cyrilzakka/clinical-trials huggingface dataset:
Urinary Incontinence After Radical Prostatectomy

The aims of this project are; 1) To examine the efficacy of ultrasound-guided pelvic floor muscle training compared to standard care on urinary incontinence in patients undergoing robot assisted radical prostatectomy and 2) To compare physical function, incontinence, and QoL in two groups of patients with low or high function of the pelvic floor muscles respectively before the surgery.

This study consists of two parts. The first part is a randomized controlled trial where 44 patients with weak pelvic floor muscle function are randomized to either treatment as usual (control group 1) or ultrasound-guided pelvic floor muscle training (Intervention group). In the second part the patients in control group 1 will be compared with 22 patients with normal/strong pelvic floor muscle function (control group 2).

Patients not able to perform the pelvic floor muscle test consisting of 8 repetitions of 4-seconds pelvic floor muscle contraction and 1 repetition of 15-seconds pelvic floor muscle contraction will be randomized to either intervention group or control group 1. Patients able to perform the pelvic floor muscle test will be included in control group 2.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 and above
* Diagnosis of prostatic adenocarcinoma and referred to robot assisted radical prostatectomy
* No comorbidity that prevents pelvic floor training or effects the function of the pelvic floor
* Adequacy in written and spoken Danish Performance status 0-1
* Able to understand the study procedures and willing to provide written informed consent

Exclusion Criteria:

* Major surgery within the last month that may affect pelvic floor function.
* Urinary incontinence prior to surgery
Influence of Different PEEP Levels and Tidal Volumes on Regional Lung Function

Mechanical ventilation is indispensable for most of surgical interventions but can induce lung injury even in pulmonary healthy patients. This can lead to postoperative pulmonary complications. These adverse effects could be prevented by a better monitoring of intraoperative lung function. Electrical impedance tomography is able to visualize aeration within the lung in real time.

The planned study investigates the influence of different levels of positive endexspiratory pressure and different tidal volumes on the aeration.

Available perioperative parameters to set mechanical ventilation parameters represent only global lung function. But to reduce postoperative pulmonary complications induced by mechanical ventilation a better monitoring of intraoperative lung function seems to be crucial, that provides more regional information of lung collapse or over distention.

By application of small currents via electrodes around the thorax and measuring of the resultant resistance the electrical impedance tomography (EIT) can determine the level of aeration of the lung in a cross sectional plane. The EIT device used in this study calculates the percentage of the investigated lung area that can be defined as over distended or collapsed respectively. In these sections the change of resistance within a respiration cycle is reduced compared to well ventilated areas are therefore called silent spaces. Silent spaces located ventral are termed non-dependent (NSS) and silent spaces located dorsal are termed dependent (DSS). Based on this information the clinician is able to set the respirator in a more lung protective manor.

To better understand the influence of positive endexspiratory pressure (PEEP) and tidal volume (Vt) on reginal lung function we are going to carry out the presented study.

40 patients undergoing robot assisted prostatectomy should be enrolled in a study that consists of two phases. In the first phase 20 patients are ventilated with constant PEEP (10mbar) and in ten patients each the Vt is set to 5 or 12ml/kg ideal body weight. In the second phase in further 20 patients the Vt is set to 8ml/ kg ideal bodyweight and the PEEP is 3 or 12mbar in one half of the patients. Under the different ventilation settings the NSS and DSS, the oxygenation index and lung compliance will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* scheduled for robot assisted prostate ectomy

Exclusion Criteria:

* body mass index \>35 kg/m²
* chronic obstructive lung disease (GOLD III or IV)
* obstructive sleep apnoe syndrome
* planned or unplanned admission to intensive care unit for prolonged ventilation
* mechanical ventialtion within the last 30 days
* lung operation in the past
* other lung disease that impairs activity
Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder

Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the adaptation of inhibitory control.

1. Assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs in patients with ADHD, using quantitative electroencephalography;
2. Study the contribution of transcranial direct current stimulation compared with sham in the adequacy of inhibitory control in ADHD patients through neuropsychological test-Go/No Go;
3. Assessing the efficacy of tDCS in neurobiological parameters evidenced by quantitative EEG in patients with ADHD;
4. Perform the Reconstruction of the Functional Brain Network of each subject based on the quantitative EEG data through computational and mathematical modeling;
5. Register indicators of quality of life in adults with Attention Deficit Hyperactivity Disorder through the Quality of Life Questionnaire for Adults with ADHD (AAQoL).

