cyrilzakka/clinical-trials huggingface dataset:
Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study

Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10.

The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.

Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Studies performed on American and Chinese populations have shown positive results. These studies need confirmation in different populations. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10. The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\>18 years)
* Indication to mild or moderate statin based on AHA 2013 guidelines
* Treatment naïve

Exclusion Criteria:

* Allergy to rice
* Renal or hepatic terminal disease
* Any contra indication to statin treatment
* Pregnancy wish during study period
* Familial hypercholesterolemia
Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia

The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH.

The secondary objective is to assess the safety of SL77.0499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride.


Eligibility Criteria:
Inclusion Criteria:

* Japanese;
* Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months;
* Suffering for at least 6 months from lower urinary tract symptoms related to BPH.

Exclusion Criteria:

* Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment;
* Inpatient;
* Patients having participated in a clinical trial within the previous 6-month;
* Patients previously treated with SL77.0499-10;
* Patients whose I-PSS total score do not meet ≥ 13;
* Patients whose urinary peak flow rate (PFR) do not meet 5.0-12.0mL/s for a voided volume of at least 150mL;
* Patients whose residual urine are \> 200mL;

The investigator will evaluate whether there are other reasons why a patient may not participate.
Periodontal Disease as a Risk Indicator for Erectile Dysfunction - A Cross-sectional Study on 100 Patients

Background Increased levels of C reactive protein (CRP) can be found not only within individuals with periodontal diseases and those with atherosclerotic alterations but also have been proved in men with erectile dysfunction (ED). NO seems to be the key mediator in the endothelial-derived vasodilation and penile erection.

The incidence of ED increases in patients with diabetes, hypertonia, hypercholesteremia, cardiovascular diseases and renal failure. First evidence suggests that there is a relationship between periodontal disease and ED as well. Due to slow progression of chronic periodontal disease (0.3-0.5mm attachment loss/year) it can be assumed, that periodontal disease exists mainly before ED develops.

Specific Aims This cross-sectional study aims to assess the incidence of periodontal disease in male individuals with ED. A possible correlation between severity of periodontal disease, level of systemic hs-CRP and ED will be assessed. Additionally, further risk factors for endothelial dysfunction, such lipid values, will be determined and regarded in the analysis.

Hypothesis The investigators assume, that severity of ED correlates with severity of periodontal disease as well as with systemic involvement assessed by CRP-levels. In detail, the investigators hypothesize, that severity of ED (assessed by the questionnaire "International Index of Erectile Function") correlates with the mean probing depth and the level of systemic hs-CRP.

Material and Methods

1. st appointment: In the present cross-sectional study 100 male patients with ED will be included. Patients who visit the urological department (Rudolfstiftung) for ED-treatment will be asked to participate. The erectile dysfunction will be assessed by means of a questionnaire (International Index of Erectile Function - IIEF-5). Urologic examination. The following blood parameters will be assessed: testosterone, prolactin, hs-CRP, tumor necrosis factor (TNF)-alpha, Interleukin-1, total cholesterol, LDL, HDL, HbA1c and fasting glucose.
2. nd appointment: At the department of Oral Surgery (Bernhard Gottlieb School of Dentistry) the periodontal situation and the index of decayed-missing-filled permanent teeth (DMFT) index of the patients will be determined. A panoramic radiograph for assessment of alveolar bone loss and a periodontal status (probing depth, recession, bleeding- and plaque-indices) will be performed. The observer at the dental clinic will have no information on the severity of the ED (observer blinded).


Eligibility Criteria:
Inclusion criteria:

* male patients with ED defined by an IIEF-5 score of ≤ 21
* age between 18-45a

Exclusion criteria:

* systemic diseases (e.g. diabetes mellitus, heart disease, hypertension, neurological disorders etc.)
* pure psychogenic (non-organic) ED with good spontaneous / nightly erections
* periodontal treatment within the last 3 months
* antibiotic intake within the last 3 months
An Exercise Intervention to Prevent Gestational Diabetes

Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the United States. GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes and thus provides an excellent opportunity to intervene years before the development of this disorder. It is well recognized that acute as well as chronic physical activity reduce fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. Recent studies have suggested that women with higher levels of physical activity have reduced risk of GDM. Therefore, we will test the hypothesis that an exercise intervention is an effective tool for preventing GDM among women with a history of GDM.

