cyrilzakka/clinical-trials huggingface dataset:
A Trial of Transcutaneous Nerve Stimulation for OAB

Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

1. Female, \>18 years of age, with the clinical diagnosis of overactive bladder.
2. Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms.
3. Baseline patient perception of bladder condition score of 2 or higher.

Exclusion Criteria:

1. Current or previous percutaneous or sacral neuromodulation therapy
2. Stress predominant urinary incontinence
3. Newly added bladder medication or dose change with the last 2 months (Tamsulosin, Silodosin, Alfuzosin, Terazosin, Baclofen, Diazepam, amitriptyline, imipramine, DDAVP, tolterodine, oxybutynin, fesoterodine, darifenacin, solifenacin, trospium, mirabegron)
4. Intravesical botulinum toxin use within the last 1 year
5. Implanted pacemaker or defibrillator
6. History of epilepsy
7. Unable or unwilling to commit to study treatment schedule
8. Pregnant, or possible pregnancy planned for the duration of the study period
9. Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
10. Documented allergy to patch electrodes or their adhesive
11. Abnormal sensory function of the lower limb
12. Metallic implant within the lower limb
Effectiveness of Technology-based Interventions for the Improvement of Cognitive Processes in ADHD.

To scientifically demonstrate the improvements in cognitive functions and core symptoms of children and adolescents diagnosed with ADHD through the implementation of a cognitive rehabilitation program based on the use of the most relevant technologies found in the systematic review carried out during the first phase.

Two intervention groups will be randomly assigned for the study:

G1: composed of 20 patients who will receive neurocognitive therapy based on new technologies. This will be the experimental group.

G2: composed of 20 patients who will receive conventional neurocognitive therapy for ADHD treatment. This group will be the control group


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents diagnosed with ADHD
* Age: 6-17 years old

Exclusion Criteria:

* Children and adolescents diagnosed with ADHD + ADD.
* Age: under 6 years old or over 17 years old.
* Other psychopharmacological treatments not specific for ADHD.
Sensors for HEalth Recording and Physical Activity Monitoring

The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. However, two specific applications will be addressed, in which the partners have already acquired some expertise: the recognition and quantification of physical activity with energy expenditure estimation, and the assessment of walking ability in patients with obliterative vascular disease in the lower limbs. Another application concerns the monitoring of the practice of physical activity and some biological signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases). Despite various clinical contexts and health goals, a common approach will be developed.

To assess the SHERPAM Device (DS) by the continuous acquisition and transmission of data (accelerations, rotations, alterations in thoracic volume, heart rate, electrocardiogram) in a real life physical activity practice (subjects in their living environment and during their usual physical practices) using the DS's real-time communication tools, automatic data processing, and the DS's ability to produce information.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers Healthy active subjects aged 50 or over (ie without diagnosed disease, without chronic treatment) and recruited in the sports associations of Ille et Vilaine (cycle tourism clubs).

  * having benefited from an oral or written prescription of physical activity carried out by a health professional and applying this prescription daily in autonomy or in a sports club.

Common to all subjects

* physically active (adherent to a club or sports association or practicing independently according to the recommendations of their physician);
* practicing at least once a week;
* residence located less than 100 km return from Rennes University Hospital
* affiliate or beneficiary of a social protection scheme;
* having given his written consent

Exclusion Criteria:

Common to all subjects

* wearing a pacemaker or implanted cardiac defibrillator (precaution because using telemetry);
* participation in another research protocol;
* persons aver 18 yrs-old subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty;
* pregnant or nursing woman.
Evaluation Study for the Chef Anchor 3.0 Program

Objectives:

1. (Primary)To estimate the potential effects of the cooking program on the people with MCI/dementia and their informal caregivers;
2. To investigate if the potential effects can be maintained after the completion of the program.

Study design and participants:

A convenience sample of 68 pair older adults with MCI/dementia and their informal caregivers from the Chef Anchor 3.0 Programme will be referred to the research team. Overall, participants will be assigned to intervention group and waitlist control group in a ratio of 1:1. Allocation will take into account the participants' availability and the programme capacity. Assessors of outcomes and data analyst will be blinded throughout the whole study.

During the first 10 weeks, the intervention group will undergo the 10-week programme in the "Chef Anchor 3.0", while no activity for the waitlist control group. Then, from week 10 to 20, the waitlist control group will attend the same 10-week programme.

Measurements:

Main outcome measures for people with MCI/dementia will include confidence in cooking (Primary), cooking capability, satisfaction with autonomy in cooking, Satisfaction with meal choices, Worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family harmony and satisfaction, as well as self-rated health.