Eligibility Criteria:
Inclusion Criteria:

* Signature of the informed consent;
* Diagnosis of Attention Deficit Hyperactivity Disorder based on DSM-IV-TR and Adult Self-Report Scale (ASRS-18);
* Adequate eyesight and hearing (or usual corrective methods such as glasses or hearing aid) that allows performing neuropsychological test and questionnaires;
* Residents in Bahia/Brazil;
* Over 18 years.

Exclusion Criteria:

* Major psychiatric disorders such as schizophrenia and bipolar disorder;
* Inability to understand the questionnaires used or illiterate;
* Abuse of psychoactive substances, except nicotine and caffeine, in the last 12 months.
Maintenance Plasma Exchange for Neuromyelitis Optica

Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for NMO.

Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for participants with NMO, NMO spectrum disorders, and recurrent idiopathic longitudinally extensive transverse myelitis.

Eligibility Criteria:
Inclusion Criteria:

* Neuromyelitis optica
* Neuromyelitis optica spectrum disorder
* Recurrent idiopathic longitudinally extensive myelitis
* Age 18 years or greater

Exclusion Criteria:

* Any condition that in the opinion of the investigator could increase a participant's risk by participating in the observational study or confound the outcome of the study
Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome

Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS) involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP), which are generally used to establish the presence of hyperandrogenemia. In general, these levels are obtained during the follicular phase to maintain sampling uniformity and avoid spurious increases due to corpus luteum function. However, because most hyperandrogenic patients are oligo/amenorrheic, it is frequently necessary to administer a progestogen to induce withdrawal bleeding and properly time the blood sampling.

Several medications have been described to properly induce withdrawal bleeding , with medroxyprogesterone acetate (MPA) being the most widely use. However, synthetic compounds as MPA do not replicate precisely the constellation of biologic activities of the parent hormone and results in a temporary, albeit clinically relevant, suppression in ovarian function and circulating androgen levels , in addition of several adverse side effects .

In this study, it is hypothesized that the administration of natural progesterone vaginally, which will avoid hepatic first pass, may result in significantly less hormonal suppression.

The authors test this hypothesis by prospectively determining the effect of vaginal micronized progesterone (OMP), administered for the induction of withdrawal bleeding, on the circulating androgen and 17-OHP levels in women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Chronic ovulatory dysfunction, defined as intermenstrual intervals of \>45 days or a total of \<8 menstrual cycles per year
* Polycystic ovaries, defined as at least one ovary with \>12 follicles between 2 and 9 mm or an ovarian volume \>10 mL
* Clinical hyperandrogenism, defined by a Ferriman Gallwey score \>8

Exclusion Criteria:

* non-classic congenital adrenal hyperplasia,
* hyperprolactinemia
* thyroid dysfunction
* Oral contraceptives pills taken at least 3 months before the study
The Novel Approach of Minimally Invasive Parathyroid Surgery Requires Precise Identification and Localization of the Lesion Prior to Exploration

Purpose of this study is to compare the image quality and diagnostic accuracy obtained with ultrafast solid state short SPECT in comparison with the routine SPECT protocol.

Single-tracer, dual-phase Tc-MIBI parathyroid scintigraphy is based on the differential washout rate of the tracer (MIBI) from the thyroid and the parathyroid tissue. A distinct focus of increased MIBI uptake relative to the thyroid gland, either on the early or late image or on both, or a focal uptake in the mediastinum, is considered positive for abnormal parathyroid tissue. Tc99m-MIBI planar scintigraphy was found to play a major role in the preoperative localization of a parathyroid adenoma (PTA), with a sensitivity ranging from 85% to 95% and specificity of up to 99%. Subsequently, the use of MIBI- Single photon emission computed tomography (SPECT) significantly improved the sensitivity of the test and improved the accuracy of lesion localization.

A limitation of adding the SPECT component is related to its relatively long duration. The duration of a MIBI-SPECT acquisition of neck and the mediastinal area may take up to 15-20 minutes using a standard nuclear medicine camera. Long acquisition time may lead to patient discomfort and movement resulting in image degradation, artifacts and may lead to overall decreased diagnostic accuracy.

