cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effect of Endoscopic Urethral Procedures Applied After Radical Prostatectomy on Urinary Incontinence

The researchers investigated whether endoscopic retrograde urethral interventions applied for various reasons after radical prostatectomy (RP) operation cause a change in urinary incontinence (UI) level, and if there is a change, whether it changes according to the endoscopic procedure time and the endoscopic instrument used.

Localized prostate cancer is usually treated with RP. The most common complications after RP are erectile dysfunction (ED) and UI. After RP, some patients may require retrograde endoscopic urethral intervention. In this study, researchers investigated whether there is a change in the UI level in patients that underwent retrograde urethral intervention after RP and whether this change was affected by the duration of the procedure and type of endoscopic device used.

Methods: Eighteen patients were included in the study. The patients were divided into 3 groups based on the endoscopic device used: group 1 rigid cystoscopy, group 2 flexible cystoscopy, and group 3 semi-rigid ureterorenoscopy (URS). The Turkish version of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) and the number of pads used daily was questioned before the endoscopic procedure and 1 month after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone radical prostatectomy
* Patients that had undergone an endoscopic procedure 1 year after RP

Exclusion Criteria:

* Patients with urinary tract infection before the endoscopic procedure,
* Urinary tract infection at 1st month follow-up
* Central neurological deficit
* History of adjuvant radiotherapy after RP
* Bladder neck stenosis and urethral stenosis
* Patients that had undergone endoscopic urethral intervention before this scheduled procedure
* Patients who had a double J stent inserted during the endoscopic procedure and required a second endoscopic intervention
* Patients that required the use of bipolar or monopolar cautery
Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Serious, suspected or documented gram-positive infection

Exclusion Criteria:

-
Visual Acuity and Optical Coherence Tomography One Year After Peeling of Epiretinal Membranes

Improvement in visual acuity and retinal anatomy one year after surgery is assessed and compared to data preoperative and 3 months after surgery

Improvement in visual acuity and retinal anatomy (documented by optical coherence tomography) one year after surgery is assessed and compared to data preoperative and 3 months after surgery. Improvements in retinal morphology are analysed by remission of optical coherence biomarkers after surgery. Aim of the study is to examine possible improvements of surgical outcomes in the period up to the one year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* vitrectomy with Membrane Peeling due to an epiretinal membrane

Exclusion Criteria:

* none
Photoplethysmographic Dichrotic Notch Reflexes Systemic Hemodynamics

Changes in the vascular tone of anesthetized patients is common and cause hemodynamic problems. The investigators have previously demonstrated that the shape of the pulse oximetry waveform (photoplethysmography) is closely related to the changes observed in systemic vascular resistence. The main change in pulse waveform is based to the dichrotic notch position. The present study was designed to determine if the dichrotic notch position is related to a local or a systemic change in the vascular tone.

This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform of surgical patients is related to a local or a sistemic changes in the vascular tone. The investigators will studied 15 patients undergoing regional brachial plexus anesthesia for upper limb surgeries. Photoplethysmography will be continuously recorded in the thumb of the tested hand (anesthetized hand) and in the thumb of the control, opposite hand. Duplex color and power Doppler will measure flow in the both brachial arteries and in the aorta (supraesternal view). The contour analysis of both, photoplethysmogram and arterial flow velocities will be analyzed, correlated and compared.

Eligibility Criteria:
Inclusion Criteria:

* Written Inform Consent
* Programmed surgery
* Supine position

Exclusion Criteria:

* Emergency surgery
* Peripheral vascular diseases
The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

