cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Pilates in the Recovery of Post-prostatectomy Urinary Incontinence

The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in the recovery of urinary continence (UI) after radical prostatectomy.

There are no studies that evaluate Pilates mat exercises for incontinence in men although it can be assured that this method has the pelvic floor contractions as a principle for practice. If this new therapeutic approach proves to be as effective as described treatment in improving urinary complaints, it will be an option for patients who prefer a non-invasive treatment.

This randomized clinical trial includes 69 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. Urinary frequency, nocturia, 24-hour pad test, number of pads used per day, and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated.

The subjects were allocated in one of two treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training). Volunteers participated of 10 sessions of the corresponding treatment and were reassessed objectively by the number of pads used per day, and subjectively with the score of quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers between 50 and 75 years old;
* Submitted to radical prostatectomy;
* With complaints of urinary incontinence;
* That completed one month of surgery;

Exclusion Criteria:

* History of incontinence;
* Transurethral resection of the prostate;
* Diagnosis of neurological or cognitive impairment;
* Subjects who were unable to attend treatment sessions, due to distance or physical limitations.
An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer

The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) study. The total duration of study will be 3 weeks. The study consists of 2 periods and 4 visits: screening period (1 week; Visit 1) and treatment period (2 weeks; Visit 2, 3 and 4). During screening period at Visit 1, potential participants will receive previously administered oral opioid analgesic until the second visit and with immediate-release opioid analgesic whenever breakthrough pain is present. During treatment period, from second visit to the fourth visit, participants will receive the hydromorphone HCl OROS once daily for 2 weeks. At Investigator's discretion, participants completing 2 weeks of treatment with study drug could be enrolled into the extension phase of 12-weeks. The dose of study drug is flexible and will be increased or decreased based on the frequency of immediate-release opioid analgesic doses needed to manage pain. At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion tablet (oxycodone 10 milligram \[mg\] twice daily is equal to hydromorphone HCl 8 mg once daily). The Investigator will increase a participant's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Cancer participants administering only strong oral opioid analgesic for cancer pain control
* Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)
* Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators
* Abstinent or surgically sterile female participants

Exclusion Criteria:

* Participants with cancer pain who are potentially unresponsive to narcotic analgesics
* Participants with presence or history of drug or alcohol abuse within the past 6 months
* Participants with hypersensitivity to hydromorphone HCl
* Participants with history of colectomy (surgery to remove part or all of the colon)
* Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication
LoBAG30 Diet in Patients on Metformin

We will determine the metabolic response to a Low Biologically Available Glucose Diet (LoBAG30) in subjects currently receiving the maximum dose of metformin as monotherapy in whom the glycohemoglobin is not at an acceptable level (\>8.0%). Our hypothesis is that introduction of a LoBAG30 diet to subjects currently treated with a full therapeutic dose of metformin will improve blood glucose control in people who have not achieved an acceptable total glycohemoglobin on metformin alone.

Subjects will ingest a control diet (55% carbohydrate (CHO), 15% protein, 30% fat) or a LoBAG30 diet (30% CHO, 30% protein, 40% fat) in a parallel design with block randomization in pairs of two. Subjects will return to the study center twice each week while on the diets to have blood glucose, glycohemoglobin, lactate, weight and blood pressure measured, and to have urine assayed for urea and creatinine. At the beginning and end of the 5 week study period, the subjects will be admitted to the study center for 28 hours during which time blood will be drawn for 24 hour profiles of glucose, insulin, other hormones and several metabolites. For those subjects randomized to the LoBAG30 arm of the study, the control diet will be given during the first 24 hour study period; the assigned diet will be given at the end of the 5 week period.

Eligibility Criteria:
Inclusion Criteria:

* People with type 2 diabetes mellitus who currently are receiving the maximal dose of metformin monotherapy (2500 mg/day).
* These subjects will have had a stable glycohemoglobin (tGHb) in an unacceptably high range (8-11%) for at least 4 months prior to beginning the study.
* Subjects with tGHB \> 11% (HbA1c \> 10%) will not be recruited into the study.

