cyrilzakka/clinical-trials huggingface dataset:
Surface Stimulation for Female Sexual Dysfunction

Female sexual dysfunction, including sexual arousal disorder, has a significant clinical impact, affecting millions of women in the United States alone. Peripheral nerve stimulation, such as posterior tibial nerve stimulation (PTNS) and dorsal genital nerve stimulation (DGNS) can modulate neural circuits for bladder and fecal continence. The investigators hypothesize that periodic DGNS and PTNS will modulate autonomic neural circuits and promote improvements in sexual function in women with sexual arousal disorder. Subjects will be randomized to receive one of the stimulation approaches. Subjects will have weekly 30-minute sessions across twelve weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult women ≥ 18 years of age
* Sexually active ≥ 1 time per month (≥ 2 times per month preferred)
* Score of 19 or less on a 6-question set of the Female Sexual Function Index (FSFI) survey
* Neurologically stable
* Ambulatory
* Capable of giving informed consent
* English speaking
* Capable and willing to follow study procedures

Exclusion Criteria:

* Men
* Women ≤ 17 years of age
* Pregnant or planning to get pregnant during the study period
* Clinically diagnosed neurological bladder dysfunction
* Prior experience with PTNS or DGNS
* Current use of transcutaneous electrical nerve stimulation (TENS) on pelvis, back, or legs
* Implanted pacemaker, defibrillator, spinal cord stimulator, or sacral root stimulator
* Taking flibanserin
* Taking any investigational drug
* History of neurologic diseases or impairments
* Any other factors that the investigators feel would place the patient at increased risk from this study
Meal-induced Thrombin Generation Before and After Gastric Bypass

The purpose of this study is to investigate harmful effects of intentional weight loss. Intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. Postprandial coagulation activation, including thrombin generation, is a potential mechanism after high-fat meals. Thirty obese patients admitted to gastric bypass will be included in a randomized, cross-over clinical trial. All patients will consume a high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven days apart). This cross-over study will be carried out before weight loss, during lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass. Fasting and postprandial blood samples are collected on each study days, while one fecal sample is collected for each study period. The study will contribute to our understanding of mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in relation to intentional weight loss programs must be modified.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for gastric bypass surgery

Exclusion Criteria:

* Use of anticoagulants, platelet inhibitors and oral contraceptives
* Known liver diseases, any malignant disorders, or known coagulation diseases
HCV Epidemiological Survey in China Rural Area

The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese population.

Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million patients. More importantly, many of those patients with chronic hepatitis C eventually develop cirrhosis and hepatocellular carcinoma(HCC).Our survey found the rate of hepatitis c infection in northeastern China without intervention is 34.3%, due to the abuse of caffeine sodium benzoate. This population has the similar mode of transmission, which is a fine study of the natural outcome hepatitis C. We plan to carry out epidemiological studies for this population, review of the influencing factors of the disease, and analyze the host factors that can effect the prognosis.

Eligibility Criteria:
Inclusion Criteria:

* aged from 20 to 65

Exclusion Criteria:

* Has history of decompensated liver diseases
* Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
* Has a history of autoimmune hepatitis
* History of a severe seizure disorder or current anticonvulsant use
* History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated
* History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts

The purpose of this study is to evaluate the healing of split thickness skin grafts when treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.


Eligibility Criteria:
Inclusion Criteria:

* Partial of full thickness burns requiring split thickness grafts
* Target burn wound size 10cm2-1000cm2
* Age ≥ 18 years
* Ability to read, write and speak German.
* Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent approved by the Institutional Ethics Committee (IEC) prior to all evaluations. Informed consent will be obtained from the patient or by a legal representative if the patient is not able/competent to consent. In this case, informed consent will be also obtained by the patient when he/she regains competence.
* Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e. g. oral contraceptive, IUD, intra-muscular contraceptive, abstinence).