This study is designed to pilot an intervention technique to reduce the self-stimulating behaviors seen in individuals with autism spectrum disorders using intervention with ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and rocking, can interfere with the individual's ability to interact with their peers. Participants will wear the pellets for four week and measures with taken again. Another group of participants will not get the pellets. Both groups will be tested at the beginning and end of the study. Any variations in self-stimulating behaviors will be documented through parent report, Observational data. The investigators hypothesize that they will see changes in self- stimulating behaviors as a result of the strategic placement of the ProFoveate™ pellets on the ears of one group of the participants.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of high functioning autism spectrum disorders (autism, Asperger's syndrome, or Pervasive Development Disorder (PDD) as reported by specialists who use the established criteria (American Psychiatric Association,2000)
* Pass a hearing screening at 25 decibels for the frequencies 1000, 2000 and 4000 hertz
* Score 85 or above on the Test of Nonverbal Intelligence- 4 (TONI-4; Brown, Sherbenou \& Johnsen, 2009)
* Exhibit noticeable self- stimulating or ritualistic behaviors (i.e., scratching, hand flapping, eye blinks, etc.) and/or visual characteristics of Autism Spectrum Disorder (ASD) (sensitivity to light, visual fixations, poor eye contact, etc.) as reported by parents and/or observed on videos taken during assessment.

Exclusion Criteria:

* Known history of latex allergy
* Intelligence Score below 85
* Fail the hearing screening
Genetic Identification of Monogenic Disorders in Early-onset Stroke Using Targeted Next Generation Sequencing Panel

The study was designed as a multicenter multiracial prospective observational study of acute ischemic stroke and TIA patients across china. The purpose of this study is to determine the monogenic disorders incidence of Chinese early-onset stroke patients. We plan to consecutively enroll more than 500 patients with early-onset stroke(in the 18- to 45-year age range) admitted in stroke units within 7 days after symptoms onset in participating centers. These early-onset stroke patients are referred for targeted sequencing using 'cerebrovascular disease panel'. By analyzing the sequencing results, we intend to identify monogenic causes causing early-onset stroke and develop clinical algorithms that might assist the clinician in deciding in which early-onset stroke patients testing for monogenic causes of stroke.

The study was designed as a multicenter multiracial prospective observational study of acute ischemic stroke and TIA patients across china. The purpose of this study is to determine the monogenic disorders incidence of Chinese early-onset stroke patients. We plan to consecutively enroll more than 500 patients with early-onset stroke(in the 18- to 45-year age range) admitted in stroke units within 7 days after symptoms onset in participating centers. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be referred for targeted sequencing using 'cerebrovascular disease panel'. When one or multiple pathogenic or possible pathogenic exonic mutations are found, a Sanger Sequencing (SS) on somatic DNA from peripheral blood leukocyte of the index case and affected relatives will be performed for the screening of the same mutations. And the sporadic patient's mutations will be checked by SS in the unaffected family members. By analyzing the sequencing results, we intend to identify monogenic causes causing early-onset stroke and develop clinical algorithms that might assist the clinician in deciding in which early-onset stroke patients testing for monogenic causes of stroke.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent.
* Female or male aged ≥ 18 years and ≤ 45 years.
* Acute ischemic stroke or Transient ischemic attack((Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset) patients that can be enrolled within 7 days of symptoms onset defined by the"last see normal"principle.

Exclusion Criteria:

* Asymptomatic brain infarction
* Neurological deficit due to causes other than ischemic stroke or TIA
The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)

This randomized clinical trial is designed to evaluate the effect of selected antioxidant vitamins and minerals supplement named as ASTED:

1. β- Carotene (30 mg)
2. Vit C (100 mg)
3. Vit E (Alpha-Tocopherol Acetate): 60-200 IU
4. Calcium phosphate dihydrate (40 mg)
5. Zinc oxide (4 mg, elemental)
6. Copper gluconate (3.5 mg)
7. Sodium selenite 23 mg= Selenium 100 µg
8. Nicotinamide (a form of vit.B3) (10 mg)

in patients with mild Thyroid eye disease according to EUGOGO classification. To be given twice a day.

1. To determine total eye score (NOSPECS severity score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
2. To determine Score of thyroid eye disease Quality of life questionnaire (TED-QOL) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
3. To determine clinical activity score (CAS Score) before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
4. To determine Serum thyroid auto-antibodies (Anti thyroid peroxidase (TPO), Anti-thyrogluboline) and Thyroid function test (Free T4, T3, and TSH) level before and after treatment in each of the three arms of the study and make a before - after as well as an inter-arm comparison.
5. To determine the rate of side effects in each arm and make a comparison.