Outcome measures for informal caregivers will include confidence in care recipient' s cooking, worried about future cooking ability and meal choices of care recipient, caregiver burden, psychological well-being, family harmony and satisfaction, as well as self-rated health.

Other measures will include attendance rate, home practice rate, drop-out rate, programme satisfaction, and recommendation to others.

Hypotheses

1. The confidence in cooking, cooking capability, satisfaction with autonomy in cooking, satisfaction with meal choices, worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family satisfaction, and self-rated health of older adults with MCI/dementia would improve after the programme;
2. The confidence in care recipient's cooking, worried about future cooking ability and meal choices of care recipient, psychological well-being, family satisfaction, caregiver burden, and self-rated health of informal caregivers would improve after the programme;
3. The 10-week programme is acceptable for the most of older adults with MCI/dementia and their informal caregivers.


Eligibility Criteria:
Inclusion Criteria:

i. Aged 60 or above;

ii. Diagnosed by medical doctor has having MCI/dementia as reported by the older adults or their informal caregivers, or with reported subjective decline of cognitive function and with 5-min MoCA score ≤7th age- and education-specific percentile (Wong et al., 2015);

iii. Ability to follow simple instructions;

iv. Adequate physical strength to attend cooking workshops.

Exclusion Criteria:

i. Without caregiver
International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)

The study design consists of a cross-sectional survey on the clinical characteristics of patients with asthma and their level of asthma control and current quality of life, and on a prospective evaluation of the rate of switch from the uncontrolled/poorly controlled condition to the status of controlled asthma. Asthma control will be based on the Asthma Control Questionnaire scoring system, that has been fully validated for use in both clinical practice and clinical trials and has strong discriminative properties which means that it can detect small differences between patients with different levels of asthma control and it is very sensitive to within-patient change in asthma control over time.

Quality of life as a reflection of the control of the disease, will also be evaluated by means of the Mini Asthma Quality of Life Questionnaire scoring system.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

  1. Written informed consent obtained.
  2. Male or female adult (at least 18 years of age) patients with asthma diagnosed (according to GINA guidelines and confirmed by a chest physician) for at least 6 months.
  3. Patients in treatment with the same antiasthmatic drugs in the last 4 weeks before enrolment.
* Exclusion criteria:

  1. Patients enrolled in clinical trial in the previous 4 weeks or subjects already admitted in this study.
  2. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.
The Relation Between Constitutional Types and Indices of Tongue, Pulse,and Ausculative Diagnosis

This study aims to evaluate indices of tongue diagnosis, ausculative diagnosis, and pulse diagnosis in the determination of institutions.

Constitution differentiation is important for the prescription of Chinese medicines. In previous studies, researchers usually used constitutional questionnaires to determine constitutions.However, the importance of tongue diagnosis and pulse diagnosis remained unclear. The specific aim of this study is to evaluation indices of tongue diagnosis, auscultative diagnosis, and pulse diagnosis in the determination of constitutions. Meeting of specialists will determine the characteristics for each constitution first. This study plans to recruit 200 volunteers and determine their constitutions by constitutional questionnaires. Tongue manifestations and pulse pressure waveforms will be taken at the same time by standardized instruments. Relations between the indices and each constitution will be determined by multiple linear regression and logistic regression analysis. Then the percentage of importance of a specific index in a specific constitutional type could be determine.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers without aged older than 20 years old

Exclusion Criteria:

* Pregnant
* taking any medicine currently
* suffering for acute disease currently
A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®

The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma for at least 6 months
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one

Exclusion Criteria:

* Respiratory infection affecting asthma within 30 days prior to study
* Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
* Any significant disease or disorder that may jeopardize the safety of the patient
Effects of Different Assisted Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients

The aim of this study is to evaluate the effects in terms of gas exchange, respiratory mechanics and comfort of breathing, of different assisted mechanical ventilation in ALI/ARDS patients.