Exclusion Criteria:

* Target wound has exposed hyaline cartilage
* Connective tissue disorder
* Previous skin graft failure at target wound site
* Total burn surface area ≥ 70%
* Infected target wound
* Immunosuppression therapy
* Chronic hemodialysis
* Steroid use
* Diabetes (Type I)
* Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X
* Allergy or sensitivity to chlorhexidine
* Pregnancy
* Simultaneous participation in another clinical trial
Memantine and Intensive Speech-Language Therapy in Aphasia

* Aphasia, the loss or impairment of language caused by brain damage, is one of the most devastating cognitive impairments of stroke. Aphasia can be treated with combination of speech-language therapy and drugs. Conventional speech-language therapy in chronic aphasic subjects is of little help and several drugs have been studied with limited success. Therefore other therapeutic strategies are warranted.
* Recent data suggest that drugs (memantine) acting on the brain chemical glutamate may help the recovery of cognitive deficits, included language, in subjects with vascular dementia. The present study examines the safety profile and efficacy of memantine paired with intensive language therapy in subjects with stroke-related chronic aphasia (more than 1 yr. of evolution).

* The efficacy of drugs that act on glutamate such as the N-methyl-D-aspartic acid (NMDA) receptor antagonist memantine requires to be explored in this population. The rationale for using memantine in post-stroke aphasia comes from recent studies on vascular dementia. Data extracted from a recent Cochrane review of randomized controlled trials of memantine in different types of dementia (vascular dementia, Alzheimer's disease, mixed dementia) reveal, after 6 weeks of treatment, beneficial effects on cognition (including language), activities of daily living, behavior and global scales as well as in the global impression of change.
* Recovery from aphasia is possible even in severe cases. While speech-language therapy remains as the mainstay treatment of aphasia, its effectiveness has not been conclusively proved. This has motivated the planning of more rational therapies (e.g., constraint-induced language therapy \[Pulvermüller et al., 2001; 32: 1621-1626\]).
* In addition, the neural correlates of improvement of language function can now be readily detectable with event-related potentials. This is a noninvasive technique that can detect in real time functional brain changes during recovery promoted by the combined action of memantine and constraint-induced language therapy.
* The aim of the present study is to assess the efficacy, safety profile, and functional correlates of memantine paired with massed language therapy in a sample of patients with chronic poststroke aphasia.

Eligibility Criteria:
Inclusion Criteria:

* Chronic aphasia of more than one year duration
* Must be able to complete protocol

Exclusion Criteria:

* Dementia
* Major psychiatric illness
* Severe global aphasia (precludes participation in constraint-induced language therapy)
Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Patients With Amyotrophic Lateral Sclerosis

The goal of this study is to investigate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells administration in the individuals with diagnosed amyotrophic lateral sclerosis.

Amyotrophic lateral sclerosis (ALS) is one of the progressive neurodegenerative disorders, affecting upper and lower motor neurons in the cerebral cortex, brainstem and spinal cord. Hence, the signs of damage motor neurons are both at the peripheral (eg. atrophy), and central (eg. spasticity) level. There is no effective treatment for ALS and the majority of patients die within 5 years after diagnosis, usually due to respiratory failure. Numerous studies on murine models revealed that mesenchymal stem cells (MSCs) successfully improve the clinical and pathological features of ALS. The goal of this nonrandomized, open label study is to investigate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cell transplantation into the individuals with diagnosed amyotrophic lateral sclerosis. This clinical trial is conducted to test the therapeutic (neuroprotective and paracrine) effect of autologous bone marrow-derived mesenchymal stem cells (BM-MSCs). All patients enrolled will have a documented history of ALS disease prior to study enrollment. Patients are recruited for a clinical trial not longer than 1 year from disease diagnosis. Then, patients are divided into two groups: Group I - patients receiving intrathecally one application of BM-MSCs and Group II - patients receiving intrathecally three applications (each administration every two months) of BM-MSCs. Subsequently, autologous bone marrow-derived mesenchymal stem cell transplantation to the cerebrospinal fluid at the site of the spinal cord will be performed. Finally, treatment safety, adverse events and exploratory parameters, including electromyographic (EMG) studies, forced vital capacity (FVC) and functional rating scale (FRS) to establish ALS progression rate will be recorded throughout the duration and in the post-treatment follow up period.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of the ALS disease before the cell transplantation (diagnose established following the El Escorial criteria for definite ALS)
* good understanding of the protocol and willingness to consent
* signed informed consent
* disease duration: up to 2 years
* FVC \> 50% / pulmonologist certificate about respiratory function of the patient

