cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia

The goal of this prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic BPH and to assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.

This was a hospital-based prospective observational study.

All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH, including incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia, and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic BPH.

Exclusion Criteria:

* Patients with indwelling catheters
* Recent antibiotic use
* Immunocompromised states (e.g., HIV, HCV)
* Uncontrolled diabetes mellitus (Hemoglobin A1c \> 7%)
* Steroid therapy
* Those who declined to provide consent
A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer

The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic breast cancer
* postmenopausal females with amenorrhoea \> 12 months and an intact uterus
* FSH levels within postmenopausal range or have undergone a bilateral oophorectomy
* ER \&/or PR positive
* previous adjuvant hormone therapy \> 12 months prior to enrolment
* previous adjuvant chemotherapy \> 6 months prior to enrolment
* measurable disease according to RECIST and/or non measurable bone disease
* life expectancy of at least 12 weeks
* World Health Organisation (WHO) performance status (PS) of 0 to 1.

Exclusion Criteria:

* Male
* life-threatening metastatic visceral disease
* evidence of clinically active interstitial lung disease
* ER and PR negative
* treatment with LHRH analogues \< 3 months prior to enrolment
* patients who have restarted menses or do not have FSH levels within the postmenopausal range
* treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months
* Treatment with hormonotherapy and/or chemotherapy for advanced disease
* extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. \>30% of bone marrow, e.g. whole of pelvis or half of spine)
* currently receiving oestrogen replacement therapy
* treatment with a non-approved or experimental drug within 4 weeks before enrolment
* absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy
* any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known
* severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile


Eligibility Criteria:
Inclusion criteria:

* 19-45 years healthy Chinese
* Body weight \> 50 kg
* BMI between 19-25
* serological negative for HIV, syphilis and hepatitis B and C
* no abnormalities in ECG
* Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

Exclusion criteria:

* History of chronic physical/mental disease, current disease and concomitant medication
Assessment of Fractional CO2 Laser in Treatment of Post-surgical Scarring of Cleft Lip

This is a prospective comparative study on 120 patients divided to three groups. Group A: 40 patients laser will be applied 3 weeks post-surgical. Group B: 40 patients laser will be applied 3 months post surgical. Group C: 40 patients as a control not treated with laser from 2017 to 2020 which will be conducted on patients with post-surgical cleft lip repair scaring.

All patients will have 5-7 sessions with 4 weeks interval.

Photographic documentation and evaluation of the scar will occur every 4 weeks.

The carbon dioxide laser (CO2 Laser) was one of the earliest gas lasers to be developed. It was invented by Kumar Patel of Bell Labs in 1964.

CO2 laser is the highest power continuous wave lasers that are currently available which produces a beam of infrared light with the principal wavelength bands centering on 9.4 and 10.6 micrometers. Patel, C. K. N. (1964).

When CO2 beam of light is selectively applied to the skin, it heats and vaporizes various layers of skin, instantly treating damaged skin and wrinkles while smoothing out the surface of the skin.

The skin remodeling occurs with new skin and collagen growth. The healing typically involves an open surface which takes weeks to heal and typically results in loss of the baseline pigmentation leading to variable lightening of skin. Dover, J. S. (2012) Fractional CO2 laser resurfacing is a revolutionary delivery system that provides dramatic skin improvement without surgery. Matrix combines the benefits of CO2 laser by using micro laser columns "points of light" to treat the epidermis and dermal layers of your skin.

Bernstein et al, (1997) Cleft lip is a form of lip malformation that occurs very early in pregnancy, the incidence of cleft lip in the population is approximately 0.5-2 in 1000 live births. Male children are affected more often than female children.

Michalski AM et al, (2015). Because each cleft is unique, definitive repair of the cleft lip should be individualized as Mirault, Le Mesurier, Tennison, and Millard.

Stal S et al, (2009)

Eligibility Criteria:
Inclusion Criteria:

* Any age with acceptable scar which would not need further revision.
* Group A: three weeks after repair \& group B: three months after repair with no hypertrophy, erythema or any other scar complication.

Exclusion Criteria:

* Any case with deformity needing further surgical interference.
Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods

REDEMPTION (Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods) is observing and collating the treatment course, safety profile, and outcomes of patients around the world who are choosing to self import generic versions of the Direct Acting Antivirals Sofosbuvir, Ledipasvir and Daclatasvir from countries like China, India and Bangladesh.

The high prices of Hepatitis C Virus (HCV) Direct Acting Antiviral (DAA) medications in many countries have led patients to seek out less expensive generic alternatives.

The efficacy and safety of these generic medications has not been formally demonstrated in clinical practice.

The primary goal of REDEMPTION is to collate the clinical results of these generic medications.

The secondary goal is to answer efficacy questions for which there is currently insufficient trial data available - for example Sofosbuvir+Daclatasvir appears to be an inexpensive pan genotypic solution to treat HCV globally but this is supported by a total n of less than 1000, and in some common genotypes, such as HCV Genotype 2, by an n of only 52 making for a wide margin of error and a high degree of uncertainty.