The primary goals of the application are to investigate the effects of a motivationally-tailored, individually targeted 12-wk physical activity intervention on 1) risk of GDM in women at high risk of the condition, 2) serum biomarkers associated with insulin resistance, 3) and the adoption and maintenance of exercise during pregnancy. Secondary goals are to investigate the impact of the intervention on gestational weight gain and selected birth outcomes. The overall goal of the intervention is to encourage pregnant women to achieve the American College of Obstetricians and Gynecologists (ACOG) Guidelines for physical activity during pregnancy (30 minutes or more of moderate- intensity activity on most days of the week) through increasing walking and developing a more active lifestyle. The intervention draws from the theory of Stages of Motivational Readiness for Change and Social Cognitive Theory constructs for physical activity behavior and will take into account the specific social, cultural, economic, and physical environmental challenges faced by women of diverse socioeconomic and ethnic backgrounds. The application is innovative in being the first, to our knowledge, to test a physical activity intervention designed to prevent GDM among high risk women. The intervention protocol can readily be translated into clinical practice in underserved and minority populations.

Eligibility Criteria:
Inclusion Criteria:

* history of gestational diabetes or overweight (\>25 kg/m2) with family history of type 2 diabetes
* sedentary

Exclusion Criteria:

* history of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
* current medications which adversely influence glucose tolerance
* not planning to continue the pregnancy to term
* \>16 weeks gestation
* contraindications to participating in moderate physical activity
* inability to read English at a 6th grade level
* self-reported participation in \>30 min of moderate or vigorous-intensity exercise on \>3 days/wk
* prior participation in the study
* non-singleton pregnancy
Dimethyldiguanide Combined With Aromatase Inhibitor (AI) in Metastatic Breast Cancer

The addition of dimethyldiguanide might increase the efficacy of AI treatment in metastatic breast cancer.

The addition of dimethyldiguanide might increase the efficacy of AI in patients with metastatic breast cancer after the failure of the first line endocrine therapy.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal HR positive breast cancer patients;
* inoperable locally advanced or metastatic breast cancer patients;
* candidate for endocrine therapy;
* ECOG equal to or less than 1;
* adequate bone marrow function(Hb\>=90g/L, WBC \>=3.5×10\^9/L,ANC\>=1.5×10\^9/L, PLT\>=80×10\^9/L; adequate renal function(Ccr\<=ULN);adequate liver function(ALT,AST,AKP\<=2.5\*ULN,or \<=5\*ULN if liver metastases)
* life expectancy \>=12weeks;
* no severe history disease of liver,heart,lung or kidney;
* written informed consent form;

Exclusion Criteria:

* Her-2 overexpression;
* patients who has visceral endocrisis；
Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers

This 18-week, randomized, double blind clinical trial provided treatment for 160 cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM maintenance during the first 4 weeks and cocaine use was assessed; participants were then stratified by level of cocaine use and randomly assigned to receive one of the following: placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or disulfiram at 250 mg/day. During induction onto LAAM, participants were administered increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus disulfiram or placebo disulfiram according to their randomized assignments, and were maintained on these agents through week 16. At the end of the study, participants underwent detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who received ongoing supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes included reductions in other illicit drug and alcohol use, as well as improvements in psychosocial functioning.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65 years.
* Are not currently enrolled in treatment.
* Participants must demonstrate opioid dependence, as evidenced by documentation of prior opioid agonist maintenance and/or have signs of withdrawal upon administration of naloxone (\<0.8 mg, i.m.), and an opioid-positive urine screen.
* Participants also must be current users of cocaine with self-reported use of \> 7 gm during the preceding 12 months, self-reported use of \> 1 time/week in at least one month preceding study entry, and cocaine-positive urine screen.
* Participants must fulfill DSM-IV criteria for opioid and cocaine dependence.