Exclusion Criteria:

* cancer,
* autoimmune diseases
* renal failure,
* subject is a respiratory dependent.
* subject unwilling or unable to comply with the requirements of the protocol
* pregnancy, breastfeeding
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants

Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of "cottage cheese" or an orange peel. Rapid Acoustic Pulse (RAP) is an electrohydraulic (EH) device developed to improve the appearance of cellulite through microscopic disruption of the connection between the skin and underlying tissue leading to a reduction in the severity of dimples and ridges. The purpose of this study is to assess adverse events and effectiveness of RAP in adults seeking treatment of cellulite.

RAP is an FDA approved device for the short-term improvement in the appearance of cellulite in the buttocks and thighs. Participants 18-50 years of age seeking treatment of cellulite will be enrolled. Up to 15 participants will be enrolled in the study at 1 site in the United States.

Participants will receive 3 separate cellulite treatment sessions. Each treatment session will consist of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides. The study duration is up to 72 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Participants seeking treatment of cellulite in the thigh and/or buttock areas.
* Areas of moderate to severe cellulite on bilateral thigh and/or buttock using the Cellulite Dimple - At Rest Scale at Baseline with grades of 2 or 3 based on review of photos taken under the same lightening conditions planned for the trial.
* Participant will not have had invasive or energy-based cellulite (liposuction, subcision, RF, laser, ESWT, cryo-lipolysis, muscle stimulation, etc.) treatments in the treatment areas in the prior 12 months.
* Participant will not have used topical based cellulite treatments for prior 3 months and will not use during the trial
* Participant will not have used spray-on tanning treatments for 3 months prior to or during the term of the trial.

Exclusion Criteria:

* Metal or plastic implants (vascular stent, or implants in the hips, knees, etc.) in the treatment areas.
* Active electronic implants such as pacemakers, defibrillators
* History of coagulopathy and/or on anticoagulant medication
* Skin disorders (skin infections or rashes, psoriasis, etc.) in the treatment areas.
* Medical disorder that would hinder wound healing or immune response.
* Any surgical procedure in the treatment areas in the prior 3 months or planned during the duration of the study.
* Any other condition/disease/situation which, as deemed by the PI, would preclude participant from safely participating in or completing the study visits or that may confound study results.
SMART Program for Paroxysmal Atrial Fibrillation

This is a pilot study to test the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on quality of life, mental health, arrhythmia burden, and heart rate variability (HRV) in patients with paroxysmal atrial fibrillation (PAF).

Mind-body practices that elicit the relaxation response (RR) have been used worldwide to prevent and treat disease. The Stress Management and Resiliency Training - Relaxation Response Resiliency Program (SMART-3RP) is an 8-week manualized psycho-educational program that incorporates RR methods such as meditation or seated yoga along with cognitive skills building and lifestyle approaches to increase resiliency to stress. This study will use a randomized, wait-list controlled trial design to test the effects of the SMART-3RP on quality of life (QoL), mental health, arrhythmia burden, and HRV in patients with PAF. The program will be delivered virtually (via computer video conferencing), questionnaires will be completed, and physiological data as well as blood will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with documented recurrent symptomatic PAF.
* Currently on stable medical therapy for AF and willing to continue on the same treatment regimen while participating in the study.
* No current daily practice of yoga, meditation, guided imagery or other techniques that elicit the RR.
* Able to provide informed consent and to understand written and spoken English.

Exclusion Criteria:

* Allergy to adhesives that prevents wearing the HRV monitor.
* Patients unable or unwilling to participate in an intervention delivered via video conferencing.
* End Stage renal failure or heart failure, severe unstable medical or psychiatric disease.
* Patients deemed unable to complete protocol due to cognitive or other reasons.
* Patients on psychoactive medications will have eligibility determined by the PI or MD co-investigator on a case-by-case basis, and will be admitted to the study if medication is deemed stable
Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire

There is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.