Exclusion Criteria:

* Hematological abnormalities
* liver disease
* kidney disease
* macroalbuminuria (\>300 mg albumin/24 hours)
* untreated thyroid disease
* congestive heart failure
* angina
* life-threatening malignancies
* proliferative retinopathy
* severe diabetic neuropathy
* peripheral vascular disease
* serious psychological disorders
* a body mass index \> 35
* and a fasting triglyceride of \>400 mg/dl.

  * Subjects taking slow-release metformin will not be studied.
  * Subjects taking medications other than metformin, known to affect fuel metabolism such as:
* insulin
* the sulfonylureas
* glucagon-like peptide 1 (GLP-1) analogs and metabolic inhibitors
* pramlintide
* prednisone and similar steroids
* thyroid hormone
* antipsychotic medications
* thiazide diuretics
* medroxyprogesterone
* high dose aspirin, also will be excluded.

  * If concentrations of serum folate, B12 or iron are low, the subject will be excluded from the study until corrected, i.e. until normal concentrations are recorded.
Plant-based Nutrition for Patients With Cardiovascular Risk Factors

Plant-based nutrition may have positive effects on chronic diseases such as cardiovascular or metabolic disorders. This study investigates the effects of a 8 week plant-based diet for patients with metabolic syndrom and cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Blood pressure \> 140 mmHg systolic and/or \> 90 mmHg diastolic, in case of medication also increased values \> 140 mmHg systolic and/or \> 90 mmHg diastolic needed
* Adipositas with a waist circumference of \> 94 cm in men and \> 80 cm in women
* A non-vegetarian diet in the past 6 months (at least 4x meat and/or meat products per week, at least 5x dairy products per week)
* No fasting, no specific diet or change of diet in the last 2 months
* Weight stable over the last two months (+- 3 kg)
* Medication unchanged for at least one month
* No fasting, no change of diet in the last 2 months

Exclusion Criteria:

* Poor general condition
* Coronary heart disease
* Diabetes mellitus Type I
* Cerebrovascular diseases
* Severe mental illness
* Severe acute or chronic comorbidity
* Pregnancy and lactation or planned pregnancy in the next 6 months
* Eating disorder
* Max. 2 beers 0,5l or 2 wines 0,2l per day
* No alcohol abstinence 48 hours before blood samples possible
* Max. 5 cigarettes/day
* Medicine that affect weight
* Antibiotics within the last 6 months
* Major surgery \<6 months prior to randomization
* BMI \> 40 kg/m2
* Existing vegetarian or plant-based diet
* Bariatric surgery (obesity surgery)
* Simultaneous participation in another clinical trial
* Participation in a clinical trial within the last 3 months prior to inclusion in the study
* Lack of consent to participate in the study
Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. In addition, fitting the invasive frame and the need to travel to GammKnife centers often limit access to treatment in this population of elderly patients.

Linear accelerators have greatly improved their precision, now reaching that of GammaKnife. A possible alternative is therefore to treat patients on linear accelerators, without an invasive frame.

The objective of the FRACTHAL study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator.

The main hypothesis of the FRACTHAL study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.


Eligibility Criteria:
Inclusion Criteria:

* patient with disabling essential tremor, dystonic and / or parkinsonian in one or more limbs superiors ;
* patient contraindicated or refusing deep brain stimulation ;
* patient ≥ 18 years old,
* women of childbearing potential must take effective contraception ;
* signature of informed consent ; p- atients who benefited from contralateral thalami c stimulation can be included in the study

Exclusion Criteria:

* brain irradiation history ;
* contraindication or inability to perform injected MRI ;
* life expectancy \<12 months ;
* claustrophobic patient who cannot stand the radiotherapy mask ;
* abnormal anatomy of the thalamic region ;
* treatment with a trial drug within 30 days of entering the study ;
* presence of medical, psychological, social or geographic factors likely to modify the patient's compliance with the protocol under study or the monitoring or signing of the consent
Axium Coil in Completing Endovascular Aneurysm Surgery Study

The current observational evaluation is designed to evaluate the performance of the Axium™ MicroFx™ Detachable Coil System for the treatment of intracranial aneurysms in the real life practice.