ALI/ARDS patients (during assisted ventilation) will be ventilated with different types of assisted ventilation (pressure support, pressure support plus sigh, BIPAP, variable ventilation) and gas exchange, comfort of breathing, respiratory mechanics and pattern of breathing will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ALI/ARDS

Exclusion Criteria:

* COPD patients
* Barotrauma
* Hemodynamic instability
* Age less than 18
Local Anesthetic Properties of Neosaxitoxin

The purpose of this study is to evaluate the local anesthetic properties of neosaxitoxin in humans

Neosaxitoxin is a phycotoxins that reversible block the voltage-gated sodium channels at neuronal level. Its activity is express as blocking the axonal conduction, stopping the propagation of the nerve impulse. The objective of the present work is to evaluate the neosaxitoxin efficacy and safety as local anesthetic in a human trial

Methods: Randomized, double-blind, placebo-controlled trial, with 10 healthy volunteers. The anesthetic effect will be evaluated using a standardized human sensory and pain model. TSA Neurosensory analyser and Von Frey Technique will be used to evaluate five parameters: sensory threshold for warm and cold, pain thresholds for heat and cold and mechanical touch perception threshold.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males with the abilities to understand and respond the tests to perform

Exclusion Criteria:

* Use of any oral analgesics at least ten days before the study
* Drugs abuse history
* Showing at the clinical examination any signal of psychiatric disorder
Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

This is a multicentre, multinational clinical study. It comprised two consecutive segments (A and B). Segment A was designed as a randomized, double-blind, double-dummy, active-controlled, two-arm parallel-group study. The patients received either budesonide or prednisone for 6 months. During segment B all patients received budesonide as an open treatment for additional 6 months.

In this confirmatory study the proportion of patients with complete response was compared between the two treatment groups. Complete response was defined as biochemical remission (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of segment A and lack of steroid specific side effects throughout segment A.


Eligibility Criteria:
Inclusion Criteria:

* age 10 to 70 years
* Diagnosis of acute AIH according to Alvarez score
* normal range of TPMT activity
* normal ACTH test
* negative pregnancy test at screening for females of childbearing potential
* written informed consent

Exclusion Criteria:

* presence of Hepatitis A, B, C, E or G virus infection
* liver cirrhosis or clinical signs of portal hypertension
* PBC
* PSC
* history of hypersensitivity to the study medication
Comparison of Ultrasonic Osteotome and Conventional Drill Osteotome

Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. In the present study, the investigators are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

Ultrasonic bone osteotome has been utilized in various surgical field, but the use in neurosurgery especially in spine surgery is not widely spread. The tissue selectivity of ultrasonic osteotomy may enhance operative time and reduce tissue trauma. Moreover, bony fusion rate may be increased because of low thermal injury to the bone. In the present study, we are going to compare bony fusion rate after cervical laminotomy either with ultrasonic osteotome or conventional drill.

Eligibility Criteria:
Inclusion Criteria:

1. cervical myelopathy at 3 or more levels due to spondylosis, congenital stenosis, or OPLL;
2. aged more than 20 years
3. with American Society of Anesthesiology physical status class 1 or 2

Exclusion Criteria:

1) concomitant neurological disease such as cerebral palsy or amyotrophic lateral sclerosis; 2) concurrent cancer or infection; 3) previous cervical spinal surgery; 4) a trauma-associated lesion; 5) inability to be followed up (i.e., foreign patients); 6) refusal to participate in the study
Pioglitazone and Losartan Provides Additional Renoprotection

Peroxisomal proliferator-activated receptor agonist pioglitazone and rosiglitazone are currently used in the treatment of type 2 diabetes, as efficient insulin sensitizers alone or in combination with insulin.angiotensin II receptor antagonist losartan reduced the levels of proteinuria.Whether Combination therapy with pioglitazone and losartan provides additional renoprotection in subjects with type 2 diabetic nephropathy,it's worth researching.


Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose (FPG) level of 3.3-9.0mmol/L
* 2h plasma glucose level of 7.5-13 mmol/L
* serum creatinine values between 190 and 660umol/L
* Two occasions of a ratio of urinary albumin to urinary creatinine≥300 or 24 hours urinary protein concentration is \>150mg
* Informed consent

Exclusion Criteria:

* Type1 diabetes or nondiabetic renal disease
* abnormal liver function
* heart dysfunction
Predictive Factors in Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia

Trigeminal neuralgia is one of the most common craniofacial neuralgias and one of the most severe types of facial pain, typically limited to the distribution of the trigeminal nerve. The first-line treatment for trigeminal neuralgia is medical therapy and primarily antiepileptic drugs. Various interventional and surgical methods can be used in patients who do not respond to medical treatment or who cannot tolerate side effects. Pulsed radiofrequency treatment of maxillary and mandibular nerves may provide longer-lasting pain relief in trigeminal neuralgia.This study aimed to investigate the clinical and demographic characteristics affecting treatment success in patients who underwent ultrasound-guided pulsed radiofrequency of the maxillary and/or mandibular nerves for trigeminal neuralgia.