Eligibility Criteria:
Inclusion Criteria:

1. Mild TED of less than 18 months duration (as recorded by the patient).
2. No active state (Clinical activity score of less than 3).
3. No previous specific therapy for TED, except for local measures (artificial tear, head elevation, low salt diet).
4. Euthyroidism as a result of remission after a course of antithyroid drug (ATD) therapy, or euthyroidism for at least 2 months since commencing ATD or after thyroidectomy, or euthyroidism for at least 6 months after radioiodine therapy. Hypothyroid patients after thyroidectomy or radioiodine were replaced with levothyroxine. Euthyroidism was defined as normal serum free thyroxine, total or free triiodothyronine concentrations, and thyrotropin (TSH) levels below 4 mU/Liter Patients were kept euthyroid for the whole duration of the study.
5. Age 18-70 years.

Exclusion Criteria:

1. TED severity of more than mild TED.
2. Pregnancy
3. Drug and/or alcohol abuse
4. Severe concomitant illness
5. Inability to comply with the study protocol
6. No informed consent
7. Use of selenium- or vitamin/minerals-containing preparations in the last 3 months.
8. Developing more severe TED in the course of the trial so that requires steroid treatment.
Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of BILR 355 BS Plus Low Dose Ritonavir in HIV-uninfected Male Volunteers

Study to determine the safety, tolerability and pharmacokinetics of BILR 355 BS plus low dose ritonavir in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Males who meet the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
   * No finding deviating from normal (except as noted below) and of clinical relevance
   * No evidence of a clinically relevant concomitant disease
2. Age ≥18 years and \<60
3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Current and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
2. Surgery of gastrointestinal tract (except appendectomy)
3. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
4. History of relevant orthostatic hypotension, fainting spells or blackouts
5. Chronic or relevant acute infections
6. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
7. Intake of drugs with a long half-life (\>24 hours) within one month prior to administration of study drug or during the trial
8. Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation
9. Participation in another trial with an investigational drug within one month prior to administration or during the trial
10. Smoker
11. Inability to refrain from smoking on trial days
12. Alcohol abuse (more than 60 g/day)
13. Drug abuse
14. Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
15. Excessive physical activities (within 1 week prior to administration or during the trial)
16. Any laboratory value outside the normal reference range that is of clinical relevance
17. Inability to comply with dietary regimen of study centre
18. Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody positive)
19. HIV-1 infected as defined by a positive HIV ELISA test
Premenstrual Symptoms Treatment Comparing Between Oral Contraceptives Containing Desogestrel and Drospirenone

The purpose of this study is to determine whether low-dose combine oral contraceptives (COC) containing desogestrel 150 mg and drospirenone 3 mg are effective in the treatment of Premenstrual symptoms.

Premenstrual syndrome is commonly reported 20-90 percent in reproductive-aged women. Only a small percentage of women (2 to 5%) have significant premenstrual symptoms defined as Premenstrual dysphoric disorder (PMDD). The exact symptoms and their intensity vary from woman to woman and even from cycle to cycle.While exact causes of PMS are not fully understood,current thinking suspects that fluctuation of endogenous sex hormones are relevant. The standard 21/7 design may induce menstrual-related symptoms including headache, mood swings, abdominal cramping, bloating, and breast tenderness that increase during the last week of active pills extending along the 7-day hormone free interval(HFI). The decline in endogenous estradiol levels during HFI may be responsible for the estrogen-withdrawal symptoms. While a new COC with drospirenone introduced in 24/4 design has been shown in clinical trials to significantly improve the symptoms of PMS, there has been questioned about efficacy of the other kind of COC which has optimal properties, for example, good-control cycles extend to the similar 24/4 regimen.

