cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome

Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was reported at the congress of the "Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Perinéologie" (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder. Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated with subjective improvement of LUTD assessed with the Patient Global Impression of Improvement (PGI-I) in 5 of the 6 patients.

In view of the encouraging results of this pilot study, we hypothesize that TENS treatment may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and multisystem atrophy (MSA).

The principal objective is to compare the efficacy of transcutaneous electrical nerve stimulation of the posterior tibial nerve with placebo stimulation, applied 20 minutes daily for 3 months, in Lower Urinary Tract Disorders (LUTD) in patients with Parkinson's disease or multisystem atrophy, evaluated using the PGI-I (Patient Global Impression of improvement) tool.

The secondary objectives are to compare the efficacy of TENS with placebo stimulation on change before/after 3 months of treatment on:

* the intensity of urinary symptoms, evaluated using the Patient Global Impression of Severity (PGI-S) scale
* the number of voidings in 24 hours, number of episodes of urinary incontinence in 24 hours and maximum bladder capacity, evaluated by a voiding diary over 3 days
* urinary symptoms, evaluated with the urinary symptom profile (USP) questionnaire
* quality of life, assessed by the Qualiveen-SF® questionnaire
* post-void residual volume measured by bladder ultrasound and effect on the development of infectious complications, by comparing the number of urinary infections over 3 months in each group.

Lastly, the safety of TENS will be compared with that of placebo stimulation by the occurrence of adverse events during the 3 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of Parkinson disease or multisystem atrophy
* Refractory lower urinary tract disorders or contra-indications or intolerance to the usual oral treatments
* Patient capable of completing the questionnaires
* Patient whose written informed consent has been obtained
* Patient registered with a social security scheme

Exclusion Criteria:

* Pregnancy and breast-feeding
* Contra-indications to TENS (local skin problems, metal ankle joint replacement, cardiac pacemaker, peripheral neuropathy, subthalamic deep brain stimulation)
* Associated neurological disorders (stroke, dementia, multiple sclerosis, spinal cord lesions, peripheral neuropathy) or urological disorders (bladder outlet obstruction, cancer, pelvic organ prolapse, interstitial cystitis)
* Unilateral neurological disability
* Legally incompetent patient, patient under legal protection
* Participation in another study during the present study
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD

Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Gastric SET up to 15 mm (measurement: endoscopic ultrasound)

Exclusion Criteria:

* Age \< 18 years
* Gastric SET \> 15 mm and/or large extramural part
* Criteria of Lipoma (endoscopic ultrasound)
* Positive lymph nodes (endoscopic ultrasound)
* Stenosis (Esophagus)
* Diverticulum (Esophagus)
* Pregnancy or Nursing period
The Effect of Carvedilol VS Endoscopic Therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding

To compare the efficacy and safety of Carvedilol and endoscopic therapy in Primary Prophylaxis of High-risk Esophageal Gastric Variceal Bleeding.

The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the endoscopy group. Treatment allocation is by block randomization, with an two-to-one ratio for Carvedilol and endoscopy. The results are concealed in opaque envelopes. The dose of Carvedilol is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d. Patients receiving endoscopic therapy every 4 weeks until eradication of varices. Patients will come for clinic visit every 6 months, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* the presence of severe esophageal and gastric varices at upper gastrointestinal endoscopy without a previous haemorrhage
* a diagnosis of liver cirrhosis based on histology, clinical or imaging manifestation

Exclusion Criteria:

* age greater than 80 years old or younger than 18 years old
* non-cirrhotic portal hypertension
* contraindications to NSBB including bronchospasm, severe bradycardia, severe heart failure, acute pulmonary edema, atrioventricular block and so on
* ABPsys less than 95 mmHg or HR less than 50 bpm
* prior treatment for prevention of bleeding from EGV
* presence of spontaneous bacterial peritonitis or other severe infections
* presence of hepatorenal syndrome
* uncontrolled hepatic encephalopathy
* presence of refractory ascites
* pregnancy
* presence of portosystemic shunt or portal cavernous transformation
* refusal to participate in the study
Drug Use Investigation for AVOLVE(BPH)

The study is designed to investigate the safety and efficacy of dutasteride capsules 0.5 mg collected from the required number of Japanese subjects with benign prostatic hyperplasia (BPH) in order to identify concerns or problems, if any, about the efficacy and safety of its use at post-marketing clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Must be male subjects
* Use dutasteride capsules for the first time

Exclusion Criteria:

* Subjects who is hypersensitivity to dutasteride or 5α reductase inhibitor
* Subjects with severe hepatic function disorder
* Dutasteride capsules shall not be used to female or child
Interaction of Apelin and Angiotensin in the Human Forearm Circulation

The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Apelin has the ability to cause blood vessels to relax, increasing their diameter and hence blood flow down the blood vessel. The researchers wish to investigate the hypothesis that an infusion of apelin will reduce the effects of angiotensin II, which is know to reduce the diameter of blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Healthy volunteers

Exclusion Criteria:

* Lack of informed consent
* Age \< 18 years,
* Current involvement in other research studies,
* Systolic blood pressure \>190 mmHg or \<100 mmHg
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co morbidity
* Women of childbearing potential.
* Any regular medication

  * Previous history of any cardiovascular disease
Using Simulation to Ensure Basic Competence in Gastroscopy

The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Medical students enrolled at the University of Southern Denmark who have passed their anatomy exam.
* Experienced endoscopy nurses, who have assisted to more than 100 gastroscopies and with no prior self-performed gastroscopies.
* Experienced medical doctors in medical gastroenterology or surgery, who have self-performed more than 500 gastroscopies.