Pulsed radiofrequency treatment applied to the maxillary and mandibular nerves, which are the peripheral branches of the trigeminal nerve, is frequently used in patients with trigeminal neuralgia who do not adequately respond to medical treatment.

Pain intensity was evaluated at baseline and 3 months after US-guided maxillary and/or mandibular nerve PRF treatment using NRS (numerical rating scale). The primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 3 months was defined as a positive categorical outcome.

In addition, demographic data such as age (years), gender, duration of pain (months), etiology (idiopathic or secondary), MRI findings (normal findings or abnormal findings due to conditions such as vascular compression and demyelinating plaque), pain side (unilateral or bilateral), and history of Gasser ganglion RF ablation were obtained from patient data. NRS scores before and 3 months after PRF were collected from the patient data and recorded. Pre-procedural cranial MRI and MR cisternography reports were accessed from patient records, and any abnormalities were recorded. We retrospectively analyzed the patient's electronic medical history records and the archive system containing the imaging results to obtain the variables.

The main aim of this study was to determine the clinical and demographic variables associated with treatment outcomes in patients with TN who underwent PRF of the maxillary and mandibular nerves. The secondary aim of this study was to determine the incidence of procedure-related adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of trigeminal neuralgia according to the IHS 3-beta criteria
* No response to conservative treatment for \> 3 months
* Magnetic resonance imaging within 1 year prior to injection
* Access to clinical data

Exclusion Criteria:

* Inadequate medical records with missing numerical rating scale (NRS) scores and MRI images
* Patients lost to follow-up within three months after the procedure
* History of surgery or gamma-knife radiosurgery for trigeminal neuralgia
* History of malignancy
Endovascular GSN Ablation in Subjects With HFpEF

The purpose of this study is to evaluate the safety and potential benefits of single-side block of a nerve that connects to the intestines, liver and spleen called the "greater splanchnic nerve" for the treatments of patients with symptomatic heart failure who have normal pumping of the heart. The study will be performed in patients whose heart failure is not responding well to standard treatments and remain symptomatic.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic heart failure
* Transthoracic echocardiographic evidence of diastolic dysfunction
* Ongoing stable GDMT HF management and management of potential comorbidities
* LVEF ≥50% in the past 3 months

Key Exclusion Criteria:

* Cardiac resynchronization therapy initiated within the past 6 months
* Advanced heart failure
* Admission for HF within the past 30 days
* Presence of significant valve disease
* Mean right atrial pressure (RAP) \>20mmHg during hemodynamic screening
Effect of Aging and Aerobic Fitness Level on Heat Dissipation

In the context of global aging, the health risk factors associated with exercising or working in the heat for aging population are exacerbated by the rising in global surface temperatures. The purpose of this investigation is to determine at what age the heat loss decrements occur and to examine if aerobic fitness level can affect the heat loss capacity in neutral environmental conditions.

All trials were conducted to indoor gyms with the same environmental temperature and relative humidity, 26 - 30oC and 40-50% respectively, to ensure no difference in body temperature were due to the external thermal stress. The participants were instructed to refrain from intense exercise as well as alcohol and caffeine consumption for 24 hours prior to experimental trial and to had a light meal 2h before their arrival.

Upon arrival, participants would have to wear running shoes, light and short running shorts and light cotton socks. Participants received comprehensive instructions about the shuttle run test and the whole process of measurements. Firstly participants answered the International Physical Activity Questionnaire (IPAQ). Thereafter, anthropometrics data (weight and height) were evaluated as well as the body temperature in external ear canal and axillary. All participants followed five minutes warming up and then performed to 20 m shuttle run test until their volitional limit. Once the participants could no longer run, the test was over and the number of laps was recorded. After the end of the shuttle run, were evaluated the body temperature and the weight of each participants. No fluids consumptions were permitted until the second weighing. They were weighed twice, at baseline and at the end of the running test with a precision weight scale (Kern DE 150K2D, KERN \& SOHN GmbH, Balingen, Germany).

Environmental data including air temperature and relative humidity were measured continuously using a portable weather station (LCD Digital Temperature \& Humidity Meter HTC-1). The weather station was placed 1 meter above the ground according to the manufacturer's guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children and adults

Exclusion Criteria:

* Diagnosed chronic medical condition;
* Symptoms of acute illness;
* Recent (past 4 weeks) usage of medications known to affect the circulatory system, the thyroid, the pituitary function, or the metabolic status