Exclusion Criteria:

* current diagnosis of other drug or alcohol physical dependence (other than opiates, cocaine or tobacco)
* significant medical conditions such as abnormal liver function (with laboratory findings greater than three times normal).
* active hepatitis; hypertension; a current cardiac condition or high risk of cardiovascular disease; seizure disorders; or another significant underlying medical condition which would contraindicate disulfiram or LAAM treatment.
* meets DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders; exhibiting current suicidality or homicidality; current use of a prescribed psychotropic medication that cannot be discontinued.
* pregnancy.
Comparison of Biodegradable Polymer vs Durable-polymer in Diabetic Patients

Both biodegradable polymer-based biolimus-eluting stents (BP-BES) and durable polymer-based everolimus-eluting stents (DP-EES) have been shown to improve long-term clinical outcomes as compared with early generation DES. BP-BES with DP-EES have been directly compared in 2 randomized trials, showing no differences between the two devices in all-comer patients during long-term follow-up. It is unknown whether these results are consistent in real-world patients with diabetes mellitus during long-term follow-up. To evaluate the safety and efficacy profile of biodegradable polymer-coated biolimus-eluting stents (BP-BES) as compared to durable polymer-coated everolimus-eluting stents (DP-EES) in patients with diabetes mellitus during long-term follow-up.

Consecutive diabetic patients undergoing percutaneous coronary interventions with BP-BES or DP-EES implantation were included in a multicenter registry between January 2007 and May 2012. Long-term clinical outcomes between BP-BES and DP-EES will be compared using propensity score matching. The pre-specified primary endpoint is the occurrence of major cardiac adverse events (MACE) - a composite of all-cause death, myocardial infarction (MI) or target-vessel revascularization (TVR). Secondary endpoints are the individual components of the primary endpoint as well as definite stent thrombosis (ST).


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* diabetes mellitus
* percutaneous coronary interventions with biolimus eluting stent or everolimus eluting stent implantation
* signed informed consent

Exclusion Criteria:

* planned procedure requiring antiplatelet therapy withdrawal within 12 months from index coronary angioplasty
* patients with contraindication to dual antiplatelet therapy (aspirin plus ticlopidine or clopidogrel)
* known allergy to stent drugs
Changes of Oxygen Saturation in Inferior Vena Cava (IVC) in Patients During and After High Risk Abdominal Surgery and Relationship to the Outcome

Tissue hypoxia is one of the most important factors leading to the development of multiorgan failure. Patients presenting for emergent major abdominal surgery might suffer from organ hypoperfusion. Thus, early detection of the imbalance between oxygen supply and demand may improve the outcome. The investigators believe that hypoperfusion of the abdominal organs will cause a decrease of the saturation in the hepatic vein and in the IVC.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients presenting for emergency surgery due to acute abdomen pain
* Older than 18 years old
* Not pregnant

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Major coagulopathy
* Permanent pacemaker
Safe Water Techniques in Kenya

Consumer preferences for POU technologies vary across consumers and products, and largely determine their adoption and subsequent usage. This is a marketing study that asks which products consumers prefer and why, and what is their willingness to pay, as understanding this is crucial to attain their widespread adoption and usage.

Visit 400 households and distribute 1 of 3 different POU technologies on randomized basis for a two-month trial. Cycle each household through trials with all 3 technologies in random order such that at the end of 6 months all households have experienced 2-month trials with each technology.

Eligibility Criteria:
Inclusion Criteria:

* At least partial reliance on turbid water supply

Exclusion Criteria:

* At least partial reliance on turbid water supply
Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients

The aim of this study was to determine the effectiveness of transitional care in patients with total knee arthroplasty on patients' functional status, perceived self-efficacy, and health care use. Based on the sampling inclusion criteria, we assigned the patients who would undergo knee arthroplasty to the control (n=35) and intervention (n=35) groups, via the block randomization method. The intervention group received transitional care, while the control group received usual care. Data were collected on post-intervention functional status, level of self-efficacy, and hospital visits outside of routine control.

