walk with or without technical assistance
* following rehabilitation program for lower limbs

Exclusion Criteria:

* patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia
* previous orthopedic surgery in paretic lower limb (\<6 moths)
* usual tDCS contraindications
* pregnant woman
The Impact of 24/7-phone Support on Readmission After Aortic Valve Replacement, a Randomized Clinical Trial

Aortic Valve Replacement (AVR) surgery for aortic valve disease continues to increase in numbers. With better surgical techniques and equipment, also older patients can be operated on, resulting in an growth of the older population. AVR is characterized by high rates of hospital readmissions, resulting in suboptimal care planning and higher health care costs. Hence, it is important to develop strategies to reduce hospital readmissions following AVR. The purpose if this study is to develop and test the efficacy of a 24/7-phone support in the reduction of readmissions after AVR treatment. Secondary outcomes are a reduced level of anxiety, less depressive symptoms and a better health related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with AVR (biological or mechanical) single, AVR (b or m)+aortocoronary bypass, AVR (b or m)+supra coronary tube graft
* Can understand, speak and write native Language (norwegian), and be able to fill in the questionnaires
* Can be contacted by phone after discharge from hospital

Exclusion criteria:

* Patients who have been admitted to intensive care for more than 24 hours
* Patients who have complications related to surgery e.g. cerebral insult with significant impact on cognitive functions after surgery
Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. The patients will receive treatment for 12 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female subjects (aged 18 or older)
2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by the treating physician to require additional intraocular pressure (IOP)-lowering treatment with netarsudil 0.02%.
3. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests

Key Exclusion Criteria:

1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and not using a medically acceptable form of birth control. Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use an effective method of birth control during the treatment period and for 3 months after the subject has completed the study.
3. Known sensitivity or allergy to the study medication or components
4. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
5. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit
A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor

The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.


Eligibility Criteria:
Inclusion Criteria:

1. Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel.
2. Prior systemic radiation therapy must be completed at least 4 weeks before the first dose of study drug.
3. Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.
4. Adult age(as defined by respective country)
5. The nature of the study and voluntarily sign an ICF
6. ECOG 0 or1
7. Adequate hematologic function, hepatic function, and renal function

Exclusion Criteria:

1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody
2. Known presence of symptomatic CNS metastases
3. Any active autoimmune disease or a documented history of autoimmune disease
4. Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
5. Pregnant or lactating
Positive Discipline in Parent Training

The aim of this study was to examine the effectiveness of a Positive Discipline Program applied to the parents of preschool children. Accordingly, the tertiary aims of this study included determining the effects of a positive discipline program on the child upbringing attitudes of parents with preschool children, their perceptions regarding each other's child upbringing attitudes, and the communication between preschool children and their parents.

This randomized controlled experimental study included pretest, posttest, and monitoring test applications with an intervention group, an active control group, and a no-contact control group. The study was conducted between May 2020 and June 2022. The universe of the study consisted of 653 parents with preschool (ages 3-6) children registered to the Izmir Bornova Şükrü Ergil Family Health Center No:9. Sample size was calculated using power analysis and assigned randomly to the intervention, active control, and no-contact control groups in groups of 24 (n=72). The intervention group was provided with 8 weekly sessions of a 90 minutes positive discipline program while the active control group was provided with 8 weekly 90 minute sessions of free interaction. No intervention was performed with the no-contact control group. Data collection was performed using a Personal Information Form, Parental Attitude Scale (PAS), Assessment of Parenting Attitudes of Couples Scale (APACS) and the Parent Child Communication Scale (PCCS).

Eligibility Criteria:
Inclusion Criteria:

* Registered at Şükrü Ergil Family Health Center No. 9 in Bornova,
* Agreeing to participate in the research,
* Having children between the ages of 3-6,
* Parents have not participated in any parent education program before,
* Having the cognitive ability to receive education,
* Able to read and write,
* Having no problems in hearing, seeing and understanding,
* Will be able to participate in at least 7 sessions of the positive discipline program and active control group,
* Capable of using an online program (because it is made online).

Exclusion Criteria:

* Failure to attend at most one of the positive training program and active control group sessions,
* Parent's request to withdraw at any stage of the trial.
Study of BD Pre-filled Flush Syringes in China

This study is to compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by Suzhou Becton Dickinson Medical Devices Co., Ltd.) for locking and flushing the end of catheter line in Chinese popluation.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age \>or equal to 18, no limitation on gender; 2. Hospitalized patients; 3. Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC)); 4. Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form.