Exclusion Criteria:

* None
Food and Crohn's Exacerbation Study (FACES)

The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have an established diagnosis of CD.
2. All patients must be in clinical remission at the time of entry into the study. Remission is defined as an aCDAI of less than 150.

Exclusion Criteria:

Inflammatory bowel disease (IBD) unspecified / Indeterminate colitis

Total or sub-total colectomy, ileostomy, or colostomy

Unable to read and speak English

No internet access

Steroids other than budesonide ≤6mg/day with the prior two weeks

Perianal fistula or abscess with more than scant drainage

Age less than 18 years

Pregnant or breastfeeding women

Unwilling to follow the study diet
InveStigAting Bladder fiELd-cycLing imAging

The goal of this pilot study is explore the parameters that can be obtained in bladder tumours by Field-Cycling Imaging (FCI) in patients with both muscle-invasive and non-muscle invasive tumours. The main question it aims to answer is if FCI can give more diagnostic information than conventional tests.

Participants will have one FCI scan and the results will be correlated with the results of CT urogram or CT scan.

Patients with organ-confined muscle invasive bladder cancer are treated either by removal of their bladder at cystectomy or by organ-preserving treatment, generally following neoadjuvant chemotherapy. In some cases, the neoadjuvant chemotherapy can shrink the tumour so that it is clinically undetectable but there may still be tumour cells present microscopically. This presents a difficulty during planning of radiotherapy treatments, which could then miss the tumour and lead to tumour recurrence.

Field-Cycling Imaging (FCI) is an emerging imaging technology pioneered at the University of Aberdeen. FCI can image human tissues non-invasively over a wide range of magnetic field strengths, directly informing on multi-scale tissue structure from nanometres to micrometres. FCI has already shown significant potential for enhanced diagnosis in a range of diseases, and recent results show several potential biomarkers of cancer in breast, colon, and brain.

FCI has not been used in bladder cancer before. In this proof-of-concept study, we will recruit patients with both muscle-invasive and non-muscle invasive tumours to explore the parameters that can be obtained in bladder tumours by FCI. Results of the FCI scans will be correlated with the results of CT urogram or CT scan.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending for flexible cystoscopy found to have a tumour of at least 3 cm in diameter (muscle-invasive or non-muscle invasive)
* Participants must be aged 18 and above
* Participants who meet the safety criteria for undergoing an MRI scan
* Participants who are able to fit inside the scanner
* Participants must be able to give fully informed consent
* Participants must be mobile enough to be positioned onto the FCI scanner couch

Exclusion Criteria:

* Patients with total hip replacement
* MRI-incompatible conditions, as detected in the MRI safety screening sheet
* Participants under 18 years old
* Participants who are unable to communicate in English
* Participants who are unable to give fully informed consent
* Women who are pregnant
* Restrictions to mobility that would prevent the correct positioning in the scanner
* Participants who suffer from claustrophobia
Mucins and Toll-like Receptors in Asthma

This study raises two main hypotheses: 1) Asthmatics patients who present with bronchial hypersecretion differ phenotypically from asthmatic patients without hypersecretion and 2) mucins in asthmatic patients with hypersecretion of bronchial mucus and the expression of TLRs differ from non-mucus hypersecretory asthmatics patients.

Asthma with bronchial hypersecretion is a type of asthma poorly studied. Its pathogenesis is not well understood but probably is related to the innate impaired immunity, particularly with "toll-like receptors" (TLR) and secretory mucin (MUC).

Objectives 1) Define the clinical and inflammatory phenotype of asthma with bronchial hypersecretion of mucus. 2) Compare the type of mucin present in induced sputum (IS) of patients with and without bronchial hypersecretion. 3) Determine the expression of TLRs in the IS and in the peripheral blood of asthmatics with and without bronchial hypersecretion.

Method: Cross-sectional study which included 43 asthmatic patients, 19 with and 24 without bronchial hypersecretion. All patients underwent the following: IS, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins (MUC2, MUC5AC, MUC5B and MUC1) was determined by ELISA and expression of TLR2 and TLR4 by flow cytometry. The level of asthma control was determined by the asthma control test questionnaire (ACT) and quality of life was assessed by the MiniAQLQ questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Non-smokers, asthma diagnosed as per the Global INitiative for Asthma (GINA) criteria on maintenance treatment for asthma, aged 18 to 80 years.