A reduced SPECT acquisition time without image quality degradation may decrease patient discomfort and increase clinical throughput. An ultrafast solid state CZT camera (GE Healthcare Discovery 570C) is currently used for routine cardiac SPECT imaging achieving high quality cardiac studies for a significantly shorter acquisition time. Present study evaluates the potential use of the ultrafast camera in patients with a clinically suspected PTA who perform Tc-MIBI imaging.

Eligibility Criteria:
Inclusion Criteria:

1) The subject is 18 years old or older. (2) The subject is clinically suspected or known to have parathyroid adenoma and is scheduled to have a MIBI study as part of his/her standard clinical evaluation.

(3) The subject is able and willing to comply with the additional procedure (ultrafast MIBI SPECT) and a signed and dated informed consent is obtained before any procedure for study purposes is performed.

Exclusion Criteria:

1. Pregnancy.
2. Psychosis or any other condition, which, in the investigators opinion would prevent adherence to the study protocol.
DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years

The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.

DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subject aged \<2 years (term newborn infants to toddlers 23 months of age inclusive). Term is defined as ≥37 weeks of amenorrhea
* Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region (e.g. CNS, cardiac) at the dose of 0.1 mmol/kg BW (0.2 mL/kg BW)
* Subject with normal renal function for its age, estimated glomerular filtration rate calculated based on the Schwartz formula

Exclusion Criteria:

* Subject planned for intervention (e.g. surgery) between the screening visit and up to 24 hours after DOTAREM injection
* Subject whose preceding or subsequent treatment to DOTAREM injection (e.g., blood loss or receiving blood, treatment with diuretics, etc...) would alter DOTAREM pharmacokinetics parameters
* Subject with subsequent planned treatment after DOTAREM injection that would prevent obtaining the required blood samples (e.g., emergency surgery, etc...)
* Subject with a history of a bleeding disorder
* Subject with severe liver disease (Child's Pugh Classification B or greater or serum direct bilirubin greater than 0.3 mg/dL, age adjusted)
* Subject with electrolyte or fluid imbalance that presents undue risk
* Subject undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after DOTAREM injection
* Subject who received or will receive any other contrast agent within 72 hours prior to DOTAREM injection or up to 24 hours after DOTAREM injection
* Subject with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
* Subject with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
* Subject having participated within 30 days in a clinical study involving an investigational drug or device
* Subject planned to participate simultaneously to another clinical study
Study of the Occurrence of Cardiocirculatory Arrest as a Function of the Level of Hypoxemia During a Maastricht 3 Procedure

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

Evaluation of the level of hypoxemia during the occurrence of cardiocirculatory arrest during a Maastricht III organ donation procedure.

Eligibility Criteria:
FOR THE DONORS :

Inclusion Criteria :

* Patient over 18 years of age
* Organ donation procedure initiated in accordance with the legislation and procedures in force in France for the Maastricht III category
* No opposition formulated by the relative to the patient's participation in the study

Exclusion Criteria :

* Patient registered on the national register of refusals or living refusal of donation
* Pregnant or breast-feeding women
* Patients under guardianship, curatorship or legal protection
* Medical contraindication to organ donation according to the recommendations of the Agence de Biomédecine currently in force in France

FOR THE RECEIVER

Inclusion Criteria :

* No opposition to the collection of data concerning him/her
* Patient over 18 at pre-transplant consultation
* Patient who has received an organ from a donor participating in the HEPHAISTOS protocol

Exclusion Criteria :

- Patients under guardianship, curatorship or legal protection
Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.

To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily \[BID\]) in subjects diagnosed with IBS-M/IBS-U.

Eligibility Criteria:
Inclusion Criteria:

* Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III Diagnostic Questionnaire for Adult Functional GI Disorders.
* Subject Screening diary entries must show an average worst abdominal pain in the past 24 hours score of at least 4 on a 11-point scale.
* Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors if taking antidepressants.