Exclusion Criteria:

* 1. Patient reports pregnancy or lactation (self-report); 2. Subjects who are known to have blockage or recanalization of vascular access prior to this trial.

  3. Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial.

  4. Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.
Acute Microbial Switch

In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo

Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.

In this project the investigators aim to test whether it is possible to precisely measure the changes in fermentation gas patterns after supplementation of a complex fibre mixture over a 36-hour period in both lean normoglycemic and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo. Additionally, the investigators will investigate whether changes in fermentation patterns will be directly related to changes in carbohydrate and fat oxidation and to microbial composition or related metabolites and hormones in blood, faeces, and urine.

Eligibility Criteria:
Inclusion Criteria:

* Lean normoglycemic individuals:
* Lean (BMI ≥ 18.5 kg/m2 and ≤ 24.9 kg/m2 );
* Normal fasting glucose (plasma glucose \< 5.6 mmol/L) and a HOMA-IR\< 2.2

Individuals with overweight/obesity and prediabetes/insulin resistance:

* Overweight/obesity (BMI ≥ 28 kg/m2 and ≤ 40 kg/m2 );
* insulin resistance (HOMA-IR\>2.2) and/or impaired fasting glucose (IFG: plasma glucose ≥ 5.6 mmol/l)

For both subject groups:

* Aged 30 - 75 years;
* Normal blood pressure (systolic blood pressure 100-150mmHg, diastolic blood pressure 60-100 mmHg);
* Weight stable for at least 3 months (± 2 kg)

Exclusion Criteria:

* T2DM (defined as fasting plasma glucose ≥ 7.0 mmol/L)
* Gastroenterological diseases
* Abdominal surgery affecting the GI tract;
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than five years;
* Abuse of products;

  * Alcohol (\> 15 standard units per week)
  * Drugs
  * Excessive nicotine use defined as \>20 cigarettes per day;
* Plans to lose weight or following of a hypocaloric diet
* Regular supplementation of pre- or probiotic products, use of pre- or probiotics three months prior to the start of the study;
* Intensive exercise training more than three hours a week;
* Use of most medications that influence glucose or fat metabolism, like some lipid lowering-drugs (e.g., PPAR γ or PPARα (fibrates) agonists), glucose-lowering agents (including all sulfonylureas, biguanides, α-glucosidase inhibitors, thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g., anti-inflammatory\* or immunosuppressive drugs) and anti-oxidants;
* Regular use of laxatives;
* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
* Veganism
* Lactose intolerance
* For women: pregnancy or lactation
Aczone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Aczone 5% Gel

This pilot study will explore if continuation of treatment of treatment with Aczone 5% gel following combination treatment with with doxycycline and Aczone 5% gel can maintain therapeutic response.

This is a two-center, open-label pilot study. The study is apprised of 7 study visits: Baseline and Weeks 4, 8, 12, 16, 20 and 24. All subjects will receive Aczone 5% gel BID and doxycycline 100mg by mouth once daily at Baseline. Those subjects achieving treatment response (i.e., IGA of 0, 1 or 2) at Week 12 will continue treatment with Aczone 5% gel BID at Week 12. Subjects not achieving treatment response will discontinue study participation.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient, male or female subjects of any race, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
* Facial acne vulgaris characterized by the following:

IGA Score \>3 10-50 facial inflammatory lesions (papules,pustules) 10-100 facial non-inflammatory lesions (open/closed comedones)

* Able to understand and comply with the requirements of the study and sign Informed Consent/HIPAA Authorization forms

Exclusion Criteria:

* Female subjects who are pregnant (positive urine pregnancy test), breast feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
* Allergy/sensitivity to any component of the test treatment (Section 5.2), lincomycin, tetracyclines, or sulfites.
* Subjects who have not complied with the proper wash-out periods for prohibited medications/procedures (Supplement 1)\>
* History of clinically significant anemia or hemolysis.
* History of enteritis (regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis).
* Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
* Evidence of recent alcohol or drug abuse
* Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
* History of poor cooperation, non-compliance with medical treatment or unreliability
* Participation in an investigational drug study within 30 days of the baseline visit.