Balance disorders are the most common cause of dizziness in children with a prevalence of 0.7 to 15%. Vestibular migraine, benign paroxysmal positional vertigo of the child, post-concussion dizziness as a result of cranial trauma, and viral vestibular neuritis are the most common causes. However, these disorders are often undiagnosed in children as many doctors may attribute these symptoms to behavioural disorders or clumsiness. This is probably because of the difficulty children may have in expressing or describing their dizziness symptoms without specific questioning, but also because of the tendency of children to accept the terminology that an adult offers them or even tend to cling to their parents when they experience a balance disorder or vertigo. Vestibular disorders can also have secondary psychological symptoms with an impact on school learning and quality of life. A precise interrogation to check the symptoms, to look for the triggers and to trace the installation of the symptoms is fundamental to diagnose and make a therapeutic decision. Thus, it is very important to help the child express his or her feelings by proposing different descriptions and formulations to determine the etiology and diagnosis. While a number of international questionnaires validated and translated into French exist in the adult to assess the presence, severity and impact of vestibular symptoms, there is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Non-opposition of the holders of parental authority and the subject to participation in the study
* Subjects between 7 and 17 years of age
* Patients : patients followed in the clinic at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery and presenting with dizziness without associated ophthalmological or neurological disorder.
* Controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background.

Exclusion Criteria:

- Absence of diagnosis after etiological assessment.
The Management of Systemic-Pulmonary Collateral Blood Flow in Cyanotic Children During Cardiopulmonary Bypass - Pilot Study

The purpose of the study is to determine whether it is possible to manage the flow of blood through blood vessels using varying levels of carbon dioxide during cardiac surgery, and what effect this has on how well the major organs of the body work.

A great number of studies have shown that MAPCAs are a real issue for these patients, who require far higher blood flows than previously suggested. However, the optimal method of CPB is still unknown. Recent research by Sakamoto et al., showed that a raised carbon dioxide (pCO2) increased brain blood flow in cyanotic patients, suggesting a noticeable decrease in aorto-pulmonary blood shunting. However, the mechanism of this action is not understood and it is unclear if this observation is an associated or causative one. Whilst the vasoconstrictive (narrowing of vessels) effect of hypoxia has been well documented, with and without high carbon dioxide, there are no reports indicating that pCO2 alone increases the narrowing of blood vessels in the lung. We hypothesize that a rise in pCO2 could cause a shift in blood flow from pulmonary to systemic circulation, either through direct constricting action on MAPCA vessels, or through a vasoconstriction of blood vessels in the lung. Furthermore, we predict the phenomenon could potentially be used to optimize the method of treatment, ensuring that vital organs receive the correct amount of blood flow during the surgical correction of these rare congenital heart diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose parents/guardians are willing and able to provide written informed consent for participation in the study
* Patients undergoing elective TCPC surgery
* MRI proven presence of MAPCA vessels
* Patients between 1 day and 5 years of age

Exclusion Criteria:

* Emergency surgery
* Documented history of cognitive impairment (may have an effect on biochemical markers of cerebral injury)
* Documented history of major organ dysfunction
Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care

Participants (patients and volunteers) will be recruited to have their blood pressure measured by standard blood pressure assessment methods while having their face video recorded. The data collected will help improve the blood pressure measurement accuracy of Transdermal Optical Imaging, which relies on machine learning to extract physiological information from videos recorded.

There are many ways to measure blood pressure (monitors, mercury sphygmomanometer, aneroid devices), with most relying on a cuff-inflation. Transdermal Optical Imaging measures blood pressure using a video captured by any conventional camera (e.g., those on a phone, tablet, laptop) and advanced machine learning algorithms.

The current study aims to improve the accuracy of Transdermal Optical Imaging algorithms for measuring blood pressure. The investigators will recruit participants (patients with medical problems and healthy volunteers) to have their blood pressure measured in various ways (e.g.,by registered nurses with sphygmomanometer and stethoscope, continuous blood pressure monitor, etc.). Further, participants will have their faces video-recorded intermittently between standard measurements or at the same time as standard measures.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).

Exclusion Criteria:

* No exclusion criteria