Up to 25 patients from from US centers are anticipated to be enrolled for this evaluation. Published literature on coils with electrolytic, thermal or hydraulic detachment will serve as the basis for control comparisons to the Axium™ MicroFx™ Detachable Coil System for patients undergoing embolization of intracranial aneurysm. Comparison will be based on criteria evaluating the safety of the procedure, the reliability of detachment, the occlusion stability and the packing density impact.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of one or more intracranial aneurysm, either ruptured or unruptured.
* Information on data collection provided to the patient or legally authorized representative and signed informed consent.
* Aneurysm diameter ≤10mm
* Age range of 18 - 90.

Exclusion Criteria:

* Aneurysm previously treated.
* Aneurysm AVM related or dissecting.
* Participation in a clinical investigation of other aneurysm treating or related devices.
* Any condition that would preclude the conduct of protocol follow-up.
* Aneurysm anatomy that is determined inappropriate for Axium coil placement, prior to opening of an Axium coil.
Newborn Head Molding and Later Asymmetries

Prospective randomized clinical interventional trial after birth in maternity ward, and follow up to 8-9 years of age.

Hypothesis: Preventive handling and caring advices to parents of newborns decrease craniofacial asymmetries (deformational plagiocephaly and torticollis). The minimum sample size of the study was calculated at 86 (43 in each arm) using a 5% significance level, a power of 80% and a fall in the prevalence of DP from 31% to 8%. Craniofacial asymmetries and appearances of occlusal defects are followed up to 9 years. 50 preterm infants can participate without intervention.

The amount of craniofacial abnormal molding after birth in newborns and the frequency of plagiocephaly in infancy or later consequences of those in childhood are not known in finnish population. Head malposition and deformational plagiocephaly, however, have been linked to delayed development in early life and even much later to orthognathic problems demanding surgery in adulthood.

In this study parents with healthy newborns are randomized to have normal discharge home or discharged with extra advice information for caregivers; to charge both sided feeding and handling habits; to change regularly sleeping and lying positions; to have early tummy times.

Anthropometric measurements of the infants; tilting degrees of the head and rotations of the neck (range of movement =ROM) are taken at discharge home and at the age of 3 and 6 months, and 1, 3, 5-6 and 8-9 years. Two-dimensional digital photographs (upto the age of 6 months) and three-dimensional imaging (from the age of 3 months) are taken to measurements of the head shape (Cephalic index=CI and (approximate) Oblique Cranial Length Ratio= (a)OCLR measured using a semiautomated, computer-based method). The development quotient by Griffiths scales are assessed at the age of 3 and 6 months. Dental occlusal defect evaluation are started at the age of 3 ys.

Eligibility Criteria:
Inclusion Criteria:

* 1-6 days after birth;
* Healthy newborns in maternal ward, and living in near by Oulu region.
* Preterms at the age of 34-44 gestation weeks in near by Oulu region (non randomized)

Exclusion Criteria:

* Congenital anomalies,
* Very early discharge,
* Parental refusal
Learning Curve CUSUM of LV Ejection Fraction by Visual Estimation in Novice Practitioners

This retrospective, cross-sectional cohort study was conducted to investigate the novice practitioners' learning curve of visual estimation of LV ejection fraction (%) through a echocardiographic video files at the academic emergency department (ED) in tertiary urban hospital.

Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file. They received echocardiography interpretation skill training which included one hour of lecture. Twenty echocardiography videos files were provided during training session, they were instructed how to estimate EF by looking at the LV contractility without taking any measurement.

This procedure took less than 2 minutes in each case. An evaluation form was completed by each EP. EF is estimated qualitatively (Normal / Global hypokinesia), RWMA and quantitatively (%) by EP with echocardiographic certification(cardiologist). An each echocardiography has been performed with M7R® model ultrasound machine was reported by experienced echocardiographers as using MSM. The echocardiography results were reported blinded to our study.

A participant estimated the EF based on a complete assessment of LV wall motion including parasternal long-axis, short-axis, and apical four chamber view except for MSM.