Eligibility Criteria:
Inclusion Criteria:

* age 18-35years
* Regular menses, I:21-35 days
* Willingness to take COC for 6 months
* No history of COC in last 6 months
* No history of injected contraception in last 6 months
* History of implant contraception need to have regular menses 3 cycles
* History of miscarriage need to have regular menses 3 cycles

Exclusion Criteria:

* Pregnant or suspected pregnant
* Breast feeding
* Smoking
* Contraindication of WHO 2,3 and 4
* PMDD
Upper Extremity and Muscle Oxygenation

The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy.

Our study aims to determine the acute oxygen response in the upper extremity muscles against a resistance exercise fatigue protocol, in order to demonstrate the effect of muscle oxygenation levels on the occurrence of symptoms such as fatigue in upper extremity use, and to provide reference information for the development of exercise programs.

It is known that resistance exercise increases resting energy expenditure and promotes fat oxidation for weight loss. Changes in cardiopulmonary function that occur in chronic diseases reduce oxygen uptake and decrease energy production, leading to increased fatigue. Resistance exercises in chronic diseases can regulate an individual's energy production capacity.

The main objective of our study is to investigate the effect of muscle oxygenation levels on the occurrence of symptoms such as fatigue by determining the oxygen response in the upper extremity muscles based on a resistance exercise protocol.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being over 18 years old
* Having a Body Mass Index (BMI) value between 23-30 kg/m2
* Absence of comorbid disease of the orthopedic, neurological, cardiopulmonery system

Exclusion Criteria:

* Smoking / alcohol use
* Presence of orthopedic disease effecting the upper extremity or previous surgery
* Presence of cardiopulmonery disease that prevents exercise
* Participants who performed resistance exercise regulary for more than 6 months
Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders

The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.

Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).

PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits.

Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.

Study Hypothesis:

The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

Comparison(s):

Tiotropium 18 mcg once daily vs Placebo

Eligibility Criteria:
* Diagnosis of COPD according to the European Respiratory Society (ERS) (R95-3225) and matching the following criteria:

  * Stable moderate to severe airway obstruction
  * Baseline 30 % \< FEV1 \< 65 % of European Community of Coal and Steel (ECCS) predicted values (R94-1408).
  * Baseline FEV1/SVC\< 70 %.
* Smoking history \> 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking
* One pack of cigarettes per day for one year.
* History of exacerbation in the past year.
A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects

This trial was conducted in Europe. The aim of this clinical trial was to compare the exposure and effect of NN1250 (insulin degludec) after different routes of injection in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
* Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability

This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.

The effects of TDCS on corticobulbar excitability of the brain after inhibitory pre-conditioning will be compared in patients with different BDNF phenotypes

Eligibility Criteria:
Inclusion Criteria:

* Age 19-40 years
* Informed consent

Exclusion Criteria:

* History of epilepsy
* Presence of cardiac pacemaker
* previous brain surgery
* previous swallowing problems
* current use of medication which acts on the central nervous system
* presence of implanted metal intracranially
An Observational Study of Risk Factors and Long-term Prognosis of Patients With Liver Abscess in the "Real-world"

Pyogenic liver abscess is one of the most common visceral abscesses, its incidence is increasing worldwide. According to the previous literature, the mortality rate of pyogenic liver abscess is as high as 31% and become a serious social health problem. However, the data of prospective observational real-world studies are scarce and no relevant research of the liver histological change has been reported, so the long-term prognosis and the risk factors for pyogenic liver abscess are still unknown. Patients will be followed up prospectively for a period of 2 years and observed clinical prognosis (all-cause mortality, the recurrence rate, and the rehospitalization rate). The investigators will investigate the predictive value of clinical risk factors for clinical prognosis and establish clinical prediction models to predict the long-term prognosis of pyogenic liver abscesses.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age;
* Irrespective of gender;
* Symptomatic patients of liver abscess confirmed with radiology imaging, either by ultrasonography or computed tomography scan.

Exclusion Criteria:

* Patients \<18 years old;
* Pregnancy at presentation.