Eligibility Criteria:
Inclusion Criteria:

Quantitative HCV RNA \> 100

Exclusion Criteria:

Contraindications to DAA medications
High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic lung adenocarcinoma
* Progression of imaging-confirmed extracranial lesions after first- or second-line treatment with Osimertinib
* Previous genetic testing for a definite EGFR-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with Osimertinib; or previous genetic testing for a definite T790M mutation and imaging-confirmed extracranial lesion progression after second-line treatment with Osimertinib.
* Pre-existing clinical benefit after treatment with Osimertinib, including CR, PR, SD (duration \>6 months);
* Patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
* Normal functioning of major organs
* Pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug
* Subjects volunteered and signed a written informed consent form.

Exclusion Criteria:

* Previous chemotherapy or immunotherapy
* Patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types
* Progression of imaging-confirmed extracranial lesions after prior Osimertinib treatment with accessible treatment options after genetic testing
* Patients with symptomatic brain metastases, meningeal metastases or spinal cord compression
* Any unrecovered CTCAE \> grade 1 toxicity reaction following prior Osimertinib treatment at the start of study drug therapy
* Other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc.
* History of interstitial pneumonia with previous diagnosis
* Other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study
Continuation Protocol for Obstructive Sleep Apnea (OSA)

The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.


Eligibility Criteria:
Inclusion Criteria:

* Completion of APC-APN-304 without permanent discontinuation of IMP.
* Completion of APC-APN-305 without permanent discontinuation of IMP.

Exclusion Criteria:

* Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.
* Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies.
Prevalence of Oral Mucosal Alterations in Mucocutaneous Ocular Disorders

The patients will be selected from the pool of the Clinics (Rheumatology, Ophthalmology and Dermatology) of Faculty of Medicine and (Diagnostic center and Oral Medicine) of Faculty of Dentistry -Cairo University. For each eligible participant, a full history will be obtained followed by thorough clinical examination.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with one of the mucocutaneous disorder.
* Patient who will agree to participate in the study.
* Patients who will accept to sign the informed consent.

Exclusion Criteria:

* Patients not physically able to participate in survey or clinical oral examination.
Are the Patients Having Pets at Greater Risk of Carrying Multidrug Resistance Bacteriae?

Introduction : The multidrug resistance (MDR) Bacteriae are growing and are a public health problem. The known risk factors to be expanding of MDR Bacteriae are: taken antibiotics, hospitalization, journey in a country at risk. Other risk factors are emitted in hypothesis as the presence of pets.

Aim : The primary objective is to study the association between the presence of a pet and the presence of a MDR bacteria. Methods : Cross sectional study will be performed in Reims University hospital in internal medicine ward.

Introduction : The multidrug resistance (MDR) Bacteriae are growing and are a public health problem. The known risk factors to be expanding of MDR Bacteriae are: taken antibiotics, hospitalization, journey in a country at risk. Other risk factors are emitted in hypothesis as the presence of pets.

Aim : The primary objective is to study the association between the presence of a pet and the presence of a MDR bacteria.

Methods : Cross sectional study will be performed in Reims University hospital in internal medicine ward. Within the framework of the management of patients in internal medicine ward, all the hospitalized patients have systematically a screening of MDR Bacteriae. A questionnaire will be put handed to all the patients during their hospitalization as soon as they will be able to answer it. They will be informed about the objectives of the study. If the patient agrees to participate in the study, the questionnaire will be filled by every patient. It includes essentially closed questions and some open questions. A descriptive analysis will be performed. Bivariate analysis will be performed to investigate the relation between the presence of a pet and the presence of a MDR bacteria and clinical variables Multivariate logistic regression will be performed to investigate the factors independently related to the presence of a MDR bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were screened for MDR bacteria
* Patients who accepted to participate in the study
* \>18yo

exclusion criteria :

* Patient hospitalized before admission in our ward and having acquired a MDR bacteria in the course of care.
* Patients coming from nursing home or institutionalized patients
* Patient who cannot communicated
Coffee Polyphenols Antioxidants

Coffee is one of the most widely consumed beverages. It contains polyphenols (chlorogenic acids) and bioavailability of these bioactive compounds is now somewhat well understood. In addition, chlorogenic acids are known to be antioxidants in the cup, but reliable evidence remains to be observed in vivo. The objective of this trial is to understand if regular (10d) coffee intake may be beneficial on biomarkers of oxidative damage measured in urine and plasma. A secondary objective is to understand if polyphenols isolated from coffee may be as beneficial as the whole beverage in reducing oxidative stress compared to placebo

This is an interventional study with a crossover randomized placebo-controlled double-blind design to assess the effect of regular consumption of coffee on oxidative stress compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* 20 - 70 years, male and female
* healthy
* BMI 19 - 29 kg/m2
* Coffee drinkers with an average consumption of 1-3 cups per day
* having given informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases / disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer- Have had a gastrointestinal surgery, except appendicectomy
* Difficulty to swallow
* Have a regular consumption of medication
* Have taken antibiotic therapy within the last 6 months
* Alcohol consumption \> 2 units a day
* Smokers (more than 5 cigarettes per day)
* Have given blood within the last 3 weeks
* Volunteers who cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial during the last 3 weeks
CT Perfusion Scans in Detecting Changes in Blood Flow to the Liver After Portal Vein Embolization

This trial studies the use of computed tomography (CT) perfusion scans in detecting changes in blood flow to the liver after portal vein embolization in patients with liver cancer. CT perfusion scans use a standard contrast drug given by vein to measure blood flow to the liver. CT perfusion scans may predict the rate and amount of growth of new, healthy tissue on one side of the liver after a portal vein embolization and detect change to the size of the liver tumor as result of the procedure.