And, participants wrote down EF(%) and a region of WMA as visual assessment and checked Normal wall motion or Global hypokinesia in EF reporting paper.

Eligibility Criteria:
Inclusion Criteria:

* EM residents who have no experience of echocardiography

Exclusion Criteria:

* They do not want to participate this study
Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol

To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients


Eligibility Criteria:
Inclusion Criteria:

* non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8
* mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg)

Exclusion Criteria:

* congestive heart failure
* azotemia
* insulin dependent diabetes
* liver insufficiency
* pregnancy
* cancer

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Acute Effects of Isoenergetic HIIE Vs. MICE on Key Parameters of Fat Mass Loss in Young Females with Overweight or Obesity

Overweight and obesity, particularly increased total and/or abdominal fat mass (FM), are strongly linked to the development of cardiovascular diseases. Managing obesity effectively requires lifestyle and dietary modifications, including increased physical activity. Among the various exercise strategies, Moderate-Intensity Continuous Training (MICT) and High-Intensity Interval Training (HIIT) are widely recommended for reducing FM. Compared to MICT, HIIT is a time-efficient approach, often perceived as more enjoyable, and has been shown to promote greater total and abdominal fat loss in a shorter period. However, the precise mechanisms underlying this enhanced fat loss remain unclear.

This study aims to compare the acute effects of two isoenergetic exercise sessions - MICE (Moderate-Intensity Continuous Exercise) and HIIE (High-Intensity Interval Exercise) - on key physiological responses involved in fat mass loss. Specifically, we will assess plasma catecholamine levels during exercise and recovery, as well as oxygen consumption, substrate oxidation, and appetite over the 2-hour post-exercise period in young females with overweight or obesity. By elucidating the role of catecholaminergic stimulation as a potential regulator of fat mass loss, this research could provide valuable insights for optimizing exercise strategies in weight management and metabolic health.


Eligibility Criteria:
Inclusion Criteria:

* women with overwieght or obesity (BMI: 25-35 kg/m²)

Exclusion Criteria:

* contraceptive use
* menopause
* irregular menstrual cycle
* medical contraindications to intense physical activity,
* painful joints,
* taking ß-blocker
Functional Outcome of Free Muscle Flaps Versus Free Skin Flaps for Post-traumatic Foot Plantar Surface Reconstruction

the investigators are trying to detect what is the best tissue constituent suitable for reconstruction of large post traumatic sof tissue defects of foot plantar surface


Eligibility Criteria:
Inclusion Criteria:

1. Posttraumatic large soft tissue defects of plantar surface requiring free tissue transfer for coverage
2. At any age

Exclusion Criteria:

1-defects that can be managed by local flaps 2-Non traumatic soft tissue defects

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The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment

Intrauterine devices (IUDs) are a highly effective form of reversible contraception with a less than 1% failure rate. They can be easily placed in the office and require little maintenance care. However, despite their benefits, pain during insertion remains a barrier for patient uptake. Currently there is no standard of care for pain management during IUD insertion. The aim of this study is to determine whether local anesthetic, in the form of injecting 1 percent lidocaine into the cervicovaginal junction, reduces pain during insertion. Participants will be randomly assigned to receive 1 percent lidocaine, placebo, or no injection. All patients presenting for IUD placement, regardless of indication, will be offered participation in the study. Following IUD placement, patients will be asked to rate their pain at key "pain points" during the procedure as the primary outcome. Other outcomes collected will include provider-related complications, length of time to place IUD, and overall patient and provider satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Any participant presenting for an IUD placement, either for contraception or treatment of abnormal uterine bleeding or to regulate menstrual periods
* All IUDs (copper, hormonal) eligible
* All parities of patients are eligible

Exclusion Criteria:

* Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
* Confirmed pregnancy
* Any diagnosed chronic pain conditions (fibromyalgia, vaginismus, interstitial cystitis)
* Misoprostol administration within 24 hours of enrollment
* Known contraindications to IUD placement
* Contraindication to lidocaine
* IUD exchange
* Previous unsuccessful attempt for IUD by the same practitioner