Exclusion Criteria:

* Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation (IBS-C), according to Rome III Criteria.
* Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or defecation.
* Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

This study evaluates increased hydration (1.5 L of water daily during 6 weeks) on top of habitual water intake in the lowering of the vasopressin marker copeptin and in the lowering of plasma glucose concentration in adults with signs of low water intake at recruitment (elevated levels of copeptin, high urine osmolality, low urine volume).

High plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease and premature death. The main physiological role of vasopressin is to maintain constant plasma osmolality. Previous studies in rats and a Mendelian randomization study in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. As vasopressin can be suppressed by increasing water intake, the investigators hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes.

The aim of this pilot study is to test if six weeks of water supplementation of 1.5 Liters of extra water per day in low-drinkers with high copeptin can significantly alter hydration markers in general and reduce plasma copeptin in particular. Furthermore, the investigators also aim at investigating whether this 6-week water intervention can significantly reduce fasting plasma glucose concentration.

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Age 20-75 years
* High plasma concentration of copeptin of \>6.1 pmol/L in women and \> 10.7 pmol/L in men
* 24-hour urine osmolality \> 600 milliosmol (mosm) /kg water.

Exclusion Criteria:

* 24-hour urine volume \>1.5 L
* Pregnancy or breastfeeding
* Plasma sodium \<135 mmol/L
* Use of diuretics, lithium or SSRI drugs
* Chronic kidney disease (estimated glomerular filtration rate \< 30mL/min)
* Heart failure
* Inflammatory bowel disease
* Type 1 diabetes or type 2 diabetes treated with insulin
* Vulnerable subjects (subjects with legal guardian, with loss of personal liberty)
Kinesio Taping and Hand Sensorimotor Control

We explored the effect of Kinesio taping with different tension on hand force control, joint proprioception, reaction time and brain activity.

Healthy participants randomly received three wrist/finger flexor taping conditions: (1) taping with 20% additional tension (taping20), (2) taping with neutral tension (tapingN), and (3) without taping (control). Grip force, wrist joint angle, electroencephalogram and electromyogram were recorded during proprioception and force control tasks to determine the effects of Kinesio taping on sensorimotor control.

Sensorimotor control involves the integration of sensory information in the brain to ensure appropriate joint position, force control and timing during movement. Kinesio taping can provide additional sensory input and improve sensorimotor control performance. Hand function is important in daily activities and fine control of the fingers and wrist is required in many sports. Therefore, we explore the effect of Kinesio taping with different tension on hand force control, joint proprioception, reaction time and brain activity.

This is an observational study with single-group repeated-measures design. Participants will be randomly received three wrist/finger flexor taping conditions: (1) taping with 20% additional tension (taping20), (2) taping with neutral tension (tapingN), and (3) without taping (control). Grip force, wrist joint angle, electroencephalogram and electromyogram were recorded during proprioception and force control tasks.Repeated-measures one-way analysis of variance and the Bonferroni post hoc comparison test determined the differences among the taping conditions. The Pearson correlation test determined the correlation between changes in motor performance and brain activities. Statistical significance was set at .05.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults who are 20-40 years old

Exclusion Criteria:

1. Have irreversible injury on forearm, wrist or hand
2. Feel pain or any uncomfortable symptom on forearm, wrist or hand
3. Muscular disease on upper extremity in 6 months
4. Impaired sensation
5. Allergy to Kinesio tape
6. Neurological disease
Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension

This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients \>= 18 years and \< 86 years
* Patients with essential diastolic hypertension
* At visit 1, the patient must have mean sitting diastolic blood pressure \>= 95 mmHg and \< 10 mmHg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure \< 100 mmHg
* At visit 2, patients must have a mean sitting diastolic blood pressure of \>= 95 mmHg and \< 100 mmHg
* At visit 3, patients must have a mean sitting diastolic blood pressure of \>= 90 mmHg and \< 110 mmHg

Exclusion Criteria:

* Severe hypertension \>= 180/110 mmHg
* Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
* Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
* History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
* Malignant hypertension
* All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment
* Pregnant or nursing women
* History of heart failure
* Angina pectoris
* Second or third degree heart block
* Life threatening or symptomatic arrhythmias
* Clinically significant valvular heart disease
* Evidence of a secondary form of hypertension
* Known or moderate malignant retinopathy
* Evidence of hepatic disease
* Evidence of renal impairment

Other protocol-defined exclusion criteria may apply.