Exclusion Criteria:

* Patients were excluded from the study if they had a respiratory tract infection and/or required the use of oral corticosteroids within 30 days prior to inclusion; if they had a concomitant disease (sarcoidosis, lung cancer, pulmonary tuberculosis, bronchiectasis, nephropathy, rheumatic or liver disease); significant comorbidity that could affect the study results in the physician's judgment; or a cognitive impairment that could limit their comprehension of the subject under study or their ability to participate
Effect of Upper Third Molar Extraction on Distalization Carriere Motion Appliance :A Prospective Clinical Study

This clinical study will be directed to compare the effect of presence or absence of third molar on distalization of the upper posterior segment by using carriere motion appliance


Eligibility Criteria:
Inclusion Criteria:

1. Angle´s Class II canine relationship, at least half-unit.
2. Skeletal Class I or mild Class II relationship.
3. Upper second molars were fully erupted before starting distalization.
4. Normal or horizontal growth pattern.
5. Good oral hygiene.
6. Absence of any systemic diseases

Exclusion Criteria:

Previous orthodontic treatment. 2. Patients who required surgery to correct skeletal discrepancies (sever skeletal class11).

3. Patients with hyperdontia, hypodontia, or syndromic diseases. 4. Extraction or badly destructed teeth in upper arch

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GliaSite 1-3 Mets Study

This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.

Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery

Eligibility Criteria:
Inclusion Criteria:

* Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan
* Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report
* Have a Karnofsky Performance Status (KPS) \>=70
* Have systemic disease which is judged to be stable and has been staged within the last 6 weeks
* Have a life expectancy of \>= 6 month, based upon extent of systemic disease
* Be at least 18 years of age Give informed consent (or have legal representative give informed consent)

Exclusion Criteria:

* Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor.
* Be receiving or have plans to receive external beam radiation therapy to the brain.
* Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis.
* Be pregnant or breast-feeding.
* Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia.
* Have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy.
* Have histology of lymphoma or small-cell lung cancer.
Body Temperature and Perioperative Bleeding in Adolescent Idiopathic Scoliosis Surgery

In this study, patient groups in which normothermia is preserved by using multiple active warming methods in the intraoperative period in AIS surgery, followed by a single compressed air blowing system and allowed mild to moderate hypothermia were compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 12-18 who were evaluated as ASI by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents

Exclusion Criteria:

* Patients with body weight \<35kg, morbid obesity (BMI\> 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate
Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study

Recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life. The impaired emotional status is also related to the recurrence of the events, closing a negative cycle for the evolution of the disease. This study aims to evaluate the effect of psychotherapy on the quality of life and in the number of syncope and pre-syncope events during one year of follow-up of patients with recurrent vasovagal syncope.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months)
* Signed Free and Informed Consent Form

Exclusion Criteria:

* Severe comorbidity with life expectancy \<1 year
* Age \<18 years
* Current psychotherapeutic follow-up
* Cardiac or neurological syncope
* Pregnancy
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients

Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by isolated low platelet counts. The aim of treating patients with ITP is to increase the platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy and safety of Ig NextGen 10% in adult patients with ITP.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of ITP
* platelet count of \<50 X 10\^9

Exclusion Criteria:

* planned splenectomy
* previous non-responders to IVIg treatment
* known or suspected hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy
* patients who have received treatment with:

  1. IVIg or anti-D immunoglobulin
  2. immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
  3. patients who have received IV administration of steroids OR have had a change of oral corticosteroid treatment OR danazol within 15 days prior to first day of study drug administration.
Feasibility Trial of the Early Psychological Support for the Critically Ill

This is a pilot study designed to test feasibility of a psychotherapeutic intervention for the critically ill patients in intensive care units. Intervention is named Early Psychological Support for the Critically Ill (EPSCI)


Eligibility Criteria:
critically ill adults admitted to the medical intensive care unit (ICU) and expected to stay \>48 hours

Inclusion criteria:

-mechanically ventilated patients receiving vasopressors

Exclusion criteria:

* history of dementia
* mental retardation
* suicide attempt
* psychotic disorders such as schizophrenia
* patients on comfort care non-English speaking.
Fundus Image-guided Focal Electroretinography, Usability Study

The purpose of this study is to investigate the usability of fundus image-guided focal electroretinography device with healthy subjects and with macular edema and macular degeneration patients.

In this study, we will study the usability of focal electroretinography device combined with slit lamp biomicroscope. The device allows simultaneous fundus imaging and focal ERG recording from the desired retinal area.

In phase I, the usability of the investigational device is tested with 10 healthy volunteers. The examinations include focal ERG and noise tests with commercial ERG electrodes. The stimulus lights are guided to the fundus using either non-contact of contact fundus lens. One electrode is selected for phase II based on signal-to-noise ration, usability, and comfort.

In phase II, fundus image-guided focal ERG recordings are conducted with total of 10 patients having either macular edema or macular degeneration. The aim of the phase II is to test whether the investigational device can be used to record focal ERG signal from the desired symptomatic retinal area.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with no signs of macular edema or macular degeneration (phase I)
* Patients with either macular edema or macular degeneration (phase II)
* Able to give informed consent

Exclusion Criteria:

* Epileptic patients
* Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.