PRIMARY OBJECTIVES:

I. To assess whether perfusion changes to the liver following portal vein embolization (PVE) correlate with hypertrophy of the future liver remnant (FLR).

SECONDARY OBJECTIVES:

I. To assess perfusion changes to liver tumors following PVE. II. To assess whether PVE may affect tumor growth.

OUTLINE:

Prior to PVE, patients undergo CT perfusion scan of the liver and liver biopsy over 15 minutes. Patients undergo a second CT perfusion scan immediately after PVE and a third CT perfusion scan 3-6 weeks post PVE.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned to undergo major liver resection for cancer who need PVE to increase the size of the FLR prior to surgery.
* Patients who are able to understand and give consent to participate in the study.

Exclusion Criteria:

* Pregnant or nursing.
* Allergy to iodinated contrast which cannot be safely pre-medicated.
* History of severe renal dysfunction (glomerular filtration rate \[GFR\] \< 30 mL/min/1.73 square meters). Patients with a GFR between 30-50 mL/min/1.73 square meters will receive the standard contrast-induced nephropathy prophylaxis at our institution (i.e. N-acetylcysteine and sodium bicarbonate \[150 mEq/L\] in D5W intravenous).
The Use of Tamsulosin in Treatment of (10-15 mm) Lower Ureteric Stones in Adults With Non-emergent Symptoms

To estimate the efficacy of tamsulosin in:

A - Expulsion of lower ureteric stones from10-15 mm diameters (primary goal).

B - Pain relief and hyronephrosis improvement (secondary goal).

Urolithiasis affects 4-15% of world population and the incidence of this disease is increasing day by day . Of all the urinary tract stones, 20% are ureteral stones, and 70% of these ureteral stones are found in the distal part of the ureters . The goal of treatment of patients suffering from ureteral calculi is to achieve complete stone clearance with minimal morbidity .

Ureteral calculi of any size may be associated with renal obstruction and care must be taken to prevent irreversible damage to kidney, whether patient selects expectant or active treatment . An expectant treatment or watchful waiting approach may be expected to produce spontaneous stone expulsion up to 50% of cases but some complications such as urinary infection, hydronephrosis, and repetitive colicky pain may occur . Once a conservative approach proves to be unsuccessful, interventional treatment becomes necessary. After a period of conservative treatment, however, intervention is often inefficient or has a higher risk for complications due to stone impaction and the associated inflammatory reaction of the ureter . Non-invasive treatment with extracorporeal shockwave lithotripsy and minimal invasive approach with ureteroscopy allow ureterolithiasis to resolve in almost all cases but these procedures are not risk free and they require some experience and not cost effective .

The therapeutic potential of α-blockers for ureteral stone disease has been investigated, prompted by the detection of α-receptors in ureteral smooth muscle cells . We choose to focus on tamsulosin because it is the most frequently studied α-blocker, recommended in urology treatment guidelines, and, in our experience, the most common medical expulsive therapy used by emergency physicians .

The objective of this trial was to evaluate the efficacy of MET with tamsulosin for ureteral stones from 10-15 mm diameter in a randomised, placebo-controlled setting.

Eligibility Criteria:
Inclusion Criteria:

1. Lower ureteric stones from(10-15) mm diameters.
2. Age group equal or more than 18 years.
3. Normal renal function.

Exclusion Criteria:

1. Lower ureteric stones less than 10mm and more than 15 mm diameters.
2. Age group less than 18 years.
3. Associated ureteric strictures.
4. Febrile urinary tract infections.
5. Severe hydronephrosis.
A Study of Dipeptidyl-peptidase IV (DPP-IV) RO4876904 in Patients With Type 2 Diabetes.

This 5 arm study will assess the efficacy, pharmacokinetics, safety and tolerability of a DPP-IV inhibitor compared to placebo in patients with type 2 diabetes. Patients will be randomized to receive DPP-IV(3) at one of 4 doses (of 12.5mg and above), or placebo p.o. Patients receiving metformin before the study will continue on the same dose of metformin. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes diagnosed \>= 1 month before screening;
* drug-naive, or pretreated with maximum tolerated dose (MTD) of metformin;
* BMI 25-45kg/m2.

Exclusion Criteria:

* type 1 diabetes;
* any anti-hyperglycemic medication other than metformin, or weight-lowering drug, during last 3 months.