This randomised control study was conducted 70 eligible partients with total knee arthroplasty in a public hospital orthopedic and traumatology service. Participants were randomly assigned to receive either the 6-week 'Transitional Care Model' program or usual care. Assessments of self-efficacy and functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge. Time-dependent changes in patient outcomes were assessed by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Arthritis Self-efficacy Scale (ASES) measurements tools. Assessments of hospital visits outside of routine control were conducted 2nd week, 6th week, 9th week, and 12th weeks after discharge. The functional status of the intervention group patients improved more than the control group according to WOMAC mean scores. Intervention group patients receiving transitional care had higher mean scores at the 2nd-week and 9th-week postoperatively in perceived self-efficacy . Besides, the rate of admission to the hospital in the intervention group was lower compared to the control group, and a significant difference was observed in the 6th-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Having decided to undergo total knee arthroplasty for the first time due to osteoarthritis
* Volunteering to participate in the research, not having a psychological, physical, and mental disability that may prevent communication, not having any major chronic problems such as end-stage organ failure, kidney, neurological, cancer
* Being discharged to the home from a hospital
* Being able to speak Turkish
* Being available by phone
* Being aged 50 and over

Exclusion Criteria:

* Unwillingness to continue the study
* Rehospitalization
* Exposure to a disease or trauma that would affect functional independence during the study
Basal Instincts: Towards Better Understanding of Basal Cell Function in Chronic Rhinosinusitis With Nasal Polyps

During this project, the investigators want to explore in vitro changes in basal cells and the crosstalk with residing immune cells as potential pathogenic mechanisms in CRSwNP vs healthy controls by using surgically resected patient samples.

The investigators want to use patient and healthy control samples to study/compare the following aspects in vitro:

1. Investigate differences in epithelial and basal cell functions and differentiation characteristics.
2. Characterize the differences in epithelial cell populations and gene expression patterns. Also include an AR subset, to see if changes are specific for CRSwNP or more general for type 2 inflammatory disease of the upper airways.
3. Investigate basal cell activation via different environmental triggers through TLR stimulation.
4. Look at the genetic imprinting of basal cells before and after being exposed to specific triggers.
5. Investigate whether the secreted proteins from basal cells are chemotactic for other cell populations.
6. Investigate the interaction between basal and regulatory T cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* Males and females

Exclusion Criteria:

* CRSwNP
* AR
* Smoker, or \< 1-year ex-smoker
* Underlying systematic pathology (Morbus Wegener or Churg Strauss Syndrome for example)
Use of RDS MultiSense® in Post-ICU Patients in the COVID-19 Era

In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 post-ICU (Intensive Care Unit) patients and over 7 days.

The MultiSense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. The MultiSense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: ECG trace, heart rate, oxygen saturation (SpO2), respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. Designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower.

The aim of this study is to determine the quality of measurements of clinical signs provided by MultiSense® strip in comparison to measurements made with conventional medical devices in the hospital setting, in terms of accuracy, connectivity, generation of artifactual data and stability of data transmission. The study population includes 60 patients transferred to post-ICU units for a minimum of 5 days. Once in the post-ICU unit, the MultiSense® strip will be attached on patient's thorax. The monitoring will last between 5 to 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman over 18 years old.
* Patient previously cared in an ICU for severe COVID-19 pneumonia, COVID-related condition or similar neurological compromise necessitating post-ICU rehabilitation
* Negative respiratory SARS-CoV-2 (Severe Acute Respiratory Syndrome-Corona Virus-2) samples
* Patient admitted in a post-ICU rehabilitation unit with an expected length of stay \> 5 days
* Patient able to receive and understand information related to the study and give written informed consent.

OR If the patient is not capable, presence of a next of kin able to receive and understand information related to the study and give written informed consent for the patient

* Patient authorizing the treatment of their personal data collected during the study (box checked in the consent form)
* Patient affiliated to the French social security system.

Exclusion Criteria:

* Patient with a skin disease that would preclude the use of an adhesive.
* Patient with an implantable device such as a pacemaker
* Pregnant or lactating patient.
* Patient in exclusion period (determined by a previous or a current study).
* Patient under guardianship or trusteeship.
* Patient under the protection of justice.